US Approves OTC Differin in First Retinoid Drug Switch

Home , Ornella Barra, Retinoid, Stefano Pessina

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22 July 2016

COMPANY NEWS 2 US approves OTC Differin Moberg buys three brands 2 from Prestige J&J takes 19.9% stake 3 in Japan’s Ci:z Holdings in first retinoiddrugswitch WBA to enter South Korea 4 with Emart cne sufferers in the US will soon be able Taisho takes DHG stake 5 Ato buyGalderma’sadapalene-based to aid its expansion plans Differin Gel 0.1% without aprescription, Alibaba grabs Chinese pharmacy chain 6 after the Food and Drug Administration Japan’s Suntorypicks up 7 (FDA)approvedthe product for OTC sale. GSK’s drinks in Nigeria Differin is the first retinoid-based product Alphrema purchase grows 8 to be made available OTCfor the treatment of Urgo’s presence in Italy acne in the US, with adapalene the first new Pharmacy2U agrees merger 8 ingredient for treating acne to be switched in the country since the 1980s. The product has Differin Gel 0.1% is the first retinoid-based product to GENERAL NEWS 9 been approvedfor the OTCtreatment of acne be available OTC in the US vulgaris in people aged 12 years or older. vations to enhance skin health,”hesaid. German experts against 9 Miles Harrison, president and general man- Commenting on the switch, LesleyFurlong, switching metronidazole ager of Galderma, claimed that the switch would deputy director of the FDA’sOffice of New PRACopens safetyreview 10 be a“game-changer for consumers and the acne Drugs IV,said that millions of consumers, of modified paracetamol category”, butdid not give alaunch date for from adolescents to adults, would nowhave BAH wants EMA to move to Bonn 10 the OTCproduct. access to a“newsafe and effective OTCoption” German manufacturers 11 “Weare excited to deliverthis levelofeffi- for tackling their acne. anticipateconsolidation cacy without aprescription to consumers,”he Differin’ssafety and efficacyhad initially ICH welcomes WSMI as amember 11 added, “and to bring the first newactive in- been establishedthrough five clinical trials in CHPAand FDAdebate 12 gredient to the category for over30years.” people with mild to moderate acne, the FDA user-fee system Acne wasthe most common skin condition pointed out. To support its OTCswitch appli- in the US, Galderma pointed out, affecting up cation, Galderma had submitted post-market- MARKETING NEWS 13 to 60 million teens and adults annually. ing safety data accrued between 1996 –when Bayeradds TENS device 13 However, only athird of those affected the product wasapprovedasaprescription to Aleve range in the US sought the help of ahealthcare provider to product –and 2016, the agencyadded. Con- ASA bans Nurofen 14 tackle the problem, the companynoted, add- sumer studies, including alabel comprehension Joint &Back spot ing that 45% of adults were not satisfied with study,aself-selection study and an actual-use Remisens peps up Germans’ sexlives 14 theproducts theyused, with nearly half of them trial, as well as data from amaximum-use trial, Social data can 15 using three or more acne products. had also been submitted. back product claims There wasagrowing trend amongst con- Overall, results from the consumer studies Startengaging with consumersdigitally 16 sumers to self-treat, with manyturning to the had shown that consumers understood the in- Digital media promoteshealth literacy 17 skin-care aisle at their local drugstore, Gal- formation on the OTClabelling of the prod- derma said. Until now, however, there had only uct, the FDAsaid, could appropriately select Pharma FGP spends C5mn 18 on Neodolor television push been five active ingredients available OTCin whether the product wasright for them and the US, with twoofthose ingredients–ben- use the product correctly. Stada renames Hoggar Balance 18 zoyl peroxide and salicylic acid –accounting Furthermore, the maximum use trial –a FEATURES 20 for 99% of the market. study of absorption of the drug through acne- Philip Brown, Galderma’ssenior vice-pres- affected skin when applied daily overalarge Perrigo offers ‘total healthcare’ 20 ident for medical and regulatory affairs, said surface area –had demonstrated that absorp- in the UK the switch had been “years in the making”. tion waslimited, thus supporting safe OTCuse, “This landmark approvaldemonstrates our the FDApointed out. REGULARS ongoing commitment to individuals with der- The switch receivedfinal approvalafter Events – Our regular listing 19 matologic concerns such as acne,”headded. the FDA’sNonprescription Drugs Advisory People – Stada makes board 23 “Galderma will continue to partner with health- Committee (NDAC)voted unanimously in picks to counter activist investor care professionals and invest in prescription, April to recommend switching adapalene gel OTC, aesthetic and correctivemedical inno- ■ Continued on page 11 OTC22-07-2016p2-9_Layout 1 19/07/2016 12:57 Page 2

