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Bulletin Publishing Group is a division of OTC Publications Ltd Registered Office: 4 Poplar Road, Dorridge, Solihull B93 8DB, UK. Registered in England No 2765878 OTC25-10-13p1_OTC15/11/2005 p1&24 22/10/2013 15:43 Page 1

25 October 2013

COMPANY NEWS 2 Sanofi’s Nasacort Allergy Novartisstays quiet on 2 Consumer Health future Bayeropens new US headquarters 2 Atriumgrows CEEreach 3 getsOTC approval in US with MucosPharma buy Haniel is silent on Celesiosale 3 Sallergy sufferers will soon be able to Pharmaceuticals at SanofiUS, said the firm UbuySanofi’sNasacort AQ nasal spray believedthat there was“significant value in McNeilreturnboosts US OTCmarket 4 (triamcinolone acetonide) without aprescrip- making certain types of medicines, likeNasa- Revolymer starts roll out 6 tion after the Food and Drug Administration cort, directly available to consumers”. of nicotine guminEurope (FDA)approvedthe product’sswitch from “Allergy sufferers will benefit from having ScripsAmericasecures funding 6 prescription-to-non-prescription status. an additional treatment option,”Whitaker main- Futura’s CSD500 gets 7 The French firm said that Nasacort Allergy tained, “and it is astrong addition to our ex- CE markapproval 24HR wasset to be launched in spring 2014 and isting consumer healthcare portfolio.” GENERAL NEWS 8 would be the “only single active ingredient OTC Nasacort Allergy receivedfinal approval medicine” that relievedthe “full range of nasal after the switch had been recommended by the PolishOTC marketset to 8 allergy symptoms, including nasal congestion, FDA’sNonprescription Drugs Advisory Com- return to growth in 2013 for 24 hours with asingle daily dose”. mittee (NDAC)inAugust (OTC bulletin,23 Study calls for betterherbals 8 Indicated to treat “seasonaland year-round August 2013, page 1). Europe won’t treat e-cigs 9 nasal allergies in adults and children twoyears The agency’sfinal decision on the switch as medicines of age and older”, Nasacort Allergy offered the had also been based on data submitted by the Stakeholdersdefend useof 10 60 million Americans who suffered from nasal companyfrom 13 placebo-controlled efficacy vitaminDsupplements allergies anew OTCtreatment option, San- studies, Sanofiadded, along with safety infor- VitaminDintakeshouldincrease 10 ofipointed out. mation from 43 clinical studies and 16 years Wockhardt issues recall 11 Anne Whitaker,president of North America ■ Continued on page 23 of five OTCproducts in UK PRAC examines dihydrocodeine 11 MARKETING NEWS 14 Stada expands in Russia with Aqualor Unileveriswarned against 14 tada Arzneimittel is set to expand the reach Floracholesterolclaims Sof its Branded Products business in Russia GSKurges UK consumers 14 to “trade up” by acquiring the Aqualor brand of seawater- based sprays and drops for C131 million in cash. GSKclaimsNiQuitinStrips 15 arefirsttothe UK market The deal is expected to close early next year. The deal gave Stada arange of Aqualor- Altacorunveils eye-health bar 15 branded OTCmedical devices for adults, chil- NovartisConsumer Health 16 dren and infants used to treat avariety of con- rolls out 12-hour Voltaren ditions, the German firm noted, including sinus- RB spends £3.5mn on 17 itis and sore throat. Acquiring Aqualor has given Stada arange of Cold &Flu line Aqualor products generated sales of approx- seawater-based products in Russia MerckoffersUKmothers 17 imately C28 million in 2012, Stada pointed out, Under the terms of the deal, Stada will im- free folic acid and an earnings before interest, tax, depreci- mediately pay 83% of the total purchase price FEATURES 20 ation and amortisation (EBITDA) margin that to Cyprus-based Butterwood Holdings and Rus- was“significantly above”the average 32% plus sia’sZAO Pharmamed. The remainder will be GSK brings science to 20 EBITDAmargin generated by the Branded paid to them within 12 months of the deal clos- shopper insights Products division’sother products. ing once certain conditions have been met. Since the range had been launched in 2007, Acquiring Aqualor,Stada explained, would REGULARS Aqualor had achieved“vigorous sales growth”, strengthen its branded OTCpresence in Russia, Events – Our regularlisting 19 Stada claimed, and had become one of Russia’s amarket which was“strategically important” People – Sanofi appointsWarnery 23 leading brands in the seawater products cate- to the company. to lead global Consumer unit gory,which had grown by over34% in the past Stada expanded aggressively its Branded five years. ■ Continued on page 6 OTC25-10-13p2-7FIN_Layout 1 22/10/2013 14:50 Page 2

OTC COMPANY NEWS

BusinessStrategy Mergers&Acquisitions Bayer opensnew Novartis stays quiet on US headquarters ConsumerHealth future ayer’sHealthCare sub-group has opened B itsnew US headquarters on a94-acre site ovartis has refused to comment on claims The future of Novartis’ Consumer Health in Whippany, NewJersey. The Whippanycamp- Nby an analyst that it is looking to sell its business has been unclear since December 2011, us consolidates Bayer HealthCare’sUSopera- Consumer Health business, which includes the when the firm suspended production at its US tions, which had previously been spread across company’sglobal OTCunit. manufacturing plant in Lincoln, Nebraska due the states of NewJerseyand NewYork. In an investor note, TimAnderson, senior to quality issues. Soon afterwards, the com- Marijn Dekkers, chairman of the German analyst at Bernstein Research, said that during panyannounced that it had recalledExcedrin company’sboard of management,said that al- aface-to-face meeting with Novartis’ chief ex- and anumber of other OTCbrands manufac- though the aim of the project wastobring ecutive officer,Joseph Jimenez, he had been tured at the facility (OTC bulletin,23January together all HealthCare employees in one loca- “struck by howopenly Jimenez seemed to ac- 2012, page 1). tion, it wasalso about building the Bayer brand knowledge” that the Swiss firm’sConsumer In February,when asked whether Novartis and the firm’sreputation. Health business –containing its OTCand Ani- had considered selling its OTCbusiness, given The Whippanycampus would serveas mal Health units –and its Vaccines &Diagnos- the problems it had faced, Jimenez insisted that Bayer’s“footprint” on the east coast, Dekkers tics division were “on the block”. it had akey role to play in the company’sstrat- Noting that there had been “speculation in egyof“growth through focused diversification” the investment community” for some time that (OTC bulletin,8February 2013, page 2). Novartis waslooking to sell its Consumer Speaking to OTC bulletin in February,Brian Health business, Anderson stated that “hearing McNamara, division head, Novartis OTC, said it directly ourselves from management makes the firm was“aggressively pursuing opportu- us think this has ahigher likelihood of happen- nities to growour business by expanding the ing than we previously thought”. reach of our keybrands and delivering acon- Claiming that Novartis would makeafinal stant stream of innovation to the market” (OTC decision on the future of its Consumer Health bulletin,8February 2013, page 21). and Vaccines &Diagnostics divisions “fairly In July,Novartis reported an 11% increase Bayer HealthCare’s new US base consolidates all of soon”, Anderson speculated that the twounits in second-quarter turnoveratits Consumer its operations on one campus could “fetch something in the order of US$15 Health business to US$1.0 billion (OTC bul- pointed out, as the companylooked to invest billion-US$20 billion (C11 billion-C15 billion)”. letin,26July 2013, page 7). further in the US. OTC Boasting 70,000sq mofoffice space, the newfacility would house approximately 2,400 BusinessStrategy/Mergers&Acquisitions employees, Bayer said, covering Bayer Health- Care’sAnimal Health, Consumer Care, Medi- UK’s Burrand Burrtargets acquisitions cal Care and Pharmaceuticals divisions. Bayer HealthCare reported sales in North ewly-established UK supplements firm Burr’sproducts though various distribution chan- America –Canada and the US –upby13.8% NBurr and Burr said it waslooking further nels”, Thornblom claimed. to C 4.96 billion in 2012. The region accounted to build its fledgling portfolio of natural health This team included the former owner of for 27% of HealthCare’sworldwide 2012 sales, products, after snapping up the OmegaVita and Findus Group, Geir Frantzen, Thornblom point- which improvedby8.4% to C 18.6 billion. Go3 supplement brands in adeal worth atotal ed out, who had “years of experience” in the OTC of £35.0 million (C41.5 million). omega-3 category in multiple global markets. Chris Thornblom, Burr and Burr’sinterim In acquiring OmegaVita and Go3, Burr and chief executive officer,said the company’sstrat- Burr had added two“long established names” IN BRIEF egywas to “continuously seek to acquire addi- to its portfolio, the companysaid. ■ VITAMIN SHOPPE has opened anew tional brands” and establish itself as a“leading Both brands consisted of “innovative omega- distribution centre in Virginia, US. Tony Trues- player in the health supplement field”. 3products, vitamins, food recipes, and omega-3 dale, the US-based vitamins and supplements Thornblom told OTC bulletin that the firm emulations for drinks and dairy products”, retailer’schief executive officer,said the facil- planned to build aportfolio of supplement Thornblom pointed out. ity had “positionedthe companyfor future brands that tapped into the “increased health Burr and Burr had been established in Aug- growth” and had “opened on time and on bud- consciousness” of consumers by leveraging the ust 2013 with aviewtoacquiring all assets get”. As of 15 October,the centre wasdistribut- “vast” amounts of research that supported the of OmegaVita and Go3, Thornblom noted, ing products to 56 Vitamin Shoppe stores locat- use of omega-3 and fish-oil products. and had been backed by private equity groups. ed in Louisiana, NewMexico, Oklahoma and To ensure Burr and Burr’sproduct portfo- Looking ahead, Thornblom said that once Texas, the companypointed out, and would be lio achievedthe right levelofdistribution, the established as aleading UK distributor,the firm serving 120 stores by the end of the year. companyhad assembled amanagement team would look to enter international markets. OTC with “the industry expertise to move Burr and OTC

2 OTC bulletin 25 October 2013 OTC25-10-13p2-7FIN_Layout 1 22/10/2013 14:50 Page 3

COMPANY NEWS OTC

Mergers&Acquisitions Mergers&Acquisitions Hanielissilent Atrium grows CEE reach on Celesio sale withMucos Pharma buy ranz Haniel &Cie has refused to comment F on reports it has agreed to sell its majority trium Innovations is set to expand its reach stakeinCelesio to US pharmaceutical whole- Ain Central and Eastern Europe (CEE) by saler McKesson. acquiring Czech companyMucos Pharma, the Anumber of media reports claimed Mc- distributor of its Wobenzym enzyme brand in Kesson had already started due diligence, with the region. Haniel having already agreed to tender its stake The Canadian natural healthcare products in the pan-European wholesaler and retailer. firm said that under the terms of the deal, it In June, Haniel denied it had held talks about would pay US$15.9 million (C11.8 million) selling its controlling stakeinCelesio to US for an initial 70% stakeinMucos Pharma and drugstore giant CVS Caremark(OTC bulletin, acquire the remaining 30% on or before 31 28 June 2013, page 5). December 2015. Haniel reduced its stakeinCelesio from Based in the Czech Republic, Mucos Pharma Mucos Pharma has distributed Wobenzym in anumber of 54.64% to 50.01% earlierthis year (OTC bul- had distributed the Wobenzym, Phlogenzym Central and EasternEuropean markets for over 20 years letin,18January 2013, page 3). and Prevenzym enzyme-based OTCjoint-health Pierre Fitzgibbon, Atrium’spresident and OTC brands for over20years, Atrium noted, primar- chief executive officer,said that snapping up ily in the Czech Republic, Russia and Slovakia. Mucos Pharma would not only “solidify” its Mergers&Acquisitions Mucos Pharma also had subsidiaries in an- Wobenzym business, butwould give the com- other 12 countries throughout the CEE region, panyaplatform from which it could launch DSM increases its the companynoted, and had generated sales its other brands into the CEE region and, most of around C40 million in the past 12 months. significantly,into Russia. Atrium gained the Wobenzym brand in 2007 Taking acontrolling interest in Mucos Phar- interest in Pectin when it acquired Germany’sMucos in adeal ma reflected the “strategic importance” of the oyal DSM has lifted its interest in Chinese worth C128 million (OTC bulletin,31July region, Atrium explained, as well as the poten- Ringredients and supplements firm Yantai 2007, page 1). The Czech Mucos Pharma was tial of the Wobenzym brand and the potential Andre Pectin to 29%, after completing adeal neverowned by its German namesakeand only for future cross-selling opportunities, particu- to acquire afurther 19% stakeinthe Shandong served as adistributor. larly in Russia. Province-located company. OTC The Netherlands-based life sciences and materials sciences firm has also been granted an option to increase its staketoamajority IN BRIEF holding at alater date. ■ ALLIANCE PHARMA is looking forac- The newfacilities would immediately replace Established in 2003, Yantai generates annual quisition opportunities after securing enlarged the existing ones, the UK speciality pharmaceu- sales of around C30 million from its apple and banking facilities of £55 million (C 65 million). tical firm said, and would be available until citrus pectins –akey food ingredient–and The companysaid the newfacilities left it “well 30 June 2018. Newacquisitions would be fund- pectin-related health supplements. placed to fund the acquisition opportunities ed by a£25 million revolving credit facility. OTC which are anticipated overthe coming years”. OTC

