OTC07-11-14p1_OTC15/11/2005 p1&24 05/11/2014 09:07 Page 1

7November 2014

COMPANY NEWS 3 Bayertakes leading spot 3 fires Viehbacher in ChinawithDihon deal BoehringersaysnotoOmegabuy 3 GSKhints at Consumer divestments 4 afterfall out with board Merck waves goodbye to 5 Consumer Care business hris Viehbacher,chief executive officer Bayertargets critical mass 6 in Consumer Cof Sanofi, has been firedafter the firm’s board of directors concluded that his “man- Nasacortdrives salesforward 7 at Sanofi agement style was not adequate”. Oriola wantsafairprice 8 In asurprise move,the board of the French for itsRussian operations companyannounced it had “decided unani- BioGaiareports a 9 mously” to remove Viehbacher after six years double-digitsales rise at the helm. Celesioputsfaith in 11 “The group needs to pursue its development new leadership team with amanagement aligning the teams, harness- expects Lipitortrialresults 12 ing talent and focusing on execution with aclose in 2015 and confident co-operation with the board,” Sanofistated, adding that its chairman, Serge GENERAL NEWS 13 Weinberg, would takecharge while it search- ed for achief executive. Most Germans have 13 Expanding on the rationale behind the deci- used homoeopathy sion, Weinbergsaid that the board was“strongly Chris Viehbacher has left Sanofi after the board Health Canada approves 16 dissatisfied” with Viehbacher’sability to work Aspirin heart-attack claim criticised his management style with board members to examine the company’s Germans reject OTCguidance 16 strategy “in aconfident manner”. (OTC bulletin,27February 2009, page 1). Australia settooverhaul 17 “The fluidity of the relationship between Acquisitions were central to Viehbacher’s TGAmedicines regulation the chief executive officer and the board was expansion strategy,with the companysnapping MARKETING NEWS 18 inadequate,”herevealed. up to enter the US OTCmarket in In addition,Viehbacher’sexecution of 2010 (OTC bulletin,20January 2010, page Ricola offerscoldsufferers 18 Sanofi’sstrategy had not been “sufficient”, 1) and adding BMP Sunstone to strengthen its arevitalisingherbal option Weinbergclaimed, noting that the company’s presence in China the same year (OTC bul- OnlineStrepsils campaign 19 fiscal 2013 “had not been very satisfying”. letin,16November 2010, page 1). urgesIndians to speak up Group sales in 2013 had fallen by 5.7% to Under Viehbacher’sleadership, Sanofilifted German companies offer 20 C33.0 billion, he pointed out, with the firm its Consumer Healthcare sales from C1.42 bil- nasal sprays for winter experiencing “significant problems” related to lionin2008 to C3.01 billion in 2013. Omegaintroduces Nasodren 20 its Consumer Healthcarebusiness in China and Weinbergrevealed that discussions among to Spain its Generics business in Brazil. board members overViehbacher’sfuture had Vitabiotics’ commericals 21 Commenting on the problems in China at been ongoing since “the middle of summer”. banned by ASA the time, Sanofisaid the Consumer Healthcare However, the board had not planned on remov- RB launches ‘Junior Notes’app 21 business in the country had been blighted by ing Viehbacher until alater date, he noted. in Austria alack of transparencyinthe distribution chan- “Wehavebeen forced to accelerate the nel (OTC bulletin,21February 2014, page 6). decision because of leaks that came out in the FEATURES 24 The firm admitted that it had no real control press on 26 October,” Weinbergstated. RB plots the future 24 overthe “flowofmargin” between the com- “Wefelt that uncertainty at the head of the of consumer health panyand retailers. firm wasnot good,”heexplained, “so we need- During his six-year tenure, Viehbacher made ed to act rapidly and that is what we have done.” REGULARS Consumer Healthcare one of the company’s Looking ahead, Weinbergsaid that Sanofi’s “growth platforms”. Shortly after he joined the strategy “would remain the same”. “It is busi- Events – Our regularlisting 23 firm, he announced in 2009 that Sanofiintend- ness as usual on all aspects,”headded. People – Rawlinstosucceed Duff 27 ed to double the size of its OTCbusiness to The search for Viehbacher’spermanent re- as chairofUK’sMHRA approximately C3billion within five years ■ Continued on page 27 LI FE VER SA SA VER ME TI

Saving time means saving lives. Keep your vital supply chain moving with an array of shipping designed especially for healthcare providers like you. To learn more, go to fedex.com/gb/healthcare or email us at [email protected]

FedEx. Solutions powered by people.

©2014 FedEx. All rights reserved. OTC07-11-14p3-12_Layout 1 05/11/2014 09:24 Page 3

COMPANY NEWS OTC

Mergers&Acquisitions Mergers&Acquisitions Boehringer says takesleading spot no to Omega buy in China with Dihon deal oehringer Ingelheim has no interest in ac- Bquiring Omega Pharma, aspokesperson for ayer nowholds aleading position in ingbrands into our growing OTCportfolio,” the German firm has told OTC bulletin. BChina’sOTC market, according to the Brandicourt added, “and to leverage the know- The family-controlled companyhad been company’schief executive officer Marijn Dek- ledge and expertise of our newemployee base linked with amove for Omega,along with San- kers, after completingits CNY3.6 billion (C460 to further growand develop these self-care solu- ofi, store-brand specialist Perrigo and the gener- million) acquisition of privately-owned Dih- tionstothe benefit of consumers across China ics giant Actavis. on Pharmaceutical. and other parts of the world.” Adeal for Omega could be struck before the Announced in March (OTC bulletin, 17 Bayer also believesitcan leverage the herb- end of the year,according to anumber of media March 2014, page 1), the deal givesBayer a als expertise of the German firm Steigerwald reports, with the privately-owned Belgian OTC “portfolio of well-known consumer brands” –which it acquired last year (OTC bulletin, 31 firm expected to fetch around C4billion. and amajor foothold in the country’stradi- May2013, page 1) –and Dihon’sTCM expe- tional Chinese medicines (TCMs) market. rience to bolster its natural-products business. Omega’s sales increase by 40% Dihon’srange of OTCbrands and TCMs Bayer’sConsumer Care operation has a Afocus on increasing organic growth – generated sales of C123 million in 2013, the number of brands in the Chinese OTCmarket, coupled with the companyacquiring abasket of German companynoted, making it a“leading including the Aspirin, the antifungal GlaxoSmithKline’snon-core brands in Europe player” in China’sOTC market with brands Canesten, the gastrointestinal remedy Talcid (OTC bulletin,16March 2012, page 1) –has such as the Kang Wang dandruff treatment, Pi and the vitamin brand Redoxon. seen Omega’s sales increase by 40% to C1.2 Kang Wang antifungal and the TCM In 2008, the companyrelaunched, under billion in the four years ending 31 December brand Dan EFuKang for women’shealth. theBayer name, the White &Black ‘western- 2013 (OTC bulletin,15August 2014, page 4). style’ cough and cold brand it gained by acquir- In the summer,Omega’s chief operating Brands sold outside China ing Chinese firm Topsun (OTC bulletin, 31 officer Christoph Staeuble told OTC bulletin In addition to China, Dihon’sbrands were October 2006, page 3). that the companywas committed to becoming sold in anumber of other markets, Bayer Dekkers pointed out that following Bayer’s the third-largest OTCplayer in Europe with- pointed out, including , , US$14.2 billion (C11.3 billion) purchase of US- in the next four years. and . based Merck &Co’sglobal Consumer Care Omega wastaken private by its founder Dr Olivier Brandicourt, chief executive offi- business, the deal for Dihon fitted perfectly with Marc CouckeinFebruary 2012 in adeal which cer of Bayer Healthcare, said Dihon’sman- the company’saim of further growing its Con- valued the company at C870 million (OTC agement team had built a“strong business” with sumer Care business through bolt-on acqui- bulletin,29February 2012, page 11). a“track record of success”. sitions (see page 6). OTC “Weare delighted to bring Dihon’soutstand- OTC

7November 2014 Number 432 Individual subscriptions Te rms &Conditions: These can be viewed in An annual subscription comprises: full at www.OTC-bulletin.com/subscribe. Editor: Matt Stewart ■ 20 OTC bulletin newsletters; No partofthis publication may be copied, Editor-in-Chief: Aidan Fry reproduced, stored in aretrieval system, distributed Production Editor: Jenna Meredith ■ AND at least 45 weekly news@OTCbulletin or transmitted by anymeans, including electronic, Assistant Editors: To mGallen, electronic newsflashes containing the week’s mechanical, photocopying or recording, without Liudmila Kotko, Marie McEvoy top news stories (currentlydelivered by email). the prior written permission of the publisher, or under the terms and conditions of aGlobal Site Contributing Editor: David Wallace Choice of formats Licence or of alicence issued by the Copyright Advertising Controller: Debi Minal The 20 OTC bulletin newsletters are available: Licensing Agency (CLA) in London, UK, or rights Director of Subscriptions:ValDavis ■ EITHER as the digital OTC bulletin-i for bodies in other countries that have reciprocal agreements with the CLA. Group Sales Manager: Anisa Shan online access by desktop,and and Awards Manager: Natalie Cornwell smartphone.Mobile devices can have Apple or Neither maythis publication be exported, Managing Director: Mike Rice distributed or circulated by anymeans without Android operating systems. the prior written permission of the publisher. Editorial enquiries: OTC bulletin, ■ OR in traditional hard-copyprint format, While due care has been taken to ensure the 4Poplar Road, Dorridge,Solihull, delivered by airmail. accuracy of information contained in this West Midlands B93 8DB, UK. publication, the publisher makes no claim that Website: www.OTC-bulletin.com Corporate and multiple subscriptions it is free of errorand disclaims anyliability Te l: +44 (0)1564 777550 Global Site Licences are available to companies. whatsoeverfor anydecisions or actions taken Fax: +44 (0)1564 777524 These provide in-house electronic access for as aresult of its contents. Email: [email protected] staff to OTC bulletin and news@OTCbulletin. ©OTC Publications Ltd. All rights reserved. Please ask foraquotation. OTC bulletin® is registered as atrademark in Advertising enquiries: the European Community. Discounted multiple subscriptions are available to As above,[email protected] ISSN 1742-0784. OTC bulletin-i at the same location. SUBSCRIPTIONS Companyregistered in England No 2765878. Subscription rates are published at Subscription enquiries: Printed by Warwick Printing CompanyLimited, www.OTC-bulletin.com/subscribe. Contact [email protected] Leamington Spa CV31 1QD,UK.

7November 2014 OTC bulletin 3 OTC07-11-14p3-12_Layout 1 04/11/2014 16:33 Page 4

OTC COMPANY NEWS

GSKThird-QuarterResul hintsts at Consumerdivestments

ivesting “parts” or even “whole bits” of Business Third-quarter sales Change 2013/2014 (%) Proportion DGlaxoSmithKline’s(GSK’s) upcoming (£ millions) £CER* of total (%) consumer healthcare joint venture with Novar- tis could be on the cards if those assets “have Oral health 446 -6 +2 42 the potential to create more value” under dif- Wellness 394 -15 -8 37 ferent ownership, according to the firm’schief Nutrition 160 –+415 executive officer AndrewWitty. Skin health 71 -21 -13 6 Speaking as GSK announced its third-quar- Total Consumer Healthcare1,071 -10 -3 100 terresults, Witty said that once the three-part deal with Novartis wascompleted, the company *CER is at constant exchange rates would judge whether assets in anyofits three Figure1:GlaxoSmithKline Consumer Healthcare’s sales in the thirdquarter ended 30 Sepember 2014 broken businesses –Consumer Healthcare, Pharma- down by business (Source –GlaxoSmithKline) ceuticals or Vaccines –“would create more tive viewabout when, if ever,abusiness has letin, 25April 2014, page 1). value with adifferent approach”. the potential to create more value in adiffer- The deal will also see GSK divest its Onc- GSK had a“clear track record” of taking ent structure or with adifferent ownership than ology portfolio to Novartis for US$16 billion “thoughtful and objective decisions” around within the current structure,”Witty insisted. (C2.7 billion) and acquire Novartis’ Vaccines which businesses it wanted to own, Witty noted, However, before possible sales could be business for US$5.25 billion, plus up to US$1.8 highlighting the divestment of its Lucozade considered, it was“key” to get the transaction billion in milestone payments. and Ribena drinks business to Japan’sSuntory with Novartis closed, he noted. After the deal Commenting on the Novartis transaction, last year as good example (OTC bulletin, 27 wascompleted –which is expected to be in Witty said it gave GSK the opportunity to take September 2013, page 1). “I don’tsee us chang- the first half of 2015 –GSK could “move for- “twostrong businesses” –Consumer Health- ing that mindset,”headded. ward”, Witty said. “Then we’ll see what the care and Vaccines –“and really establish them The firm also divested anumber of non-core situation is at that point.” as global leaders”. OTCbrands across Europe, the US and other Witty’sremarks came around six months “The deal will ensure market leadership and regions for net cash proceeds of approximately after GSK announced that its Consumer Health- true global scale for both Consumer Health- £690 million (C875 million) in the first half of care business would assume 63.5% control care and Vaccines,”Witty claimed, “and will 2012 (OTC bulletin, 30April 2012, page 1). of ajoint venture with Novartis that had pro- allowusfor the first time to appropriately re- “Weare taking, and we take, avery objec- forma 2013 sales of £6.5 billion (OTC bul- port on these businesses alongside the Phar- maceuticals division.” Region Third-quarter sales Change 2013/2014 (%) Proportion “When we close the transaction, we will (£ millions) £CER* of total (%) begin to report much more distinctlyConsum- er Healthcare, Pharmaceuticals and Vaccines, Rest of World 559 -7 +1 52 so that you can clearly see the different profiles Europe 310 -12 -5 29 of those businesses and their different character- US 202 -13 -7 19 istics,”Witty added. Total Consumer Healthcare1,071 -10 -3 100 Last month, GSK revealed it had made two senior appointments to the management team *CER is at constant exchange rates of the consumer healthcare joint venture, which Figure2:GlaxoSmithKline Consumer Healthcare’s turnover in the thirdquarter ended 30 September 2014 is to be led by GSK’spresident of Consumer broken down by region (Source –GlaxoSmithKline) Healthcare Emma Walmsley(OTC bulletin, Third quarter Change 2013/2014 (%) Proportion 24 October 2014, page 27). (£ millions) £CER* of total (%) Brian McNamara, currently worldwide head of Novartis OTC, will takeresponsibility for the Coresales Americas and Europe at the combined business. Pharmaceuticals and Vaccines 4,575 -10 -3 81 In addition,Zubair Ahmed, currentlyvice- Consumer Healthcare 1,071 -10 -3 19 president for the Indian subcontinent at GSK Total 5,646 -10 -3 100 Consumer Healthcare, will takecharge of - Pacific, and . Coreoperating profit Meanwhile, GSK reported Consumer Health- Pharmaceuticals and Vaccines 1,683 -3 ±0 91 care turnoverdownby10% –3%atconstant Consumer Healthcare 174 -18 ±0 9 exchange rates –to£1.07 billion in the third quarter (see Figure 1). Total** 1,887 -6 -1 100 Simon Dingemans, GSK’schief financial *CER is at constant exchange rates ** After corporate and other unallocated costs of £30 million officer, blamed the decline on the “ongoing

Figure3:GlaxoSmithKline’s ‘core’ sales and operating profit in the thirdquarter of 2014. Coreresults impact of supply issues” which had affected exclude amortisation, goodwill, restructuring costs, legal charges and other items (Source –GlaxoSmithKline) the unit since the start of the year.