OTC COMPANY NEWS

Mergers&Acquisitions Mobergbuys three brands from Prestige

weden’sMobergPharma has expanded fur- Commenting on the rationale behind the Stherits presence in the US consumer health- deal, Peter Wolpert, Moberg’schief executive care market by acquiring three brands from Pres- officer,said the acquisition was“in line with tige Brands for US$40 million (C36 million). ourstrategy to add critical mass to our US op- The three brands –Fiber Choice, New-Skin erations, as well as aleading topical brand to and PediaCare –had generated sales of around our core dermatology franchise”. US$24.4 million in the year ended 31 March “The acquired brands,”continued Wolpert, 2016, Mobergsaid, and were “well-established” “will immediately contribute significantly to in the US OTCmarket. our sales and earnings and also to our long-term The New-Skin liquid bandage wasthe “main financial goal of delivering profitable growth profitabilitycontributor” in the acquired port- andanearnings before interest, tax, depreciation MobergPharma has snapped up three brands –including the New-Skin liquid bandage –fromPrestige Brands folio, the companypointed out, and was“well- and amortisation (EBITDA) margin of 25%.” aligned with Moberg’sstrategic focus on topi- “This transaction is an excellent use of the brands would enable Mobergtofocus further cal dermatology”. proceeds from the bond loan issue earlier this on its “strategic assets, and mergers and ac- “Wesee excellent opportunities to build on year and the funds releasedinthe recent di- quisitions activities”. thebrand equity of New-Skin,”commented Jeff vestment of non-core brands to Strides Phar- Moberg’sstrategic OTCbrands include the Vernimb, general manger of MobergPharma ma,”Wolpert added. Balmexdermatology range, Domeboro skin- North America. In February,Mobergissued abond valued at care line and the Kerasal Nail/Nalox/Emtrix “This is amarket-leading brand with exciting SEK300 million (C32.2 million),with the com- anti-fungal nail-carebrand. prospects for growth,”Vernimb insisted. “We panynoting that the proceeds would allowthe Meanwhile, Prestige said offloading New- will leverage our innovation engine to further firm to “increase its acquisitionactivities going Skin, Fiber Choice and PediaCare to Moberg strengthen the future value proposition of this forward”, expand the international distribution would enable the firm to “move closer to its brand, as well as Fiber Choice and PediaCare, of its products and “strengthen” the “brand plat- stated goal of having aportfolio consisting of to consumers and retailers.” forms” of its strategic brands in the US market 85% of its revenue from ‘invest for growth’ The PediaCare children’spain-relief brand (OTC bulletin,5February 2016, page 8). brands and 15% in ‘manage for cash’ brands”. had “strong equity amongst mums” thanks to its The following month, Mobergoffloaded Achieving this goal, Prestige claimed, would “highly-effective products”, Vernimb insisted, the Fergon, JointFlexand Vanquish brands to “help support long-term organic growth”. while the Fiber Choice range comprised a“com- India’sStrides for US$10 million (OTC bul- Prestige noted that it planned to use the pelling line-up of product options for daily letin,25March 2016, page 2). proceeds from the sale to “pay down debt and fibre supplementation”. Wolpert said at the time that selling the three accelerate de-leveraging”. OTC Distribution contract and IN BRIEF ■ ACHÉ LABORATÓRIOS –the Brazil- product rights on offer ... ian OTCand prescription medicines manufacturer –has strengthened its position in its domestic market by snapping up Laborat- German companycompany is sellingsellinga food for special ório Químico Farmacêutico Tiaraju for an undisclosed sum. Through the deal, Aché gains medicalmedical purposespurposes for diabetes type IIII.. Tiaraju’srange of herbal medicines, nutra- ceuticals and nutricosmetics. Santo Ângelo- The product fulfils the criteria laid down in the European Union based Tiaraju’sportfolio comprises the Ad- Regulation 609/2013 that comes into effect on 20 July 2016. mire skin-care line, Biofibra herbal supple- On offer is a distribution contract exclusively for the German market ment and the MultiVita multivitamin. Aché reported sales up by 9.3% to BRL2.3 billion which will run until 2021, as well as the product rights. (C634 million) in 2015, thanks to newprod- As the product has been extensively analysed and clinically-proven, uct launches across its non-prescription and claims can be made on its packaging, as determined by a structure- prescription medicines businesses. The com- function or astructure-illness relation for the ingredients. pany’sOTC portfolio includes the Accuvit multivitamin, Dorilax analgesic and Prolive For more information, contact: probiotic. Aché recentlyenlarged its portfolio by acquiring Brazil’sNortis Farmacêutica and Email: [email protected] its range of OTCproducts (OTC bulletin,22 Website: www.praevomed.de April 2016, page 7). OTC