25 October 2013 Number 411 Advertising enquiries: [email protected] Terms &Conditions: No part of this publication may be copied, reproduced, stored in aretrievalsystem, distributed or Individual subscriptions: Editor: Matt Stewart transmitted by anymeans, including electronic, mechanical, Asubscription to OTC bulletin includes this hard-copynews- photocopying or recording, without the prior written permission Editor-in-Chief: Aidan Fry letter published 20 times ayear –twice monthly,except of the publisher,orunder the terms and conditions of aGlobal Production Editor: Jenna Lawrence monthly in July,August, December and January,and de- Site Licence or of alicence issued by the Copyright Licensing livered by air mail –and afree weekly email newsflash Agency(CLA) in London, UK, or rights bodies in other countries Assistant Editor: Marie McEvoy news@OTCbulletin published 45 times ayear.Annual sub- that have reciprocal agreements with the CLA. Neither may this Business Reporter: TomGallen scriptions in Europe cost £685.00 (additional copies at the publication be exported, distributed or circulated by anymeans Contributing Editor: David Wallace same address £385.00); outside Europe £715 (£415). Single outside the staffwho work at the address to which it is sent by copies cost £50 each. Subscription rates may be adjusted the publisher without the prior written permission of the publisher. Advertising Controller: Debi Minal to coverany period and can be backdated. Subscriptions may While due care has been taken to ensure the accuracyofinform- Director of Sales &Marketing: ValDavis only be cancelledatexpiry. ation contained in this publication, the publisher makes no claim Corporate subscriptions: that it is free of error and disclaims anyliability whatsoever Awards Manager: Natalie Cornwell for anydecisions or actions taken as aresult of its contents. Managing Director: MikeRice Global Site Licences are available to companies. These provide in-house electronic access for stafftoOTC bulletin ©OTC Publications Ltd. All rights reserved. OTC bulletin® is OTC bulletin is published by OTCPublications Ltd, and [email protected] ask for aquotation. Such registered as atrademark in the European Community. 4Poplar Road, Dorridge, Solihull B93 8DB, UK. licences are supplied strictly on the condition that both pub- ISSN 1350–1097. Tel: +44 1564 777550. Fax: +44 1564 777524. lications are the intellectual property of the copyright holder, Companyregistered in England No 2765878. Email: [email protected] OTCPublications Ltd, and are protected by copyright, trade- Printed by Warwick Printing CompanyLimited, Website: www.otc-bulletin.com mark and other laws. Leamington Spa CV31 1QD, UK.

25 October 2013 OTC bulletin 3 OTC25-10-13p2-7FIN_Layout 1 22/10/2013 14:50 Page 4

OTC COMPANY NEWS

McNeiThird-QuarterResults lreturnboosts US OTC market

he return of keyMcNeil OTCbrands to of anumber of manufacturing problems. ed the company’smarket share in the adult in- TUS retail stores has not only boosted John- McNeil is still operating under aconsent ternal analgesics category in each of the four son &Johnson’sOTC sales, buthas also given decree filed by the US Department of Justice most recent 13-week periods to 25 August 2013. the entire US OTCmarket alift, according to and the Food and Drug Administration (FDA) Furthermore, overthe same four periods, Johnson &Johnson’schief financial officer, in 2011 for failing to comply with good manu- Johnson &Johnson’sshare of the US paediatric Dominic Caruso. facturing practice (GMP) requirements at its analgesics segment had increased, the spokes- Speaking as Johnson &Johnson reported Fort Washington plant and its Las Piedras facil- person revealed, adding that Tylenol and Motrin adouble-digit rise in third-quarter US OTC ity in Puerto Rico (OTC bulletin,17March were nowthe twoleading brands in the category. sales, Caruso said returning a“reliable supply 2011, page 1). The roll-out of returning brands had con- of high-qualityOTC products” to US retail- US OTCsales had improvedby17.9% to tinued in the third quarter,the spokesperson ers, had caused a“strong uptick” in the mar- US$310 million (C228 million) in the third quar- noted, with grape-flavoured Children’sTylenol ket’soverall performance. ter of 2013, Johnson &Johnson noted, driven reappearing in stores, along with grape- and Johnson &Johnson’sMcNeil business is by its Tylenol and Motrin analgesic brands. cherry-flavoured Infant Tylenol products. planning to be able to supply 75% of its OTC Expanding on howthe returning brands had Several adult Sudafed and Benadrylprod- brands consistentlyinthe US market by the been performing, aspokesperson for Johnson ucts had also returned to market, the spokes- end of 2013, after the bulk of the company’s &Johnson told OTC bulletin that the return person added, as well as Pepcid Complete in OTCportfolio had been withdrawn in the wake of various Tylenol and Motrin products had lift- mint and berry flavours. In July,Sandra Peterson, group worldwide Business Third-quarter Change Operational Currency chairman with responsibility for Johnson & sales (US$ millions) (%) change (%) effect (%) Johnson’sconsumer group of companies, said that the successful return of Tylenol and Motrin Pharmaceutical 7,036 +9.9 +10.9 -1.0 to the US market demonstrated that the com- Medical Devices &Diagnostics 6,928 -2.0 +0.3 -2.3 panywas “winning the hearts of consumers”, Consumer 3,611 +0.8 +2.0 -1.2 as products returned to shelves (OTC bulletin, Total Johnson &Johnson 17,575 +3.1 +4.7 -1.6 26 July 2013, page 4). Turning to howthe firm planned to support Figure2:Johnson &Johnson’s sales in the thirdquarter of 2013 (Source –Johnson &Johnson) themarket return, Peterson said the focus was

Business Third-quarter sales Change Operational Currency (US$ millions) 2012/2013 (%) change (%) effect (%) OTC–US310 +17.9 +17.9 – OTC–International 665 +1.8 +2.0 -0.2 Total OTC975 +6.4 +6.5 -0.1 Skin Care–US404 +3.6 +3.6 – Skin Care–International 520 +1.2 +2.1 -0.9 Total Skin Care 924 +2.2 +2.7 -0.5 Baby Care–US99-4.8 -4.8 – Baby Care–International 461 +0.2 +4.3 -4.1 Total Baby Care 560 -0.7 +2.6 -3.3 Women’sHealth –US77-4.9 -4.9 – Women’sHealth –International 331 +1.5 +4.3 -2.8 Total Women’sHealth 408 +0.2 +2.5 -2.3 Oral Care–US142 -12.3 -12.3 – Oral Care–International 253 +0.8 +3.2 -2.4 Total Oral Care 395 -4.4 -3.0 -1.4 Wound Care/Other –US193 -9.8 -9.8 – Wound Care/Other –International 156 -4.3 -3.0 -1.3 Total Wound Care/Other* 349 -7.4 -6.9 -0.5 Total Consumer 3,611 +0.8 +2.0 -1.2 Consumer –US1,225 +0.9 +0.9 – Consumer –International 2,386 +0.8 +2.6 -1.8 *Now includes Nutritionals, which waspreviously grouped with OTC

Figure1:Breakdown of sales by Johnson &Johnson’s Consumer division in the thirdquarter of 2013 (Source –Johnson &Johnson)

4 OTC bulletin 25 October 2013 OTC25-10-13p2-7FIN_Layout 1 22/10/2013 14:50 Page 5

COMPANY NEWS OTC

currently on McNeil’s“top retail customers”. advance would have been even greater,John- Full distribution of keybrands had been son &Johnson pointed out, butfor anumber achievedatall top retailers, and point-of-sale of divestments which had offset a“strong” per- support had improvedaswell, Peterson added. formance by the Aveeno brand. Excluding the Furthermore, McNeil had developed “strategic divestments, Skin Care’sturnovergrewby4% initiatives” that would help rebuild its relation- on an operational basis. ships with these keyretailers, Peterson pointed Meanwhile, strong growth in the sanitary out, as well as support retailers’ health and well- protection category outside the US had boosted ness strategies. sales at the Women’sHealth business, Johnson By partnering with retailers, the company &Johnson noted. This posted turnoverupby would be able to help educate consumers, Peter- 0.2% to US$408 million. Berry-flavoured Pepcid Complete was one of anumber son noted, which would help simplify con- The improvement wasdue solely to a1.5% of key McNeil OTC products that returned to US shelves in the thirdquarter sumers’ purchasing experience and ultimately jumpininternational sales, which offset a4.9% bring morecustomers into stores. drop in US turnover. International sales would Having adiversified healthcare business re- The double-digit rise in US OTCsales in the have finished further ahead, butfor a2.8% neg- mained the “best strategy for the long-term” to third quarter overshadowed amore modest 1.8% ative currencyeffect. deliverboth innovation and wider-ranging solu- increase in international turnovertoUS$665 By contrast, Baby Care reported worldwide tions for the healthcare market, Caruso claim- million. The improvement wasthanks to an op- turnoverdownby0.7% to US$560 million, ed, although he admitted the Consumer business erational gain of 2.0%, which wasslightly off- due to adecline in US turnoverand negative ex- had faced “some challenges”. set by a0.2% negative currencyeffect. change rates. The economic slowdown had hampered Worldwide OTCsales movedforward by Turnoverinthe US fell by 4.8%, butgrew sales, Caruso said, and although overall eco- 6.4% to US$975 million, thanks to an opera- by 0.2% in international markets. The rise out- nomic activity had picked up, it had yet to reach tional gain of 6.5%. Currencyeffects had a0.1% side of the US would have been amuch health- thelevel the companywould likeittobe. There negative impact. ier 4.3% butfor a4.1% negative currencyeffect. were still “carryoverelements” hurting sales, International Baby Care sales had been driv- Caruso explained, such as “trading down to store Mixed set of results en by acquisitions, the companynoted, including brands and the like”. The strong growth in OTCsales wasahigh- the Chinese firm Shanghai Elsker Mother & “What is incumbent upon our business is to light in what wasamixed three months for Baby (OTC bulletin,26April 2013, page 4). create the innovations that consumers will want Johnson &Johnson’sConsumer division, which Commenting on the deal in April, Caruso said and will remain loyal to,”headded. reported worldwide turnoverupbyjust 0.8% to that Shanghai Elsker Mother &Baby wasknown Innovation had been more visible in “cer- US$3.61 billion in the three months (see Fig- for its portfolio of natural products. The buywas tain pockets of our business than in others”, ure 1). At an operational level, Consumer’ssales also in line with Johnson &Johnson’sstrategy Caruso admitted, highlighting the success of the advanced by 2.0%, butthis waspartially offset of “driving global growth with products intend- Aveeno skincare range, which thanks to new by anegative currencyeffect of 1.2%. ed for use in specific local markets”, he added. products and fresh advertising campaigns had Johnson &Johnson noted that for financial Consumer’sOral Care business reported a seen sales rise by 16% year-on-year. reporting purposes, the sales generated by the 4.4% slip in worldwide sales to US$395 million. In other areas of the Consumer business, firm’sNutritionals business were nowconsider- The drop had been due entirely to a12.3% slide progress had been hard to measure due to div- ed part of Wound Care/Other. Previously,Nutri- in US sales, Johnson &Johnson noted, follow- estments, Caruso said, butthe companywas tionals had been grouped with the OTCbusiness. ing the sale of its North American manual tooth- poised to “continue to capture market share Apart from the OTCunit, Skin Care and brush business. through innovation”. Women’sHealth were the only other Consumer The US performance easily offset a0.8% rise “I think we still have alittle bit of away businesses to post better sales in the quarter. in international turnover. International Oral Care to go with some innovation,”Caruso conceded, Worldwide Skin Care sales rose by 2.2% sales would have grown quicker,but theywere “but we have been very fortunate with the level in the third quarter to US$924 million, as both impacted by a2.4% negative currencyeffect, of innovation we have been able to deliverthus US and international turnoverincreased. The which offset a3.2% operational gain. farand Iamconfident we will see more com- Competitive pressures, the impact of divest- ing in the near term.” Pharmaceutical ments and the addition of Nutritionals to the Caruso added that the Consumer business Consumer 40% 21% US$7.04 billion mix, had led to the 7.4% decline in worldwide hadcontinued to perform in emerging markets, US$3.61 billion Wound Care/Other sales to US$349 million, even when economic growth in those markets Johnson &Johnson noted. US sales had dropped had slowed somewhat. by 9.8%, the companypointed out, while inter- Johnson &Johnson wasconfident that as national turnoverhad slipped back by 4.3%. consumers in emerging markets begantopur- Giventhat Johnson &Johnson’sdominant chase more personal-care products, the Con- Pharmaceuticals division –which posted third- sumer business would continue to do well and quarter sales up by 9.9% to US$7.04 billion showgrowth, Caruso noted. Medical Devices (see Figure 2) –had driventhe firm’ssales The Consumer division accounted for afifth &Diagnostics growth in past several quarters, Caruso wasalso of Johnson &Johnson’stotal third-quarter sales 39% US$6.93 billion asked whether the firm had considered selling (see Figure 3), which improvedby3.1% to its Consumer business. Caruso insisted, how- US$17.6 billion. Pre-tax profits advanced by Figure3:Johnson &Johnson’s sales in the third quarter of 2013 –US$17.6 billion –broken down by ever,that Johnson &Johnson wascommitted 2.0% to US$3.67 billion. business segment (Source –Johnson &Johnson) to maintaining a“broad base in healthcare”. OTC

