Q&A with Spotlight Beware Galderma’s on the new June Risser Serrix competitors page 17 page 8 page 20

Contents PfizerUKwants to 7April 2017 Issue Number 480 switch sildenafil COMPANY NEWS RB exploring sale 3 en in the UK could soon have OTC of Food business Maccess to Pfizer Consumer Health- Alliance in the marketfor deals 4 care’serectile-dysfunction drug sildenafil Stada holds takeover talks 5 –the active ingredient in the blockbuster prescription brand Viagra –ifaswitch ap- Futurasecures Portugal deal 6 plication by thefirm is successful. J&J to kick-start7 According to the Medicines and Health- safety challenge careproducts Regulatory Agency’s(MHRA’s) GENERAL NEWS ARM94 switchconsultation document, Pfizer wants to move sildenafil 50mg film-coated tab- Pfizer wants to switchsildenafilfromPOM to P CHPAeyesmonograph win 10 letsfromprescription-only medicine (POM) Calcipotriol set forUKswitch 12 to pharmacy(P) status. claimed, “as the condition may be an early Med devices rules 13 Sildenafil will be availablefromapharma- warning sign of amore serious underlying con- ripe forpublication cist without aprescription for men aged 18 dition, such as heart disease, which may other- years or older suffering from erectile dysfunction, wise go undetected.” NHS to stop paying 14 ARM94 states.The maximum doseisone tablet It wasestimated that up to 70% of men went forsome OTCdrugs aday,with apack size of up to eight tablets. without, or delayed seekingtreatment. Thiswas MARKETING NEWS potentiallydue to the stigma associatedwiththe Checklist forpharmacists condition, Pfizer said, noting that erectile dysfunc- Chameleon fronts 15 Pharmacistswillbesupplied with achecklist tion could have asignificant impactonaman’s Berocca campaign to determine aman’ssuitability for the product, overall health and wellbeing, and could lead to TheOTCLab grows16 the document adds, with additional advice pro- depression, anxiety,and relationship difficulties. reachofEarClin vided on the product label and leaflet. Furthermore, manymen with erectile dys- RB focuses on Easter 17 Furthermore, all men enquiring after the function bypassed the healthcare system com- drug –including those supplied sildenafil by pletely,Pfizer claimed, and purchased “alterna- Owl promotes Sanofi’s Xyzal 18 apharmacist –will be advised to see their gen- tive therapies from unregistered,illegalsources, REGULARS eral practitioner (GP) for ahealth check. which might supplycounterfeit productscon- Commentingonthe application, Dr Berke- taining no active ingredient, the wrong active Spotlight on –Serrix 8 leyPhillips, Pfizer’sUKmedical director,said ingredientor, worse,potentially toxic and dan- Q&A –with Galderma’s 17 that the“availability of pharmacist-supplied, gerous ingredients”. June Risser non-prescription sildenafil could offer men a The proposed switch has been welcomed by Events –Our regular listing 19 newand additional waytoaccess alegitimate, theRoyal PharmaceuticalSociety (RPS), which long-established, andwell-studied treatment for pointed out that “discussing health problems People –HRA names Wright 23 as chief executive erectile dysfunction”. with patients and advising on the benefits and “Thiscouldhavefurther benefits,” Phillips Continued on page 9 Connect with us on: Twitter LinkedIn OTC-bulletin.com DEVELOP WINNING DISTRIBUTIONSTRATEGIES MARKET REPORTS FROM JAMESDUDLEYMANAGEMENT

NEW FOR 2017 OTC DISTRIBUTION IN EUROPE MAILORDER AND INTERNET THE NEW GLOBAL AGENDA PHARMACY IN EUROPE REAPINGTHE BENEFITS OF AN Now in its 10th edition, this in-depth study identifies thefactors driving change in the OMNICHANNEL PRESENCE supply network serving Europe’s non-prescription and OTC self-medication sectors. This expanded fourth edition examines how e-commerce is reshaping the It provides acomprehensive, data-driven pharmacy landscape and playing a analysis of the unfolding strategies required to key role in the omnichannel strategies of achieve competitive success. leading healthcareretailers.

OVER 590 PAGES AND300 GRAPHS, TABLES AND COVERS 17 EUROPEAN COUNTRIES AND CONTAINS FIGURES COVER 20 EUROPEAN MARKETS KEY LEARNINGS FROM THE USA AND CHINA

®

Download online at www.james-dudley.co.uk JAMES DUDLEY® MANAGEMENT COMPANY NEWS OTC

Licensing Agreements Business Strategy AFT grabs RB exploring sale NovaTears of Food business ovaliq’s NovaTears dry-eyes treatment Nwill soon be available across Australasia, eckitt Benckiser (RB) has launched a“strat- afterthe Germany-basedfirmsignedalicens- Regic review” of its “non-core” Food busi- ing deal with AFT Pharmaceuticals. nessasitcontinues to move towards becoming Under the terms of the agreement, NewZea- amore health and hygiene focused company. land-based AFT will launch NovaTears –an In ashort statement, the UK-based fast- OTCmedical device –inAustralia and New moving consumer-goods (FMCG) giantsaid it Zealand. In return, Novaliq will receive an up- wanted to respond to “recent press speculation” front payment and sales royalties. that it wasconsidering putting the Food busi- NovaTears is sold across Europe under the ness up for sale. brandnameEvoTears as atreatment forevapo- “French’sFoodisatrulyfantastic business RB’sFrench’smustard rative dry-eye diseases. with great brands, people and ahistory of out- Rakesh Kapoor, RB’schief executive officer, “Theaddition of NovaTears to our eye-care performance. It is nevertheless non-coretoRB,” saidatthe time the deal wasannounced that it line will be welcomed by doctors and patients commented the firm. eh“W avetherefore decid- wasa“significant step forward in RB’sjourney alike,”commented AFT’schief executive of- ed to initiate astrategic reviewofFood where as aleader in consumer health”. ficer HartleyAtkinson. we will explore all options for this great business”. Acquiring Mead Johnson wasa“natural ex- “The product is afirst-in-class,water-freeand “RB will update the market going forward, tension” to RB’sconsumer health ‘powerbrands’, preservative-free treatment,”Atkinsonpointed when appropriate,”itadded. Kapoor said, adding that Mead Johnson’sgeo- out, “based on Novaliq’sproprietary EyeSol tech- Thefirm’s food brandsinclude French’smus- graphic footprint would strengthen “significant- nology platform.” tard and ketchup and Frank’sRed Hot sauces. ly” RB’sposition in developing markets. “The deal will also help advance our position RB’s reported sales at its Food business up by Expandin gonthe rationalefor the deal,RB in the lubricating eye-drop market,”Atkinson 5% to £411 million (C481 million) in 2016. Oper- said thatadding MeadJohnson’s “deepunder- explained, “where currently AFT holds the ating profit advanced by 16% to £118 million. standing of anew mother’sjourney”, along with number-four positioninboth Australiaand New Thecompanylaunchedthe strategic review its“well-established relationships with healthcare Zealand. This fits withour strategy of strengthen- as it works to close its US$17.9 billion (C16.8 mil- professionals”, would enhance RB’sreputation ing our market position in categories where we lion) acquisition of US-based Mead Johnson with the“millions of mothers”itreaches through already hold asignificantposition.” (OTC bulletin,17February 2017, page 1). its hygiene education programmes and with the Christian Roesky,Novaliq’schief executive Once the deal is finalised, RB will gain a children’svariationsofNurofen and Mucinex. officer,saidthe firm was“delighted” to col- portfolio of brands which includes the Enfamil, Furthermore, the dealgaveRBaleading po- laborate with AFT. “Weare confident thatdry- Enfagrowand Enfapro infant formulas, the Choco sition in the global infant and children’snutri- eyepatients in Australasia will greatly benefit Milk, Lactumand Sustagen children’snutritional tion category,the companyadded, which was from theuse of NovaTearsand ourpartnership milk supplements, as well as the Nutramigen expected to grow at between3%-5% per an- with AFT.” OTC formula for infants with food allergies. num in the medium-to-long-term. OTC

Editor: Matt Stewart Production Editor: Jenna Meredith Advertising Controller: Debi Minal Contributing Editor: DavidWallace Director of Subscriptions: Val Davis Deputy Editor: Tom Gallen Editor-in-Chief: Aidan Fry Group Sales Manager: Rob Coulson Assistant Editor: Marie McEvoy Managing Director: MikeRice Awards Manager: Natalie Cornwell

7April 2017 |Number 480 Editorial enquiries: OTC bulletin, Te rms &Conditions: While due carehas been taken to ensurethe accuracy of 4 Poplar Road, Dorridge,Solihull, These can be viewedinfull at www.OTC-bulletin.com. information contained in this publication, the publisher West Midlands B93 8DB, UK. No partofthis publication maybecopied, reproduced, makes no claim that it is free of errorand disclaims any Website: www.OTC-bulletin.com stored in aretrieval system, distributed or transmittedby liability whatsoeverfor anydecisions or actions taken as aresult ofits contents. Te l: +44 (0)1564 777550 anymeans, including electronic,mechanical, photocopying Fax: +44 (0)1564 777524 or recording, without the prior written permission of ©OTC Publications Ltd. All rights reserved. the publisher,orunder the terms and conditions of Email: [email protected] ® aGlobal Site Licence or of alicence issued by the OTC bulletin is registered as atrademark in the European Community. Advertising enquiries: Copyright Licensing Agency (CLA) in London, UK, or Contact: [email protected] rights bodiesin other countries that have reciprocal ISSN 1350-1097. Subscription enquiries: agreements with the CLA. Companyregistered in England No 2765878. Subscription rates arepublished at Neither maythis publication be exported, distributed www.OTC-bulletin.com/subscribe. or circulated by anymeans without the prior written Printed by Warwick Printing CompanyLimited, Contact: [email protected] permission of the publisher. Leamington Spa CV31 1QD,UK.

7April 2017 OTC bulletin 3 OTC COMPANY NEWS

Business Strategy Business Strategy/Annual Results Galenica Alliance Pharma in starts IPO the marketfor deals alenica has launched an initial public Goffering (IPO) on the SIX Swiss Exchange lliance Pharma is back in the market for for its Galenica Santé business. AOTCacquisitions in 2017 aftercompleting The move forms part of the firm’splanned the integration of alarge portfolio of brands separation into twoindependent, listed companies from SinclairISPharma, according to chief ex- (OTC bulletin,3February 2017, page 5). ecutive officer John Dawson. Notingthat the share capital of GalenicaSanté Speaking to OTC bulletin,Dawsonsaid wasdivided into 50 million ordinary shareswith Alliance had a“pipeline of [acquisition] op- anominal value of CHF0.10 (C0.10) each, the portunities to evaluate in 2017”, including both Swiss firmsaidthe price range for the offered consumer healthcare and prescription products. shares had been set at CHF37.00 to CHF39.00. “Special attention” would be given, he noted, This implied atotal market capitalisation of to opportunitiestopick up dermatology, ophthal- GalenicaSantéofapproximatelyCHF1.85 bil- mology and mother and baby brands, three liontoCHF1.95 billion, the firm pointed out. categories in which the companyalready had Galenicawill offload its entireholding in astrong presence. John Dawson GalenicaSanté, ratherthan retaininga13.75% In terms of geography, Alliance’s“strategic stakeaspreviously planned. focus” for deals wasWestern Europe, he said. Turning to Alliance’s2016 results, Dawson re- “The IPO will enable Galenica Santé to However, the firm wasnot averse to looking ported sales of £97.5 million, up from £48.3 further implement its strategy and build on its “in other parts of the world”. million in the prior year, thanks to theaddition of strengths,”commented the company. “Wewill do aone-country acquisitionthat’s the ex-Sinclair brands. “2016 has been trans- The first day of trading of Galenica Santé not close to home, if the right opportunitycomes formationalfor Alliancefollowing the Sinclair on the SIXSwiss Exchange wasexpected to be along,”Dawsoninsisted. “Wehaveour ownman- deal,”heexplained. “Sales have broadly dou- “on or around7April2017”, thecompany noted. agers in Singapore and Shanghai, China that bled and our geographic reach nowextends to Galenica Santé –which houses the firm’s canlook for,and evaluate, these things, using more than 100 countries.” Vifor Consumer Health business, as well as their local knowledge.” Commenting on the performance of the Retail and Services units –generated salesof “Whether an acquisition happens this year or firm’sbiggest brands, Dawson said Macushield CHF3.0 billionin2016. The businessoperates not we cannot be sure,”headmitted. “Never- –asupplement targeted at sufferers of age- the largest network of pharmacies in Switzer- theless, we have people engaging with poten- related macular degeneration –had enjoyed land, including the Amavita, Coop Vitality,Medi- tial divesting companies to pick up brands.” “strong” growth in 2016, posting sales up by Service and Sun Store chains. Deals had been offthe table for Alliance for 40% to £5.3 million.The product hada“tremen- Following IPO, shareholdersinthe rump Gal- overayear,henoted, while the firmconcentrated dous” amount ofpotential, he said, adding that enica operation will vote at its annual general on integrating Sinclair’sHealthcare Products the firm wascommitted to taking Macushield meeting on 11 May on aproposal to change the business, “which wasapproximately equivalent outside its UK base and into newmarkets. company’sname to Vifor Pharma Group. in size to Alliance”. Meanwhile, distributiongains forAshton& Galenicafirstannounced in 2014 its intention Alliance paid around £132 million (C154 Parsons had helped to drive up sales of the teeth- to divide the business to allowits Vifor Pharma million) forthe portfolio, whichcomprises 27 ing powders brand by 34% to £2.0 million, he pharmaceuticals division and Galenica Santé unit OTCand prescription dermatology lines (OTC noted. Turnoverhad also been boosted, Daw- to operateindependentlyfrom eac( hother OTC bulletin,11December 2015, page 3). The OTC son added,byincreasedpromotional activity. bulletin,12September 2014, page 3). OTC range includes the Aloclair mouth-ulcer treat- “Ashton &Parsonsisonagood growth curve,” ment, Atopiclair atopic dermatitis line and Ke- he insisted, “and we’re supportingthatbyroll- lo-Cote scar-reduction brand. ing out anew television campaign.” OTC IN BRIEF

