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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 OTC08-11-13p1_OTC15/11/2005 p1&24 05/11/2013 19:12 Page 1

8November 2013

COMPANY NEWS 3 McKesson set to acquire Hutchinsonstartsreview 3 of AS Watson businesses Merckkeeps eyeonConsumer Care 4 Novartisconsiders 5 Celesio for US$8.3 billion futureofOTC unit Chinaholds backOTC salesatGSK 6 Spharmaceutical wholesaler McKesson Uis set to acquireits European counter- BioGaiasigns deals 7 to aidexpansion part Celesio in an US$8.3 billion (C6.0 billion) deal that, according to the twocompanies, Taisho strugglingto 8 ignite home market will create a“leading global healthcareser- P&Greports gainsatits 9 vices platform”. Personal Health Care unit Celesio’smajority shareholder Franz Haniel Vitamins liftPfizer 10 &Cie has already agreed to sell its controlling Consumer Healthcare 50.01% stakeinthe pan-Europeanwholesaler and Sanofi solves Chinacrisis 11 retailer to McKesson for US$23.00 per share. to boostsales McKesson is also set to launch atender offer RB enjoysdouble-digitHealth gain 12 for the remaining Celesio shares at the same price, which representsa39% premium over Currencyhurts Bayer 13 Consumer Care thethree-monthvolume-weighted average price John Hammergren, McKesson’s chairman and prior to 8October 2013. chief executive officer,said acquiring Celesio Arbidol drives biggains 14 The deal –which will also see McKesson would create acompany capable of addressing at PharmstandardOTC “global healthcare challenges” assume Celesio’sdebt –isexpected to close by GENERAL NEWS 15 mid-2014, with McKesson taking full opera- McKesson and Celesio combined would tional control of Celesio later that year. create a“global leader in healthcareservices”, Germany considers 15 After completion of the transaction, McKes- thetwo companies claimed, “with deep expertise switchingketotifen son and Celesio will retain their ownbrands and in delivering solutionstopharmacies, manu- Procedures seeimprovement 18 continue to supply all their customers through facturers, patients and other customers”. in Europe existing channels. “The transaction brings together the strength Flat pharmacovigilancefees 19 The combined entity will have annual sales of twoleaders with complementary geographic today no morethan atax in excess of US$150 billion, approximately footprints, shared values and aheritage of trust- Cultureclash hurts 20 81,500 employees worldwide and operations ed healthcare services –through pharmaceutical OTCswitches in 20 countries. wholesaling, community pharmacycare and MARKETING NEWS 21 McKesson and Celesio would supply around information technology –dating back approx- 120,000 pharmaciesand hospitals daily across imately 180 years,”the firms pointed out. Social mediamakes mark 21 Brazil, Canada, Europe and the US, the two Explaining howthe enlarged companywould on OTCMarketing Awards firms noted, including11,000 pharmaciesthat benefit its customers, McKesson and Celesio OTCmalefertilitytestis 22 were either owned by the combined business or said that it would be able to deliver“exceptional said to be theUK’sfirst were part of avirtual network it operated. value” through “increased supply chain efficien- Nelsons sets itssightson 23 Explaining the rationale behind the deal, cies and enhanced global sourcing”. sports nutritioncategory John Hammergren, McKesson’schairman and Customers would also benefit from “global chief executive officer,said the worldwide distribution and logistics capabilities” and a FEATURES 26 healthcare industry was“evolving rapidly,mark- “broad array” of technology and business ser- How to climb the 26 ed by convergence between segments and in- vices, the companies promised, as well as “op- social-media ladder creased globalisation”. erating best practices” across an “extensive”dis- Stada aspires to be 28 Combining McKesson and Celesio, Ham- tribution network that covered three continents. atop OTC player mergren claimed, would “bring together the Hammergren insisted that its customers – strengths and expertise of each companyto from communitypharmacies to major hospital REGULARS address global healthcare challenges”. networks –would “benefit from the increased Marion Helmes, Celesio’schief financial scale, supply-chain expertise and sourcing capa- Events – Our regularlisting 25 officer,said the deal represented an “exciting bilities of the combined company”. People – Teva’s Levin steps down 31 newchapter” for the German firm and position- Celesio’soperation –which includes 2,200 after clashing with board ed its operations for success. ■ Continued on page 31

OTC08-11-13p2-14_Layout 1 05/11/2013 17:59 Page 3

COMPANY NEWS OTC

DistributionAgreements BusinessStrategy MobergPharma Hutchinson starts review gets MENA deal of AS Watson businesses obergPharma’sKerasal Nail product will M soon be available in anumber of coun- ome of Europe’sbiggest drugstore chains, tries around the Middle East and North Africa Sincluding Kruidvat, Superdrug and Watsons, (MENA) region, after the firm signed adistri- are being reviewed by their owner,Hong Kong- bution deal with Leosons International. based Hutchinson Whampoa. The Swedish development companysaid The “strategic review” would explore “all that Leosons had been granted exclusive rights options for maximising the value and future to distribute Kerasal Nail –which is anon-pre- growth potential” of the retail businesses in the scription product for treating discoloured and firm’sASWatson subsidiary. damaged nails caused by nail fungus or nail Hutchinson insisted, however, that it would psoriasis –in16countries across the region, not consider giving up control of anyofthe re- including Egypt, Iraq, Saudi Arabia, Tunisia tail businesses. The firm added that public offer- and the United Arab Emirates (UAE). ings of “all or some” of the businesses would Mobergpointed out that Leosons –which be considered “in appropriatemarkets”. Hutchinson Whampoa is reviewing its Kruidvat, has distributed the firm’sJointFlexbrand in the Currently,ASWatson operates 20 health Superdrug and Watsons retail chains Middle East for the past 10 years –planned and beauty retailers with over11,000 stores in to launch Kerasal Nail in 2014. 33 markets worldwide. to AS Watson’sretail businesses (OTC bul- The deal is the latest in along line of dis- Since AS Watson became awholly-owned letin,30August 2002, page 1). Today,Krudi- tribution agreements struck for Kerasal Nail, subsidiary of Hutchinson in 1981, the firm has vatwas nowthe “market-leading drugstore in which is also known as Emtrix or Nalox in a gradually expanded its heath and beauty busi- the Netherlands”, Hutchinson claimed, with number of markets. nesses across Europe and Asia. Superdrug a“leading health and beauty retailer” Most recently,Mobergagreed adeal with The acquisition of Holland’sKruidvat for in the UK market. Menarini Asia-Pacific to launch Kerasal Nail C1.3 billion in 2002 added health and beauty AS Watson entered the Baltic States in 2004, in China. The agreement expands an existing chains Kruidvat, Superdrug and Trekpleister when it acquired the Drogas chain of 83 health tie-up with Menarini, which led to the launch and beauty stores in Latvia and Lithuania (OTC of the product in Italy. bulletin,16June 2004, page 3). The Drogas The companysaid that in partnership with chain nowincludes over120 stores across the Menarini it wasnow seeking marketing ap- IN BRIEF twocountries. provalfor the product in China. ■ INDENA –the Italy-based ingredientscom- Meanwhile, Hutchinson has revealed that Commenting on the continuing roll-out of pany–has gained the rights to manufacture it will not sell its PARKnSHOP grocery chain Kerasal Nail, Mobergsaid that launches were Pharmatoka’sGikacran cranberry juice –which operates in anumber of Asian markets – underway in 50 markets worldwide through dis- extract and exclusively market the product in following astrategic reviewofthe business. tribution deals with 10 different partners. Mo- China, India, Japan, Russia and South Korea. Selling PARKnSHOP wasnot appropriate bergdistributes Kerasal Nail itself in the US, Indena said the deal waspart of a“newstrate- “at this time”, Hutchinson said, as it “would not after acquiring the distributor Alterna ayear gic initiative,aimed at strengthening the com- delivermaximum value to the shareholders ago (OTC bulletin,9November 2012, page 3). pany’spresence in cranberryderivatives”. of the company”. OTC OTC OTC

8November 2013 Number 412 Advertising enquiries: [email protected] Terms &Conditions: No part of this publication may be copied, reproduced, stored in aretrievalsystem, distributed or Individual subscriptions: Editor: Matt Stewart transmitted by anymeans, including electronic, mechanical, Asubscription to OTC bulletin includes this hard-copynews- photocopying or recording, without the prior written permission Editor-in-Chief: Aidan Fry letter published 20 times ayear –twice monthly,except of the publisher,orunder the terms and conditions of aGlobal Production Editor: Jenna Lawrence monthly in July,August, December and January,and de- Site Licence or of alicence issued by the Copyright Licensing livered by air mail –and afree weekly email newsflash Agency(CLA) in London, UK, or rights bodies in other countries Assistant Editor: Marie McEvoy news@OTCbulletin published 45 times ayear.Annual sub- that have reciprocal agreements with the CLA. Neither may this Business Reporter: TomGallen scriptions in Europe cost £685.00 (additional copies at the publication be exported, distributed or circulated by anymeans Contributing Editor: David Wallace same address £385.00); outside Europe £715 (£415). Single outside the staffwho work at the address to which it is sent by copies cost £50 each. Subscription rates may be adjusted the publisher without the prior written permission of the publisher. Advertising Controller: Debi Minal to coverany period and can be backdated. Subscriptions may While due care has been taken to ensure the accuracyofinform- Director of Sales &Marketing: ValDavis only be cancelledatexpiry. ation contained in this publication, the publisher makes no claim Corporate subscriptions: that it is free of error and disclaims anyliability whatsoever Awards Manager: Natalie Cornwell for anydecisions or actions taken as aresult of its contents. Managing Director: MikeRice Global Site Licences are available to companies. These pro- vide in-house electronic access for stafftoOTC bulletin ©OTC Publications Ltd. All rights reserved. OTC bulletin® is OTC bulletin is published by OTCPublications Ltd, and [email protected] ask for aquotation. Such registered as atrademark in the European Community. 4Poplar Road, Dorridge, Solihull B93 8DB, UK. licences are supplied strictly on the condition that both pub- ISSN 1350–1097. Tel: +44 1564 777550. Fax: +44 1564 777524. lications are the intellectual property of the copyright holder, Companyregistered in England No 2765878. Email: [email protected] OTCPublications Ltd, and are protected by copyright, trade- Printed by Warwick Printing CompanyLimited, Website: www.otc-bulletin.com mark and other laws. Leamington Spa CV31 1QD, UK.

8November 2013 OTC bulletin 3 OTC08-11-13p2-14_Layout 1 05/11/2013 17:59 Page 4

OTC COMPANY NEWS

MerckThird-QuarterResults keepseye on Consumer Care

erck &Co’sConsumer Care business is Business Third-quarter sales Change Proportion Munder constant reviewtoensure that it (US$ millions) 2012/2013 (%) of total (%) is playing aworthwhile role within the group, according to chairman and chief executive offi- Pharmaceutical 9,475 -4 86 cer Kenneth Frazier. Animal Health 800 -2 7 Speaking as Merck announced a2%de- Claritin OTC123 +5 1 cline in Consumer Care’ssales in the third Consumer Care 443 -2 4 quarter,Frazier said that the firm wasalways Other 314 -9 3 looking at its “complementary businesses” – Animal Health and Consumer Care –todeter- Total Merck &Co11,032 -4 100

mine whether their divestment would be “more Figure1:Merck &Co’s sales in the thirdquarter of 2013 broken down by business (Source –Merck &Co) advantageous” to the group. Anydecision on the future of Consumer nesses, such as Consumer Care, versus other back by 3% to US$282 million, while in inter- Care, Frazier explained, would involvejudging opportunities to do that.” national markets turnoverdeclined by 1% to if the business would perform better opera- Frazier had already backed Consumer Care US$160 million. tionally outside of Merck and also whether di- in August, when he lauded the groundbreaking Worldwide sales of Claritin –Consumer vesting the division would create the most value switch of Oxytrol for Women in the US and Care’sleading brand –improvedby5%inthe for shareholders. held it up as an example as to whythe com- third quarter to US$123 million, drivenentirely Frazier’slatest comments come less than a panyhad held onto the business (OTC bulletin, by an 11% jump in US turnovertoUS$90 mil- month after he said that Consumer Care had a 23 August 2013, page 5). lion. Outside of the US, Claritin’ssales fell back future within the group as long as it continued Described as the “first and only” OTCtreat- by atenth to US$33 million. to amakeacontribution to the firm’sdevelop- ment for overactive bladder (OAB) in women, Consumer Care generated 4% of Merck’s ment (OTC bulletin,11October 2013, page 5). Oxytrol for Women (oxybutynin transdermal total third-quarter sales, which slipped back by Announcing anew global cost-saving initia- system, 3.9mg/day) wasapprovedinJanuary 4% to US$11.0 billion. Excluding currencyef- tive in October,Frazier said that he viewed the (OTC bulletin,8February 2013, page 1) and fects, the drop was2%. Consumer Care division as an “important con- launched in September (OTC bulletin,27Sept- Merck blamed the lower sales on the loss of tributor to Merck”, which complemented nicely ember 2013, page 1). patent protection on anumber of its block- the company’score prescription pharmaceuti- The launch of Oxytrol for Women, combined buster prescription-only drugs, including the cals business and contributed to both top- and with “strong sales” of the loratadine-based al- asthma medicine and potential OTCswitch bottom-line growth. lergy medicine Claritin, managed to offset a candidate Singulair (montelukast sodium). However, Frazier stressed that if Merck ever lower turnoverfrom Consumer Care’sfootcare The firm has not ruled out switching Sin- came to the conclusion that Consumer Care andgastrointestinal brands. This left the divi- gulair,which lost exclusivity in November last would be more productive outside of the group, sion’ssales flat at an operational levelatUS$443 year (OTC bulletin,16November 2012, page the firm would “consider other alternatives”. million (C322 million). 5). Asked whether adecision had been made “Atthe end of the day,our goal is to maxi- Includingcurrencyeffects, Consumer Care’s on whether to switch Singulair,aspokesperson mise long-term cash flowfor our shareholders,” turnoverfell by 2% in the third-quarter. said that Merck wasstill evaluating its “options Frazier said, “and we will look at those busi- In the US, Consumer Care’ssales dropped and opportunities”. OTC

IN BRIEF Mergers&Acquisitions ■ HI-TECH PHARMACAL is set to settle India’sPiramal snaps up Caladryl brand aclass action lawsuit which claims that ad- vertising for the company’sNasal Ease brand ndia’sPiramal Enterprises has expanded its Magic, Polycrol, Tetmosol and Triactivbrands. wasmisleading. The US-based firm said it I domestic OTCdermatology portfolio by buy- Valeant acquired Caladryl from Johnson & stood by the advertising for the homoeopathic ing the Caladryl brand from Valeant Pharma- Johnson in 2012. allergy brand and admitted no wrong doing. ceuticals International for an undisclosed sum. Meanwhile, Piramal said that sales at its The proposed settlement will see the company An anti-puritic designed to treat minor skin global Pharmaceutical business –consisting of makesome changes to its advertising for Nasal irritation and itching, Caladryl joins Piramal’s its critical care business, as well as its OTCop- Ease; refund anyeligible members of the class existing collection of skincare brands, which eration –posted sales up by 10.3% to INR13.5 action for the cost of the product; pay legalfees includes Lacto Calamine, i-Pill, Itchmosol, Sari- billion (C 160 million) in the six months ended and expenses up to US$250,000 (C 185,000); don and SupractivComplete. 30 September 2013. and pay the lead plantiffuptoUS$2,500 as an Piramal –which claims to be the seventh Pharmaceutical sales accounted for around incentive award. Hi-Tech relaunched the Nasal biggest OTCfirm in India –pointed out that its 64% of the firm’stotal turnoverinthe period, Ease brand in 2012. consumer portfolio also included anumber of which improvedby31% to INR21.1 billion. OTC “niche” products including, i-Sure, i-Can, Jungle OTC