4 OTC bulletin 7November 2014 OTC07-11-14p3-12_Layout 1 04/11/2014 16:33 Page 5

COMPANY NEWS OTC

Supply problems had hit sales of the com- Third-QuarterResults pany’ssmoking-cessation products and Alli weight-loss brand, he said, as well as the Bac- Merck waves goodbye to troban skin-care line in China. Despite GSK making “significant progress” in “remediating” these issues, Consumer Health- care’ssales had continued to suffer during the Consumer Carebusiness three months, Dingemans noted. All three of the unit’skey regions –Europe, Rest of World and US –had been impacted by erck &Coreported Consumer Care sales Merck bolstered its OTCportfolio last Sept- the supply issues, he said, and would continue Mdown by 9% to US$401 million (C318 ember when it launched Oxytrol for Women to be affected for the remainder of 2014. million) in the third quarter of 2014, as it began (oxybutynin transdermal system, 3.9mg/day) “Even though we do not expect the business cancelling distribution agreements in prepa- in the US as the “first and only” OTCtreat- to be back in full supply before the end of this ration for the sale of the business to Bayer. ment for overactive bladder. year, wecontinue to expect Consumer Health- During the quarter,Merck had terminated However, its attempt at switching the asthma care to be broadly flat at the top line for 2014 in China anumber of Consumer Care distribu- medicine Singulair (montelukast) –which lost as awhole,”Dingemans added. tionagreements, the firm explained, and revers- its US exclusivity as aprescription medicine The supply issues that hit sales of smoking- ed sales previously made to those distributors. in August 2012 –for use as an OTCallergy cessation products and Alli pushed turnover The restructuring had negatively impacted treatment wasblocked earlier this year over in Consumer Healthcare’sWellness category Consumer Care sales in China, Merck noted. fears that off-label use by asthma patients might down by 15% as reported –8%atconstant ex- The moveswere made ahead of the sale of have lead to adverse outcomes (OTC bulletin, change rates –to£394 million. the business to the German firm for US$14.2 15 August 2014, page 17). billion, which wascompleted on 1October According to members of the US Food and Oral health leads division (OTC bulletin, 10October 2014, page 1). Drug Administration’s(FDA’s) Non-prescrip- Wellness’ poor performance meant Oral Speaking as the deal closed, Merck’schair- tion Drugs Advisory Committee, Singulair’s health maintainedits position as the leading man and chief executive officer,Kenneth Fra- safety as an OTCmedicine for the relief of al- Consumer Healthcaresegment for the third zier, said the proceeds from the sale, in com- lergy symptoms, “considering potential off-label quarter running, despitesales declining by 6% bination with “strong” operating cash flow, use”, had not been adequately demonstrated. as reported to £446 million. At constant ex- gave the firm “greater flexibility to invest in Merck has had apresence in the OTCmar- change rates, sales improvedby2%. opportunitiesthat augment the company’spipe- ketsince 2009 when it acquired US-based Sensodyne turnoverhad risen by 13% at line and product portfolio”. Schering-Plough for US$41 billion (OTC bul- constant exchange rates, GSK noted, offsetting Sales of Consumer Care’sleading brand, letin, 17March 2009, page 1). The deal brought a13% decline in Aquafresh business, which the loratadine-based allergy medicine Claritin, Claritin, Coppertone, Dr Scholl’sand MiraLAX wasdue in part to supply problems. had also been hit by the restructuring in the under the Merck umbrella. Skin health sales, down by 21% –or13% three months, Merck noted, with brand turnover at constant exchange rates –to£71 million, had down by 11% to US$110 million (see Figure 1). Constant speculation been primarily affected by lower turnoverof Consumer Care generated 3.8% of Merck’s However, from the moment the deal was Bactroban in China. total third-quarter sales, which slipped back finalised, Merck had to deal with questions over On aslightly more positive note, Nutrition by 4% to US$10.6 billion in the period. the future of the OTCbusiness. The company turnoverwas flat as reported at £160 million, The companyblamed the decline in group hadtofend offnumerous enquiries that Con- thanks to sales of Horlicks rising by 8%, with turnoveronaloss of US$425 million in sales sumer Care wasfor sale until it put the busi- particularly strong growth in India. At constant due to divestments, and terminating its phar- ness on the block earlier this year. exchange rates, Nutrition sales advanced by 4%. maceuticals joint venture with AstraZeneca. Formanyyears, Merck had only an indirect Constant-currencyshortfalls in European Bayer has gained Merck’sConsumer Care presence in the market through the Johnson and US sales –5%and 7% respectively –had portfolio, which includes arange of brands – &Johnson/Merck Consumer Pharmaceuticals reflected the supply issues, GSK said, highlight- such as Claritin, Coppertone, Dr Scholl’sand joint venture. The business –which ended in ing the 1% growth in Rest of World markets MiraLAX –across anumber of therapeutic 2011 –had aportfolio of OTCbrands in the (see Figure 2). As reported, turnoverinEurope categories including cold, allergy, sinus and US, including Pepcid heartburn remedies. slipped back by 12%, in the US by 13% and flu, dermatology and gastrointestinal. OTC in Rest of World by 7%. Consumer Healthcare contributed 19% of Business Third-quarter sales Change Proportion GSK’score sales that declined by 10% –3%at (US$ millions) 2013/2014 (%) of total (%) constant exchange rates –to£5.65 billion in the Pharmaceutical 9,134 -4 86 third quarter (see Figure 3). Core sales and op- erating profit exclude amortisation, goodwill, Animal Health 885 +11 8 restricting costs, legalcharges and other items. Claritin OTC110 -11 1 Less than 10% of GSK’score operating Consumer Care 401 -9 4 profit came from Consumer Healthcare after Other 137 -56 1 an 18% drop to £174 million. At constantcur- Total Merck &Co10,557 -4 100 rencyrates, the unit’soperating profit wasflat. OTC Figure1:Merck &Co’s sales in the thirdquarter of 2014 broken down by business (Source –Merck &Co)

7November 2014 OTC bulletin 5 OTC07-11-14p3-12_Layout 1 04/11/2014 16:33 Page 6

OTC COMPANY NEWS

BusinessStrategy/Third-QuarterResults Bayertargets critical mass in Consumer

cquiring Merck &Co’sglobal Consumer Business Third-quarter sales Change EBIT Change ACare business has brought Bayer’sOTC (C millions) 2013/2014 (%) (C millions) 2013/2014 (%) operations closer to achieving “critical mass”, butthe companyintends to keep looking for Pharmaceuticals 3,039 +7.8 699 +9.7 opportunitiestofurther growthe business, ac- Consumer Care1,006 +2.2 –– cording to the firm’schief executive officer Medical Care585 -5.5 –– Marijn Dekkers. Animal Health 330 +2.8 –– Speaking as Bayer announced a2.2% rise Consumer Health 1,921 -0.2 338 -8.9 in third-quarter sales at its Consumer Care unit (see Figure 1), Dekkers said that with further Total Bayer HealthCare4,960 +4.6 1,091 +11.6

consolidation in the OTCindustry likely to Figure1:Breakdown of Bayer HealthCare’s sales and earnings beforeinterest and tax (EBIT) in the third come, Bayer would keep akeen eyeondev- quarter of 2014 (Source –Bayer) elopments to see if it wanted to play apart. Consumer Care was“an important part of ober (OTC bulletin, 10October 2014, page 1), increased by 2.2% –orby5.7% when ad- the business and very strategic” for Bayer,Dek- making it the second-biggest OTCplayer in justed for currencyand portfolio effects –to kers insisted, noting that “critical mass in con- theworld, jumping ahead of Johnson &John- C1.01 billion in the third quarter, with all but sumer healthcare” was“important” as success son and falling just short of the upcoming twoofthe business’ six biggest-selling brands in the market depended on “howmanyprod- GlaxoSmithKline and Novartis joint venture reporting arise in turnover. ucts you can offer clients”. (OTC bulletin, 25April 2014, page 1), which Consumer Care’sbest performer wasthe Gaining this critical mass wasone of the will come into effect next year. Aleve range of pain relievers, with sales grow- reasons behind Bayer paying US$14.2 billion At the time of closing, Dekkers said Bayer ing by 15.2% to C91 million (see Figure 2). The (C11.3 billion) for US-based Merck’sOTC, foot- would continue to growConsumer Care both rise had been drivenbythe launch of Aleve care and sun-care business, Dekkers pointed out. organically and with bolt-on acquisitions. PM in the US, Bayer noted, which had taken Bayercompleted the Merck deal on 1Oct- Meanwhile, worldwide Consumer Care sales the brand into the night-time pain- relief arena (OTC bulletin, 10October 2014, Brand (business unit) Third-quarter sales Change 2013/2014 (%) page 20). Adjusted for currencyeffects, turn- (C millions) C CER* overimprovedby14.2%. Contour (Medical Care) 167 -5.1 -4.7 Sales of Consumer Care’sbiggest brand – Aspirin –increased by 3.4% –6.5% when ad- Aspirin** 122 +3.4 +6.5 justed for currencyeffects –to C122 million Advantage (Animal Health) 120 +1.7 +1.1 in the quarter.The brand had been bolstered Aleve/naproxen 91 +15.2 +14.2 by the launch in Germanyand Italy of anew Bepanthen/Bepanthol84+6.3 +11.7 500mg-size tablet, Bayer noted. Ultravist (Medical Care) 73 -5.2 -2.4 Total Aspirin sales –including Aspirin Car- Canesten 67 +4.7 +8.0 dio, which is part of the Pharmaceuticals divi- Gadovist (Medical Care) 58 +13.7 +12.2 sion–were up 6.0% to C246 million. One-A-Day 39 -11.4 -10.7 Thanks to “considerably higher sales, partic- Supradyn 35 -10.3 -0.7 ularly in emerging markets”, Consumer Care’s Top-10 total 856 +1.3 +3.1 Bepanthen/Bepanthol skin-care line reported turnoverupby6.3% to C84 million. When ad- Consumer Health total 1,921 -0.2 +2.4 justed for currencyeffects, the gain wasan *CER is constant exchange rates ** Total Aspirin sales –including Aspirin Cardio, which is part of the Pharmaceuticals division –were C246 million even stronger 11.7%. Canesten had also performedpositively in Figure2:Sales of the top-10 best-selling brands in Bayer’s Consumer Health division in the thirdquarter of all regions, Bayer noted, with sales rising by 2014. Brands arepartofthe Consumer Carebusiness unit unless stated (Source –Bayer) 4.7% to C67 million. When adjusted for cur- Region Third-quarter sales Change 2013/2014 (%) rencyeffects, the antifungal brand’sturnover ( millions) C CER* had improvedby8.0%. By contrast, Consumer Care’stwo best-sell- Europe 732 ±0.0 +1.2 ing vitamin, mineral and supplement brands North America 592 -4.1 -3.7 (VMS) –Supradyn and One-A-Day –both had Asia/Pacific 300 +6.8 +7.1 adisappointing quarter. /Africa/Middle East 297 +1.0 +11.6 Turnoverfrom the Supradynbrand had fallen Consumer Health total 1,921 -0.2 +2.4 by 10.3% –0.7% when adjusted for currencyef- fects –to C35 million, Bayer said, while sales *CER is constant exchange rates of One-A-Day had been hit by “lower volumes Figure3:Breakdown of Bayer Consumer Health’s sales in the thirdquarter of 2014 by region (Source –Bayer) in the US” and dropped by 11.4%, or by 10.7%

6 OTC bulletin 7November 2014 OTC07-11-14p3-12_Layout 1 04/11/2014 16:33 Page 7

COMPANY NEWS OTC

Third-QuarterResults Nasacort drives sales forwardatSanofi

aunching Nasacort Allergy 24HR in the If aswitch wasgiven the go-ahead, Sanofi transfer had added C64 million to the Consum- LUS at the beginning of February helped anticipated marketing Cialis OTCafter the “ex- er Healthcare sales total. Without it, the divi- to drive up Sanofi’sConsumer Healthcare sales piration of certain patents”, the firm noted. sionwould have reported a4.0% constant cur- in the third quarter by 12.9% to C819 million at Total Nasacort OTCsales in the third quar- rencygain. constant exchange rates. ter were C23 million, putting the brand into On aregional basis, more than half of Con- Nasacort Allergy 24HR (triamcinolone ace- seventh place in Sanofi’sroster of Consumer sumer Healthcare’ssales were generated in tonide) had generated C18 million in US sales Healthcare brands (see Figure 1). Emerging Markets, where turnoveradvanced in the three months, the French companypoint- The fexofenadine-based brand Allegra was by 26.2% in constant currencies to C452 ed out, following the prescription-to-OTC switch thebest-selling of Sanofi’sestablished brands, million (see Figure 2). of the product last year. with sales up by 31.7% to C78 million at con- In the US, sales of Nasacort helped to lift The switch of the inhaled corticosteroid was stant exchange rates. turnoverinthe region by 3.3% to C158 million. approvedbythe US Food and Drug Adminis- The company’snine top-selling Consumer Sales in Western Europe remained flat at tration (FDA) in October 2013 to treat “sea- Healthcare brands had total sales of C372 mil- C157 million, while turnoverinthe Rest of sonal and year-round nasal allergies in adults lion in the third quarter, just under half of the World region dropped by 11.9% to C52 million. and children twoyears of age or older” (OTC division’stotal. Consumer Healthcareaccounted for 9.3% bulletin, 25October 2013, page 1). Sanofipointed out that its sales in the three of Sanofi’stotal third-quarter sales, which in- Sanofiposted its third-quarter results just a months had also been boosted by the transfer creased by 5.1% at constant exchange rates to day before the firm announced it had fired chief of products “previously reported in prescription C8.78 billion. executive officer,Chris Viehbacher, after afall pharmaceuticals” in the prior-year period. This OTC out with the board of directors(see front page). Viehbacher had led Sanofifor oversix years. Business Third-quarter sales Change (%) Proportion Following the successful switch of Nasacort (C millions) CER* of sales (%) in the US, Sanofinoted it wasnow gearing up Allegra78+31.7 >1 for the potential switch of Eli Lilly’serectile Doliprane 74 +4.2 >1 dysfunction drug Cialis (tadalafil). Essentiale 53 +46.2 >1 Sanofiacquired in May the rights to switch Enterogermina 48 +53.1 >1 theproduct in Europe, Japan and the US (OTC No Spa 31 +6.3 >1 bulletin, 30May 2014, page 1). Lactacyd 24 -3.7 >1 Commenting on the potential switch recent- Nasacort 23 –>1 ly,Viehbacher said Sanofibelievedthere was Maalox 23 +9.5 >1 an exciting opportunity to open up anew OTC Dorflex18-25.0 >1 category and to drive further strong growth Other Consumer Healthcarebrands 447 +4.1 5 at its OTCfranchise (OTC bulletin, 15Aug- Consumer Healthcare819 +12.9 9 ust 2014, page 2). Diabetes 1,799 +8.3 20 649 +24.6 7 Generics 451 +8.3 5 when currency-adjusted, to C39 million. Oncology/Other Pharmaceutical 3,097 –35 The Consumer Care business accounted for Pharmaceuticals 6,815 +3.4 78 52% of third-quarter turnoveratBayer’sCon- sumer Health division, which dropped by 0.2% Vaccines 1,451 +11.2 17 to C1.92 billion. Sales edged up by 2.4% when Animal Health 515 +12.7 6 adjusted for currencyand portfolio effects. Total Sanofi8,781 +5.1 100 Bayer’stop-10 Consumer Health brands *CER is constant exchange rates formed 45% of total divisional sales, up by 1% from the same period ayear earlier. Figure1:Sanofi’s sales in the thirdquarter of 2014 broken down by business (Source –Sanofi) Europe remained Consumer Health’sbiggest Region Third-quarter sales Change (%) Proportion region in turnoverterms, despite flat sales of (C millions) CER* of sales (%) C732 million (see Figure 3). When adjusted for currencyeffects, turnoveredged up by 1.2%. Emerging Markets 452 +26.2 55 Sales in the Asia/Pacific region grewquick- US 158 +3.3 19 est, rising by 6.8% –7.1% adjusted for currency Western Europe 157 ±0.0 19 effects –to C300 million. Turnoverinthe region Rest of World 52 -11.9 6 is likely to be boosted going forward following Total Consumer Healthcare819 +12.9 100 Bayer’srecent acquisition of Dihon Pharma- ceutical in China (see page 3). *CER is constant exchange rates OTC Figure2:Sanofi’s Consumer Healthcaresales in the thirdquarter of 2014 by region (Source –Sanofi)