CIPLA MEDPRO –the South African sub- IN BRIEF sidiary of India’sCipla –ispoised to strengthen its position in the local market by buying Western BIONORICA –the German herbal medi- through the economic crisis thanks to avery Cape-based Anmaraté Pharmaceuticals in an cines specialist–reported turnoverupby 3% moderate pricing strategy with along-term all-cash deal worth ZAR26.3 million (C1.83 mil- to C254 million in 2016.Strong performances focus.” Commentingonthe firm’splans forthe lion). Established in 1996,Anmaratémanufac- in Russia, Ukraine and in its domestic market yearahead,Bionoricasaiditwould begincon- turers anddistributesbothprescriptionand OTC had been behind the single-digit rise in sales, struction this summer of amanufacturing facil- products in South Africa. The firm’s OTCportfolio the companyexplained. “Weare especially ity in Voronezh,Russia to enablethe company includes the HydraSure rehydration drink.Anmara- proud of developments in Russia and Ukraine, to “further develop” its Eastern European busi- té reported sales down by 11% to ZAR2.5 million despite very difficult times,”commented the ness. Production at the site is expected to be- in itsfinancial year ended February 2016.OTC firm. ew“W ere able to navigate successfully gin in around three years. OTC

4 OTC bulletin 7April 2017 COMPANY NEWS OTC

Mergers &Acquisitions/Annual Results Stada holds takeovertalks

tadaArzneimitteliscontinuing to hold talks rejected the notion that aset target wasinplace. Germany Swithtwo potential acquirers,the chairman “A specific stock price target is not some- Others +38% of the company’s executive board, Matthias thing that I’ve heard from Oetker or anyother e275 mn e177 mn Wiedenfels, has confirmed. supervisory boardmember,” he insisted. “Oet- While he did not reveal the identity of the kerhas nevermentioned an amount of C70.00 interested parties,Wiedenfels insistedthat the to me or anyone else.” bidding process was“intact and running”. Turning to Stada’s2016results,the company Speaking at apressconference to announce reported turnoverfromBranded Products up by the firm’sannual results, Wiedenfels saidStada 1% to C859 million, as sales improvedinfour UK wasoperating a“structured and fair bidding of its fivebiggest markets. Vietnam +4% process” to bring about the “best result” for the In Stada’shome market of Germany, sales +19% e175 mn e37 mn Stada, its employees and its shareholders. “This of Branded Products movedahead by 38% to Italy Russia is not about the fastest result,”hepromised. C177 million (see Figure 1). +9% -29% e44 mn Pressed on the likelihood that the bidding “Strong growth of core products and new e150 mn process would eventually result in thesaleof product launches”, in combination with success- Figure 1:Sales at Stada’sBrandedProducts the company, Wiedenfelsrefused to be drawn. ful efforts to “optimise” the firm’s OTCoffering division in 2016 by country(Source –Stada) “I will not andcannot commentonthe like- in Germany, had been behind the double-digit thanks primarily to acquisitions. lihood of asale,”hestressed. “It is not the ex- improvement, Stada said. Branded Products accounted for22% of total ecutive board, butthe supervisory board that turnoverinItaly,which movedforward by 6% sells the company.” German brands are 37% of total to C202 million. “If there is atakeoveroffer,which is not Branded Products’ turnoveraccounted for Rounding out Stada’stop-fivemarkets for onlyatthe rightprice, butwhichisthe fullpack- 37% of group sales in Germany, which grewby BrandedProducts,Vietnam postedsales up by age, then it will be for shareholders to decide 11% to C485 million. 19% to C36.7 million. whether or not to tender their shares,”hesaid. In the UK,whereStadaacquired Thornton Branded Products’ generated 35% of total Last month, the companypostponed the bid- &Ross in 2013 (OTC bulletin,23August 2013, group sales in Vietnam, which advanced by 13% ding process to give rivalbidders the oppor- page1), Branded Products’ sales improvedby to C106 million. tunity to improve their offers (OTC bulletin, 4% to C175 million. Branded Products accounted for 40% of 24 March 2017, page 1). Acquisitions had driventhe rise in sales, Stada’stotal sales in 2016. These movedfor- “The executive andsupervisory boards mutu- Stada said, adding that growth had been held ward by 1% to C2.14 billion (see Figure 2). allyagree that the indicative bidsdonot yet re- back by a“weak cough and coldseason” at the Stada’sdominant Generics business accounted flectthe fundamental value of Stada,”commented start of the year. for the bulk of the remainder. OTC Stada at the time.“Thus,the company, for the Stada did not give afigure for its total sales timebeing, wantstoprovidethe bidders with the in the UK in 2016. opportunity to increase their offers.” Meanwhile, Branded Products’ sales had been BusinessStrategy On 25 February,Stada launched a“trans- held back, Stada noted, by aweaker perform- parent and fair” bidding process for the firm to ance in Russia. Phoenix opens give all interested parties alevel playing field to Difficult economic conditions, “particularly “present their plans forStada” (OTC bulletin, in the self-pay market”, had caused sales of Serbia facility 3March 2017, page 1). The companymade Branded Products to decline by 29% to C150 an-Europeanpharmaceuticalwholesaler themoveafter one interested party,private-equity million, the firm said. Lower sales had been Pand retailer Phoenix has opened alogistics firm Advent International,submitted alegally- compounded by negative currencyeffects re- centre for “drug packages and other health prod- binding takeoverbid worth C58.00 per share, lated to the Russian rouble. ucts” in Serbia. valuing the firm at around C3.6 billion. Branded Products accounted for 62% of Located in the country’scapital, Belgrade, Asked by the media if Stada’ssupervisory group sales in Russia, which declined by 18% the facility waspart of the company’s“newcross- board –and specifically the board’schairman to C243 million. border healthcare logistics solution CEE Bridge”, Carl Ferdinand Oetker –was holding out for a In Italy,turnoverfromBrandedProducts had which connected the pharmaceutical industry, bid of closer to C70.00 per share, Wiedenfels improvedby9%to C44 million, Stada reported, wholesalers and retailers in Central and East- ern Europe, Phoenix explained. Business Annual sales Change Operating profit Change Having spent C3million to construct the site, (€ millions) (%) (€ millions) (%) Phoenix said it expected its investment “first and Generics 1,281 +2 195 +10 foremost”toleverage the firm’s “business and Branded Products 859 +1 81 -37 collaboration with numerous partners in the Group/Other –– -98 – Western Balkans”. The facility would allow Phoenix to “supply healthcare solutions”tocon- TotalStada 2,139 +1 178 -20 sumers in Bosnia and Herzegovina, Macedonia, Figure 2:Stada’ssales and operating profit in 2016 (Source –Stada) Serbia, Montenegro, Albania and Kosovo.OTC

7April 2017 OTC bulletin 5 OTC COMPANY NEWS

Licensing Agreements/Business Strategy Futurasecures Portugal deal

utura Medical has granted FLimathe exclu- through its network of eight international partners. Away from CSD500, Barder said Futura had Fsive rightstoits CSD500erection-maintain- “Werecently launched in Saudi Arabiaand been “delighted”earlier this year to secure a ingcondom in Portugal. the product has been well received, with our licensing deal for itsTPR100 noveldiclofenac Under the terms of the agreement, Lisbon- distributor placing further orders,”henoted. “It’s pain-relief gel with Stada Arzneimittel’sUK based FLimawill commence the marketing and still early days, butwe’re encouraged by what subsidiary Thornton &Ross. distribution of CSD500 in its domestic market we’ve seen so far.” Under the terms of the agreement, Thornton & “as soon as practicable”. “Wehope thataswerollout CSD500inad- Ross will “conduct the manufacturing scale- While thefinancial terms of the transaction ditional markets and it begins to gain traction, up of TPR100 andholdrights to manufacture, were notdisclosed, Futura revealed that it would it will help us to secure further distribution deals,” market and distribute the product in the UK for receive royalties on all product sales, along with Barder said. the lifetime of the product’spatents” (OTC “certain minimum performance guarantees” bulletin,3February 2017, page 7). from FLima. Partnering discussions ongoing Insisting that TPR100 had “significantpoten- “Weare delighted to sign thisagreement with Discussioons with p tentialpartnersfor the tial” in the UK consumer healthcare market, FLimafor the marketing and distribution of productin“certain territoriesinAsia and South BardersaidFuturawas pleased “to get the first CSD500 in Portugal,”commented Futura’schief America” were “progressing”, he noted. deal underour belts, which validates the technol- executive officer JamesBarder. “F Limaisa While the company had launched thecon- ogy in the first instance”. well-established companywithastrong track dom itself under the Blue Diamond name in a Outside the UK, the firm wasinvolved in “on- recordofbuilding consumer healthcarebrands.” limited number of countries (OTC bulletin,3 goingdiscussions” with potential licensing part- The UK-based development companyan- April 2015, page 9), the firm’sdistributor partners nersfor TPR100 “inboth Europe and the US”. nounced the deal with FLimaasitreported had been reluctant to do so until the product’s Noting thatthe companyhad recentlyheld a an operating lossof£4.55 million (C5.30 mil- shelf life had been improved. meeting with the US Food and Drug Administra- lion) in 2016.However,Futura ended the year This problem had nowbeen overcome, Barder tion (FDA) to “confirm the regulatory strategy” with cash of £12.4 million. explained, and the companyhad submitted a for TPR100 in the country,Barder said that as Commenting on the firm’sglobal strategy patent application for CSD500 based on the afurtherclinical study would be required, Futura for CSD500, Barder told OTC bulletin that “extended shelf life manufacturing process” wouldnot progress “without aclea rindication of Futura wasfocusedonrolling the productout for the product. interestfrom apotentialcommercialpartner”. OTC

Business Strategy Mergers &Acquisitions Clinova seeks Tula gets capital investment rivate-equity firm LCatterton has made healthofthe skin,”the firmexplained, “result- Asia growth Pa“significant growth capital investment” ing in amore youthful appearance”. K-based consumer healthcarefirmClinova in US-based Tula Life’s“innovative” Tulapro- “Tula appealed to us because it is the first Uhassigned up market-expansion specialist biotic skin-care brand. premium beauty brand to leverage probiotics DKSH to “drive its expansion” across Asia. Thefinancial details of thetransaction were across itsentireproductline,”saidJon Owsley, Under the terms of the agreement, DKSH’s not disclosed. co-managing partner at LCatterton. Healthcare unit will provide marketing, sales, Theinvestment,Tula Lifesaid,wouldbeused “Wesee atremendous opportunity to ac- distribution, logistics and regulatory services to “drive Tula’s rapid growthbyfunding market- celerateTula’sgrowth by capitalising on its in- for Clinova’s O.R.S oral rehydration brand in ing, working capital andproduct development”. novative formulations, strongrelationshipwith four Asian markets. Containing four strains of probiotics, the television network QVC,distinctive and digi- Consumers in Hong Kong, Malaysia, Singa- Tula range –which includes theHydrating Day tal-first positioning, and talented management pore and Thailand will gain access to O.R.S in &Night Cream and the Exfoliating Treatment team,”Owsleyinsisted. pharmacies, hospitals and e-commerce channels. Mask –was “formulated to help improve the “Welook forward,”continued Owsley, “to “With ahot climate and agrowing middle leveraging our experience to help drive Tula’s class placing high value on personal health,Asia is success for years to come.” an increasingly attractive region for Clinova,” Julia Straus, chief executive officerofTula commented the firm’schairman for Asia-Pacific Life, said the firm was“excited” to work with Charles Toomey. LCatterton at atime of “rapid expansion” for “Building our ownAsian growth platform the company. would be costly andtimeconsuming,hence we “L Cattertonbrings deep knowledge of the rely on DKSH to quickly growinto newmarkets,” consumer space and an unparalleled track record Toomeyexplained. “DKSH’sability to offer helping boutique beautybrands thrive and grow,” regulatory,commercial and distribution services Straus claimed. across multiple channels and markets is invalu- “Weare confident it will be an excellentlong- able to us.” OTC The Tula probiotic skin-care range term partner for Tula,”she insisted. OTC