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COMPANY NEWS OTC

Mergers&Acquisitions Mergers&Acquisitions Italy’s Recordati J&J takes19.9% stake grabs ProFarma in Japan’s Ci:z Holdings taly’sRecordati has expanded its consumer Ihealthcareportfolio by acquiring for CHF16 million (C15 million) Swiss pharmaceutical ohnson &Johnson has taken aminority stake and driving skin-care innovation globally.” companyPro Farma. Jin Japanese cosmetics companyCi:z Hold- “Welook forward to partnering to acceler- Pro Farma marketed arange of proprietary ings and entered into abusiness partnership atethe growth of Dr.Ci:Labo and its associated and in-licensed OTCand prescription drugs, with the firm, in amove which is claimed will brands in markets outside of Japan,”Johnson Recordati noted, and wasexpected to generate support the global expansion of Johnson & &Johnson added. turnoverofaround CHF10 million in 2016. Johnson’sConsumer business. The firm picked up skin-care companyNeo- The Baar-based firm’sconsumer healthcare Under the terms of the agreement, Johnson Strata and its line of dermocosmetic brands in portfolio includes the Lacdigest digestive en- &Johnson will acquire a19.9% stakeinTokyo- May (OTC bulletin,6May 2016, page 3). De- zyme and the Vitacal dietary supplement. based Ci:z and become the company’ssecond- scribing the private-held firm as a“global lead- “The acquisition of Pro Farma represents largest shareholder. er in dermocosmetics”, Johnson &Johnson said an excellent base on which to develop our op- Ci:z will appoint twoexecutivesfrom John- at the time that the deal would add to its Con- erations in Switzerland, where Recordati has son &Johnson to its board of directorsand sumer portfolio “a range of clinically-proven, recently started to sell its product Livazo (pita- grant the US firm the rights to its main cos- dermatologist-developed, skin-care products vastatin) directly to the market,”commented metic brands outside Japan. that meet the needs of every skin type”. Giovanni Recordati,the Italiancompany’s Led by the Dr.Ci:Labo dermocosmetics Meanwhile, Ci:z claimed that by entering chairman and chief executive officer. brand, Ci:z’sportfolio also includes the Gen- into partnership with Johnson &Johnson, the “Furthermore,”continued Recordati,“the omer range of “high-end” anti-ageing products firm would be in abetter position to further main product Lacdigest will contribute to en- and the Labo Labo skin-care line. its overseas expansion strategy.The deal, the hancing our presence in gastroenterology.” Commenting on the deal, aspokesperson for companysaid, supported its long-term plan to The deal comes just overamonth after Rec- Johnson &Johnson told OTC bulletin that the “increase awareness” of its brands in markets ordati expanded its footprint in its domestic firm was“pleased to have entered into along- outside Japan. market by acquiring for C130 million Italian term strategic partnership with Ci:z”. Ci:z has aCosmetics unit which had sales of pharmaceutical firm Italchimici (OTC bulletin, “The addition of the leading brand Dr.Ci: ¥33.6 billion (C287 million) in the 12 months 17 June 2016, page 5). The Milan-basedfirm Labo to our skin-careportfolio,”the company ended 31 July 2015. It also has aHealth Food generated sales of C46 million in 2015 from explained, “will enable Johnson &Johnson division –offering Japanese consumers vita- its portfolio of food supplements, medical de- Consumer to further our ambition of expanding mins, mineralsand supplements –which posted vices and prescription medicines. agrowing dermocosmetics offering, including sales of ¥4.1 billion in the same period. OTC our recent acquisition of US-based NeoStrata, OTC