7November 2014 OTC bulletin 7 OTC07-11-14p3-12_Layout 1 05/11/2014 09:10 Page 8

OTC COMPANY NEWS

Mergers&Acquisitions/Second-QuarterResults BusinessStrategy/Third-QuarterResults Reddy’s grows Oriolawants afair price with Habitrol forits Russian operations rReddy’sislooking to widen its OTC Dofferings in the US after agreeing to ac- riola KD is not looking to offload its sian wholesaling business in its 2014 second- quire the title and rights to Novartis’ Habitrol ORussian operations at the first opportunity quarter results. (nicotine) smoking-cessation transdermal patch, andwill only sell the businesses to abuyer will- The charge had resulted from a“revised subject to final US Federal Trade Commis- ingtopay a“reasonable price”, according to business plan” developed by the unit’snew sion (FTC) approval. the company’spresident chief executive offi- management team, the firm said, which had cut The Indian generics specialist announced cer Eero Hautaniemi. forecasted growth rates and profitability. thedeal as it reported group sales up by 7% to Speaking as the firm announced its third- Meanwhile, Hautaniemisaid the “weak dev- INR35.9billion (C466 million) in its second quarter results, Hautaniemi said Oriola wascur- elopment” of the company’sRussian wholesale quarter ended 30 September 2014. Turnover in rently investigating whether its Russian phar- business had hit Oriola’ssales and operating North America increased by 8% to INR14.3 bil- maceutical wholesale and retail businesses could profit in the third quarter. be divested “on reasonable terms and at a reasonableprice”. Sales down by 13.6% “If that cannot be achievedwewill continue Oriola posted sales down by 13.6% to C566 to develop the Russian businesses according to million in the period. Operating profit declined our plans,”hepromised. even faster,falling by 47.2% to C4.6 million. Oriola announced last month it wasconsider- Turnoveratthe Russian businesses –includ- ing divesting its Russian operations as it ex- ing both wholesale and retail –dropped back plored its “strategic options” for the businesses by 27.6% to C176 million. (OTC bulletin,24October 2014, page 5). The problems in Russia had been com- The companyrevealed it had appointed a pounded by lower sales at the firm’sSwedish financial advisor to “investigate the conditions” business, Oriola pointed out, with turnover at Habitrol comes with afreesupport programme in the US to help users quit smoking forselling its Russian operations and had already the unit down by 10.9% to C281 million. “conducted negotiations in the matter”. On amore positive note, sales at Oriola’s lion, representing almost half of sales at the The news came after Oriola reported a C77.2 Finland and Baltics business unit advanced by firm’sGlobal Generics unit, which houses its million impairment charge related to its Rus- 13.1% to C109 million in the three months. OTCinterests.Global Generics’ sales advanced OTC by 9% to INR28.9 billion. TurnoverinIndia rose by 14% to INR4.80 Third-QuarterResults billion, while “strong growth” in Venezuela helped almost double the division’ssales in its Boiron cautious over outlook for 2014 Rest of the World region to INR3.55 billion. These gains were partly offset by double- rench homoeopathyspecialist Boiron said Boiron made the statement as it posted sales digit sales falls in Europe, and in Russia and the Fit remained “cautious”regarding its finan- up by 1.5% –3.3% at constant-currencyrates – Commonwealth of Independent States (CIS). cial performance for the year ending 31 Decem- to C172 million in the third quarter of 2014. OTC ber 2014, “giventhe uncertainty of seasonal The majority of the company’sturnover illnesses” in the second half of the year. came from its portfolio of OTCSpecialties. Sales of these products movedforward IN BRIEF Business Third-quarter Change by 3.4% to C99.0 million in the three months ■ PODRAVKA said sales from its portfolio sales (C millions) (%) (see Figure 1). By contrast, turnoverfrom Boiron’snon- of non-prescription brands had improved by France 92.5 -0.1 4.5% in the opening nine months of 2014, as proprietary homoeopathic medicines slipped Europe* 62.8 +2.5 the companycontinued to expand its OTCoffer- back by 0.9% to C73.0 million. North America 13.1 +7.9 ing in anumber of markets. Non-prescription Turning to the company’sgeographic per- Other countries 3.8 +8.6 sales had movedahead to HRK63 million formance, international sales improvedby3.6% International 79.6 +3.6 (C8.21 million) in the period, the Croatian com- to C79.6 million. panypointed out, thanks to “stable growth in Total Boiron 172.1 +1.5 TurnoverinNorth America movedfor- all markets”. Over the nine months, the firm OTCSpecialties 99.0 +3.4 ward by 7.9% to C13.1 million, while sales in had expanded its OTCrange with the Sily- Europe, excluding France, edged up by 2.5% Non-proprietary 73.0 -0.9 marin herbal liverfunction product and the to C62.8 million. Other 0.1 +71.1 Lordiar diarrhoea treatment in Croatia, Pod- Sales in France had slipped back by just ravka noted, and added numerous products *Excluding France 0.1%, Boiron noted, with turnoverdropping to

in other markets. Figure1:Breakdown of Boiron’s sales in the third C92.5 million in the three months. OTC quarter of 2014 (Source –Boiron) OTC

8 OTC bulletin 7November 2014 OTC07-11-14p3-12_Layout 1 04/11/2014 16:33 Page 9

COMPANY NEWS OTC

Nine-MonthResults BioGaia reports adouble-digit sales rise

ioGaia posted sales up by 60% to SEK360 what by falling sales in Ukraine, BioGaia noted, Rothschild noted BioGaia would look to Bmillion (C39.2 million) in the first nine “due to current instability in the country”. takeadvantage of this trend by expanding the months of 2014, as turnoveratits dominant Pae- Turning to its Adult Health business, the geographic distribution of its products. The com- diatrics unit advanced at adouble-digit rate. firm reported turnoveratthe unit down by 10% panywas currently in the “launch process” in Higher Paediatrics sales offset falling turnover to SEK46.4 million in the nine months. anumber of markets worldwide, he noted. at BioGaia’ssmaller Adult Health business. Lower sales of digestive-health tablets in both As part of the company’sexpansion strat- In October last year,BioGaia announced it Finland and Italy had been responsible for the egy, BioGaia signed in June adistribution deal would from 2014 restructure its business into decline, the companysaid. In Finland, BioGaia’s with Swiss firm Pharma Base to takeits pro- aPaediatrics unit and an Adult Health unit. The distribution partner continued to face “aggres- biotic drops into India (OTC bulletin, 27June neworganisation replaces BioGaia’sprevious sive price competition”, the firm explained. 2014, page 3). structure, which divided the business into - On amore positive note, BioGaia said sales The deal will see Pharma Base cooperate ed consumer products and component products. of its oral-health tablets had increased, with the with alocal Indian distributor to market and sell BioGaia said it had made the changes in gain primarily attributed to abetter perform- BioGaia’sProTectis baby drops in the Indian order to maintain its “growth momentum” and ance in Japan. state of Maharashtra, including Mumbai. “retain short decision-making paths and entre- The drops will be sold under BioGaia’sown preneurialspirit in the company”. Growth in global probiotics market brand, with the launch scheduled for 2015. The Paediatrics unit includes products such Looking ahead, Peter Rothschild, BioGaia’s Meanwhile, Nestle Nutrition UK has been as ProTectis baby drops and ProTectis Junior chief executive officer, said the growth of the granted the exclusive rights to sell, in the UK digestive-health tablets, while the Adult Health global market for probiotic supplements gave and Ireland, BioGaia’sProTectis baby drops and unit covers brands includingGastrus probiotic the company“good reason for optimism”. ProTectis baby drops with vitamin D. BioGaia tablets and ProDentis lozenges. “The probiotics supplement market is grow- said the launch in both markets wasplanned Meanwhile, BioGaia said aSEK95.4 million ingby8-10% annually, which provides asolid for the start of 2015. payment relatedtothe company’smost recent ground for continued growth,”hepointed out. OTC deal with Nestlé had helped to drive up sales at the Paediatrics unit by 80% to SEK311 mil- lion in the nine months. Signed in March, the agreement will see BioGaia carry out clinical studies and develop newproducts for the Swiss food and drinks giant (OTC bulletin, 28March 2014, page 8). Growth had also been boosted by improved sales of probiotic drops in Brazil, Germany and Mexico, BioGaia said. Sales of digestive-health tablets had also movedforward, the companypointed out, pri- marily in Brazil and the US. However, growth had been held back some-

IN BRIEF ■ AB-BIOTICS –aSpanish biotechnology company–has signed up Sanofitodistribute in Spain its probiotic supplement forchild- ren under the Sanogermina brand name. The French firm would launch the product be- fore the end of 2014, AB-Biotics pointed out, adding that Spain would be the first market in the world where the product would be avail- able. The product had been specially formu- lated to treat gastrointestinal problems in child- ren, the companynoted, claiming that 14 days’ use would reduce daily crying time by 67.5%. AB-Biotics said it planned to roll out the prod- uct in other markets in the near future. OTC

7November 2014 OTC bulletin 9 Think Inside The Box

Carryout research in hours rather than days or weeks

OTC Innovations

and product innovations

OTC Deals Database OTCToolbox search for Meda on 15th September 2014

This searchable database provides you with awealth of information about deals and individual OTC companies

News, News Extras, Briefings and Reports

Visit www.OTCToolbox.com

A4eaet-201014.indd2 2/10/2014 13:24 OTC07-11-14p3-12_Layout 1 04/11/2014 16:33 Page 11

COMPANY NEWS OTC

Nine-MonthResults Celesio puts faith in new leadershipteam

elesio’snew leadership team will chart the Business Nine-month sales Change EBITDAChange Cright course for the company, identify areas (C millions) 2013/2014 (%) (C millions) 2013/2014 (%) of potential and aid asuccessful integration PharmacySolutions 13,755 +2.1 241 -11.5 into US pharmaceutical wholesaler McKesson, according to the pan-Europeanwholesaler and Consumer Solutions 2,706 +7.6 212 +12.4 retailer’snew chairman of the management Other ––-83 – board Marc Owen. Total Celesio 16,460+2.9 370 -7.5 The companyhad already begun integrating itself into the Distribution Solutions division Figure1:Celesio’s sales and earnings beforeinterest, tax, depreciation and amortisation (EBITDA) in the first nine months of 2014, broken down by business (Source –Celesio) of McKesson, Owen said, after McKesson in February acquired over75% of Celesio’sshares Consumer Solutions division increasedby (OTC bulletin, 18December 2012, page 1). following aprotracted takeoverprocess (OTC 7.6% to C2.71 billion (see Figure 1), as the com- The aim of the concept, Celesio said, wasto bulletin,7February 2014, page 1). panycontinued to roll out its European Phar- develop a“competitive pan-European pharmacy “Future development of the companywill macyNetwork concept. network” that unified the company’sown phar- nowhinge on howquickly the international plat- In March, Helmes revealed that the pilot macies and its partner pharmaciesto“offer form can be set up,”hewarned, “so the coordi- phase of the European PharmacyNetwork, comprehensive patient services”. nation team will thereforebetasked with iden- under the ‘Lloyds’ banner, had “provedasuc- In the UK, the Lloydspharmacychain – tifying areas of potential, preparing solutions cess” and would be expanded further in 2014 which accounts for the bulk of Consumer and then effecting agradual alignment with (OTC bulletin, 28March 2014, page 5). Solutions’ turnover–had performed “very well” McKesson’sorganisation structure.” The firm has nowstarted rolling out the key in the nine months, Celesio pointed out, with The combined McKesson/Celesio entity will elements of the concept in the rest of its 2,175 an increase in revenues from services to hos- have annual sales in excess of US$150 billion pharmacies, and has also started to invite part- pitals and the provision of homecare. These in- (C110 billion), approximately 81,500 employees ner pharmaciesinFrance and Germanytoadopt creases had offset the negative effect of gov- worldwide and operationsin20countries. the concept in line with national regulations. ernment price cuts. Owen took overaschairman of Celesio’s Focused on offering “newand comprehen- Across the rest of Europe, sales at the firm’s management board on 16 July, after McKesson sive advisory and other healthcare services”, Norwegian pharmacychain –its second-biggest made sweeping changes to the management the concept –which has already been intro- after the UK –had advanced significantly in team (OTC bulletin, 30May 2014, page 27). duced to over100 stores –had helped “streng- local currencies, Celesio noted, thanks to better Formerly presidentofMcKesson Specialty then the role” of pharmacists as both “competent sales of OTCproducts and services, combined Health, Owen wasdrafted in to replace Dr healthcareadvisors” and as service providers with newstore openings and acquisitions. Marion Helmes as head of Celesio. Helmes for national healthcare systems, the firm said. In Italy, the company’sretail business had –who had held the joint positions of speaker Launched in late 2012, the newEurope- benefitted from better sales of OTCproducts, of the management board and chief financial wide Lloyds concept featured “innovative ser- Celesio said, thanks to implementing the Euro- officer –has nowleft the firm. vice formats, high-quality products and the pean PharmacyNetwork concept. This had Another McKesson executive,Alain Vach- latest technologies”, the companyexplained, completely offset the impact of lower prescrip- on, has taken overHelmes’ role of chief finan- and had been based on “comprehensive”mar- tion sales caused by government cutbacks, the cial officer. ketstudies, best practice at its existing phar- firm added. Meanwhile, nine-month sales at Celesio’s macies, and completelynew developments Celesio’sgrowth strategy for its Swedish pharmaciescontinued to be drivenforward, the firm pointed out. But althoughhigher sales and Mergers&Acquisitions better cost management had improvedmargins, earnings still remained lower than expected. Fleet sells stake to private-equity firm Consumer Solutions’ earnings before interest, tax, depreciation and amortisation (EBITDA) rivate-equity firm Gryphon Investors has would remain in place, Gryphon noted, along had “increased sharply”, advancing by 12.4% Psnapped up amajority stakeinfamily- with the rest of Fleet’smanagement team. to C212 million in the nine months, Celesio owned personal healthcare and OTCcompany “Fleet is atrue platform that provides an noted. Adjusted for special effects, EBITDA Fleet Laboratories for an undisclosed sum. excellent opportunity from which to make movedforward by 12.1%. Under the terms of the deal, Fleet’sUSman- numerous add-on acquisitions in desirable cat- The Consumer Solutions unit accounted for agement team and several additional investors egories,”the companyrevealed. 16% of Celesio’ssales in the nine months, which will hold minority stakes in Gryphon. Fleet offers arange of personal-healthcare and crept up by 2.9% to C16.5 billion. EBITDA Furthermore, Steve LaMonte, an advisor to OTCbrands, including Boudreaux’s, Fleet, Nor- slipped back by 7.5% to C370 million. Gryphon and former senior executive at John- forms, Pedia-Lax, Phazyme and Summer’sEve. Celesio’sdominant PharmacySolutions son&Johnson, Pfizer and Schering-Plough, The firm has apresence across North Amer- wholesale division posted a2.1% rise in sales will become chairman of Fleet’sboard. ica, Asia-Pacific and Latin America. to C13.8 billion in the period. JeffRowan, Fleet’schief executive officer, OTC OTC