6 OTC bulletin 7April 2017 COMPANY NEWS OTC

Business Strategy Business Strategy Mylan shuts J&J to kick-start Meda plant safety challenge ylan has announced plans to close the MUS manufacturing facility in Decatur, Illi- nois,that it obtained through acquiring Meda ohnson &Johnson (J&J)Innovationislook- increased dissemination and sharing of health last year. Aphasedwind-downwillrun into Jingtowork more closely with entrepreneurs information via social media and online, there 2018,with 90 staff affected. who aredeveloping “innovative solutions to is agreater need than ever before for bioethi- “Since 2015, Mylan has made anumber of advance safety in healthcare products”, includ- cal,transparentand evidence-based information significant acquisitions,”aMylan spokesper- ing OTC medicines. sources that help patients andconsumersmake son pointed out, “and as part of the holistic, Launching its ‘Advancing the Safe Use more informed healthcare decisions.” globalintegration of these acquisitions,[the of Healthcare Products QuickFire Challenge’, “Tohelp make thispossible,”she explained, company]announced in December 2016 that J&J Innovation said it wasoffering aprize of “the challenge aims to improve safety in health- [we] would befocusing on howtobest opti- up to US$0.20 million (C0.19million) to “en- care through improving the provision of bal- mise and maximise all of our assets across the trepreneurs, academics, scientists, engineers anced and factual information –and develop- organisation and across all geographies.” or start-ups” working on “novelsolutions that ment of solutions –toensure safety across the Mylan at that time announced that it could advance safety by informing patients and con- spectrum of medical devices, pharmaceutical potentiallycut up to 10% of its global workforce sumers, simulating surgical procedures or en- and consumer products.” –oraround 4,000 jobs –aspart of abroader suring proper storage and use of prescription, The QuickFire Challenge focuses on the cost-reduction programme. OTCand cosmetic products”. following areas: Closing the Decatur facilitywas “part ofthe Successful applicants willalso receive “en- l Empowering patients and consumers integration process” with Meda, the firm stated. trance to aJ&J Innovation JLABS facility and/ to makemore informed healthcare decisions “The decision to close the site comes after a or mentoring from J&J Innovation”. by providing better information and education careful assessment of bringing the twobusi- “Through our collaboration with J&J Inno- about the safety of healthcare products, includ- nesses together as part of our integration pro- vation on this challenge, we hope to identify ingpharmaceuticals, medical devices and con- cess and is consistent with our ongoing efforts scientifically sound, breakthrough ideas that sumer healthcare products to operate ourbusinesses as efficiently as possi- will advanceboth thesafeuse and agreater l Improving training and development for ble,”Mylan said. “Operations will continue at understanding of the safety of healthcareprod- surgeonsbyidentifying newmodels that simu- the site for several months and staffing reduc- ucts to positively impactoutcomes,” commented late the operating room environment tions will takeplace in phases.” J&J’schief medical officer Joanne Waldstreicher. l Empowering patients and consumers to Mylan said it expected to completethe entire “Prescription medication errors cause at more safely administer and handle healthcare process by 2018, adding that all 90 affected least one death every day andinjureapproxi- products. employees would be “offered severance pack- mately 1.3 million people each year,” Wald- The deadline to submit applications is 24 ages that include severance pay,benefit continua- streicher pointedout. May 2017. The winners in each categorywillbe tion, and outplacement counselling and assis- “Moreover,”continued Waldstreicher,“with selected in autumn 2017. OTC tanceaccording to the company’sseverance plan”. Products manufactured at Decatur –which in- Business Strategy clude the Geritol supplement range and pre- scription lines Astepro (azelastine) and Soma (carisoprodol) –would “continue to be manu- Takeda completes spin-off factured in the US”. akeda has completed the transfer of its business model”, Takeda explained, enabling it to Separately,Mylan has completed its acquisi- TJapanese Consumer Healthcare business “promptly meet environmental changes and tion of the Cold-EEZE homoeopathic cold and into awholly-owned subsidiary, the Takeda consumers’ needs in the OTCmarket”. flu brand from US-based ProPhase Labs. Consumer Healthcare Company. Masashi Sugimoto, president of the Takeda Thedeal–announcedinJanuary (OTC bul- Announcing the spin-offlast year,Takeda ConsumerHealthcareCompany,said the spin- letin,13January 2017, page 4) –gives Mylan said the move would enable it to “accelerate” offwould enable Takeda to “promptly meet” “all assets and rights relating to the Cold-EEZE thebusiness’ growth (OTC bulletin,19Febru- consumers’ “diversifying needs” and growing brand, includingall US businesses and US and ary 2016, page 1). interest in their ownhealth. international trademarks”. Takeda said the time wasright to separate “Fromnow on, we will continue to contrib- “The completion of this transaction is an its domestic Consumer Healthcare division, as ute to better health for consumers through our important step as we continue to expand our thebusiness wasenjoyingaperiodof“sustained brands such as Alinamin, Benza, and Midori- consumer healthcareofferings,” commented growth”, thanks to the performance of its key no-Shukan in the field of self-medication,”Sugi- Mylan’s chief executiveofficer Heather Bresch. brands: Alinamin vitamin tablets and health moto insisted. “Cold-EEZE is nowMylan’slargest US con- tonics, Benza coldremedies and the Midori- “Atthe same time,”headded, “we aim to sumer healthcare brand,”Bresch pointed out, no-Shukan health food. become aleading companyinthe consumer “and is part of agrowing portfolio of OTC Through the spin off, the Takeda Consumer healthcaremarkets of theAsianregion, focus- products in the country.” OTC Healthcare Companyhad gained a“more agile ing primarily on Japan.” OTC

7April 2017 OTC bulletin 7 OTC COMPANY NEWS

Spotlight on…Serrix

l ESTABLISHED: 2007 l PRODUCTS: Mycosan l BASED: Amsterdam, anti-fungal foot treatment, the Netherlands Sorefix cold-sore line, l SALES: €7.5 million Obesistop appetite reducer (2017 forecast) l SELECTED MARKETS: Europe, l LEADERSHIP: Ruben Visser, Commonwealth of managing director Independent States (CIS) l WEBSITE: serrix.com

BUSINESS FOCUS “Both brands hold top-three positions in their of chronic gastric disorders.” “Serrix is adynamic and well-established respective categories in numerous markets “In the paediatrics category,wewill launch companywith aprimary focus on the develop- worldwide,”hepointed out. twoeffective lines –aspart of anew product ment, sales and marketing of consumer health- “Mycosan is themost complete fungaltreat- range –totreat the symptoms of eczema and care products,”according to the firm’sman- ment for nails and feet with six stock-keeping chickenpox,”Visser revealed, “while in the ager of newbusiness development Gerard units (SKUs),”Visser noted. “Itisaclinically anti-fungal category,wehavedeveloped an ef- Visser.“We are an experienced team of pro- proven, effective solution for the treatment fective fungal treatmentfor the body whichhas fessionals who are dedicated to innovation, and prevention of nail and skin fungal infec- an easy and hygienic application.” creativity and meeting consumer needs.” tions. Since its launch, more than 10 million Noting thatall ofthese products were class The Netherlands-based firm’sportfolio in- units of Mycosan have been sold.” II medical devices, Visser said the company cludesthe Mycosan anti-fungal foot treatment, Meanwhile, Sorefix wasa“uniqueinnova- hadalso been developing arange of “special- Sorefix cold-sore line, and the Obesistop ap- tion” that was“effective in all phases of acold ity”dietary supplements. petite reducer. sore”, he claimed. Serrix had created asupplement for age- Serrix marketed its products in “more than “Sorefix is distinctive from its competitors,” relatedmacular degeneration, and anotherto 27 countries”, Visser pointed out, through its Visser said, “offering arescue remedy that “maintain andoptimise brain function”, he stat- global network of distributors. works effectively in all four phases of the cold ed.Bothproducts contained“high-end nutrients “Our companyaims to develop accessible sore, and aprevent formula whichblocks health in aprovenformula”, Visser explained, and were and effective consumer healthcare solutions cells from infection.” presented in an “innovative”dosage form. to help consumers live healthier and happier “Recent research with one of our distribu- Forthese innovations, Serrix wasonthe lives,”heexplained. tors, PGTHealthcare, showed that85% of the look-out for distributors, Visser noted, while “Wehaveabold ambition,”Visser stated, Sorefix users would recommend the product for its existing product range –primarily Sore- “tohaveaworldwidenumber-one niche OTC to their family andfriends,” he pointed out. fix –the companywantedtofind partners in product by 2025.” France, Germany, Italy, Spain and the UK, as FUTURE STRATEGY well as Eastern Europe, North Africa and the KEY BRANDS Serrix has anumber of products in the pipe- Middle East. OTC “Theleading brandsinSerrix’ portfolio are line–including medical devices and dietary Mycosan and Sorefix,”commented Visser. supplements –which the firm is preparing to launch in 2017, according to Visser. “In the gastrointestinal category,wehave developed atriple-action treatment presented in apremeasured liquid-dose stick-pack,”he noted. “The product –known currently as DIA001–isanaturalremedy fortreatingdiarr- hoea, which also reduces the risk of dehydra- tion. It can also help to relieve the symptoms

For the opportunity to feature in the Spotlight section, email [email protected]

IN BRIEF BIOGARAN –the French generics and staffand markets prescription treatments, OTC plement. Biogaran’spresident Pascal Brière biosimilars specialist –has taken “an impor- medicines and dietary supplements. Swipha’s said Nigeria had been identified as “the best tant step forward in internationalisation” by consumer healthcareportfolio includes the Swif- entrypoint on the Africancontinent”,thanks acquiring Nigeria’s Swipha,which has annual en children’spain-reliefline, Bio-Strath Digest to its growing population and “solid econom- turnoverofaround C20 million, employs 300 herbal medicine and the Supra Cdietary sup- ic fundamentals”. OTC

8 OTC bulletin 7April 2017 GENERAL NEWS OTC

Switches Pfizer wantssildenafil switch

Continued from front page Addressingsimilar concernstothose raised aresuppliedsildenafil in the pharmacysetting,” risks of treatmentoptionsisanintegralpart of by the EMA in 2008, the MHRA’s ARM94 docu- the documents adds,“andthatall men, includ- the role of the pharmacist”. ments says that direct and indirect risks to human ing thosewho aresupplied sildenafil in the phar- “Thepotential switch of sildenafil increases health posed by sildenafil can be “minimised macysetting, are advised to see their GP for access to amedicine that has been proven to to an acceptable level” by the pharmacypro- ahealth check.” be safe andeffective whenused appropriately tocol proposed by Pfizer. In addition, Pfizer has been asked by the through overadecadeofreal-worlduse by mil- Furthermore, ARM94 states that there is MHRA to undertakeaquestionnaire- or survey- lions of men,”the RPS said. “little evidence of harm” from intentionalmis- based study to “assess the utilityand effective- Echoing the RPS, John Smith, chief execu- use of Viagra as arecreational drug and that nessofthe proposed pharmacy-risk minimisation tive of the Proprietary Association of Great the drug’ssafety profile is well known and well material in conveyingthe keymessages to both Britain (PAGB), said that the industry association established over 18 years of use. patients and pharmacists, and their impact on supported Pfizer’sswitchattempt, especially self-reported patient behaviour and pharmacy as erectile dysfunction wasacondition that was Training forpharmacists practice”, ARM94 points out. “easily self-diagnosed and suitable for self-treat- Noting that as pharmacysupply of Viagra Summing up the application, the MHRA ment with the support of apharmacist”. means that men won’tbeassessed by a GP says that switching Viagra would be “of value “Pharmacists are expert healthcare profes- for underlying cardiovascular (or other) causes to men who suffer from erectile dysfunction”, sionals whocan offer advice on healthcondi- of erectiledysfunction–and an opportunity to adding that the UK’sCommission on Human tions and medicines use,” Smithcontinued.“We diagnose and treat underlying cardiovascular Medicines –whichadvises governmentonthe believe the highly-skilled pharmacists working in disease may be missed –ARM94 says that safety,efficacyand quality of medicinal prod- pharmacies across the UK are ideally placed Pfizer has committed to providing pharmacy ucts –has also backed the move. to support men with erectile dysfunction and iden- training materials and achecklist. Comments on the ARM94 switch proposal can be sent tifywhether sildenafil is asuitable treatment for “The pharmacytraining materials will be de- to the MHRA by email: [email protected]. the condition.” signed to ensure only men who are fit for sex The comment period closes on 18 April 2017. OTC “Pfizer’sapplication will be supported by an extensive pharmacyeducation and training pro- gramme,”headded, “which will ensure that UK pharmacists have theknowledge theyneed to appropriately supply sildenafil OTC.” If approved, the UK will be the second Leading Innovation and Vision major market to allowOTC access to Viagra. Just under ayear ago, Poland allowed men to buysildenafil withoutaprescription after the country’smedicines regulator approvedanappli- cationbyAdamed to sell OTCits MaxOn Active sildenafil product, butatthe lower strength of 25mg (OTC bulletin, 27 May 2016, page 1). Prior to the ‘true’ prescription-to-OTC switch of sildenafil in Poland,wZ Ne ealand had come closest to granting OTCstatus. Sildenafil, how- ever,remains partially restricted in thecountry. It is still aprescription medicine “except when supplied by apharmacist who has successfully completed theapproved training programme for the treatment of erectile dysfunction in males aged35to70years” (OTC bulletin,24Octo- ber 2015, page 1). Pfizer tried and failed to switch sildenafil 1 Pharmacy Sales, Marketing & Distribution 5 Brand Strategy through theEuropeanUnion’s (EU’s) central- ised procedure in 2008 (OTC bulletin, 28 Nov- 2 Global Grocery H&B Sales, Marketing & Distribution 6 Creative Design ember 2008, page 1). 3 Category Management & Shopper Insight 7 Data Insight The US firm withdrewits Viagra applica- tioninthe EU following“some concerns”–in- 4 Field & Experiential Marketing 8 Advisory cluding alack of medical supervision, potential for unintentional misuse and possible abuse Get in touch today! of the drug for recreational purposes –atthe Visit www.ceutagroup.com - Call +44 (0)1202 449763 - email [email protected] European Medicines Agency(EMA).