4 OTC bulletin 8November 2013 OTC08-11-13p2-14_Layout 1 05/11/2013 17:59 Page 5

COMPANY NEWS OTC

NovartisBusinessStrategy/Third-QuarterResul considerts sfutureofOTC unit

ovartis is considering the strategic options Region Third-quarter sales Change 2012/2013 (%) N for its Consumer Health division –which (US$ millions) US$ Local currencies includes the firm’sglobal OTCoperation –and its other businesses that do not have “global Europe 512 +6 +4 scale and critical mass”. US 222 +50 +51 Speaking as Novartis reported an 11% rise Asia/Africa/Australasia 201 -1 +7 in Consumer Health’sthird-quarter sales, Joseph Canada and Latin America 104 -1 +6 Jimenez, the Swiss firm’schief executive offi- Total Novartis Consumer Health* 1,039 +11 +12 cer,revealed the companywas carrying out a “strategic review” of its “smaller businesses”, *Continuing operations including Consumer Health. Figure2:Breakdown of Novartis Consumer Health’s sales in the thirdquarter of 2013 (Source –Novartis) However, the outcome of the reviewwould not be made public, Jimenez said, until action last year,having been manufactured by third Furthermore, Voltaren had “tripled its mar- to address the results had been taken. parties. These brands represented around 25% ketshare” in the Japanese market. Aspokesperson for Novartis told OTC bul- of the US$1.0 billion (C 0.7 billion) in annual sales Meanwhile, strong seasonal demand in Ger- letin that the firm believeditwas important that products manufactured at Lincoln generated. manyand Russia had drivena“high double- that each of its businesses matched the “global Excedrin Extra Strength had been relaunch- digit” increase in sales of the Fenistil skin irri- scale and critical mass” enjoyed by its Alcon, ed earlier this year,Novartis noted, while Bene- tation brand, Novartis said. Pharmaceuticals and Sandoz units. fiber had returned to the US market in June The big rise in OTCsales, coupled with better “Novartis is continuing to look at ways to and had “successfully” regained distribution Animal Health performance, drove up turnover strengthen its other businesses or think about and market share. at Novartis’ Consumer Health business by 11% newopportunitiesfor those businesses, such However, plans to relaunch Theraflucold –12% in local currencies –toUS$1.04 billion as collaboration or partnerships,”the spokes- and flu products in North America by the end (C754 million) in the third quarter (see Figure 1). person added. of this year had been shelved, the companysaid, In the US, Consumer Health’sfirst-quarter Meanwhile, Novartis said its OTCsales had as it wanted to takethe “necessary time to en- sales jumped by 50% –51% in local currency grown at adouble-digit rate in the third quar- sure that the manufacturing of the brand by a terms –toUS$222 million (see Figure 2) as terof2013, as keybrands continued to return third-party met Novartis’ quality standards”. OTCbrands started to return to market. to the US market and its largest global brands Turning to the most recent US Food and Consumer Health’sbiggest region in terms performedwell. Drug Administration (FDA) inspection of the of sales –Europe –posted a6%increase in The companysaid returning brands to the Lincoln plant, Jimenez pointed out that the FDA turnovertoUS$512 million. In local currencies, US market –that had been withdrawn follow- had not identified anyissues that the company the improvement was4%. ing manufacturing problems at its facility in needed to address. By contrast, sales in Consumer Health’sAsia/ Lincoln, Nebraska –had played akey role in Commenting on the OTCbrands that had Africa/Australasia region, slipped back by 1% boosting sales. In December 2011, Novartis not been impacted by the Lincoln closure, to US$201 million due entirely to negative suspended production at the Lincoln plant due Novartis said that Voltaren –“the second-largest currencyeffects. In local currencies, turnover to quality issues and soon afterwards recalled andfastest-growing OTCanalgesic brand glob- in the region advanced by 7%. Excedrin and anumber of other OTCbrands ally” –had delivered double-digit growth in Sales in Canada and Latin America also de- manufactured at the facility (OTC bulletin,23 the third quarter.This had been drivenbythe clined by 1%, dropping down to US$104 mil- January 2012, page 1). launch in several European markets of astrong- lion. Negative currencyeffects were again the Anumber of selectedOTC brands formerly er formulation under the Voltaren 12hr name. culprit, with turnoverinlocal currencies grow- produced at Lincoln –Excedrin Migraine, Lam- This wasnow available in 15 European coun- ing by 6%. isil and Triaminic –returned to market late tries (OTC bulletin,25October 2013, page 16). OTC

Division Third-quarter sales Change 2012/2013 (%) Operating income Change Operating (US$ millions) US$ Local currencies (US$ millions) 2012/2013 (%) margin (%) Pharmaceuticals 7,893 +1 +4 2,267 -10 28.7 Alcon 2,539 +3 +6 251 -30 9.9 Sandoz 2,273 +11 +11 242 -3 10.6 Consumer Health* 1,039 +11 +12 90 +88 8.7 Vaccines and Diagnostics 594 +2 +1 33 –5.6 Corporate –––-212 –– Total Novartis 14,338 +4 +6 2,671 -9 18.6

*Continuing operations

Figure1:Breakdown of the financial performance of Novartis in the thirdquarter of 2013 (Source –Novartis)

8November 2013 OTC bulletin 5 OTC08-11-13p2-14_Layout 1 05/11/2013 17:59 Page 6

OTC COMPANY NEWS

ChinaThird-QuarterResults holdsback OTC sales at GSK

ower sales of twokey brands in China held Business Third-quarter sales Change 2012/2013 (%) Lback growth at GlaxoSmithKline Consum- (£ millions) £CER* Ongoing CER** er Healthcare’sTotal Wellness OTCbusiness in the third quarter of 2013. Total Wellness 482 -3 ±0 ±0 Sales of the Contac decongestant and Fen- Oral Care 476 +5 +6 +6 bid topical analgesic in China had fallen by 43% Nutrition 290 +5 +10 +10 and 40% respectively,GlaxoSmithKline said, Skin Health 65 ±0 ±0 ±0 offsetting good performances elsewhere and leav- ing Total Wellness’ ongoing turnoverflat at £482 Consumer Healthcare1,313 +2 +4 +4 million (C566 million) at constant exchange rates. *CER is at constant exchange rates ** Growth excluding non-core OTCproducts at constant exchange rates Includingthe non-core brands divested in the Figure1:GlaxoSmithKline Consumer Healthcare’s sales in the thirdquarter of 2013 broken down by business first half of last year,Total Wellness’ sales had (Source –GlaxoSmithKline) declined by 3% as reported, GlaxoSmithKline noted, butwere flat at constant exchange rates. in the opening six months of 2012. TheNutrition business reported turnoverup The companyblamed the collapse in Contac The disposals had total 2011 sales of £370 by atenth at constant exchange rates to £290 sales in China on the government’sdecision to million, the companyreported. Selling 17 North million in the quarter,thanks to a16% jump in move the product behind pharmacycounters, American brands to Prestige Brands Holdings sales of Horlicks in India and an even bigger 19% while Fenbid had been hit by upcoming price for US$660 million (C515 million) account- increase in turnoverfrom Boost energy drinks. reductions after it had been added to the coun- ed for sales of £126 million (OTC bulletin,16 Sales of Lucozade and Ribena had risen by try’s essential medicines list. April 2012, page 5). 9% and 11% respectively,GlaxoSmithKline Simon Dingemans, GlaxoSmithKline’schief To this wasadded £185 million in European noted, thanks to good weather in the UK, new financial officer,warned that the problems in sales from divesting non-core brands to Omega flavours and “strong seasonal promotions”. China would likely continue throughout the year Pharma for C470 million in cash (OTC bul- Prior to the close of the quarter,GlaxoSmith- as the price reductions were implemented. letin,16March 2012, page 1); and £60 million Kline announced it had agreed to sell its Luc- To help regain the lost sales in China, Con- in international brand sales from a£164 mil- ozade and Ribena drinks brands to Japan’sSun- sumer Healthcare had initiated strong above- lion deal with Aspen Holdings (OTC bulletin, tory Beverage &Food for £1.35 billion. The and below-the-line support for Contac, aspokes- 30 April 2012, page 1). deal should close later this year. person for GlaxoSmithKline told OTC bul- Suntory is paying 2.7-times the combined letin,and had launched anew television adver- Rebuilding the Alli brand sales of the twobrands, which were approxi- tising campaign for Fenbid which highlighted However, the firm failed to find abuyer for mately £0.5 billion in 2012. the brand’s“multiple pain treatment” message. Alli and has nowstarted rebuilding the brand David Redfern, GlaxoSmithKline’schief On abrighter note, sales of the company’s in major markets around the world (OTC bul- strategy officer,said the companybelievedthat vitamins products had improvedby30% in the letin,10August 2012, page 4). thefuture of Lucozade and Ribena wasin“good three months, GlaxoSmithKline pointed out. Unaffected by the non-core divestments, hands” givenSuntory’sestablished beverages Total Wellness accounted for 37% of Glaxo- GlaxoSmithKline Consumer Healthcare’sNutri- business, ambitious growth plans and its recog- SmithKline Consumer Healthcare’stotal on- tion and Oral Care businesses reported gains in nition of the “strong performance and capa- going third-quarter sales, which increasedby the third quarter,while sales at the Skin Health bility of the GlaxoSmithKline employees work- 4% at constant exchange rates to £1.31 billion unit were flat. ing on these products”. (see Figure 1). Includingthe divested non-core Oral Care sales grewby6%atconstant ex- Under the terms of the deal, Suntory will brands, the division’ssales edged up by 2% as change rates to £476 million. Strong contribu- also takeoverarecently-formed unit designed reported and by 4% at constant exchange rates. tions from Sensodyne Sensitivity and Sensodyne to ease the transfer of the brands to their new The UK-based firm divested OTCbrands Acid Erosion, and denture-care brands –upby owner.Headed by Peter Harding –former gen- across the US, Europe and other regions for net 14% and 10% respectively –had offset a9% eral manager of Consumer Healthcare’sGreat cash proceeds of approximately £690 million drop in sales of Aquafresh, the companynoted. Britain &Ireland business –the unit consists of amanufacturing plant and 700 staff(OTC Region Third-quarter sales Change 2012/2013 (%) bulletin,13September 2013, page 22). (£ millions)£CER* Ongoing CER** The sale came six months after GlaxoSmith- Kline put Lucozade and Ribena up for sale fol- Rest of World 607 +3 +4 +5 lowing the results of astrategic review(OTC Europe 473 +9 +6 +6 bulletin,10May 2013, page 6). US 233 +3 ±0 ±0 Announcing the strategic reviewinFebruary (OTC bulletin,22February 2013, page 6), Total Consumer Healthcare1,313 +2 +4 +4 AndrewWitty,GlaxoSmithKline’schief exec- *CER is at constant exchange rates ** Growth excluding non-core OTCproducts at constant exchange rates utive officer,said the twobrands did not fitin

Figure2:GlaxoSmithKline Consumer Healthcare’s turnover in the thirdquarter of 2013 broken down by region with the two“significant” synergy opportuni- (Source –GlaxoSmithKline) ties enjoyed by Consumer Healthcare.

6 OTC bulletin 8November 2013 OTC08-11-13p2-14_Layout 1 05/11/2013 17:59 Page 7

COMPANY NEWS OTC

BioGaiaDistributionAgreements/Third-Quar signsterResults deals to aid expansion

ioGaia has grown its presence in Europe by 8% to SEK46.4 million (C5.27 million). stop stocking BioGaia’sproducts. Bandthe Middle East by signing four dis- BioGaia’stotal sales decreased by 1% year- However, sales of finished consumer prod- tribution deals for its oral-health products. on-year to SEK62.2 million. ucts in the Rest of World and North America The Swedish probiotics specialist said that In Italy,sales of finished consumer products regions improvedduring the period. agreements had been made in Europe with hadbeen hit by areduction in inventory at Bio- BioGaia pointed out that sales to Gerber,the George Petrou for Cyprus, Plac Control for Gaia’sdistributor,the firm noted, plus the “on- firm’snew distributor of colic drops in the US, Greece and Streuli Pharma for Switzerland. going difficult economic situation in the coun- had accounted for the rise in that market. PharmaPal Drugstore has also been signed try”. It was“difficult to predict when the Italian In contrast to the overall decline in con- up to distribute BioGaia’soral-health products market will recover”, BioGaia said. “But in sumer products, sales of component products –containing its patented probiotic Lactobacil- September,” it added, “sales of our products in increased by 26% to SEK15.7 million, as the lusreuteri –inthe United Arab Emirates(UAE). pharmaciesreturned to normal levels.” revenue from the company’slatest deal with Meanwhile in Germany, BioGaia relaunch- Nestlé wasrecognised during the quarter. ed its oral-health products through its distrib- Price war in Poland Signed in May,the deal will see BioGaia’s utor Sunstar in September. Aggressive price competition in Poland neg- patented Lactobacillus reuteri probiotic added The newagreements will give BioGaia the atively impacted the company’sconsumer prod- to an existing line of Nestlé products (OTC opportunity to lift its European sales, after prob- ucts sales in the country as BioGaia refused to bulletin,17June 2013, page 6). lemsinthe Italian and Polish markets led to a engage in a“price war”. In the three months, operating profit edged decline in turnoverinthe region during the In the company’sAsian markets, adown- up slightly by 2% to SEK13.8 million. Exclud- third quarter.Turnoverfrom the company’sfin- turn in sales wasattributed to the decision by ingcurrencyeffects, operating profit slipped ished consumer products unit dropped back an unnamed drugstore client in the region to back by 3%. OTC

First wasthe interaction between the firm’s Theadvance in Europe reflected strong sales strong growth in the oral-care category. Pharmaceutical business and Consumer Health- of pain, smoking-reduction/cessation and res- GlaxoSmithKline reported acore operating care’sOTC business, Witty pointed out. piratory health brands, GlaxoSmithKline said, profit at Consumer Healthcareof£239 million, ManyofConsumer Healthcare’sOTC drugs along with the good performances from Luc- up by 6% at constant exchange rates (see Fig- had been prescription pharmaceuticals origi- ozade and Ribena. These gains had been par- ure 3). The firm explained the core result ex- nally.These OTCbrands, liketheir prescrip- tially offset by lower sales of Maxinutrition cluded amortisation and goodwill, major re- tion counterparts, were very often distributed products, the firm noted. structuring costs, legalcharges, other operating through pharmacies, Witty explained, so there In Consumer Healthcare’sRest of World income, net royalty income, disposals of asso- existed a“tremendous” opportunity for syner- region, core sales improvedby5%atconstant ciates, and acquisition accounting adjustments gies in this area. exchange rates to £607 million. The rise would for material acquisitions. Second, the company’sPharmaceutical and have been greater butfor a29% drop in China Consumer Healthcareaccounted for afifth Consumer Healthcarebusinesses had “very due to lower sales of Contac and Fenbid. of GlaxoSmithKline’stotal third-quarter sales, strong” distribution synergies in emerging mar- Core US Consumer Healthcareturnoverhad which improvedby1%atconstant exchange kets, Witty pointed out, and as those markets been flat at constant exchange rates at £233 rates to £6.51 billion. Pharmaceuticals and Vac- developed, more opportunities for collabora- million, the firm said, as lower sales of Alli and cines accounted for the remaining 80%. tion would arise. smoking-reduction/cessation products offset OTC In addition,GlaxoSmithKline believedthat having a“science-endorsed or expert-endorsed Third quarter Change 2012/2013 (%) Proportion proposition” behind manyofits Consumer (£ millions) £CER* of total (%) Healthcare brands wasone of the business’ key competitive advantages, Witty said. Sales Consumer Healthcare’sSkin Health business Pharmaceuticals and Vaccines 5,197 -1 ±0 80 reported flat third-quarter sales of £65 million Consumer Healthcare 1,313 +2 +4 20 at constant exchange rates. The stagnant per- Total 6,510 ±0 +1 100 formance had been due primarily to “retailer stocking movements” in the US. These had neg- Coreoperating profit atively impacted sales of the Abreva range, Pharmaceuticals and Vaccines 1,768 –-288 GlaxoSmithKline said. Consumer Healthcare 239 –+612 Excluding the divested brands, core Con- Total** 2,059 +6 +11 100 sumer Healthcare sales grewquickest in Europe in the third quarter,with turnoverimproving by *CER is at constant exchange rates ** Excluding non-core items of £490 million and corporate costs of £52 million

6% at constant currencyrates (see Figure 2) Figure3:GlaxoSmithKline’s ‘core’ sales and operating profit in the thirdquarter of 2013. Coreresults exclude to £473 million. amortisation, goodwill, restructuring costs, legal charges and other items (Source –GlaxoSmithKline)