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OTC COMPANY NEWS

BusinessStrategy/Third-QuarterResults WBA to enter South Korea with Emart

algreens Boots Alliance (WBA) is set 31 May 2016, Pessina claimed that Russia also Senior management responsibility had now Wto create aBoots-branded, pharmacy-led represented a“big opportunity” for the com- been changed, he noted, “to structure the com- health and beauty retail franchise in South Korea pany nowthat it held aminority stakeinlocal panyinaway that is more efficient”. after striking adeal to form afranchise partner- player 36.6. Last month, WBAnamed AlexGourlay, ship with local hypermarket retailerEmart. The Noting that 36.6 currently operated around president of Walgreens, and Ornella Barra, the firm has also secured an option to acquire in 1,000 stores, Pessina claimed the deal had given firm’spresident and chief executive officer of five years’ time Russia’sPharmacyChain 36.6. WBAastakeinthe “largest pharmacychain” global wholesale and international retail, as co- Under the terms of the deal signed with in Russia. chief operating officers (OTC bulletin,17June Emart, Boots-branded stores would be open- In April, WBAtook its first steps into the 2016, page 27). ed in “shopping malls, on high streets and Russian retail pharmacymarket by swapping Gourlay nowoversees the Walgreens busi- within the outbound areas of Shinsegaedepart- itsAlliance Healthcare Russia wholesale business in the US and Boots in the UK. In addi- mentstores and Emart hypermarkets”, the US- ness with 36.6 in exchange for a15% stake tion to her previous role, Barra is nowrespon- based wholesale and retail giant explained. in the leading Russian pharmacychain (OTC sible for global brands, human resources and The Boots stores would each feature an in- bulletin,22April 2016, page 1). other functions. dependent pharmacy, WBArevealed, and offer 36.6 is set significantly to expand its net- Commenting on the management shake-up, arange of “Boots-owned products and ‘exclu- work after it agreed earlier this year to merge Pessina said it would allowhim to “focus even sive to Boots’ brands, as well as leading Korean with local rivalA5PharmacyRetail (OTC more on driving the growth strategy and dev- brands”. The first stores were expected to open bulletin,5February 2016, page 5). The deal eloping the company”. “before the end of the first half of 2017”, the –which wasapprovedbyRussia’sFederal Anti- “You can be assured, however, that these companyadded. monopoly Service (FAS) last month –will add changes will not in anyway reduce my scrutiny Ornella Barra, WBA’sco-chief operating more than 900 drugstores to 36.6’schain. andexpectations of our business and the team,” officer,claimed South Korea wasa“leading he insisted. market for skin-care and cosmetics products Pharmacies becoming profitable Meanwhile, WBAreported that turnoverat in Asia”. Commenting on the rationale for swapping the Retail PharmacyUSA division had risen by “Webelieve there is asignificant opportu- WBA’sRussian wholesale business for astake 3.7% to US$21.2 billion in the third quarter. nity to extend the reach of Boots own-brands in 36.6, Pessina claimed that pharmacieswere Prescription sales, which accounted for into this market,”Barra insisted, “and are thrill- “becoming the most profitable part of the sup- 67.4% of the total, had increasedby5.8%, the ed to be doing so with Emart.” ply chain” in the country. companynoted, while prescription sales in com- “Emart is the pre-eminent retailer in South “In the past, pharmacies were not particu- parable stores had improvedby4.5%. Korea. The company’sstrong experience, as larly profitable because the cost of [building] The division’soperating income movedfor- well as its marketing expertise, givesusgreat rent wasreally very,very high,”Pessina ex- ward by 4.1% to US$1.4 billion in the period. confidence in the long-term potential of the plained. “Nowthe situation has normalised. You At the end of the company’sfinancial year partnership,”she added. can have long- or medium-term rent with the on 31 August 2015, Retail PharmacyUSA was Part of the ShinsegaeGroup, Emart operates option of extending [the contract].” operating 8,173 drugstores across all 50 US 157stores in South Korea, plus eight in China Turning to WBA’sthird-quarter results, Pess- states, the District of Columbia, Puerto Rico and one in Vietnam. inareported “another solid performance”, with and the US Virgin Islands. Meanwhile, WBA’schief executive officer, sales up by 2.4% to US$29.5 billion (C26.6 bil- WBAannounced late last year it wasto Stefano Pessina, revealed that WBAhad taken lion), after eliminations of US$629 million. significantly expand Retail PharmacyUSA an option –which it can exercise in around five Noting that integration of the Alliance Boots after agreeing to buydrugstore rivalRite Aid years’ time –toacquire the remaining 85% andWalgreens businesses had been completed in atransaction valued at around US$17.2 bil- stakein36.6 that it does not already own. “successfully” following the merger deal (OTC lion, including acquired debt (OTC bulletin, Speaking as the wholesale and retail giant bulletin,17April 2015, page 5), Pessina said the 6November 2015, page 1). reported the results for its third quarter ended firm wasnow operating as a“unified company”. Pessina said at the time that the acquisition