7April 2017 OTC bulletin 9 OTC GENERAL NEWS

RegulatoryAffairs CHPAeyesmonograph win

onsumers andindustryare setto benefit troducing an OTCmonograph user-feesystem Cfrom awave of innovation in the US, driven in the US without “thorough discussion and by reformtothe OTC monographsystem, ac- study” could be a“disincentive for innovation” cording to Scott Melville, presidentand chief (OTC bulletin, 17June 2016, page 14). executive officer of the US ConsumerHealth- TheCHPAtold the meeting that charging fees care Products Association (CHPA). “could createcertain incentivesordisincentives” Speaking to delegatesatthe CHPA’sannual for consumer healthcare companies. executive conferenceinFlorida, US, atthe end “Fees for non-prescription medicines under of March,Melvillesaidthatafter initially seeing the monograph system couldbeadisincentive the US Food and Drug Administration’s(FDA’s) for innovation,”the association claimed, “or pushfor OTCmonograph reform as athreat, the they couldincentivise innovation, dependingon industry had nowembraceditasanopportunity. howtheyare applied.” Monograph reformlegislation based on the “For example, today, veryfew manufactur- Scott Melville CHPA’swork would be introduced in Congress ersare filing wDNe rug Applications (NDAs) “anyday now”, Melville added, although he and payingthe PrescriptionDrug User FeeAct he noted,“and60% of all pharmaceuticalsused could not comment on the contents of the legis- (PDUFA) fee to innovate with monograph in- in the US are OTCmedicines.” lation before it wasunveiled. gredients,”itpointed out. “98% of doctorsrecommend OTCproducts “I’moptimisticabout theinnovation that will Noting that theCHPAdid not want to “dis- in the first instance when treating patients,”he be unleashedonce these reforms are enacted,” courage activities that could benefit public health”, pointed out,“andthat’s because theyknowwhen he told delegates. the CHPAargued thatany potentialuser-fee pro- peopletakemoreresponsibilityfor their health TheCHPAhad worked together with the FDA gramme needed to contain “mechanisms to sup- theyare more empowered, theyare healthier, andUSCongress to develop a“better regulatory port innovation”. theyhavelonger life expectancy, andtheyulti- framework that could preserveand improve” “In terms of fees in general,”the association mately use fewer other healthcare services.” the monograph system for “generations to come”, added, “we would expect them to be justified “Weare on the vergeofachieving enhance- he promised. and spending transparent.” mentstoupdateand modernise the FDA’sOTC In June last year, the CHPA said that it had “Fees should not be disproportionately tar- monograph system,”Needham said, “but an- entered aperiod of “detailed talks” with the geted at rebuilding and maintaining capability,” other waywecan accelerate growth is to fully FDA, which would include “the parameters of it insisted. “Wewould expect to see abalance embrace and understand all the trends affect- apotential user-feeframework” for the mono- in the application of fees between long-standing, ing the consumers we serve.” graph system (OTC bulletin, 22July 2016, needed actions under the monographs and act- “The role of consumer technology in per- page 12). ing on innovation.” sonal health, howconsumers viewand use dietary While the CHPAsaidatthe time that it Picking up on Melville’scomments on the supplements for wellness and prevention, along strongly supportedthe OTCmonograph system, ability of OTCmonograph reform to drive with national health reform, will affectour in- the association believedthat “policyreforms growth in the industry,JeffNeedham, CHPA dustryorour customers,”Needham pointedout. couldmakethe systemmoreflexible, responsive president and head of Perrigo’sUSConsumer “I suppose Ican sum up the state of our indus- and accommodating to innovation”. Healthcare business, said the industry in the US, trythis way: self-care is on the rise,”Needham “Werecognise that resource constraints would while growing, wasnot growing fast enough. stated, “and all indications are thatitwill con- affect the ability of the FDAto implement any “[The OTCmarket] has grown at around tinue to do so.” potentialmonographreforms,”the CHPA said, 3% to 4% eachyear over thepast severalyears,” “Wehavesafe and effective OTCmedicines “andweare opentoways of adequatelyfunding he told delegates. “That’sone of the reasons why for self-care, butwe’ve only seen modest in- reforms, including consideration of auser-fee we at the CHPAfeel it’s criticaltoreinvigorate dustry growth,”hepointed out. Are we satisfied programme for OTCdrugs.” industry growth by advocatingfor an improved with this? Or can we do better?” However, speakingatanFDA public meet- regulatory system for OTCmedicines.” Lookingahead, Needham said when think- inginJunelastyear, the CHPA warned that in- “Today, the consumer healthcare products ing about howthe industry would look in the industry is propelled by the continued rise in future, he drewinspirationfromthe CHPA’svision the prevalence of, and reliance on, self-care,” of “happier, healthier livesthrough responsible he claimed. self-care” and its mission to “empowerself-care “Thanks to thehigh quality, safe, effective, by preserving and expanding choice and avail- and affordable OTCmedicines that our com- ability of consumer healthcare products”. panies offer, more and morepeoplehavetaken However, Needham explained that he did not their health into their ownhands,”Needham think of “self-care” as just about medicines. continued,“andour US$43 billion(C40 billion) “Self-care means preventi ngillness, not just industry is just one partofthe family healthcare managing it,” he continued.“Self-care is about solution –but it’sthe first part.” properlyidentifying yourhealth problems be- “OTC medications arethe first-line of treat- fore theyget too big, and having the right an- Jeff Needham ment for more than 240 million Americans,” swers to health questions without needing to

10 OTC bulletin 7April 2017 GENERAL NEWS OTC

see adoctor or other healthcare professional.” of them,”Needham pointed out, “to find out Digital Health Self-care today included tracking health and where consumers are looking forhealth solu- fitness with “gadgets and apps”,Needham said, tions, how manufacturers and retailers are reach- UK creates withpeople learninghow to adjusttheir behav- ing their customers and what types of innova- iour and choices, and monitoring their progress. tionare on the horizon thatwillshape self-care “And of course self-care is about having in the future.” virtual GP the freedom and choices to makeyour own The second phase wasevaluation, Need- healthcare decisions,”heinsisted, “and having ac- ham continued, in whichthe association would K-based digital andsocial-mediacompany cess to thebestoptions, no matterwhat aisle they take“ahard look” at the answers to the ques- UOrbital Media is teaming up withthe Uni- happen to be in at the drugstore and no matter tions posed in the exploration phase. versity of Essex to create an automated virtual which website you are going to online.” This second phase wouldalsoinclude alook generalpractitioner (GP) service with the aim Theindustryhad aresponsibilitytokeep the at the strengths and weaknesses of the CHPA of reducing doctors’ time spent on minor ail- “consumer at the centre”, Needham said, and and the industry, hepointed out, to see how ments andsavingthe National HealthService help peopletoget andstayhealthyby“expand- members reacted to changes in consumers’ be- (NHS) money. ing access to existing healthcare products and haviour and demands. Over the next two-and-ahalf years, the ‘Virt- by developing newsolutions as well”. Furthermore, the CHPAwouldlook at wheth- Turi’ project –part-funded by the Engineer- By meeting those goals, Needham stated, er it needed to “broaden its scope beyond OTC ing and Physical Sciences Research Council thanks to an “improvedregulatorystructure” that medicines to include the full range of other (EPSRC), the Economic and Social Research allowed and incentivised “speed and innova- consumer healthcare products”, Needham said, Council (ESRC) and the UK’sinnovation agency, tion”, the OTCindustry would “growasmuch and what capacity, skill, and resources the InnovateUK–willdevelopservices to assistthe and as fast as self-care is itself growing”. CHPAhad to support the future industry. “increasing numbers” of peoplewho seek medi- “Howdoweget from the industry of today, The third and fourth phases of the CHPA cal advice online. to the industry of tomorrow?” Needham asked, 2020progamme were determination and action, PeterBrady, chiefexecutiveofficerofOrbital “and howcan astrong association help us?” Needham said. Media, said VirtTuri would combine artificial The answer, herevealed, would be sought “Based on the findings from the evaluation intelligence and “machine-learning technology” in the CHPA2020 initiative. phase, we will need to choose the direction in to provide patients sufferingfromminorailments CHPA 2020, Needham explained, wasa“stra- which we want to go as an association and take with “quick, consumer-friendly information” tegic planning initiative andprocess” that began agood look at the steps –and resources –re- –provided by the NHS –that could help them lastyear to “envision thefuture of our industry, quired to get us there,”heexplained. better understandtheir conditions in away that to anticipatethe needsthatconsumers andmem- “Finally, afterall of the assessment and plan- would “enhance recall”. bers willhaveinthe future, and to keep the asso- ning, we can set out and drive the change we ciation highly relevant and effective”. want,”heconcluded. Cost NHS £2 billion Throughout 2017, CHPA2020 would be “Over the course of this year,wewill be engag- According to theProprietaryAssociation developed in four phases, he said. ing with members, plus experts at the CHPA, of GreatBritain (PAGB), GP appointments for “First, exploration. We will identify consumer, members of our board, and thought-leaders self-treatableproblems costthe NHS £2.0 bil- member, and industry needs, as well as the trends, throughout industry,” Needham said, “all to lion (C2.3 billion) ayear, Brady pointed out. opportunities and challenges inherent in each create and finalise our A2CHP 020 plan.” OTC Once the technology had been developed, patients suffering from such minor ailments as coughs, colds and flu would be able to type in questionsabout their conditions, he explained. These queries would be answered using a video featuring alifelike‘avatar’to giveinforma- tion on their problem, Brady noted, adding that this health advice would be “supplemented by ani- mations, imagery and video, whereappropriate”. Users would be made aware of any‘redflag’ symptoms that required aGPappointment, Brady pointed out, noting that VirtTuri would also tell users that pharmacists could answer queries on minor ailments. While the initial focus would be on coughs, Jeff Needham highlighted the role of OTCproducts in helping US consumers to manage their health colds and flu, Brady said that the aim wasto roll out future versions of the technology to deal with other problems such as hayfever, warts and verrucas, insect bites and travelsickness. Thetechnology would initiallybeavailable via a“website-based platform”, Brady said, and later through specially-created mobile appli- cations. It wasanticipated that the first working platform would be available for testing in the next 12 months, he added. OTC