25 October 2013 OTC bulletin 5 OTC25-10-13p2-7FIN_Layout 1 22/10/2013 14:50 Page 6

OTC COMPANY NEWS

BusinessStrategy DistributionAgreements/BusinessStrategy ScripsAmerica Revolymer starts roll out securesfunding of nicotinegum in Europe Spharmaceuticals distributor ScripsAmer- Uica has secured up to US$2.0 million (C1.6 evolymer’snicotine gum products will soon “With Revolymer’ssuperior product, we be- million) in newfinance to help fund the man- Rbe available to companies in anumber of lieve we have aquality offering for our cus- ufacture and marketing of its RapiMed OTC Central and Eastern European (CEE) markets, tomers,”Zarnowski claimed, “and we look for- children’sanalgesics range in both the US and after the UK-based development firm signed ward to achieving market penetration.” internationally. asupply and distribution deal with Poland’s Revolymer claims to have developed a“new Under the terms of the deal struck with Amma Polska. generation of nicotine gum” that –thanks to GEM Global Yield Fund, the companywould Revolymer –which specialises in polymer the company’s“polymer and formulation ex- be able to sell shares of its restricted common technology –said that the agreement would pertise” –has none of the poor texture and stock to GEM, subject to certain conditions, see Amma takeresponsibility for marketing, chewproperties of existing nicotine gums. Its ScripsAmerica said. sales and distribution of its nicotine gum in owngum offers “similartexture and chewchar- Bob Schneiderman, ScripsAmerica’schief markets such as the Czech Republic, Hungary, acteristics” to confectionery gum. executive officer,said that drivenbyits recent Poland and Slovakia. Furthermore, the companyhad also masked distribution deals in the US, the firm had per- Jonathan Swanston, Revolymer’svice-pres- the bitter nicotine taste, Revolymer pointed out, formed well so farin2013. This newfinancing ident of business development, said that now to achieve abetter-tasting product. deal would enable the companyto“focus on the companyhad bioequivalence data for the Revolymer’snicotine gum is already avail- executing” its distribution and acquisition strat- gum, it had started work on registering the prod- able in certain areas of Canada through twore- egy, he added. uct in European markets. tail subsidiaries of the US-based pharmaceuti- The newfunding comes just afew months cal wholesaler McKesson. after ScripsAmerica said that its RapiMed prod- Important commercialisation step Sold under McKesson’sPreferred brand ucts were set to be launched into large US The deal with Amma wasanimportant part name, the product is available through phar- retail chains such as CVS and Walgreens, after of its commercialisation programme,Swanston macies that are members of the Associated Re- entering into atwo-year representation agree- claimed, adding that Amma had a“detailed tail Pharmacies (ARP) group and the Family ment with DPG Distribution (OTC bulletin, knowledge of the customers and markets for Health Care Pharmacies chain, Revolymer said. 26 July 2013, page 20). nicotine-replacement therapygum”. Meanwhile, Revolymer noted it wasalso The deal gave US firm DPG Distribution Adam Zarnowski, owner and co-founder of using its technology to develop chewing gum the exclusive rights to purchase,promote and Amma, said that there existed “significant com- products that contained dimenhydrinate to com- resell ScripsAmerica’sRapiMed Pain Reliever mercial potential for smoking-cessation aids” batmotion sickness, antacids to neutralisestom- and FeverReducer line of orally-disintegrat- in CEE markets, thanks to “increasing health ach acid and vitamin blends to provide anew ing, rapid-dissolvetablets. awareness and changes in fashion and culture”. format for vitamin supplement companies. Comprising twoparacetamol products –an OTC 80mg strength for children aged twotosix years and a160mg strength for children aged Mergers&Acquisitions between six and 11 –the line is indicated for thetemporary relief of feverand minor aches Stada expands in Russia with Aqualor and pains due to colds, flu and headaches. Claiming that RapiMed was“faster-dissolv- ■ Continued from front page 2013, page 1) and forms part of its wider strat- ing” than the leading brand –bydissolving Products business in Russia during 2012, ac- egytoreduce its exposure to hard-pressed in 25 seconds compared with 35-60 seconds quiring the nutritional supplements Vuka Vuka national healthcareservices. by competitors, such as Johnson &Johnson’s and Vuka Drive (OTC bulletin,30March Earlier this year,Stada said that having out- Children’sTylenol Meltaways and Novartis’ 2012, page 4) –adeal which also included performedthe rest of the group in 2012, the Triaminic FeverReducer Pain Reliever–Scrips- the rights to Vuka Vuka in Central and East- Branded Products division would continue to America said it wasaiming for “100%” of the ernEurope (CEE) –the tranexamic acid brand growata“disproportionate rate” in 2013, as child-pain and fever-relief market. Tranexam and the antiviral Ingavirin. the companysought further opportunitiestoex- OTC These acquisitions lifted Stada’sBranded pand the business (OTC bulletin,29March Products turnoverinRussia by 25% to C 192 2013, page 7). million in 2012, making it the division’sbig- The company’sdominant Generics unit IN BRIEF gest market in terms of sales. Brands represent- wasparticularly exposed to national healthcare ■ GANEDEN BIOTECH –the US-based pro- ed 56% of Stada’stotal sales in Russia, which systems that were under increasing pricing pres- biotics specialist–said that its GanedenBC30 improvedby23% to C 343 million. sures, Stada pointed out. Branded Products’ probiotic formulation would soon be available The deal comes shortly after Stada expand- “better margins”, however, and its better pro- in Venezuela after the firm struck an exclusive ed the reach of its Branded Products busi- tection from “regulatory intervention”, made it deal with local distributor Biotechnologica3000. ness in the UK by acquiring OTCcompany an attractive area in which to invest. OTC Thornton &Ross (OTC bulletin,23August OTC

6 OTC bulletin 25 October 2013 OTC25-10-13p2-7FIN_Layout 1 22/10/2013 14:50 Page 7

COMPANY NEWS OTC

BusinessStrategy Futura’s CSD500gets CE mark approval

utura Medical’sCSD500 erection-maintain- national Consumer Products, said that the firm Eastern and North African countries after the F ing condom has been authorised for sale waslooking forward to working with Futura to companyagreed adeal with an unnamed local throughoutEurope and anumber of non-Euro- launch what wasan“extremely novelcondom”. healthcare group. pean countries with the grant of aCEmark. Futura said it believedthat CSD500 –which The twolicensing deals for CSD500 covered The UK-based development firm announced contains the erectogenic gel Zanifil –would atotal of 24 countries, the firm noted, pointing in September that CSD500 wasclose to receiv- “fundamentally change the condom market” out that it had been granted patents, or wasin ing its CE mark, after the product’sregulatory duetoits “highly innovative ‘disruptive’tech- the process of being granted patents, related to dossier had receivedapositive opinion from nology”, and would command a“significant the product in 36 countries worldwide. the relevant notified body (OTC bulletin,27 price premium overexisting condoms”. With the CE mark nowgranted and the deal September 2013, page 6). in the Middle East and North Africa finalised, James Barder,Futura’schief executive officer, Take abig shareofthe market CSD500 should be “launched in three conti- said the companywas “delighted” that CSD500 Furthermore, CSD500’s“appealing propo- nents during 2014”, Futura claimed. had overcome the regulatory hurdle, noting that sition and unique claims” would help growthe “Webelieve this ambition is deliverable and Church &Dwight had already snapped up the overall condom category,the firm insisted,add- will transform Futura into arevenue-generating rights to sell the product in some European ing that it expected the product to gain amar- business at the forefront of topical drug in- markets under the US-based consumer goods ketshare of over10% in the UK and the US. novation,”the companyinsisted. giant’sTrojan brand name. Three marketing claims for the product had Barder said that discussions with potential In April, Futura announced that it had grant- beenapprovedbyregulatory authorities, Futura licensing partners for other territories within ed Church &Dwight the rights to CSD500 in pointed out, including the maintenance of a Europe and worldwide were “proceeding well”. North America and parts of Europe (OTC firmer erection; increased penile size; and a Futura regained the rights to CSD500 from bulletin,12April 2013, page 3). longer-lasting sexual experience for women. Reckitt Benckiser (RB) in August last year Commenting on CSD500’sapproval, Steve In September,Futura revealed that CSD500 (OTC bulletin,14September 2012, page 3). Cugine, Church &Dwight’spresident of Inter- could soon be available in anumber of Middle OTC

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25 October 2013 OTC bulletin 7 OTC25-10-13p8-11FIN_Layout 1 22/10/2013 14:54 Page 2