7November 2014 OTC bulletin 11 OTC07-11-14p3-12_Layout 1 04/11/2014 16:33 Page 12

OTC COMPANY NEWS

Switches/Third-QuarterResults Pfizer expects Lipitor trial results in 2015

fizer expects to announce in 2015 the re- Business Third-quarter sales Change Proportion Psults of its Lipitor actual-use trial, as the (US$millions) 2013/2014 (%) of sales(%) companypresses ahead with plans to switch the cholesterol-lowering drug from prescription Global Established Pharmaceutical 6,239 -7 51 to non-prescription status in the US, aspokes- Global Innovative Pharmaceutical 3,490 -4 28 person for the firm told OTC bulletin. Global Vaccines 1,140 +19 9 The Lipitor (atorvastatin) trial wascur- ConsumerHealthcare 821 +4 7 rently “ongoing”, the spokesperson said, with Global Oncology 551 +16 4 completion of the final stages of the actual-use Global Vaccines, Oncology and 2,511 +13 20 study “anticipated in December 2014”. Results ConsumerHealthcare from the trial –expected in 2015 –would “in- Other 120 – 1 form the next steps,”the spokesperson added. Total Pfizer 12,361 -2 100 Pfizer had a“robust study programme in place” for Lipitor, the spokesperson pointed Figure 1:Pfizer’ssales in thethirdquarter of 2014 broken down by business (Source –Pfizer) out, and the companywas “committed to ad- vancing the delivery of care for those who are Vaccines, Oncology and Consumer Healthcare. Launching Nexium 24HR in the US help- able to self-manage”. At the time of the restructure, Pfizer said ed to lift Consumer Healthcare’ssales in the “Webelieve an OTCstatin may provide im- themove wasthe best wayfor the companyto country by 4% to US$413 million. provedaccess to treatment, generate significant “focus and maximise” the different parts of Growth in the US had been held back by economic savings to the healthcare system and thegroup, as each segment operated adifferent lower sales of Advil, Pfizer noted. The company engage people in their cardiovascular health- business model (OTC bulletin,8November blamed the drop in turnoveronthe launch in care who would otherwise not be engaged,”the 2013, page 10). the prior-year period of anew Advil line of film- spokesperson insisted. Read made his comments as Pfizer reported coated tablets, which had “triggered increased Pfizer announced in 2011 its intentions to third-quarter Consumer Healthcare sales up retailer purchases” in the third-quarter of 2013. switch Lipitor from prescription-only to OTC by 4% to US$821 million (C658 million). International turnoverhad movedforward status “at some point” (OTC bulletin, 16Nov- Pfizer said that the single-digit growth re- by 4% to US$408 million, Pfizer pointed out, ember 2011, page 7). corded by the division had been primarily due due to the “growth of vitamin supplement prod- Astatin has neverbeen granted OTCsta- to the launch in the US in May of the esome- ucts in emerging markets”. tus in the US before and it is nowmore than prazole-based proton-pump inhibitor Nexium Consumer Healthcareaccounted for 33% adecade since Bristol-Myers Squibb and 24HR (OTC bulletin, 30May 2014, page 1). of Pfizer’sGlobal Vaccines, Oncology and Con- Merck &Coattempted to switch Pravachol Indicated for the treatment of frequent heart- sumer Healthcare unit’ssales, which increased (pravastatin) and Mevacor (lovastatin) respec- burn, Nexium 24HR (20mg esomeprazole) had by 13% to US$2.51 billion (see Figure 1). With tively (OTC bulletin, 30June 2000, page 16). been approvedfor OTCuse by the US Food both Pfizer’sGlobal Established Pharmaceu- Meanwhile, Pfizer may spin offits Global and Drug Administration (FDA) in March. The tical and Global Innovative Pharmaceutical Established Pharmaceutical business from its companypaid AstraZeneca an initial US$250 units losing ground, Pfizer’stotal group sales two“innovation segments” –which include million for the global rights to non-prescription slipped back by 2% to US$12.4 billion. itsConsumer Healthcare unit –ifthe company versions of Nexium in 2012 (OTC bulletin, OTC decides that the “sum of the parts is greater 14 September 2012, page 1). than the whole”, according to chief executive Speaking at the time of the launch, Paul First-QuarterResults officer Ian Read. Sturman, president of Pfizer Consumer Health- Speaking as the US-based firm announced care, said the OTCavailability of Nexium P&G posts positive its third-quarter results, Read said Pfizerwould 24HR in its domestic market marked the “first in 2015 “maintain asignificant effort towards step” in the company’sefforts to “build astrong Health Careresults setting up the groundwork required” to facilitate global position in digestive health”. a“potential split”. Pfizer recently launched Nexium OTCin rocter &Gamble noted that sales at its Per- Adecision on whether the split would occur Germanyunder the Nexium Control brand Psonal Health Care business –which includes had “not yet been taken”, Read insisted. name (OTC bulletin, 15August 2014, page its OTCoperations –had improvedinthe three “What we do will depend upon howour 19), and is preparing to roll out the product months ended 30 September 2014. commercial businesses are performing, how across anumber of other markets in the Euro- Turnoveratthe PGT Healthcare joint ven- our shareholders value these businesses and if pean Union (EU). ture with Teva, however, had fallen back by the sum of the parts is greater than the whole,” Authorised as anon-prescription medicine 0.5% to US$372 million (C297 million). he explained. in all 28 member states in October last year Sales at Procter &Gamble’sHealth Care Read’scomments came ayear after Pfizer –after becoming the EU’sthird centrally- division –including its Oral Care and Personal hadreorganised itself into three separate seg- switched medicine –Nexium Control is for the Health Care businesses –edged up by 6% to ments: Global Established Pharmaceutical, short-term treatment in adults of reflux symp- US$2.01 billion in the period. Global Innovative Pharmaceutical and Global toms (OTC bulletin, 11October 2013, page 11). OTC

12 OTC bulletin 7November 2014 OTC07-11-14p13-17_Layout 1 04/11/2014 17:09 Page 2

GENERAL NEWS OTC

Market Research Most Germans have used homoeopathy

hree out of five Germans have used ahomo- No answer, Homoeopathyis Prepared in Teopathic remedy at some time, according Not helped 4% not for me, principle to use, Helped, at all, 12% 8% to arepresentative survey of 1,503 people aged 48% Undecided/ 9% no answer, 16 years and above conducted for Germany’s Would 6% medicines manufacturers’ association, the BAH. depend, 14% Noting that the 60% user rate wasseven percentage points higher than the 53% estab- lished in asimilar survey in 2009, the BAH’s director for herbal and homoeopathic medicines, Dr Barbara Steinhoff, commented: “The circle of users has widened considerably.” Not always However, the research –based on oral inter- Have used, helped, 60% views carried out by market researcher Demo- 39% skopie Allensbach in May and June this year – found adistinct gender gap. Nearly three-quar- Figure1:Responses of the 60% of Germans who Figure2:Responses of 1,503 Germans when asked have used homoeopathic medicines when asked whether they had used homoeopathic medicinesand, ters of women had used ahomoeopathic rem- whether such remedies had helped if not, whether they would be prepared to do so edy,compared to just half of men. (Source –BAH/Demoskopie Allensbach) (Source –BAH/Demoskopie Allensbach) Similarly,barely half of people aged 16 to 29 years had taken such aproduct, whereas Identifyingthe ailments theyhad treated all Germans –said theywould be prepared in almost two-thirds had done so in the 45 to 59 with homoeopathic products, 56% of users principle to try aremedy,while just overathird years age group. pointed to colds and flu, while three in 10 had said it “would depend”. Another 15% of non- Looking solely at Western Germany, Demo- used such remediestoboost their immune sys- users were undecided or gave no answer,while skopie Allensbach noted that the proportion of temand prevent illness. three out of 10 –or12% of all Germans –felt homoeopathyusers had more than doubled Almost aquarter of users had employed homoeopathywas “not for me” (see Figure 2). from 24% in 1970 to 64% this year. homoeopathyfor insect bites or sunburn, while On the basis of this finding, Demoskopie Almost all Germans –94% –had heard of more than afifth cited headaches or digestive Allensbach concluded that 28% of Germans homoeopathic medicines,upslightly from 92% complaints. And almost one in five had turned were “potential users” of homoeopathic reme- in 2009. to homoeopathytotreat insomnia,anupset dies who had yet to be convinced. When asked about howtheyhad come to stomach or nervousness. Just overathird of all Germans surveyed use homoeopathy, two-thirds of users said they Presented with alist of statements about –and approaching half of homoeopathyusers – were following recommendations from friends homoeopathic remedies,two-thirds of all Ger- believedhomoeopathic medicines would gain or family members. Just overhalf had been mans agreed that they“hardly have side-effects”. in importance in Germany, and barely anyfelt prescribedorrecommended such products by Half believedtheywere “particularly well tol- theimportance of such remedies would wane. adoctor or healthcarepractitioner. erated”, and nearly half –45% –felt that such Citing 2013 data, the BAH’sSteinhoff said Slightly more than athird –37% –had relied products were “well suited for children”. homoeopathic products accounted for 8% of on the advice of apharmacistorpharmacyassis- Asimilar proportion –43% –said homo- Germany’snon-prescription medicines market, tant, while one in four said theyhad heard or eopathic medicines were easy to use. But nearly implying retail sales of around C482 million. read good things about such treatments. Barely aquarter of Germans maintainedthat such About three-quarters of total turnoverwas afifth admitted to having been influenced by products should only be taken if theywere pre- duetoself- purchases from pharma- media reports, while 16% cited concerns about scribed by adoctor or healthcarepractitioner. cies, and the remainder to prescription sales. side-effects of conventional medicines. Not surprisingly,homoeopathyusers were OTC Thesurvey participants gave amixed picture more positive about such remedies, with more on the effectiveness of homoeopathic remedies. thanthree-quarters saying theyhardly had side- Just under half of those who had taken effects, and nearly two-thirds saying theywere IN BRIEF such products –48% –said theyhad “helped”, well-tolerated. ■ EFSA’s –the European Food Safety Auth- while 39% said theyhad “not always helped”, Profiling typical “convinced users” of homo- ority’s–Scientific Panel on DieteticProducts, and 9% felt theyhad “not helped at all” (see eopathy, Demoskopie Allensbach said they Nutrition and Allergies (NDA) has extended Figure 1). Another 4% were unable to say. would be women aged between 45 and 59 who the use of docosahexaenoic acid (DHA) and “The circle of those who report without livedinthe middle or south of Germany. Such eicosapentaenoic acid (EPA)-rich algal oil restriction positive experiences with homoeo- persons would have high educationalachieve- from schizochytrium sp. marine algae as anovel pathyhas grown markedly overthe past five ment and would be covered by both statutory food ingredient (NFI). It may nowbeincluded years,”remarked Demoskopie Allensbach. and private health insurance. in food supplements up to amaximum DHA In 2009, the market researcher noted, only Taking only 40% of Germans who had never and EPAcontent of 3g per daily dose for the 24% of all Germans had said homoeopathic used homoeopathy, the market researcher asked adult population, excluding pregnant and lac- medicines “helped”. By 2014, that proportion if theywould consider doing so in future. tating women. had risen to 29%. One out of five of the non-users –8%of OTC

7November 2014 OTC bulletin 13 Presented by In association with

Gala Dinner &Awards Presentation Park Lane Hotel, Piccadilly,London, Thursday,5th March2015

Take Centre Stage at the Awards that Really Matter

Sponsored by

2015 Awards Advert-040914.indd 2 04/09/2014 14:13 ENTRY is the deadline for AwardsDEADLINE entries The 5th December 2014 s… The Awards that Really Matter

Get all of your great ideas,hardwork and commercial success in the UK recognised by entering for OTC bulletin ’s OTCMarketing Awards 2015.

Companies of all sizes –fromthe biggest down to the smallest –havethe opportunity to win one of OTC bulletin’s prestigious UK OTCMarketing Awards 2015.