7April 2017 OTC bulletin 11 OTC GENERAL NEWS

RegulatoryAffairs Switches PASMI waits Calcipotriol set for forGSL draft resh proposals for reducing pack sizes and UK psoriasis switch Fingredient strengths of common OTC prod- ucts for grocery sale in Poland willbereleased eo Pharma’s Dovonex could be the first be when no more than 10% of the patient’sbody by mid-April, according to the Polish Asso- Lcalcipotriol-based medicine to be made is affected and where the psoriasis is confined ciation of the Self-Medication Industry (PASMI). available without aprescription in the UK, if to the body and/or limbs only. PASMI strongly criticised the first draft the firm’sswitchapplication forthe psoriasis Furthermore, the frequencyofapplication has released by the Polish government earlier this treatment is approved. been limited to once-daily,ARM95 says, and year, claiming that the move would spell the Currently available as aprescription-only the amount applied in one week to 60g. end of non-pharmacysales of such products medicine under the DovonexOintment name, Pharmacists will also only be able to supply (OTC bulletin, 17February2017, page 14). the product is indicated for the treatment of theproduct to adults who have beenpreviously Commenting on the government’splans to adults aged 18 years and older with mild-to- diagnosed with plaque psoriasis by their doctor, reduce the maximum amount and strength of moderate plaque psoriasis. the document notes, adding that pharmacists active ingredients in analgesics, cough, cold In its ARM95 switch consultation docu- andtheir staffwill be providedwith training and gastrointestinal products for general sale, ment, theUKMedicines and Healthcare prod- materials to helpthem provide suitable advice PASMI said that the newrequirements would ucts Regulatory Agency(MHRA)proposes to and help patients decide whether the product lead to the end of non-pharmacysupply, asit make50µg/g calcipotriol ointment available is suitable for them. would not be economically viable for manu- as apharmacy(P) medicine for adults with mild- The training will also help pharmacists iden- facturers to produce lower-dose products and to-moderate plaque psoriasis, when previously di- tifypatients that had previously used the pre- smaller pack sizes. agnosedbyadoctor.Itwould be availableas scription product, which is indicated for use 90% of the OTCmedicinal products avail- DovonexPsoriasis Ointment nameina60g pack twice daily, unlikethe OTCproduct which is for ablefor sale outside of pharmacy would “disap- size with amaximum duration of use of 12 weeks. use once daily,ARM95 says. pear”, the association claimed, if the changes The major risk with the useofcalcipotriol The UK’sCommission on Human Medicines, were implemented. without medicalsupervisionisthat of develop- the document says, having taken in the views Ahuge swathe of the Polish population ing excessive levels of calcium in the blood, of astakeholder group consisting of healthcare –particularly those in small towns or rural ARM95 states. professionals and people suffering from pso- areas –would have no easy access to basic medi- To minimisethis risk,Leo has proposed re- riasis, has backed the switch. cations, the association warned. Manydid not stricting the indication to adults with mild-to- Comments on the ARM95 switch proposal can be sent to live within areasonable distance of apharmacy moderate psoriasis, the document points out, the MHRA by email: [email protected]. or, iftheydid live closeby, thepharmacydid not which for this reclassification is considered to The closing date for comments is 20 April 2017. OTC open at weekends. Takingthe example of the government’splans to reduce the maximum dose of paracetamol on RegulatoryAffairs general salefrom500mg to 300mg, PASMI said thatmanymanufacturers didnot produce the TGAfinds pregnancytest flaws drug at such alow strength, as the standard dose review by Australia’s Therapeutic Goods pregnancytest, the product wastested by the for treating painand feverwas 500mg. AAdministration (TGA) has seen some preg- TGA, shown to be insensitive, recalled and can- Only onemanufacturer in Poland currently nancy self-testingkits removedfrom the mar- celled from the Australian Register of Thera- produceda300mg paracetamol product, PASMI ket as they were found not to be accurate or peutic Goods (ARTG), the TGA said. said, and this wasnot enough to guarantee supply. work reliably. In response to the One Step case, the TGA If the government wasdetermined to push Noting thatithad reviewed all “human cho- had identified 36 self-carehCG pregnancytests through thechanges, industry mustbegiven time rionic gonadotropin (hCG)pregnancyself-test on the ARTG and twofurther products on in- to adjust, PASMI insisted. kits on the Australian market”, the TGA said a ternet auction site eBay and requested informa- Under the proposals listed in the first draft, number of devices had been found not to “work tion from manufacturers. manufacturers would have hadonly30days to reliably and accurately”. These had nowbeen Rat herthan supplyinformation, nine spon- implementthe changes, the associationpointed “either corrected or removedfrom the market”. sors had cancelled their ARTG listings and out, which could meanshortages and stock-outs “All devices remaining on the market in stopped supply, while the agencyhad cancelled for manyOTC medicines. OTC Australia,”the TGA continued, “have beenshown the entries of twofurther products. to work reliably and accurately.” Meanwhile, Church &Dwight’sFirst Re- Explaining the reasons for carrying out the re- sponse Digital products had been recalled from IN BRIEF view, theagencypointed out that the kits relied on themarketafter too manydeviceshad malfunc- detecting the hCG hormone and some had claimed tioned for the tests to be carried out, the TGA EMA –the European Medicines Agency–has to be able to detect extremely lowlevels, as would said. An investigation by Church&Dwight had revealed that 19 of the 249 finalised mutual be found in the first week after conception. identified amanufacturing fault, which had been recognition procedures were related to non- After areport of threefalsenegative results corrected, the agencynoted, and the corrected prescription medicines in 2016. OTC from women using the One Step hCG urine devices had passed subsequent testing. OTC

12 OTC bulletin 7April 2017 GENERAL NEWS OTC

Switches RegulatoryAffairs MHRA mulls Med devices rules Maloff status Kconsumers could soon be able to buy ripe forpublication Uantimalarial tablets containing atovaquone andproguanilhydrochloride withoutaprescrip- he long-awaited European Union (EU) had beenapplied to ensure that medical devices tion, if aswitchproposed by the country’s Medi- Tmedical devices regulation should become wouldonly beconsidered class III devicesif cines and Healthcareproducts Regulatory Agency law by early May, with the European Parlia- theyachievedtheir intended purpose in the stom- (MHRA) is given the go-ahead. ment(EP)having completed asecond reading ach or lower intestinal tract. Glenmark Pharmaceuticals is seeking to on 4April 2017. And if theywere applied in the nasal or switchits MaloffProtect antimalarial tablets– On 21 March, the EP’sEnvironment Commit- oral cavity, and achievedtheir intended purpose containing250mg atovaquone and 100mg pro- tee –ENVI –adopted adraft recommendation for in those cavities, theywould be placed in the guanil hydrochloride –fromprescription-only asecond reading on the adoption of the legislation, lower-risk class IIa. to pharmacy (POM-to-P) status. having endorsed without amendment the Euro- Similarly, nanomaterials would only be placed The MHRA’s ARM93 consultation docu- pean Council’sfirstreading position. in class III if there wasahigh or medium risk ment points out that MaloffProtect will be indi- With theseformalities completed, the legis- of exposure. If thepotential risk wasnegligi- cated to “prevent malaria in adults weighing lation is set to be published in the EU Official ble, they would be put in class IIa, Ritter said. more than 40kg travelling to areas where ma- Journal by the end of April/early May. Thefinalised language endedalong period laria is widespread”. of uncertainty around the fate of the European Noting that MaloffProtect will be used to Implementation priorities self-care medical devices market. “preventand not treat malaria”, ARM93 points Earlier in March, the Associationofthe Euro- In its draft ofthe medical devices legislation, out that “no diagnosisofacondition is needed”. pean Self-Medication Industry, the AESGP, par- filed in 2012, the Commission had noted that Consumers will be advisedby the proposed ticipated in ameeting of the European Com- the line between medicines and medical devices label and patient information leaflet to get ad- mission/CompetentAuthorities for Medical De- was“difficult to draw”. vice from ahealthcare professional on whether vices(CAMD)on the newregulationswiththe It then suggested–underRule 21 in Annex MaloffProtect is correct forthe partofthe world aim of identifying the highest-priority issues VII–that substance-based medical devices should theyare visiting. around implementing the law. be classified in the highest-risk class as this Training materials, the document adds, will Reporting back, the AESGP said there were wasappropriate to ensure ahigh levelofsafety, be made available for pharmacists “to enable many similarities in the keyconcerns expressed regardless of their use. them to identify the correct choice of product by all industry groups impacted by the newlegis- The AESGP warnedatthe time that Rule 21 for an individual”. lation. It noted, however, thatthe meeting had would place manyself-care medical devices, If approved, MaloffProtect will not be the not been intended to reach anyagreement on suchasnasal sprays and throat lozenges, in the first antimalarial available without aprescription theimplementation priorities, butmore to col- highest-risk category and arguedthatthis pro- in the UK. Antimalarial medicines containing lect the comments from stakeholders. posal was“neither appropriate nor justified by proguanil hydrochloride alone or in combination The Commission highlighted that every the risk profile” of these products (OTC bul- with chloroquinephosphate alreadyhavePstatus implementing or delegated act called for by letin, 18December 2012, page 10). in the country. the newlaw would be subject to afour-week Welcomingthe potentialswitch, the Propri- public feedback procedure. Hundreds of amendments etary Association of Great Britain’s(PAGB’s) Publication of the medical devices legislation Six months later, the Parliament’senviron- chiefexecutive John Smithpointed out that ad- in the EU Official Journal will come just under ment, public health and food safety (ENVI) vice on malaria prevention was“readily avail- ayear after it wasannounced that the words committee proposed amassive762 amendments able to people online from the UK government “intendedpurpose” hadbeenused to break the to the legislation, ontop of the 145 that had been through the TravelHealthPro website and other deadlock on the controversial Rule 21 of the proposed by the legislation’sthen rapporteur online sources”. legislation, ensuring that OTCnasal sprays and Dagmar Roth-Behrendt (OTC bulletin, 31May “It makes sense, therefore, to enable people the likewould not be consigned to the highest 2013, page 14). who are travelling to these regions to purchase class III risk category (OTC bulletin, 17June The Parliament backedanumber of the sug- theirantimalarials from apharmacyprior to 2016, page 1). gestedchanges in aplenary vote in April2014, their trip,” he said, “ratherthan having to book Lars Ritter, anassociate of Gesine Meissner, including deleting Rule 21 and removing the an appointment with adoctor, something we rapporteur on the proposed legislation for the requirement to comply with medicines legisla- knowcan involveup to athree-week wait.” Liberal Group in the European Parliament, said tion, Directive 2001/83/EC(OTC bulletin, 25 “Pharmacists are highly-trained healthcare thatafinalagreement had been reachedonleg- April 2014, page 13). professionals with the skills and expertise to ad- islation on 25 May 2016 at the 10th Trialogue However, just overayear later, the Council vise people on anymedications and vaccina- between the Parliament, Council andCommission. expanded the scope of Rule 21 to cover“all de- tions needed before travelling,”Smith added. Afew weeks later, the Council approvedthe vices that are introduced into the human body “Manypharmacies already offer dedicated travel- regulation, four years after it had been first pro- via abody orifice or applied on skin”, amove health clinics and some also have online tools posed(OTC bulletin, 30June2016, page 13). that the AESGP said put numerous self-care whichoffer information in addition to the ad- Commentingonhow thedeadlock had been medical devices unnecessarily under the defini- vice available in store.” OTC broken, Rittersaidthata“risk-based approach” tion (OTC bulletin, 24July 2015, page 1).OTC

7April 2017 OTC bulletin 13 OTC GENERAL NEWS

RegulatoryAffairs RegulatoryAffairs EMA/HMA NHS to stop paying tackle data he European Medicines Agency (EMA) forsome OTCdrugs Tand the Heads of MedicinesAgencies (HMA) have established ajoint taskforce to he National HealthService (NHS) in Eng- However, the Royal College of General Practi- explore howregulatorscan best use‘bigdata’ Tland hasrevealedplans to stop prescribing tioners (RCGP) warned that anymove to delist to drive innovation in the healthcare sector. “low priority” medicines, including some OTC some medicinesmustbedone in away that did Over the next 18 months, the EMA/HMA painkillers, to help save money. not “disadvantage vulnerable patients”. taskforce will: NHSEnglandconfirmed reports in the Daily Helen Stokes-Lampard, chair ofthe RCGP, l Map sources and characteristics of bigdata Mail and the Health Service Journal that it was said that prescription costs were asignificant l Explore the potential applicability and planning to stopdoctors prescribing painkillers expense for the NHS and the association sup- impact of big dataonmedicines regulation and and sun creams thatcouldbemorecheaply be ported movestolower the costs. develop recommendations on necessarychanges bought OTC, along with other products such as “If patients are in aposition that theycan to legislation, regulatory guidelines or datasecu- gluten-free foods. afford to buyOTC medicines and products, then rity provisions we would encourage them to do so,”Stokes-Lam- l Create aroadmap for developing big Save £128 million pard noted, “butthisisn’t the case for everyone.” data capabilities for evaluating applications for The first phase of the plan wasintended to save “Prescribingisacoreskill in general prac- marketing authorisations or clinical trials by the £128 million (C150 million) by delisting 10 items. tice and familydoctors will always prescribe national competent authorities In an interviewwith the Health Service in the best interest of the patient,”she added. l Collaborate with other regulatoryauth- Journal,JulieWood,chiefexecutiveofNHS “Imposing blanket policies on general practi- oritiesand partners outside the EuropeanEco- Clinical Commissioners, said the public needed tioners (GPs) that don’ttakeinto account the nomicArea to ensure bilateral insights on big to understand thatthe planswereabout “taking demographic differences across the country, or data initiatives. difficult relative prioritisation decisions” and allowflexibility for apatient’s individual cir- The taskforce is chaired by the Danish medi- that the NHS could either spend its budget on cumstances, risk alienating the mostvulnerable cines agency’sThomas Senderovitz and co- paracetamol or something that wasneeded to in society,and we will be seeking assurances from chaired by the EMA’s Alison Cave. OTC improve mental health or primary-care services. NHSEnglandthatthis won’tbethe case.” OTC

Insanely Effective Year-Round Business Development Pharma Partnering euroPLX 64 Vienna (Austria) euroPLX is the world’smost oftenheldpartnering conferencefor the pharma and biotech industries. Because of results delivered. May 29 30,+ 2017 6644 euroPLX 64 Vienna (Austria) May29+30, 2017 Austria Trend Hotel Savoyen, Vienna Register online: euroPLX 65 London (UK) November 27 +28, 2017 www.europlx.com Sofitel London Heathrow

euroPLX 65 London (UK) Seeking and offering business opportunities tein pa nted and generic (incl. biosimilars), prescription and OTCdrugs,medical devices,and nutraceuticals -

development, licensing,marketing,promotion, and distribution… November 27 28,+ 2017 Each euroPLX Conference’sactual collaboration interests aresummarised and displayed on www.europlx.com as an hourly updated Dynamic Partnering Focus, as soon as sufficientdataare submitted by registrants. 6655

www.europlx.com TheOriginal since1995. [email protected] ph. ++49 (6221) 426296-0 Often copied.Never equaled.

