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Bulletin Publishing Group is a division of OTC Publications Ltd Registered Office: 4 Poplar Road, Dorridge, Solihull B93 8DB, UK. Registered in England No 2765878 OTC23-08-13p1_OTC15/11/2005 p1&24 20/08/2013 17:01 Page 1

23 August 2013

COMPANY NEWS 2 Stada Arzneimittel adds Perrigo expects big gains 2 from launches Perrigo to pay US$8.6bn 3 to acquire Ireland’s Elan Thornton & Ross in UK Sanofi “very confident” in OTC 4 Merck&Co backs Consumer Care 5 tada Arzneimittel has expanded the reach deals that would help it reach £100 million in China holds back OTC growth at GSK 6 Sof its Branded Products business in the sales before its centenary year in 2022. Return of big rival brands 7 UK by acquiring OTC company Thornton Speaking to OTC bulletin earlier this year, impacts sales at Prestige & Ross for £221 million (C259 million). the company’s chief executive officer Dieno Merck KGaA pleased with Consumer 8 The German firm completed the deal shortly George said that the firm had enjoyed 11 years New Chapter lifts P&G’s 9 after it announced that it had entered exclusive of continuous sales growth (OTC bulletin,31 Personal Health Care unit talks to buy the family-owned company. May 2013, page 24). International expansiondrives Taisho 10 Based in Huddersfield, Thornton & Ross “Turnoverwill have risen by over300% in Emerging markets boostOTC at Bayer 11 generated sales of around £66 million in the the 11 years between 2001 and 2012,”hesaid. Centrum lifts 12 year ended 31 March 2013, primarily from its International business, meanwhile, had grown Pfizer Consumer Healthcare range of OTCbrands, including Covonia cough tenfold from anegligible £1.3 million in 2002- Brands and acquisitions drive RB 13 medicines, Hedrin head-lice treatments, Meta- 2003 to £12.4 million in the year just ended, Celesio remains on track 14 nium nappy-rash products and Radian B top- excluding divested brands. Arbidol leads Pharmstandard 15 ical analgesics. Although 75% of the company’s sales are sales rise Explaining the rationale behind the deal, generated by its OTC portfolio, its biggest op- Stada said that Thornton &Ross would streng- portunity lies in its prescription drugs business GENERAL NEWS 16 then its business activities in the UK, especially – which accounts for 11% of sales – and the FDA takes action against 16 in the “strategically important” OTC market. work it has done to get Altoderm sodium cro- illegal diabetes products In addition, the deal gave Stada the oppor- moglycate-based cream in aposition to file for UK considers diclofenac options 17 tunity to introduce more of its branded non-pre- authorisation as atreatment for atopic derma- scription products in the UK, the firm added. titis and eczema. EFSA is positive about 18 Limicol cholesterol claim The acquisition comes a few months after “This is the biggest single product develop- Thornton &Ross said it wasonthe look out for Folic acid claim receives 19 ■ Continued on page 30 green light from EFSA Plan BOne-Step gets US exclusivity 20 MARKETING NEWS 21 Sanofi’s Nasacort switch moves closer

Romania set for Pfizer’s 21 anofi’sproposed switch of its Nasacort AQ older with the indication: “Temporarily relieves ThermaCare patch launch Snasal spray (triamcinolone acetonide) from these symptoms of hayfeverorother upper res- Hisamitsu promises US 22 prescription to non-prescription status in the piratory allergies: Nasal congestion, runnynose, “unique” pain-relief gel US has movedastep closer after the Food and sneezing, itchy nose”. Thornton & Ross creates 23 Drug Administration’s (FDA’s) Nonprescrip- The Committee noted that it was “reason- “new sector” for head lice tion Drugs Advisory Committee (NDAC)rec- able to conclude” that consumers would be able UK ASA cries foul over 24 ommended the move. to “self-diagnose and self-select” to use Nasa- misleading Infacol claim The Committee’s recommendation would cort AQ “based solely on the information pro- FEATURES 26 nowbeconsidered by the FDAinits reviewof vided on the nasal spray drugs facts label”. Sanofi’sSupplemental NewDrug Application In a briefing document presented to the Making pharmacy focus 26 (sNDA), the French firm said. The agency’s Committee, Sanofisaid that the outcome of a on your brands decision would also be based on data submit- label comprehension study had shown that con- ted from 13 placebo-controlled efficacystudies, sumers, even those with “lowhealth literacy”, REGULARS Sanofi added, along with safety information could understand the instructions in the pro- from 43 clinical studies and 16 years of post- posed consumer label. These label directions Events – Our regular listing 25 marketing surveillance data. would help mitigate potential risks with the People – Gourlayswitch triggers 31 use of Nasacort AQ in the consumer envi- Alliance Boots shake-up Sanofi wants to switch Nasacort AQ for both adults and children two years of age or ■ Continued on page 30 OTC23-08-13p2-3FIN_Layout 1 20/08/2013 10:02 Page 2

OTC COMPANY NEWS

Annual Results Perrigo expects big gains from launches

errigo is expecting a double-digit rise in Business Annual sales Change Operating income Change Psales at its Consumer Healthcare business (US$ millions) (%) (US$ millions) (%) in the year ending June 2014, as the company rolls out store-brand versions of several big- Consumer Healthcare 2,089 +15 394 +21 name branded products. Prescription Pharmaceuticals 710 +15 321 +17 Joseph Papa, Perrigo’schairman, president Nutritionals 508 +1 64 +1 and chief executive officer,said the US-based Active Pharmaceutical Ingredients 159 -4 51 -9 store-brand specialist was confident about its Other 74 ±0 -25 – launch roster for the next 12 months. Total Perrigo 3,540 +12 805 +19 During the year,Perrigo planned to launch store-brand versions of several products from Figure 1: Perrigo’s sales and operating income in the year ended 29 June 2013 (Source – Perrigo) Reckitt Benckiser’s (RB’s) Mucinex range of guaifenesin-based cough and cold remedies, by 10%-14% in the 12 months ended June 2014. had increased by 8.2%, butthat national brands which had annual branded sales of US$160 mil- Balancing out these beneficial events would had outpaced store-brands. lion (C120 million), Papa pointed out. be the ongoing return to the US market of a The 9.1% rise in sales of national cough, The companywould also benefit from afull number of McNeil’sOTC brands, Brown warn- cold, allergy and sinus brands had been driven year of sales from its 600mg guaifenesin tab- ed, along with a drop in revenues from the primarily by astrong performance from RB’s lets, Papa noted, which had been launched in company’s contract manufacturing business. Mucinex range, Papa said, thanks to a com- March this year. As Figure 1 shows, Consumer Healthcare bination of core product sales growth and the A store-brand version of RB’s Children’s posted sales up by 15% to US$2.09 billion in launch of a number of line extensions. Delsym cough liquid would also be launched, the12months ended 29 June 2013. Operating However, the strong Mucinexperformance Papa said, which wasaproduct that had annual profit increased by 21% to US$394 million. could be beneficial for Perrigo, Papa noted, branded sales of US$100 million. Turning to the major US OTCand vitamins, as it gave the company a bigger pool of con- Perrigo would also add astore-brand equiv- minerals and supplements (VMS) markets, Papa sumers to target with its store-brand equiva- alent of Merck &Co’sClaritin 24 Hour Liqui- pointed out that IRI data for the 52 weeks ended lent to Mucinex600mg guaifenesin extended- Gel –which had annual branded sales of US$35 30 June 2013 had shown that sales of national release tablets. million –toits loratadine-based allergy prod- OTCbrands had advanced by 1.7%, while sales Looking ahead, Papa reiterated the com- uct line, he added. of OTC store-brands had moved forward by pany’s belief that products with over US$10 Judy Brown, Perrigo’schief financial officer, 6.4%, thanks primarily to newproduct launches billion in annual US sales were in line to move expected these newproducts and anumber of and the residual impact of national brand re- fromprescription-only to OTCstatus during the other smaller launches –combined with acon- calls (see Figure 2). next five years, with overUS$5 billion of that tinued shift by consumers to store-brand prod- Looking at the cough, cold, allergy and sinus total expected in the next three years. ucts –todrive up Consumer Healthcare’ssales category,Papa noted that sales of these products Papa pointed out that already this year Merck & Co’s switch of Oxytrol for Women (OTC bulletin,8February 2013, page 1) had opened Store brands National brands Total for category Series1 Series2 Series3 up an entirely newOTC category,targetting the treatment of overactive bladder in women. 1515.0 Furthermore, anew category of OTCnasal +11.2% inhalers to treat allergies would be created once 1010.0 +9.1% +8.5% Sanofi’sswitch of Nasacort AQ wasgiven final +7.5% +8.0% approval (see front page), he added. +6.3% +6.4% +5.5% OTC 55.0 +4.0% +3.0% +3.3% th (%) +2.0% +2.1% +2.1%

ow IN BRIEF

00.0 ■ WALA HEILMITTEL –the German nat-

Sales gr +8.2% +2.8% +2.2% +6.2% +1.7% -0.6%123 4 5-0.5% 6 7 8 -1.4% ural products group – will have to pay C 6.5 million after Germany’s federal cartel office -3.6% -5-5.0 found the firm guilty of pressuring retailers to maintain recommended retail prices for its -7.3% Dr Hauschka line of natural cosmetics. -10-10.0 Analgesics Cough, Cold, Diabetes Gastrointestinal Infant Smoking VMS* Total Allergy,Sinus Formula Cessation OTC ■ VA LEANT PHARMACEUTICALS said * VMS is vitamins, minerals and supplements its sales had jumped by 34% to US$1.1 billion

Figure 2: Retail sales growth of major categories in the US OTC medicines and vitamins, minerals and ( C 828 million) in the second quarter of 2013. supplements markets in the 52 weeks ended 30 June 2013 (Source – Perrigo/IRI) OTC

2 OTC bulletin 23 August 2013 OTC23-08-13p2-3FIN_Layout 1 20/08/2013 10:02 Page 3

COMPANY NEWS OTC

BusinessStrategy/Second-QuarterResults Mergers&Acquisitions GNC reveals its Perrigo to pay US$8.6bn plans for China to acquire Ireland’s Elan NC Holdings is planning rapidly to ex- G pand its presence in China overthe next errigo has agreed to pay US$8.6 billion any sales above that threshold. 12 months after opening its first standalone P(C6.4 million) to acquire Elan, the Ireland- Perrigo currently operates in seven coun- store in the country. based developer of the Tysabri (natalizumab) tries, including Canada, Mexico, Israel, the UK The US-based nutritional products firm said blockbuster multiple-sclerosis drug. “Through and the US. Papa said Ireland would act as an that in addition to the Shanghai store which this transaction, Perrigo establishes adiversified “international business hub and a gateway to opened this week, it would open a further 25 platform for further international expansion,” Europe” for Perrigo. “We really view this as an stores across China within the next 12 months. commented the US group’schairman and chief enabler –there clearly is more we think we can Joseph Fortunato, GNC’schairman, presi- executive officer, Joseph Papa. do in Europe,” he stated. dent and chief executive officer,noted that in the However, Papa added, Perrigo would con- The boards of both firms have recommend- past twoyears the GNC brand had developed tinue to focus on its core OTC and generics ed the deal, which is expected to close by the astrong acceptance among Chinese consumers. business. “We are not going to get into the endofthis year,subject to antitrust and share- GNC entered China in 2010 through a joint branded pharma or biotech business,”hestated. holder approvals. Thereafter, the combined venture with Bright Food, which gave the Chi- company will be incorporated in Ireland and nese state-owned company the rights to dis- Financially compelling led by Perrigo’s current management team. tribute GNC-branded products in the country According to the US-based store-brand spe- The US group anticipates generating more ( OTC bulletin, 26 February 2010, page 9). cialist, the “financially compelling” transaction than US$150 million in annual post-tax oper- “GNC will continue to expand its retail will: diversify its business, including through ating and tax synergies. Perrigo’sshareholders store presence in this dynamic and fast-grow- royalties on sales of Tysabri through Elan’s will hold around 71% of the combined com- ing market,”Fortunato added. “Weare excited partner,Biogen; give access to Elan’sELND005 pany, and Elan’s shareholders the other 29%. about finding newopportunities to address the small-molecule candidate for central nervous Theywill receive US$6.25 in cash and 0.07636 needs of China’s many health and wellness system diseases that is in Phase II clinical trials shares in the combined companyfor each Elan consumers with newand innovative products.” and which Perrigo will look “to monetise” once share they currently hold. Based on Perrigo’s Meanwhile, GNC said that gains across it hits keymilestones; provide US$1.9 billion closing share price on 26 July,this values each its retail, franchise and manufacturing/whole- in cash from Elan’sbalance sheet; and reduce Elan share at US$16.50. sale operations had drivenuptotal group sales the group’s corporate tax rate to around 17% by 9.2% to US$676 million (C 509 million) in within 18 months of closing by legally domicil- Sales of US$56.5 million the second quarter of 2013. ing the group in Ireland. Elan – which put itself up for sale in mid- Total group operating income movedahead Papa insisted the cash-and-shares offer “fully June – reported a turnover from continuing by 5.6% to US$124 million. takes into account the value of Elan’sassets, in- operations of US$56.5 million in the opening As of 30 June 2013, GNC was present in cluding alarge cash balance and adouble-digit six months of this year. more than 8,300 locations, of which over6,200 royalty claim on Tysabri”. At present, Dublin- Transaction and other charges contributed –including 969 franchise and 2,189 Rite Aid based Elan earns a 12% royalty on global net to an US$157 million operating loss, butElan franchise in-store locations –were in the US. sales of the brand, which amounted to around posted a net profit of US$2.35 billion after it The company also had franchise operations US$1.6 billion last year.But from 1May next sold Tysabri intellectual-property and other as- in 55 countries. year, the royalty rate will increase to 18% for sets to Biogen in early April. OTC sales up to US$2.0 billion, and up to 25% on OTC

23 August 2013 Number 407 Individual subscriptions: Terms & Conditions: No part of this publication may be Asubscription to OTC bulletin includes this hard-copynews- copied, reproduced, stored in aretrievalsystem, distributed or Editor: Matt Stewart letter published 20 times a year –twice monthly, except transmitted by any means, including electronic, mechanical, monthly in July, August, December and January, and de- photocopying or recording, without the prior written permission Editor-in-Chief: Aidan Fry of the publisher,orunder the terms and conditions of aGlobal livered by air mail –and a free weekly email newsflash Site Licence or of alicence issued by the Copyright Licensing Production Editor: Jenna Lawrence news@OTCbulletin published 45 times a year.Annual sub- Agency(CLA) in London, UK, or rights bodies in other countries Assistant Editor: Marie McEvoy scriptions in Europe cost £685.00 (additional copies at the that have reciprocal agreements with the CLA. Neither may this same address £385.00); outside Europe £715 (£415). Single publication be exported, distributed or circulated by anymeans Contributing Editor: David Wallace copies cost £50 each. Subscription rates may be adjusted outside the staffwho work at the address to which it is sent by Advertising Controller: Debi Minal to cover any period and can be backdated. Suscriptions may the publisher without the prior written permission of the publisher. only be cancelled at expiry. While due care has been taken to ensure the accuracyofinform- Director of Sales & Marketing: Val Davis ation contained in this publication, the publisher makes no claim Managing Director: Mike Rice Corporate subscriptions: that it is free of error and disclaims any liability whatsoever Global Site Licences are available to companies. These pro- for any decisions or actions taken as a result of its contents. OTC bulletin is published by OTC Publications Ltd, vide in-house electronic access for staff to OTC bulletin © OTC Publications Ltd. All rights reserved. OTC bulletin® is 4 Poplar Road, Dorridge, Solihull B93 8DB, UK. and news@OTCbulletin. Please ask for a quotation. Such Tel: +44 1564 777550. Fax: +44 1564 777524. registered as a trademark in the European Community. licences are supplied strictly on the condition that both pub- ISSN 1350–1097. Email: [email protected] lications are the intellectual property of the copyright holder, Company registered in England No 2765878. Website: www.otc-bulletin.com OTCPublications Ltd, and are protected by copyright, trade- Printed by Warwick Printing Company Limited, Advertising enquiries: [email protected] mark and other laws. Leamington Spa CV31 1QD, UK.

23 August 2013 OTC bulletin 3 OTC23-08-13p4-5FIN_Layout 1 20/08/2013 12:41 Page 2

OTC COMPANY NEWS

Second-QuarterResults Sanofi “veryconfident” in OTC business

anofiis“very confident” in the future of Sits Consumer Healthcarebusiness, thanks Region Second-quarter sales Change (%) Proportion in part to twopotential product launches in the (C millions) CER* of sales (%) US, according to Pascale Witz, vice-president Emerging Markets 352 +2.8 48 of the firm’sGlobal Divisions &Strategic Com- Western Europe 162 +0.6 22 mercial Development unit. US 151 -2.5 21 Speaking as the French companyreported Rest of World 64 +9.5 9 a1.2% drop –1.8% rise at constant exchange Total Consumer Healthcare729 +1.8 100 rates –inConsumer Healthcare’ssecond-quar- tersales, Witz noted that it had been “very en- *CER is constant exchange rates couraged” by Consumer Healthcare’sability to Figure2:Sanofi’s Consumer Health Caresales in the second quarter of 2013 by region (Source –Sanofi) find newopportunitiestohelp drive growth. Citing Consumer Healthcare’sUSsubsid- tion, runnynose, sneezing, itchynose”. contain the original active ingredient fexofena- iary Chattem as an example, Witz said that the Reviewing Consumer Healthcare’ssecond- dine(OTC bulletin,26April 2013, page 14). successful switch and launch of Allegra Allergy quarter performance, Witz pointed out that the By contrast, the No Spa antispasmodicand would soon be followed by the relaunch of the constant-exchange rate improvement had been Lactacyd feminine wash lines reported sales Rolaids antacid brand it had acquired from drivenby“solid growth” from the division’s down by 7.4% and 3.8% respectively to C24 Johnson &Johnson earlier this year (OTC bul- four largest brands: Allegra, Doliprane, Essen- million each. Dorflexanalgesics rounded out letin,18January 2013, page 1). tiale and Enterogermina. Consumer Healthcare’sleading brands with Furthermore, Chattem’sportfolio in the US The Doliprane paracetamol line wasthe turnoverofC20 million, an increase of 4.8%. looked set to be expanded, Witz pointed out, division’sbiggest-selling brand, with turnover Turning to Consumer Healthcare’sgeograph- after an advisory committee to the US Food and rising by 7.7% at constant exchange rates to ic performance, Emerging Markets remained Drug Administration (FDA) had givenaposi- C69 million in the quarter (see Figure 1). the division’sbiggest region in terms of sales. tive recommendation to the proposed switch of Essentiale wasthe best performer,with sales These grewby2.8% at constant exchange rates Sanofi’sNasacort AQ nasal spray (triamcino- increasing by 43.9% to C57 million, while En- to C352 million in the quarter (see Figure 2). lone acetonide) from prescription to non-pre- terogermina probiotics also posted adouble-digit Sales in the Emerging Markets had been held scription status in the US (see front page). gain, with turnoverupby13.8% to C29 million. back somewhat by distribution changes in China, Sanofiwants to switch Nasacort AQ for Sales of Allegra OTCadvanced by 8.2% at Sanofinoted, although turnoverinthe country both adults and children twoyears of age or constant exchange rates to C65 million as the had improvedafter atough first-quarter. older.Itwants the OTCindication: “Tempor- allergy brand waslaunched in Japan. In April, Explaining what wascausing the problems arily relievesthese symptoms of hayfeveror Sanofiexpanded the Allegra brand in the US in China, Sanofisaid that there had been a other upper respiratory allergies: Nasal conges- by launching twoanti-itchcreams that do not lackoftransparency in the distribution channel and no real control overthe “flowofmargin” Business Second-quarter sales Change (%) Proportion between the companyand retailers. (C millions) CER* of sales (%) To ensure the firm had better control over Doliprane 69 +7.7 <1 products in the Chinese system and the waythe Allegra65+8.2 <1 margins were shared, it had ended a“significant Essentiale 57 +43.9 <1 number”ofdistribution deals and cut the num- Enterogermina 29 +13.8 <1 berofdistributors it worked with, Sanofinoted. No Spa 24 -7.4 <1 Althoughthese changes had damaged sales Lactacyd 24 -3.8 <1 in the short-term, the companyconceded, the Dorflex20+4.8 <1 changes had givenita“better understanding” Other Consumer Healthcarebrands 441 -3.6 6 of the flowofgoods in the marketplace. Consumer Healthcare 729 +1.8 9 Consumer Healthcare’ssmallest region – Diabetes 1,621 +16.2 20 Rest of World –was its best performing, with turnoverrising by 9.5% at constant exchange Genzyme 525 +25.6 7 rates to C64 million. Generics 300 -36.8 4 Elsewhere, Consumer Healthcare’sturnover Oncology/Other Pharmaceutical 3,539 –44in Western Europe crept up by 0.6% at con- Pharmaceuticals 6,714 -7.1 84 stant exchange rates to C162 million, while US Vaccines 760 +0.4 9 sales declined by 2.5% to C151 million. Animal Health 529 -5.7 7 Consumer Healthcareaccounted for 9% of Total Sanofi8,003 -6.3 100 Sanofi’stotal second-quarter sales, which fell by 6.3% at constant exchange rates to C8.00 billion. *CER is constant exchange rates As reported, group turnoverdeclined by 9.8%. Figure1:Sanofi’s sales in the second quarter of 2013 broken down by business (Source –Sanofi) OTC