Awards categories coverawide range of disciplines in the OTCindustry, including television advertising, The OTC Marketing Awards 2015: trade advertising, pharmacy training, public relations initiatives, sponsorship,packaging design and ◆ OTC Company of the Year Sponsored by IMS Health Consumer Health and IRI digital &social media. ◆ OTC Brand of the Year Newthis year is acelebratoryOTC Lifetime ◆ OTC Launch of the Year Achievement Award, marking the first 20 years of the ◆ OTC Brand Revitalisation of the Year OTCMarketing Awards. This Awardwill be presented ◆ Most Innovative New OTC Product to the brand that has made the greatest contribution to OTCexcellence by winning the most OTCMarketing ◆ Best OTC Marketing Campaign on aBig Budget Sponsored by Skills in Healthcare Awards since they began in 1995. ◆ Best OTC Marketing Campaign on aSmall Budget It’s nowtime to startpreparing your entries. Ourentry ◆ Best OTC Consumer Advertising on Television deadline of 5th December 2014 probably seems a ◆ Best OTC Consumer Advertising in the Press or Out-of-Home long way ahead, but youneed to startthinking about ◆ Best OTC Campaign in Digital &Social Media turning your latest campaign into aprestigious ◆ Best OTC Public Relations Campaign for aMedicine Awardwinner.Thewinners will be announced at a Sponsored by Sound Creative Gala Dinner &Awards Presentation on Thursday, ◆ Best OTC Public Relations Campaign for aNon-Medicine 5th March2015 at London’s Park Lane Hotel. ◆ Best OTC Sponsorship Campaign Also presented on the night will be the Awardfor ◆ Best New OTC Packaging Design Best OTCMultiple Retailer of the Year. ◆ Best OTC Trade &Professional Advertising ◆ Best OTC Pharmacy Training &SupportPackage Visit the Awards website at Sponsored by IMS Health Consumer Health www.OTC-bulletin.com/Awards ◆ Best OTC Pharmacy Salesforce to find out more ◆ Best OTC Performer Outside Pharmacy Sponsored by IRI

◆ Best OTC Multiple Retailer of the Year Sponsored by GlaxoSmithKline Consumer Healthcare

◆ OTC Lifetime Achievement Award NEW Sponsored by Spink

OTC bulletin is pleased to announce that IMS Health Consumer Health and IRI will once again be jointly co-hosting the OTCMarketing Awards 2015.

2015 Awards Advert-040914.indd 3 04/09/2014 14:14 OTC07-11-14p13-17_Layout 1 04/11/2014 17:09 Page 3

OTC GENERAL NEWS

Market Research Regulatory Af fairs Germansreject Health Canada approves OTC guidance Aspirin heart-attack claim ore than two-fifths of German commu- Mnity pharmacists say at least one in five ayer is nowable to highlight better to of their customers to whom theyrecommend BCanadian consumers the benefits of using an OTCremedy do not buythat product in its Aspirin OTCanalgesic during aheart attack, store, according to research conducted by IFH after the country’sregulator Health Canada ap- Institut für Handelsforschung.And another provedastronger health claim for the product. 45.3% of pharmacists said the same of around The companyisnow able to claim for its one in 10 customers. Aspirin Quick Chews 81mg and Aspirin Reg- Three-fifths of the 277 pharmacists surveyed ular Strength 325mg: “Aspirin may help save said the proportion on customers who were not your life if you think you are having aheart at- Bayer Canada has gained astronger claim for its acting on OTCpurchasing recommendations tack”. The claim would be printed on the patient Aspirin Quick Chews containing 81mg of aspirin wasincreasing. information leaflet for both products, Bayer said. of the use of acetylsalicylic acid during aheart Askedabout which product categories were The newclaim presented Bayer with an attack, in addition to “proprietary information”. most affected, 57.0% of pharmacists mentioned “opportunity to reach Canadians about apoten- Previously,Bayer wasonly able to state on vitamins and minerals,with three out of 10 citing tial health issue and help them to be prepared”, its patient information leaflet for OTCversions skin-, wound- and nail-care. aspokesperson for the firm told OTC bulletin. of the product that: “Aspirin can help save your Just overthree-quarters of the community “Wewill encourage Canadians to keep Aspirin life in the following situations: to help prevent pharmacists believedthat customers later bought 81mg on hand and to be prepared,”the spokes- afirst heart attack in those who are at increas- the recommended product from amail-order person added. ed risk; or to help prevent asecond heart attack pharmacyretailer. Bayer wasable to get the claim approved, or strokeinthose who have already had such But asimilar proportion of those surveyed the spokesperson revealed, after it submitted an event; or when you suspect you are having were adamant that advice gained via telephone, “a clinical overview” of the existing evidence aheart attack.” online or by email could not replace the service OTC theycould provide in store. OTC Regulatory Af fairs

IN BRIEF HMPC adoptsfinal herbal monograph ■ FDA –the US Food and Drug Administra- he European Medicines Agency’s(EMA’s) excluded by amedical doctor.” tion–is warning consumers that theycould TCommittee on Herbal Medicinal Products It is also indicated for “relief of mild symp- be endangering their health by mixing OTC –HMPC –has adopted afinal European tomsof mental stress and to aid sleep”. or prescription medicines and dietary supple- Union (EU) herbal monograph on hedge mus- Comments on the draft monograph should be ments. The agencypoints out that certainsup- tard –known as sisymbrii officinalis herba –at submitted by 15 January 2015, the HMPC said. plements can change the “absorption, meta- its latest meeting held on 29-30 September. Meanwhile, the committee has decided to bolism or excretion” of amedicine “and there- The final EU herbal monograph on hedge revise the public statements for the use of fore affect its potency”. Forexample, aspirin mustard –used for the symptomatic relief of herbal medicinal products containing estragole and vitamin Ecan each thin the blood, the throat irritation, such as hoarseness and dry as well as products containing pulegone and FDAnotes, so taking both together “may in- cough –was adopted by consensus upon rec- menthofuran, based on newly-available data crease the potential for internal bleeding or ommendation by the Working Party on EU andrecommendations from the Safety Work- stroke”. The FDAisadvising consumers to talk monographsand EU list (MLWP). ing Party.Draft revisions for public consultation to ahealth professional before taking anynew Meanwhile, adraft monographhas been are expected to be adopted this month. supplements simultaneously with OTCorpre- adopted for public consultation on crataegi The HMPC also highlighted afurtherneed scription medicines. herba cum flore –hawthorn leaf and flower – to reviewavailable data on herbal medicinal with the indication: “Torelieve symptoms of products containing polycyclic aromatichydro- ■ CHPA –the US Consumer HealthcareProd- temporary nervous cardiac complaints –pal- carbons (PAH). Areflection paper would be ucts Agency–says it is “encouraged” by re- pitations, perceivedextra heartbeat due to mild developed for release at the beginning of 2015, search indicating that between 2002 and 2012 anxiety –after serious conditions have been the committee pointed out. cough and cold medication errors in children OTC under six years of age “decreased significant- ly”. Published in Pediatrics,the study found We also publish Generics bulletin that overthe 11-year period, the number of medication errors related to OTCcough To find out morevisit and cold products decreased by 66.1%. www.generics-bulletin.com OTC

16 OTC bulletin 7November 2014 OTC07-11-14p13-17_Layout 1 04/11/2014 17:09 Page 4

GENERAL NEWS OTC

Regulatory Af fairs Regulatory Af fairs PASMI defends Australiaset to overhaul access to OTCs TGA medicines regulation onsumers in Poland should not be “de- Cprived” of access to non-prescription medi- ustralia is set to overhaul its system for paper on possible changes to the regulatory cines by limiting the sale of such products only Aregulating medicines and medical devices, framework, inviting comments from interested to pharmacies, according to the Polish Associ- including OTCproducts. parties, will be published “in the near future”. ation of the Self-Medication Industry (PASMI). Announcing a“landmark review” of the The panel will also be “actively consulting” The association has defended access to wayinwhich the country’sTherapeuticGoods with “peak health professional, industry and OTCmedicines through “pharmacyand non- Administration (TGA) currently regulates medi- consumer groups”. pharmacychannels” in Poland in response to cines and medical devices, Australia’sDepart- Peter Dutton, Australia’shealth minister, aproposal by the country’sGeneral Pharma- ment of Health (DoH) says the reviewwill pro- said it wasimportant for the country’smedi- ceutical Council to limit the sale of such prod- vide recommendations for changes to the reg- cinesregulations to keep up to speed with “con- ucts to pharmacies. ulatory frameworks developed for both OTC stantly evolving” medical technology. Aspokesperson for PASMI told OTC bul- and prescription products. letin that the General Pharmaceutical Council Carried out by an expert panel, the review Need amodern framework had submitted aproposal to Poland’sCabinet will identify opportunities to “enhance” the “Weneed amodern regulatory framework to of Ministerscalling for “non-prescription medi- country’sregulatory framework for medicines ensure Australians can access the latest treat- cines and food supplements only to be sold and medical devices, the DoH claims, “so that ments in atimely manner,” he argued. in pharmacies”. Australia continues to be well positioned to Assistant minister for health, Fiona Nash, Responding to the proposal in awritten respond effectively to global trends in the dev- claimed the reviewwould form a“keystep” in letter to Poland’sprime minister,Ewa Kopacz, elopment, manufacture, marketing and regu- efforts to “remove ineffective regulation and PASMI argues that “all citizens should have lation of therapeutic goods”. encourage greater competition and innovation” easy access to non-prescription medicines”. in the medicines and medical devices sectors. “Due to the fact that currently non-pre- Areas can be streamlined “This reviewwill identify ways to assist scription medicines are available both through The panel will also look to uncover“areas medicine and medical device producers and pharmacyand non-pharmacychannels, all con- of unnecessary,duplicative or ineffective reg- suppliers struggling with complexand costly sumers have equal access to medicines that ulation that can be removedorstreamlined”, regulatory pathways, while upholding the safety treat simple yet oppressive symptoms,”the as- without undermining the quality of medicines andefficacyof therapeutic goods available in sociation points out. and medical devices available in Australia, the Australia,”Nash insisted. “If only pharmacies were allowed to sell department points out. Meanwhile, the DoH says it will undertake non-prescription medicines,then 40% of the Noting that the panel –led by Professor aseparate reviewof the regulatory framework population would become deprivedof access Lloyd Sansom of the University of South Aus- forAustralia’s complementary medicines sector to these products. This constitutes 15 million tralia –will provide its recommendations by –covering vitamins, minerals and supplements – people living in rural areas and small towns 31 March 2015, the DoH says adiscussion during the second quarter of 2015. in locations that are deemed unprofitable by OTC pharmacists,”PASMI claims. The association argues that non-prescription Regulatory Af fairs medicines “play avital role” in managing health problems in Poland and constitute an “impor- CHMP wants to get inputfrompatients tant part” of the country’smedicines policy. The promotion of “rational self-medication he European Medicines Agency(EMA) Thepilot project would run for at least one practices” across all European Union (EU) Thas launched apilot project to involve year,the EMA noted, to allowfor a“full assess- countries is supported by the European Parlia- patients in assessments of the benefits and ment of the feasibility of involving patients in ment, PASMI claims, to help develop aposi- risks of medicines made by its Committee for CHMP oral explanations”. tive attitude among citizens towards assuming Medicinal Products for Human Use (CHMP). The project wasinline with the CHMP’s responsibility for their ownhealth. Under the scheme, patients would be invited work programme, the agencypointed out, which OTC to present their views on medicines for which recommendedfurther integrating patients’ views there wasanunmet medical need, the EMA into the benefit/risk assessment and increas- pointed out, and for which the CHMP still had ing stakeholder involvement. IN BRIEF concerns or doubts. Patient representativeswere already involved ■ AAC –the US AcetaminophenAwareness Furthermore, patients could also be invited in benefit/risk evaluations through anumber of Coalition –has launched its annual “Double to give their views on cases where the commit- different routes, the EMA explained, butthe Check; Don’t Double Up”campaign to re- tee is considering whether to recommend the pilot project represented the first time patients mind people not to double up on medicines withdrawal, suspensionorrevocation of amar- would be invited to participate directly in dis- containing acetaminophen (). keting authorisation,orarestriction of the in- cussions held by the CHMP. OTC dication of an authorisedmedicine. OTC

7November 2014 OTC bulletin 17 OTC07-11-14p18-21_Layout 1 04/11/2014 18:37 Page 2

OTC MARKETING NEWS

AdvertisingComplaints ProductLaunches/LineExtensions UK’s ASA bans Ricola offers coldsufferers Pollenna claims arevitalising herbal option oots’ online advertisement for homoeo- Bpathic firm Nelsons’Pollenna hayfevertab- icola claims its newvitamin B-enriched lets made claims beyond the Product Licence RRevitalizing Herb Drops offer US cough of Right (PLR) and must not appear again in and cold sufferers “a naturally effective energy its current form, the UK’sAdvertising Standards boost” to help them “get through their busy Authority (ASA) has ruled. work day,evenwhen they’re not feeling well”. The UK-based retailer stated on its website Said to be the only herbal drops to offer vita- that Nelsons’ Pollenna –containing allium cepa, mins B6 and B12, each lemon-zest-flavoured euphrasia officinalis and sabadilla officinarum supplement drop contains an effervescent, pow- –featured “a selection of homoeopathic reme- der-filled centre. This wasfilled with a“propri- dies, specifically combined to protect from and etary blend” of 10 Swiss herbs as well as gin- bring fast, effective relief for the distressing seng, the Switzerland-based firm pointed out. symptoms of hayfever”. Claiming researchhad highlighted that 84% Ricola’s Revitalizing Herb Drops aresaid to be the only herbal drops on the US market to also offer B-vitamins Although Boots argued that the statements of Americansstill went to work when they were in line with the permitted indication of the were ill or felt unwell, Ricola maintained that on ajet-pack, while the message that “Chrüter- PLR –which provided for claims regarding “the its Revitalizing Herb Drops also provided con- chraft restores”appears on screen. relief of symptoms associated with hayfever sumers with “soothing relief” so that theycould The companyisalso encouraging consum- andsimilar allergies” –the ASA pointed out that get back to feeling like themselves. ers to trial the herbal drops through a‘spin to “protect oneself from the symptoms of hay- Aimed at women aged between 25 and 54 and win’ sweepstakes competition on its US ” would require taking the medicine before years, Ricola Revitalizing Herb Drops will be microsite, getalittleboost.com. hayfeversymptoms presented. marketed throughoutthe cough and cold sea- By playing aslot-machine style game, part- Therefore, the claim that the product would son using the global “Chrüterchraft” theme icipants have the chance to win either an 18- “protect from” hayfeverrelated to preventing launched just overayear ago (OTC bulletin, count bag of the drops –which has arecom- symptoms rather than to relieving them, the 25 October 2013,page 15). mended retail price of US$3.29 (C2.58)–or watchdog noted. As the PLR’spermitted indi- Noting at the time that the literal translation adownloadable voucher offering aUS$0.75 cation related only to the relief of symptoms of Chrüterchraft was“herbal power”, Ricola discount on purchases of the product. and not to prevention, the claim wasnot con- said the word incorporated all of the firm’s The overarching US campaign would also sistent with the authorised wording, it added. values and its Swiss heritage. include television advertising to support the Furthermore, the permitted indication in the A15-second television spot for Ricola Re- “core” Original Natural Herb CoughDrops, PLR did not refer to the wayinwhich the medi- vitalizing Herb Drops shows an office worker Ricola noted,aswell as the Extra-Strength cine could bring relief, the watchdog maintained. coughing at his desk. After puttingadrop in Cough-Suppressant variant. There will also be Boots’ claims that Nelsons’ Pollenna wasfor his mouth, he is shown flying around the office public-relations and digitalactivity. the “natural relief” of the symptoms associated OTC with hayfeverand similar allergies –and that it would “bring relief for the distressing symp- toms of hayfever” –were related to the word- ing in the PLR, the ASA noted, buttheywent beyond the specific wording in the indication. In such instances, it added, advertisers must hold evidence in support of such claims, which Boots had not provided. OTC