8November 2013 OTC bulletin 7 OTC08-11-13p2-14_Layout 1 05/11/2013 17:59 Page 8

OTC COMPANY NEWS

First-HalfResults Taisho struggling to ignite home market

apan’sTaisho Pharmaceutical admitted that Business First-half sales Change Forecast sales Change Jbetter sales in the cold remedies category (¥ billions) (%) (¥ billions) (%) overthe summer and investment in newprod- ucts had not been enough to combat the per- Japan 77.0 -0.7 151.6 +0.3 sistent weakness in Japan’sself-medication mar- International OTCdrugs 7.8 +81.2 15.8 +65.3 ketinthe six months ended 30 September 2013. International energy drinks 4.8 +33.7 9.6 +36.2 Despite continued investment behind various International other 0.4 –0.8 – projects to help kick-startthe stagnant Japanese International 13.0 +57.0 26.2 +49.2 market, the Self-Medication division’sdomestic Others 1.4 +5.5 2.6 +1.1 sales –including the Bioferminand Tokuhon Total Self-Medication91.4 +4.9 180.4 +5.3 subsidiaries–dropped by 0.7% to ¥77.0 billion Prescription operations 53.1 +0.7 114.1 +0.2 (C575 million) in the period (see Figure 1). Total forTaisho 144.6 +3.3 294.5 +3.3 Taisho –which is Japan’slargest OTCcom- pany–pointed out that the Self-Medication Figure1:Taisho Pharmaceutical’s sales in the first half ended 30 September 2013. Forecasted sales arefor the division would continue trying to “energise” the year ending 31 March 2014 compared with actual sales in the previous year (Source –Taisho Pharmaceutical) market in Japan by focusing its efforts on the Business First-half sales Change Forecast sales Change “lifestyle diseases” category and by strength- (¥ billions) (%) (¥ billions) (%) ening further its product information and in- store sales promotions. Lipovitan D25.0 -3.9 43.1 -3.7 In April, Taisho successfully claimed Japan’s Other Lipovitan 12.6 +3.8 23.3 +6.0 first prescription-to-OTC switch of amedicine Total Lipovitan brand 37.6 -1.5 66.4 -0.5 indicated to treat high cholesterol with the Zena brand 1.5 +4.6 3.4 +8.1 launch of Epadel T(600mg ethyl icosapentate), Other drinks 0.9 ––– and said it would continue to broaden its range Total tonics and nutrient drinks 40.0 -1.6 –– of category 1medicines –OTC products deem- Cold remedies (Pabron brand) 10.4 +0.3 26.3 +0.9 ed to hold the greatest degree of risk –byiden- Hair treatments (RiUP brand) 7.0 +1.6 14.1 +1.4 tifying further switch candidates (OTC bulletin, Biofermin 3.2 -8.1 6.7 +0.3 26 April 2013, page 1). Livita series 2.1 -14.0 4.3 -10.5 Just last month, Taisho said it intended to Analgesics (Naron brand) 2.1 +0.1 4.1 -1.0 introduce further prescription-to-OTC switch Gastrointestinal treatments 1.9 -5.5 4.0 -6.5 products in Japan in the coming years to help Laxatives(Colac brand) 1.7 -6.3 3.6 -3.1 revive the domestic OTCmarket and address Cold remedies (Vicks brand) 1.2 +6.8 3.4 +7.6 growing concerns surrounding the country’slow birth rates and aging population (OTC bulletin, Tokuhon 0.8 +40.5 1.3 -9.3 11 October 2013, page 4). Other Self-Medication products 6.6 –14.0 – Although domestic sales had suffered in the Total Domestic Self-Medication77.0 -0.7 151.6 +0.3 six months, overall turnoveratTaisho’sSelf- Medication division advanced by 4.9% to ¥91.4 Figure2:Breakdown of Taisho Pharmaceutical’s Self-Medication sales in Japan in the first half ended 30 September 2013. Forecasted sales arefor the year ending 31 March 2014 compared with actual sales in the billion, thanks to a57.0% increase in interna- financial year ended 31 March 2013 (Source –Taisho Pharmaceutical) tional turnoverto¥13.0 billion. Other sales add- ed the remaining ¥1.4 billion to the total. the six month period (see Figure 2). First-half sales Change International sales of the division’sOTC Turnoverfrom Lipovitan Dfell by 3.9% to (¥ billions) (%) products grewby81.2% to ¥7.8 billion, while ¥25.0 billion, while sales of other Lipovitan internationalturnoverfrom energy drinks im- products –including the low-calorie Lipovitan Food channels 21.7 -0.6 provedby33.7% to ¥4.8 billion. Feel –advanced by 3.8% to ¥12.6 billion. Drug channels 18.3 -2.7 Sales outside of Japan had been boosted by Sales of Taisho’stonic and nutrient drinks Total 40.0 -1.6 theinclusion of the Osotspa OTCjoint venture through drug channels decreased by 2.7% to in Thailand (OTC bulletin,16April 2012, page ¥18.3 billion, and by 0.6% to ¥21.7 billion Figure3:Breakdown by distribution channel of Taisho Pharmaceutical’s sales of tonics and nutrient 5), Taisho said, along with the Mexican OTC through food channels (see Figure 3). drinks in Japan in the first half ended 30 September firm Compañia Internacional de Comercio and The firm’sPabron cold remedies posted sales 2013 (Source –Taisho Pharmaceutical) its US distribution arm Vitacilina Corporation up by 0.3% to ¥10.4 billion, thanks to steady of America, which Taisho had acquired in July growth of mainstay general cold remedies from thanks to continued good performance of RiUP last year (OTC bulletin,27July 2012, page 3). July.Taisho’sother cold remedies brand, Vicks, Jet, ahair regrowth treatment with a“push- Meanwhile, domestic sales of Taisho’score posted turnoverupby6.8% to ¥1.2 billion. activated jet nozzle”, which waslaunched in Lipovitan brand of energy and tonic drinks The RiUP hair-regrowth brand reported a December 2012. slipped back by 1.5% to ¥37.6 billion during 1.6% rise in sales to ¥7.0 billion, primarily OTC

8 OTC bulletin 8November 2013 OTC08-11-13p2-14_Layout 1 05/11/2013 17:59 Page 9

COMPANY NEWS OTC

Third-QuarterResults First-QuarterResults North American P&G reports gains at its sales liftProbi Personal Health Careunit nincrease in North Americansales ac- A counted for a“significant portion” of the rocter &Gamble said that sales at its Per- Pet Care turnoverdue to aproduct recall. growth recorded by Probi’sConsumer Health- Psonal Health Care business –which in- The recall of the Natura pet food brand – care business in the third quarter,according to cludes its OTCoperations –had movedfor- coupled with higher investment in the Oral Care the company’sinterim chief executive officer ward in the company’sfirst quarter ended 30 unit –had also impacted Health Care’spre-tax Gun-Britt Fransson. September 2013. earnings, the companynoted, which had slipped Turnoveratthe Swedish probiotic firm’s The US-based consumer goods giant said back by 18% to US$398 million. Consumer Healthcaredivision climbed by 45% the rise in turnoveratits Personal Health Care to SEK14.5 million (C 1.66 million) during the business had been aided by double-digit sales New Global Health business three months. The rise had been driven, Probi growth at PGT Healthcare, the 51%/49% OTC Procter &Gamble recently announced that noted, by deliveries of its gut-health capsules joint venture that it establishedwith Teva Phar- it wasreorganising its business to create anew to its North American distributor Pharmavite. maceutical Industries twoyears ago (OTC bul- Global Health and Grooming business “sec- Fransson revealed that Probi’sfirst launch letin,16November 2011, page 1). tor”, which would include anew streamlined through its partnership with US probiotics Despite the gains made by the Personal Health Care unit (OTC bulletin,17June 2013, specialist Viva 5had taken place in the quarter, Health Care unit, sales at Procter &Gamble’s page 7). with more launches in the US “planned for Health Care business –which also includes the The new-look Health Care unit would no later this year”. Pet Care, Oral Care and Feminine Care units, longer include Oral Care or Feminine Care and In January,Viva 5agreed to conduct busi- as well as Personal Health Care –were flat at instead would coveronly Procter &Gamble’s ness development activity on behalf of Probi US$2.31 billion (C1.69 billion). wholly-owned US OTCbusiness as well as and its Probi Digestis and Probi Defendum Procter &Gamble said the better Personal PGT Healthcare, the companynoted. products in North America (OTC bulletin,18 Health Care sales had been offset by afall in OTC January 2013, page 4). As aresult of the Viva 5partnership, Probi had receivedproduct orders from additional distributors in the US, the firm pointed out. The improvement in Consumer Health- care’ssales had been the primary reason be- hind the rise in Probi’stotal group turnover, Fransson said. Sales grewby16% to SEK24.1 million in the three months. The Functional Foods division posted adecline in sales of 10% to SEK9.7 million. Probi’soperating profit advanced by 13% to SEK4.5 million, as Consumer Healthcare post- ed an operating profit of SEK0.17 million. During the quarter,Probi continued to pur- sue its global expansion strategy to develop its Consumer Healthcarebusiness. In July,the firm signed adeal with healthcare companyBio-Life to distribute its Probi Digestis digestive health brand in Malaysia (OTC bulletin,26July 2013, page 11). The launch wasset to takeplace be- fore the end of 2013, Probi pointed out. Probi Digestis would also be launched in Morocco during the first quarter of 2014, Probi announced,following adeal signed in Aug- ust with Botanic Pharma. Furthermore, Probi expanded its partner- ship with Health World in Australia during the three months, penning adeal to distribute its Probi Defendum immune product in Australia and NewZealand from 2014 (OTC bulletin, 11 October,page 6). OTC

8November 2013 OTC bulletin 9 OTC08-11-13p2-14FIN_Layout 1 06/11/2013 08:56 Page 10

OTC COMPANY NEWS

Third-QuarterResults VitaminsliftPfizer Consumer Healthcare

fizer said that worldwide sales at its Con- Business Third-quarter sales Change Proportion Psumer Healthcare division had edged up by (US$ millions) 2012/2013 (%) of sales (%) 1% to US$788 million (C573 million) in the third quarter of 2013, thanks primarily to strong Specialty Care 3,349 -2 26 growth of its Emergen-C vitamin Cbrand in the Primary Care 3,259 -10 26 US and of its Centrum multivitamin range in Emerging Markets 2,431 +2 19 international markets. Established Products 2,296 -4 18 Acquired in March last year (OTC bulletin, Consumer Healthcare 788 +1 6 16 March 2012, page 1), Emergen-C had ben- Oncology 407 +24 3 efitted from “expanded distribution and promo- tional activities”, Pfizer said. Other 113 –1 Meanwhile, several product launches had Total Pfizer 12,643-2100 boosted Centrum’ssales, the companypointed out, along with increasedpromotional activities Figure1:Pfizer’s sales in the thirdquarter of 2013 broken down by business (Source –Pfizer) in keymarkets. However, the success of Emergen-C and tion (FDA). Pfizer anticipated launching an Consumer Healthcareaccounted for around Centrum had been partiallyoffset by lower sales OTCversion of the product in 2014. 6% of Pfizer’stotal third-quarter sales, which of respiratory products and “certainother prod- Meanwhile, Pfizer’splan to switch the chol- fell by 2% to US$12.6 billion (see Figure 1). ucts” in international markets, Pfizer said, due esterol-lowering drug Lipitor (atorvastatin cal- The decline wasprimarily due to adrop in to “unfavourable seasonal conditions”. cium)from prescriptiontonon-prescription turnoveratthe company’sdominant prescrip- In the US, the good performance from the status in the US had continued to progress at a tion pharmaceuticals operations, after several Emergen-C brands had lifted Consumer Health- “good pace”, aspokesperson for the company keyproducts –including Lipitor –lost exclu- care’ssales by 2% to US$396 million. Inter- told OTC bulletin. sivity last year. national turnover–despite Centrum’sstrong Earlier this year,Pfizer said that it was“ad- Pfizer’spre-tax income from continuing op- showing –was flat at US$392 million. vancing the various phases” of its Lipitor switch erations improvedby27% to US$3.57 billion. Looking ahead, Consumer Healthcare is set programme and was“actively working to ad- This wasthanks to adecline in operating costs to launch an OTCversion of AstraZeneca’s dress the challenges highlighted by previous and lower restructuring and acquisition-relat- proton-pump inhibitor esomeprazole –under the industry attempts to switch acholesterol-low- ed charges. brand name Nexium Control –across the Euro- ering product”. In January 2014, Pfizer plans to reorganise pean Union (EU) in the near future, after the “Solving these issues and challenges, such the firm into three separate business segments. European Commission approvedthe switch as ensuring appropriate self-selection, is an iter- Consumer Healthcarewill join Pfizer’sVac- (OTC bulletin,11October 2013, page 11). ative process,”the spokesperson pointed out. cines and Oncology units in one of twoInno- Indicated for short-term treatment in adults Asked when aswitch application for Lipitor vation segments. The other Innovation segment of reflux symptoms,such as heartburn and acid would be filed with the US Food and Drug Ad- will coveranarray of therapeutic categories, regurgitation, Nexium Control is the third med- ministration (FDA), the spokesperson said that while aValue segment will house Pfizer’soff- icine to be switched through the EU’scentral- giventhe “multiple layers of complexity with patent products, mature brands and biosimilars. ised procedure. this particular switch and competitor interest Operations currently covered by Pfizer’sEm- Pfizer snapped up the global rights to non- in the market”, the firm could not be “specific erging Markets division will be split between the prescription versions of Nexium from AstraZen- about other programme details or timelines”. Value segment and twoInnovative segments. eca for an initial US$250 million last September Astatin has neverbeen granted OTCstatus Amy Schulman, Pfizer’sexecutive vice-pres- (OTC bulletin,14September 2012, page 1). in the US before and it is nowmore than a ident, general counsel and head of Consumer The companynoted that its proposed switch decade since Bristol-Myers Squibb and Merck Healthcare, will lead the Vaccines, Oncology and of Nexium in the US wasontrack and that a &Coattempted to switch Pravachol (pravas- Consumer Healthcare Innovation unit. NewDrug Application (NDA) had nowbeen tatin) and Mevacor (lovastatin) respectively Commenting on the newstructure, Ian Read, filed with the US Food and Drug Administra- (OTC bulletin,30June 2000, page 16). Pfizer’schief executive officer,said that the companybelieveditwas the best wayfor it to “focus and maximise” the different parts of the group, as each segment operated adifferent IN BRIEF business model. ■ OXFORD PHARMASCIENCE –the UK- pilot testing of the tablet wasset to begin in Asked whether the newstructure prepared based development firm –said that it had suc- early 2014, Oxford Pharmascience pointed the ground to sell or spin-offparts of the busi- cessfully formulated “gastric safe” 400mg ibu- out, noting that its target market for the prod- ness, Read said that he felt the move gave Pfizer profen tablets using its OXPzero delivery tech- uct waspatients requiring relief from the symp- the ability to look at “different ways” of creating nology.The firm said that its OXPzero tech- toms of rheumatoid arthritis, osteoarthritis and shareholder value, and that decisions on howbest nology reduced the adverse effects of ibupro- other similar conditions. to do this would be made at the appropriatetime. fen on the stomach and small intestine. Clinical OTC OTC

10 OTC bulletin 8November 2013 OTC08-11-13p2-14_Layout 1 05/11/2013 17:59 Page 11

COMPANY NEWS OTC

Third-QuarterResults Sanofi solves China crisis to boost sales

anofi’sConsumer Healthcaredivision en- Region Third-quarter sales Change (%) Proportion Sjoyed a“robust” third quarter,asthe busi- ( C millions) CER* of sales (%) ness overcame its distribution problems in China and returned to growth in the country,accord- Emerging Markets 374 +11.5 50 ing to chief executive officer Chris Viehbacher. Western Europe 156 +4.0 21 Speaking as Consumer Healthcare reported US 153 +16.4 21 a9.8% rise in third-quarter sales at constant Rest of World 59 ±0.0 8 exchange rates –1.2% as reported –toC742 Total Consumer Healthcare742 +9.8 100 million, Viehbacher said the French firm’s OTCbusiness had reversed the “distortions in *CER is constant exchange rates