4 OTC bulletin 23 August 2013 OTC23-08-13p4-5FIN_Layout 1 20/08/2013 12:41 Page 3

COMPANY NEWS OTC

Second-QuarterResults Merck &Cobacks Consumer Careunit

he successful OTCswitch and imminent Business Second-quarter sales Change Proportion Tlaunch of Oxytrol for Women in the US (US$ millions) 2012/2013 (%) of total (%) demonstrates whyMerck &Cohas held onto itsConsumer Care business, according to chief Pharmaceutical 9,310 -12 85 executive officer Kenneth Frazier. Animal Health 851 -2 8 However, Frazier conceded that if Merck Claritin OTC78-46 1 ever viewed Consumer Care as an asset which Consumer Care 490 -11 4 could perform better outside of the company, Other 359 +8 3 it would “consider other alternatives”. Speaking as the US-based firm reported an Total Merck &Co11,010 -11 100

11% drop in Consumer Care’ssecond-quarter Figure1:Merck &Co’s sales in the second quarter of 2013 broken down by business (Source –Merck &Co) sales to US$490 million (C369 million) due to restructuringinChina, Frazier pointed out that ment for overactive bladder (OAB) in women, the 2% rise in US turnovertoUS$390 million. the companywas constantly assessing and eval- Oxytrol for Women (oxybutynin transdermal Sales of Consumer Care’sleading brand, uating its entire portfolio. system, 3.9mg/day) wasapprovedbythe US theloratadine-based allergy medicine Claritin, Consumer Care remained abusiness that Food and Drug Administration (FDA) in Jan- suffered the same fate, with a7%increase in complemented Merck’sdominant Pharmaceu- uary (OTC bulletin,8February 2013, page 1). US sales to US$108 million wiped out entirely tical division, Frazier insisted, butthe company Aspokesperson for Merck told OTC bul- by the companychanging distributors in China. had aduty to look at the overall performance letin that Oxytrol for Women remained on track Associated rebates left Claritin’sinternational of its portfolio and decide howitcould “max- to be available in US stores in the autumn. turnoverstanding at anegative US$29 million imise long-term cash flowfor shareholders”. Meanwhile, Merck blamed the changes it in the second quarter. Asked howthe firm sawConsumer Care as had been making to anumber of distribution Consumer Care generated 4.5% of Merck’s an asset when it only contributed 4% of its total agreements in China, combined with negative total second-quarter sales, which fell by 11% earnings before interest, tax, depreciation and currencyeffects, for the 11% fall in Consumer to US$11.0 billion. Excluding currencyeffects, amortisation (EBITDA), Frazier said that the Care’ssecond-quarter sales to US$490 million the drop wasaslightly less dramatic 8%. division’sprofitability wasinline with its peers. (see Figure 1). Merck blamed the decline in sales on the loss “I agree that [Consumer Care] is smaller Throughoutthe quarter,Merck had been ter- of patent protection on anumber of its block- compared to our Pharmaceutical business and minating in China certain Consumer Care distri- buster prescription-only drugs, including the Ihavesaid before that it is not global in scale,” bution arrangements, the firm noted, and revers- asthma medicine and potential OTCswitch Frazier said. “But it is avery good business that ingsales previously made to those distributors. candidate Singulair (montelukast sodium). produces really strong cash flow.” Excluding these actions, Consumer Care’s The firm has not ruled out switching Sing- Merck also continued to exploit opportuni- worldwide sales would have movedforward ulair,which lost exclusivity in November last ties, of which Oxytrol for Women wasthe most by 2%, Merck pointed out, including anegative year (OTC bulletin,16November 2012, page recent example, which showed howConsumer currencyeffect of 1%. 5). Asked whether adecision had been made on Care complemented the Pharmaceutical divi- The restructuring in China led to a41% drop whether to switch Singulair,the spokesperson sion, Frazier noted. in Consumer Care’sinternationalsales to US$99 said that Merck &Cowas still evaluating its Described as the “first and only” OTCtreat- million. This had the effect of easily offsetting “options and opportunities”. OTC

IN BRIEF First-HalfResults ■ RECORDATI has reported sales up by Omega Pharma posts big rise in sales 13.8% to C 478 million in the first half of 2013. Internationalturnoverrose by 17.1%. The Ital- mega Pharma posted first-half sales up 60% to C 81.4 million in the six months. iancompany’soperating income improvedby O by 30% to C 611 million, thanks to strong Western Europe –excluding Belgium and 13.8% to C 103 million in the six months. The organic growth and the OTCbrands it acquired France –remained Omega’s biggest market. firm has adopted an aggressive acquisition in Europe from GlaxoSmithKlinelast year. Adding the GlaxoSmithKline brands pushed policyoverthe past year,which has seen it The privately-owned Belgian OTCspecial- up sales by 48% to C 288 million. expand its OTCbusiness in anumber of mar- ist said that the contribution from the basket of TurnoverinBelgium advanced by 4% to kets, most notably Germanyand Russia. In non-core GlaxoSmithKline brands –which it C 136 million; while in France, sales improved March, the companysaid it would continue acquired in May last year (OTC bulletin,16 by atenth to C 101 million. Sales in Emerging to seek out and acquire “well known” OTC March 2012, page 1) –had been boosted by Markets increased by 59% to C 86.4 million. brands in markets across Europe to drive up strong organic gains in Belgium, France, Ger- Omega recently acquired supplements firm its OTCsales by 50% in the next twoyears many, Russia and the UK. Naturoteek and the Arterin food supplement ( OTC bulletin,15March 2013, page 5). Tight cost controls combined with the good brand (OTC bulletin,15March 2013, page 3). OTC sales growth pushed up operating profit by OTC

23 August 2013 OTC bulletin 5 OTC23-08-13p6-7FIN_Layout 1 20/08/2013 14:35 Page 2

OTC COMPANY NEWS

ChinaSecond-QuarterResults holdsback OTC growth at GSK

ower sales of twokey brands in China Business Second-quarter sales Change 2012/2013 (%) Lheld back growth at GlaxoSmithKline Con- (£ millions) £CER* Ongoing CER** sumer Healthcare’sTotal Wellness OTCbusi- ness in the second quarter of 2013. Total Wellness 468 -4 -7 ±0 Sales of the Contac decongestant and Fen- Oral Care 481 +9 +8 +8 bid topical analgesic in China had fallen by Nutrition 291 +7 +7 +7 54% and 32% respectively,GlaxoSmithKline Skin Health 69 +13 +11 +11 said, offsetting good performances elsewhere. This had left Total Wellness’ core turnoverat Consumer Healthcare1,309 +3 +2 +5 constant exchange rates flat at £468 million *CER is at constant exchange rates ** Growth excluding non-core OTCproducts at constant exchange rates (C542 million) for the period. Figure1:GlaxoSmithKline Consumer Healthcare’s sales in the second quarter of 2013 broken down by business Includingthe non-core brands divested in (Source –GlaxoSmithKline) the first-half of last year,Total Wellness’ sales dropped back by 4% as reported and by 7% million, confirmed the company. Selling 17 Lucozade sales had advanced by 4%, Glaxo- at constant exchange rates. North American brands to Prestige Brands SmithKline pointed out, while Ribena had de- The companyblamed the dramatic decline Holdings for US$660 million (C515 million) livered a2%decline. in Contac sales in China on the government’s accounted for sales of £126 million (OTC bul- AndrewWitty,GlaxoSmithKline’schief ex- decision to move the product behind pharmacy letin,16April 2012, page 5). ecutive officer,said that the companywas con- counters, Fenbid, meanwhile, had been hit by To this wasadded £185 million in Euro- fident of reaching an agreement to sell Luco- price reductions after it wasadded to the coun- pean sales from divesting non-core brands to zade and Ribena by the end of the year,having try’sessential medicines list. OmegaPharma for C470 million in cash (OTC put the twodrinks brands up for sale in April, Outside of China, Total Wellness’ smoking bulletin,16March 2012, page 1); and £60 mil- following astrategic review(OTC bulletin,10 reduction/cessation franchise had also reported lion in international brand sales from a£164 May 2013, page 6). lower sales, GlaxoSmithKline said, due to a million deal with Aspen Holdings (OTC bul- Announcing the strategic reviewinFebruary change in stocking patterns. letin,30April 2012, page 1). (OTC bulletin,22February 2013, page 6), On abrighter note, the Panadol analgesics However, the companyfailed to find abuyer Witty said the twobrands did not fitinwith the brand had posted sales up by 2%, despite some for Alli and has nowstarted rebuilding the brand two“significant” synergy opportunities enjoyed supply issues, the companynoted, while turn- in major markets around the world (OTC bul- by Consumer Healthcare. overfrom vitamin products had improvedby letin,10August 2012, page 4). First wasthe interaction between the firm’s 16%. The weight-loss medicine Alli (orlistat) Unaffected by the non-core divestments, Pharmaceuticalbusiness and Consumer Health- had performedwell since it had returned to GlaxoSmithKline Consumer Healthcare’sOral care’sOTC business, Witty pointed out. market in Europe and the US, the firm added. Care, Nutrition and Skin Health businesses all ManyofConsumer Healthcare’sOTC drugs Total Wellness accounted for 36% of Glaxo- reported gains in the second quarter. had been prescription pharmaceuticals origi- SmithKline Consumer Healthcare’stotal sec- Oral Care sales grewby8%atconstant ex- nally.These OTCbrands, liketheir prescrip- ond-quarter sales, which increasedby5%to change rates to £481 million. Strong contri- tion counterparts, were very often distributed £1.31 billion (see Figure 1). Including the div- butions from the Sensodyne Sensitivity and through pharmacies, Witty explained, so there ested non-core brands, the division’ssales edged Acid Erosion and its denture-care brands –up existed a“tremendous” opportunity for syner- up by 2% at constant exchange rates and by by 19% and 7% respectively –had offset a9% gies in this area. 3% as reported. drop in sales of Aquafresh, the companynoted. Second, the company’sPharmaceutical and The UK-based firm divested OTCbrands The Nutrition business reported turnover Consumer Healthcarebusinesses had “very across the US, Europe and other regions for up by 7% at constant exchange rates to £291 strong” distribution synergies in emerging mar- netcash proceeds of approximately £690 mil- million in the quarter,thanks to a23% jump in kets, Witty pointed out, and as those markets lion in the opening six months of 2012. salesofHorlicks in India and a10% rise in turn- developed, more opportunities for collabora- The disposals had total 2011 sales of £370 overfrom Boost energy drinks. tion would arise. In addition,GlaxoSmithKlinebelievedthat Region Second-quarter sales Change 2012/2013 (%) having a“science-endorsed or expert-endorsed (£ millions) £CER* Ongoing CER** proposition” behind manyofits Consumer Healthcare brands wasone of the business’ key Rest of World 608 +2 +4 +6 competitive advantages, Witty said. Europe 463 +1 -2 +4 Consumer Healthcare’sSkin Health busi- US 238 +8 +5 +5 ness reported an 11% rise in second-quarter sales at constant exchange rates to £69 million, Total Consumer Healthcare1,309 +3 +2 +5 drivenbya17% rise in sales of the cold-sore *CER is at constant exchange rates ** Growth excluding non-core OTCproducts at constant exchange rates brand Abreva.The double-digit jump had been

Figure2:GlaxoSmithKline Consumer Healthcare’s turnover in the second quarter of 2013 broken down by thanks to the “continued success” of Abreva region (Source –GlaxoSmithKline) Conceal in the US, the companynoted.

6 OTC bulletin 23 August 2013 OTC23-08-13p6-7FIN_Layout 1 20/08/2013 14:35 Page 3

COMPANY NEWS OTC

Third-QuarterResults First-QuarterResults NBTY gets rise Returnofbig rivalbrands from coreunits impacts sales at Prestige BTY said its sales had grown by 2.6% to NUS$803 million (C 603 million) in its third restige Brands said that the return of a tralia’sCare Pharmaceuticals for an undisclosed quarter ended 30 June 2013, as turnoveratits P number of high-profile rivalOTC brands sum (OTC bulletin,26July 2013, page 3). Wholesale and European Retail units increased. to the US market had hit sales in keycate- Care generated annual turnoverofaround Sales at NBTY’score Wholesale division gories in its first quarter ended 30 June 2013. A$20 million (C 14 million),primarily from grewby1.9% to US$489 million. MatthewMannelly,the US-based firm’s sales of Fess saline-based nasal health prod- NBTY’sEuropean Retail division posted chief executive officer,said that the relaunch of ucts and its other keybrands, includingFab sales up by 8.6% to US$192 million. As of 30 McNeil’sTylenol and Motrin brands into the nutritionalsupplements, Painstop analgesics June 2013, the European Retail unit wasoper- US OTCpaediatric market had led to a1.2% and Rectogesic rectal discomfort treatments. ating 969 stores, of which 896 were company- drop in sales by Prestige’s core OTCportfolio. Commenting on the rationale behind the owned and 73 were franchise stores. Prestige’stotal OTCsales –including core deal, Mannelly said that Care gave the com- and non-core brands –fell by 2.6% to US$123 panya“hub” in the Asia-Pacific region. Fall in Direct Response sales million (C 92.4 million) in the three months, On this newplatform, Prestige could dev- Direct Response/E-Commerce reported sales including the loss of US$1.6 million in sales elop its “aspirations” in the Asia-Pacific mar- down by 4.1% to US$63.7 million. from the Phazyme brand, which it sold last year. ket, Mannelly noted, and also pursue other Meanwhile, North American Retail’sturn- OTCturnoveraccounted for 86% of Pres- merger and acquisition targets in the region. overdropped by 1.9% to US$58.2million. As of tige’stotal group sales in the quarter,which Asked whether Prestige planned to bring 30 June 2013, the North AmericanRetail busi- dropped by 3.0% to US$143 million. House- anyofCare’sexisting brands to the US market, ness wasoperating 423 Vitamin World stores. hold Cleaning accounted for the remaining 14%, Mannelly said that the companyhad yet to NBTY’stotal operating profit for the quar- with sales down by 4% to US$20.0 million. decide, butthat the twofirms were talking ter –including corporate costs –fell back by Following the close of the quarter,Prestige about howbest to “exchange ideas, formulas, 13.1% to US$100 million. expanded its international reach by buying Aus- and product technologies”.

OTC OTC

Excluding the divested brands, core Con- Core US Consumer Healthcaresales had profit at Consumer Healthcareof£224 million, sumer Healthcare sales grewquickest in the improvedby5%to£238 million at constant up by 3% at constant exchange rates (see Fig- division’sRest of World region in the second exchange rates, the firm said, thanks to the re- ure 3). The firm explained the core result ex- quarter,with turnovergrowing by 6% at con- stocking of Alli and strong sales of certain oral- cluded amortisation and goodwill, major re- stant currencyrates (see Figure 2). care brands. These had offset lower sales of structuring costs, legalcharges, other operating Rest of World sales had improvedto£608 smoking cessation and reduction products. income, net royalty income, disposals of asso- million, GlaxoSmithKline said, reflecting strong In Europe, core turnoverhad increased by ciates, and acquisition accounting adjustments growth across most markets and categories, par- 4% at constant exchange rates to £463 million. for material acquisitions. ticularly in India. The return of Alli and strong sales of oral-care Consumer Healthcareaccounted for afifth The rise would have been greater butfor a products had driventhe improvement, Glaxo- of GlaxoSmithKline’stotal second-quarter sales, 19% sales drop in China due to lower sales of SmithKline pointed out. which improvedby2%atconstant exchange Contac and Fenbid, the companyadded. GlaxoSmithKline reported acore operating rates to £6.62 billion. Pharmaceuticals and Vac- cines accounted for the remaining 80%. Meanwhile, GlaxoSmithKline said it had de- Second quarter Change 2012/2013 (%) Proportion (£ millions) £CER* of total (%) layed increasing its stakeinits Nigerian consum- er subsidiary to consider “appropriate amend- Sales ments” to the proposed scheme of arrangement. Pharmaceuticals and Vaccines 5,309 +2 +1 80 In December last year,the firm launched Consumer Healthcare 1,309 +3 +2 20 aNGN15.4 billion (C72.1 million) bid to in- Total 6,618 +2 +2 100 crease its stakeinGlaxoSmithKline Consumer Nigeria from 46.4% to 80.0% (OTC bulletin, Operating profit 18 December 2012, page 3). Pharmaceuticals and Vaccines 1,932 –+590GlaxoSmithKline also noted that it had com- Consumer Healthcare 224 –+310menced work to formalise long-term arrange- Total** 2,156 –+5100 ments that would see its Nigerian subsidiary

*CER is at constant exchange rates ** Including corporate costs of £213 million continue to distribute Lucozade and Ribena in Nigeria and certain other markets in West Africa Figure3:GlaxoSmithKline’s ‘core’ sales and operating profit in the second quarter of 2013. Coreresults after the twobrands had been sold. exclude amortisation, goodwill, restructuring costs, legal charges and other items (Source –GlaxoSmithKline) OTC

23 August 2013 OTC bulletin 7 OTC23-08-13p8-9FIN_Layout 1 20/08/2013 14:38 Page 2

OTC COMPANY NEWS

MerckSecond-QuarterResults KGaA pleased with Consumer

erck KGaA’s Consumer Health division best chance of success were properly funded. Rest of Mis stable and performing better than ex- These changes led to Consumer Health’s World North pected, thanks to the turnaround plan started earnings before interest and tax (EBIT) jump- Emerging 3% America <1% almost twoyears ago, according to the German ing by 72.8% to C18.1 million in the second Markets 32% firm’schief financial officer Matthias Zachert. quarter of 2013. Speaking as Consumer Health posted a The big rise in EBIT came despite a4.5% slight drop in second-quarter sales, butadouble- drop in Consumer Health’ssales –excluding digit rise in earnings, Zachert pointed out that income from royalties, licences and commis- overthe past fewyears the division’sfortunes sions –toC116 million in the three months had been “a little volatile”. Now, however, the (see Figure 1). Includingincome from royalties, Europe business wasgoing in “exactly the direction” licences and commissions, the division’sturn- 65% that Merck wanted, he said. overfell by 3.9% to C117 million.