OTC GENERAL NEWS

Research Market Research Study calls for Polish OTC market set to better herbals returntogrowth in 2013 erbal products sold in North America H frequently contain unlisted ingredients oland’sOTC market will recoverin2013 Themarket remained flat during 2012, PMR that could pose health risks. As aconsequence, Pfrom the negative effects last year of the reports, as the impact of the Reimbursement manufacturers should embrace DNAbarcoding country’sReimbursement Act and growby11% Act wasbalanced by rising prices and the to ensure that their products are “authentic” and to almost PLN10 billion (C2.4 billion), accord- launches of newproducts. “high quality”, according to anew study. ingtoareport from researcher PMR. Growing numbers of parapharmacies –offer- Published in the journal BMC Medicine, Defining the Polish OTCmarket as pharmacy ing only OTCproducts –are another conse- the study’sauthors claim that DNAbarcoding and non-pharmacysales of OTCmedicines and quence of the newlegislation, PMR says, as they –which identifies plant material based on dietary supplements, PMR projects that the mar- are not subject to the advertising restrictions im- short, standardisedgene sequences –when ap- ketwill be worth PLN9.91billion this year.It posed on pharmaciesbythe Reimbursement Act. plied to 44 herbal products from 12 companies adds that average market growth will be 6.6% Meanwhile, the advertising restrictions neg- had found that 59% of the products contain- in the four-year period to 2016. atively impacted online pharmacies. The rate ed DNAbarcodes from plant species not listed Increased co-payments for reimbursed medi- at which newonline pharmacies were establish- on the label. cines and aban on pharmacies using price pro- ed declined last year,PMR points out, as the Furthermore, product substitution wasde- motions for reimbursed drugs were twoofthe websites could not be promoted. tected in 30 out of the 44 products, the authors measures in last year’sReimbursement Act. Looking forward, PMR believesgrowth in point out, and only twoout of the 12 companies These measures negatively impacted the 2013 will be drivenbypharmacies focusing on had manufactured products which contained OTCmarket in 2012, PMR notes, despite ear- sales of OTCproducts and increased consumer no substitutes. lier forecasts that the Reimbursement Act would interest in OTCmedicines and dietary supple- These deficiencies, the authors claimed, benefit the non-reimbursed, non-prescription ments as theylook for lower-cost alternatives diluted the effectiveness of “otherwise useful segment as aresult of consumers seeking alter- to prescription drugs. remedies”. Moreover, the perceivedvalue of all nativestoexpensive prescription medicines. An extension of the increased 8% VATrate related productswas tarnished because of alack The opposite effect wasactually recorded, as for drugs from 2013 to 2016, PMR notes, will of consumer confidence in them, theyadded. 14% of Polish customers reduced their spend- not have anegative impact on the growth of the The use of a“DNAherbal barcode library” ing on OTCdrugs during the year,PMR claims. Polish OTCmarket in the four-year period. for testing bulk materials could improve man- OTC ufacturing practices, the authors say,and produce “safe, high-quality herbalproducts”. Market Research OTC Supplements can reduce healthcarecosts Health Claims upplements can reduce the ‘medicalevents’ potentially save “hundreds of millions of dol- EU Commission to Sassociated with chronic diseases and save lars”, theyadded. millions of dollars in healthcare costs, accord- An average of US$4.38 billion (C3.22 billion) allow exemptions ing to anew economic report carried out for the peryear from 2013-2020 could be savedinUS US Council for Responsible Nutrition (CRN). hospitalisation costs if all US adults over55 ood and beverage producers can nowob- Conducted by Frost &Sullivan, the report diagnosed with CHD –the most costly dis- Ftain exemptions from having to secure examined four chronic diseases –coronary ease in the US –were to use psyllium dietary European Union (EU) clearance for specific heart disease (CHD), diabetes attributed to CHD, fibre at preventive daily intakelevels, the re- ‘generic descriptors’ or denominations. aged-related eyedisease and osteoporosis –and searchers argued. EU Commission regulation 907/2013on thepotential for healthcare cost savings if all US Furthermore, using omega-3 supplements “setting the rules for applications concerning adults over55diagnosed with these diseases at preventive daily intakelevels by CHD pat- the use of generic descriptors” became applica- used certain dietary supplements, including ients could reduce US hospitalisation costs by ble in all EU member states on 11 October. omega-3, psyllium dietary fibre or vitamin D. US$2.06 billion per year,the researchers said. This regulation provides exemptions from The report’sauthors noted that its claims The report also suggested that if all US the strictures of the nutrition and health claims were based on scientific research into the reduc- women over55diagnosed with osteoporosis regulation 1924/2006 for generic descriptors tion in risk of medical events associated with used calcium and vitamin Dsupplements at pre- “which have traditionally been used to indicate certain supplements. ventive daily intakelevels, an average of US$1.9 aparticularity of aclass of food or beverages”, If the total US adult population with these billion per year could be saved. even when such names “could imply an effect chronic diseases used aspecific supplement Steve Mister,CRN’spresident and chief ex- on health”. Provenusage of 20 years is required. at preventive intakelevels, the number of dis- ecutive officer,claimed the report “emphati- Digestive biscuits, for example, might fall ease-associated medical events would be re- cally” indicated that dietary supplements could into this category. duced, the researcherssaid. In turn, this would contribute to healthcare savings. OTC lead to fewer hospital admissions and could OTC

8 OTC bulletin 25 October 2013 OTC25-10-13p8-11FIN_Layout 1 22/10/2013 14:54 Page 3

GENERAL NEWS OTC

Regulatory Af fairs Europe won’t treat e-cigs as medicines

he European Parliament has rejected apro- could potentiallyalso be prescribed under pub- after a13-week course of treatment. Tposal from the European Commission that lic health guidance on reducing the harms of Commenting on the outcomes of the study, all electronic cigarettes –commonly known as smoking from NICE –the National Institute Bullen pointed out that while the results had e-cigarettes –should be regulated as medicines. for Health and Care Excellence. not shown any“clear-cut differences between In the first reading of aproposal for are- The European Parliament’svote came shortly e-cigarettes and patches in terms of quit success vised Tobacco Products Directive,members of after the first clinical trial to compare e-cigar- after six months”, it had been clear that e-cig- the European Parliament (MEPs) agreed that ettes with nicotine patches revealed that the two arettes had been “more effective in helping while e-cigarettes should be regulated, they methods were both equally effective in helping smokers who did not quit to cut down”. should not be subject to the same rules as medi- smokers to quit (OTC bulletin,13September Bullen claimed that the study had establish- cinal products unless theywere “presented as 2013, page 11). ed a“critical benchmark” for e-cigarette per- having curative or preventative properties”. formance compared to nicotine patches and E-cigarettes for which no such claims were E-cigarettes help smokers quit placebo e-cigarettes, butwarned that there were made should contain no more than 30mg/ml Published in The Lancet in early Septem- still anumber of unknowns about the “effective- of nicotine, should carry health warnings and ber, the study led by Associate Professor Chris ness and long-term effects” of using e-cigar- should not be sold to anyone under 18 years Bullen, director of the National Institute for ettes, whether to help quit or not. of age, MEPs said. The products would also be Health Innovation at the University of Auckland “Giventhe increasing popularity of these subject to the same advertising restrictions as in NewZealand, claimed to showthat using devices in manycountries, and the accompany- tobacco products, the parliament added. either e-cigarettes or nicotine patches resulted in ing regulatory uncertainty and inconsistency, Furthermore, manufacturers and importers “comparable success in quitting”. larger,longer-term trials are urgently needed to of e-cigarettes should have to supply the com- The study’sauthors said theyfound that a establish whether these devices might be able petent authorities with alist of all the ingre- “roughly similar”number of smokers who had to fulfil their potential as effective and popu- dients that the products contained. used either e-cigarettesorpatches had remain- lar smoking-cessation aids,”Bullen said. The directive is expected to come into force ed abstinent from smoking for six months OTC in 2014. European Union (EU) member states will then have 36 months to transpose the new rules on e-cigarettes into national laws. Commenting on the vote, the Association of the European Self-Medication Industry,the AESGP,told OTC bulletin that it believed that the interests of European consumers would be “better served” if e-cigaretteswere regulated as medicines. The AESGP said that it agreed with the European Commission’sassessment that existing pharmaceutical legislation provided for a “coherent and well-established regulatory frame- work” in which to assess the “safety,quality and efficacy” of e-cigarettes. In the UK, the decision could hamper the government’splan for the Medicines and Health- care products Regulatory Agency(MHRA) from 2016 to regulate e-cigarettes as medicines (OTC bulletin,17June 2013, page 18). The parliamentary vote, the MHRA insisted, wasjust one stage in the legislative process – which wasstill not complete –and there would be further negotiation. It added that it continued to believe “medicinal regulation of nicotine containing products” wasthe “best waytode- liverabenefit to public health”. “Wewill be continuingtoencourage companies voluntarily to seek alicence for their products,”the MHRA said, “so that theycan be seen to meet appropriate standards of safety, quality and efficacy.” The agencyadded that licensede-cigarettes

25 October 2013 OTC bulletin 9 OTC25-10-13p8-11FIN_Layout 1 22/10/2013 14:54 Page 4

OTC GENERAL NEWS

Regulatory Af fairs Research Vitamin Dintake Stakeholders defend use should increase of vitaminDsupplements he recommendeddaily intakeofvitamin T Dand selenium for people in the Nordic he AustralianSelf-Medication Industry Both MacKay and Scarffinsisted that the region should be increased, according to the T(ASMI) and the US Council for Responsi- study should not discourage consumers from fifth edition of the Nordic Nutrition Recom- ble Nutrition (CRN) have jumped to the defence taking vitamin Dsupplements as apreventive mendations ( NNR). of vitamin Dsupplements, after areviewstudy approach for osteoporosis. Published every eight years by the Nordic concluded that the use of vitamin Dfor osteo- MacKay added that beyond osteoporosis, Council of Ministers,the NNR constitutes the porosis prevention wasinappropriate. vitamin Dprovided extensive benefits in other “scientific basis for the planning of diets for Duffy MacKay,CRN’svice-president of areas. “The body of scientific literature,”Mac- population groups and for the development of scientific and regulatory affairs, said that the Kayclaimed, “shows vitamin Dplays an impor- food-based dietary guidelines” across Åland, findings published in The Lancet had “serious tant role in cardiovascular health, immune health Denmark, Faroe Islands, Finland, Greenland, limitations”. The study had investigated the and diabetes.” Iceland, Norway and Sweden. effects of vitamin Dsupplements on bone den- “For people who aren’tobtaining adequate In its latest edition, the working group be- sity,but had failed to look at howvitamin D calcium or vitamin Dfrom natural sources, hind the three-year systematicreviewrecom- worked with calcium, MacKay pointed out. He supplementation is known to be ahighly effec- mend raising the daily intakelevel of vitamin insisted that the nutrients in combination helped tive waytofill the gap,”Scarffargued. Dfrom 7.5µgto10µgfor adults and children to prevent osteoporosis, as “vitamin Disneces- In the study,researchers at the University above twoyears of age. Adults aged 75 years sary for calcium absorption and bone density”. of Auckland reviewed 23 clinical trials that as- or older should take20µgdaily,the NNR says. Steve Scarff, ASMI’sregulatory and scien- sessed the effect of vitamin Donbone mineral Meanwhile, the recommended daily intake tific affairs director,also claimed that vitamin density in atotal of 4,082 participants. of selenium should increase from 40µgto50µg Dincombination with calcium could “provide Reviewing the results of the trials, the re- for adult females and 50µg to 60µg for adult aprotective effect against osteoporosis”. “There searchers noted “six findings of significant ben- males, the report notes. In pregnant and lac- is astrong body of evidence,”Scarffargued, efit, twoofsignificant detriment, and the rest tating women, the daily intakelevel should “which shows that calcium or calcium-vitamin were non-significant”. rise from 50µg to 55µg, it adds. Dsupplements may be beneficial for general Theyconcluded that “continuing widespread The Nordic Council of Ministers’ Commit- health as well as reducing fracture risk in peo- use of vitamin Dfor osteoporosis prevention in tee of Senior Officers for Food will formerly ple who may not be getting enough calcium individuals without specific risk factors for vita- approve the report in the autumn and the full, through their diet.” min Ddeficiencyseems to be inappropriate”. newedition of the NNR will be published short- OTC ly afterwards. OTC Regulatory Af fairs IN BRIEF Alternative source of folate approved ■ HMPC –the European Medicines Agency’s he European Food Safety Authority (EFSA) Regarding the safety of 5MTHF-glucos- (EMA’s)Committee on Herbal Medicinal Prod- Thas confirmed that 5MTHF-glucosamine amine, EFSA stated the ingredient wassafe ucts –has added the scientific body Good is asafe, alternative source of folate for use for use in supplements at the proposed levels Practice in Traditional Chinese Medicine Re- in food supplements. to treat folate deficiency. search Association and the industry organisa- EFSA’s Panel on Food Additivesand Nutri- The EFSA reviewhad been prompted by a tionEuropean Confederation of Pharmaceu- ent Sources added to Food (ANS) had been petition the European Commission received tical Entrepreneurs to its “list of interested asked by the European Commission to deliver from Italian biotechnology firm Gnosis. Gnosis’ parties”. The list includes bodies that repre- an opinion on the safety of 5MTHF-glucos- Quatrefolic supplement is afolate derivative sent industry and healthcare professionals, along amine “when added for nutritional purposes made from glucosamine. Quatrefolic had a with scientific societies and patients’ and con- to food supplements as asource of folate, and number of applications, the manufacturer indi- sumers’ organisations. on the bioavailability of folate from this source”. cated, including the treatment of folate defi- It had been proposed as an alternative source ciencyinpregnant women and in children. ■ CRN –the US Council for Responsible of folate to the calcium salt of 5-methyltetra- Commenting on EFSA’s positive opinion, Nutrition –has welcomed three newvoting hydrofolic acid (5MTHF-Ca), the regulator Renzo Berna, chief executive officer of Gnosis members to the association. The three com- pointed out, when used to makefood supple- said: “It givesusgreat opportunities in the mar- panies are Barrington Nutritionals; Stratum ments at doses of up to 1.8mg/day. ketplace and astrong competitive position.” Nutrition;and Vitatech Nutritional Sciences. The panel reviewed acrossovercompara- The firm noted that Quatrefolic had been The CRN represents over100 companies that tive bioavailability study which had been per- approvedinthe US as aNew Dietary Ingredient manufacture dietary ingredients and/or supple- formed in human volunteers. It concludedthat (NDI) in 2010, which had enabled Gnosis to ments, or supply services to the industry. folate from 5MTHF-glucosamine exhibited sim- market the product in the country. OTC ilar bioavailability to folate from 5MTHF-Ca. OTC