the trade channel in China” and had posted Figure1:Sanofi’s Consumer Health Caresales in the thirdquarter of 2013 by region (Source –Sanofi) “double-digit growth” in what wasone of its keyemerging markets. in terms of sales –by11.5% at constant ex- haled corticosteroid to treat “seasonal and year- Earlier this year,Sanofirevealed that its change rates to C374 million (see Figure 1). round nasal allergies in adults and children aged Consumer Healthcarebusiness in China had Consumer Healthcareperformed best in the twoyears of age or older”. been blighted by alack of transparencyinthe US, where the relaunch of the Rolaids ant- Nasacort Allergy 24HR is set to be launched distribution channel, admitting that it had no acid range –which Viehbacher described as an in spring 2014, Sanofipointed out, adding that real control overthe “flowofmargin” between “iconic brand” –helped drive up sales by 16.4% it would be the “only single active ingredient the companyand retailers. at constant exchange rates to C153 million. OTCmedicine” that relievedthe “full range of To ensure Consumer Healthcare had better Sanofisnapped up the rights to Rolaids from nasal allergy symptoms, including nasal conges- control overits products in the Chinese system Johnson &Johnson’sMcNeil-PPC unit for an tion, for 24 hours with asingle daily dose”. and the waythe margins were shared, it had undisclosed sum earlier this year (OTC bul- Elsewhere, Consumer Healthcare’sturnover ended a“significant number” of distribution letin,18January 2013, page 1). in Western Europe advanced by 4.0% at con- deals and cut the number of distributors it work- Meanwhile, Chattem –Sanofi’sUSConsum- stant exchange rates to C156 million, while Rest ed with, Sanofinoted. er Healthcare subsidiary –isset to expand the of World sales were flat at C59 million. Although these changes had damaged sales company’sOTC offering in the country with the Following the close of the quarter,Sanofi in the short term, the companyconceded, the launch of Nasacort Allergy 24HR, following the announced that for the first time it would group changes had givenita“better understanding” successful prescription-to-non-prescription switch all of its global OTCsubsidiariesunder one ban- of the flowofgoods in the marketplace. of the triamcinolone acetonide-based nasal spray ner (OTC bulletin,25October 2013, page 23). The better performance in China lifted Con- (OTC bulletin,25October 2013, page 1). Led by Vincent Warnery,the newGlobal sumer Healthcare’sthird-quarter turnoverin In October,the US Food and Drug Admin- Consumer Healthcaredivision would support Emerging Markets –the division’sbiggest region istration (FDA) approvedthe switch of the in- the company’sstrategy of building innovative global brands, Sanofisaid, and would ensure Business Third-quarter sales Change (%) Proportion the continued growth of Consumer Healthcare. ( C millions) CER* of sales (%) Turning to Consumer Healthcare’sleading Doliprane 71 +10.9 >1 brands, Sanofisaid that the division’sfivebig- Allegra60+22.2 >1 gest sellers had all recorded double-digit gains. Essentiale 39 +20.0 >1 The Doliprane paracetamol line remained Enterogermina 32 +35.7 >1 the division’sbest seller,with turnoverrising by No Spa 32 +17.2 >1 10.9% at constant exchange rates to C71 million Lactacyd 27 +3.4 >1 in the three months (see Figure 2). Dorflex24±0.0 >1 Enterogermina probiotics wasthe best per- Other Consumer Healthcarebrands 457 +6.4 5 former,with sales increasing by 35.7% to C32 Consumer Healthcare 742 +9.8 9 million, while sales of Essentiale supplements Diabetes 1,670 +20.1 20 improvedbyafifth to C39 million. Sales of Allegra OTCadvanced by 22.2% Genzyme 529 +21.1 6 at constant exchange rates to C60 million as the Generics 424 -5.4 5 allergy brand waslaunched in Japan. Oncology/Other Pharmaceutical 3,309 –39 Completing the top-fivewas the No Spa Pharmaceuticals 6,674 +2.7 79 antispasmodic line, which reported sales up by Vaccines 1,300 -7.2 15 17.2% to C32 million. Animal Health 458 -6.4 5 The Lactacyd feminine wash line reported Total Sanofi8,432 +0.6 100 a3.4% increase in turnovertoC27 million, while sales of the Dorflexanalgesics brand were *CER is constant exchange rates flat at C24 million. Figure2:Sanofi’s sales in the thirdquarter of 2013 broken down by business (Source –Sanofi) OTC

8November 2013 OTC bulletin 11 OTC08-11-13p2-14_Layout 1 05/11/2013 17:59 Page 12

OTC COMPANY NEWS

Third-QuarterResults Reckitt enjoys double-digitHealth gain

olid performances from existing brands and Business Third-quarter sales Change 2012/2013 (%) Srecent acquisitions drove adouble-digit rise (£ millions) £CER* in third-quarter sales at Reckitt Benckiser’s (RB’s) Health segment. Hygiene 948 +5 +6 Turnoveratthe UK-based consumer goods Health 707 +27 +25 giant’sHealth category jumped by 27% –25% Home 500 -1 -1 in constant currencies –to£707 million (C830 RB Pharmaceuticals 191 -14 -16 million) during the three months (see Figure 1). Portfolio Brands 128 -19 -22 Acquisitions had accounted for 17 percent- Food 74 +3 +1 age-points of the rise, RB pointed out, organic growth afurther 8percentage-points and posi- Total Reckitt Benckiser 2,548 +5 +5 tive currencyeffects the remaining twoper- *CER is constant exchange rates

centage-points. Figure1:Reckitt Benckiser’s sales in the thirdquarter of 2013 by business (Source –Reckitt Benckiser) “If you look at our Health performance, all of our keybrands have done very well,”said Region Third-quarter sales Change 2012/2013 (%) Rakesh Kapoor,RB’schief executive officer. (£ millions) £CER* Increased sales of RB’sPowerbrands –in Europe and North America 1,308 +9 +5 particular Durex, Mucinex, Nurofen and Scholl LAPAC** 623 +7 +15 –had been drivenbycontinued investment and brand innovation, commented Kapoor. RUMEA*** 352 +2 +5 During the quarter,the Mucinexbrand had Other**** 265 –– been expanded beyond cough and congestion, Total Reckitt Benckiser 2,548 +5 +5 Kapoor noted, with the launch of MucinexFast Max Night-Time Cold &Flu (OTC bulletin, *CER is constant exchange rates ** LAPAC region consists of Australia/NewZealand, Latin America, North Asia, and South and South-East Asia 23 August 2013, page 24). *** RUMEA consists of Middle East, North Africa and Turkey,Russia and the CIS, and Sub-Saharan Africa Brand innovations at Durexinthe three **** RB Pharmaceuticals and Food, which are not reported as part of anyregion months had included ‘Reel Feel’ polyisoprene Figure2:Reckitt Benckiser’s sales in the thirdquarter of 2013 by region (Source –Reckitt Benckiser) condoms and DurexEmbrace gels, Kapoor pointed out. These newproducts were helping December 2012, page 1). RB had also spent Kapoor pointed out. Growth had been driven Durexbecome a“sexual wellbeing brand”. more on marketing at Schiff, Kapoor added. by sales of RB’sHealth Powerbrands, Kapoor Meanwhile, RB’srecent consumer health ac- Turning to the firm’sother recent acquisi- noted, in particularScholl in Europe and Muc- quisitions had delivered strong growth, Kapoor tions, Kapoor said that the Myanshuning sore- inexinthe US. All European regions had re- said. In particular,US-based vitamins, minerals throat brand in China had made a“strong start” corded increased sales, Kapoor added, with the and supplements (VMS) firm SchiffNutrition (OTC bulletin,22February 2013, page 5) and exception of Southern Europe. International (OTC bulletin,18December 2012, RB had seen “early encouraging results” from In the LAPAC region –consisting of Aus- page 1) had achievedahead of expectations. its OTCcollaboration in Latin America with tralia/NewZealand, Latin America, North Asia, Kapoor revealed that RB had made opera- Bristol-Myers Squibb (OTC bulletin,22Feb- and South and South-East Asia –growth in tional changes at Schiff–that included improv- ruary 2013, page 1). the Health category had been drivenbyDurex ing the business’ distribution –since acquiring On aregional basis, Europe and North Am- and Gaviscon, RB said. thefirm at the end of 2012 (OTC bulletin,18 erica had reported arise in Health turnover, Strong sales of Nurofen and Strepsils had offset slowing market growth during the quar- ter in the RUMEA region, RB reported, which covers the Middle East, North Africa and Turkey, Mergers&Acquisitions Russia and the Commonwealth of Independent Recordati completes Casen Fleet buy States (CIS), and Sub-Saharan Africa. Health accounted for 28% of RB’stotal ecordati has closed its acquisition of Labo- it had also gained Casen Fleet’smanufacturing third-quarter sales, which improvedby5%to Rratorios Casen Fleet –the Spanish sub- facility in Zaragoza, Spain. £2.55 billion (see Figure 2). sidiary of Fleet Laboratories –for C93 million. Meanwhile, Fleet said it had taken the deci- Kapoor announced that RB would be under- Casen Fleet generated sales of C45.3 million siontosell its Spanish business so it could ded- taking a“strategic review” of its Pharmaceuti- in 2012 from its range of prescription and non- icate resourcestoits “core US market”. cals segment to consider all options for “max- prescription brands led by Citrafleet, aprod- Fleet noted that the proceeds of the sale imising value for our shareholders”. The review uct used to prepare patients for colonoscopy. would help the firm to better execute its strat- wasexpected to takesome time, Kapoor added, Recordati pointed out that as part of the ac- egyofbuilding a“portfolio of consumer health- noting that the firm would update shareholders quisition –which wasannounced in September care products in the US and other core markets”. “during the course of 2014”. (OTC bulletin,27September 2013, page 3) – OTC OTC

12 OTC bulletin 8November 2013 OTC08-11-13p2-14_Layout 1 05/11/2013 17:59 Page 13

COMPANY NEWS OTC

Third-QuarterResults Currency hurts Bayer Consumer Care

ayer Consumer Care’ssales fell back by Brand (business unit) Third-quarter sales Change 2012/2013 (%) B0.1% to C984 million in the third quarter ( C millions) C CER* of 2013, as negative currencyand portfolio effects offset gains made by anumber of its Contour (Medical Care) 176 -6.9 -3.5 keybrands. Adjusted for currencyand portfolio Advantage (Animal Health) 118 -5.6 +0.5 changes, Consumer Care’ssales actually ad- Aspirin** 118 -11.9 -1.5 vanced by 5.1% overthe three months. Aleve/naproxen 79 -6.0 +2.6 The negative currencyeffects had taken the Bepanthen/Bepanthol 79 +21.5 +29.6 shine offthe “strong growth” achievedbya Ultravist (Medical Care) 77 ±0.0 +3.1 number of Consumer Care’score brands, Bayer Canesten 64 -5.9 +2.7 noted, especially the division’sBepanthen/Be- Gadovist/Gadavist (Medical Care) 51 ±0.0 +3.6 panthol skincare range. One-A-Day 44 -12.0 -7.4 Sales of Bepanthen/Bepanthol had increas- Supradyn 39 +11.4 +19.8 ed by 21.5% –29.6% adjusted for currency effects –toC79 million, the companysaid, Top10total 845 -3.8 +2.6 thanks to good performances in emerging mar- Total Bayer Consumer Health 1,924 -3.1 +2.9 kets and Western Europe. *CER is constant exchange rates The Supradyn dietary supplement had also ** Total Aspirin sales –including Aspirin Cardio, which is part of the Pharmaceuticals division –were C 226 million been astandout performer,Bayer noted, with Figure1:Sales of the top 10 best-selling brands in Bayer’s Consumer Health division in the thirdquarter of sales developing especially well in Russia over 2013. Brands arepartofthe Consumer Carebusiness unit unless stated (Source –Bayer) the three months. This boosted the brand’s turnoverby11.4% –19.8% adjusted for cur- dropped by 12.0% to C44 million in the three takeninto account, sales of the antifungal brand rencyeffects –toC39 million (see Figure 1). months. When adjusted for currencyeffects, movedforward by 2.7%. However, these gains had been partially off- One-A-Day’sturnoverslipped back by 7.4%. The Consumer Care business accounted for set by lower volume sales of its keyAspirin an- Meanwhile, sales of the painkiller brand 51% of third-quarter turnoveratBayer’sCon- algesic brand and its One-A-Day multivitamin Aleve had fallen back by 6.0% to C79 million, sumer Health division, which dropped by 3.1% range in the US. Bayer pointed out. When adjusted for currency to C1.92 billion. Sales advanced by 2.9% when This led to worldwide sales of Aspirin –Con- effects, however, the brand’sturnoverhad in- adjusted for currencyand portfolio effects. sumer Care’sbiggest brand –falling by 11.9% creased by 2.6%. Europe remained Consumer Health’sbiggest to C118 million in the third quarter.Adjusted Canesten suffered asimilar fate to Aleve region in terms of sales, with turnoverimprov- for currencyeffects, the decline was1.5%. –with reported turnoverdeclining by 5.9% to ing by 6.9% –9.5% adjusted for currencyef- Worldwide sales of One-A-Day vitamins C64 million –yet when currencyeffects were fects –toC732 million (see Figure 2). Currencyeffects had amassive impact on Region Third-quarter sales Change 2012/2013 (%) sales in the Latin America/Africa/Middle East ( E millions) C CER* region, where sales were flat as reported at C294 Europe 732 +6.9 +9.5 million. However, when adjusted for currency effects, turnoverinthe region jumped by 14.3%. North America 617 -9.1 -3.5 By contrast, sales in the Asia/Pacific region Asia/Pacific 281 -14.1 -2.1 slipped back by 14.1% –2.1% when adjusted Latin America/Africa/Middle East 294 ±0.0 +14.3 for currencyeffects –toC281 million. Total Bayer Consumer Health 1,924 -3.1 +2.9 TurnoverinNorth America fell by 9.1% to C617 million, as negative currencyeffects com- *CER is constant exchange rates pounded a3.5% drop in operational terms. Figure2:Breakdown of Bayer Consumer Health’s sales in the thirdquarter of 2013 by region (Source –Bayer) Consumer Health’sthird-quarter earnings Business Third-quarter sales Change EBIT Change before interest and tax (EBIT) had increased ( C millions) 2012/2013 (%) (C millions) 2012/2013 (%) by 19.2% to C341 million (see Figure 3), Bayer noted, due primarily to abig reduction in Pharmaceuticals 2,818 +3.1 637 +65.0 ‘special item’ costs. Consumer Care984 -0.1 ––The Consumer Health division generated Medical Care619 -6.2 ––41% of sales at the Bayer HealthCaresub-group, Animal Health 321 -5.6 ––which posted turnoverupby0.5% –7.4% ad- Consumer Health 1,924 -3.1 341 +19.2 justed for portfolio and currencyeffects –to C4.74 billion. Total Bayer HealthCare4,742 +0.5 978 +45.5 The remaining 59% of HealthCare’ssales

Figure3:Breakdown of Bayer HealthCare’s sales and earnings beforeinterest and tax (EBIT) in the thirdquarter came from the dominant Pharmaceuticals unit. of 2013 from continuing operations (Source –Bayer) OTC

8November 2013 OTC bulletin 13 OTC08-11-13p2-14_Layout 1 05/11/2013 17:59 Page 14

OTC COMPANY NEWS

Nine-MonthResults Regulatory Af fairs Arbidol drives biggains Industrywaryof at PharmstandardOTC devices process uestions remained overthe proposed auth- harmstandard said its OTCsales had risen for most of the remainder. Qorisation procedure for medical devices Pby 17.3% in the opening nine months of Pharmstandard is set to spin-offits branded in Europe, said the Association of the European 2013, led by the “significant growth” of its OTCbusiness into aseparate legalentity called Self-Medication Industry,the AESGP,despite Arbidol anti-viral flu brand. OTCPharm early next year (OTC bulletin,11 the European Parliament adoptingsome help- Total OTCturnoverhad reached RUB11.9 October 2013, page 5). ful amendments to the European Commission’s billion (C271 million),the Russian firm noted, The spun-offbusiness would be staffed by proposed medical devices legislation. with sales of Arbidol –its biggest-selling OTC “key Pharmstandard individuals”, the firm point- Commenting on the latest move,the AESGP brand –advancing by 19.6% to RUB3.04 bil- ed out, who had historically been responsible told OTC bulletin that while it welcomed mea- lion. Arbidol accounted for aquarter of all OTC for the company’sleading OTCbrands (OTC sures aimed at “ensuringahigh levelofhealth sales during the period (see Figure 1). bulletin,26July 2013, page 6). and safety protection” –such as stricterrules Sales of Pharmstandard’sunbranded OTC OTCPharm will include the recently-acquired for the designation and monitoringofnotified products grewby16.4% to RUB1.92 billion. Singapore-basedservices companyBever Phar- bodies and the introduction of unannounced in- OTCproducts generated 42% of Pharm- maceuticals, which the firm said would give spections determined in relation to the risk of standard’stotal sales for the nine months, which the newbusiness its ownsource of active phar- the device –itremained “sceptical” on the new fell back by 7.6% to RUB28.6 billion. Branded maceutical ingredients (OTC bulletin,11Octo- authorisation procedure. prescription and third-party products accounted ber 2013, page 5). The AESGP said that it had concerns about howthe newauthorisation procedure –which Business Nine-month sales Change Proportion involves European Medicines Agency(EMA) (RUB millions) 2012/2013 (%) of total (%) designated Special Notified Bodies, the Med- Arbidol 3,038 +19.6 11 ical Device Coordination Group (MDCG) and Pentalgin 1,401 -18.2 5 possibly the Assessment Committee for Med- Complivit 1,086 +15.7 4 ical Devices (ACMD) –would impact “self- Amixin 880 +61.9 3 care medical devices placed on the market in Afobazol 819 +38.5 3 the form of gelatin capsules”. Flucostat 638 +14.7 2 Acipol 410 +54.0 1 Lengthierauthorisation timelines Codelac 367 +11.0 1 Twonewly-established committees –the Ingalypt 333 –1MDCG and the ACMD –plus apossible clock- Corvalol 240 +7.7 1 stop period if additional information wasre- Other OTCbrands 787 –3quested by the ACMD would lengthen the Branded OTCproducts 9,998 +17.5 35 authorisation timeline, the association claimed. Unbranded OTCproducts 1,923 +16.4 7 This could negatively impact self-care med- Total OTCproducts 11,920 +17.3 42 ical devices in the form of gelatin capsules, Prescription drugs 4,543 +24.7 16 as theyfell under the remit of the procedure as “devices manufactured utilising tissues or Third-party prescription drugs 10,678 -32.6 37 cells of human or animal origin, or their de- Medical equipment 679 +6.1 2 rivatives, which are non-viable or are render- Other sales 747 –3ed non-viable”. Total Pharmstandard 28,567 -7.6 100 On amore positive note, the AESGP wel- comed the deletion of Rule 21 (in Annex Figure1:Breakdown of sales by Pharmstandard’s best-selling OTC brands and other businesses in the opening VII) which classified manyself-care medical nine months of 2013 (Source –Pharmstandard) OTC devices in the highest risk class and deletion of the need to comply with medicines legis- IN BRIEF lation, Directive 2001/83/EC. These provisions would have impacted anumber of medical ■ FDA –the US Food and Drug Administra- peatedly distributed adulterated dietary sup- devices such as gels for vaginal discomfort, tion –has filed apermanent injunction with the plements and unapproveddrugs through its certain nasal sprays, and throat lozenges. US Department of Justice to stop dietary website. Cole has also violated dietary sup- The adopted amendments will form part supplement manufacturer James G. Cole from plement current good manufacturing practice of the European Parliament’sfinal position on promoting and distributing its products, follow- (cGMP) requirements, the agencyalleges, by the legislation, which waspublished in draft ing repeated violations of the Federal Food, not conducting appropriatetests to verify the form ayear ago (OTC bulletin,12October Drug and Cosmetics Act. In the filing against identity of its supplements’ ingredients. 2012, page 7). the US firm, the FDAclaims Cole has re- OTC OTC