“Weconsider this business is farbetter posi- Merck noted that it had seen “good demand” Figure2:Sales by Merck KGaA’s Consumer tioned in 2013 than in 2012,”Zachert noted. By for Consumer Health’sBion3 and Femibion Health Carebusiness in the second quarter of 2013 focusing on building Consumer Health’sstrate- vitamins brands in the quarter,along with the – C116 million –broken down by region (Source –Merck KGaA) gic brands, expanding in the right markets and Kytta joint-care range. However, these gains changing resource allocation, the division was had been offset by the decision to stop export- been caused by the decision to halt exports nowmoving in the right direction, he added. ing products sold by Consumer Health’sUK of SevenSeas products. Udit Batra, worldwide head of Consumer subsidiary SevenSeas, the companysaid. Emerging Markets generated 32% of sales, Health, initiated the division’sturnaround plan Sales results had also suffered due to atough with organic sales growing by 0.4% to C36.5 shortly after he joined Merck in 2011 (OTC comparison with the prior-year quarter,Merck million, fuelled by good growth in Brazil, bulletin,29July 2011, page 1). pointed out, when turnoverhad been bolster- Chile, Mexico, Venezuela and anumber of Speaking to OTC bulletin in April, Batra ed by the launch of twoline extensions to the Asian markets. This rise, however, waswiped said that operational discipline, afocus on costs, Apaisyl anti-itch brand in France as well as out by a7.5% negative currencyeffect, leaving and mining the potential of acore group of large shipments to Russia. turnoverasreported down by 7.1%. brands in keyregions, would help re-establish Negative currencyeffects had also impact- Pulling out of the Canadian market earlier the Consumer Health division as aleader in ed the results, the companynoted, especially this year effectively ended Consumer Health’s the global marketplace (OTC bulletin,26April the devaluation of the Venezuelan bolivar. interest in North America, yet due to afav- 2013, page 18). From ageographical perspective,all regions ourable comparisonwith the prior-year quarter, The business had agood base consisting of except for North America posted adrop in sales in the region increased dramatically by strong brands, with strong category positions sales in the second quarter. 28.7% to C0.2 million. in keymarkets, Batra had pointed out, butalack In Europe –which accounted for 65% of Consumer Health accounted for 4% of of direction and oversight in the past fewyears Consumer Health’stotal sales –astrong per- Merck’stotal second-quarter sales –excluding had meant that it had not performedtothe best formance in Germanywas wiped out by the income from royalties, licences and commis- of its ability.Things nowhad to change. endofSeven Seas’ exporting activities, resulting sions –which were flat at C2.74 billion. Total Investment behind unprofitable ventures had in a1.9% drop in turnovertoC75.0 million. Ex- turnoverincluding income from royalties, been stopped, Batra explained, and the business cluding currencyeffects, turnoverfell by 0.9%. licences and commissions, fell back by 0.4% hadbegun to “revise go-to-marketmodels –in- Rest of World wasthe weakest performer to C2.84 billion. cluding exiting Canada, Ecuador and Ireland – with turnoverdeclining by 23.8% to C3.9 mil- Group EBIT improvedtoC465 million from where the business wasnot performing”. lion, cutting its contribution to the division’s just C23.2 million in the prior-year quarter.The Low-value research and development pro- total sales to 3% (see Figure 2). dramaticrise had been caused by the large jects had also been scrapped, Batra noted, while Anegative currencyeffect of 10.7% had one-time expenses booked in the second quar- the allocation of resources had been overhauled compounded a13.2% drop in Rest of World’s ter of 2012, Merck noted. These had been relat- to ensure that areas where the business had the organic sales, Merck pointed out, which had ed to its “Fit for 2018” efficiencyprogramme. OTC Business Second-quarter Change EBIT Change sales (C millions) (%) (C millions) (%) IN BRIEF Merck Serono 1,531 -1.0 283 >100 ■ ORIOLA KD –the Finnish wholesaler and Merck Millipore 666 +2.6 72 +3.0 retailer –posted an operating loss of C 0.3 Performance Materials 431 +1.2 170 -5.7 million in the second quarter of 2013, despite Consumer Health 116 -4.5 18 +72.8 sales rising by 10.6% to C 652 million. The firm Corporate and others ––-78 – blamed the loss on delivery problems at its Total Merck 2,744 ±0 465 >100 Russian wholesale business and restructuring costs related to its Swedish retail business. Figure1:Merck KGaA’s sales and EBIT in the second quarter of 2013 (Source –Merck KGaA) OTC

8 OTC bulletin 23 August 2013 OTC23-08-13p8-9FIN_Layout 1 20/08/2013 14:38 Page 3

COMPANY NEWS OTC

BusinessStrategy/Second-QuarterResults Fourth-Quarter/Annual Results Teva expands New Chapter lifts P&G’s OTC thinking Personal Health Careunit eva Pharmaceutical Industries is focusing T on researchthat will have an impact on its rocter &Gamble said that the NewChapter In the fourth quarter,sales improvedatProc- growing OTCbusiness, according to the Israeli Pvitamins, mineralsand supplements (VMS) ter &Gamble’sHealth Care business –which firm’spresident of research and development business acquired last year had helped its Per- includes the Oral Care and Feminine Care units, and chief scientific officer,Michael Hayden. sonal Health Care business post arise in net as well as Personal Health Care –by6%to Speaking as Teva posted a17% rise in sales in its fourth quarter ended 30 June 2013. US$3.12 billion (C2.35 billion), thanks to strong second-quarter OTCsales to US$257 million NewChapter –which Procter &Gamble volume growth. Health Care’spre-tax income ( C 193 million),Hayden said that the company acquired for an undisclosed sum in March last increased by 10% to US$547 million. had added an OTCarm to its research and year (OTC bulletin,30March 2012, page 1) – In the year ended 30 June 2013, Health Care development organisation. had been Personal Health Care’sprimary growth posted sales up by 3% to US$12.8 billion, with The move wasa“natural extension” of driverinthe three months, the firm noted. pre-tax income rising by 2% to US$2.77 billion. thinking about the company’scapabilities in the Acquiring NewChapter gave Procter & Procter &Gamble recently reorganised its generic medicines arena and howthese could Gamble arange of VMS products for men’sand business, creating anew Global Health and be used in the OTCmarket, Hayden claimed. women’shealth. The portfolio includes the Life- Grooming business “sector” from 1July,includ- “Weare building on the generic mindset,” shield mushroom supplements and Wholemega inganew streamlined Health Care unit (OTC Hayden noted, “and are already coming up fish-oil products. bulletin,17June 2013, page 7). with some very interesting and novelinnova- Procter &Gamble did not comment on the The new-look Health Care unit no longer in- tive ideas in the OTCspace.” progress of PGT Healthcare, the 51%/49% OTC cludes Oral Care or Feminine Care and instead Teva has expanded significantly its reach in joint venture that it establishedwith Teva Phar- covers only Procter &Gamble’swholly-owned the OTCmarket overthe past fewyears, most maceutical Industries in 2011 (OTC bulletin, US OTCbusiness as well as PGT Healthcare. notably through its PGT Healthcare joint ven- 16 November 2011, page 1). OTC ture with Procter &Gamble. Established in November 2011, PGT oper- ates essentially in all markets outside of North America and also develops newbrands for the North American market (OTC bulletin,16 November 2011, page 1). Teva is acting as manufacturer and supplier both for the PGT business and Procter &Gamble’sNorth Amer- ican OTCbusiness.

PGT boosts OTC sales PGT wasthe primary reason behind the rise in Teva’s OTCturnoverinthe second quarter, with the joint venture posting strong sales and market-share growth in all its keymarkets. Eyal Desheh, Teva’s chief financial officer, noted that PGT had already launched the Vicks cough and cold range in anumber of countries across Eastern Europe and the Commonwealth of Independent States (CIS). Plans to launch Vicks in Ukraine and the rest of the CIS were also in place, he added. Commenting on PGT’spotential,Desheh noted that the joint venture had recruitedsome “good talent” from global OTCplayers, such as Johnson &Johnson. These recruits, Desheh said, would enable PGT to get the best out of Teva’s capacity for developing, manufacturing and distributing products, as well as out of Proc- ter &Gamble’sskills in consumer marketing. “[PGT] is working very well so far,”Desheh pointed out, “so we are very optimistic.” OTC

23 August 2013 OTC bulletin 9 OTC23-08-13p10-11FIN_Layout 1 20/08/2013 13:47 Page 2

OTC COMPANY NEWS

First-QuarterResults International expansion drives Taisho

apan’sTaisho said its international expansion Business First-quarter sales Change Forecast sales Change Jwasthe sole driverofgrowth at its Self-Med- (¥ billions) (%) (¥ billions) (%) ication division in the three months ended 30 June 2013, as it continued to invest in various Japan 35.6 -3.2 154.0 +1.9 projects to help kick-start astagnant domes- International OTCdrugs 3.7 +75.5 15.5 +62.2 tic market. International energy drinks 2.3 +30.5 9.3 +31.9 Sales at Taisho’sSelf-Medication division International other 0.2 –0.5 – advanced by 2.5% to ¥42.4 billion (C324 mil- International 6.2 +53.1 25.3 +44.1 lion) in company’sfirst quarter,drivenbya Others 0.6 +13.1 1.9 -26.1 53.1% increase in international turnoverto¥6.2 Total Self-Medication42.4 +2.5 181.2 +5.8 billion (see Figure 1). Prescription operations 25.7 -2.5 111.8 -1.8 International sales of the division’sOTC Total forTaisho 68.2 +0.6 293.0 +2.7 products grewby75.5% to ¥3.7 billion, while international turnoverfrom energy drinks im- Figure1:Taisho Pharmaceutical’s sales in the first quarter ended 30 June 2013. Forecasted sales arefor the provedby30.5% to ¥2.3 billion. year ending 31 March 2014 compared with actual sales in the previous year (Source –Taisho Pharmaceutical) Sales outside of Japan had been boosted by Business First-quarter sales Change Forecast sales Change the inclusion of the Osotspa OTCjoint venture (¥ billions) (%) (¥ billions) (%) in Thailand (OTC bulletin,16April 2012, page 5), Taisho said, along with the Mexican OTC Lipovitan D11.0 -7.9 43.2 -3.4 firm Compañia Internacional de Comercio and Other Lipovitan 5.9 +3.7 23.7 +7.9 itsUSdistribution arm Vitacilina Corporation Total Lipovitan brand 16.9 -4.2 67.0 +0.3 of America,which Taisho had acquired in July Zena brand 0.7 -5.7 3.4 +7.4 last year (OTC bulletin,27July 2012, page 3). Other drinks 0.4 ––– By contrast, Self-Medication sales in Taisho’s Total tonics and nutrient drinks 18.0 -4.5 –– home market –including the Bioferminand Cold remedies (Pabron brand) 4.2 -12.8 26.2 +0.3 Tokuhon subsidiaries –fell back by 3.2% to Hair treatments (RiUP brand) 3.3 -0.7 14.0 +0.6 ¥35.6 billion (see Figure 2). Other sales add- Gastrointestinal treatments 1.1 -16.3 5.0 +5.3 ed the remaining ¥0.6 billion to the total. Livita series 1.0 -23.1 4.0 -2.4 Following the close of the quarter,Taisho Analgesics (Naron brand) 1.0 -7.9 4.4 +1.4 expanded its stakeinBiofermin by acquiring Laxatives(Colac brand) 0.8 -8.6 3.7 +1.9 an additional 8.15% stakefrom Takeda. As part Cold remedies (Vicks brand) 0.4 +11.5 3.4 +7.4 of the deal, Takeda will continue to distribute Biofermin 1.6 -2.0 6.7 +0.3 Biofermin’sOTC products in Japan for Taisho. Tokuhon 0.4 –1.8 +25.5 Sales of the Biofermin subsidiary in Japan slipped back by 2.0% to ¥1.6 billion, while the Other Self-Medication products 3.8 –14.4 – Tokuhon business contributed ¥0.4 billion. Total Domestic Self-Medication35.6 -3.2 154.0 +1.9 Taisho pointed out that the Self-Medication division would continue trying to “energise” Figure2:Breakdown of Taisho Pharmaceutical’s Self-Medication sales in Japan in the first quarter ended 30 June 2013. Forecasted sales arefor the year ending 31 March 2014 compared with actual sales in the financial the market in Japan by focusing its efforts on year ended 31 March 2013 (Source –Taisho Pharmaceutical) the“lifestyle diseases” category and by strength- ening further its product information and in- Lipovitan products movedforward by 3.7% to First-quarter sales Change store sales promotions. ¥5.9 billion. (¥ billions) (%) In April, Taisho successfully claimed Japan’s Sales of Taisho’stonic and nutrient drinks first prescription-to-OTC switch of amedicine through drug channels decreased by 5.1% to Food channels 9.7 -3.9 indicated to treat high cholesterol with the ¥8.4 billion, and by 3.9% to ¥9.7 billion through Drug channels 8.4 -5.1 launch of Epadel T(600mg ethyl icosapen- food channels (see Figure 3). Total 18.0 -4.5 tate), and said it would continue to broaden its The company’sPabron cold remedies post- range of category 1medicines –OTC products ed asharp fall in sales, with turnoverfinishing Figure3:Breakdown by distribution channel of Taisho Pharmaceutical’s sales of tonics and nutrient deemed to hold the greatest degree of risk – down by 12.8% to ¥4.2 billion, due to “weak” drinks in Japan in the first quarter ended 30 June by identifying further switch candidates(OTC sales of mainstay general cold remedies in the 2013 (Source –Taisho Pharmaceutical) bulletin,26April 2013, page 1). three months. By contrast, Taisho’sother cold Meanwhile, domestic sales of Taisho’score remedies brand, Vicks, posted turnoverupby idil product. However, the brand had benefitted Lipovitan brand of energy and tonic drinks fell 11.5% to ¥0.4 billion. from the launch of RiUP Jet, ahair regrowth by 4.2% to ¥16.9 billion in the three months. The RiUP hair-regrowth brand suffered a treatment with a“push-activated jet nozzle”, Turnoverfrom Lipovitan Dslipped back 0.7% drop in sales to ¥3.3 billion, primarily which had been launched in December 2012. by 7.9% to ¥11.0 billion, while sales of other due to lower sales of the original RiUP minox- OTC

10 OTC bulletin 23 August 2013 OTC23-08-13p10-11FIN_Layout 1 20/08/2013 13:47 Page 3

COMPANY NEWS OTC

Second-QuarterResults Emerging markets boost OTC at Bayer

ayer Consumer Care posted sales up by Business Second-quarter sales Change EBIT Change B 2.5% to C 950 million in the second quar- (C millions) 2012/2013 (%) (C millions) 2012/2013 (%) ter of 2013, drivenbyastrong performance in emerging markets. Pharmaceuticals 2,831 +5.5 472 >100 The German firm said the Consumer Care Consumer Care950 +2.5 –– business had achieved“gratifying sales gains” Medical Care657 +0.3 –– in anumber of such markets, especiallythose Animal Health 362 +0.6 –– of Argentina, Brazil and Russia. Consumer Health 1,969 +1.4 257 +38.2 Adjusted for currencyand portfolio changes, the rise in Consumer Care’ssales wasaneven Total Bayer HealthCare4,800 +3.8 729 >100 more impressive 5.4%. Figure3:Breakdown of Bayer HealthCare’s sales and earnings beforeinterest and tax (EBIT) in the second Bayer’smore intense focus on its emerg- quarter of 2013 from continuing operations (Source –Bayer) ing markets region also benefitted anumber of its keyConsumer Care brands, with four of the Adjusted for currencyeffects, turnovermoved sales in Russia, the companyexplained. business’ six biggest-selling brands posting forward by 14.9%. Consumer Care’sbiggest-selling brand, As- notable performances in the region. Canesten had also benefitted from increased pirin, reported a2.8% advance in sales to C 110 Sales of the painkiller brand Aleve had risen marketing in emerging markets, Bayer point- million in the three months. However, when by 3.7% –5.0% when adjusted for currency ed out, with sales of the antifungal brand ad- taking into account currencymovements, the effects –toC 85 million (see Figure 1), Bayer vancing by 14.8% –19.1% adjusted for cur- brand’sturnoverslipped back by 2.0%. noted, thanks in part to higher demand in Brazil. rencyeffects –toC 70 million. The Consumer Care business accounted for Expanding marketing activities across the Meanwhile, the Supradyn multivitamin brand 48% of sales at Bayer’sConsumer Health div- company’semerging markets had helped drive had posted turnoverupby15.2%, or 21.5% ision, which movedforward by 1.4% –4.2% up sales of the Bepanthen/Bepanthol skincare when adjusted for currencyeffects, to C 38 mil- adjusted for currencyand portfolio effects – line by 11.4% to C 78 million, the firm said. lion, thanks to a“significant” improvement in to C1.97 billion. Europe remained Consumer Health’sbiggest Brand (business unit) Second-quarter sales Change 2012/2013 (%) region in terms of sales, with turnoverimprov- (C millions) C CER* ing by 5.1% –5.7% adjusted for currency effects –toC720 million (see Figure 2). Contour (Medical Care) 197 +13.2 +15.0 Turnoverinthe Latin America/Africa/Mid- Advantage (Animal Health) 148 -5.1 -3.0 dleEast region grewquickest, with sales rising Aspirin** 110 +2.8 -2.0 by 7.0% to C304 million. Adjusted for currency Ultravist (Medical Care) 87 ±0.0 +3.2 effects, the jump wasanimpressive 14.1%. Aleve/naproxen 85 +3.7 +5.0 By contrast, sales in the Asia/Pacific region Bepanthen/Bepanthol 78 +11.4 +14.9 slipped back by 6.2% to C301 million. How- Canesten 70 +14.8 +19.1 ever,adjusted for currencyeffects, turnover Gadovist (Medical Care) 49 -3.9 -3.9 edged up by 0.3%. One-A-Day 45 -10.0 -8.5 Currencyeffects also impacted the North Supradyn 38 +15.2 +21.5 America region. Sales as reported dropped by Top10total 907 +4.1 +5.6 1.2% to C644 million, butwhen adjusted, turn- overinNorth America improvedby0.8%. Consumer Health total 1,969 +1.4 +4.2 Consumer Health’ssecond-quarter earnings *CER is constant exchange rates ** Total Aspirin sales –including Aspirin Cardio, which is part of the Pharmaceuticals division –were C226 million before interest and tax (EBIT) had increased by a“substantial” 38.2%, to C257 billion (see Figure1:Sales of the top 10 best-selling brands in Bayer’s Consumer Health division in the second quarter of Figure 3), Bayer noted, due primarily to abig 2013. Brands arepartofthe Consumer Carebusiness unit unless stated (Source –Bayer) reduction in ‘special item’ costs. Region Second-quarter sales Change 2012/2013 (%) The Consumer Health division generated (E millions) C CER* 41% of sales at the Bayer HealthCaresub- group, which posted turnoverupby3.8% – Europe 720 +5.1 +5.7 7.6% adjusted for portfolio and currencyeffects North America 644 -1.2 +0.8 –toC4.80 billion. Asia/Pacific 301 -6.2 +0.3 The remaining 59% of HealthCare’ssales Latin America/Africa/Middle East 304 +7.0 +14.1 came from the dominant Pharmaceuticals busi- ness, which reported sales up by 5.5% to C2.83 Total Bayer Consumer Health 1,969 +1.4 +4.2 billion. Adjusted for currencyeffects, the im- *CER is constant exchange rates provement was10.0%. Figure2:Breakdown of Bayer Consumer Health’s sales in the second quarter of 2013 by region (Source –Bayer) OTC