10 OTC bulletin 25 October 2013 OTC25-10-13p8-11FIN_Layout 1 22/10/2013 14:54 Page 5

GENERAL NEWS OTC

ProductRecalls Regulatory Af fairs Wockhardt issues recall PRAC examines of five OTC products in UK dihydrocodeine he European Medicines Agency’s(EMA’s) ockhardt UK has recalledvoluntarilyfive ply”, the MHRA said it wasallowing Wock- T Pharmacovigilance Risk Assessment Com- WOTCpainkillers that it markets under its hardt to continue to supply UK patients with mittee (PRAC) is to consider whether products ownbrand names and supplies as own-label 10 prescription-only medicines made at the containing dihydrocodeine should be subject products to several leading retailers. Chikalthana site. Although the Indian firm’s to the same warnings recently placed on medi- The recall results from manufacturing de- drugs had not been made to GMP standards, cines containing codeine. ficiencies identified by the UK’sMedicines the agencysaid, there was“no evidence of a Dihydrocodeine is available OTCasasingle- and Healthcare products Regulatory Agency patient-safety risk from medicines that have dose preparation or combined with other pain- (MHRA) during an inspection of Wockhardt’s been sold in the UK”. killers –such as paracetamol –inanumber facility in Chikalthana, India. Earlier this year,the MHRA recalled16 of markets, including Australia,Ireland, Switz- The agencyrecently withdrewits previously- drugs made at Wockhardt’smanufacturing fac- erland and the UK. issued good manufacturing practice (GMP) ility in Waluj, India, due in part to arisk of In June, the PRACrecommended that the certificate for the plant and replaced it with a cross-contamination. product information of medicines containing co- restricted GMP certificate that permitted the deine should include awarning that children Indian firm to makeonly “critical” products to Co-codamol products recalled with respiratory conditions should not use the avoid market shortages. In March 2012, Wockhardt recalled one batch painkiller (OTC bulletin,28June 2013, page 9). Included in the recall are aspirin, ibuprofen of anon-prescription co-codamol –codeine and The committee also recommended that and paracetamol products made for leading paracetamol –medicine in the UK because tab- medicines containing codeine should only be UK retail chains Co-op, HappyShopper,Spar lets containing too much codeine phosphate used to treat short-term moderate pain in child- and Superdrug. The companyhas also recall- were found inside the blister packs. Nearly ren above 12 years of age when symptoms ed products sold under the Best In and Gal- 40,000 packs were affected by the patient-level could not be relievedbyother painkillers such as pharm names. recall (OTC bulletin,30March 2012, page 11). paracetamol or ibuprofen.This wasdue to the Meanwhile, the MHRA has also recalled The recall followed reports receivedbythe risk of respiratory depression, the PRACsaid. from pharmacies,dispensing clinics and whole- generics companythat packs from one batch These recommendations were endorsed salers, five prescription-only drugs manufactur- of non-prescription co-codamol tablets con- by Europe’sCoordination Group for Mutual ed by Wockhardt at the Chikalthana facility. tained rogue prescription-only strength tablets. Recognition and Decentralised Procedures Most of the medicines affected by the pre- The lower-strength 8/500 co-codamol tablets human (CMDh) in July (OTC bulletin,26July cautionary recall were used for pain relief, the contained 8mg codeine phosphate and 500mg 2013, page 13). MHRA noted, butitalso included one medicine paracetamol, were mixed with higher-strength At the PRAC’sSeptember meeting –the –gliclazide –used to treat type 2diabetes. 30/500 co-codamol tablets containing 30mg co- minutes of which have just been released – Citing “concerns overthe continuity of sup- deine phosphate and 500mg paracetamol. members from Spain presented abrief review OTC which concluded that the metabolism of dihydrocodeine showed some similarities with the Distribution metabolism of codeine, and requested that the committee discuss whether the drug should Afipa rebuts price-competition proposals be subject to the same warnings as the medicines that contain codeine. roposals by France’sCompetition Author- self-medication prices in France “reflect asit- Although the PRACfound that evidence of Pity aimed at encouraging greater price com- uation that, farfrom being characterised by asimilar risk profile between dihydrocodeine petition and widening the distribution of certain dysfunctional competition, instead shows signs and codeine “appeared to be limited”, it noted self-medication products have been criticised of being avirtuous circle”. that there were “very limited data on the cor- in adocument published by local industry as- Addressing suggestions that the distribution relation between dihydrocodeine and the an- sociation Afipa. of certainproducts could be widened, Afipa algesic effects of its active metabolites”. Earlier this year,the Competition Authority warned of “considerable risks” and “threats to The PRACrecommended a“data-gather- had suggested that allowing outlets other than patient health” that could be posed by mov- ing exercise to identify those dihydrocodeine pharmacies to sell certain self-medication prod- ing away from the pharmacymodel. medicinal products approvedfor the treatment ucts could “foster price-basedcompetition” that Emphasising the “essential role of the phar- of pain in children in European Union (EU) would benefit consumers (OTC bulletin,26 macist” in recommending and ensuring the member states, and their current usage”. July 2013, page 17). The proposals were part of safety of self-medication, Afipa said that “un- Once this information had been collected, areport setting out the initial findings of aphar- likeinparapharmacies, pharmacists have teams the PRACwould offer further advice to EU maceutical sector inquiry announced earlier this of trained professionals, in daily contact with member states, the committee noted, adding year (OTC bulletin,29March 2013, page 10). patients,that can offer personalised advice” that afollow-up discussion would be planned But in adocument addressing the Com- to consumers. for an upcomingmeeting. petition Authority’sproposals, Afipa said that OTC OTC

25 October 2013 OTC bulletin 11 Presented by In association with

Marketing Awards Recognising the best of the British OTC industry

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2014 Awards Advert.indd 3 17/10/2013 12:30 OTC25-10-13p14-17FIN_Layout 1 22/10/2013 15:36 Page 2

OTC MARKETING NEWS

AdvertisingComplaints Unilever is warned against Flora cholesterol claims

nileverUKhas been forced by the UK’s made it an unauthorised health claim. UAdvertising Standards Authority (ASA) to However, the ASA also took issue with the pull twotelevision advertisements which makean omission of part of the authorised health claim, unauthorised health claim for its Flora Pro- which states: “Plant sterols have been shown activmargarine. to lower/reduce blood cholesterol. High choles- “Wherewill you take Oscillo?” is the theme of the In the advertisements, women are shown terol is arisk factor in the development of coro- photography contest currently being runinthe US either swimming or cycling and holding cards nary heart disease.” by homoeopathic firmBoiron for its Oscillococcinum –‘Oscillo’ –flu-relief product. comparing their previous levelofcholesterol Unileversaid in its response to the watch- Entrants must submit their favourite original with the current number.On-screen text states dog that its advertised claim did not imply that travel photo –via Facebook or through the Oscillo that the product contains plant sterols, adding: the product wasbetter than anyother food at website –for the chance to win agrand prize of a five-day,four-night trip for two to Paris, as well as “A daily consumption of 1.5-2.4g of plant sterols lowering cholesterol. US$500 (C 368) in spending money. can lower cholesterol by 7-10% in twotothree Furthermore, as it was“well-known and One winner will be chosen each week to receive weeks as part of ahealthydiet and lifestyle.” widely publicised” that high cholesterol was asix-dose pack of Oscillococcinum and abranded scarf. The winner of the grand prize will be chosen This statement is listed as an authorised arisk factor in the development of coronary from the weekly winners. claim on the European Union (EU) Register heart disease, the inclusion of the full word- Each entrant will receive avoucher offering of nutrition and health claims for food. It can ing of the claim was“superfluous”. US$2.00 offthe Oscillococcinum product, which contains anas barbariae hepatis et cordis extractum only be applied to yellowfat spreads, dairy Marketers could only “exercise some flex- 200CK and is indicated for the temporaryrelief of products, mayonnaise and salad dressings. ibility in rewording authorisedclaims”, the ASA ‘flu-like symptoms’ such as fatigue, headache, body The creativesend with the claim: “No other noted. This meant the claim could be simplified aches, chills and fever. Boiron is promoting the competition –which food lowers cholesterolmore.”This wasaspe- for consumers, the watchdog explained, provid- will rununtil 30 March 2014 –via “robust cific health claim, the ASA pointed out. It was ed the meaning wasnot changed. By omit- social-media channels”,including Facebook, not listed as authorised on the EU Register, ting the sentence about the risk factors of high Instagram, Pinterest and Twitter,aswell as within retailers. The company has also created aspecial the watchdog noted, nor did it form part of the cholesterol, Unileverhad “significantly alter- travel webpage at oscillo.com/travel. authorised disease risk-reduction claim. This ed” the meaning of the permitted claim. OTC OTC

ProductLaunches/LineExtensions GSK urges UK consumers to “trade up”

laxoSmithKline is encouraging UK con- sale list medicine is the first-evereffervescent G sumers to “trade up” from using pain- format under the Beechams cold-relief umbrella. killers to treat the first signs of cold and flu to It wasintended to help relieve the first signs of treating themselves with its Beechams Cold cold and flu symptoms such as asore throat, Relief Orange Flavour Effervescent Tablets. headache or fever, GlaxoSmithKline said, and Noting that the product provided “an effec- could be absorbed by the body in “in minutes”. tive paracetamol-basedformulation”, the firm Educating consumers about the benefits of insisted that general painkillers were most fre- the tablets would form a“pivotal” part of the