14 OTC bulletin 8November 2013 OTC08-11-13p15-20FIN_Layout 1 05/11/2013 18:07 Page 3

GENERAL NEWS OTC

Switches Germany considersswitchingketotifen

witching ketotifen 0.25mg/ml eyedrops able without prescription. Shortly thereafter, without aprescription,the expert committee Sfrom prescription-only to non-prescription the Ministry asked the expert committeetocon- proposed last year (OTC bulletin,16March status will be discussed by Germany’sexpert sider aswitch, based on the latest evidence. 2012, page 12). This recommendation joined an committee for prescription at its meeting to be Regardless of the expert committee’srec- earlier switch proposal for oral sumatriptan. held on 14 January next year. ommendation, the Bundesrat’s health commit- But the Bundesrat committee observed that Ketotifen fumarate is the active ingredient tee has already prepared draft provisions for non-prescription use of the triptans waspro- in Théa Pharma’sZaditen Ophtha 0.25mg/ml switching levonorgestrel –insingle doses up to posed to occur “under supervision by adoctor”. treatment for allergic conjunctivitis. 1.5mg –toOTC status. The switch is sched- Furthermore, labelling of the migraine remedies As previously announced, the committee –at uled to come into effect on 1May next year. wastocontain “comprehensive contra-indica- the request of Germany’sfederal Ministry of Also on the committee’sagenda for its Jan- tions and safety warnings”. Health –will once again consider whether lev- uary meeting is reverse-switchingthe head-lice “These conditions for removing prescription- onorgestrel pills should be available without treatment malathion to prescription-only status. only status,”the Bundesrat committee comment- aprescription as an emergencycontraceptive And the committee will also consider wheth- ed, “showthat these substances can directlyor (OTC bulletin,27September 2013, page 11). er there should be anyexemptions from agen- indirectly endanger human health –evenwhen Switching levonorgestrel to non-prescrip- eral prescription-only status for quinine. used as directed –iftheyare taken without super- tion status in Germanywas first proposed by Meanwhile, the expert committee’searlier vision by adoctor,dentist or veterinarian.” the expert committeeadecade ago (OTC bul- recommendations that the migraine remedies Furthermore, the committee continued, such letin,31July 2003, page 14). However, the sumatriptan and zolmitriptan should be switch- conditions were “not practical”. Pharmacists dis- Ministry neveracted on that proposal, citing ed to OTCstatus look set to be rejected. pensing the migraine remedies without apre- likely opposition from certain states in the coun- The Bundesrat’s health committeesaid pro- scription would not be able to ensure that their try’s upper house of parliament, the Bundesrat, posals to switch the twotriptan drugs should use would occur under adoctor’ssupervision. which has to give its assent to anyswitch. be deleted from aforthcoming statutory order Rules covering Germany’sfiveprescription-only However, Bundesrat politicians recently call- on medicines classification. and twoOTC triptans were currently incompre- ed for the emergencycontraceptivetobeavail- Oral zolmitriptan forms should be available hensible, the Bundesrat committee concluded. OTC

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8November 2013 OTC bulletin 15

OTC08-11-13p15-20FIN_Layout 1 05/11/2013 18:07 Page 6

OTC AESGP MEETING

ProceduRegulatory Af fairs ressee improvement in Europe

ot perfect,but generally better than in 2010 icines agencies’ Co-ordination group for the even if it wasstill ongoing. Nwhen it had previously conducted asur- Mutual-recognition and Decentralised proce- Atotal of 42 completed questionnaires had vey,was the verdict of the Associationofthe dures-human (CMDh). been submitted, she said, covering issues –key European Self-Medication Industry,the AESGP, Eising noted that the OTCfirms surveyed had performance indicators (KPIs) –such as chal- on Europe’smutual-recognition and decen- rated as high both the role and accessibility of lenges during validation, to legalstatus and tralised marketing authorisation procedures. reference member states (RMSs) and the acces- affecting the national phase. Of the total, 14 Outlining the results of the AESGP’slatest sibility of concerned member states (CMSs). covered mutual-recognition and 28 were decen- survey at the association’srecent workshop The slot-booking process waswell-under- tralised procedures. in London, Novartis Consumer Health’sChris- stood, butthere wasalack of visibility of slots “The decentralised procedure is the pro- tine Eising said there wasnow abroader choice that became available at the last minute. cedure of choice for newregistrations of non- of countries acting as reference member states Explaining the survey methodology,Eising prescription medicines,” she commented, add- in the decentralised procedure. said AESGP member companies had been ask- ing that the most used type of application was “Overall, there has been asuccessful up- ed last September and October to complete a bibliographicinthe mutual-recognition proce- takeofthe best-practice guide on non-prescrip- questionnaire for each marketing-authorisation dure and generic in the decentralised procedure. tion medicines,” she said, referring to the doc- procedure that theyhad started in the period Looking at the number of times acountry ument releasedinFebruary 2012 by the med- between 1January 2010 and 31 August 2012, had been chosen to act as aRMS or been aCMS in both procedures (see Figures 1and 2), Eis- ingpointed out Germanyand Sweden had been Concernedmember state Referencemember state the most popular in mutual-recognition pro- cedures; while the UK had been chosen most 8 7 often to be the RMS in decentralised procedures, 3 with Germanyand Sweden close behind. 3 66 6 4 4 2 Latvia and Sweden were rated as the best 1 1 3 555555 RMSs with average scores between very good 44444 and excellent (see Figure 3). Germanyand the ountry was chosen 4 1

sc UK scored between good and very good – 2 3333 around the mean for all RMSs –while Belgium, 2222 2 Czech Republic and Finland were all above the 11 mean. France and Italy were rated least highly.

Number of time The average number of days between the 0 date of the requested timeslot in the RMS and rg nia gal kia UK Italy va the allocated timeslot had ranged from 50 days ve Spain France Malta Poland SwedenLatvia CyprusFinlandGreeceIreland Norway Estonia Iceland Austria RomaniaGermany Bulgaria Slo HungaryLithuania Portu Denmark Slo Belgium with Finland to more than 200 days in the UK, Luxembou Czech Republic The Netherlands Eising noted, although she added that the pro- cess wasgenerally found to be easy and the Figure 1: Breakdown of the number of times acountrywas chosen to act as aconcerned or reference member agencies to be flexible. Some national peculiar- statein14surveyed mutual-recognition procedures (Source –AESGP)

Concernedmember state Referencemember state 5

3 20 15 4 16 5 1 10 14 15 3 Mean average 15 11 14 14 14 1 12 3 12 3 1 1 8 10 10 11 11 11 9 1

ountry was chosen 99

10 erage rating 1 2 sc 8 6 77 Av 666 5 5 1

1 Number of time 0 0 UK kia rg gal nia Italy UK Latvia Spain va Italy ve Malta Finland France SpainIreland Cyprus GreeceFrance Iceland Latvia Sweden Belgium PolandSweden BelgiumAustria Finland NorwayPortu BulgariaEstonia Germanyetherlands Germany Hungary DenmarkSlo Romania LithuaniaSlo Luxembou eN Czech Republic Th Czech Republic The Netherlands Figure3:Average company rating of reference member Figure 2: Breakdown of the number of times acountrywas chosen to act as concerned or reference member states during 42 surveyed procedures, with 0being statein28surveyed decentralised procedures (Source –AESGP) poor and5being excellent (Source –AESGP)

18 OTC bulletin 8November 2013 OTC08-11-13p15-20FIN_Layout 1 05/11/2013 18:07 Page 7

AESGP MEETING OTC

Regulatory Af fairs ities were found in the request ‘window’, she ob- served, with the Czech Republic, Finland and Flat pharmacovigilance fees Sweden having local rules for submission dates. “In general, there wasalack of visibility of available timeslots,”maintained Eising. “If aslot today no morethan atax becomes available, it should become visible and accessible so that another applicant can use it.” She added, however, that industry also carried ees should be levied for aservice, other- ing PSURs for generic and bibliographic appli- some responsibility to cancel timeslots suffi- F wise theyare simply atax, is the Associa- cations, and for registered products. ciently early for them to be useful, such as at tion of the European Self-Medication Indus- However, he added, the AESGP would like least four weeks before the due date. try’s, the AESGP’s, fundamental objection to to propose apragmatic implementation of the Addressing timelines, Eising noted that the the proposed annual flat fees for pharmaco- newrules to include all well-established use average number of days between submission vigilance activities. products that had been authorised on the basis and validation of the application was“farhigh- Speaking at the AESGP’srecent workshop of afull application before the bibliographic er” than the expected 14 days. “The average in London, Elmar Kroth, adirector of Germany’s legalbasis existed. number of days [in decentralised procedures] medicines manufacturers’ association, the BAH, Moreover, it would also likethe PSUR re- ranged from 24 in Finland to 91 in the UK,” said annual flat fees should not be payable until lief for authorised homoeopathic products. she said. There were manyreasons for delays, the corresponding services for which theywere “Following the spirit of the legislation,” butsome were additional requirements beyond being levied were fully operational. Kroth suggested, “no PSURs should be requir- those contained in best-practice guides. Moreover, there should be no annual fees ed for all well-established medicines –inde- RMSs were informing CMSs and applicants for authorisedherbal and homoeopathic med- pendent of their legalbasis –and for homoeo- during clock-stop periods if adelay to the re- icines “giventhat pharmacovigilance activities pathic medicines.” start wasforeseen, she said, butthere were are still at anational level”. Looking more closely at EMA literature “huge differences” in the times taken during monitoring, Kroth said the AESGP supported national phases of the procedures. Limited access until 2015 or 2016 the concept of central literature monitoring, but Noting that the legislation allowed just 30 The annual flat fee wassupposed to cover –and it wasabig but–itshould be made days for both procedures, Eising said none of IT systems such as the EudraVigilance data- clear that marketing authorisation holders were the member states had succeeded in meeting processing network and arepository of periodic not liable for monitoring carriedout by the this target. “Denmark achievesaround 30 days, safety update reports (PSURs), Kroth said. But EMA. Terms such as “selected medical litera- while Estonia and Portugal makeitinaround 50 marketing authorisation holders would have ture” also needed clarification. days,”she commented about mutual-recognition limited access to the former until 2015 or 2016; He maintained that running twosystems in procedures, adding that only Denmark “came while the latter wascurrently non-existent, and parallel would defeat the anticipated benefits close” to 30 days in decentralised procedures. would probably not be ready for at least the of central monitoring. “Could the RMS extend its role to support same time. And he insisted that the EMA’s Pharmaco- the national phase,”wondered Eising. “Delays Meanwhile, literature monitoring by the vigilance Risk Assessment Committee (PRAC) in the national phase makelaunch planning dif- European Medicines Agency(EMA) wasinits should focus on evaluating newrisks. Of the 19 ficult and result in delays to market access. “conception phase” and industry had limited PRACprocedures during the past 12 months, Forseasonal products, we could lose ayear if access to EudraVigilance signal detection. the majority had been for products marketed we are faced with adelay.” Kroth acknowledged that the European for decades, such as tetrazepam. OTC Union’s(EU’s) revised pharmacovigilance rules Moreover, the time frame of the Commu- were “a huge step forward in better regulation”. nication Plan wasunrealistic when aCommis- Regulatory Af fairs He added, however: “But even agood system sion decision wasrequired, which wasthe case Simple plans needed can get better.” when there wasonly amajority decision, not Important savings of some C 150 million had consensus, in the Co-ordination group for the ll products on the market for over10 been anticipated by industry on the basis of the Mutual-recognition and Decentralised proce- A years, both prescription and non-prescrip- European Commission’simpact assessment, dures-human (CMDh). tion, should only be required to have simplified he said, even though C 10 million would be add- risk-management plans (RMPs) which would ed to industry’sbill in potential fees. Article 57 “well meant” not “well done” be more closely aligned with the stage they In the event, the annual flat fee income alone Turning to the Article 57 database –which had reached in their lifecycles, according to would be more like C 19 million –ormaybe as Marcus Müllner,director general of the Austrian GlaxoSmithKline’sWendy Booth. high as C 30 million –based on somewhere medicines agencydescribed as “very,very well Speaking at the AESGP’sworkshop, she between 320,000 and 500,000 chargeable units meant, when ‘well meant’ wasthe opposite of said both the innovator and OTCindustries at C 60 each. Added to this could be 600 PSURs ‘well done’” –Kroth pointed out that the data wanted asimilar approach to that taken for at C 19,500 each, 35 post-authorisation safety wasnow 18 months old, and without an update generic medicines. “Wepropose that all key studies (PASS) at C 43,000 each and 40 refer- process, more and more information wasbe- information on risk should be included, but rals at C 168,000 per procedure, making atotal coming out of date. non-critical information should be removed.” of C 39 million, or nearly four-times the Com- “Industry urgently needs amaintenance pro- The resulting document, she said, could be mission’soriginal estimate. cess as well as guidelines and clear time- four pages rather than 45. Moving on to PSURs, Kroth said the AESGP lines,”heinsisted. OTC appreciated the relief from routinely generat- OTC

8November 2013 OTC bulletin 19 OTC08-11-13p15-20FIN_Layout 1 05/11/2013 18:07 Page 8

OTC AESGP MEETING

Switches Cultureclash hurts centralised switches

he cultural differencesbetween European ing products with certain conditions attached improve the advice receivedbythe CHMP,this TUnion (EU) member states on non-pre- could also help calm the fears of EU member might not be enough to tackle ingrained opin- scription medicines are the biggest barrier to states which were more resistant to switches. ions held at national level, Wathion warned. the OTCindustry making full use of the cen- There were no healthcare professional or Approving non-prescription switches sub- tralised procedure, according to Nöel Wathion, patient representativesonthe CHMP,Wathion ject to certain conditions wasalso an “inter- head of Patient Health Protection at the Euro- noted, and changing this might help strengthen esting idea”, Wathion commented, butagain pean Medicines Agency(EMA). the case for switches when theyarose. this threwupsome problems. Presenting apersonal viewofthe difficulties Wathion’scomments on adding more OTC Even with conditions attached, the CHMP of making the centralised procedure work for expertise to the process echoed those made by still had to agree to the switch, Wathion said, OTCmedicines, Wathion insisted that imple- Colette McCreedy,head of the self-medica- which remained the fundamental problem. menting changes to makeitwork better for in- tion unit at the UK Medicines and Healthcare Commenting on using post-authorisation dustry would be tough while the system was products Regulatory Agency(MHRA). safety studies (PASS) to help allay the fears of subject to national opinions. McCreedy told the meeting that the MHRA certain member states, Wathion said that the Speaking at arecent meeting of the Asso- had started work on building an EU-wide “in- problem then wasconvincing people that data ciation of the European Self-Medication Indus- formal network” of national non-prescription collected outside of their country applied to them. try,the AESGP,hesaid the different national experts in EU member states. The studies would be conducted ideally in an views on non-prescription medicines were being National regulators would be invited by the EU member state, Wathion said, or in an OTC- “reflected at the levelofthe Committee for MHRA to identify akey person within their friendly country from which the data could be Medicinal Products for Human Use (CHMP)”, organisations to join the network, McCreedy easily extrapolated to more resistant EU markets. making it difficult for switches to navigate the said, which would focus on the non-regulatory However, asuccessful switch would still centralised procedure successfully. issues surrounding medicines reclassification. need to rely on members of the CHMP dis- As achange in legislation looked unlikely, The idea of an informal network of non- counting opinions held at anational level. it wasnow up to industry and the regulatory prescription experts had been floated earlier Despite these hurdles, the EMA would cer- authorities to figure out howbest to work with- this year by June Raine, who on behalf of the tainly be willing to engage with industry if it was in the existing framework, he pointed out. MHRA, co-chaired the good governance Tijani serious about making the centralised procedure Highlighting twoideas that he felt would project under the European Commission’s‘Plat- work for OTCmedicines, Wathion said. be worth pursuing, Wathion said he believed form on Access to Medicines in Europe’ (OTC Anew stakeholder management department that having OTCexperts advise the CHMP bulletin,17June 2013, page 1). had been formed within the agency, he noted, would “certainly help decision making”. Switch- Ultimately,however,while industry could to better address industry concerns. OTC