14 OTC bulletin 7April 2017 MARKETING NEWS OTC

Marketing Campaigns Marketing Campaigns Hexalbacks Chameleon fronts MometaHexal

ayfeversufferersare shown hugging trees, Berocca campaign Hleaping through fields and rubbing flowers on their faces in Hexal’s television advert- dancing chameleon has been chosen by isement for itsMometaHexalnasal spray con- ABayer Consumer Health to portray “the tainingmometasone furoate, whichwas switch- thrill of feeling energised” after taking Berocca ed in Germany last year. in a£3.0 million (C3.5 million) UK multimedia Scheduled to run until the end of May, the campaign to promotethe vitamin brand. 30-secondspotalso features avoiceoverthat As part of the “Be more Berocca”-themed states: “For everyone who has been suffering from campaign, the firm is airing a30-second tele- hayfeverfor years, who has not been able to enjoy vision advertisement, whichshows the chame- nature for so long, it is time to change something.” leon–known as ‘Roccy’ –dancing and changing Theaforementioned people are then shown colour in atropical rainforesttoahigh-energy dancing in acircle as pollen fliesaroundthem, song as others watch on. ‘Roccy’ fronts the ‘be moreBerocca’ push Text at the bottom of the screenpoints outthat In addition to the television creative, the Beroccacontains vitamin B1 to supportnor- campaign encompassed out-of-home and digital mal energyrelease. The advertisement then ends out-of-home advertising, Bayer said, as well as pub- withthe campaign slogan next to apack of Ber- lic-relations, online, and social-mediaactivity, occa, as Roccycontinues to dance. “targeting those on their daily commute”. The target audiencewas people between 30 Supportedbyvideo-on-demand and 44 years, the companynoted. Bayer said the television spot would run Meanwhile, the out-of-home and digital out- until May, and be supported by “a comprehen- of-home elements included advertisements for sive video-on-demand strategy to maximise the Berocca on south-eastern rail networks and the potential reach”. London Underground until the end of this The campaign includes television advertising Theaim of the latest campaign wastocom- month, Bayer said. municatehow Berocca could“help energise The social-media activityonBerocca’sFace- whilethe voiceoverstates the spray “will change your day to help combat tiredness and fatigue”, book, Instagramand Twitter profiles would run your life”. the companyexplained, noting that –accord- until September, the firm noted, alongwiththe On-screen text highlights that MometaHexal ing to market-research firm Nielsen –this was “highly-disruptive”public-relationsactivity and an is “especially effective”, and that it only needs the main concern of 66% of UK consumers. “in-store and online presence” for the brand. to be used once aday, aswell as being suitable Roccyrepresented “healthyenergy”, the firm Bayer added thatanew-look berocca.co.uk forlong-term useand non-drowsy. The end of added, and brought an “entertaining, vibrant website would also provide consumers with nu- theadvertisement refers to the productas“the and charismatic personality back to the brand”. trition and lifestyle content. OTC blue power spray” and highlights that it is “now available without aprescription”. Product Relaunches In addition to the television creative, market- ing support for MometaHexal included point- Synthol Gel returnstoFrance of-sale materials, Hexal said, along with a brand website, mometahexal.de, which offers laxoSmithKline (GSK)ConsumerHealth- gredients, but had relaunched Synthol Liquid a‘pollen level’ app. This allows consumers to Gcare hasre-introduced its SyntholGel to in June 2016. click through to aseparate page featuring a the French market. It had suspended marketing Pharmacy-press advertising proclaims “Syn- map. Theycan input their postcode to see a Synthol Gel –aswellasits liquid counterpart– tholGel is back”, noting that aseven-week pollen forecast for their area and alist of dif- due to supply issues for oneofthe brand’s in- publicitycampaign is plannedfor summer, in- ferent pollen types, as well as information on cluding on majortelevision networks. Thetopi- what types are present. cal treatment for minor bumps, bruises and insect Theapp can also be downloaded to Apple bites –formulated with levomenthol, veratrol, and Android devices. resorcinol and salicylic acid –isavailable in a Meanwhile, pharmacistsand specialists are 75g tube with arecommended price of C5.95. being targeted through aprintcampaign featur- Also available as aliquid in 225ml or 450ml ing advertisements and advertorials. bottles, Synthol is recommended for adults and Each spray of MometaHexal –which is suit- children overseven years of age and can be ablefor those aged over18years –provides 50µg used twoorthree times daily. of the active ingredient, which wasswitched TherelatedSyntholKiné range, includes heat from prescription to OTCstatus last year (OTC patches, as well as massageproducts in roll-on bulletin, 21October 2016, page 11). OTC Synthol Gel is backon the Frenchmarket and gel-cream forms. OTC

7April 2017 OTC bulletin 15 OTC MARKETING NEWS

Product Launches Product Launches EndWarts to TheOTCLab grows freeze Swiss reachofEarClin ylan is settoroll out its EndWarts Freeze Mcryotherapy wart treatment in Switzer- utch firm TheOTCLab has expandedthe land next month. Dreach of its EarClin earshower ear-wax Currently available in anumber of markets – remover into Belgium and Italy. including Austria, Denmark, Finland, France, Previously only available inAustria –where Germany, Norway and Sweden –the medical it waslaunched in 2015 –EarClin contained device is claimed by thefirm to be thefirst home a“unique natural soap”, the Dutch firm ex- treatment to use nitrous oxide to freeze warts. plained, to be mixed with water to weaken The product’s“UltraFreeze” technology and “flush out” excess ear wax. –owned by Belgiandevelopment companyOys- To use EarClin –amedical device –con- tershell Laboratories –created atemperature of sumers should squeeze the product’ssuction bulb

-80degC at the applicator tip, Mylan explained, to draw up lukewarm water of amaximum tem- EarClin has been launched in Belgium and Italy to destroywarttissueatadeeper level. perature of 40degC, the firm says. This made EndWarts –which is suitable for Users should then tilt their head to the side The firm wasalso aiming to roll out the prod- use on the hands, arms, and feet in those from before placing the EarClin nozzle at the en- uct “soon” in other European markets such as four years of age –the coldest wart-freezing op- trance of the ear canal and squeezing three times France, Germanyand the UK, he noted, as well tionfor self treatment, the firm claimed, as most to release the soapyliquid, before tilting their as Scandinavia. other products contained dimethyl ether or adi- head back to drain the ear. Marketing activity for EarClin in Belgium methyl ether-propane gasmixture, and only reach- Theempty earshower couldthenbeused to wascurrentlyunderway,Swane said, and includ- ed temperatures of around -50degC. “gentlyblowair intothe ear canaluntil dry”, ed print, education and sampling activity. As aresult of treatment, the wart wasusually TheOTCLab explained. Both earsshould be Meanwhile, the launch support in Italywould gone within 10-14 days, the companyexplained. rinsed, “every other day”. begin next month, he noted, while the market- Mylan already offers under the EndWarts EarClin is available in twosizes –one for ing push for EarClin in the Netherlands was brand umbrella asolution with formic acid – useonchildren aged overthree years, and alarger scheduled to start in June. The campaign in whichshouldbedabbed on the wart with cotton variant for adults –and “a range of colours”. the Netherlands would also include television swabs –aswell as an EndWarts Pen, for more From next month, EarClin would also be advertising, he added, which would “most precise application of formic acid. launched in Australia, Canada, Hong Kong, the likely” begin airing in September. Thefirm gainedEndWartsthrough itsacqui- Netherlands, NewZealand, Singapore andSouth “Quick, easy and safe –clean ears for the sition of Swedish firm Meda in 2016 (OTC Africa, Albert Swane, managing director of wholefamily”was the taglineofthe marketing bulletin, 19 February 2016, page 3). OTC TheOTCLab, told OTC bulletin. activity,Swane pointed out. OTC

Product Launches blood when you brush or floss, you mayve ha gum disease, and could be on the journeyto GSK’sParodontax enters US much worse”. After seeingthe signs, sheman- laxoSmithKline (GSK) Consumer Health- being promoted withatelevision campaign and ages to get offthe train before the doors close. Gcare has launched its Parodontax toothpaste digital advertisements, GSK said, as well as via Asimilar commercial is currently being onto the US market to help consumerstreatand the brand’sFacebook page. used to support the Corsodyl toothpaste line in the prevent bleeding gums. Public-relations and in-store store activity is UK, including the recently-launched Ultra Clean Noting that asurvey had shown that more supporting the launch further, while abrand variant. The creative –part of an £8.8 million than athird of US adults spat blood when they website, parodontax.com, isalso live. (C10.1 million) campaign –also shows the brushed or flossed their teeth, GSK claimed Theaim of the marketingpush wastohigh- woman on atrain, and points out that Corsodyl most consumers didn’trealise it could be asign light that Parodontaxhelped prevent bleeding toothpaste is “four-times more effective at re- of aserious oral-health problem. gums, GSK said, which, if left untreated, could moving the main cause of bleeding gums”. Containing stannous fluoride –ananti-gingi- cause “gum tenderness, bad breath, receding The television spot would air in the UK until vitis active ingredient listed on the OTCdrug gums and, ultimately, tooth loss”. November,GSK said, accompanied by “educa- monograph–Parodontax is said by the firm to “Leave bleeding gums behind” is the tag- tional” out-of-home anddigital activity. be “40% more effectiveatreducing bleeding gums line of the campaign, which the companynoted Meanwhile, GSK noted that it planned to than asodium monofluorophosphate toothpaste”. would “continue throughout 2017”. introduce “in stages” to the whole UK Corsodyl Thetoothpasteisalsoclaimedto“strengthen In the 30-second television spot, awoman range the updated packaging –featuring ared teeth and keep thesealbetween gumsand teeth is shown spitting blood when brushing her teeth, flash–that it beganrolling out acrossthe Paro- tight, helping to protect against gum disease”. before embarking on atrain journey that stops dontax brand earlierthis year(OTC bulletin, 13 Parodontax –which is available as Clean at differentstationsshowing symptoms of gingi- January 2017, page 16). It also features on the Mint, Whitening and Extra Fresh variants –was vitis. Avoiceoverpoints out that “if you spit Parodontax toothpaste line in the US. OTC

16 OTC bulletin 7April 2017 MARKETING NEWS OTC

Marketing Campaigns Q&A with RB focuses Galderma’s on Easter June Risser eckitt Benckiser (RB) is focusing on the Reffects of overindulging at Easter in the Vice-President for latest UK campaign for its Gaviscon Dual Action heartburn- and indigestion-relief range. Marketing, Consumer Targeting “those who may suffer discom- fort after afew too many chocolate eggs”, the marketing activityincludedspecially-designed point-of-sale displays in pharmacies, the firm What has been the biggest achieve- of people’s daily lives. This makes the chal- noted, to “makeclear the linkbetweenindulg- Q ment of your OTCmarketing career? lenge formarketeers more complex, but also ing at Easter and heartburn and indigestion” more exciting, as it gives us the ability to tell and “raise awarenessamong consumers”. Launching Differin (adapalene) in the brand stories in morerelevant channels, with Television and radio advertising wasalso A US following its prescription-to-OTC morerelevant content, at morerelevant times. supportingthe general-salelist (GSL)Gavis- switch (OTC bulletin, 17February2017, page Being mobile-first is amust for marketing now, conDual Action range –which comprises a 16).The firsttopical retinoid approved by as well as ensuring that your brand is present liquid, chewable tablets, and liquidsachets–RB the country’s Food and Drug Administration when consumers are searching for solutions. said, as well as out-of-home activity. (FDA) to go OTC for acne wasgame-changing The 20-second television advertisement– for the millions of US acne sufferers, especially What has been the most important which is alsorunningonYouTube –shows twin given that the vast majority of them do not visit Q lesson of your career? brothers at afamily meal, before avoiceover healthcareprofessionals (HCPs)for treatment. pointsout that “special occasionsshouldbecele- To truly understand what my brand brated”. It adds that such celebrations mean heart- What hasbeenthe biggestchallenge A stands for, and defining the unique role burn for one twin and indigestion for the other. Q of your OTC marketing career? it plays in consumers’dailylives.Too many It goes on to highlight that Gaviscon Dual brandswaste timeand energy chasing the“fla- Action –containing sodiumalginate, sodium bi- When Ijoined Galderma in April 2016, vour of the month” and changing their brand carbonate andcalcium carbonate –“gets to work A Iled the skin-care brand Cetaphil, which positioning.How your brand appears through hadastrongequityamongdermatologists and innovation and marketing can evolve, but it other HCPs, but very limited spontaneous should do so in away that alwayslinksback to awareness, market share and penetration among whatthe brandrepresents. consumers. We had created a360-degree “Cet- aphil is beautiphil” campaign in the second How do you see OTC marketing dev- half of 2015 and continued this throughout Q elopinginthe future? 2016. This led to the brand outperforming in Easter is the focus on the campaign the market in 2016, with over 8% growth. Therewill be more investment in digi- instantly” and “lasts twice as long as antacids”, so A taladvertising on mobile, more online bothmen can getrelieffrom theirsymptoms. How have consumers changed over shopping on mobile, and more in-store, at- Meanwhile, the out-of-home activity included Q the course of your career, and how shelf research to compareproducts and pricing digital advertisements at railwaystations, RB have you responded? on mobile. OTC marketeers will also need to said, adding that these would last until 16 April. continue to develop new and innovative ways The television andYouTube support would run One of the biggest changes in con- to educate consumers about products and how until 24 April, thefirm added, while the radio ad- A sumerbehaviour andexpectations is the to use them, as well as to drive compliance, as vertisements would air until the beginning of May. rise of the smartphone and how digital is part people trend towards more “self-care”. OTC RB added that there would be digital sup- portfor Gaviscon DoubleAction “throughout For the opportunity to feature in the Q&A section, the year”. This includedadvertisementson email [email protected] search engines andacollaboration withhealth website BootsWebMD. OTC