Spanish generics specialist Kernsaid it had IN BRIEF reaffirmed its “commitment to the area of self-care” by launching Somnolin, its first food supplement. Pierre Fabrehas extended its Mycoster dermatology ■ PFIZER has launched in Germanysmaller Targeted at consumers suffering from jet lag range in France by launching a10mg/g ciclopirox versions of its ThermaCareheated pain-relief or who have general difficulties sleeping, Somnolin shampoo under the name Mycoster Shampooing. The patches,which the firm says allowfor “flex- delivers 1mg melatonin per menthol-flavoured treatment for seborrhoeic dermatitis –acondition orodispersible sheet. that Pierre Fabresays affects 1%-3% of the French ible” application to areas such as the arms, legs Each pack of Somnolin contains 30 sheets. A population –isavailable in a60ml bottle. and between the shoulder blades. Available recommended dosage is one-to-two sheets per night. Noting that Mycoster Shampooing was “simple and exclusively in pharmacies, the non-medicated Somnolin adds anew categorytoKern’s current quick” to use –itshould be applied on wet hair for three range of non-prescription products. This includes the minutes beforebeing rinsed –Pierre Fabresaid the line extensions are being promoted via tele- Dolostop paracetamol line, Idasal nasal product should be initially used once or twice aweek vision advertising and public-relations activity. spray and Kerngrip flu treatment. for four weeks, depending on the severity of symptoms. OTC OTC OTC

18 OTC bulletin 7November 2014 OTC07-11-14p18-21_Layout 1 04/11/2014 18:37 Page 3

MARKETING NEWS OTC

MarketingCampaigns Online Strepsilscampaign urges Indians to speak up

eckitt Benckiser (RB) aims to highlight Diomed is encouraging UK consumers not to be ‘heroes’ Rhowits sore-throat lozenges give when suffering from aches and pains in the latest young Indian consumers “a healthyvoice” to television spot for its Ibuleve topical-analgesic brand. Created by the Oscar-winning animation studio “speak their mind without anyinhibitions” Aardman, the 30-second commercial –which focuses through its ‘AbMontu Bolega’online campaign. on aRenaissance painting in an artgallery–issaid Fronted by Bollywood actor Saqib Saleem, to highlight how consumers are“quick to moan RB has signed up Bollywood actor Saqib Saleem as the about everyday aches and pains, but slow to do the Ab Montu Bolega campaign –which trans- face of its ‘Ab Montu Bolega’ campaign anything about them”. lates as “speak now, Montu” in Hindi –isrun- The creative shows the painting’s ‘heroes’ dropping ning across the StrepsilsIndia Facebook and five INR2,000 (C26.00) gift vouchers weekly the heavy items they arecarrying as soon as the gallery’s visitors have left, so that they can clutch the Twitter profiles, as well as on the brand’sYou- until 6December.Toenter the competition, con- areas –such as their knees and back –that arecausing Tube channel. An abmontubolega.com micro- sumers must followthe brand’sFacebook and them pain. Rather than taking something to ease their site has also been launched by the company. Twitter profiles and post their opinions on a discomfort, however,they prefer to “fight on”. “Joint, muscle or back pain? Don’t be ahero. Acampaign video shows Saleem playing trending topic, using both the topic’shash tag Ibuleve it,” avoiceover states, while apack shot of the role of Montu, who is forced by his parents, and the campaign hash tag #abmontubolega. Ibuleve Speed Relief Max-Strength Gel –containing friends and colleaguesthroughout his life to Ab Montu Bolega is RB’slatest effort to 10% w/w ibuprofen –appears on screen. This is accompanied by text stating that the product provides keep his opinions to himself. “leverage the digital medium” in India, after the “fast, targeted pain relief”. After taking aStrepsils lozenge, he has the firm launched an online #DotheRex campaign The Ibuleve range also includes an original Ibuleve courage to speak up about the subjects that mat- for its Durexcondom brand earlier this year Gel, aSpeed Relief Gel, Speed Relief Spray and a Maximum-Strength Gel. ter most to him. (OTC bulletin,30May 2014, page 21). OTC As part of the campaign, RB is giving away OTC

7November 2014 OTC bulletin 19 OTC07-11-14p18-21_Layout 1 04/11/2014 18:37 Page 4

OTC MARKETING NEWS

ProductLaunches/LineExtensions German companies offer nasal sprays forwinter everal of Germany’sleading cold-remedy Splayers have introduced nasal sprays in preparation for the winter season. Johnson &Johnson has launched Olynth Ectomed, apharmacy-exclusive medical device “No appointment necessarytotreat cold and flu” is containing Ectoin, anatural hydrofilm, as well the message of Benckiser’s (RB’s) campaign as an isotonic salt-water . encouraging UK consumers to self-treat winter ailments. This combination offered the benefits of Set to runthroughout the cough and cold season, the UK-based consumer-goods giant’s campaign salt-water sprays as well as the decongestant Olynth Ectomed salt-water nasal spray contains features its Lemsip, Nurofen and Strepsils brands. effect of other shorter-term treatments contain- Ectoin, anatural hydrofilm It highlights that antibiotics do not kill the symptoms ing oxymetazoline, the firm said. Olynth Ecto- centration is intended for daily use, such as by of upper-respiratorytract infections –such as colds, cough, flu, runny or blocked nose and sorethroat – med can be used for up to 30 days. allergy sufferers. Aversion for infants and child- and that these can be treated without visiting a To support the launch, Johnson &Johnson ren also contains 0.9% salt. general practitioner (GP). is running television advertising that features Launch trade-press advertising features The firm’s message complemented the “Treat Yourself Better with Pharmacist Advice” initiative run amodelling-clay man created by the UK’sAard- Olympic skiing champion Maria Höfl-Riesch. by UK OTC industrybody,the ProprietaryAssociation man Animations. The commercials are backed Merck Selbstmedikation’sNasivin salt- of Great Britain (PAGB), and community pharmacy up by consumer and trade-press advertising water spray brand nowalso includes a3%- association Pharmacy Voice, RB noted. This encourages sufferers of colds and flu to visit apharmacist before as well as point-of-sale materials. strength version with dexpanthenol and “re- seeking the advice of aGP(OTC bulletin,10October Meanwhile, Procter &Gamble’sWick range freshing menthol”. Apharmacy-exclusive med- 2014, page 13). nowincludes salt-water VapoSpray variants in icaldevice, Nasivin Mentholfrisch is support- RB is spreading the “no appointment necessary” message through educational point-of-sale materials, 100ml bottles. A2.3% salt format is intended ed by advertising in publications such as Bild, as well as pharmacy and grocerytrade-press advertising. forrelieving blocked noses, while a0.9% con- Focus and Stern. OTC OTC

ProductLaunches/LineExtensions Omega introduces Nasodren to Spain

mega Pharma has extended its Labora- Otorios Mejoral respiratory-health umbrella brand in Spain by launching Nasodren nasal spray for treating sinusitis. Positioned as a“revolutionary product for the treatment of sinusitis”, Nasodren –which is also known as Sinuforte in some Eastern Sanofi Consumer Healthcarehas expanded its Nature’s Own vitamins, minerals and supplements European markets such as Russia and Ukraine – (VMS) brand to offer Australians smoothies and contains cyclamen europaeum l. extract as its meal-replacement drinks. active ingredient. Both the Nature’s Own Superfood Smoothie and Nasodren is claimed by Omega to provide “rapid relief Nature’s Own Protein plus Superfood Shake contain It provides “rapid relief of all symptoms” of all symptoms” –including and ingredients such as alfalfa, kelp and spirulina. –including nasal congestion and facial pain – facial pain –within three minutes of application Described as a“supplementaryfood”, the within three minutes of application, Omega dairy-free Nature’s Own Superfood Smoothie is said to offer consumers “phytonutrients, organic whole claims, by reducing the swelling of the mucous Laboratorios Mejoral umbrella brand. grains, multivitamin and mineral complexes and membranes of the nose and paranasal sinuses, The recommended daily dosage is one spray prebiotics”. Meanwhile, the Nature’s Own Protein as well as stimulating mucus secretion. in each nostril twohours before bedtime. The plus Superfood Shake is positioned as a“high-protein meal-replacement” powder that also provides Nasodren’spackaging highlights that the spray should be used for at least sevendays vitamins, fibreand prebiotics when mixed with milk. spray provides “rapid relief of symptoms after and for no more than twoweeks. Available in berry and cocoa flavours, Nature’s the first dose” and that it does not contain Omega markets and distributes Nasodren in Own Superfood Smoothie has arecommended retail price of A$3.49 (C2.43) per 250ml carton. Abox of antibiotics or corticosteroids. Spain for the UK-based Hartington Pharma. five 26g Natures Own Protein plus Superfood Shake Suitable for use by those aged five years The product is also sold under Omega’s Phyto- sachets –available as acocoa or vanilla-flavoured and above,Nasodren adds to the Allergia Dir- sun medicinal aromatherapybrand in Belgium, option –has arecommended retail price of A$12.95. The shake and smoothie join existing tonics and ect microgel treatment for allergic rhinitis and as part of its Bional Medical range in France, powder products in the Nature’s Own Superfood line. the Congestion Naturale sea-water spray,which and under its Prevalin name in Switzerland. OTC are already available under the company’s OTC

20 OTC bulletin 7November 2014 OTC07-11-14p18-21_Layout 1 04/11/2014 18:37 Page 5

MARKETING NEWS OTC

AdvertisingComplaints Vitabiotics’ commercials banned by ASA

itabiotics’ national television spot for its argument that Beckett wasnot ahealth pro- Meanwhile, the firm has also been warned VWellman and Wellwoman supplements fessional as defined by UK law. in aseparate ruling not to include stated or has been banned by the UK’sAdvertising Stan- Beckett had been aformer president of the implied unauthorised health claims in advertis- dards Authority(ASA) for referring to ahealth Royal Pharmaceutical Society (RPS), the ASA ingfor its Menopace menopause supplement. professionaltoemphasise health claims. pointed out. While his pharmacyqualifications Anational print advertisement for Meno- The creative for the twoproducts included hadnot been referred to specifically in the ad- pace had claimed that the product was“formu- avoiceoverstating that each provided “over vertisement, arecommendation from ascientist lated for during and after the menopause” and 20 micro-nutrients and vitamins, including iron, with an expertise in the relevant field would that it was“ideal whether or not you are on which helps reduce tiredness and fatigue”. This be “likely to influence consumers’ purchasing hormone replacement therapy(HRT)”. It also wasfollowed by the claim: “Theywere dev- decisions”, it noted. emphasised that the product was“not HRT”. eloped with pioneering British scientist Pro- Furthermore, the mention of Beckett had Only health claims that appeared on the fessor Arnold Beckett.” followed an authorisedhealth claim for iron, European Union (EU) Register of authorised Responding to the watchdog, Vitabiotics the ASA added, and he had been referred to health claims could be made in advertisements insisted that the reference to Beckett had been as the inventor of the product for which the promoting foods, including food supplements, intended to communicate that the company claims were made. the ASA pointed out. had a“credible scientific pedigree” and to act As this linked him with the featured health Although Vitabiotics insisted that the claims as aquality mark for its products. claim –and the overall impressionofthe ad- were “simply factual statements”, the watchdog Although the firm added that an on-screen vertisement wasthat the product had been rec- noted that consumers might interpretclaims disclaimer had read: “Professor Arnold Beckett ommended by ahealth professional –the dis- referring to HRTtomean that Menopace was is cited as aproduct inventor and former Vitabi- claimer had been insufficient, the watchdog said. apossible alternative to–orsomething that otics chairman, not as ahealth professional,” Vitabiotics must not use the claim: “They could enhance the effects of –HRT. the ASA pointed out that the disclaimer had were developed with pioneering British scien- Overall, the impression of the advertisement not been shown at the same time as the voice- tist Professor Arnold Beckett” –orother health wasthat Menopace could treat or alleviate overclaim wasmade, and so it wasless likely claims that refer to the recommendation of menopausal symptoms, the ASA stated. This to be noticed by viewers. an individual health professional –infuture claim –although implied –was not included The watchdog also rejected Vitabiotics’ advertisements that include health claims. in the EU Register,itpointed out. OTC

mHealth RB launches ‘Junior Notes’ app in Austria

eckitt Benckiser (RB) aims to educate Aus- about the products within the Nurofen portfo- Rtrian parents about the benefits of its Nuro- lio” –which includes Nurofen Rapid capsules fen ibuprofen range –aswell as to “guide them and 200mg ibuprofen tablets –the ‘Junior through the first years of their child’sdevelop- Notes’ app allowed parents to track the dev- ment” –with its ‘Junior Notes’ app. elopment stages and personal milestones of their As well as providing “basic information baby or toddler,the companypointed out. Other features include aselection of sounds and melodies to help children fall asleep, health Eucalyptus oil drops to relieve cold symptoms are tips and apain diary for tracking doctors ap- MerzConsumer Care’s latest offering to German pointments, immunisations and medication. consumers under its Tetesept umbrella brand. Containing 100% pureeucalyptus oil, Tetesept The app also highlights that ibuprofen is the Eukalyptusöl Tropfen Nase &Kopf –“Nose &Head” – “number one” ingredient for pain and fever. is said to help “loosen tight mucus, relieve nasal and Available for download on Apple and And- respiratorypassages and relieve the uncomfortable feeling of pressureinthe head”. roidsmartphones and tablets, the ‘Junior Notes’ The oil’s packaging states that the product –which apphad been adapted for the Austrian market is claimed to have an antibacterial and anti-inflammatory from the German ‘Nurofen Mein Kind’ (‘My effect –can be used in three ways. It could be ingested when mixed into aglass of warmwater or dropped on Child’) app, RB noted. This had been down- asugar cube, inhaled through steam when combined loaded approximately 35,000 times since its with hot water,orapplied externally,Merzsaid. launch in 2012, the firm added. Suitable for use by those aged over two years, the drops complement the Tetesept Eucalyptusöl Kapseln While the ‘Junior Notes’ app wascurrently Nase &Kopf capsules –containing 200mg eucalyptus being promoted through flyers and point-of-sale oil per –launched late last year. materials in pharmacies, RB revealed that dig- A10ml bottle of Eukalyptusöl Tropfen Nase &Kopf Reckitt Benckiser’s ‘Junior Notes’ app provides has arecommended retail price of C3.49. information about ibuprofen as well as allowing ital advertising wasplanned for 2015. OTC parents to track their child’s development OTC

7November 2014 OTC bulletin 21 Project3_Layout 130/10/2014 14:50 Page 1

presents mHealth: Driving wellness in a connected world Le Méridien Hotel, London, UK 27th November 2014

Join OTC bulletin at this one-day event and discover how the mHealth revolution is driving the global wellness agenda. ● Find out how you can use mHealth technologies to influence the way consumers manage their health. ● Find out what Omega Pharma, Reckitt Benckiser and Sanofi are doing to exploit the potential of mHealth in the consumer healthcare space. OTC bulletin’s mHealth conference will open up for you a whole new world of possibilities for better communicating with consumers and building your consumer healthcare brands.