23 August 2013 OTC bulletin 11 OTC23-08-13p12-13FIN_Layout 1 20/08/2013 13:50 Page 2

OTC COMPANY NEWS

Second-QuarterResults Centrum lifts PfizerConsumer Healthcare

fizer said that worldwide sales at its Con- Business Second-quarter sales Change Proportion Psumer Healthcare division had risen by 4% (US$ millions) 2012/2013 (%) of sales (%) to US$800 million (C604 million) in the second quarter of 2013, thanks to “strong growth” of Specialty Care 3,378 -3 26 the Centrum multivitamin brand. Primary Care 3,333 -17 26 Several product launches in “key interna- Emerging Markets 2,615 ±0 20 tional markets” had boosted Centrum’ssales, Established Products 2,385 -11 18 the companypointed out, along with increased Consumer Healthcare800 +4 6 promotional activities in the US. These followed Oncology 399 +24 3 favourable results from a“landmark study” that evaluated the long-term health benefits of multi- Other 63 +5 >1 vitamins for men aged 50 years and older. Total Pfizer 12,973-7100 However, the success of Centrum wasnot enough to lift Consumer Healthcare’sUSsales, Figure1:Pfizer’s sales in the second quarter of 2013 broken down by business (Source –Pfizer) which fell back by 1% to US$337 million. By contrast, international turnoverhad advanced The companynoted that its proposed switch about other programme details or timelines”. by 8% to US$463 million, Pfizer said. of Nexium in the US wasontrack and the Astatin has neverbeen granted OTCstatus Looking ahead, Pfizer Consumer Health- companyexpected to launch an OTCversion in the US before and it is nowmore than a care is set to launch an OTCversion of Astra- of the product in the US in 2014. decade since Bristol-Myers Squibb and Merck Zeneca’sproton-pump inhibitoresomeprazole, Meanwhile, Pfizer’splan to switch the chol- &Coattempted to switch Pravachol (pravas- under the brand name Nexium Control, across esterol-lowering drug Lipitor (atorvastatin cal- tatin) and Mevacor (lovastatin) respectively the European Union (EU) in the near future. cium) from prescription to non-prescription (OTC bulletin,30June 2000, page 16). Indicated for short-term treatment in adults status in the US had continued to progress at Consumer Healthcare accounted for around of reflux symptoms, such as heartburn and acid a“good pace”, aspokesperson for the com- 6% of Pfizer’stotal first-quarter sales, which fell regurgitation, Nexium Control should be the panytold OTC bulletin. by 7% to US$13.0 billion (see Figure 1). third medicine switched through the EU’scen- In May,Pfizer said that it was“advancing the The decline wasprimarily due to adrop in tralised procedure after the European Medicines various phases” of its Lipitor switch programme turnoveratthe company’sdominant prescrip- Agency(EMA) said that its Committee for and was“actively working to address the chal- tion pharmaceuticals divisions, after several Medicinal Products for Human Use (CHMP) lenges highlighted by previous industry attempts keyproducts –including Lipitor –lost exclu- had adopted apositive opinion on the switch. to switch acholesterol-lowering product”. sivity last year. Once the European Commission has adopt- “Solving these issues and challenges, such Pfizer’spre-tax income from continuing op- ed the opinion, Nexium Control will be auth- as ensuring appropriate self-selection, is an iter- erations improvedby19% to US$3.58 billion. orised as anon-prescription medicine in all 28 ative process,”the spokesperson pointed out. This wasthanks to adecline in operating costs member states of the EU. Asked when aswitch application for Lipi- and lower restructuring and acquisition-relat- Pfizer snapped up the global rights to non- tor would be filed with the US Food and Drug ed charges. prescription versions of Nexium for an initial Administration (FDA), the spokesperson said The results were announced as Pfizer reveal- US$250 million (C191 million) from Astra- that giventhe “multiple layers of complexity ed plans to reorganise the companyinto three Zeneca last September (OTC bulletin,14Sept- with this particular switch and competitor inter- separate business segments from January 2014. ember 2012, page 1). est in the market” the firm could not be “specific Consumer Healthcarewill join Pfizer’sVac- cines and Oncology units in one of twoInno- vation segments. The other Innovation segment will coverabroad array of therapeuticcategories, Second-QuarterResults while aValue segment will house Pfizer’soff- Avid Health helps sales at Church &Dwight patent products, mature brands and biosimilars. Operations currently covered by Pfizer’sEm- cquiring Avid Health and its range of Personal Care Products accounted for 40% erging Markets division will be split between Achewable “gummy” format vitamins, min- of sales at the company’sdomestic consumer the Value segment and twoInnovative segments. erals and supplements helped drive up Church business, which posted turnoverupby17.4% Amy Schulman, Pfizer’sexecutive vice pres- &Dwight’ssales by 13.1% in the second quar- to US$595 million. ident, general counsel and head of Consumer ter of 2013. Household Products generated the remain- Healthcare, will lead the Vaccines, Oncology Reporting turnoverofUS$788 million der of the firm’sdomestic consumer sales. and Consumer Healthcare Innovation unit. (C593 million) for the three months, the US- International consumer sales improvedby Meanwhile, Pfizer has sold its remaining based consumer products companysaid that 9.4% to US$133 million. The company’sSpe- 80.2% stakeinits Animal Health division –now adding Avid had drivenupsales at its domes- cialty Product division posted turnoverdownby called Zoetis –through ashare exchange offer tic Personal Care Products business by 50.0% 12.0% to US$60.4 million. valued at US$11.4 billion. to US$241 million. OTC OTC

12 OTC bulletin 23 August 2013 OTC23-08-13p12-13FIN_Layout 1 20/08/2013 13:50 Page 3

COMPANY NEWS OTC

First-HalfResults Brands and acquisitionsdrive Reckitt

trong performances from both existing Business First-halfsales Change 2012/2013 (%) S brands and recent acquisitions had led to (£ millions) £CER* an “excellent” opening six months of 2013 for Reckitt Benckiser’s(RB’s) Health category, Hygiene 1,993 +6 +6 according to the company’schief executive offi- Health 1,197 +32 +31 cer Rakesh Kapoor. Home 979 +2 +1 Sales at the UK-based consumer goods RB Pharmaceuticals 400 +4 +2 giant’sHealth category movedforward by 32% Portfolio Brands 265 -31 -33 –31% at constant exchange rates –to£1.20 Food 160 +3 ±0 billion (C 1.38 billion) in the first half of the year (see Figure 1). Total Reckitt Benckiser 4,994 +7 +6 Organic growth accounted for 14% of the *CER is constant exchange rates

total gain, acquisitions afurther 17% and pos- Figure1:Reckitt Benckiser’s sales in the first half of 2013 by business (Source –Reckitt Benckiser) itive currencyeffects the remaining 1%. “Our Health portfolio has had an excellent good progress on costs and synergies. In the US, Mucinexhad outperformed a first half,”Kapoor said, “with Mucinexout- Schiff’s“excellent” results in the first half strong market, RB said, while Durex, Gavis- performing avery strong market with excellent of 2013 had proventhat RB had acquired “very con, Scholl Footcare and Strepsilshad all per- innovations such as Sinus-Max and the con- high-qualitybrands in an exciting VMS cate- formed well in Europe, thanks to an increase tinued success of our Fast-Max line.” gory”, Kapoor claimed, which would deliver in investment and newproduct innovations. Durexhad also delivered strong growth, “sustainable shareholder returns”. In the LAPAC region –consisting of Aus- supported by the roll out of ‘Real Feel’ polyiso- RB had also started to improve Schiff’s tralia/NewZealand, Latin America, North Asia, prene condoms in anumber of markets, Kapoor “in-store execution”, Kapoor pointed out, and and South and South-East Asia –Health’s pointed out, and “creative digital communica- had increased“brand equity investment” be- Durex, Gaviscon and Nurofen powerbrands tions” around the world. This wasthe case in hind Schiff’skey brands such as MegaRed and had posted strong gains, RB said. China in particular, which had nowbecome the Move Free. This had drivenlike-for-likegrowth Meanwhile, Durexhad been the Health sexual health brand’sbiggest market. that waswell above that of the US VMS mar- category’smain growth driverinthe RUMEA Furthermore, there had been encouraging ketasawhole. region, which covers the Middle East, North starts for the Strepsils Children 6+ sore-throat Africa and Turkey,Russia and the Common- lozenge product, RB noted, along with Nuro- Good startfor acquisitions wealth of Independent States (CIS), and Sub- fen heat patches. Turning to the company’sother recent health- Saharan Africa. In addition to the good performances from care acquisitions, Kapoor said that the Myan- Sales of the Nurofen powerbrand in the established brands, RB’sHealth category also shuning sore-throat brand in China had achiev- RUMEA region had suffered, the companyex- benefitted from solid early results from its re- ed “good growth” in the first half of the year. plained, after some of the range had been re- cent acquisitions, most notably the US-based RB had receivedregulatory clearanceinMay verse-switched in Russia. vitamins, minerals and supplements (VMS) firm for its OTCcollaboration in Latin America with Health accounted for 24% of RB’stotal first- SchiffNutrition International. Bristol-Myers Squibb and integration was“fully half sales, which improvedby7%asreported Having paid US$1.4 billion (C 1.1 billion) on track”, he added. andby6%atconstant exchange rates to £4.99 for Schifftowards the end of last year (OTC On aregional basis, Health’ssales in the billion (see Figure 2). bulletin,18December 2012, page 1), RB had Europe and North America reporting region The Hygiene category generated 40% of the already harmonised trading terms with cus- had been drivenbystrong performances by total, with sales growing by 6% as reported and tomers, Kapoor explained, and had begun to all the company’sHealth powerbrands, includ- at constant exchange rates to £1.99 billion. implement its operational plans while making ing Durex, Mucinex, Nurofen and Strepsils. This rise had been drivenbystrong growth from the Dettol/Lysol brand globally,the com- Region First-half sales Change 2012/2013 (%) pany said, thanks to newinitiativesinthe kitch- (£ millions) £CER* en, soap and body-wash categories. OTC Europe and North America 2,451 +6 +4 LAPAC** 1,280 +11 +13 RUMEA*** 703 +4 +5 IN BRIEF Other**** 560 ––■ HYPERMARCAS said sales at its Pharma Total Reckitt Benckiser 4,994 +7 +6 division, which includes the Dorsay Monange OTCbusiness, had risen by 13.3% in the sec- *CER is constant exchange rates ** LAPAC region consists of Australia/NewZealand, Latin America, North Asia, and South and South-East Asia ond quarter of 2013 to BRL601 million ( C 199 *** RUMEA consists of Middle East, North Africa and Turkey,Russia and the CIS, and Sub-Saharan Africa million). The Brazilian consumer goods firm’s **** RB Pharmaceuticals and Food, which are not reported as part of anyregion total sales grewby11.7% to BRL1.07 billion. Figure2:Reckitt Benckiser’s sales in the first half of 2013 by region (Source –Reckitt Benckiser) OTC

23 August 2013 OTC bulletin 13 OTC23-08-13p14-15FIN_Layout 1 20/08/2013 14:45 Page 2

OTC COMPANY NEWS

First-HalfResults Celesio remains on track after changes

he change of senior management at Cele- Business First-half sales Change EBITDAChange Tsio will not knock offcourse the restruc- (C millions) 2012/2013 (%) (C millions) 2012/2013 (%) turing of the business, according to aspokes- PharmacySolutions 9,052 -5.0 180 +3.0 person for the pan-Europeanwholesaler and retailer’smanagement board and chief finan- Consumer Solutions 1,680 -2.3 127 +7.5 cial officer,DrMarion Helmes. Other ––-39 – Speaking as Celesio reported its first-half Total Celesio 10,733-4.6 268 +10.3 results, Helmes said that the company’scost- saving and efficiencyprogramme continued to Figure1:Celesio’s sales and earnings beforeinterest, tax, depreciation and amortisation (EBITDA) from continuing operations in the first half of 2013, broken down by business (Source –Celesio) improve its competitiveness, while the pilot pro- ject for its European pharmacynetwork was line its business by selling anumber of assets, business and negative currencyeffects. “progressing well”. including its underperforming Czech retail phar- Adjusted for portfolio and currencyeffects, “These successes encourage us to forge macyand wholesaling operations (OTC bul- turnoverhad increased by 1.2%, Celesio said. ahead with the strategic realignment as plan- letin,14September 2012, page 6) and its Doc- Sales at the Lloydspharmacychain in the ned,”Helmes insisted. Morris business to Switzerland’sZur Rose UK –which accounts for 65% of Consumer Helmes made her comments shortly after (OTC bulletin,9November 2012, page 15). Solutions’ turnover––had fallen in the six Celesio fired its chief executive officer Markus In December,Pinger announced that Celesio months, Celesio pointed out, due primarily to Pingerafter less than twoyears in the role due intended to makeLloyds the leading pharmacy government measures. to a“difference of opinion” overthe manage- brand in Europe(OTC bulletin,18December Despite the drop in turnover, Lloydsphar- ment of the company(OTC bulletin,26July 2012, page 1). The Lloyds name originated in macy’s earnings in the three months had grown, 2013, page 27). the UK, where the Lloydspharmacychain now the firm noted, thanks to anew operational struc- In the surprise July announcement, the pan- includes more than 1,500 stores. ture, which more closely linked the pharmacy European wholesaler and retailer said Pinger All of its 2,177 retail pharmacies across six and wholesale sides of its UK business. had left the companywith immediate effect, European countries would be rebranded under Across the rest of Europe, sales at the com- with Helmes taking overPinger’sresponsibil- the Lloyds banner as part of anew strategy, pany’s Norwegian pharmacychain –its second itiesonaprovisional basis. Pinger said, which also included the creation of biggest after the UK –had developed well, Commenting on Helmes’ expanded role, apan-European virtual pharmacynetwork. Celesio pointed out, with turnoverfrom OTC Stephan Gemkow,chairman of Celesio’ssuper- Turning to Celesio’sperformance in the products growing strongly.However,this was visory board, pointed out that she had “con- opening six months of 2013, the firm pointed not enough to offset the negative impact of ris- tributed decisively to the chosen path of the re- outthat the Consumer Solutions division –for- ingcosts on earnings, the companyadded. alignment of the group”. merly known as Patient and Consumer Solu- In Italy,anincrease in sales of OTCproducts Pinger joined Celesio from Beiersdorf in tions –had posted sales down by 2.3% to C1.68 had offset adrop in prescriptionrevenues, Cele- August 2011 (OTC bulletin,30June 2011, page billion (see Figure 1). sionoted, while earnings had also grown thanks 1) and afew months later instigated aturn- Austerity measures affecting healthcare pol- to cost-saving measures. around plan that he claimed would return the icyinanumber of European markets –in- Celesio’sfledgling Swedish pharmacychain firm to its roots in wholesaling and retailing cluding the UK –had negatively impacted had also fared well in the first half, the com- (OTC bulletin,31October 2013, page 1). sales, the companynoted, along with the sale panynoted, thanks to better buying policies The turnaround plan has seen Celesio stream- of the firm’sunderperforming Czech retail and further cost savings. Thedivision’searnings before interest, tax, depreciation and amortisation (EBITDA) im- provedby7.5% to C127 million. Adjusted for First-HalfResults special effects, EBITDAfell back by 5.7%. Boehringer Ingelheim posts OTC increase Celesio attributed the reported increase in EBITDAtothe positive impact of the cost sav- oehringer Ingelheim said sales at its Con- OTCswitch product Vaprino, anew “mono ings in the UK and the advantageous effect of Bsumer Health Care business in the open- substance” for treating acute diarrhoea. currencyfluctuations on expenses. ingsix months of 2013 had improvedby8.3% Amonth later the companyadded another The Consumer Solutions division accounted when adjusted for currencyeffects. switch product to its German OTCrange, when for 15% of Celesio’sfirst-half sales, which de- Consumer Health Care’sturnoverjumped it launched the Boxagrippal combination cough clined by 4.6% to C10.7 billion. EBITDAad- to C712 million in the first half of the year,the and cold product. vanced by 10.3% to C268 million. privately-owned German firm said, account- Earlier this year,the firm said that both prod- Celesio’sdominant PharmacySolutions ing for atenth of its total group sales. These ucts would “offer considerable growth opportu- wholesale division posted a5.0% drop in sales had increased by 3.1% when adjusted for cur- nities for the German self-medication business”, to C9.05 billion in the six months. EBITDA rencyeffects to C7.1 billion. andwould also be “launched in additional coun- at the PharmacySolutions business edged up In June, Boehringer Ingelheim bolstered its tries” (OTC bulletin,10May 2013, page 2). by 3.0% to C180 million. German OTCbusiness with the prescription-to- OTC OTC