Switches to their reference products –but centrally-auth- orised and nationally-authorised versions of the Centralised but not harmonised same brand were not possible –Griffiths pon- dered on what constitutedsufficient differenti- n“honest debate” is needed on making berstates had switched triptans to OTCstatus, ation to enable anational application. “Would Athe centralised procedure work for OTC the centralised switch of sumatriptan had been national procedures be possible on the basis medicines after only three brands –Alli (orli- rejected in 2011. of differencesinsupply route or pack size?” stat), Nexium Control (esomeprazole) and Pan- “There is simply no mechanism available he wondered. toloc Control (pantoprazole) –havebeen switch- for companiestogenerate ‘OTC experience’in Griffiths also considered whether OTCap- ed successfully in almost adecade, according the EU without prior approval,”Griffiths said. provals could be subject to certain conditions, to Pfizer Consumer Healthcare’sMark Griffiths. Referring to the failure of OTCViagra (silde- such as satisfactory collection of additional data Speaking at aworkshop of the Association nafil) in 2008, Griffiths noted that the rappor- in an OTCsetting, possibly using post-approval of the European Self-Medication Industry,the teur and co-rapporteur had been assigned on the safety studies (PASS); or maybe OTCpart-ap- AESGP,Griffiths pointed out that the three suc- basis of the original prescription procedure. provals only in supportive member states. cessful brands had been allowed access to the “Clearly there were concerns, butthe switch “There needs to be greater recognition of centralised procedure on public health grounds. wasalso denied in the member states which OTCbenefits,”hesaid, “such as increased ac- Meanwhile, however, the proportion of pre- were in favour.” cess and choice as well as public awareness of scription products authorised by the centralised “Risks are increasingly seen as outweighing illness.”The MHRA’s June Raine added, in the procedure wasincreasing, which meant that benefits,”heobserved. “Benefits are frequently context of OTCbenefit-risk assessments, that anyfuture switches of these brands would be misunderstoodand overlooked, butrisks are the focus should be on “knowledge gaps” rather obliged to use the same pathway. well publicised and can be misjudged in terms than risk proportionality.“Aspirin would not Even if amember state were in favour of a of severity.” get an OTClicence today,” she noted, “but we prescription-to-OTC switch, it would be restrict- Noting that generic versions of centrally- have sufficient knowledge of its use in practice ed from doing so by an adverse centralised deci- approvedprescription brands could apply for to allowit.” sion, he said, noting that although some mem- national licences, provided theywere identical OTC

20 OTC bulletin 8November 2013 OTC08-11-13p21-23_Layout 1 05/11/2013 19:01 Page 3

MARKETING NEWS OTC

ProductLaunches OTCMarketing Awards 2014 French mousse Social media makes mark expands Alostil on OTC Marketing Awards ohnson &Johnson Santé Beauté has ex- J panded its range of Alostil hair-growth treat- ith social media playing an increasingly ments in France by launching amousse form Wimportant role in marketing communi- of the minoxidil-based brand, which is sold as cation strategies for OTCbrands, OTC bulletin Regaine and Rogaine in other markets. The has introduced an Award for Best OTCCam- 5% mousse extends arange that also includes paign in Digital &Social Media into its UK 2% and 5% solutions. Marketing Awards 2014. Available in apack of three 60g bottles, each OTCmarketeers have amonth –until the of which contains enough mousse for amonth, closing date on 6December –toput together the treatment for moderate hair-loss boasts “clin- an entry that showcases just howeffective these newmedia can be in promoting an OTCbrand directlyorindirectlytoatarget audience. An Awardfor the Best OTC Campaign in Digital &Social Media is the latest addition to the OTC Open to anydigital and/or social-media cam- Marketing Awards 2014 paign for an OTCbrand during 2013, the Award covers website wizardry as well as compulsive Dinner &Awards PresentationonThursday, mobile device apps and energetic activity on 6March 2014 at London’sPark Lane Hotel. social networks likeFacebook, Twitter and You- With only four weeks left until the deadline Tube. Such work can be aimed at consumers, of 6December,the good news is that submit- pharmacists or other healthcareprofessionals. ting potential winning entries just got easier. Judges will be looking for creative excel- OTC bulletin can nowaccept entries sub- lence and effectiveness in raising awareness of mitted electronically through the Awards por- the OTCbrand as well as promotingits per- tal at http://entry.otc-bulletin.com. sonality and encouraging sales. Entry Information Packs giving more details Spanning 20 categories, OTC bulletin’s OTC about entering the Awards can be downloaded ResultsfromAlostil mousse should be visible after Marketing Awards 2014 also coversuch com- at www.otc-bulletin.com/awards. eight weeks of use, accordingtoJohnson &Johnson munications activities as public relations, spon- Alternatively,you can contact Natalie Corn- ically-provenefficacy”, according to pharmacy- sorship and advertising in all types of media. well at OTC bulletin (Tel: +44 (0)1564 777 press advertising for Alostil mousse. Results The winners will be announced at aGala 550; Email: [email protected]). from the treatment should be visible after using OTC Alostil for eight weeks, the advertisement adds. Johnson &Johnson will be supporting the MarketingCampaigns launch of Alostil 5% mousse with pharmacy displays and targeted product information aim- Church &Dwightcreates first-aid guide ed at pharmacists and healthcare profession- als. Internet advertising aimed at the general hurch and Dwight’sSterimar sea water Noting that research had shown nearly half public will also promote the brand. C nasal-spray brand has partnered with UK of expectant parents lacked “baby lifesaving OTC first-aid charity St John Ambulance to create skills”, the companysaid the handbook would afree first-aid handbook for parents. coverarange of first-aid situations, from minor accidents through to life-threatening occur- IN BRIEF rences such as choking. ■ MENTHOLATUM is providing UK phar- Sterimar branding features on the front and macies with informationleaflets forits top- back coverofthe handbook, which contains ical analgesics brands in support of Self Care information on the benefits of using the spray. Week. The leaflet summarises the main appli- It would be available for download from the cations for each of its brands –Deep Freeze, Sterimar website until the end of 2014, Church DeepHeat, Deep Heat Muscle Rescue, and &Dwight pointed out, and would also be in- DeepRelief –tohelp pharmacists makerec- cluded in Bounty packs –distributed to new ommendations to suit individual customer’s mothers –until the end of the year,and in requirements. Organised by the UK’sSelf Care birth registration wallets from parenting pro- Forum and supported by National Health gramme Emma’sDiary throughoutthe first Service (NHS) England, Self Care Week will quarter of 2014. It is also being distributed to run from 18-24 November and carry the theme general practitioners and hospitals, and can be Church &Dwight said research had shown alarge ‘Self Care forLife –TakeControl’. proportion of expectant parents lacked baby ordered from independent and chain pharmacies. OTC lifesaving skills OTC

8November 2013 OTC bulletin 21 OTC08-11-13p21-23_Layout 1 05/11/2013 19:01 Page 4

OTC MARKETING NEWS

ProductLaunches ProductLaunches Beiersdorfoffers OTC malefertility test is eczema options saidtobethe UK’s first eiersdorf is targeting sufferers of atopic der- Bmatitis –eczema –with the global roll-out Sbiotechnology companyContraVac has of six products under its Eucerin skincare brand. Ulaunched what it claims is the “first” OTC Pointing out that around 10% of the world’s male fertility test available in the UK. The de- population suffered from the condition, the Ger- vice –known as SpermCheck –was a“revo- man firm noted that the Eucerin AtopiControl lutionary male fertility product”, the firm said, range would be launched in 44 countries. that would “save time, moneyand embarrass- Positioned as dermo-cosmetics, all products ment for millions of couples in the UK”. –anActive Care line, aBasic Care line and a Already available in Canada and the US, Shower and Bath Oil –had been clinically and SpermCheck would nowbeexclusively avail- dermatologically proventoreduce dryness, able in the majority of Boots stores across the scaling and tightness while also relieving itch- UK, the companyrevealed. ing, Beiersdorf maintained. ContraVac maintainedthat in a“one-step ContraVac claims its SpermCheck fertility test is the Furthermore, aclinical study had shown “a 10-minute test” SpermCheck could identify first OTC male fertility test available in the UK comparable cosmetic effect of the skin caring whether the man’ssemen had alow sperm propertiesofEucerin AtopiControl Acute Care count “belowthe positive sperm count of 20 theNational Health Service (NHS), or had to pay million/ml or more”. “hundreds of pounds” at private fertility clinics, SpermCheck used apatented process to the firm claimed the device had the potential count “specific protein” in the sperm, the firm to save consumers both time and money. said, and had been proventobe98% accu- SpermCheck has arecommended retail price rate under laboratory testing. of £29.99 (C35.18). “Sperm count is amajor determinant of fer- Promotional activity would occur during “key tility status,”ContraVac pointed out, adding that periods”, ContraVac said, initiallyrunning for male infertility accounted for “nearly half” of one month in November 2013 and then from all infertility cases in the UK. January until March 2014. Television commer- Noting that men who wanted asperm an- cials would be accompaniedby“online video” alysis currently had to “wait up to ayear” on and other digital advertising, it added. The Eucerin AtopiControl range contains six OTC dermo-cosmetic products, including an Active Care line and aBasic Careline.

Cream to the effects of a1%hydrocortisone cream on the complexion of atopic skin”, Beiers- dorf claimed of the Active Care product. The companyadded, however, that the cream was“not apharmaceutical product” and was “not meant to replace one”. Containing such active ingredients as menth- oxypropanediol, licochalcone A–liquorice extract –and omega-6 fatty acids, the Acute

Care cream is said to provide effective relief “Because you don’t stop when cold and flu starts” is during the “flare-up” phases of the condition. Reckitt Benckiser’s (RB’s) message to consumers The other product in the line, the Anti-Itch Care in aUKtelevision spot for its recently-launched Nurofen Cold and Flu range. Spray,contains menthol and polidocanol for Running on arange of television stations across the immediate relief of severe itching. People who want to relieve their drycough while “key” daytime schedules and “prime-time”slots, Meanwhile, the Basic Care line consists of travelling areamong the targets for Steigerwald the 30-second creative shows ateacher on aschool aBody Care Lotion, as well as aFace Care Arzneimittelwerk’s line extension to its Phytohustil trip, avet, and awoman in ameeting room. It brand in Germany. highlights how the adult range –comprising two Cream, and aCare Cream, which are said to be The marshmallow-root traditional medicine is general-sale list Cold &Flu Relief products and a suitable for use during “asymptomatic” phases now available as lozenges –each containing 160mg pharmacy-only variant –is“heretohelp you battle of atopic dermatitis. dried extract of the herb –aswell as in the familiar on” through the winter months by targeting aches syrup form. and pains, fever,and congestion. As well as targeting pharmacies and derma- Launch trade-press advertising describes the The spot, which uses the current “for lives tologists, the launch campaign for the Atopi- lozenges as “Die kluge Entscheidung fur unterwegs”, bigger than pain” tagline, forms partofa£3.5 million Control range would also include consumer- or “The clever decision when underway”. ( C 4.1 million) campaign that RB claims will reach Apack of 20 blackcurrant-flavoured lozenges has 85% of the UK adult population (OTC bulletin,25 press and point-of-sale advertising, the firm said. arecommended retail price of C 9.25. October 2013, page 17). OTC OTC OTC

22 OTC bulletin 8November 2013 OTC08-11-13p21-23_Layout 1 05/11/2013 19:01 Page 5

MARKETING NEWS OTC

ProductLaunches/LineExtensions Nelsons sets its sights on sports nutritioncategory

elsons is entering the sports nutrition arena N in the UK and Ireland with the launch of aSports Pack variant of its Spatone liquid iron supplement, targeted at endurance athletes and Prestige Brands has launched a“Fastest Fan” fitness enthusiasts. competition in the US to supportits Goody’s Noting that most sports nutrition products Headache Relief Shot. related to muscle building and instant energy, Entrants have until 1December to upload an original video showing their “speediest moments” to the natural healthcare firm said it aimed to tackle either their Facebook, Instagram or Twitter profiles, the “more long-term problem” of iron depletion along with the hashtag “FastestFan”. Once five in athletes, which could affect performance. Nelsons Spatone Sports Pack is designed to tackle the finalists have been selected, fans must vote on the issue of iron depletion in athletes and sports enthusiasts Goody’s Facebook page for the winner. Runners especiallyneeded to ensure appro- Whoever is chosen will receive the grand prize of priate iron intake, the companyclaimed, due to ily” in the launch of the Sports Pack. an “ultimate” NASCAR stock-car racing weekend, acombination of ‘footstrikehaemolysis’ –the The product wasthe official supplement of which includes VIP tickets to the Goody’s Headache Relief Shot 500 race and US$1,000 (C725) in destruction of red blood cells due to the repeat- mass-participation sports event firm Human spending money.The winner also receives apersonal ed pounding of feet on hard surfaces –and iron Race, Nelsons pointed out. This would be pro- meeting with NASCAR driver Dale Earnhardt Jr,one loss through “sweat and wastage”. moted on-pack and throughoutadvertising. The of the brand’s ambassadors. Avideo featuring Earnhardt Jr “speeding Pointing out that Spatone could previously companywould also provide branded signs, through his day” –completing tasks such as solving “only be found in the pregnancyorvitamins educational materials and sampling at Human aRubik’s cube and commuting to work quickly –is sections of retailers”, brand manager Ngaire Race events –such as triathlons and duathlons featured on the Facebook pages of both Earnhardt Jr and Goody’s to promote the competition. The Mitchell told OTC bulletin that the Sports –throughout 2014, it added. video is also running on the brand’s website Pack –containing the recommendeddaily Meanwhile, apublic relations campaign and on YouTube. amount (RDA) of iron and vitamin Cineach would run from January 2014 and include Prestige launched the Headache Relief Shot in June this year (OTC bulletin,28June 2013, page 16). sachet –enabled Spatone to enter the sports athlete sponsorship, in-store training and sam- OTC nutrition category and more easily attract the pling, Nelsons pointed out. Print and digital attention of athletes. media activity would run across “key”running, “Wesaw an opportunity to be able to reach cycling and triathlon titles. athletes more directly by creating apack which Available from GNC, Holland &Barrett and clearly communicates the importance of iron to online, the Spatone Sports Pack has arecom- an athlete’straining regime,”she commented. mended retail price £6.25 (C7.29) for 14 sachets. Although the firm did not specify the mar- It is also available in independent pharmacies keting spend, it said it would be “investing heav- and health food stores. OTC

Retailers Boots offers smokers NRTexchange oots is offering UK consumers a“unique sumers could swap NRTformats if their orig- B nicotine-replacement therapy(NRT) ex- inal choice wasnot effective. change offer” as part of its ‘SmokeLess’ flex- Theycould change NRTformats twice – ible stop-smokingprogramme, which borrows once after starting and again at the “get back from Alcoholics Anonymous style counselling. on track stage” if theylapsed or relapsed –but Claiming that research had shown there only at the store where theyhad started. were over160,000 ways to stop smoking, the ‘SmokeLess’ is offered in 547 of the 2,500 Abarrelofgunpowder with alit fuse is the way that Reckitt Benckiser (RB) has chosen to depict the firm said the programme provided personalised UK Boots stores, alongside the free National explosive pain of acid reflux in advertising for its new support to those who wanted to quit smoking, Health Service (NHS) stop-smoking plan and oral powder formofGavisconell in France. with specially-trained healthcare advisors to free NHS Quit Kits that are already available. “Some powders ignite the fire, others extinguish it!” is the slogan accompanying the image, which provide encouragement,aswell as ongoing con- As well as the in-store support, guidance appears in pharmacy-press advertising for the new tact with individuals to track their progress. wasavailable on the ‘SmokeLess’ pages of the product. “You’ll feel the difference”, the Although the service wasfree, Boots said, Boots website, the firm noted. The plan also advertisement promises. The sugar-free, passion fruit-flavoured product is prescription charges might apply if the con- offers incentivessuch as vouchers and points available in single-use sachets and can be taken sumer chose to try an option that involved the for Boots’Advantage Card loyalty scheme. without water,the advertisement emphasises. purchase of an NRTproduct. However, con- OTC OTC