It’snot too late to attend and experience the powerofmHealth Call Natalie Cornwell on +44 1564 777 550, email [email protected], or visit www.otc-bulletin.com/conference. OTC07-11-14p23Events_Layout 1 04/11/2014 15:59 Page 2

EVENTS OTC

27 November NOVEMBER 13-14 November ■ mHealth: Driving ■ 9th Ceuta Healthcare 18 November wellness in a International Alliance Conference ■ Meeting the Challenges connected world Berlin,Germany of Preparing Quality London, UK This two-day meeting will bring together manufacturers, outsource sales Dossiers for Join OTC bulletin at this one-day and marketing service providers (distributors) and industry opinion lead- Herbal Medicines event and discoverhow to join ers in health and beauty from over100 markets worldwide. London, UK the mHealth revolution and drive Contact:Ceuta Healthcare. Speakers from the UK Medicines the global wellness agenda. Tel: +44 1202 449 709. Email: [email protected]. and Healthcare products Regu- Contact: OTC bulletin. Website: www.ceutaalliance.com/2014_conference_berlin.html. latory Agency(MHRA) will attend Tel: +44 1564 777 550. this one-day workshop. Fax: +44 1564 777 524. Fax: +44 20 7537 2003. Contact:HFMA. Email: [email protected]. MARCH Email: [email protected]. Tel: +44 208 481 7100. Website: www.otc-bulletin.com/ Website: www.topra.org/mscmod1. 2-5March Fax: +44 208 481 7101. conference. OTC Pharma Asia 2015 Email: [email protected]. 9-12 December ■ Singapore Website:www.hfma.co.uk/events.asp. DECEMBER ■ Good Distribution IBC Asia claims this four-day Practice and 18 November 1-3December event is the only regional OTCand ■ Pharmacovigilance Good Manufacturing ■ ASMI Annual health supplement marketing con- London, UK Practice Conference ference in Asia. Drug safety monitoring in the London, UK Sydney,Australia Contact:IBC Asia. European Union (EU), Japan and Day one of this two-day meeting – ‘Self-Care: Abrighter and health- Tel: +65 6508 2401. the US will be discussed at this organised by the UK Medicines ierfuture’ is the theme of this Fax: +65 6508 2407. three-day training course. and Healthcare products Regula- one-day conference organised by Email: [email protected]. Contact:Management Forum. tory Agency(MHRA) –will focus the Australian Self-Mediation In- Website: www.otcpharmaasia.com. Tel: +44 1483 730071. on good distribution practice, dustry (ASMI). Fax: +44 1483 730008. while day twowill look at good 9-10 March Contact:ASMI. Email: registrations@management- manufacturing practice. The two ■ EuroPLX 57 Tel: +61 29922 5111. forum.co.uk. days will then be repeated. Lisbon, Portugal Fax: +61 29959 3693. Website: www.management-forum.co.uk. Contact:Glasgows. This two-day conference will pro- Email: [email protected]. Tel: +44 1772 767715. vide aforum for business devel- Website: www.asmi.com.au/events/. 9December Email: [email protected]. opment decision makers for dis- ■ The Supply of 20-21 November Website: www.mhragmdp.co.uk. cussing and negotiating collabor- OTC Medicines ative agreements in licensing, mar- ■ EMA Review Bonn, Germany JANUARY2015 of the Year and keting, and distribution of patented Aone-day seminar,organised by medicines, generics, biosimilars, Outlook for 2015 Germany’smedicines manufactur- 27-28 January OTCproducts, medical devices London, UK ers’ association, the BAH. ■ The European and food supplements. This two-day conference run by Contact:BAH. Medical Devices Contact:RauCon. The Organisation for Profession- Tel: +49 228 957 450. Regulation Tel: +49 6221 426 2960. als in Regulatory Affairs (TOPRA) Fax: +49 228 957 4590. Brussels,Belgium Fax: +49 6222 9807 77. will feature speakers from the Euro- Email: [email protected]. This two-day conference –which Email: [email protected]. pean Medicines Agency(EMA). Website: www.bah-bonn.de. will be accompanied by apre- Website: www.europlx.com. Contact:TOPRA. and post-conference workshop – Tel: +44 20 7510 2560. 9-10 December will discuss recent and impending 18-19 March Fax: +44 20 7537 2003. ■ Gaining Marketing changes to the proposed European ■ RegulatoryAffairs Email: [email protected]. Authorisations in CIS Medical Devices Regulation. in India and China Website: www.topra.org/ London, UK Contact:Informa UK. Frankfurt, Germany emareview2014. Strategies for gaining market Tel: +44 20 7017 7481. Day one of this two-day confer- access in the Commonwealth of Fax: +44 20 7017 7823. ence will focus on India, while day 24-26 November Independent States (CIS) will be Email: [email protected]. twowill look at China. ■ Pharmaceutical covered at this two-day seminar. Website: www.informa-ls.com/ Contact:Forum Institut für Management. RegulatoryAffairs Contact:Informa UK. meddevregulation. Tel: +49 6221 500 680. in Latin America Tel: +44 20 7017 7481. Fax: +49 6221 500 555. London, UK Fax: +44 20 7017 5656. FEBRUARY Email: [email protected]. Day one of this three-day seminar Email: [email protected]. Website: www.forum-institut.com. will coverBrazil, Colombia and Website: www.pti-global.co.uk/event/cis. 23 February2015 Peru, while day twowill look at ■ Hot Topics 18-20 March countries such as Argentina, Mex- 10-12 December in Advertising ■ Nutra India Summit ico and Venezuela. Day three will ■ Strategic Planning London, UK Mumbai,India focus on Central America. in RegulatoryAffairs Aone-day seminar run by the UK Athree-day showcovering nutra- Contact:Management Forum. London, UK Medicines and Healthcare prod- ceuticals and dietary supplments. Tel: +44 1483 730071. Athree-day masterclass run by ucts Regulatory Agency(MHRA). Contact: MM Activ. Fax: +44 1483 730008. The Organisation for Professionals Contact:Glasgows. Tel: +91 22 2438 5007 9. Email: registrations@management- in Regulatory Affairs (TOPRA). Tel: +44 1772 767 7706. Fax: +91 22 2437 9882. forum.co.uk. Contact:TOPRA. Email: [email protected]. Email: [email protected]. Website: www.management-forum.co.uk. Tel: +44 20 7510 2560. Website: www.hottopics.glasgows.co.uk. Website: www.nutraindiasummit.in.

7November 2014 OTC bulletin 23 OTC07-11-14p24-27_Layout 1 04/11/2014 16:05 Page 2

OTC BUSINESS STRATEGY RB plots the futureofconsumer health

Having altered the OTCmarket with its fast-moving consumer-goods business people are healthier and theylivebetter”. model, Reckitt Benckiser (RB) is nowlooking to shape the future of the industry The investment also reflected the wayRB thought about research and development in the with heavy investment in researchand development. Matt Stewart explores consumer healthcare space, James claimed. the thinking behind the firm’sdesire to lead arevolution in healthcare. Unlikemanytraditional big pharmaceutical players that operated in the OTCarena, all of he consumer healthcareland- and capacity to lead the consumer healthcare RB’smajor innovations started with the con- scape is going to change enor- industry through this revolution in health. sumer,she insisted. mously in the next 10 years. In August,RBannounced that it planned Having spent overseven years on the pre- “TWhat you see today is not to spend £100 million (C127 million) on anew scription side of the healthcare industry at what you will see tomorrow,”according to consumer healthcare research and develop- GlaxoSmithKline, James said that when she Sharon James, head of research and develop- ment centre in the UK, which according to the joined RB in 2002 it wasquite apparent that ment at Reckitt Benckiser (RB). firm’s chief executive officer,, the twocompanies had completelydifferent ap- Speaking to OTC bulletin at the UK-based would play akey role in its drive to “create a proaches to research and development. consumer goods giant’sheadquarters in Slough, revolution” in the sector (OTC bulletin,15 Prescriptionbusinesses dominated many James pointed out that the consumer healthcare August 2014, page 1). pharmaceutical companies, James pointed out, industry wasalready in the middle of aseismic Kapoor told OTC bulletin that the Centre of and as aresult the processes needed to develop shift away from the traditional model of treat- Scientific Excellence would give the company newmolecules –such as the longer time lines ing problems as theyoccurred. the “right infrastructure, the right technical and the regulatory rigour –“basicallycascaded” The industry wasbeginning to embrace pre- abilities and, most importantly,the right people” all the waydowninto OTCresearch and dev- vention, James explained, and that change was to deliverthe innovations in consumer health- elopment activities. “seismic in terms of health economics”. care that would enable RB to be a“global “When Ijoined RB –and of course the “In the past it wasproblem/solution and it leader in this newhealth revolution”. firm’s heritage washousehold and very much wasvery difficult, back in those days, to con- “Wehaveworld-class talent on this site and consumer –Ifound that the companywas used vince people that prevention and its positive theydeserveaworld-class facility,” he pointed to asking the consumer what theywanted and impact on health economics wasalong-term out. “It will become amagnet for talent from needed,”she maintained. thing,”she noted. around the world.” Marrying the prevention and wellness ap- “But if you manage to embed the prevention Based at the company’sexisting site in Hull, proach to the problem/solution approach –and idea into the mind of the consumer,” James the newfacility –set to open in 2018 –would finding the “sweet spot” between both –had argued, “it changes the whole paradigm of con- become the “global technical innovation hub” been akey goal for RB, James said, since it had sumer healthcare.” for the firm’sconsumer-health powerbrands, entered the global consumer healthcare space This idea of keeping your body in harmony such as Nurofen and Strepsils, Kapoor said. in earnest back in 2005 when it acquired Boots so the problem neveroccurs, James said, was The innovation that would come out of the Healthcare International (OTC bulletin,17Oct- a“very simple wayofthinking” but“huge” for newfacility would makeareal difference to ober 2005, page 1). The deal added the , the industry. howpeople managed their health, he claimed. Nurofen and Strepsils powerbrands to ahealth- RB wasready to takefull advantage of this James said the investment in the newfacil- care stable that already included Lemsip cold and shift towards “wellness”,James claimed, and itywould enable the companytoachieve its flu remedies and Gaviscon heartburn products. had the researchand development capabilities goal of ahelping to create a“world where “You cannot lose your consumerfocus, because at the end of the day this is ‘consumer healthcare’, butyou also need to have that sci- entific, regulatory and medical rigour that al- lows you to play in this space, and that is the journeywehavebeen on,”James pointed out. “Wehaveput alot of focus overthe past two years on strengthening those skill sets,”she revealed, “and we are certainly getting closer to that sweet spot. Ireally do believe we are.” While admitting that other consumer health- care companies had made strides in placing the consumer at the centre of their thinking, James claimed that RB’sheritage in the fast- moving consumer-goods sector meant it still had an advantage. “Without ashadowofadoubt we still lead the way,”she said. “Over the last fewyears

RB expanded its OTC portfolio –which includes the and Nurofen global powerbrands –into the vitamins, we have been significantly strengthening our minerals and supplements space when it acquired SchiffNutrition and its MegaRed krill-oil brand skills in the science areas –mainly recruiting

24 OTC bulletin 7November 2014 OTC07-11-14p24-27_Layout 1 05/11/2014 09:12 Page 3

BUSINESS STRATEGY OTC

from the pharma companies –and by just listen- To takeadvantage of this change, the re- ing to the feedback from our ownemployees search and development operation at RB had we knowweare so much more agile and quick- become even more outward-facing, James re- er because our focus is on the consumer.” vealed, adding that “partnerships and collab- “Welook at whole consumer lifestyles and orations are absolutely essential to success”. howwecan help consumers to be healthier and “Long gone are the days when you could live better,” she added. “Wehavethat mindset do everything internally,” James claimed. “Con- and we are quite away ahead in that thinking.” sumers are nowmanaging their ownconditions, Furthermore, research and development at which brings considerable complexity in terms the companyfocused on the whole product of where we, as aconsumer healthcarecom- and howitmatched howconsumers lived, pany, intervene.” James noted. “From the API, to the format – It wasnot just about the products these days tablets, capsules, gummies, sachets, liquids –all either,James pointed out, it wasabout the aspects of the product are very much developed ecosystem that wasgrowing up around con- with the lifestyle of the consumer in mind.” sumer healthcare. “Welook at the entire customer experience; Taking mHealth as an example, James said the packaging, howcustomers purchase and that the range of skills that were needed to com- use the product, and howtheyremove the lid,” pete in the fledgling space had “exploded”. RB’s head of research and development, Sharon she explained, “and of course the flavour.” “Back in the day,most researchand dev- James, says the company is ready for the new consumer healthcareenvironment “Iftheir experience is positive,theyare more elopment people were nearly all chemists. Now likely to want to repeat it in the future,”James we need really good medical science, good digi- In 2008, the companypushed into the US noted. “Ultimately it’sabout reinforcing the tal skills, good structural design skills; there is by acquiring Adams RespiratoryTherapeutics trust that theyalready have in our brands, and awhole myriad of stuffthat we need. To think and its -based Mucinexcough brand building long-term engagement and loyalty.” that we can access all of that internally is naive (OTC bulletin,14December 2007, page 1). In “Wehavereally been very mindful of build- to be honest,”James pointed out. 2011, it added to its US portfolio by snapping ing up that skill set and that givesusthe best It wasalso important, James said, that RB up abasket of brands, including the Lanacane product –not just the best ingredient –and the changed its relationships with its core stake- skin-care line, from Combe (OTC bulletin, 21 best consumer experience,”James insisted. holders and collaborated more with both sup- January 2011, page 1). The Nurofen ibuprofen range wasaprime pliers and retailers. Prior to the Combe deal, RB had put the example of this thinking in action, James said. Last year the companyhad gone out on “a Durexcondom brand and Scholl foot-carerange “Ifyou look at the amount of Nurofen formats mission” to change its relationship with sup- on its global powerbrand list when it acquired and occasions for use we have,all of them pliers, James said. “Instead of doing the clas- SSL International (OTC bulletin,30July 2010, have come from listening to the consumer.They sic transactional type of deal, we nowhave page 1), and had also expanded its reach in reflect our ability to adapt and develop to meet more of apartnership with them.” emerging markets by buying India’sParas Phar- consumer needs.” “Wewent out and said: ‘Weare RB, we are maceuticals, together with its D’Cold winter However, RB could not afford to stand still nowthe number one health and hygiene com- remedy and Moovtopical analgesic (OTC bul- when it came to expanding and improving its re- panyinthe world, howcan we work together letin,16December 2010, page 1). search and development activities, James said. At the end of 2012, the firm Reiterating the ongoing shift in the way took amajor step towards its people viewed and managed their ownhealth, “It is not just about the products these days aim of providing consumers James said that the rise of the internet and the either,itisabout the ecosystem that is with the fullest spectrum of more informed healthcare consumer had already growing up around consumer healthcare.” consumer healthcare products had adramatic impact on howRBviewed the when it entered the VMS space future of the market and howitapproached by agreeing to pay US$1.4 bil- product development. for mutual benefit?’ So we changed that fun- lion to acquire SchiffNutrition International “In the US, 89% of people who use the damental relationship.” (OTC bulletin,18December 2012, page 1). internet are accessing health information,”James Turning to retailers, James said RB wasnow Acquiring SchiffgaveRBthe MegaRed claimed. “If you look at spending on healthcare talking to its customers likeWalmart, and say- brand in the cardiovascular category,Move Free it currently stands at around US$500 billion ing: “Weknowresearch and development, you in the joint-health segment, Digestive Advan- (C400 billion) ayear,but in the next five years knowyour customers. What do theywant?” tage in the digestive health market and Airborne it will growtoUS$750 billion. Only asmall “Wehavebeen doing co-creation work with in the immunity category. percentage of that will be associated with tra- those stakeholders, and while that is amore This inorganic expansion wassomething ditional problem/solution medicines.” recent development, we are keen to do more that waslikely to continue, James pointed out, Most of this newspending would be around of it. Retailers knowaheck of alot about their noting that Kapoor had been clear in stating wellness and prevention, James pointed out, customers,”James explained. that RB would seek out acquisition opportu- with vitamins, minerals and supplements (VMS) “Weneed to be very outward facing, we need nities that benefitted the business. and healthcare technologies taking abigger our stakeholders and partnerships,”she insisted. While refusing to give specifics, James ad- cut of the total. The companyhas also not been shyinac- mitted that there were areas where the com- “The spectrum of treatment has expanded quiring brands and products to expand its global panyneeded to get stronger. massively and the opportunity is phenomenal,” footprint to compete in the newwellness arena It was“no secret” that RB waslooking to James insisted. in consumer healthcare and hygiene. expand its “repertoire” across the “spectrum