14 OTC bulletin 23 August 2013 OTC23-08-13p14-15FIN_Layout 1 20/08/2013 14:45 Page 3

COMPANY NEWS OTC

First-HalfResults Arbidol leadsPharmstandardsales rise

harmstandard said its OTCsales had im- Business First-halfsales Change Proportion P provedbyafifth in the first half of 2013, (RUB millions) 2012/2013 (%) of total (%) led by astrong performance from its keyArb- idol influenza brand. Branded OTCproducts 5,366 +19 33 Total OTCsales had reached RUB6.64 mil- Unbranded OTCproducts 1,270 +25 8 lion (C 151 million) in the six months, the Rus- Total OTCproducts 6,635 +20 40 sian firm noted, as sales of Arbidol –the com- Prescription drugs 2,932 +30 18 pany’s biggest-selling OTCbrand –jumped by Third-party prescription drugs 5,892 -24 36 75% to RUB1.14 billion. Medical equipment 464 +22 3 All Pharmstandard’stop 10 biggest-selling Other sales 512 +103 3 brands reported double-digit gains in the period, helping drive up the company’sbranded OTC Total Pharmstandard 16,436+2100 sales by 19% to RUB5.37 billion (see Figure 1). Another anti-viral brand, Amixin, wasthe Figure1:Breakdown of sales by Pharmstandard’s top 10 OTC brands and other businesses in the first half of 2012 (Source –Pharmstandard) next best performerafter Arbidol, with sales rising by 72% to RUB432 million, while the which edged up by 2% to RUB16.4 million. Meanwhile, Pharmstandard planned to ac- Afobazol anxiety product posted turnoverup Following the close of the period, Pharm- quire Beverand transfer that business to the by 58% to RUB469 million. standard revealed plans to spin-offits brand- newbranded OTCentity,giving the spun-off Complivit vitamins, Pharmstandard’ssec- ed OTCbusiness into aseparate legalentity business its ownsource of active pharmaceu- ond-biggest OTCbrand, wasthe worst per- ( OTC bulletin,26July 2013, page 6). tical ingredients. former of Pharmstandard’sleading brands, but The firm also announced that it wasinad- If the plans –which shareholderswill vote still reported sales up by atenth to RUB728 vanced talks to acquire Singapore-basedservices on in September –are approved, the newbrand- million in the six months. companyBever Pharmaceuticals for US$630 ed OTCbusiness wasexpected to become fully Sales of Pharmstandard’sunbranded OTC million (C 471 million).Shareholdersvoted in operational in February or March 2014. brands increasedevenquicker than their brand- favour of the buyon17August 2013. Pharmstandard is also set to takefull con- ed counterparts, with turnovergrowing by Explaining the details of the twostrategic trol of its Donelle subsidiary by acquiring the 25% to RUB1.27 billion. moves, Pharmstandard said that shares in the 10.87% of the business it does not already OTCproducts accountedfor 40% of Pharm- newbranded OTCbusiness would be “propor- own. Donelle’sAfofarm unit owns the rights to standard’stotal sales in the first half of 2013, tionally distributed among shareholders”. the Afobazol OTCanxiety product. OTC

IN BRIEF BusinessStrategy/Second-QuarterResults ■ MOBERG DERMA has launched its Ker- Actavis mulls European business options asal NeuroCream in the US. Described as a triple-action formula that relievesstabbing, ctavis is considering “a range of strategic chief executive officer,Paul Bisaro, insisted burning, tingling foot pain, warms cold feet, A alternatives”, including “possible divesti- that the firm would “look at the pharmaceuti- and soothes and moisturises dry skin, Kerasal ture”, for some of its businesses in Western cal space holistically” and “provide those prod- NeuroCream contains capsaicin and camphor Europe, the companyhas confirmed, as it con- ucts that the markets we operate in need”, in- and features a“no mess” foam applicator. tinues to explore plans to restructure its opera- cluding OTCproducts. Meanwhile, Mobergposted sales up by 83% tions in the region. At the same time, Actavis has registered an to SEK44.9 million (C 5.2 million) in the sec- Siggi Olafsson, president of the firm’sAct- impairment charge linked with its European ond quarter of 2013, as the international roll- avis Pharma generics division, said the com- operations after combining its Arrowunit with out of its Emtrix/Nalox/Kerasal Nail anti-fungal pany wasexamining in particular“six or seven the ‘legacy Actavis’ business that wasmerged nail-care product continued. markets” in which “the healthcare environment with the former Watson business last year has changed”. Whilst Olafsson acknowledged ( OTC bulletin,30April 2012, page 1). ■ PHARMACY CHAIN 36.6 said sales at its that Actavis wasconsidering restructuring or Total impairment charges of US$655 million core Retail business had slipped back by selling certain operations in these countries, he ( C 495 million) reported in the second quarter 2% to RUB3.64 billon ( C 83.1 million) in the insisted that the firm was“not leaving these of 2013 included US$648 million relating to first quarter of 2013. This decline had been markets” outright. “These markets have to be Europe and afurther US$4.4 million from the compounded by a27% fall in sales to RUB1.20 part of aglobal leading speciality companylike Arrowacquisition. billion at its manufacturing unit Veropharm, we are today,” he stated. Actavis Pharma’ssales in the quarter rose by the Russian companynoted, leading to a9% Restructuring could include leaving “some 58% to US$1.57 billion. Including Specialty drop in total group turnovertoRUB5.02 bil- of the businesses up and running”, Olafsson Brands and Anda distribution sales, Actavis’ lion. Other sales made up the remainder. said, including the company’sOTC and Spe- group total grewby47% to US$1.99 billion. OTC cialty Brands businesses. Actavis’ president and OTC

23 August 2013 OTC bulletin 15 OTC23-08-13p16-20GN_Layout 1 20/08/2013 16:20 Page 2

OTC GENERAL NEWS

Regulatory Af fairs Regulatory Af fairs US warns on FDA takes action against skinreactions illegal diabetes products arnings that acetaminophen –paraceta- W mol –can cause serious skin reactions he US Food and Drug Administration companies that sold illegalproducts that claim- should be added to labels of all prescription T(FDA) is clamping down on unlicensed ed to treat diabetes. products containing the ingredient, the US Food products, including dietary supplements that The most high-profile recipient of aWarning andDrug Administration (FDA) has said. The claim to cure or prevent diabetes, and has ad- Letter wasHi-Tech Pharmacal. The US-based agencyadded it would also push for manufac- vised consumers to stop using such products. firm waswarned overthe labelling of three of turers of acetaminophen-containingOTC medi- Warning Letters had been sent to 15 domes- its OTCproducts aimed at people with diabetes. cines to add the warnings to their labels. tic and international firms, the FDAsaid, inform- The letter says that certain statements on the Although rare, the twomost serious reac- ing them that the products theysold to treat dia- labelling of its Diabeti-Derm Antifungal Cream, tions linked with acetaminophen were Stevens- betes and its complications violated federal law. Zostrix Diabetic Foot Pain Relief Cream and Johnson syndrome (SJS) and toxic epidermal At the same time, the agencyissued abul- Zostrix Diabetic Joint &Arthritis Pain Relief necrolysis (TEN), the FDApointed out. These letin advising consumers to stop using such Cream claim that the products can treat certain could cause rashes, blistering and extensive products as theycould contain “harmful ingre- symptoms related to diabetes. damage to the surface of the skin, and could dients” or “may be otherwise unsafe”. occur with first-time use of acetaminophen or It added that some treatments may be “im- Claims made products unapproved drugs at anytime while it wasbeing taken. Such properly marketed as OTCproducts” when they Although the three products are labelled reactions usually required hospitalisation, the should be marketed as prescription products. as either topical analgesics or antifungals with agencyadded, and could potentiallybefatal. Manyofthe products sold illegally included stated uses that do not include the symptoms Athird reaction –acute generalised exan- claims such as “prevents and treats diabetes”, of diabetes, these other claims makethe Dia- thematous pustulosis (AGEP) –usually cleared and “can replace medicine in the treatment of beti-Dermand Zostrix products “unapproved within twoweeks of taking the medication that diabetes”, the FDAsaid. Other claims included newdrugs” in violation of section 505 of the caused the reaction, the FDAnoted. There was “lower your blood sugar naturally” and “for Federal Food, Drug and Cosmetic (FD&C) Act, currently “no wayofpredicting who might relief of diabetic foot pain,”the agencyadded. the FDAnotes. be at ahigher risk”, it added. Margaret Hamburg, FDAcommissioner, Furthermore, the Diabeti-Derm Antifungal Those who had suffered aserious skin reac- pointed out that diabetes wasa“serious chronic Cream is also misbranded under section 502 of tion with acetaminophen should stop taking the condition that should be properly managed using the FD&C Act, the letter states, as it lists un- drug and contact their healthcareprofessional. safe and effective FDA-approvedtreatments”. decylenic acid 10% as the active ingredient in “Consumers who buythese products that the drugs facts information, butthe labelling Review found 91 cases of SJS or TEN claim to be treatments are not only putting them- describes l-arginine –aninactive ingredient – Thewarning is based on the FDA’sreview selves at risk,”Hamburgnoted, “but also may in arole greater than its inactive purpose. of its ownadverse-event reporting system data- not be seeking necessary medical attention, The Warning Letter advises Hi-Tech to re- base and medical literature. It wasfound that which could affect their diabetes management.” viewall information related to its products to there had been 91 identified cases of SJS or Howard Sklamberg, director of the FDA’s assure compliance with all requirements of fed- TENand 16 cases of AGEP between 1969 and Center for Drug Evaluation and Research’s eral lawand FDAregulations. 2012, which had resulted in 67 hospitalisations Office of Compliance, said the agencywould In response, Hi-Tech said that it intended to and 12 deaths. Of the 91 cases, six were cate- continue to take“aggressive action” against “fully comply” with the FDArequirements. gorised as probablecases associated with ace- OTC taminophen, the FDAadded, noting that the majority of cases had involved products con- Regulatory Af fairs taining the substance as asingle ingredient. However, the agencystressed that it con- CRN opposes new labelling law proposal tinued to consider the benefits of acetamino- phen to outweigh the risks. The FDApointed he US Council for Responsible Nutrition the FDAtorequire labels for products or in- out that its actions should be “viewed within T (CRN) has hit out at abill covering the gredients that could cause adverse effects or the context of the millions who, overgenera- labelling of dietary supplements proposed by potential risks,”Mister said, “as this is acase tions, have benefitted from acetaminophen”. twoUSsenators. of precautionary principle run amok.” “Nonetheless, giventhe severity of the risk, Steve Mister,the CRN’spresident and chief Introduced by Senators Richard Durbin and it is important for patients and healthcare pro- executive officer,claimed the Dietary Supple- Richard Blumenthal, the Dietary Supplement viders to be aware of it,”itadded. ment Labeling Act of 2013 would create “add- Labeling Act of 2013 would amend the Federal The warning comes twoyears after the FDA ed burdens” for the US Food and Drug Admin- Food, Drug, and Cosmetic Act to require manu- cut the maximum prescription dose of acetam- istration (FDA) and for companies that were al- facturers of dietary supplements to register diet- inophen to 325mg, to help reduce liverdamage ready complying with the existing Dietary Sup- ary supplements with the FDAand to change ( OTC bulletin,21January 2011, page 1). plement Health &Education Act (DSHEA). labelling requirements. OTC “Wecannot support legislation that directs OTC

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GENERAL NEWS OTC

UKRegulatory Af fai considerrs soral diclofenac options

he UK is considering whether to reverse- option three is to reverse-switch diclofenac tion, the MHRA promises. Tswitch oral diclofenac from pharmacy(P) tablets to POM status. Responding to the consultation paper,Sheila to prescription-only (POM) status following a Themeasures identified by the CHM include: Kelly,chief executive of the Proprietary As- recent safety reviewbythe European Medicines removing from the indications ‘the symptoms sociation of Great Britain (PAGB), said that the Agency’s(EMA’s)Pharmacovigilance Risk As- of colds and flu, including fever’; strengthen- association would work with its member com- sessment Committee (PRAC). ing the warnings on the pack about use by those panies to “improve the information givento In its consultation paper MLX382,the with cardiovascular disease or with significant patients when theybuy the product” so tablets Medicines and Healthcare products Regula- risk factors for cardiovascular events; and remained available without prescription. tory Agency(MHRA) says that in light of the strengthening warnings on the pack about not In July,the PRAC’srecommendations were PRAC’s recent recommendations –that patients taking diclofenac with other non-steroidal anti- endorsed by Europe’sCoordination Group for with serious underlying heart conditions should inflammatory drugs (NSAIDs). Mutual Recognition and Decentralised Proce- not use diclofenac due to asmall increased dures-human (CMDh). risk of heart attack and stroke(OTC bulletin, Work to minimise risk Aspokesperson for the EMA told OTC 28 June 2013, page 9) –itwas considering Furthermore, the CHM recommends work- bulletin:“The PRACrecommendation applies whether diclofenac tablets should remain avail- ingwith the pharmacyprofession to implement to all doses of diclofenac, regardless of their able to buywithout aprescription. further measures to minimise the risk of OTC status. There wasnodistinction made in the The MHRA says it is considering three diclofenac,and requesting that the marketing PRACrecommendation between prescription options for minimising the risks of oral diclo- authorisation holders prepare arisk-manage- and non-prescription diclofenac.” fenac to certain users. Option one is to takeno ment plan to minimise the dangers of oral diclo- TheCMDh position on diclofenac will now newrisk-minimisation measures, the consulta- fenac as aPmedicine. be sent to the European Commission, which will tion paper says. Option twoistoimplement all No matter what the outcome of the con- makeadecision that is legally-binding through- the measures identified by the agency’sCom- sultation, topical diclofenac formulations would out the European Union (EU). mission on Human Medicines (CHM), while continue to be available without aprescrip- OTC

23 August 2013 OTC bulletin 17 OTC23-08-13p16-20GN_Layout 1 20/08/2013 16:20 Page 4

OTC GENERAL NEWS

Regulatory Af fairs with 30-36mg of caffeoylquinic acids; 500mg red yeast rice with 2mg monacolin K; 10mg EFSAispositiveabout sugar-cane derivedpoliosanols; 20mg French maritime pine bark extract with 18mg OPC; 30mg garlic dry extract with 0.25mg allicin; 30mg alpha-tocopherol equivalents; 5mg ribo- Limicolcholesterol claim flavin and 9mg inositol hexanicotinate. The target population wasadults wishing to rench firm Laboratoire Lescuyer has been hydrogen succinate,riboflavin and inositol hex- reduce their blood cholesterolconcentrations, Fgivenapositive opinion by the European anicotinate –onthe concentrations of LDL- the EFSA panel stated. It also noted that “dou- Food Safety Authority (EFSA) for its health cholesterol in the blood. bling the dose of [Limicol] did not have an addi- claim that its food supplement Limicol can re- The panel had been asked to approve the tional effect on LDL-cholesterol concentrations”. duce cholesterol. wording: “Oral consumption of the food sup- Meanwhile, three health claims have been The firm has asked that its proprietary data plement Limicol significantly reduces circulat- rejected by the EFSA panel. for its Article 14 disease-risk reduction claim ing LDL-cholesterol level, thus reducing the Through the Finnish competent authority, should be protected under the provisions of risk of coronary heart disease.” FukoPharma had wanted to claim that Lac- the Health Claims Regulation 1924/2006. The target audience wassaid to be “males tobacillus rhamnosus helps to maintain normal In reaching its positive opinion that Limicol and females from 18 to 65 years with mild to defecation during antibiotic treatment. Vivatech, reduced blood low-density lipoprotein(LDL) moderate hypercholesterolaemia”. meanwhile, had used the French competent auth- cholesterol concentrations, EFSA’s Panel on ority to submit aclaim for its Transitech food Dietetic Products, Nutrition and Allergies, the Not comfortable with Limicol name supplement that it improvedbowel function. NDA, noted that no evidence had been provided However, the EFSA panel wasnot comfort- Both health claims were rejected, however, showing an effect of anyofthe single ingredients able with using the Limicol brand name. It said for lack of acause and effect relationship be- of Limicol on lowering blood LDL cholesterol. the claim that reflected the scientific evidence tween consumption and outcome. Neither had Lescuyer –applying through was: “A combination of artichokeleaf dry ex- Clasado’sappeal via the Maltese competent the French competent authority –explained how tract standardised in caffeoylquinic acids, mon- authority wasalso turned down by EFSA’s Diet- the ingredients individually or in anycombina- acolin Kinred yeast rice, sugar-cane derived etic Products, Nutrition and Allergies panel. tioncould contribute to the claimed effect. policosanols, OPC from French maritime pine The company’searlier application had not However, three human intervention studies bark, garlic dry extract standardised in allicin, established acause and effect relationship be- conducted by twoindependent researchgroups d-a-tocopheryl hydrogen succinate, riboflavin tween consuming its Bimuno GOS food con- hadshown an effect of the combination of food andinositol hexanicotinatereduces blood LDL- stituent and reducing gastrointestinal discom- ingredients –artichokeleaf dry extract stan- cholesterol concentrations. High LDL choles- fort (OTC bulletin,14September 2012, page dardised in caffeoylquinicacids, monacolin K terol is arisk factor in the development of coro- 21). Additional information provided by Clas- in red yeast rice, sugar-cane derivedpolico- nary heart disease.” ado to support the claim “did not address im- sanols, oligomericproanthocyanidins (OPCs) Moreover, Limicol could only bear the claim portant methodological limitationswhich were from French maritime pine bark, garlic dry ex- in the context of three daily doses with major identified by the panel in its previous opin- tract standardised in allicin, d-alpha-tocopheryl meals of 600mg of artichokeleaf dry extract ion”, EFSA pointed out. OTC

IN BRIEF Regulatory Af fairs ■ EMA –the European Medicines Agency– EMA wants oral ketoconazoleban has revised its procedural guidance to reflect changes to the European Commission’sguide- he European Medicines Agency’s(EMA’s) wastriggered by the suspension of the medi- lines on variations.Two newclassifications TCommittee on Medicinal Products for cine in France. The French medicine agency of variations have been created. One relates Human Use (CHMP) has recommended ban- hadconcluded that the benefit-riskbalance of to obligations of amarketing authorisation, ning all oral ketoconazole-containingmedicines oral ketoconazole wasnegative,the EMA said, while the other covers data previously submit- throughout the European Union (EU). due to ahigh levelofliver injury associated ted as apost-authorisation measure that now An EU-wide reviewoforal ketoconazole with the medicine, and the availability of safer, needs to be filed as avariation. had led the CHMP to conclude that the risk alternative treatments. of liverinjury from taking ketoconazole orally The EMA noted that national competent ■ PAGB –the Proprietary Association of outweighed the benefits in treating fungal in- authorities should ensure that ketoconazole was Great Britain –has launched the 21st edition of fections, the EMA noted. available to patients who used it off-label to itsOTC Directory,subtitled ‘Self-Care Treat- However, the EMA pointed out that topical treat Cushing’ssyndrome. ments forCommon Ailments’. Listing over formulations of ketoconazole, such as creams, Meanwhile, the US Food and Drug Ad- 1,000 products across 20 therapeuticcategories, ointments and shampoos, were safe to use as ministration (FDA) has advised that oral keto- the 2013/14 directory is provided free-of-charge the amount of ketoconazole absorbed through- conazole –which is aprescription-only medi- to general practitioners, pharmacists and prac- out the body wasvery low. cine in the US –should not be used as a“first- tice nurses to encourage recommendation of The CHMP opinion will be sent to the Euro- linetreatment” for fungal infectionsdue to the OTCmedicines. pean Commission for alegally-binding decision. increased risk of liverdamage. OTC The EU-wide reviewoforal ketoconazole OTC