Parents of overexcited or anxious children and quently used by consumers on the first day product launch, the firm pointed out. This infants arethe target purchasers for the latest of acold or flu. would be bolstered by “impactful” point-of- addition to HevertArzneimittel’s range of However, it added, its research had also sale materials and out-of-store support. homoeopathic medicines in Germany. Calmy Hevertisapharmacy-only medicine that shown that 74% of consumers would buymedi- Apack of 16 effervescent tablets has arec- is indicated for children aged over six months. It is cated effervescent tablets in addition to their ommended retail price of £3.99. based on three homoeopathic extracts. usual products. According to Hevert–which is supporting the launch with an information leaflet –oat extract helps Pointing out that the “winter remedies cat- to combat nervousness, exhaustion and sleep egory” –according to Nielsen data –was cur- disturbances, while strychnine (nux vomica) acts rently worth £452 million (C 534 million) an- against increased irritability and sensitivity.Zinc isovalerate is said to promote sleep and relieve nually and wasgrowing at arate of 6.7% year- nervous complaints. on-year,the UK companysaid it expected £5.3 Calmy Hevertsucrose globules –which dissolve million incremental sales from the introduc- GlaxoSmithKline will encourage consumers to trade in the mouth –come in 7.5g packs that will be up from using generic painkillers for the first signs of available in German pharmacies from 1November at tion of the tablets. cold and flu symptoms to using its orange-flavoured arecommended retail price of C 9.77. Containing 500mg paracetamol, 125mg vita- effervescent tablets OTC min C, and 65mg caffeine per tablet, the general- OTC

14 OTC bulletin 25 October 2013 OTC25-10-13p14-17FIN_Layout 1 22/10/2013 15:36 Page 3

MARKETING NEWS OTC

ProductLaunches ProductLaunches/LineExtensions Altacorunveils GSK claims NiQuitin Strips eye-healthbar arefirst to the UK market more pleasing waytotakearegular “A ocular health supplement to help main- laxoSmithKline is claiming its NiQuitin tain healthyvision” is the promise to UK con- GStrips are the first of their kind in the UK sumers from ophthalmic firm Altacor for its smoking-cessation category. EyeBar fortified chocolate bar. Containing 2.5mg of nicotine per strip, the Containing vitamins Cand E, zinc and cop- general-sale list medicines were a“completely per,aswell as lutein and zeaxanthin (LZ), the newformat to the market”, the firm pointed “unique and innovative ocular supplement” pro- out. Placed on the tongue and pushed to the vided the nutrients recommendedbythe orig- roof of the mouth to dissolve, the mint-flav- inal Age Related Eye Disease Study (AREDS) oured oral film started to relieve the urge to andrecent AREDS2 study,the UK-based con- smokein50seconds. NiQuitin Oral Strips aresaid to reduce the need to sumer eyecare companyclaimed. The Strips variant adds to the existing NiQuit- smoke in 50 seconds According to the AREDS and AREDS2 in line of nicotine replacement therapy(NRT) be backed by a£1.6 million marketing cam- findings, taking regular eye-specific supple- products, which includes NiQuitin patches, Ni- paign. This would run into the first quarter of ments might reduce the risk of deterioration in Quitin Gum and the NiQuitin Pre-Quit range 2014, the companyadded, and included “a eyehealth by up to 26% when compared to a of patches and lozenges. number of online and television activities”, as diet of lowLZintake, Altacor pointed out. Of the 10 million adult smokers in the UK, well as in-store and point-of-sale materials, and EyeBar offered an alternative to pills or around two-thirds wanted to cut down, Glaxo- pharmacy-educationprogrammes. tablets, the firm added, which some people SmithKline claimed, while 2.5 million wanted Meanwhile, GlaxoSmithKline has also intro- might find difficult to digest. It recommended to quit. “By delivering avariety of formats, duced an orange-flavoured variant of its NiQuit- this will give our quitters the opportunity to in Minis lozenges, containing 1.5mg of nicotine. find amethod and format that works best for NiQuitin Minis are already available in mint them and their lifestyles,”commented Eliza- and cherry flavours, along with amint-flavoured beth White, NiQuitin brand manager. option that contains 4mg of nicotine. Claiming that IMS data valued the UK Furthermore, packaging for the NiQuitin line “smoking-cessation sector” at £222 million would be refreshed, GlaxoSmithKline added, (C263 million) annually –ofwhich NiQuitin to “bring areally strong brand presence to the wasthe second-largest brand, with a25.2% shelf”. The newpackage design can already share –the firm said the Strips product would be seen on the Strips product. OTC

Altacor's EyeBar is said to offer consumers a different way of obtaining the nutrients required to AdvertisingCampaigns maintain eye health Ricolalaunches first global campaign that consumers should eat one-to-twobars daily. Forconsumers who “prefer atraditional cap- icola’sherbal lozenges are getting their and would be extended across Europe and the sule format”, the firm has also introduced Eye- R first global marketing campaign.The aim Middle East in 2014. Tabs capsules. The “easy-to-swallow” capsules is to “strengthen Ricola’sposition as the world’s Every version of the commercial would con- contained vitamins B,C,E, as well as omega- leading brand of quality herb drops”. tain the same opening and closing scenes, the 3, lutein and zinc, Altacor noted, and could be Aseries of television advertisements would companysaid, to promote the “magical blend” used alongside the EyeBar. be supported by digital, print and point-of-sale of 13 herbs contained in its lozenges. Each spot Aconsumer public relations campaign for activities, the Swiss firm said. The campaign would conclude with an image of the product, both products wasplanned “for the next few wasalready underway in Austria, Germany, Ricola added, accompanied with the newbrand months”, the companypointed out. The Eye- Switzerland and the US, the companyindicated, tagline: “Famous for its Chrüterchraft”. Bar and EyeTabs products add to Altacor’s Noting that the literal translation of Chrüter- existing consumer eyecare range, which in- chraft was‘herbal power’, Ricola maintained cludes its Clinitas line of eyedrops and gels that the word incorporated all of the company’s for treating dry eyes, and its Blepha blephar- values and its Swiss heritage. tis-relief brand. The commercials would use avariety of Both abox of 30 bars and abox of 60 cap- situations to reveal howthe Ricola-branded sules have recommended retail prices of £20.00 lozenges –available in anumber of flavours ( C 23.66) and are available in pharmacies and including cranberry,elderflower and liquorice ‘optical retail outlets’. Ricola's first global campaign will highlight the –worked and tasted, the firm pointed out. OTC brand's “magical blend” of 13 herbs OTC

25 October 2013 OTC bulletin 15 OTC25-10-13p14-17FIN_Layout 1 22/10/2013 15:36 Page 4

OTC MARKETING NEWS

AdvertisingCampaigns Line Extensions Dr Schüssler Novartis Consumer Health gets first spot rolls out 12-hour Voltaren omoeopathic Dr Schüssler mineral salts H are the focus of the first ever television ovartis Consumer Health is rolling out a advertising run by the brand’sowner,Germany’s Ndouble-strength, 12-hour formulation of its Deutsche Homöopathie-Union (DHU). Voltaren (diclofenac) analgesic gel in Europe’s A30-second commercial running on major largest markets. channels from this month uses the keymes- In Germany, the companyissupporting its sage “DHU Schüssler-Salze. Das Original seit recently-launched diclofenacdiethylammonium 1873”, which translates as “Dr Schüssler Salts. 2.32% gel with television advertising. A30-sec- The original since 1873.” ond commercial featuresawoman with apain- The campaign –devised by Mannheim’s ful knee who is working on amarket stall. “Doppelt konzentriert, um den ganzen Tag durchzuhalten” –“Double concentrated, to last through the entire day” –isthe sign-offmessage. Novartis is augmentingthe German television campaign with trade-press advertising that highlights the pharmacy-only medicine’sprom- Novartis says the stronger 12-hour formulation of ise of up to 12 hours of pain relief. Recom- Voltaren is now available in 15 European countries mended retail prices for 100g and 150g tubes are The television campaign for Dr Schussler salts shows C16.95 and C21.98, compared to C14.30 for a supporting the launch with both television and how the brand has developed over 140 years 120g tube of Voltaren Schmerzgel 1.16% gel. press advertising. Schaller &Partner agency–features pharma- In the UK –where Voltarol 12 Hour Em- Reporting its third-quarter financial results cists preparing, and selling to patients, DHU ulgel 2.32% gel has been launched with rec- on 22 October,Novartis said the 12-hour for- Schüssler-Salze products throughout the brand’s ommended retail prices of £6.99 (C8.26) for mulation of Voltaren wasnow available in 15 140-year history.“Denn es gibt nur ein Orig- 30g and £9.99 for a50g tube –Novartis is European countries. inal” –“Because there is only one original” – OTC is the sign-offmessage. “With homoeopathic medicines, trust in their AdvertisingCampaigns heritage plays an important role,”commented DHU’smarketing director,Birgit Schäfer.“That Sanofi reinvestsinDioralytecampaign shines out from the commercial,”she added. DHU is augmenting the television cam- anofiisspending £1 million (C 1.2 million) stages of their lives, including travelling, get- paign with consumer advertising in “classic S on relaunching aUKtelevision campaign ting married, and having children. The cam- women’stitles”. for its Dioralyte rehydration therapybrand in paign highlighted the benefits of the general- OTC the lead-up to the festive season. sale list electrolyte powder,the firm said, by The campaign –which first aired in Decem- showing howthe product could be used in sev- ber last year –followed a“hugely successful eral different scenarios. It will air on arange year” for Dioralyte,the firm claimed, which of television channels, including ITV,Chan- “brought one million newusers” into the oral- nel 4, and Good Food. rehydration therapycategory and sawthe brand’s Sanofinoted it had also invested in asep- market share increase by nearly afifth to 89%. arate public relations and digital promotion to Running from 1-30 November,the 10- and support the television campaign. This will run 20-second spots feature acouple at various from 4November to 16 December.

Merck Médication Familiale is launching its first OTC television advertising campaign in France for Prospan cough syrup. The product –which contains ivy extract –ismarketed through the company’s EG Labo has launched what it claims is France’s local Mediflor subsidiary. “first range of generic nicotine substitutes in the The 20-second advertisement shows acoughing formofchewing gum”. mother and child sitting on asofa in afuturistic Marketed in two strengths across five laboratorymanned by tiny “Mediflor experts”. An ivy presentations, the mint-flavoured nicotine gum leaf is mechanically picked from aplant to produce is sold under the label ‘Nicotine EG’. abottle of Prospan, which soothes the coughing. Both the 2mg and 4mg strengths areavailable Pharmacy-press advertising for Prospan points in packs of 36 and 108 units, whilst the 2mg out that the product is sugar-free and suitable for strength is also sold in a208-count pack. EG Labo adults and children over two years old. It also notes has also introduced pharmacy posters and displays that the syrup does not cause drowsiness. to promote the product. OTC OTC

16 OTC bulletin 25 October 2013 OTC25-10-13p14-17FIN_Layout 1 22/10/2013 15:36 Page 5

MARKETING NEWS OTC

ProductLaunches/LineExtensions RB spends£3.5mn on Cold &Flu line

eckitt Benckiser (RB) is looking to reach Both options contain 200mg ibuprofen and Rover 85% of the UK adult population with 5mg phenylephrine hydrochloride and are in- a£3.5 million (C4.1 million) marketing cam- dicated for the relief of symptoms of cold and paign for its Nurofen Cold &Flu range. flu with associated congestion –such as head- Anational television campaign would air ache, fever, and blocked nose and sinuses. for the first time on 28 October and use the Meanwhile, aNurofen for Children Cold, current “for livesbigger than pain” tagline, the Pain and Feveroral suspension, containing firm noted. Launched in February,the campaign 100mg ibuprofen per 5ml, has been launched Reckitt Benckiser has extended Nurofen’s Cold & Flu range with four line extensions, including Nurofen focuses on “real people with amazing liveswho for children aged between three months and nine Cold &Flu Relief trust Nurofen to deal with their pain so they years. Available in both strawberry and orange can get on with their day” (OTC bulletin,22 flavours, the general-sale list liquid started to Nurofen for Children products together for the February 2013, page 17). Print and Facebook work in 15 minutes, the firm said, and could pro- first time in an attempt to repositionthe brand activity will further support the television cam- vide relief from symptoms for up to eight hours. as aremedy for colds and flu (OTC bulletin, paign, as well as billboards and advertising on Claiming that 27% of cold and flu sufferers 18 December 2012, page 14). London Underground trains. opted for an analgesic to ease their cold and flu Both Nurofen Cold &Flu Relief and Nuro- Containing five products in total, the line symptoms, the companysaid the line extensions fen Day &Night Cold &Flu products are nowcaters for “all ages”, RB pointed out. andaccompanying promotional campaign could available in packs of eight and 16 tablets with Adding to the existing pharmacy-only Cold see Nurofen growthe cold and flu category recommended retail prices of £2.99 and £5.49 &Flu product –which contains 200mg ibu- by 4% –or£3million –and the children’spain respectively,while the pharmacy-only Nurofen profen and 30mg pseudoephedrine –the range category by 1% –or£0.5 million –inthe 2013/ Cold &Flu tablets have arecommended price for adults also includes twogeneral-sale list 2014 season. of £5.99 for 24 tablets. Nurofen for Children variants, Nurofen Cold &Flu Relief tablets and Last winter,RBran a£1.8 million television Cold, Pain and Feverhas arecommended retail Nurofen Day &Night Cold &Flu tablets. campaign to promote its adult Nurofen and price of £3.99 for 100ml. OTC