7November 2014 OTC bulletin 25 OTC07-11-14p24-27_Layout 1 04/11/2014 16:05 Page 4

OTC BUSINESS STRATEGY

of prevention, treatment and recovery”, James manding these kinds of products.” mission because we all want safe and effective noted. “If we can find segments that fitinto By contrast, in Latin America –where in products and abetter outcome for consumers,” the firm’sheartland, or relevant adjacent seg- 2013 RB gained the exclusive distribution rights James said. ments, we will go into them.” to sevenofBristol-Myers Squibb’s OTCprod- This wasslightly easier in developing mar- In parallel with expanding its consumer ucts –the firm had anumber of lines with kets, James noted, as the regulatory agencies in health business through acquisitions, the com- strong brand loyalty,James said. those countries were changing to deal with the panyhad avery strong focus on innovating Aconsumer in Mexico that wasloyal to growth in consumer access to healthcare. across its existing healthcare powerbrands of the Tempra analgesics brand –asheorshe RB had got “super people on the ground in Durex, Gaviscon, Mucinex, Nurofen, Scholl knewitworked for them when theyhad a Brazil and China, who are in dialogue with and Strepsils, James said. headache –was very unlikely to switch to those agencies”, James revealed, and were help- “The powerbrands are tried and tested and Nurofen, James claimed. “Whyforce anew ing the authorities in those countries to deal have agreat heritage,”James pointed out. brand on them when there is no need?” with the changing healthcare environment. However, to ensure that these brands con- “Our brands stand for something and if Looking ahead, James said she believed tinued to meet consumers’ needs, James said, it theyare not appropriate for acountry we will there wasareal mood at RB and in the wider wascrucial not just to roll out line extensions, not roll them out. Instead, we leverage the OTCindustry to innovate and disrupt the con- buttoensure that theyprovided areal benefit. local brands which have got the heritage,” sumer healthcare market. “Brand loyalty is abig thing in healthcare she explained. Some of this would be achievedthrough the and interestingly it has increased recently,” Turning to the regulatory challengesfaced classic model of switching prescription-only James claimed. “If you look at consumers, they by RB when it came to innovation, James was drugs to OTCstatus, James pointed, which was aremaking alot of value purchases in certain philosophical,admitting that the current regu- something that RB waskeen to get involved in, other areas, such as food, butinhealthcare lations could be both ahelp and ahindrance even if it meant licensing or acquiring switch there remains alot of brand loyalty.” when it came to developing the consumer health- candidates from other companies. Healthcare consumers today were “savvy care category. But, the biggest disruption in the market- enough to weed out the products that don’t “Undoubtedly there could be more harmon- place waslikely to come from the burgeon- work as theysay theywill”, James stated. isation,”James said, echoing the thoughts of ing healthcare technology sector,which was “Atthe end of the day,wedohavevery enabling consumers to man- strict brand guidelines. Every brand has its “Something massively disruptive is going age their health and wellbeing footprint and we don’twant to go outside of to come out of the mHealth space,” James in ways that had neverbefore that,”she said. “Our brands are precious and been possible, James noted. theystand for something.” insisted, “as you cannot be disconnected “Something massively dis- Taking these powerbrands into newmarkets from your own health these days.” ruptive is going to come out alsoposed challenges, James admitted. While of the mHealth space,”James the companywanted to stay true to the brands’ Kapoor,who at keynote speech at the recent insisted, “as you cannot be disconnected from heritage, it had to takeinto account local pref- annual meeting of the Association of the Euro- your ownhealth these days.” erences and regulatory differences. pean Self-Medication Industry,the AESGP, “Look at Samsung’slatest Galaxy mobile “Ideally Iwant the same chassis formula- called for OTCmedicines to be authorised for phone; it has abuilt-in heart monitor and ped- tion,”James explained. “But regulatory varia- non-prescription sale globally as soon as safety, ometer whether you likeitornot,”James said. tions mean it’sunlikely that aproduct will be efficacyand appropriateuse had been estab- The “combination of healthcare consumers the same in every market.” lished (OTC bulletin,16June 2014, page 1). and mobile technology” was“very powerful” But also there wasthe “sensory experience”, “If you look at human anatomy and physiol- and RB waspreparing to takeadvantage, she added. “Wehavethe ability to look at local ogy and what happens with an active ingredi- James revealed. preferences around howaproduct tastes, its for- ent, it’svery similar in everyone,”James point- To do this, RB waslooking for people and mat and its texture, and tweak the product to ed out. “The example of the different limits organisations with “non-traditional skill sets”. meet local preferences,”she claimed. placed on ibuprofen shows that there may be “I want them to come into my organisation and “Weare quite expert nowinall the differ- room for better harmonisation.” ask me the disruptive questions,”she stated. ent formats and again there are certainly alot However, James said she wasconfident that Furthermore, partnerships would be develop- of variations locally when it comes to formats,” regulatory authorities were keen to work with ed, James said, so RB could takeadvantage James noted. industry to encourage innovation. of the latest hardwear coming to market. “Wehaveconsumer-scienceteams based “I think if you look at the spectrum of devel- “Whywould we develop these other types of in those countries so we have the capability to opment in regulatory authorities –from the US products ourselves when there is the opportu- live the livesofthe consumers,”James said, Food and Drugs Administration (FDA) and nity to create partnerships?” James asked. “We “and find out howtheysuffer,how theycon- the UK’sMedicines and Healthcare products are not in the business of developing digital sume their medicines and howwecan help regulatory Agency(MHRA) in established mar- watches that monitor heart rate, butmaybe we them to live better.” kets to the Chinese Food and Drug Adminis- should be in partnership with those that are?” Expandingonthe science behind rolling out tration (CFDA) and Brazil’sAnvisa in emerging “There is so much newtechnology and these brands in newmarkets, James said it markets –there is an opportunity to start a information for the consumer that is comple- really came down to “market intelligence and dialogue with them in amuch more proactive mentary to what RB is doing in consumer consumer intelligence”. waythan we have ever done before.” healthcare,”James said. “Looking for those “Wehavejust launched four Airborne prod- “There has to be symbiosis between what opportunitiesiswhat we are doing in research ucts in China,”James pointed out, “because we are trying to do with our mission at RB and development right now.” we knowthe market and consumers are de- and what the regulators are doing with their OTC

26 OTC bulletin 7November 2014 OTC07-11-14p24-27_Layout 1 04/11/2014 16:05 Page 5

PEOPLE OTC

Manufacturers Regulatory Agencies Sanofi fires CEO Rawlins to succeed Duff after fallingout as chair of UK’s MHRA ■ Continued from front page -placement wasalready underway,Weinberg revealed, with the companykeen to appoint a rofessor Sir Michael Rawlins has been Professor Sir “chief executive with avery solid background Pnamed as the UK Medicines and Health- Michael Rawlins in pharma”. Sanofiwas “mainly concentrating” care Products Regulatory Agency’s(MHRA’s) on external candidates to fill the position, he newchairman for athree-yearterm, effective pointed out. from 1December 2014. Viehbacher’sdeparture came aday after Rawlins will succeed Sir Gordon Duff, he had told investors during Sanofi’sthird- who took the helm in January last year (OTC quarter results presentation he was“focused bulletin,14September 2012, page 30). Duff on running the business” and the companywas will step down to takeonthe role of principal “pushing ahead on all fronts”. of St Hilda’sCollege at Oxford University. Aday earlier,Sanofi’sboard had denied that Rawlins is currently chair of national health the agenda for its upcoming meeting includ- resource UK BioBank. He wasalso chairman Professor Dame Sally Davies, the UK’schief ed “the succession of Chris Viehbacher”. of the National Institute for Health and Care Ex- medical officer,said Rawlins would “bring a Media speculation ahead of Sanofi’sthird- cellence (NICE) from its creation in 1999 until wealth of experience to the board” and play quarter results suggested Viehbacher had fallen April 2013, and had spent twoyears as pres- “a keyrole” in the leadershipofthe MHRA, out with several directors and had written to ident of the Royal Society of Medicine. which would “continue to focus on excellence the board warning that ousting him would be Commenting on Rawlins’ appointment, and innovation”. “detrimental to the interests of shareholders OTC and other stakeholders”. In his letter to the board –published by Manufacturers French national newspaper Les Echos and dated 4September 2014 –Viehbacher stated Mazzotta heads Sanofi consumer unit that it had come to his attention that Weinberg was“actively seeking asuccessor to me as chief anofiItaly has named Fabio Mazzotta as joined as president of SanofiItaly at the start executive officer”. Sdirector of its Consumer Healthcare unit. of October from Swiss firm Roche, where he Writing in defence of his performance, Vieh- He will report to Alexander Zehnder,who wasgeneral manager for Cyprus and Greece.

bacher argued that removing him as chief ex- Fabio Mazzotta Prior to joining Sanofiin2013 as field sales ecutive officer would “destabilise senior lead- director from personal-care firm Kimberly- ers” at Sanofi, “concern” the firm’sbusiness Clark, Mazzotta held positions at Reckitt Benc- partners and “raise questions” with investors. kiser (RB) and L’Oréal. Viehbacher indicated that he wasunsure In his newrole, Mazzotta would “consoli- whythe board wanted to remove him, noting datenew strategies” to improve further Sanofi that achange of chief executive was“generally Italy’sperformance in the consumer-healthcare the result of either aproblem with performance arena, the companynoted. This business was or adisagreement on strategy”. already in a“strong position” thanks to the per- “Performance is clearly not an issue,”he formance of brands such as Enterogermina, insisted, “and Iamunaware of anydisagree- Lisomucil and Maalox, it added. ment on strategy.” OTC Calling on the board not to put the develop- ment of Sanofi“at risk”, Viehbacher proposed Regulatory Agencies talks with members to understand “what the board would liketosee going forward”. Forsman named to lead Läkemedelsverket OTC he Swedish Medical Products Agency, platform for driving important issues related TLäkemedelsverket, has named Catarina to sustainable healthcare”, Forsman said she IN BRIEF Andersson Forsman as its director general. was“looking forward” to continuing its “work ■ FARMAINDUSTRIA –the Spanish nation- Prior to her appointment, Forsman spent for better health”. al association for the pharmaceutical indus- sevenyears as director of healthcare at Stock- Professor Bengt Wittgren, Läkemedelsver- try –has appointed Antoni Esteve as presi- holm County Council. She has also held posi- ket’sdirector of development, said Forsman dent. He will servefor atwo-year term, re- tions at the National Board of Health and Wel- brought to the role a“deep understanding of placing Elvira Sanz. fare and the Swedish Medical Association. delivering healthcare”. OTC Noting that the agencyprovided “a strong OTC

7November 2014 OTC bulletin 27 OTC BC House Ad AUGUST 2014_Layout 115/10/2014 10:30 Page 1

OTC bulletin print

OTCbulletin-i digital

news@OTCbulletin electronicnewsflash

INDIVIDUAL SUBSCRIPTIONS Thebest decision-makers in theOTC industry don’t have thetime An annual subscription comprises: to go looking for good information.Theylet it come to them. n 20 OTC bulletin newsletters; They subscribe to OTC bulletin. n ANDatleast 45 weekly news@OTCbulletin electronic Jointhousands of subscribers from competitor companiesin newsflashescontaining the week’stop over 35 countries whoare already benefitting from commercial news stories (currently delivered by email). intelligence aboutbusiness opportunitiesinthe global non-prescription medicinesand dietary supplements markets. CHOICE OF FORMATS The 20 OTC bulletin newsletters Good value -Individualsubscription rates start from just£975 are available: n EITHERasthe digital OTC bulletin-i for online access by desktop ANDtablet and smartphone. These mobile devices can have Apple or Androidoperating systems; AVAILABLE INSTANTLYWORLDWIDE n OR in traditional hard-copyprint format, OTC bulletin-i is the digital i-edition of OTC bulletin. delivered by airmail; Nowavailable online for desktop access,itdelivers thelatest OTC bulletin on the day of publication withnopostal delay.Italso comes –atNOEXTRA CORPORATE SUBSCRIPTIONS CHARGE –asanapp for mobile access by tablet and smartphone. Acorporate subscription provides OTC bulletin-i subscribers also get access to afully-searchable archive.This contains overfive location-,country- or company-wide years of OTCnewsand analysisinmore than 100 back issues. These offer an invaluable resource access to OTC bulletin-i. for researching marketingopportunities, benchmarking competitivestrengths, evaluating regulatory changes and assessing product developments. Contact [email protected]. Existingsubscribers can get 20% OFF when theyupgrade theirsubscriptions to include OTC bulletin-i.Contact [email protected].

Take out asubscriptionTODAY at www.OTC-bulletin.com or contact: [email protected]

Bulletin PublishingGroup, OTCPublications Ltd, 4Poplar Road, Dorridge, SolihullB93 8DB, UK. (Tel: +44 (0)1564 777550; Fax: +44 (0)1564 777524). Registered in England No: 2765878. VATNo: GB 608 0432 69