18 OTC bulletin 23 August 2013 OTC23-08-13p16-20GN_Layout 1 20/08/2013 16:20 Page 5

GENERAL NEWS OTC

Litigation Regulatory Af fairs German court Folicacid claim receives prohibits ‘akut’ greenlight from EFSA antoprazole-based OTCmedicines in Ger- Pmany are not permitted to carry the ‘akut’ ealth claims for folic acid have been ac- maternal red blood cell folate”. suffix, an administrative court in North Rhine- Hcepted by the European Food Safety Auth- Noting that the association between low Westphalia has ruled. ority (EFSA). The regulator has givenapositive maternal folate intakes and an increased risk of Upholding alower court’sprevious decision opinion on the disease-risk reduction claim – NTD was“well established”, the EFSA panel in favour of Germany’sfederal institute for from agroup of industry bodies and ahealth found that there wasa“cause and effect rela- drugs and medical devices, BfArM, the admin- charity under the name of Rank Nutrition –that tionship” between increasing maternal folate istrative court said the ‘akut’ suffixamount- increased folic acid intakereduces the risk of status by supplemental folate intakeand are- ed to misleading labelling that is prohibited neural tube defects (NTD) such as spina bifida duced risk of NTD. by Germany’smedicines law. and anencephaly in foetuses. To obtain the claimed effect, EFSA noted, Noting that pantoprazole 20mg forms had The wording approvedbyEFSA’s panel on 400µg of supplementalfolate should be con- been subject to acentralised prescription-to- Dietetic Products, Nutrition and Allergies (NDA) sumed daily for at least one month before and OTCswitch in 2009, the court said there was states: “Supplemental folate intakeincreases up to three months after conception. no guarantee that consumers buying the heart- maternal folate status. Increasing maternal folate Commenting on EFSA’s positive opinion in burn remedy would discuss the medicine’sprop- status contributes to the reduction of the risk of line with Article 14 of the health claims Reg- erties with apharmacist. NTD.”The authority noted that the target pop- ulation 1924/ 2006, Shine said: “In the future “The ‘akut’ suffixawakesamong asubstan- ulation waswomen of childbearing age. this will ensure that women of child-bearing tialgroup of consumers the incorrect impres- In its applicationthrough the UK’scom- age across the European Union (EU) will be sion that this medicine offers relief from heart- petent authority,Rank Nutrition –acting on better informed and more likely to takeaction burn or acid reflux that is rapid and/or faster behalf of the Council for Responsible Nutrition to protect their children.” than with comparable medicines,”the court said. (CRN), Health Food Manufacturers’ Associa- EFSA pointed out that its positive opinion The undisclosed plaintiff’sassertion that its tion (HFMA), the Proprietary Associationof wasnot an authorisation for marketing supple- pantoprazole 20mg product got to work with- Great Britain (PAGB) and spina bifida charity mental folate. The proposed wording of the in one to twohours wasnot sufficient to sup- Shine –had proposed aclaim for the “protec- claim, as well as its scope and conditions of port the suffix, the court stated, adding that tive effect of folic acid against neural tube de- use, could change pending authorisation by the the proton-pump inhibitor acted no quicker fects in the foetus, through beneficially raising European Commission.

than antacids and H2 -antagonists. OTC However, the court stressed, decisions on whether the ‘akut’ suffixwas suitable for any Regulatory Af fairs particular medicine should be made on acase- by-case basis. EFSA gives okay to three children’s claims Meanwhile, the same court has ruled that German civil servants can demand financial ealth claims for iron, magnesium and vita- wording of claims proposed by IDACE. support for buying non-prescription medicines. H minAin children’sdevelopment have been The association had wanted the claim for It said that there must be aprovision to fund givenapositive opinion by the European Food iron: “Important for the cognitive development prescribed, non-prescription medicines where Safety Authority (EFSA). of infants and young children”, referring to a the cost for acivil servant would otherwise Responding to an application from the Euro- target population aged from birth to three years. be unaffordable. pean dietetic food industry association, IDACE Similarly,ithad wanted to say for magnesium: OTC –via the French competent authority –EFSA “Supports the development of healthyand strong said health claims corresponding to the scien- bone in children”,for the same age group. tific evidence were: “Iron contributes to normal The proposed vitamin Aclaim for the same IN BRIEF cognitive development”; “Magnesiumcontri- target audience was: “Necessary for the devel- ■ BIOTIN, lidocaine and sumatriptan are butes to normal development of bone”; and opment and functioning of multiple aspects among the active ingredients for which the co- “Vitamin Acontributes to the normal function of the immune system”. ordination group for mutual recognition and de- of the immune system”. To be able to bear these claims, foods con- centralised procedures, human (CMDh) has The applications were made under Article taining the substances had to meet anumber of agreed public assessment reports forpaedia- 14 of the health claims Regulation 1924/2006 composition criteria, the EFSA panel stipulated. tric studies.Marketing-authorisation holders referring to children’sdevelopment and health. It said that no tolerable upper-intakelevel, have 90 days to include the information in their Noting that it had already giventhe nod to UL, had been established for magnesium or iron summaries of product characteristics (SmPCs) similar claims for all three substances –inthe for the age group. However, it also noted that a and package leaflets. The CMDh has also agreed general population for magnesium, and in chil- UL for pre-formed vitamin Ahad been establish- public assessment reports for Nasacort (trimaci- dren up to 18 years for iron and vitamin A– ed for children, and had been set at 800µg RE/ nolone acetonide) and Singulair (montelukast). EFSA’s Panel on DieteticFoods, Nutrition and day for children between one and three years. OTC Allergies (NDA) wasnot prepared to agree the OTC

23 August 2013 OTC bulletin 19 OTC23-08-13p16-20GN_Layout 1 20/08/2013 16:20 Page 6

OTC GENERAL NEWS

Regulatory Af fairs Switches MHRA to watch Teva’sPlan BOne-Step medicine sales gets exclusivity in US he UK’sMedicine and Healthcare prod- T ucts Regulatory Agency(MHRA) says it will “takeall necessary action to ensure that eva has gained exclusivity for the next three medicines are supplied in accordance with re- Tyears in the US for its Plan BOne-Step quirementsspecified in medicines legislation” one-pill emergencycontraceptive.The country’s after it receivedareport that packs of phar- Food and Drug Administration (FDA) has de- macy-only Nurofen Cold &Flu –containing cided that the Israeli firm should be allowed to pseudoephedrine –were on sale in abranch sell the levonorgestrel-based product on an ex- of low-cost convenience chain 99p Stores. clusive basis to women under 17 without apre- “Cold and flu remedies containing pseu- scription until the end of April 2016. doephedrine and ephedrine are classed as pre- The FDArecently gave Teva permission to scription or pharmacy-only medicines and can makePlan BOne-Step available OTCtowomen only be legally obtained from apharmacywhere of all ages by approving asupplemental new Teva’s Plan BOne Step is now available OTC in US theyare sold or supplied under the supervision drug application filed by the Israeli firm (OTC stores without age restrictions of apharmacist,”the MHRA told OTC bulletin. bulletin,28June 2013, page 1). The action com- The MHRA reviewed its position on ephe- plied with an April order by aNew York district sidised price, DeSimone pointed out, for women drine and pseudoephedrine last October,when court directing the agencytomakelevonorgestrel who may not otherwise be able to afford it. it confirmed its 2008 restrictions on the ingre- emergencycontraceptivesavailable as OTC However, women’shealth advocates have dients. It pointed out that the agencywas “con- products without age or point-of-sale restric- criticised the FDA’sdecision to grant Teva ex- tinuing effectively to manage the risk and mis- tions (OTC bulletin,12April 2013, page 1). clusivity.The Reproductive Health Technolo- use” of cold and flu medicines to prevent the Teva Women’sHealth –aUSsubsidiary of gies Project (RHTP) noted that the exclusivity illegalmanufacture of methylamphetamine Teva –launched Plan BOne-Step without age meant that generic OTCversions of the prod- ( OTC bulletin,9November 2012, page 19). restrictions in early August. uct would only be available for women aged

OTC Jill DeSimone, senior vice-president and 17 or older,whilst younger women would need general manager of Teva’s Global Women’s aprescription to purchase ageneric. Health business, said that women in the US had The FDA’sdecision to award Teva exclusiv- Regulatory Af fairs “faced challenges to obtaining emergencycon- ity was“not supported by the evidence,”the traception for fartoo long”, and the availabil- RHTP insisted, adding that it would “only lead UK to stop selling ity of Plan BOne-Step at retailers for all con- to more confusion on the part of consumers and sumers wasa“historic step forward”. pharmacies, and will continue to unnecessarily unlicensed herbals “Teva is committed to ensuring Plan BOne- feed the false assertions by some that emergency Step is available to all women who need it,’De- contraception is unsafe or risky”. erbal medicines that have not been licens- Simone insisted. “Assuch, the price of Plan B Actavis launched arivaltoPlan BOne-Step Hed under the 2004 European Union (EU) One-Step to wholesale and retail outlets will last year under the name Next Choice One Dose, herbals directive will not be allowed to be sold remain unchanged as it transitionstofull OTC immediately after Teva’s new-product exclu- or supplied in the UK by the end of 2013, under status,”she added. sivity ended (OTC bulletin,10August 2012, newproposals from the Medicines and Health- In addition, the product would also continue page 17). Lupin receivedFDA approvalfor its care products Regulatory Agency(MHRA). to be sold to hospitals and health clinics at asub- ownversion earlier this year. The MHRA says that it wants to end the OTC “period of grace” that allows unlicensed herbal medicines which were launched prior to 2004 to remain on the UK market, despite the end of IN BRIEF transitional arrangements in April 2011. ■ PURITY FIRST HEALTH PRODUCTS istry Vitamin C and one lot of its Healthy Under the proposal, the agencywill issue has recalled twolots of its HealthyLife Chem- Life ChemistryMulti-Mineral capsules,after newguidance to the effect that unlicensed her- istry B-50 product, after the US Food and Drug theywere found to contain dimethyltestoste- bal medicines will not be allowed to be sold or administration (FDA) warned the public that rone. The productshad been distributed nation- supplied beyond 31 December 2013. the capsules contained the potentially harm- ally via the internet and through retail stores ful anabolic steroids dimethazine and meth- between July 2012 and June 2013, the FDA ■ Comments on the proposals should be sent by 6Sept- asterone. The FDAreceived29reports of ad- pointed out. ember 2013 to Andrea Farmer,Policy, Government and verse events associated with the use of the prod- Corporate Division, MHRA, 5th Floor,151 Buck- uct, which is marketed as aVitamin Bsupple- ■ THE EUROPEAN PHARMACOPOEIA ingham Palace Road, London SW1W 9SZ, UK (Email: ment, including fatigue and muscle cramp. has granted observer status to the Medicines [email protected]). Purity First Health Products has also recall- Control Council of South Africa. OTC ed all lot numbers of its HealthyLife Chem- OTC

20 OTC bulletin 23 August 2013 OTC23-08-13p21-24MN_Layout 1 20/08/2013 14:40 Page 2

MARKETING NEWS OTC

ProductLaunches Romania set for Pfizer’s ThermaCarepatch launch

fizer Consumer Healthcare is gearing up P to launch its ThermaCare pain-relief patches in Romania on 15 September.The firm claims thetwo pharmacy-only variants –alower-back patch and aneck, shoulder and wrist patch – will be the first of their kind in the Romanian market, as there are no other products avail- able that offer drug-free pain relief in the form of aheated patch. Pfizer says thereisnoother similar heat-patch product to ThermaCareonthe Romanian market Agrowing number of consumers were seek- ing homoeopathic remedies or treatments that pharmacies, consumer information flyers and theybelievedwere more “natural”, Georgiana sampling. The main target market would be

England rugby player James Haskell has been Sfrija, marketing manager for Romania, Adri- women aged between 40 and 64, Sfrija noted. signed up by pharmacy chain Day Lewis as ahealth atics, Baltics and Bulgaria, told OTC bulletin. Pfizer would also focus on adults aged between and fitness ambassador for its e-commerce initiative, The non-medicated patches would appeal as 30 and 50 who were “living sedentary lives, the Healthcounter. Noting that Haskell –the website’s only celebrity theyposed no risk of the side effects usually spending too much time sitting down and often ambassador to date –was a“great example” of the associated with drugs, she pointed out. suffering from back and neck pain”, she added. results that could be achieved through “a good health The therapeutic heat –which Pfizer noted Although Pfizer said it had not recommend- and fitness routine”, the company said he would demonstrate ‘seasonal’ fitness routines on YouTube, reached “optimum levels” of 40degC –was ed aretail price for the products, it expected as well as sharing regular health and fitness tips generated by oxidisation of ‘heat cells’, trigger- the neck, shoulder and wrist patch to cost be- across the Healthcounter’s other social media ed when the patch wasopened, the company tween C 6.00 and C 7.00, while the back patch channels –Facebook, Pinterest and Twitter. The Healthcounter has also recently begun selling explained. The heat lasted for between eight waslikely to carry aretail price of between Haskell’s Hades ‘fat-burner’ food supplement. and 12 hours, it added. C 8.00 and C 9.00. OTC While Pfizer declined to confirm its market- The firm would “consider” extending the ing spend, it said it would promote the patches product line once the launch of the patches had through organised product demonstrations in provedsuccessful, Sfrija added. OTC

ProductLaunches Optrex expands with ActiMist in Australia

eckitt Benckiser (RB) Australia is spend- fall under the Optrexbrand umbrella. R ingAU$3.6 million (C 2.4 million) on ex- Atelevision campaign will begin airing from panding the eye-care category in its home mar- 1September to support the launch, and be

Irish natural health firmLifes2Good’s US division ketwith the launch of its OptrexActimist prod- shown between ‘prime-time’ shows across free- claims its Viviscal dietaryhair-growth supplement will uct, that can be sprayed onto closed eyes. to-air channels. RB is also running atraining be the first hair supplement brand to launch a‘direct The three variants of the medical-device module for pharmacists on its healthhub.com.au response’ television campaign when it rolls out a nationwide programme in October. spray –Dry and Irritated; Itchyand Watery; website, which offers the chance to win a‘VIP Hosted by author and sex therapist Dr Laura and Tired and Uncomfortable –will join the experience’ with television presenter and model Berman, the 30-minute infomercial will focus existing eye-drop and eye-bath products that Kris Smith if completed before 11 October. on the company’s Viviscal Extra Strength product, which Lifes2Good claims contains “a proprietary Further support will be provided by in-store blend of deep-sea marine proteins”, said to promotional and point-of-sale material. maintain healthy hair growth. It will also include Modern lifestyles had contributed to con- customer testimonials. The spot will be mostly shown at the weekend sumers of both older and younger age groups across such channels as E! and HGTV,the firm experiencing irritated eyes, RB noted, adding pointed out, with a“strong push” towards overnight that nearly athird of the Australian population and early morning airings, and atarget market of those aged between 45 and 55 years. (30%) had suffered with dry eyes, butmost Noting that the Viviscal product was available in had not sought treatment. 33 other countries including Australia, Canada, France, The firm also claimed that 74% of con- Ireland, Mexico and the UK, Lifes2Good said it foresaw an “ongoing” rollout of the television campaign in sumers in aclinical study had preferred Acti- international markets “in the coming months”. Reckitt Benckiser will spend AU$3.6 million on the Mist to “alternative conventional treatment”. OTC launch of Optrex ActiMist in Australia OTC

23 August 2013 OTC bulletin 21 OTC23-08-13p21-24MN_Layout 1 20/08/2013 14:40 Page 3

OTC MARKETING NEWS

HisamitsuProductLaunches promises US “unique”pain-relief gel

Ratiopharmistaking on Novartis Consumer Health’s apanese firm Hisamitsu’sUSdivision has Voltaren Schmerzgel topical analgesic in Germany by Jadded what it claims is a“unique” pain-relief launching its own diclofenac 1% gel. gel to its Salonpas line of topical analgesics Launch television advertising for Diclo-ratiopharm Schmerzgel opens with female twins comparing their in the US. Noting that its biggest competitors ‘back-pain faces’. The scene then cuts to each were Chattem’sIcy Hot and Aspercreme prod- picking up atube of cream, one of which bears a uctsand Johnson &Johnson’sBengay,Hisa- circular logo similar to those used on Voltaren packs, while the other is Ratiopharm’s newcomer. mitsu said Salonpas wasthe “only brand” to The twins then describe how the “proven active use a“provenskin penetrator”–inthe form ingredient” diclofenac relieves pain and combats of the inactive ingredient dimethyl isosorbide inflammation. When one claims that the treatment is inexpensive, the other twin asks if thereissomething –for topical pain relief. new available from Ratiopharm. Containing three “powerful pain-fighting Hisamitsu claims its deep relieving gel uses aunique deliverytechnology Ratiopharm–which forms partofthe global generics ingredients” –15% methyl salicylate, 10% men- market leader,Teva –has set recommended retail prices of C5.47 for a50g tube of Diclo-ratiopharm thol and 3.1% camphor –the gel lasted up to Gel forms part of aUS$26 million (C19.6 mil- Schmerzgel, and C9.97 for a100g tube. eight hours, Hisamitsu America maintained, lion) spend for 2013 on the brand, which in- A60g pack of Voltaren Schmerzgel has a and wasindicated for temporaryrelief of aches cludes Salonpas Jet Spray,Salonpas Pain Relief recommended retail price of C7.85, while a120g tube costs C14.30. Both lines of products are and pains associated with strains, sprains, Patch and Salonpas Arthritis Pain Patch. The pharmacy-only medicines. bruises, neck ache and arthritis. firm plans to spend the same amount in 2014. Aflash on packs of Diclo-ratiopharmSchmerzgel Topical pain relief was“gaining greater Aimed at consumers aged 35 and over, the says the liposome emulsion gel is absorbed quickly into the skin. market recognition” in the US, the firm noted. product is being advertised in major national OTC It added that consumer research it had com- magazines including Family Circle and Better missioned had highlighted aneed for aproduct Homes &Gardens.Atelevision advertisement that would “go on clear,dry fast and penetrate is currently airing nationally on stations such IN BRIEF deep into muscles and joints”. as CBS and HGTV,between such shows as ■ BIOCARE is supporting the British Skel- Thelaunch of the Salonpas Deep Relieving Property Brothers and The Big Bang Theory. eton team in the lead-up to 2014 Olympic OTC Winter Games in Sochi, Russia. In adeal worth £18,000 (C 21,000) the UK-based nutritional MarketingCampaigns supplements companywill provide cash sup- port and products such as carbohydrate gels RB’s Durex offers free UK gig tickets to the winter sledding team. The Biocare logo will also feature on the British Skeleton web- Kconsumers are being offered the chance Entrants have to input their details on a site www.britishskeleton.co.uk. Uto get “closer to the music –and each special website, durexintimatesessions.co.uk, other” by Reckitt Benckiser’s(RB’s) ‘Durex for the chance to see performancesfrom artists ■ MUSCLEPHARM has joined with actor Intimate Sessions’ campaign. such as electronic music duo AlunaGeorge and and bodybuilder Arnold Schwarzenegger Noting that “every relationship has asound- rapper Wretch 32. in anine-year deal that will see the US-based track”, the firm is giving away pairs of tickets Exclusive stickered packs of DurexUltra- nutritionalsupplement companycreate a to see “big-name acts in small locations” around thin Feel condoms are currently available in line of nutritional supplements. Comprising the country,inpartnership with Microsoft’s Boots stores and display acode that entrants can eight products, the Arnold Series of pills and internet portal MSN, music magazine NME input on the website for an additional chance powders will be launched at health and nutri- and music-streaming service Spotify. of winning. Each event holds only 250 people tion stores domestically and internationally and offers winners the chance to meet and in September.The products will also be avail- talk to the artists. able online. The campaign will run until 15 October and is being supported by promotional Facebook ■ NAD –the US National Advertising Divi- activity,aswell as online advertising and edi- sion –has warned New Nordic US that it torial content on MSN. Spotify is featuring ad- must remove unsubstantiated claims and atesti- vertising banners on its site and ‘Intimate monial from advertisements for its Hair Vol- Sessions’ playlists provided by ‘RB UK’. In ume dietary supplement that suggested the prod- addition, NME is promoting the campaign with uct could reverse balding –including genetic both online and print editorialcontent, as well

pattern baldness –inwomen. Reckitt Benckiser is giving consumers the chance to as producing video content of the events. OTC attend its specially-created ‘Intimate Sessions’ gigs OTC