Marketing Campaigns M e rck o ffe rs U K m o the rs fre e folic a c id

erck KGaA’s UK vitamins, minerals and Research conducted for SevenSeas had M supplements brand SevenSeas is offer- shown that 44% of mothers and pregnant ing free folic acid to expectant mothers as part women who planned their pregnancydidn’t of apartnership with parenting club Bounty. take folic acid whilst trying to conceive and in The collaboration aims to raise awareness the early stages of pregnancy, Merck said. among mothers-to-be of the importance of tak- Advertising on the Bounty website –which ingfolic acid supplements during pregnancy. is said to have 2.5 million members –and ‘pre- Forthe first time, samples of SevenSeas natal email campaigns’ would further support Pregnancytablets –which contain the recom- the partnership, Merck added, which will run mended 400µg of folic acid –and money-off until the end of the year. vouchers will be included in Bounty pregnancy The firm is also offering £1 offthe purchase Pfizer Consumer Healthcarehas signed up US sports information folders, the firm noted, adding that of either its SevenSeas PregnancyorSeven Seas personality Alex Morgan as the first spokesperson in adecade for its ChapStick lip-balm brand in the US. 910,000 pregnant women receivedafolder PregnancyPlus Omega-3 products, through The company said that Morgan –“an avid every year at their first midwife appointment. avoucher that can be downloaded from the ChapStick user” –would appear in atelevision and brand’swebsite. print media campaign for its ChapStick Hydration Lock product that will runfrom4November.The In August,the European Food Safety Auth- campaign will also include aseries of digital videos. ority (EFSA) gave apositive opinion on the In atwo-year partnership with the brand, disease-risk reduction claim that increased folic Morgan –Olympic medallist and member of the US women’s national soccer team –would “play acid intakebyexpectant mothers reduces the an integral role in spreading the wordabout the risk of neural tube defects (NTD) such as spina importance of caring for your lips and the many bifida and anencephalyinfoetuses (OTC bul- offerings ChapStick provides”, Pfizer claimed. The goal of the campaign was to “open letin,23August 2013, page 19). consumer’s eyes to overall lip health in fun and inter- To obtain the claimed effect, EFSA noted, esting ways”, commented Farrell Simon, ChapStick’s 400µg of supplemental folate should be con- senior brand manager. “Alex Morgan embodies the voice of our consumer,” sumed daily for at least one month before and he added, “making her the perfect fit to help evolve 910,000 expectant mothers everyyear aresaid to up to three months after conception. the way we view and carefor our lips.” receive aBounty pregnancy information folder OTC OTC

25 October 2013 OTC bulletin 17 NEW

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ToolboxA4leaflet-.indd 1 21/05/2013 10:54 OTC25-10-13p19FIN_Layout 1 22/10/2013 14:56 Page 2

EVENTS OTC

NOVEMBER The newgrowth imperative in 28-29 November Fax: +44 20 7017 7823. health and beauty’ is the theme of ■ EMA Review of the Year Email: [email protected]. 4-5November this two-day meeting. and Outlook for 2014 Website: www.pti-global.co.uk/cis. Contact:Lorian Pitman, ■ Futureofthe Pharmacy London, UK 16-18 December Ceuta Healthcare. Frankfurt, Germany Atwo-day conference –run by Pharmacovigilance This two-day meeting –which will Tel: +44 1202 449 709. ■ The Organisation for Professionals London, UK be conducted in German –will Email: lorian.pitman@ceuta in Regulatory Affairs (TOPRA) – Drug safety monitoring in the Euro- examine the latest developments healthcare.com. featuring speakers from the Euro- pean Union (EU), Japan and the in the healthcare market. Website: www.ceutaalliance.com. pean Medicines Agency(EMA). US will be covered at this three- Contact:Inspirato Konferenzen. Contact:TOPRA. day meeting. Tel: +49 6172 981 9680. 18 November Tel: +44 20 7510 2560. Contact:Management Forum. Fax: +49 6172 981 9689. ■ Pharma Partnering Fax: +44 20 7537 2003. Tel: +44 1483 730071. Email: [email protected]. China Email: [email protected]. Fax: +44 1483 730008. Website: www.inspirato.de/zukunft- Brussels,Belgium Website: www.topra.org. Email: registrations@management- apotheke. This one-day workshop will focus on registering and selling products 28-29 November forum.co.uk. Website: www.management-forum.co.uk. 8November in China. ■ Pharma Branding ■ The Centralised Contact:Europharm SMC. Summit 2013 JANUARY2014 Procedure Tel: +32 2529 5842. Shanghai,China Bonn, Germany Fax: +32 2529 5872. ‘Winning brand models and empir- 31 January Aone-day seminar covering the Email: [email protected]. ical solutions’ will be covered at this ■ Understanding the centralised procedure for OTCmed- Website: www.europharmsmc.org. two-day summit. Fora30% dis- Decentralised and icines, generics and newsubstances. count quote: Brandingsummit88. 19 November Mutual Recognition Contact:DrHenriette Wolf-Klein, Contact: Borscon China. Procedures Forum Institut für Management. ■ Good Manufacturing Tel: +86 21 33191337. London, UK Tel: +49 6221 500 680. Practice for Herbals Fax: +86 21 54363078. Aone-day course analysing the Fax: +49 6221 500 555. Bonn, Germany Email: [email protected]. differencesand similarities of the Email: [email protected]. Aone-day seminar,organised by Website: www.borscon-pb.com. decentralised and mutual recog- Website: www.forum-institut.com. Germany’smedicines manufacturers’ association, the BAH, and con- DECEMBER nition procedures. 11-13 November ducted in German. Contact:Management Forum. ■ Pharmaceutical Contact:BAH. 2December Tel: +44 1483 730071. RegulatoryAffairs Tel: +49 228 957 45 0. ■ Pharmaceutical Fax: +44 1483 730008. in Latin America Fax: +49 228 957 45 90. RegulatoryRequirements Email: registrations@management- forum.co.uk. London, UK Email: [email protected]. in Japan Website: www.management-forum.co.uk. Day one of this three-day confer- Website: www.bah-bonn.de. London, UK ence will coverBrazil, Colombia Aone-day seminar focusing on the FEBRUARY and Peru. Countries such as Ar- 25-26 November regulatory environment in Japan. gentina, Mexico and Venezuela ■ EuroPLX 53 Contact:Management Forum. 25 February Barcelona, Spain will be the focus of day two. Chile Tel: +44 1483 730071. ■ Hot Topics in Advertising This two-day conference will pro- and Ecuador will be discussedon Fax: +44 1483 730008. London, UK day three. vide aforum for business devel- Email: registrations@management- Aone-day event run by the UK Contact:Management Forum. opment decision makers for dis- forum.co.uk. Medicines and Healthcare prod- Tel: +44 1483 730071. cussing and negotiating collabor- Website: www.management-forum.co.uk. ucts Regulatory Agency(MHRA). Fax: +44 1483 730008. ative agreements in licensing, mar- Contact:MHRA. 2-4December Email: registrations@management- keting, and distribution of patented Tel: +44 20 3080 6000. Good Manufacturing forum.co.uk. medicines, generics, biosimilars, ■ Fax: +44 20 3118 9803. Website: www.management-forum.co.uk. OTCproducts, medical devices Practice and Good Email: [email protected]. and food supplements. Distribution Practice Website: www.mhra.gov.uk/conferences. 14 November Contact:RauCon. London, UK ■ ASMI 2013 Conference Tel: +49 6222 9807 0. Athree-day event organised by the 25-28 February Sydney,Australia Fax: +49 6222 9807 77. UK Medicines and Healthcare prod- ■ OTC Pharma Asia ‘Self Care: Driving aconsumer- Email: [email protected]. ucts Regulatory Agency(MHRA). Singapore centric future’ is the theme of Website: www.europlx.com. Contact:Glasgows. Topics to be discussed at this four- this one-day event, organised by Tel: +44 1772 767715. day conferencewill include: Con- 28 November the Australian Self-Medication In- Email: [email protected]. sumer trends and emerging mar- Building aRegulatory dustry (ASMI). ■ Website: www.mhra.glasgows.co.uk. ketopportunities;regulatory issues Contact:ASMI. Strategy for Marketing and ASEAN harmonisation; strat- Tel: +61 29922 5111. Food Supplements 12-13 December egic sales and marketing; brand- Fax: +61 29959 3693. Brussels,Belgium ■ Gaining Marketing ing and segment marketing; retail Email: [email protected]. Countries including Belarus, Kaza- Authorisations in CIS and trade marketing; and regional Website: www.asmi.com.au. khstan and Russia will be discuss- London, UK growth strategies. Fora15% dis- ed at this one-day meeting. Strategies for gaining market count quote: P46233OTCB. 14-15 November Contact: EAS. access in the Commonwealth of Contact:IBC Asia. ■ 8th International Tel: +32 2218 1470. Independent States (CIS) will be Tel: +65 6508 2401. Alliance Conference Fax: +32 2219 7342. covered at this two-day seminar. Fax: +65 6508 2407. London, UK Email: [email protected]. Contact:Informa UK. Email: [email protected]. ‘Global market expansion services: Website: www.eas.eu. Tel: +44 20 7017 7481. Website: www.otcpharmaasia.com.