IN BRIEF QUIESSER PHARMA has grown its ern nutrient combination” for those trying to as well as 1,000mg of omega-3 fatty acids, of Doppelherz System pharmacy-exclusive sup- get pregnant, the companypointed out, noting which225mg is docosahexaenoic acid (DHA) plement range in Germanywith aproduct for the addition of omega-3 fatty acids. Eachcap- and325mg eicosapentaenoicacid(EPA). One womenwanting to conceive. Doppelherz Sys- sulecontains 600µg folic acid, 10µgvitamin D, capsule should be taken daily,Quiesser Phar- tem KinderWunsch capsules provided a“mod- 10mg vitamin E, 150µg iodine, and 5mg zinc, ma instructs. OTC

7April 2017 OTC bulletin 17 OTC MARKETING NEWS

Marketing Campaigns Owl promotes Sanofi’s Xyzal

nanimatedowl is encouraging US allergy Meanwhile, in the creative to promote the Asufferers to be “wise” and choose Xyzal Children’sXyzal Allergy 24HR solution, the Allergy24HRfor their symptoms in Sanofi’s owlisshown with astory book, before point- launch television campaign for the recently- ing out that “when allergy symptoms are at switched brand. their worst, kids are not at their best”. He also Wearing amonocle and abow tie, the owl notes the product relievessymptoms while child- spokescharacter appears in anumber of tele- rensleep, so theywaketoa“full day of allergy vision advertisements for the levocetirizine hydro- relief” and “live happily ever after”. chloride-based range. These include 15- and 30- The owlalso features on the xyzal.com website, second commercials to promote the 5mg tablets, as well as Xyzal’sFacebook and Twitterprofiles. The Xyzal advertisements featurean owl and a15-second spot to support the 0.5mg/ml Xyzal waslaunched earlier this year after symptoms had on their daily lives. children’soral solution. its prescription-to-OTC switch wasapproved Claimed to be the first experiment of its “Be wise all. Take Xyzal” is the tagline of the by the US Food andDrugAdministration(FDA) kind, the testinginvolved 160 participants –with advertisements, which Sanofi said were “sched- (OTC bulletin, 17February 2017, page 11). an equal number of allergy sufferers and non- uled to run for the remainder of the year”. OneXyzal Allergy 24HRtablet –providing sufferers –who each had awearable device In the 30-second creative, the owlpoints out 5mgoflevocetirizine hydrochloride –should for 30 daystorecord their sleep andactivity. that the Xyzal Allergy 24HR tablets are the “wise be taken by those aged between 12 and 64 years. The findings are presented in avideo fronted newchoice for allergy relief”. He recommends Half atablet is recommended for those aged by an allergist, who points outthat“most peo- that viewers use the product if symptoms such as between six and 11 years, while the recom- plethink they’re only really affected by their sneezing, runny nose and itchy andwatery eyes, mended dosages for the Children’sliquid are allergiesduringthe day”. Allergy sufferers were and itchynose or throat “stop you from getting a 5mlfor thesame age group, and 2.5ml in child- shown to wake up nearly four-times more than good night’ssleep, and ruin your next day”. ren agedtwo to fiveyears. Those aged between those without allergies, she notes, and felt less He alsonotesthatXyzal –which shouldbe 12 and64 years of agecan take 5mlor10ml of restedand wereless activethe next day. taken once daily in theevening –relievessymp- the solution,Sanofi says,“depending upon the She goes on to add that she often recommends toms overnight, and “keeps relieving them all severity of symptoms”. to her patients “treatment options thatprovide day”, because it is “as effective at hour 24 as Meanwhile, the companyisalso promot- 24-hour relief”, such as Xyzal Allergy 24HR. it is at hour one”. The owladds that the prod- ing on its social-media channels –including The videoendswith the doctor encouraging uct is “original prescription strength, with no YouTube –the results of a“social experiment viewers to “wiseupaboutmanaging your aller- prescription needed”. involving allergy sufferers” to show the impact gies, so you can rise up and takeonthe day”.OTC

Marketing Campaigns Thornton &Ross blends words

hornton &Ross is building on the “recent ing’ pain after alarge shopping trip. Another Ttrend of portmanteauwords” in a£2mil- calls the characterofthe story a“brainiac”for lion (C2.3million) UK multimedialaunchcam- choosing Combogesic at the pharmacy. paign for its Combogesic pain-relief tablets. Thornton &Ross –which holds the UK Comprising television advertising and public- rights to Combogesic from NewZealand-based relations activity, aswellasdigital and point-of- AFT Pharmaceuticals –saiditwas lookingto Word combinations areused in the campaign sale materials for pharmacies, the campaign – “buck the trendinacompetitive and function- which uses the tagline: “Get Combogesic on led market, where advertisements are often clini- analgesics weren’teffective, Thornton &Ross pain” –took amore “humorous and relatable cal in tone or showstereotyped sufferers”. said, or for those wanting “stronger relief with- approach” to advertising analgesics, the firm Explaining further the idea behind the cam- out the addictive ingredients”. pointed out, through using blended words such as paign, the firmpointed out that the name of the Meanwhile, the firm pointed out that the ‘glamping’ and ‘staycation’. brand –which contains500mg paracetamol digital and public-relations activity included Such combination wordshad madetheir and 150mg ibuprofen per tablet –in itself wasan online display advertisements, as well as anew wayinto people’severyday vocabulary,Thorn- amalgamationof‘combination’ and‘analgesic’. Combogesicwebsite, combogesic.co.uk.Thorn- ton &Ross claimed. Targeted at females aged 25 years and over ton&Ross said it would also be using You- Scheduled to air until the end of May, the who are “regular users” of OTCanalgesics, the Tube to showcase aselection ofvideos presented television promotion –which consists of two promotional supporthighlightsthat Combogesic by television doctor Dr Dawn Harper. commercials –highlights through animated provides 30% more pain relief than taking either The public-relations and digital activity would stories the “combination benefits” of the phar- active ingredient on its own. run throughout all of 2017, Thornton &Ross not- macy-only (P)Combogesic tablets. One advertise- Combogesic waspositioned as an alternative ed, adding that it plannedto air the television spot ment describes howawoman suffers ‘bagonis- for those looking for pain relief when single again in the second half of the year. OTC

18 OTC bulletin 7April 2017 EVENTS OTC

MAY 30 May-1 June AESGP Conference 10 May Vienna,Austria Dietary Supplements Seminar ‘Self-care in achanging world’ is the theme of this three-day event organised by the Association Maryland, US of the European Self-Medication Industry,the AESGP. This one-day event will offer updates and in- There will be sessions on: ‘Global changes and their implications on consumer healthcare’; sights from the US Food and Drug Adminis- ‘Howtobesuccessful in self-care’; and ‘E-health facilitating self-care’. tration (FDA) as well as trade associations rep- Speakers will include: Guido Rasi and Christa Wirthumer-Hoche of the European Medicines resenting the dietary supplement industry. Agency(EMA); Brian McNamara of GlaxoSmithKline Consumer Healthcare; Catherine Devine Contact:CHPA. of Johnson &Johnson; Laurent Faracci of Reckitt Benckiser; Dirk Ossenberg-Engels of Bayer Tel: +1 202 429 3544. Consumer Health; Briain de Buitleir of PGT Healthcare; Chris Slager of Pfizer Consumer Email: [email protected]. Healthcare; Andy Tisman of IMS; and Karl Pall of Google. Website: chpa.org/OTCAcademy. Contact:AESGP.Tel: +32 273 55130. Email: [email protected]. Website: aesgp.eu/53. 9-11 May Vitafoods Europe Email: [email protected]. Tel: +41 61 225 5151. Geneva,Switzerland Website: management-forum.co.uk. Email: [email protected]. Athree-day exhibition and conference focusing Website: diaglobal.org/en/flagship/dia-2017. on nutraceuticals, and functional foods and drinks. 24 May Contact:Informa Exhibitions. Variations to Marketing 26-27 June Tel: +44 20 3377 3616. Authorisations in the EU Pharma Marketing Email: [email protected]. London, UK Bonn, Germany Website: vitafoods.eu.com. Aone-day reviewofvariation regulations in ‘Facing the future’ is the theme of this two-day the European Union (EU). event, which will discuss howthe pharmaceuti- 11-12 May Contact:Management Forum. cal industry could optimise future opportunities. CHPARegulatory,Scientific Tel: +44 20 7749 4730. Contact: Inspirato. &Quality Conference Email: [email protected]. Tel: +49 151 624 179 41. Maryland, US Website: management-forum.co.uk. Email: [email protected]. Subtitled ‘Advancing Consumer Self-Care’, Website: inspirato-pharma-marketing.de. this two-day event is run by the US Consum- 24 May er Healthcare Products Association (CHPA). Consumer Healthcare Contact:CHPA. Investment USA OCTOBER Tel: +1 202 429 9260. NewJersey, US Email: [email protected]. This one-day event is described as amarket- 10-11 October Website: chpa.org/rsq. place and showcase of ‘next-gen’ consumer AESGP Conference healthcare and wellness companies that are Brussels,Belgium 16 May actively seeking growth capital, merger and Regulatory challenges for consumer health Building Regulatory Excellence acquisition opportunities or product licensing. products will be the focus of this two-day meet- Bangalore, India Contact:Kisaco Research. ing,organised by the Association of the Euro- Aone-day seminar run by The Organisation for Tel: +44 20 3696 2920. pean Self-Medication Industry,the AESGP. Professionals in Regulatory Affairs (TOPRA), Email: [email protected]. Contact: AESGP. focusing on howpharmaceutical organisations Website: consumerhealthinvestusa.com. Tel: +32 273 55130. in India can build regulatory excellence globally. Email: [email protected]. Contact:TOPRA. 29-30 May Website: aesgp.eu/events/brussels2017. Tel: +44 20 7510 2560. EuroPLX 64 Email: [email protected]. Vienna,Austria 17-19 October Website: topra.org. This two-day meeting will provide aforum WSMI General Assembly for business development decision makers Sydney, Australia 23-26 May for discussing and negotiating collaborative ‘The Economics of Self Care’ is the theme of 3rdAnnual Asia agreements in licensing, marketing, and dis- the World Self Medication Industry’s(WSMI’s) HealthcareSummit tribution of patented medicines, generics, bio- three-day conference. Singapore similars, OTCproducts, medical devices and Contact: Arinex. Three co-located conferences will takeplace food supplements. Tel: +61 29265 0700. during this four-day event. Contact:RauCon. Email: [email protected]. Contact:IBC. Tel: +49 6221 426 2960. Website: wsmiga2017.com. Tel: +65 6508 2401. Email: [email protected]. 24 October Email: [email protected]. Website: europlx.com. Website: asiahealthcaresummit.com. Global Generics & Biosimilars Awards 23-24 May JUNE Frankfurt, Germany Pharmaceutical Regulatory These awards, organised by Generics bulletin, Affairs in the Middle East 18-22 June recognise ‘best practice’ in the global generics London, UK DIA Annual Meeting and biosimilars industries. Countries to be covered at this two-day seminar Chicago,US Contact: Generics bulletin. include Egypt, Israel, Lebanon, Qatar,Saudi ‘Driving insights to action’ is the theme of this Tel: +44 1564 777550. Arabia and the United Arab Emirates (UAE). five-day annual meeting organised by the Drug Email: [email protected]. Contact:Management Forum. Information Association (DIA). Website: generics-bulletin.com/generics- Tel: +44 20 7749 4730. Contact: DIA. biosimilars-awards.aspx

7April 2017 OTC bulletin 19 OTC MARKET RESEARCH

As thedefinitionof self-carewidens, emboldened newfirms areentering the US marketand in some cases outperforming the traditional players. IRI’s Bob Sanders urgesindustrytoget to grips with the new competitiveset. MattStewart reports.