22 OTC bulletin 23 August 2013 OTC23-08-13p21-24MN_Layout 1 20/08/2013 14:40 Page 4

MARKETING NEWS OTC

AdvertisingComplaints ProductLaunches Corsodyl spots Thornton&Ross creates not irresponsible “newsector” for head lice omplaints that print and television ad- Cvertisements for GlaxoSmithKline Con- hornton &Ross claims to have “revolu- sumer Healthcare’sCorsodyl mouthwash were T tionised” the UK head-lice treatment market misleading and irresponsible have not been up- with the launch of aleave-in conditioning spray held by the Advertising Standards Authority that has been designed for regular use. The Pro- in the UK (ASA). tect &Goaddition to the Hedrin line will be Both the advertisements stated: “If you spit backed as part of a£4million (C 4.6 million) mar- blood when brushing your teeth, it could be keting support package, which the firm notes is an early sign of gum disease, aleading cause the “largest-ever” campaign for the brand. of tooth loss.” Rather than ‘cannibalising’ other products in Five complaints were made to the authority, the Hedrin range –Hedrin, Hedrin Once Liquid including concerns that the advertisements for Gel and Hedrin Treat &Gomousse –the latest the mouthwash –which contains 0.2% chlor- product would form a“whole newsector for Thornton &Ross expects its regular-use spray to hexidine digluconate –implied that it could protection against head lice” worth aproject- create anew sector in the UK head-lice category worth approximately£30 million treat all types of gum disease, including perio- ed £30 million, Thornton &Ross insisted. It dontitis, and that it encouraged consumers to would “generate additional sales” from those holidays before children returned to school, diagnose and self-medicate, rather than advis- who had already treated their children and want- said Thornton &Ross, which has just been ing them to see adental health professional. ed “on-going protection”, the firm added, as well bought by Stada Arzneimittel (see front page). “Treat and prevent gum disease” wasone as from those who had neverexperienced head Television advertising for the Treat &Gomousse of the indications on the product label approv- lice butwere “keen” to protect their children. is running until 27 August across ITV,Chan- ed by the Medicines and Healthcare products When used twice aweek, the mango and nel 5and satellite channels, while the Protect Regulatory Agency(MHRA), GlaxoSmithKline orange-scented, water-based medical device &Gospot will air from 28 August. pointed out in its response to the ASA. As re- –containing 1% activdiol (octane 1,2-diol) – Public relations activities also formed part search had shown that manyconsumers did not offered parents “the opportunity to proactively of the campaign, the firm noted, as well as a associate bleeding gums with gum disease, it deal with infestations”, the companysaid, by Facebook page focused on the brand’s“Once added, one of the intentions of the advertisement killing anylice before an infestation could be AWeek, Take APeek” initiative.Thornton wastohighlight bleeding gums as one of the established. The product’spackaging highlights &Ross said it wasalso working on apartner- most noticeable early signs. itssuitabilityfor social situations such as sleep- ship with Lloydspharmacy, which would in- The ASA pointed out that both the advert- overs and children’sparties. volvecreating bespokehead-lice pharmacytrain- isements made it clear the product wasintend- Promotional activity would occur at “key ing and amail-out to primary schools. ed for the treatment of bleeding gums and made trigger times” such as school holidays at Christ- Recommended retail prices for a120ml bot- no reference to anyother symptoms. It ruled mas and Easter,and at the end of the summer tle of Protect &Gobegin at £4.29. that the advertisements would be understood OTC to mean that early treatment of bleeding gums could prevent more advanced gum disease, Well-built ‘twins’ symbolise the double action of which could lead to tooth loss. the Gaviscon Dual in Reckitt Benckiser’s launch advertising for the acid-reflux remedy in Germany. Furthermore, both advertisements contained One twin wears aturquoise t-shirt, which matches the text “always read the label”, the watchdog the brand’s liveryand bears the word‘Alginatus’, noted. Product labelling made it clear that if highlighting the line extension’s use of sodium alginate to formaphysical barrier to stomach acid symptoms persisted beyond the recommended rising into the oesophagus. treatment time, consumers should consult their On the pink t-shirtwornbythe other twin is the dentist, the ASA added, so the advertisements word‘Antazidus’, hinting at how acombination of calcium carbonate and sodium bicarbonate neutralises were not found to be irresponsible. excess stomach acid. The early signs of gum disease were easily Pharmacy-press advertising claims Gaviscon Dual identifiable by the consumer,itadded, so there –which is marketed as Gaviscon Dual Action and Gaviscon Double Action in other markets –offers “a wasnorequirement for gum disease to be diag- unique combination of alginate-barrier and antacid”. nosed by ahealthcare professional. The peppermint-flavoured pharmacy-only medicine Another complaint had highlighted that the is available as both chewable tablets and liquid sachets. Packs of 16 tablets –each containing 250mg of sodium television spot did not state that the product alginate, 106.5mg of sodium bicarbonate and 187.5mg should only be used for short periods. How- of calcium carbonate –have arecommended retail ever,the ASA did not consider treatment time price of C 5.45. Each 10ml sachet provides 500mg of sodium alginate,213mg of sodium bicarbonate and as necessary for inclusion in the advertisement, 325mg of calcium carbonate. Retail prices for packs and so did not find it to be misleading. of four,12and 24 sachets are C 4.45, C 8.95 and C15.90. OTC OTC

23 August 2013 OTC bulletin 23 OTC23-08-13p21-24MN_Layout 1 20/08/2013 14:40 Page 5

OTC MARKETING NEWS

AdvertisingComplaints MarketingCampaigns/ProductLaunches UK ASA criesf oul over Neunerbacks misleadingInfacol claim Carmex brand Sfirm Carma Laboratories has signed Uup former world record-breaking biathlete orest Laboratories’ claim that its Infacol wasnot in conflict with the SmPC, it wasa Magdalena Neuner as aspokesperson for its Finfant colic remedy is “clinically provento “supplementaryclarification” of the informa- Carmexlip-balm brand in Germany. Using the significantly reduce the frequencyand severity tion provided in the summary.Advertisershad slogan “the freshness in everyday life”, the col- of crying attacks associatedwith colic” is mis- to be able to provide substantiation to support laboration would run for at least ayear,the leading and unsubstantiated, the UK’sAdver- such aclaim, it added. companysaid, and wasaimed at “active wo- tising Standards Authority (ASA) has ruled. men” aged between 18 and 49 years. The claim for the simeticone-containing prod- Received licence from MHRA A‘my Carmex’ website, meincarmex.de, uct–which wasadvertised on Infacol’swebsite Responding to the watchdog, Forest Labo- will be launched in September and include tips –must not appear again in its current form. ratories provided aclinical study that it said from Neuner on training, abalanced diet, and Furthermore, the watchdog warned that the concluded that Infacol “statistically signifi- skincare. Atestimonial from Neuner will also companymust not makeclaims that went cantly” reduced crying attacks. It said it had appear on the website. In it, she states: “I beyond the wording provided in the Summary obtained alicence from the MHRA in 1986 love Carmex–whether during sports, travel- of Product Characteristics (SmPC) for Infacol on the basis of submitted evidence, which in- lingorataphotoshoot, my lips are always well unless such claims could be substantiated. cluded data showing the reduction in frequency cared for and incrediblysoft”. Although the SmPC stated that treatment and severity of such attacks. Based on her “professional and personal with Infacol “may provide aprogressive im- However, the ASA’s ownindependent ex- successes”, Neuner represented the brand val- provement in symptoms overseveral days”, pert had found the data submitted to be “a brief, ues of ahealthier,more active lifestyle “per- the watchdog noted, it did not make“express single study with major limitations”, such as fectly”, the firm said. Carma Laboratoriesal- or direct reference” to crying attacks associated variable dosages of the product,alack of sample ready has brand ambassadors in some of its with colic, or to providing asignificant re- size calculation and no statistical justification other markets, such as television presenter duction in the frequencyand severity. for the number of patients involved, the watch- Sophie Falkiner in Australia, figure skater The ASA consulted the UK’sMedicines dog said. This wasnot sufficient to support Joannie Rochette in Canada and basketball and Healthcare products Regulatory Agency the claim, it noted, and so the claim wascon- player Lebron James in the US. (MHRA), which said that although the claim sidered to be misleading. Meanwhile, the firm said it would introduce OTC limited-edition versions of its Moisture Plus lip balm in the US in “late summer 2013”. The ProductLaunches product will be available in four designs – Mucinex enters US night-time market leopard print, art deco, houndstooth and ‘retro’.

eckitt Benckiser (RB) will imminently be congestion –phenylephrine hydrochloride – Rentering the US night-time market –which that competitors’ offerings did not, he added. chief executive Rakesh Kapoor claims is worth Meanwhile, the US will also gain aJoint US$600 million (C451 million) annually –with Free Ultra product from SchiffNutrition Inter- the launch of its MucinexNight-Time Cold national, which RB acquired in December last &Flu liquid and tablets. year (OTC bulletin,18December 2012, page 1), Speaking at the firm’sfirst-half results pre- while aDurexEmbrace Pleasure Gel product sentation, Kapoor claimed that the line exten- will be rolled out in over25countries. sions were “stronger than anyother OTCnight- Kapoor claimed the Joint Free Ultra sup- time product available to US consumers”. plement wasthe firm’s“most effective joint- Theycontained an active ingredient for nasal health formula”, as one small, soft-gel capsule had been proveninclinical trials to provide twice the amount of joint comfort as an exist- ing product that contained acombination of glucosamine and chondroitin. Pointing out that nearly athird of people surveyed globally for Durexhad claimed to use gels, Kapoor added that the DurexEm- brace Pleasure Gels contained a‘warm’ and a ‘tingling’ gel duo within “breakthrough” and Former biathleteMagdalena Neuner has been signed as Carmex’s brand ambassador in Germany Mucinex will enter the ‘night-time’ categoryinthe “disruptive”packaging. US, said to be worth US$600 million annually OTC OTC

24 OTC bulletin 23 August 2013 OTC23-08-13p25FIN_Layout 1 20/08/2013 10:03 Page 2

EVENTS OTC

SEPTEMBER ulatory Affairs (TOPRA). Email: [email protected]. two-day conferenceinclude Bah- Contact:TOPRA. Website: www.forum-institut.com. rain, Egypt, Jordan, Kuwait, Leb- 18-21 September Tel: +44 20 7510 2560. anon, Libya, Qatar,Saudi Arabia 16-18 October ■ Expopharm2013 Fax: +44 20 7537 2003. and Yemen. Düsseldorf, Germany Email: [email protected]. ■ TOPRA Annual Contact:Management Forum. Afour-day internationalpharma- Website: www.topra.org. Symposium 2013 Tel: +44 1483 730071. ceutical trade fair and conference. Lisbon, Portugal Fax: +44 1483 730008. 9-11 October Contact:Gabriele Stadler, Athree-day event run by The Org- Email: registrations@management- Expopharm. ■ RegulatoryAffairs anisation for Professionals in Reg- forum.co.uk. Tel: +49 6196 928 411. in Emerging Markets ulatory Affairs (TOPRA). Website: www.management- at Fax: +49 6196 928 404. Prague, CzechRepublic Contact:TOPRA. forum.co.uk. is- Email: [email protected]. Speakers from Boehringer Ingel- Tel: +44 20 7510 2560. Website: www.expopharm.org. heim, GlaxoSmithKline, Johnson Fax: +44 20 7537 2003. 29-31 October &Johnson, Novartis and Reckitt Email: [email protected]. ■ Vitafoods Africa 18-21 September Benckiser will attend this three- Website: www.topra.org. Johannesburg, SouthAfrica ■ CRN’s Annual day event. This three-day event claims to Symposium for the Contact:Informa UK. 17 October be the only conference in Africa ■ Nutrition and te- DietarySupplement Tel: +44 20 7017 7481. to focus on regulatory,marketing Industry Fax: +44 20 7017 7823. Health Claims and research developments in nat- Utah, US Email: [email protected]. Buenos Aires, Argentina ural and nutraceutical products. Afour-day meeting organised by Website: www.informa-ls.com/RAEM. ‘Howtobuild asuccessful regu- Contact:Jacqueline Lues, IIR. latory strategy for marketing food Tel: +27 11771 7222. the US Council for Responsible 14 October Nutrition (CRN). supplements and functional foods Email: [email protected]. ■ Marketing Authorisation Contact:Katie Stevenson, CRN. across Latin America’ will be the Website: www.iir.co.za/vitafoodsafrica. in Latin America Tel: +1 202 204 7682. theme of this one-day meeting. Fax: +1 202 204 7701. Frankfurt, Germany Contact:EAS. NOVEMBER Email: [email protected]. Argentina, Brazil and Mexico will Tel: +54 11 524 584 95. 14-15 November Website: www.crnusa.org. be covered at this one-day seminar. Email: yesicaacha@eas- Contact:DrHenriette Wolf-Klein, americalatina.com. ■ 8th International 30 September-1 October Forum Institut für Management. Website: www.eas-americalatina.com. Alliance Conference ■ 10th Conference on Tel: +49 6221 500 680. London, UK Marketing Authorisation Fax: +49 6221 500 555. 20-21 October ‘Global market expansion services: Cologne, Germany Email: [email protected]. ■ Natural Products The newgrowth imperative in Day one of this two-day meeting Website: www.forum-institut.com. Scandinavia health and beauty’ is the theme of will coverregulatory challenges Malmö, Sweden this two-day meeting. 15-18 October for 2014, while day twowill focus Atwo-day trade show. Contact:Lorian Pitman, Marketing Authorisation on mutual recognition. Each day ■ Contact:Zoe Jackson-Cooper, Ceuta Healthcare. can be booked separately. in Asia, Australia and Diversified Business Tel: +44 1202 449 709. Contact:DrHenriette Wolf-Klein, New Zealand Communications UK. Email: lorian.pitman@ceuta Forum Institut für Management. Frankfurt, Germany Tel: +44 1273 645 141. healthcare.com. Tel: +49 6221 500 680. Day one of this four-day event Fax: +44 1273 645 169. Website: www.ceutaalliance.com. Fax: +49 6221 500 555. will focus on Asia. Days twoand Email: [email protected]. Email: [email protected]. three will covercountries such as Website: www.divcom.co.uk. 25-26 November Website: www.forum-institut.com. China and Korea, while Australia ■ EuroPLX 53 andNew Zealand will be discuss- 27-28 October Barcelona, Spain 30 September-2 October ed on day four. ■ Pharmaceutical Atwo-day partnering and licens- ■ Advanced Contact:DrHenriette Wolf-Klein, RegulatoryAffairs ing forum covering OTCmedi- Pharmacovigilance Forum Institut für Management. in the Middle East cines, nutraceuticals, prescription London, UK Tel: +49 6221 500 680. Dubai,UAE drugs, and generics. NewEuropean pharmacovigilance Fax: +49 6221 500 555. Countries to be covered at this Contact:RauCon. legislation will be discussed at this Tel: +49 6222 9807 0. three-day conference. 23-24 October Fax: +49 6222 9807 77. Contact:Management Forum. Email: [email protected]. ■ AESGP Conference Website: www.europlx.com. Tel: +44 1483 730071. London, UK Fax: +44 1483 730008. ‘Making the European marketing authorisation procedures work for non- 28-29 November Email: registrations@management- prescription medicines’ is the theme of this two-day event run by the forum.co.uk. ■ Pharma Branding Association of the European Self-Medication Industry,the AESGP. Summit 2013 Website: www.management-forum.co.uk. There will be sessions on: ‘The decentralised/mutual recognition pro- Shanghai,China cedures for non-prescriptionmedicines’; ‘The newpharmacovigilance ‘Winning brand models and empir- OCTOBER legislation’; and ‘Making better regulation areality’. ical solutions’ will be covered at this Speakers will include: Guido Rasi of the European Medicines Agency 3October two-day summit. Fora30% dis- (EMA); Colette McCreedyofthe UK’sMedicines and Healthcare prod- ■ Basics of count quote: Brandingsummit88. ucts Regulatory Agency(MHRA); and Marcus Müllner of AGES Pharm- Pharmaceutical Contact: Borscon China. Med, Austria. RegulatoryAffairs Tel: +86 21 33191337. Contact:Association of the European Self-Medication Industry,the AESGP. London, UK Fax: +86 21 54363078. Tel: +32 2735 51 30. Fax: +32 2735 52 22. Aone-day course from The Org- Email: [email protected]. Email: [email protected]: www.aesgp.eu/MA. anisation for Professionals in Reg- Website: www.borscon-pb.com.

23 August 2013 OTC bulletin 25 OTC23-08-13p26-29FIN_Layout 1 20/08/2013 14:55 Page 2

OTC MARKET RESEARCH Makingpharmacy focus on your brands

Many of Europe’spharmacies don’tfocus on the brands of their leading Over 200 individual pharmacists or phar- OTCsuppliers, partly because they do not fully understand the suppliers’ macy assistants in each country,who through their role and responsibilities had exposure terms and conditions designed to makethem focus. We report on arecent to OTCmanufacturers’ terms and conditions, five-country survey that has quantified the problem. were asked to answer the question: “What criteria are important in deciding which OTC ost French pharmacies–more oneproduct category (see Figure 1). And ask- products/suppliers to focus on?” than eight in 10 –concentrate on ed the same question –“Do you focus on cer- Theywere also told that the survey was selling OTCbrands from specif- tain OTCproducts within aspecific product only interested in non-prescription medicines Mic manufacturers, butfewer than category,depending on the purchasing terms available exclusively in pharmacies. Particularly half of Italianpharmaciesfocus in the same and conditions the manufacturer offers?” –only in the UK, it wasstressed that general sale list wayonspecific OTCbrands. 60% of Spanish pharmaciesanswered “Yes, (GSL) medicines were excluded. Spanish pharmacies are almost as indiffer- we focus on aspecific manufacturer in some Respondents were presented with 10 criteria, enttoOTC manufacturers as their Italian coun- or all product categories.” covering factors such as amanufacturer’sprod- terparts, butGerman pharmacies are nearly as Schmidt’sadvice to OTCmanufacturers uct range and absolute gross profit for the phar- loyal as French pharmacies. Independent UK in France and Germany–where 83% and 79% macy.Top of the pile, however, wasthe brand pharmacies, meanwhile, are in the middle, with respectively of pharmacies focus on them in at awareness of consumers, followed by attractive about two-thirds concentrating on selling OTC least one product category –istomakesure terms and conditions. products from specific OTCcompanies. Nearly three-quarters of the in- These are some of the findings of Simon- dependent pharmacists in the five Kucher &Partners, which set out to understand “OTC manufacturers should expect countries maintained that consumer what makes pharmacies in Europe’sfivemajor 100% recommendation in returnfor demand or pull wasanimportant rea- OTCmarkets “focus” on an OTCmanufacturer. their discounts and rebates” son for them to focus on aparticu- By “focus”, the strategy and marketing consult- larOTC brand. Almost as manysaid ant meant “concentrate on selling OTCproducts that attractive terms and conditions from aspecific OTCmanufacturer in one or their terms and conditions allowthem to defend were an important incentive for them to apply more product categories”. their positions if theyare well established, or the same focus. Such attractive terms includ- “This focus is important because it creates enable them to attack rivals if theyare not. ed discounts and rebates offered by the OTC astable customer base and in all likelihood These strategies, he adds, should also be manufacturer to the pharmacy. drivessell-out of the manufacturer’sproducts,” followed in the UK –where the 68% pharmacy As Figure 2shows, an OTCmanufacturer’s maintains Fabian Schmidt, managing director focus matches exactly the average across the delivery and returns policywas also highly of Simon-Kucher &Partners in Madrid, Spain. five countries surveyed –but Schmidt notes that regarded by the majority of pharmacies, with “For pharmacies,”headds, “focusing on a more work could also be done by OTCman- more than two-thirds of them saying that this specific manufacturer should mean more com- ufacturerstoincrease the overall score. wasanimportant factor in whether theyfocus- mercially attractive terms and conditions, and The face-to-face and telephone survey –of ed on that manufacturer. better services.” independent pharmacies in the five countries Less important were the pharmacyselling Yetonly 43% of Italianpharmaciessaid –nextprobed the reasons for pharmacies to price of the brand and pharmacymarketing sup- theyfocused on specific OTCbrands in at least focus on specific OTCmanufacturers. port. Only 56% rated free samples, special pro- motions and the likeasanimportant reason to focus on that manufacturer’sbrands. Average =68% “OTC companies need to understand and measure what drivestheir sales and profits France 83% most, and on that basis decide where to in- vest more: in increasing the strength of their Germany 79% brands, or in their efforts with the trade,” Schmidt advises. UK 68% Considering the results in more detail, he adds that amore flexible delivery and returns policy, butfewer discounts, “could be an attrac- Spain 60% tive offer for some pharmacies”. Respondents were next asked to character- Italy 43%  ise their focus on OTCmanufacturers. They 0255075100 were asked: “Which of the following statements    Proportion of pharmacies (%) apply to howyou do/would focus on certain OTCproducts/suppliers?”Fivepossible answers

Figure1:Pharmacists answering yes to the question: “Do you focus on certain OTC products within aspecific to each statement ranged from “doesn’tapply category, depending on the purchasing terms and conditions they offer?” (Source –Simon-Kucher &Partners) at all” to “applies completely”.