25 October 2013 OTC bulletin 19 OTC25-10-13p20-21FIN_Layout 1 22/10/2013 16:25 Page 2

OTC BUSINESS STRATEGY GSK brings science to shopperinsights

Having refocused its product portfolio on brands that can command scientific or professional endorsement, GlaxoSmithKline Consumer Healthcare is now applying the same scientific standards to discovering what consumers really want. Matt Stewart reports.

ehind the doors of an anonymous Kline Consumer Healthcare, which has seen the greybuilding overshadowed by division streamline its global product portfolio to GlaxoSmithKline’ssleek, blue tint- reflect its focus on productsthat can command Bed headquarters in west London, scientific or professional endorsement, and have UK, hides what the pharmaceutical company the potential to growinemerging markets. claims is the “most advanced shopper insight Most recently,the companyagreed to sell facility in the world”. its iconic Lucozade and Ribena drinks brands Carlton Lawson, general manager of GlaxoSmithKline A1,000sq mresearch facility filled with to Japan’sSuntory Beverage &Food for £1.35 Consumer HealthcareinGreat Britain and Ireland, ground-breaking technology –including the billion (C1.59 billion) as theydid not fitwith says the Shopper Science Lab will help the company “unlock the healthcareopportunity”. world’sbiggest seamless touch-screen –Glaxo- Consumer Healthcare’sscience-led philosophy SmithKline’sstate-of-the-art Shopper Science (OTC bulletin,27September 2013, page 1). along with agrowing awareness of self-care Lab is designed to unlock what the company This followed a2012 which sawGlaxoSmith- among consumers –are openingupopportunities describes as the “healthcare opportunity”. Kline divest anumber of Consumer Health- for manufacturers and retailers, he points out. Carlton Lawson, general manager of Glaxo- care’snon-core brands across the US, Europe Consumers are taking control of their health, SmithKline Consumer Healthcare in Great Brit- and other regions for net cash proceeds of ap- Lawson notes. Theyare not only treating minor ain and Ireland, says the facility represents the proximately £690 million. ailments, butalso managing chronic conditions, firm’sintention to focus the science it applies GlaxoSmithKline Consumer Healthcare’s while at the same time turning to preventive to both its products and behavioural programmes portfolio is nowsplit across four product seg- products as theylook to “age healthily and make to its consumer research. ments –Oral Care, Nutrition,Skin Health and the most of their lives”. Using the Shopper Science Lab, the com- Wellness –with most of its OTCbrands sitting “From diagnosis through to treatment, and panywill be able to see howshoppers interact in the Wellness segment. from prevention all the waytoenhancement, with its products, Lawson explains. It will show with our science-based offerings, we can really howshoppers judge packaging and even how Unlock the healthcareopportunity help consumers and retailers unlock the health- theyviewproduct websites. In the UK, Consumer Healthcare has turned care opportunity,” Lawson claims. “Through the Shopper Science Lab and in- its focus to “unlocking the healthcare oppor- The company’seducation programmesfor novative research techniques, we are discover- tunity” for both itself and its retail partners, both consumers and healthcareprofessionals ing newshopper insights to develop tailor-made Lawson says, insisting that the companyis“well can help people to self-diagnose safely,Lawson retail category partnerships that meet our shop- placed to do this”. points out, while products such as Corsodyl pers’ needs,”Lawson claims. “I think the time is nowfor self-care in the mouthwashes help prevent conditions such as Thelaunch of the Shopper Science Lab fol- UK,”Lawson insists. “Mega-trends” such as gum disease. lows aperiod of reorganisation at GlaxoSmith- an aging population and amini-baby boom – Consumer Healthcare’sUKoffering can even help enhance people’shealth, Lawson says, with the Maxinutrition brand providing consumers with arange of protein products designed to aid recovery and increase strength. “All of our products are unique in the fact theyare provenbyscience,”Lawson reiterates, “whether theyare innovative switches or nutrition products, theyhaveclinical science behind them.” “The question now,”Lawson asks, “is how do we translate this for the consumer?” That is where the Shopper Science Lab really comes into its own, he adds. According to Lawson, the Shopper Science Lab is the “most advanced shopper research facility in the world”, enabling the company “to really understand consumers as theyshop for their healthcare needs”.

GlaxoSmithKline’s Shopper Science Lab features a“first of its kind” mock up of aretail pharmacy,complete Loaded with advanced monitoring and with prescription counter and consultation room. interactive technology,the companyand retail-

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BUSINESS STRATEGY OTC

ers can also takeadvantage of the “first of its kind” mock-up of an entire pharmacy, complete with prescription counter and consultation room. The facility also offers “bespokeskin and facial biometric tools” to help understand a shopper’s“unconscious and emotional reac- tions”; while adedicated research control room with fixedcameras, allowing remote viewing of shoppers in all the researchareas. However, arguably the most spectacular feature is the five-metre wide, two-metre high, seamless touch-screen, known as the “Virtual Insight and Engagement Wall”. The wall offers “full 3D visualisation of retail environments”, GlaxoSmithKline points out, enabling the companyand retailers to GlaxoSmithKlineclaims that its Shopper Science Lab, based in abuilding next to its headquarters in London, wander around virtual representations of real- UK, is the most “advanced shopper insight facility in the world” life stores and even to pick up items offthe shelves and examine a3Dimage of the item. then adapt store layouts means that feedback smarter and there is increased competition both Data gathered in physical stores on where on newinitiativeswill be almost instant, Hay- in the real world and online”. people walk, which shelves theystop at and wood claims. “What this means is what has historically which products theypick up can also be over- Researchersatthe facility can look at the worked for manufacturers and retailers in the laid onto the virtual 3D image, the company complete layout and segmentation of categories past might not necessarily be arecipe for suc- notes, to showretailers howconsumers use the or departmental areas in retail stores and phar- cess in the future,”Haywood warns. store, and howshelving and merchandising macies, Haywood points out. It can also ex- “Fundamentally understanding our core shop- could be adjusted to drive sales. per and consumer needs is Crispin Haywood, director of the Shopper Manufacturers and retailers arenow operating vitally important to us,” Science Lab, says the facility enables Glaxo- Haywood insists, “so we SmithKline to generate “quicker and more in a“dynamic ever-changing environment, where can deliverbetter prod- useful insights into shoppers’ purchasing deci- shoppers aresmarter and thereisincreased ucts and work smarter and sions”, which in turn will help to increase competition both in the real world and online” more collaboratively with profitabilityand category growth for both the our retail partners.” companyand its retail partners. amine howin-store media and point-of-sale While the Shopper Science Lab will help The Shopper Science Lab enables Glaxo- materials are positioned. the companytounderstand the “very basic SmithKline to integrate shopper insights earlier General concept testing and testing of pack- needs” of the shopper in both online and off- in the product development process, Haywood aging is also available, Haywood adds, as well line shopping environments, it will also help explains, which will shorten lead times and as website testing using eye-tracking technol- bring to light some of the “higher order” needs improve the return on investment for the com- ogy to improve design and layout. of consumers. This can be used to inform future panyand retailers. Haywood points out that manufacturers and commercial decisions, Haywood says. The speed at which GlaxoSmithKline will retailers are nowoperating in a“dynamic ever- The facility will also serveasacreative gatherinsights, analyse them in real time and changing environment, where shoppers are hub, Haywood notes, which will foster better collaboration between GlaxoSmithKline and its retail partners. GlaxoSmithKline has “fantastic” consumer insights already,but so do its retail partners, Haywood points out. “Only when we bring these insights together will we get aholistic picture of shoppers’ needs and howwecan meet them together,” he adds. Once this has been done, it is afairly simple task to work with retailers to prioritise what the keyopportunitiesare, Haywood says. This may involvechanging fixtures, introducing newpack- aging or even introducing newproducts. Furthermore, the facility also allows for GlaxoSmithKline and its retail partners to use these insights to identify market opportunities that are perhaps five or even 10 years away,Hay- wood claims, and to start thinking about howbest

Akey featureofGlaxoSmithKline’s Shopper Science Lab is the world’s largest seamless touch-screen which to makethe most of these opportunitiesnow. provides full 3D visualisation of retail environments OTC

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PEOPLE OTC

Manufacturers Manufacturers J&J boardadds Sanofi appoints Warneryto past FDA chief lead global Consumer unit ohnson &Johnson has appointed former J US Food and Drug Administration (FDA) anofihas appointed Vincent Warnery to Vincent Warnery commissioner Dr Mark McClellan to the com- Sset up and lead its newGlobal Consumer pany’sboard of directors. Healthcare division. McClellan will serveonthe board’sReg- Creating the newdivision, the French firm ulatory,Compliance &Government Affairs said, would group Sanofi’sglobal OTCsub- Committee and its Science, Technology &Sus- sidiaries under one banner for the first time. tainability Committee. As senior vice-president of the division, Commenting on the appointment, Johnson Warnery would be responsible for coordinat- &Johnson’schairman and chief executive offi- ingboth newproduct development and multi- cer,AlexGorsky, said McClellan would be a regional commercial strategy,the firm explained. “valued leader on our board” and had a“dis- Warnery will report to Pascale Witz,exec- tinguished record in the public sector” as well utive vice-president of Sanofi’sGlobal Divisions in the world behind Johnson&Johnson and as a“vision for the future of healthcare”. &Strategic Commercial Development unit. Bayer.In2012, the firm’sConsumer Healthcare Currently at the Brookings Institution serv- Sanoficlaimed the newdivision would sup- unit posted sales up by 12.8% –9.9% at con- ing as director of the EngelbergCentre for port its strategy of building innovative global stant exchange rates –toC3.01 billion (OTC Health Care Reform and chair in Health Policy brands and would ensure the continued growth bulletin,22February 2013, page 4). Studies, McClellan has overtwo decades of of its Consumer Healthcarebusiness. The companyisset to expand its US OTC public service and academic experience. Warnery joined Sanofiin2011, serving as offering, after the Food and Drug Adminis- McClellan served as FDAcommissioner vice-president for Consumer HealthcareEurope tration (FDA) approvedthe prescription-to-non- from 2002-2004 and as administratorofthe and global development. Previously,hehad held prescription switch of its Nasacort AQ (triam- Centres for Medicare &Medicaid Services positions at L’Oreal and Procter &Gamble. cinolone acetonide) nasal spray to treat allergy for the US Department of Health and Human Noting that Warnery had a“broad interna- symptoms (see below). Services from 2004-2006. tional background”, the firm pointed out that Set to be launched in spring 2014, Nasacort The firm’sMcNeil US OTCbusiness is cur- he had held anumber of management posi- Allergy 24HR wasthe “only single active ingre- rently operating under aconsent decree filed by tions covering various markets across Asia, dient OTCmedicine” that relievedthe “full range the US Department of Justice and the FDAin Europe and Latin America. of nasal allergy symptoms” for 24 hours with 2011 (OTC bulletin,17March 2011, page 1). Sanofiisthe third-biggest OTCbusiness asingle dose, Sanoficlaimed. OTC OTC

Switches used OTCmedication to tackle the symptoms of allergic rhinitis, Sanofisaid, butthese had NasacortAllergy gets OTC approval in US not been indicated to treat nasal congestion, the “most bothersome symptom”. ■ Continued from front page Allegra Allergy,which waslaunched by San- Equally,OTC decongestant products, such of post-marketing surveillance data. ofi’sUSsubsidiary,Chattem (OTC bulletin, as pseudoephedrine and oxymetazoline, had a The NDAC said that it was“reasonableto 11 February 2011, page 16). number of drawbacks, including restricted ac- conclude” that people would be able to “self- Sanofisaid that there wasa“need for con- cess and short usage duration. diagnose and self-select” Nasacort AQ “based sumer OTCproducts for adults and children By contrast, Nasacort AQ had been shown solely on the information provided on the nasal that reduce allergic rhinitis symptoms, includ- to be “highly effective”intreating the symp- spray drugs facts label”. ingnasal congestion”. toms of allergic rhinitis, including nasal con- In abriefing document presented to the com- “Inadequate treatment of allergic rhinitis gestion, the document noted, and had demon- mittee, Sanofisaid that the outcome of alabel across all age groups is associated with fatigue, strated greater improvements compared to lor- comprehensionstudy had shown that consum- sleep disturbance, and substantial negative im- atadine, the active ingredient in Merck &Co’s ers, even those with “lowhealth literacy”, could pacts on quality of life, psychologicalwell- Claritin oral antihistamine. understand the instructions in the proposed being and the ability to learn and process cog- Triamcinolone acetonide –the active ingre- consumer label. These label directions would nitive input,”the companyclaimed. dient in Nasacort –isalready available OTC help mitigate potential risks with the use of The briefing document noted that “approx- in anumber of countries around the world, in- Nasacort AQ in the consumer environment, the imately one-third” of patients with allergic rhin- cluding Australia, Germany, Japan and the UK. companypointed out. itis reported that symptoms had caused them In the UK, Nasacort Allergy Nasal Spray Nasacort Allergy wasthe “first intranasal to miss work, with half maintaining that the waslaunched as an OTCmedicine in 2009, nine steroid” approvedfor OTCsale in the US, condition affected their daily lives“to some or years after the UK had first proposed the switch Sanoficlaimed, and would build on the success- to amoderate extent”. ( OTC bulletin,17March 2009, page 17). ful 2011 US switch of its fexofenadine-based Oral antihistamines were the most commonly OTC

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