Beware the newcompetitors

ess traditional players arestart- ecutive conference in Florida, US, Sanders and Kainos –which offer the Premier Protein ing tosee the growth opportu- warnedthat as the definition of self-care broad- and Slim-Fast brands respectively –were massively nityinconsumer healthcare and ened, space opened up for newentrants offer- outgrowing even the best-performing traditional Lare successfully launching brands ing products outside of traditional categories. OTCplayers in the US like GlaxoSmithKline that meet the growing health and “Lesstraditional players are beginning to see (GSK) and Johnson&Johnson(J&J), as well as wellness needs of consumers.This is the growth opportunity in health and wellness nutritional firms like Pharmavite (see Figure 1). thestark warning to the US OTC indus- and theyare launching brandsand doing well,” This wasalso reflected in the keyretailers tryfromBob Sanders,practice head Sanders stated. “That is our newcompetitive set.” for consumer healthcare products in the US, of Health and Home at IRI. Looking at the fastest-growing manufacturers he added, with sales of OTCproductsgrowing Speaking at the recent Consumer Healthcare in the US consumer healthcare space in 2016, fastest in what were predominantly grocery stores Products Association’s(CHPA’s) annual ex- Sanders pointed out that companies like Post (see Figure 2). “Industry hasalways challengedinthis space, with grocery retailers accounting for around 25%ofthe consumer healthcare market,”Sanders said, “but nowthese are the retailers that are growing, so we needtobe conscious of howto work with them.” The strong growth of new entrantsinto less traditionalhealth andwellness categories was in contrast to the overall marketpicture in the US consumer healthcare market,Sanders point- ed out, notingthat better to reflect the self-care spectrum, IRI nowincluded sales of oral-care Figure1:Fastest-growing manufacturers in the US consumer healthcarespace in 2016 (Source –IMS/IRI) products and sunscreens in itscategory defini- tion,aswell as OTCproductsand nutritionals. Retail sales in 2016 hadmoved ahead by 3.3% to US$43 billion (C40 billion), he ex- plained, around the same levelofgrowth that hadbeen achievedfor the previous three years (see Figure 3). “This levelofgrowth is okay,” Sanders claim- ed, “but we can do much, much better.” Indeed, the growth of the US consumer healthcare market had been stronger than overall sales in the USretail sector,which had edgedup Figure2:Fastest-growing retailers in the US consumer healthcarespace in 2016 (Source –IMS/IRI) by 1.1% to US$647 billion, he noted, adding

20 OTC bulletin 7April 2017 MARKET RESEARCH OTC

+1.1% +2.1% US$647 US$218 bn bn

+16%

~US$447 bn ~US$43 bn +0.7% +3.3% US$430 US$43 bn bn

Figure4:Retail sales in the US groceryand online channel broken Figure3:Growth in the US OTCmarketbetween 2012 and 2016 (Source –IMS/IRI) down by category(Source –IMS/IRI) that by farthe fastest-growing channel for as something for bodybuilders, buttohelp claimed. While manybig brands had launched consumer healthcare products –albeit from a people with weight loss. successfulline extensionsinthe past five years small base –was e-commerce, drivenprimar- This wasalsoreflected in the fastest-growing (see Figure 7), howmany, he questioned, had ily by nutritional products, such as vitamins, consumer healthcare brandsinthe US lastyear, actually added “true incremental growth” to the minerals and supplements (see Figure 4). Sanders said, noting that while the majority of consumer healthcare category? Turning to the market trends, branded prod- the biggest sellers in dollar terms were more “Oral-care is doing areal nice job in moving ucts had taken back the growth initiative from traditional brands –like Advil and Tylenol – intowhat were traditionally more professional private-labelproducts,Sanders said, with nation- three ofthe six fastest-growing brands were pro- areas,”Sanders pointed out, “with whitening al brands posting sales up by 3.7% compared tein-based nutritional products (see Figure 6). the keyexample.” to 1.9% growth for private-label products. Looking ahead, Sanders said the maxim that “But when you press the dial and look at This rise had been drivenbynot only the innovation drivesgrowth remained true. traditional OTCand nutritional products, Iwould return of anumber of national brandstothe mar- Reiterating that overthe past five years challenge the industry,” Sanders said. “Procter ket, he explained, butalsobysome successful switches alone had added US$1.1 billion in &Gamble’s (P&G’s) ZzzQuil is agreat ex- prescription-to-OTC switches, primarily in the sales to the consumerhealthcare category, Sand- ample of leveraging brand equity and adding allergy space, overthe past fewyears. ers pointed out that, while switch remained value tothe consumer healthcategory,”he noted, important, it should not be relied upon as the “but howmanyofthese other newproducts Switches account for28% of growth sole driverofinnovation in the category. launched in the past five yearshave done that?” Breaking down the US$6 billion rise in sales “You cannot plan on switches running smooth- “It is easier said than done,”Sanders ad- in the US consumer healthcare sector between ly due to regulatory challenges,”he explained. mitted, “but real innovation –where you see 2012 and 2016, Sanders pointed out that pre- “The real opportunity lies in innovating on the awhite space and fulfil areal consumer need scription-to-OTCswitches of products suchas base business.” with meaningful products –iswhere the growth GSK’sFlonase and Pfizer’sNexium had ac- However, there wasaproblem, Sanders will come from.” OTC counted for 12% of total dollar sales, but20% of the category growth (see Figure 5). “Prescription-to-OTC switch is still very important to the category,” he insisted. However, within the consumer healthcare category,nutritionals were the standout per- formers in 2016, with sales rising by 6.1% to US$10.6 billion, Sanders said. Having faced anumber anegative news stories in 2014, the nutritionals category had +87.9% +43.0% +18.2% +12.5% +12.8% +6.3% rebounded well, Sanders explained, drivenby US$82.5 mn US$47.5 mn US$46.8 mn US$41.8 mn US$37.6 mn US$50.4 mn the wider acceptance of protein products not Figure6:Top-10 US consumer healthcarebrands by growth in 2016 (Source –IMS/IRI)

Other US$28 mn US$2.1 bn Nutritonals US$82 mn US$40 mn US$46 mn US$16 mn 53% US$1.6 bn 27% US$37 mn US$54 mn US$51 mn US$34 mn US$34 mn

US$33 mn US$92 mn US$57 mn US$44 mn US$44 mn

US$64 mn US$53 mn Return US$121 mn US$25 mn US$22 mn to shelf* Prescription- US$1.0 bn to-OTC US$33 mn US$1.1 bn US$141 mn 17% US$84 mn US$83 mn US$32 mn 20% *Estimateofmajor supply outages and recalls Figure5:Breakdown of sales growth in the US OTC Figure7:Aselection of the best-selling newproduct launches in the US consumer healthcarespace sector in the past fiveyears (Source –IMS/IRI) between 2012 and 2016 (Source –IMS/IRI) g

7April 2017 OTC bulletin 21 OTCHouse Ad Full Pg OCT 2016_Layout 127/09/2016 11:34 Page 1 Youfocus on GREA V T consumer healthcare ALUE Indiv idu subscrip al So do we ... tio are onl ns y Letus bring you thenews £995 that matters to your industry

Don’twaste time sifting through pharma noise. OTC bulletin delivers allthe wellness and self-careinformationyou needto make better decisions faster.

CHOICE OF FORMATS OTC bulletin newslettersare available: ■ EITHER as the digital OTC bulletin-i foronline access by desktop and laptop computersAND Apple and Android tablets and smartphones ■ OR in traditional hard-copyprint format

PRINT DESKTOP APPLE ANDROID

INDIVIDUAL SUBSCRIPTIONS An annual subscription comprises: ■ 20 OTC bulletin newsletters ■ AND at least 45 weekly news@OTCbulletin electronic newsflashes containing the week’s topnewsstories, delivered by email

MULTIPLE&CORPORATE SUBSCRIPTIONS Discounts are available formulti-user subscriptions for colleagues at the same location. Researchedand writtenby Corporatesubscriptions provide location-, country- or consumer healthcarespecialists company-wide access to OTC bulletin. from an OTC industry perspective

Take out your own subscriptionTODAY at www.OTC-bulletin.com or for Corporatesubscriptions contact: [email protected]

Bulletin Publishing Group, OTCPublications Ltd, 4PoplarRoad,Dorridge,SolihullB93 8DB, UK. (Tel: +44 (0)1564 777550; Fax: +44 (0)1564 777524).Registered in England No. 2765878. VATGB608 0432 69 PEOPLE OTC

Manufacturers Manufacturers Takeda elects HRA names Wright Europe leader apanese firm Takeda has appointed Giles as chiefexecutive JPlatford as president of its Europe and Can- ada(EUCAN) business unit, reporting directly avid Wright –formerly head of Boeh- to the company’s chief executive officer Chris- DringerIngelheim’s global Consumer Health tophe Weber. Care business –has joined HRA Pharma as the Formerly president of Takeda’sEmerging French firm’s chief executive officer. Markets unit, Platford joined the firm in 2009 He replaces FrançoisVuillet,who had spent and hasheld numerous senior roles aroundthe 15 years at the privately-held company. He was world,including general manager of Braziland promoted to chief executive officer from his headofthe company’sMiddle East,Turkey and previous role of chief operating officer less than Africa (META) region. ayear ago, replacing Erin Gainer (OTC bul- Commenting on the appointment, Webersaid letin,22July 2016, page 23). that Platford’s“solidbusiness ability and un- Announcing the leadership change, HRA derstandingofTakeda’svalues” made him the pointed out that Wright wasa“renowned leader in David Wright the OTCspace”, adding that he had “over25years of experience in the pharmaceutical industry”. has also held roles at Boots Consumer Health- In his previous role at Boehringer’sCon- care and Sandoz. sumer Health Care business –which wasre- Following the announcement in June last centlyacquired by Sanofi (OTCbulletin,13Janu- year that Sanofi had reached an agreement to ary 2017, page 1) –Wright had “led the rapid swap its Merial animal healthcare business for organic development” of the unitas“one ofthe Boehringer’sConsumer HealthCare unit (OTC fastest-growing OTCplatforms globally,with bulletin,30June 2016, page 1), Alan Main, apresence in allkey markets and strong global formerly global president of Bayer’s Medical brands”, HRA added. Care unit, wasappointed to lead Sanofi’sglobal Appointing Wright as chief executive officer Consumer HealthCare business, including over- illustrated HRA’s “willingness to accelerate the seeingthe integrationofBoehringer’s consumer Giles Platford deployment” of its strategy to “become aglobal arm into the French company’s existing global innovative OTCplayer,bringing solutionsand OTCoperation. ideal choice tolead what had been “a high per- access to patients globally”, the companysaid. Commenting on his newrole,Wrightsaid forming region in the last fewyears”. The firm added that it wascurrently work- HRA had provenits “great capacities in delivering “His proventrack record with the firm in senior ing on “several projects” that were aimed at innovative care to womenand patients globally”. leadership rolesacrossdiverse geographies and “bringing about areal revolution in American Wright added that his ambition wastobuild cultureswill no doubtbring aunique perspective women’saccess to contraception”. on the firm’s“solidfoundations”, lead its teams and value to all facets of Takeda’sbusiness in Wright spent around 20 years at Boehringer, and “continue to expand HRA’s footprint”. Europe and Canada,”Weber added. OTC after joining in 1997 as divisional director for Private-equity firm Astorg and its co-investor the UK and the Republic of Ireland. He went on GoldmanSachsacquired HRAfrom its found- to become global marketing director for the firm’s ersand investment group,The Riverside Com- IN BRIEF Consumer Health Care business in 2004, before pany, in early 2016 (OTC bulletin,4March taking up his previous role in March 2010. He 2016, page 7). OTC GLAXOSMITHKLINE (GSK) has named Helen Tomlinson as general manager of its IndustryAssociations Consumer Healthcare businessinSpain. Pre- viouslygeneral manager of GSK Consumer Healthcare’sbusiness in Romania and the Bal- Caldini joins CHPAboard kans,Tomlinson –who has replaced Konstan- eterCaldini, Pfizer Consumer Health- care; MikeRosenberg,seniorvice president tinos Vossos –has been with the UK-based Pcare’sregional president for North Amer- for national advertising at Healthgrades; Rich firm for 11 years. In wrher ne ole, Tomlinson ica, has joined the US Consumer Healthcare Simonson,chief operating officer at Carma would be responsible for Consumer Health- Products Association’s (CHPA’s) board. Laboratories; and Jeffrey Vernimb,general man- care’soperations in Spain and Portugal, GSK Caldini is one of sevennew memberselected ager,North America at MobergPharma. said, which generatedannual sales of about C222 at the CHPA’srecentannual executive confer- Jeffrey Needham –vice-president and gen- million. Commenting on hernew role, Tomlin- ence in Florida, US. eral managerofUSstore-brand companyPer- sonsaidshe waslooking forward to leading Also among these elected were: Sharon rigo’sConsumer Healthcare unit–remains the abusiness which had brands in strong leader- Glass,senior vice president of branddevelop- board’schairman, having taken overthe role from shippositions and held the number-one spot in the ment at Catalina; Avani Kanubaddi,chief Patrick Lockwood-Taylor in June last year OTCcategoryand number-twoinoral care.OTC executive officer of Welmedix Consumer Health- (OTC bulletin,30 June 2016, page 23). OTC

7April 2017 OTC bulletin 23 T ultnid 1 Bulletin.indd OTC

˝2017 Catalent Pharma Solutions. All rights reserved. fa line better otc inno Mo de fo rm ve re lo s. ster th ped 30 an 0 an 80 +p products. va dr ye ro el duc ar to ia tiv sofi bl ts ys la nn up unch market. e ov pl ie atio ed df ex ninc ac ro Catalent us ro 1 m +1 te ss on 3s 888 70 su .M it nsions. +m es mer SO ore on LU ar -p pr TION ke 5c refe oducts ts on rr ,l (765-8846) ti ed oca nen .B do ll et y- ts se te . rt re eu at me +8 SP ·B ·C ·G ·F ·I LIQU TE nt 088 00 co an po yo sha de OT le CH et s. on re ug ur dc te xib al te pes Re at LIGHT ve NOLOG nt I- h, br rb omb de 55 er le li ni GE ia ,s ab an co li io en do lf di 61 ve iz ly LS dw ld av co ina ff rfa or 78 ta si es Y ry su er ai an ® ng ti smrhealth nsumer nd it en an CAPS pp co la fo nAP on da hc st fo bi ns ra tiati li dc e er ed li rs as us ll umerhealth. ty nal er olo ab . y- ™ on to ingl UL Is gy wit ge so to mi rs for ES e -s rp si h za wa cs ti ble on , ll catalent. ow /41 :8PM 4:18 3/24/17 co m