26 OTC bulletin 23 August 2013 OTC23-08-13p26-29FIN_Layout 1 20/08/2013 14:55 Page 3

MARKET RESEARCH OTC

More than three-quarters of the pharma- cies surveyed said theyfocused, or would foc-

us, on specific OTCproducts by placing them Consumer brand awareness 73% in full viewbehind the counter (see Figure 3). But only two-thirds said the pharmacy Attractive terms and conditions 70% team would be instructedactively to recom- mend OTCproducts on which the pharmacy Delivery service and return policy 67% wasfocusing. Schmidt insists, however: “Visible product Pharmacyselling price 61% placement is not enough return for an OTC  manufacturer’strade investments.” Pharmacymarketing support 56% “In more than 30% of the pharmacies, there  is no active recommendation of productsfrom an OTCmanufacturer on which the pharmacy Customer care 52% is supposed to be focusing.” “OTC manufacturers should expect 100% Wholesaler recommendation 18% recommendation in return for their discounts 0255075100 and rebates,”headds.    Lamenting the fact that only 38% of pharma- Proportion of pharmacies (%) cies highlighted in-store promotions, Schmidt Figure2:Pharmacists’ prompted responses to the question: “What criteria areimportant in deciding which OTC points out that this means that more than 60% products/suppliers to focus on?” (Source –Simon-Kucher &Partners) of independent pharmaciesdonot participate in these activities for favoured OTCbrands or manufacturers. By the same token, almost three-quarters Visible product placement 78% of pharmaciesfail to give preferential treat- ment in their inventory management systems Active recommendation 67% to favoured OTCbrands, while nine in 10 do not offer their pharmacyteams incentivesto In-store promotions 38% sell such brands. 

“Better terms and conditions should be Toppositions in inventory 26% matched by abetter pharmacyperformance in management system the form of more proactive sell-out activities, such as recommendations.” Incentivesfor pharmacystaff 10%

0255075100 Better performance is amust    “Better performance,”heinsists, “is amust to Proportion of pharmacies (%) increase the return on investment of an OTC manufacturer’strade investments.” Figure3:Pharmacists’ responses to the question: “Which of the followingstatements apply to how you do/would focus on certain OTC products/suppliers?” (Source –Simon-Kucher &Partners) Independent pharmacies in the five coun- tries were next tested on their knowledge of the terms and conditions of their most important OTCsupplier.Theywere givenseven elements Payment period 73% likediscount rates, volume bands and bonus agreements and asked to rank their knowledge Discount rates 70% of each from “none” to “detailed”. Schmidt’sopposite number in Simon- Return policy 63% Kucher’sMunich office, Dr Clemens Ober- hammer,highlights the fact that 30% of Euro- Services offered 55% pean pharmacists do not knowtheir discount

rates. Neither do more than aquarter know Volume bands 54% their payment terms.  As Figure 4shows, almost half of the phar- Bonus agreements 46% macies were also unaware of the volume bands  on which theyachievedbetter discounts, or the Cash discount rate 39% services offered by OTCmanufacturers. 

“More than 50% of all European pharma- 0255075100 cists are not aware of bonus agreements and      Proportion of pharmacies (%) cash discount rates,”adds Oberhammer.

He also underlines the obvious conclusion Figure4:Pharmacists’ prompted responses when asked to rank how familiar they werewith the terms and fromthese rather surprising results: terms and conditions of their most important OTC supplier (Source –Simon-Kucher &Partners)

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MARKET RESEARCH OTC

conditions cannot be expected to influence ed to what extent attractive terms and conditions strategic objectivesare not well supported. pharmacists’ behaviour if pharmacists don’t would trigger their willingness to provide vis- More specifically,Oberhammer says they understand them. ible product placement, active recommendation, “sometimes contain too manyelements with “Investments by OTCmanufacturers in dis- in-store promotions and top positions in their lowpayments and thus lack focus”, adding that counts and bonus agreements can only lead to inventory management systems. too strong afocus on sell-in (volume bands) changes in their customers’ behaviour if phar- More than half would still not participate misses the opportunity to incentivise on sell-out macies understand what theyare being offer- in in-store promotions, as Figure 6shows, or other value-adding activities of the pharmacy. ed,”adds Oberhammer. “Easy-to-understand although the 42% who would is marginally He also highlights what he calls “discount terms and conditions are vital if theyare to in- higher than the 38% in Figure 3who already inflation”, where salesforces have historical- fluence customer behaviour.” do so as part of their focus on certain OTCman- ly been giventoo much freedom, leading to Notwithstanding their relative ignorance of ufacturers’ brands. amisalignment of discount leveland phar- theterms and conditions of their most import- macyperformance. ant OTCsupplier,pharmacies were asked gen- Persuaded by attractive terms “OTC manufacturers should differentiate erally howsatisfied were theywith the terms About two-thirds of pharmacies, however, their discounts across products depending on and conditions of their OTCsuppliers. Almost would be persuaded by attractiveterms to place the pharmacy’simpact on the buying decision two-thirds of UK pharmacists were satisfied, products visibly behind the counter and actively andthe strength of the brand. ManyOTC man- butthat wasthe case for only about aquarter to recommend them to consumers. ufacturersfail to takethese factors into consid- of German pharmacists (see Figure 5). “Attractive terms and conditions do influence eration when setting discounts across products.” “Discount levels are less of an issue,”notes pharmacists’ behaviour to ahigh degree and Furthermore, Schmidt says, discounts should Oberhammer,“butthere is clearly aneed for lead to real benefits,”comments Oberhammer, be closely linked to pharmacyperformance, more comprehensible and transparent terms and who adds that well-designed terms and condi- with performance not only being defined as conditions with adegree of flexibility.” OTC tions can improve OTCmanufacturers’ “sell-out sell-in volume, butalso taking into account manufacturers should use their pharmacysales- potential” in European pharmacies. loyalty,marketing activities and other factors. forces, he maintains, to support the terms and Commenting generally on mistakes OTC He cautions manufacturers to makesure that conditions through their communication efforts. manufacturers makewhen designing terms and their discounts incentivise the right behaviour Looking to the future, pharmacieswere ask- conditions, he says that often their overarching and establish that their discounts have the in- tended impact on their bottom line. Schmidt offers the example of aleading Average =38% European OTCmanufacturer which wasincen- UK 65% tivising independentpharmacists with high dis-  count rates, butwhose discount terms were Italy 47% not closely linked to performance.  Profitability was being neglected France 40%  Moreover, while the firm focused strongly on volumes and revenues, it wasneglecting its Spain 34%  profitability. Volumes and revenues were being bought at the cost of the bottom line. Germany 26%  However, by introducing anumber of mea- sures –increasing transparency; making terms 0255075100 and conditions more comprehensible; linking     Proportion of pharmacies (%) discounts more closely to customer perfor- mance, as measured as product range and over- Figure5:Pharmacists’ positive responses to the question: “Generallyhow satisfied areyou with the terms and conditions of your OTC suppliers?” (Source –Simon-Kucher &Partners) all revenue; and implementing and monitor- ing the changes effectively,the firm enjoyed aprofit increase of 23%. Summarising what can be concluded from

Visible product replacement 68% the survey’s findings, Oberhammerremarks:  “OTC manufacturers have thoroughly to con- sider whether theyshould invest into the chan- 65% Active recommendation nel or into brand awareness across their port- folios, since the return on investment may differ In-store promotions 42% depending on the product and category.” “If investing into the channel is chosen,” Toppositions in inventory 12% he adds, “the maximum impact from invest-  management system ments in terms and conditions must be obtained. 020406080This means designing acomprehensible, trans-     Proportion of pharmacies (%) parent and performance-based system which is aligned with the company’soverarching strat- Figure6:Pharmacists’ prompted responses to the question: “Towhat extent do attractive terms and conditions egic objectives.” systems trigger your willingness to comply with the following recommendations?” (Source –Simon-Kucher &Partners) OTC

23 August 2013 OTC bulletin 29 OTC23-08-13p30-31Draft_Layout 1 20/08/2013 16:54 Page 2

OTC FRONT PAGE NEWS

Switches Mergers&Acquisitions/First-HalfResults Nasacort switch Stada Arzneimittel adds moves closer Thornton&Ross in UK ■ Continued from front page ronment, the companypointed out. Charles Hugh-Jones, chief medical officer ■ Continued from front page ed for 84% – C21.7 million –ofthe firm’stotal at SanofiUS, said the Committee’spositive vote -ment the firm has ever undertaken,”George sales in the country in the opening six months of –10tosix in favour,with twoabstentions –was told OTC bulletin,“and may also represent 2013, which declined by 3% to C26.0 million. an “important step in providing broader access the biggest product opportunity we’ve got.” The UK generated 7% of Branded Products’ to Nasacort AQ for nasal allergy sufferers”. Highlighting potential worldwide sales of total sales in the first half of the year,which in- If approvedbythe FDA, Nasacort AQ would over US$200 million (C150 million) by 2020, creased by 18% to C337 million (see Figure 1). be the “first intranasal steroid” approvedfor of which half could come from the US, George Sales of Branded Products in Stada’sdomes- OTCsale in the US, Sanoficlaimed, and would said the firm would be making aregulatory sub- tic market of Germany–primarily under the build on the successful US switch of its fexo- mission later this year in the UK. It hoped to Stada and Hemopharm brand names –moved fenadine-based Allegra Allergy in 2011 (OTC roll out the prescriptionbrand across Europe forward by 7% to C67.3 million. This was bulletin,11February 2011, page 16). via licensees,having obtained authorisations 30% of the group’stotal sales in the country, Sanofi’sbriefing documentsaid that there using the decentralised licensing procedure. which slipped back by 2% to C239 million. wasa“need for consumer OTCproducts for Chairman Jonathan Thornton said he was Acquisitions in Russia drove up Russian adults and children that reduce allergic rhinitis proud not only of the firm’ssales achievements Branded Products sales by 42% to C118 mil- symptoms,including nasal congestion”. in recent years, butalso its manufacturing tra- lion. This represented 61% of Stada’stotal sales “Inadequate treatment of allergic rhinitis ditions as “the largest independent pharma- in the country,which improvedby30% to C194 across all age groups is associated with fatigue, ceutical manufacturer in the UK”. million (see Figure 2). sleep disturbance, and substantial negative im- “Wemakeeverything we market in our In Italy,turnoverfrom Branded Products pacts on quality of life, psychological well- facilities in Huddersfield, except for tablets had dropped by 30% to C13.0 million, Stada being and the ability to learn and process cog- andcapsules,”heexplained, “which means we pointed out, due primarily to the disposal of a nitive input,”Sanoficlaimed. make90% of what we sell. Our core compe- product portfolio in the third quarter of 2012. The briefing document noted that “approx- tencies are in liquids, gels, creams and sup- As aresult, Branded Products accounted for imately one-third” of patients with allergic rhini- positories.” only 15% of the company’stotal sales in the tisreported that the symptoms associated with the Thornton &Ross will expand Stada’sBrand- country,which grewby11% to C87.2 million. condition had caused them to miss work, with ed Products business in the UK, which account- OTC half reporting that the condition affected their daily lives“to some or to amoderate extent”. Business First-half sales Change Operating profit Change Oral antihistamines were the most common- (C millions) (%) (C millions) (%) ly used OTCmedication to tackle the symptoms Generics 618 +6 81 +20 of allergic rhinitis, Sanofisaid, butthese had Branded Products 337 +18 86 +32 not been indicated to treat nasal congestion, Commercial 19 +112 0– the “most bothersome symptom”. Group/other –– -35 – Equally,OTC decongestant products, such as pseudoephedrine and oxymetazoline, had a Total Stada 974 +10 132 +30 number of drawbacks, including restricted ac- cess and short usage duration. Figure1:Stada’s sales and operating profit in the first half of 2013 by business (Source –Stada) By contrast,Nasacort AQ had been shown Country Group sales Change Branded Products’ Change Branded Products’ to be “highly effective”intreating the symp- (C millions) (%) sales (C millions) (%) shareinStada (%) toms of allergic rhinitis, including nasal con- Germany239 -2 67 +7 30 gestion, the document noted, and had dem- onstratedgreater improvements compared to Russia 194 +30 118 +42 61 loratadine, the active ingredient in Merck & Italy 87 +11 13 -30 15 Co’sClaritin oral antihistamine. Belgium 71 -1 4+65 Triamcinolone acetonide –the active ingre- Spain 53 -13 6+511 dient in Nasacort –isalready available OTCin France 46 +17 6+14 12 anumber of countries around the world, includ- Serbia 40 +29 7+30 16 ing Australia, Germany, Japan and the UK. UK 26 -3 22 -2 84 In the UK, Nasacort Allergy Nasal Spray Others 217 –94–43 waslaunched as an OTCmedicine in 2009, nine years after the UK had first proposed the switch Total Stada 974 +10 337 +18 35

(OTC bulletin,17March 2009, page 17). Figure2:Breakdown of sales by Stada and its Branded Products division in the first half of 2013, together with OTC the proportion of group sales accounted for by Branded Products (Source –Stada)

30 OTC bulletin 23 August 2013 OTC23-08-13p30-31Draft_Layout 1 20/08/2013 16:54 Page 3

PEOPLE OTC

Regulatory Bodies Wholesalersand Retailers Geslain-Lanéelle Gourlay switch triggers to leave EFSA Alliance Boots shake-up atherine Geslain-Lanéelle,executive dir- Cector of the European Food Safety Auth- ority (EFSA), has announced her resignation lliance Boots will split the management Alex Gourlay after sevenyears at the helm. Aof its Health &Beauty division into two She will takeupanew post as director gen- after the business’ managing director, Alex eral for agricultural, agri-food and territorial Gourlay,leavestotakeonarole at the com- policies in the French Ministry of Agriculture, pany’sUS-based strategic partner Walgreens Food and Forestry on 1September 2013. on 1October 2013. Bernhard Url,who is responsible for Simon Roberts –previously chief operat- EFSA’s Risk Assessment and Scientific Assis- ing officer of Boots UK with responsibility for tance Directorate, will lead the organisation its UK and Ireland store networks, along with until the management board appoints an ‘ad in- its pharmacy, operations and customer-care terim’ executive director at its October meeting. teams–will takeoverasmanaging director of Meanwhile, the European Commission will Health &Beauty UK and Ireland. SimonRoberts initiate the process for recruiting anew per- Meanwhile, KenMurphy will takeonthe manent executive director by launching an open role of managing director Health &Beauty competition to find the right candidate. International and Brands. Previously,Murphy EFSA’s newexecutive director will be ap- waschief operating officer at Boots UK with pointed by its management board on the basis responsibility for brands, marketing, trading and of alist of candidates proposed by the Com- commercial development, as well as IT. mission, and following ahearing in the Euro- Roberts and Murphywill takeoverfrom pean Parliament. Gourlay who has been named president of cus- Sue Davies, chair of EFSA’s management tomer experience and daily living at Walgreens. board, thanked Geslain-Lanéelle for her “enor- Reporting directly to Walgreens’ president

mous contribution” to EFSA’s work, including and chief executive officer GregWasson, Gour- Ken Murphy her commitment to improving its efficiencyand lay will be responsible for the US drugstore enhancing its processes to ensure that it oper- chain’s“daily living business operation”, cover- ated openly,transparently and independently. ing merchandising, marketing, customer insights, Geslain-Lanéelle wasappointed as execu- daily-living products and promotions. tive director of EFSA by the authority’sman- Gourlay will move to Walgreens just overa agement board in 2006, following an open year after Alliance Boots agreed a“transfor- competition across the European Union (EU). mative”partnership with Walgreens (OTC bul- Her initial five-year mandate wasrenewed letin,15June 2012, page 1). on 1July 2011. Walgreens completed its initial investment Prior to this, she held anumber of positions in Alliance Boots at the start of August 2012, of responsibility in the food sector,both in paying US$6.7 billion (C5.0 billion) in cash and France and at European and international lev- shares for a45% stakeinthe privately-owned and the assumption of Alliance Boots’ debt. els, including serving as director general of firm (OTC bulletin,10August 2012, page 8). Commenting on Gourlay’sappointment, food within the French Agricultural ministry Under the terms of the deal, Walgreens also Wasson said that the move represented an- at the height of the BSE –ormad-cowdis- has an option –which it can exercise in around other “important step forward” for its partner- ease –crisis. twoyears’ time –toacquire the remaining 55% ship with Alliance Boots and advanced the stakefor US$9.5 billion in cash and shares “cultural integration” of the twocompanies. Catherine Geslain-Lanéelle OTC

IN BRIEF ■ PIERRE FABRE has revealed its newman- ■ RECKITT BENCKISER has named Alex- agement team following the death of the firm’s ander Lacik as president of the firm’sNorth founder PierreFabre in July.The French com- American business. Lacik –previously world- pany said existing board member Jean-Jacques wide head of the company’sHome Care and Bertrand had been appointed chairman, while Germ Protection category –has replaced Fred- Bertrand Parmentier –currently chief exec- eric Larmuseau,who is nowexecutive vice- utive officer of aerospace firm Groupe Laté- president for Russia, Middle East and Africa. OTC coère –had been named chief executive officer. OTC

23 August 2013 OTC bulletin 31