8November 2013 OTC bulletin 23 NEW

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EVENTS OTC

NOVEMBER and procedures will be discussed 2-4December Tel: +44 1483 730071. at this three-day seminar. ■ Good Manufacturing Fax: +44 1483 730008. 14-15 November Contact:Informa UK. Practice and Good Email: registrations@management- ■ 8th International Tel: +44 20 7017 7481. Distribution Practice forum.co.uk. Alliance Conference Fax: +44 20 7017 7823. London, UK Website: www.management- London, UK Email: [email protected]. Athree-day event organised by the forum.co.uk. ‘Global market expansion services: Website: www.pti-global.co.uk/ UK Medicines and Healthcare prod- The newgrowth imperative in euregaffairs. ucts Regulatory Agency(MHRA). FEBRUARY health and beauty’ is the theme of 28 November Contact:Glasgows. 25 February this two-day meeting. Tel: +44 1772 767715. ■ Building aRegulatory ■ Hot Topics in Advertising Contact:Lorian Pitman, Strategy for Marketing Email: [email protected]. London, UK Ceuta Healthcare. Website: www.mhra.glasgows.co.uk. Aone-day event run by the UK Tel: +44 1202 449 709. Food Supplements Brussels,Belgium 12-13 December Medicines and Healthcare prod- Email: lorian.pitman@ceuta ucts Regulatory Agency(MHRA). healthcare.com. Countries including Belarus, Kaza- ■ GainingMarketing khstan and Russia will be discuss- Authorisations in CIS Contact:MHRA. Website: www.ceutaalliance.com. Tel: +44 20 3080 6000. ed at this one-day meeting. London, UK Fax: +44 20 3118 9803. 18 November Contact: EAS. Strategies for gaining market Email: [email protected]. ■ Pharma Partnering Tel: +32 2218 1470. access in the Commonwealth of Website: www.mhra.gov.uk/ China Fax: +32 2219 7342. Independent States (CIS) will be conferences. Brussels,Belgium Email: [email protected]. covered at this two-day seminar. This one-day workshop will focus Website: www.eas.eu. Contact:Informa UK. 25-28 February on registering and selling products Tel: +44 20 7017 7481. 28-29 November ■ OTC Pharma Asia 2014 in China. Sourcing from China will Fax: +44 20 7017 7823. EMA Review of the Year Singapore also be covered. ■ Email: [email protected]. and Outlook for 2014 IBC Asia’sfour-day conference Contact:Europharm SMC. Website: www.pti-global.co.uk/cis. brings together OTCbusiness lead- London, UK Tel: +32 2529 5842. ers and marketers to share the suc- Atwo-day conference –run by 16-18 December Fax: +32 2529 5872. cess factors and nuances in dif- The Organisation for Professionals ■ Pharmacovigilance Email: [email protected]. ferent markets. Performance and in Regulatory Affairs (TOPRA) – London, UK Website: www.europharmsmc.org. business opportunities across dif- featuring speakers from the Euro- Drug safety monitoring in the Euro- ferent product categories will be 19 November pean Medicines Agency(EMA). pean Union (EU), Japan and the covered and case studies from pro- Contact:TOPRA. US will be covered at this three- ■ Good Manufacturing fessionals from across the region Tel: +44 20 7510 2560. day meeting. Practice for Herbals will be discussed. Fora15% dis- Fax: +44 20 7537 2003. Contact:Management Forum. Bonn, Germany count quote: P46233OTCB. Email: [email protected]. Tel: +44 1483 730071. Aone-day seminar,organised by Contact:IBC Asia. Website: www.topra.org. Fax: +44 1483 730008. Germany’smedicines manufactur- Tel: +65 6508 2401. Email: registrations@management- ers’ association, the BAH, and con- Fax: +65 6508 2407. 28-29 November forum.co.uk. ducted in German. Email: [email protected]. ■ Pharma Branding Website: www.management-forum.co.uk. Contact:BAH. Website: www.otcpharmaasia.com. Tel: +49 228 957 45 0. Summit 2013 Fax: +49 228 957 45 90. Shanghai,China JANUARY2014 ‘Winning brand models and empir- MARCH Email: [email protected]. 30 January ical solutions’ will be covered at this Website: www.bah-bonn.de. Basics of 12-14 March two-day summit. Fora30% dis- ■ 8th Nutra India Summit Pharmaceutical ■ 25-26 November count quote: Brandingsummit88. Mumbai,India ■ EuroPLX 53 Contact: Borscon China. RegulatoryAffairs Athree-day nutraceutical, func- Barcelona, Spain Tel: +86 21 33191337. London, UK tional foods, dietary supplements This two-day conference will pro- Fax: +86 21 54363078. Aone-day course from The Org- and ingredients show. vide aforum for business devel- Email: [email protected]. anisation for Professionals in Reg- Contact: Niket Donde,MMActiv. opment decision makers for dis- Website: www.borscon-pb.com. ulatory Affairs (TOPRA). Tel: +91 22 2438 5007 9. cussing and negotiating collabor- Contact:TOPRA. Fax: +91 22 2437 9882. ative agreements in licensing, mar- DECEMBER Tel: +44 20 7510 2560. Email: [email protected]. keting, and distribution of patented Fax: +44 20 7537 2003. Website: www.nutraindiasummit.in. medicines, generics, biosimilars, 2December Email: [email protected]. OTCproducts, medical devices ■ Pharmaceutical Website: www.topra.org. 25-27 March and food supplements. RegulatoryRequirements ■ DIA Annual in Japan 31 January EuroMeeting Contact:RauCon. Understanding the Tel: +49 6222 9807 0. London, UK ■ Vienna, Austria Fax: +49 6222 9807 77. Aone-day seminar focusing on the Decentralised and There will be 16 themes covered Email: [email protected]. regulatory environment in Japan. Mutual Recognition at this three-day conference,org- Website: www.europlx.com. Contact:Management Forum. Procedures anised by the Drug Information Tel: +44 1483 730071. London, UK Association (DIA). 26-28 November Fax: +44 1483 730008. Aone-day course analysing the Contact: DIA European Office. ■ Introduction to European Email: registrations@management- differences and similarities of the Tel: +41 61 225 51 51. RegulatoryAffairs forum.co.uk. decentralised and mutual recog- Fax: +41 61 225 51 52. London, UK Website: www.management- nition procedures. Email: [email protected]. Medicine registration requirements forum.co.uk. Contact:Management Forum. Website: www.diaeurope.org.

8November 2013 OTC bulletin 25 OTC08-11-13p24-25_Layout 1 05/11/2013 19:08 Page 6

OTC MARKETING STRATEGY How to climbthe social-media ladder

Social media is playing abigger role than ever in influencing what products rather than just those people that may have al- and brands people buy, including those that address their healthcare needs. ready heard of Imigran Recovery and were more than likely already to be using the brand. Matt Stewart reports on howcompanies can avoid the pitfalls and get the Once an identity has been created, the real most out of their brands’ social media presence. work around howtoget amessage out to pot- ential consumers begins, Allen-Vercoe points ll of us will get ill at some sumer-goods and medical brands for manyyears. out. To do this, there are two“mainstay strate- point during the year and al- Most recently,headds, Orbital Media has gies” that Orbital Media typically employs for most all of us will moan been working closely with Forest Laboratories, its clients. “A about it on asocial-media and its range of healthcare brands, including The first is the ‘amplification strategy’, Allen- platform at some point,”according to Hayden Imigran Recovery,Infacol and Sudocrem. Vercoe reveals. “This essentially outlines the Allen-Vercoe, co-owner of public relations and “Social-media marketing is rapidly turning route map for growing social-media channels social-media agencyOrbital Media Network. into one of the most powerful and cost-effective to acritical mass of brand-aligned community “Luckily,every moan and groan about an ways of engaging newand existing consumers members,”heexplains. illness made on the world’sleading social net- across awide demographic, for afraction of “The process is alittle bit ‘chicken and egg’, work –Facebook –will reach an average of the large spend commanded by traditional as you need to be sharing good quality content 190 people,”Allen-Vercoe points out, “and if media,”Allen-Vercoe explains. from the outset to engage users,”Allen-Vercoe the person complaining is aged 18-24 years old, The fear of getting it wrong and the fall-out says, “but then you need the users to be will- this number increases to around 500.” of well-publicised social media “catastrophes” ing to engage in the first place.” Some of these people will then “share de- Agood start is to identify where tails and experiences”ofthe products that can your prospective target communi- “By treating social-media marketing help cure or treat their ailment, Allen-Vercoe ties exist online by making alist says. And if your brand is one of the remedies with ahealthy respect and affording of the bloggers and social-network theysuggest, then up to 500 people who may it proper forethought, you can ensure groups specific to your markets, neverhaveheard of or tried your brand will now he advises. safe and successful delivery.” be aware it exists. This makes social media a “This will come in handy when powerful tool for growing an OTCbrand. you come to seeking coverage for Established in 2003, Orbital Media wasone in other industries should not deter marketers your campaigns with the help of social influ- of the UK’sfirst specialist social-media agen- of OTCbrands from using these platforms to encers,”headds. cies, Allen-Vercoe claims, and has been work- drive sales, Allen-Vercoe insists. “Once this is done, you can start getting ing with awide range of OTC, fast-moving con- “By treating social-media marketing with a creative,” Allen-Vercoe says. He advises con- healthyrespect and affording it proper fore- ceptualising asocial-marketing campaign that thought,”hesays, “you can ensure safe and suc- will appeal to your target market; can be run cessful delivery.” offthe social channel or channels on which you The first step in developing abrand’ssocial- want to secure community growth; and enables media presence is naming its “social channels”, adegree of ‘virality’. Allen-Vercoe says. This campaign should also incentivise peo- When setting up social channels you have pleto“hook up to and engage on your social theability to assign your page a“vanity URL”, channels”, and also integrate subtle brand mes- which should clearly identify your brand or saging where possible. product, Allen-Vercoe points out. This makes “Most importantly,for improvedreturn on it easy to recognise or locate via searches, such investment, we would strongly recommend that as www.facebook.com/Nurofen. campaigns should also integrate with avariety “However, in some situations –particularly of other media activity,both on and offline, for with lesser-known brands or entry products –it optimal results,”Allen-Vercoe points out. can be beneficial initially to position social-media Furthermore, a“variety of premium and less channels as resources that address symptoms or sophisticated third-party applications can be acondition directly,”Allen-Vercoe suggests. used to deliverall kinds of weird and won- An example of this is Forest’ssumatriptan- derful campaign mechanics”, he adds. All should based migraine treatment, Imigran Recovery, offer,however,“swift or easily identifiable Allen-Vercoe notes, pointing out that “with a user journeys”, which can only be accessed view to engaging adiverse audience of migraine upon joining the brand’ssocial channel. sufferers”, all Imigran Recovery’ssocial chan- Looking at the world’smost popular social nels were labelledwith the category,but not network –Facebook –Allen-Vercoe points out Orbital Media’s ‘Is It Colic?’ application for Forest abrand-specific, ‘Migraine Matters’ URL. that up until very recently,brands were re- Laboratories’ Infacol colic brand provides distressed parents with away of gauging symptoms and advice on This tactic wasdesigned to capture UK stricted by the US-based site to using only an asuitable course of action at any time during the day migraine sufferers in general, Allen-Vercoe says, approvedthird-partyapplication to run apro-

26 OTC bulletin 8November 2013 OTC08-11-13p24-25_Layout 1 05/11/2013 19:08 Page 7

MARKETING STRATEGY OTC

motion of anydescription on aFacebook page. first required to ‘like’ the Sudocrem Facebook However, Facebook’snew guidelines have page. Additional ‘digs’ could then be earned relaxed this requirement, he notes, allowing for by sharing the campaign on the entrant’sown promotions directlywithin the page itself, with Facebook timeline, and when five of his or her no need for an approvedthird-partyapplication. friends were invited to enter themselves. Yetinmost instances, Allen-Vercoe warns, a Allen-Vercoe puts the campaign’ssuccess brand promotion run on aFacebook page with- down to the “viral mechanics of the applica- out an application will offer “limitedcreative tion” and the “intuitive game play”, all backed options, poor user experience and will not com- by “extensive integrated campaign promotion”. mand a‘like’ endorsement in return for entry”. Once you have established your social-media But, when rolling out an innovative campaign community,the next problem is keeping people concept, it is preferable to develop anew appli- engaged. This is where good content is key, cation that is completely unique, he points out. Allen-Vercoe says. “This is apotentiallymore expensive route, “Incessant brand navel-gazing is aone-way butthe flexibility to be completelyinnovative ticket to social-channel catastrophe,”Allen-

and fresh can often be akey ingredient to Vercoe warns. “Toavoid this, it is critical to fully Hayden Allen-Vercoe, co-founder of social media achieving truly impressive viral results across understand your communities’ interests, needs marketing agency Orbital Media Network, says that social media,”Allen-Vercoe explains. and touch points, then deliveranaligned con- with proper planning, healthcare companies can harness the power of social media to grow their brands “Asanexample, Orbital Media’srecent Virtu- tent programme full of variety and personality.” al Treasure Hunt application, developed for This can include asking topical questions, “Consider for amoment that manyusers Forest Laboratories’ Sudocrem,reached overfive going off-topic nowand again, creating inter- within your target market are ‘Googling’ symp- million Facebook users,”Allen-Vercoe claims, net ‘memes’ –orviral carriers –using appli- toms, causes and treatments related to aprod- “and attracted approaching 20,000 ‘likes’ to the cation-engagement tools, and using your “know- uct,”Allen-Vercoe says. Sudocrem Facebook page in under twomonths, ledge resource” to add value to things that mat- “Then add into the mix Google’slatest with the greatest levelofgrowth coming from ter to your community,heexplains. Hummingbird algorithm update –their first the keyfemale 25-34 year old market.” for almost 10 years, and achange which af- The Virtual Treasure Hunt campaign sup- Don’t be afraid to experiment fects 90% of all organic search results –and ported the launch of Sudocrem’snew brand “Finally,don’tbeafraid to innovate or ex- howitnow better values and rewards all digital positioning ‘For All Life’sLittle Dramas’ and periment with your content direction until you content that offers an ‘answer’ to search queries.” operated four virtual maps –aforest, beach, hitasweet spot of optimal community engage- By including an application, video clip or playground and lake–each hosting 10,000 ment,”Allen-Vercoe says. awidget on your website or social-media chan- spaces that could be ‘dug’ by an entrant in the Within this content framework, he adds, nel–providing the answers your target con- hope of finding one of the 5,000 prizes (OTC you can then “weave and integrate subtle brand sumers are looking for –your brand is more bulletin,28June 2013, page 15). messaging that doesn’tsend your users into likely to appear as atop answer to aGoogle Foranentrant to receive a‘dig’, theywere abrand-induced coma”. search, he points out. Forexample, operating social channels for Taking advantage of these developments, apsoriasis treatment might mean not necessar- Allen-Vercoe says, waswhat led Orbital Media ily focusing purely on topics related to the prod- to designing the ‘Is It Colic?’ application for uct or skin conditions, Allen-Vercoe explains. Forest’sInfacol. “Instead, research the demographic profile and interests of your community channel, then Interactive social tool create content that more positively aligns with Having identified that there were manytens users’ general wellbeing, aspirations, and/or trig- of thousands of consumers each month submit- gers for the condition.” ting colic-related queries into search engines This could include covering topics such as –often outside of general practitioners’ surgery nutrition, stress management, exercise or style hours –Orbital Media developed an interac- advice for sufferers, Allen-Vercoe says. Then you tive ‘social tool’, Allen-Vercoe says, to help can introduce more psoriasis/skin condition- guide parents and indicate whether colic symp- centric content, he adds, such as “positive case toms may be present in an infant. studies of celebrities who live with psoriasis, The application waslaunched last year to exclusive psoriasis sufferer and dermatologist provide distressedparents with away of gaug- interviews, psoriasis in the news, latest medical ing symptoms and advice on asuitable course research, online question and answer sessions of action at anytime during the day,henotes. or webinars”. Summing up, Allen-Vercoe says that social- Whilst these strategies work very well in media marketing is still arelatively young dis- terms of community growth, user retention and cipline and the speed at which the channel has engagement, companies should also consider developed has thrown up some cautionary tales. what additional value can be added to acam- But if you prepare properly for consumers’ paign, Allen-Vercoe points out. desires to spend more time accessing social Orbital Media’s ‘Virtual TreasureHunt’ application, developed for Forest Laboratories’ Sudocrem brand, This is where “applications, widgets and media, the rewards can be great. reached over five million Facebook users movie content” come into play,henotes. OTC

8November 2013 OTC bulletin 27 OTC08-11-13p28-29_Layout 1 05/11/2013 16:58 Page 2

OTC BUSINESS STRATEGY Stada aspires to be a top OTC player

As it completes its deal for one of the UK’s leading OTC firms, Thornton OTC brands, while it expanded its “already & Ross, Germany’s Stada Arzneimittel has ambitions to become one of extensive” network of pharmacy partners. Meanwhile, Retzlaff said the firm would Europe’s leading lights in the OTC sector. Editor-in-chief Aidan Fry reports. aim to increase the international presence of its Branded Products portfolio, not least through artmut Retzlaff, Stada Arzneimit- including Generics sales that increased by 6% seeking strategic acquisitions via a ‘buy-and- tel’s executive chairman, is charac- to C618 million (see Figure 1). build’ model. Examples of following this strat- teristically clear in his intent for the While Stada’s Branded Products segment is egy have included Stada buying both individ- HGerman group to become a major barely half the size of the firm’s Generics unit ual brands and entire companies. player in the self-medication industry. “We as- in terms of turnover, it contributed slightly more Falling into the category of buying brands, pire to a leading position in the OTC sector,” he by way of operating profit in the first half of the German group has just agreed to pay C131 told investors recently. 2013 – C85.9 million –compared to C80.7 mil- million in cash for the Aqualor range of sea- Unlike its German generics rival Ratiopharm lion from the Generics segment. water-based sprays and drops in Russia (OTC – which chose to build up a portfolio of non- “Where we want to go is to diversify the bulletin, 25 October 2013, page 1). prescription products that it sells under its cor- Branded Products/Generics mix from around The deal – which is expected to close early porate banner – Stada has developed a broad 50% to about two-thirds of the contribution to next year – gives Stada a range of Aqualor- array of individual OTC brands that it markets group operating profit,” Retzlaff stated. branded OTC medical devices for adults, chil- under ‘fantasy’ or invented names. These brands Presenting prospects for “continuous growth” dren and infants used to treat a variety of con- include the combination cough/cold remedy in the OTC market, Retzlaff said demographics ditions, including sinusitis and sore throat. Grippostad, the Ladival suncare range, the nasal favoured a “positive outlook”. He noted that Aqualor products generated sales of approx- decongestant brand Snup and the Mobilat bas- ageing populations – coupled with “greater imately C28 million in 2012, Stada pointed out, ket of topical analgesics. health awareness” and cost pressures on health- and an earnings before interest, tax, deprecia- This OTC portfolio – along with an array care systems – were creating a “market of self- tion and amortisation (EBITDA) margin that of prescription-only brands, led by the ApoGo paying patients”. was “significantly above” the adjusted 32.8% (apomorphine) Parkinson’s disease treatment Stada’s strategy for capitalising on such EBITDA margin generated by the Branded – forms the basis of the German group’s Brand- demographic trends is in part based on organic Products division’s other products. ed Products business segment that increased growth. Retzlaff pledged to pursue “brand in- Since the range had been launched in 2007, its turnover by 18% to C337 million in the first novation” by developing new claims, indica- Aqualor had achieved “vigorous sales growth”, six months of this year. The segment accounted tions, delivery forms, packaging and line ex- Stada said, and had become one of Russia’s lead- for just over a third of group first-half turn- tensions. Stada, he said, would continue to in- ing brands in a seawater products category that over that advanced by a tenth to C974 million, vest in “focused above-the-line support” for its had grown by over 34% in the past five years. Having followed other OTC acquisitions in Business segment First-half sales Change Operating profit Change Russia, including that of the Vuka line of men’s (C millions) (%) (C millions) (%) nutritional supplements (OTC bulletin, 30 Generics 618 +6 81 +20 March 2012, page 4), Aqualor will strengthen Stada’s position in the Russian nasal deconges- Branded Products 337 +18 86 +32 tants market. The German firm already has a Commercial 19 +112 0– significant presence in this space through its Group/other –– -35 – xylometazoline-based Snup brand that has grown Total Stada 974 +10 132 +30 rapidly since its local launch in 2008. Citing IMS Health data, Stada said Russian Snup sales Figure 1: Stada’s sales and operating profit in the first half of 2013 by business segment (Source – Stada) had increased to C11.6 million in the first half Brand Year of 2012 sales First-half 2013 of this year, compared to C14.4 million in the launch (C millions) sales (C millions) whole of 2012 (see Figure 2). Last year, Snup ranked fourth in terms of Snup 2008 14.4 11.6 Stada’s turnover from Branded Products in Cepefim 2011 9.6 3.1 Russia, behind only the vitamin B1-based hep- Tranexam 2012 8.2 6.4 atoprotector Essliver Forte, the chlorampheni- Depanthol 2008 4.6 2.4 col antibiotic Levomecol and the Chondroxide Tagista 2009 3.1 1.6 chondroitin brand for muscular- and joint-pain. Vankomicin 2010 2.8 1.2 Acquisitions in Russia drove up first-half Miropriston 2010 2.2 1.1 Russian Branded Products sales by 42% to C118 Beliy Ugol 2010 2.0 1.3 million. This represented three-fifths of Stada’s Vitaprost Plus 2008 2.0 1.0 total sales in the country. Eslidin 2009 1.6 0.9 Among recent company acquisitions, the

Figure 2: Sales in 2012 and the first half of 2013 of leading products launched in Russia by Stada between German group is strengthening substantially its 2008 and 2012 (Source – Stada/IMS Health) position in the UK by paying £221 million (C353

28 OTC bulletin 8 November 2013 OTC08-11-13p28-29_Layout 1 05/11/2013 16:58 Page 3

BUSINESS STRATEGY OTC

million) for local OTC specialist Thornton & Ross (OTC bulletin,23August 2013, page 1). 80 “Thornton & Ross will add C77 million to  £66.4 our annual turnoverand will more than double £58.3 £60.2 +10% +3% £52.2 +12% our UK sales,”Retzlaffpointed out, adding that 60  +16% the ‘net’ purchase price, adjusted for cash re- £44.9 £39.7 +13% serves, was C226 million. The UK firm, he add- £35.8 +11% 40 £28.8 £29.4 +22% ed, generated annual EBITDAofC20 million.  £27.1 +6% +2% +14% Describing Huddersfield-based Thornton & £23.8 Sales (£ millions) Ross as a “centre of excellence” that would 20 lead OTCdevelopment across the group, Retz-  laffsaid the deal would give Stada aplatform from which to launch its own brands in the 0  2002/ 2003/ 2004/ 2005/ 2006/ 2007/ 2008/ 2009/ 2010/ 2011/ 2012/ UK. Conversely,several of Thornton &Ross’ 2003 2004  2005  2006 2007 2008 2009 2010 2011  2012  2013  products had potential in countries in which Stada had a strong presence. Figure3:Thornton &Ross’ turnover over the past decade, excluding divested brands (Source –Thornton &Ross) The UK firm possessed Europe’s number- Rank OTC company Annual sales Change one head-lice treatment, Hedrin, Retzlaffpoint- ( C millions) (%) ed out, and also offered one of the UK’slead- ing cough and cold brands in the Covonia range 1 Novartis 1,544 +7.7 of cough remedies. 2= Sanofi1,161 +5.3 Radian B topical analgesics had proven a Bayer 1,161 +3.9 “big success in the Middle East”, Retzlaffnoted, 4Johnson & Johnson 981 -0.3 while Thornton & Ross’ multi-product Care 5Teva 598 +7.2 range was the biggest-selling OTC brand by 6GlaxoSmithKline 494 -3.0 volume through UK pharmacies. The firm’s 7Reckitt Benckiser 489 +7.5 Zoflora disinfectant was “a strong household 8Boehringer Ingelheim 468 +6.8 name”, while the UK firm’spush into the der- Stada/Thornton & Ross (proforma) 467 – matology sector was “a proven concept with significant growth potential”. 9Abbott 397 +2.8 Speaking to OTC bulletin earlier this year, 10 Stada 390 +9.4 Thornton &Ross’ chief executive officer,Dieno Total OTC market 20,286 +5.6 George, said the company generated three- Figure 4: Sales growth by the 10 leading OTC companies in the 28 European Union member states, Russia and quarters of its sales from its OTC portfolio. Switzerland in the 12 months ended June 2013 (Source – Stada/IMS Health) However, he said, the firm’s biggest opportu- nity lay in its prescription drugs business – &Ross, the combined companyranked ninth, tribute the skincare range in February 2006, which accounted for 11% of turnover – and just C1 million behind Boehringer Ingelheim Slegers pointed out. “The success story of Cetra- the work it had done to get its Altoderm sodium (see Figure 4). The operating margin achieved beninthe UK will serveasabasis for expan- cromoglycate-based cream in aposition to file by Stada’sBranded Products segment also com- sion into other European countries, such as Italy, for authorisation as atreatment for atopic der- pared favourably with those of the consumer Germany, Portugal and Russia,” he stated. matitis and eczema (OTC bulletin, 31 May healthcare operations within its OTC rivals, Cetraben is one of four key OTC brands – 2013, page 25). Retzlaff added. along with Grippostad, Ladival and the mag- Thornton &Ross will expand Stada’sBrand- nesium line Magnetrans –that Slegers identi- Thornton &Ross growing strongly ed Products business in the UK, which ac- fied as having growth potential in Europe. As can be seen from Figure 3, Thornton & counted for 84% – C21.7 million –ofthe firm’s These, he said, would complement prescrip- Ross has enjoyed 11 years of continuous sales total UK sales that declined by 3% to C26.0 tion growth drivers such as ApoGo, biosimilars growth, almost trebling its turnoverduring that million in the opening six months of 2013. through deals with Gedeon Richter and Apotex, period, with international sales outside of the UK Over the same period, the UK generated 7% and abasket of brands acquired from Grünenthal expanding to makeupnearly afifth of the total. of global sales by Stada’sBranded Products seg- that Stada feels has “created critical mass” for ex- Even before it closed the Thornton &Ross ment that totalled C337 million. pansion in the Czech Republic, Poland and Slov- takeover, Retzlaffclaimed Stada was“outper- “Around 70% of total UK sales are from akia (OTC bulletin,10February 2012, page 3). forming the OTCmarket” in Europe. Referring ourthree top brands –Cetraben, Movelat and Other than in the German group’sdomestic to IMS Health data for the 28 European Union ApoGo,”observed Luc Slegers, Stada’ssenior market, Grippostad is established in Austria, (EU) member states, plus Russia and Switz- vice-president for Europe. Cetraben was, he Czech Republic, Ireland, Poland and Spain. erland, in the 12 months ended June 2013, he noted, “one of the best-selling and popular emol- Ladival is available in Austria, Czech Repub- said: “Stada is the fastest-growing OTCcom- lients in the UK, with awide range of lotions, lic, Ireland, Portugal and Spain, and Stada is pany in the top 10.” creams and bath remedies”. There wasconsider- also taking the C17 million brand into Turkey. Stada’s9.4% OTCsales growth to C390 mil- able potential, Slegers said, to add to the range Stada markets Mobilat/Movelat topical anal- lion in the period had secured it the 10th spot with formulations that were free from parabens. gesics in Austria, Belgium, Italy,Poland, Por- in a C20.3 billion market, Retzlaffcommented. Brand sales had more than trebled since tugal and the UK. But on a proforma basis, including Thornton Stada’s UK operation, Genus, started to dis- OTC

8 November 2013 OTC bulletin 29 GenHouseAdforOTC-2013.qxd:NewGb4colourAdvert0717/1/1313:00Page1

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Manufacturers Manufacturers J&J adds global Teva’sLevin steps down marketing chief afterclashing withboard ohnson &Johnson has appointed Alison J Lewis –vice-president of strategic mar- eva’s president and chief executive officer, Eyal Desheh keting at Coca Cola North America –toover- TJeremy Levin,has stepped down from see marketing at its global Consumer business. the role with immediate effect, the Israeli com- In the newly-created role of chief marketing panyhas announced. officer,Lewis will report to Lynn Pendergrass, “The board has named Eyal Desheh,Teva’s who joined from Hewlett Packard as world- executive vice-president and chief financial offi- wide chairman of Johnson &Johnson’sCon- cer,tofill the role of president and chief ex- sumer division in August (OTC bulletin,13 ecutive officer on an interim basis,”Teva noted, September 2013, page 23). adding that the companyhad “formed acom- Lewis –who has spent nearly 18 years at mittee that will promptly begin to search for thesoft-drinks giant –would oversee the mar- apermanent successor”. keting for all of the Consumer division’sbusi- Phillip Frost, chairman of Teva’s board, ac- nesses, the companypointed out, including knowledged that Levin and the board had been forming joint ventures and the planned acceler- its global OTCunit. “truly aligned” on the firm’sstrategy,but had ation of the firm’scost-reduction programme”. Putting asingle leader in charge of the Con- “different views” overhow best to pursue it. The Israeli companyrecently announced sumer division’smarketing strategies would These differences revolved around “nuances” plans to slash around 5,000 jobs –more than enable the companytofocus its investment and “subtleties”, Frost said, butwere not able atenth of its global workforce –bythe end of “more effectively and efficiently”, Johnson & to be resolved. next year in abid to produce annual cost sav- Johnson claimed, noting that while at Coca- He said the company’smanagement team ings of US$2.0 billion (C1.5 billion) by 2017. Cola, Lewis had overseen an annual US ad- was“fully committed to the implementation of This formed part of aglobal restructuring pro- vertising budget of more than US$600 mil- Teva’s strategy,including the development of gramme outlined by Levin at the end of last lion (C 438 million). newcompounds, making strategic acquisitions, year (OTC bulletin,18January 2013, page 7). OTC OTC

Mergers&Acquisitions Claiming the plan would return Celesio to its roots in wholesaling and retailing, Pinger McKesson set to acquire Celesio streamlined the business by selling anumber of assets, including Celesio’sCzech retail phar- ■ Continued from front page retailer Alliance Boots (OTC bulletin,10Aug- macyand wholesaling operations (OTC bul- wholly-owned pharmacies, and an over4,000- ust 2012, page 8), and just afew weeks after letin,14September 2012, page 6), and its Doc- strong virtual pharmacynetwork –will be- Walgreens and Alliance Boots officially started Morris business to Switzerland’sZur Rose come part of McKesson’sDistribution Solutions a10-year partnershipwith McKesson’sUS (OTC bulletin,9November 2012, page 15). division, led by group president Paul Julian. rivalAmerisourceBergen (OTC bulletin,13 In December last year,Pinger announced Commenting on the tie-up, Julian noted that September 2013, page 5). that Celesio intended to makeLloyds the leading the leaders of both firms had built relationships In the wake of the deal between Walgreens/ pharmacybrand in Europe (OTC bulletin,18 with customers overmanyyears and had a“deep Alliance Boots and AmerisourceBergen, spec- December 2012, page 1). The Lloyds name orig- understanding of their ownunique markets”. ulation overthe future of Celesio intensified. inated in the UK, where the Lloydspharmacy “Welook forward to supporting Celesio and In June, Haniel denied it had held talks chain nowincludes more than 1,500 stores. its business leaders as theyimplement their cur- about selling its controlling stakeinCelesio to All of Celesio’s2,200 retail pharmacies rently planned strategy for growth,”Julian com- US drugstore giant CVS Caremark(OTC bul- across six European countries would be re- mented, “and ultimately aligning our organi- letin,28June 2013, page 5). branded under the Lloyds banner as part of a sations more closely in the areas where we can Alittle overamonth later,Celesio fired its newstrategy,Pinger said, which also included deliverfurther value for our customers and chief executive officer,Markus Pinger,after less the creation of avirtual pharmacynetwork. manufacturing partners.” than twoyears in the role due to a“difference In the first half of 2013, Celesio’ssales fell McKesson said it expected to generate an- of opinion” overthe management of the firm by 4.6% to C10.7 billion, while earnings before nual synergies of between US$275 million and (OTC bulletin,26July 2013, page 27) . interest, tax, depreciation and amortisation US$325 million by the fourth year following The deal with McKesson should bring to an (EBITDA) grewby10.3% to C268 million. completion of the steps needed to takeoper- end aturbulent period for Celesio, which is still TurnoveratCelesio’sdominant Pharmacy ational control Celesio. in the midst of awide-ranging restructure insti- Solutions wholesaling unit dropped by 5.0% to The tie-up comes just overayear after US- gated by Pinger in October2011 (OTC bulletin, C9.05 billion, while sales at the Consumer Solu- based drugstore firm Walgreens completed its 31 October 2011, page 1), and which the US firm tions retail division fell by 2.3% to C1.68 billion. initial investment in European wholesaler and is keen for its newacquisition to complete. OTC

8November 2013 OTC bulletin 31