WBA has an option –which it can exercise in around five years’ time –toacquirethe remaining stake in Russia’s Pharmacy Chain 36.6 that it does not already own

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COMPANY NEWS OTC

Mergers&Acquisitions Taisho takes DHG stake to aid its expansion plans

aisho Pharmaceutical has acquired for an partnering with Taisho would help to “improve Tundisclosed sum a24.5% stakeinVietnam- its competitiveness”. The deal also demon- ese OTCand prescription medicines manufac- strated the company’scommitment to “growat turer Duoc Hau Giang Pharmaceutical (DHG). the regional level”, DHG added. The Japanese firm revealed that it had also Established in 1974 and headquartered in Stefano Pessina, Walgreens Boots Alliance’s chief entered into an “alliance agreement” with DHG. Can Tho, DHG generated sales of VND3.6 tril- executive officer,said Russia represented a“big Through this alliance, Taisho said it intend- lion (C147 million) in 2015 and posted an op- opportunity” for the company ed to share with DHG its “knowledge, technol- erating profit of VND637 billion. The firm’s of Rite Aid would “accelerate” WBA’slong- ogy and know-howinthe pharmaceutical in- OTCportfolio includes the Bé Nóng child- termobjective to strengthen its “presence and dustry”, in an effort to increase DHG’ssales ren’spain-relief brand, Bipp Cand Bocalex coverage nationallyacross the US”. and further growits ownbusiness in Asia. dietary supplements, Edoz gastrointestinal line “The addition of Rite Aid,”Pessina insisted, “In addition,”the companynoted, “synergy and the Hapacol analgesic. “will accelerate our strategy by completing our is expected between DHG, with its strong pres- Taisho established asubsidiary in Vietnam network; providing alarger and more com- ence in Vietnam, and Taisho.” in 1999 and subsequently opened amanufac- prehensive portfolio; and by creating amore Describing DHG as the “largest Vietnamese turing facility in the city of Nha Trang. It mar- comprehensive and stronger platform for the domestic-invested pharmaceutical company”, kets in the country its Lipovitan range of tonics development of our brand presence and the Taisho claimed its investment wasinline with and nutrient drinks. future growth of the business.” its strategy of “enhancing” its business in the Synergies “in excess of US$1 billion” were “continuously expanding” Asian market. expected from the transaction, Pessina pointed “Taisho is striving to build astronger busi- out, adding that the firm would makedecisions ness foundation so that it can continuetostead- “overtime” about integrating the twocompa- ilygrowand develop, even in the face of global nies, with the aim of “creating afully harmon- competition,”the companyexplained. “Aspart ised portfolio of stores and infrastructure”. of our efforts to strengthen Taisho’scompeti- Commenting more recently on the Rite Aid tiveness, in addition to its domestic business, deal, Pessina said it was“progressing as plann- the firm is focusing on investments in global ed”, with WBAinthe process of seeking regu- markets, especially South-East Asia.” Taisho has taken astake in Vietnam’s DHG, which latory approvalfor the transaction. Commenting on the agreement,DHG said markets the Bé Nóng children’s pain-relief brand Meanwhile, WBAreported sales down by OTC 2.3%toUS$3.2 billion at its Retail Phar- macyInternational division –consisting of health and beauty chains in eight countries, the development at Boots UK, explained that the by 0.7% to US$5.7 billion, thanks to “strong largest of which is Boots UK –due to nega- app allowed staffto“quickly showproduct in- growth” in emerging markets. tive currencyeffects. formation, ratings and reviews, look up inven- The division reported an operating income At constant currencies, sales actually ad- tory online and makerecommendations based of US$179 million in the period. vanced by 3.4%. on online analytics,all from the shop floor”. WBApointed out that the Pharmaceutical “Strong” performances in Ireland and Thai- “It will makeevenour smallest stores feel Wholesale division supplied medicines, other land had driventhe rise in sales at constant likeaflagship shop,”heclaimed, “with access healthcare products and services to more than currencies, WBAnoted. to the entire Boots range. If aproduct is not 200,000 pharmacies, doctors, health centres Turnoverhad also movedforward at Boots in stock in store, the Boots colleague can sim- andhospitals from over350 distribution cen- UK, the companypointed out, thanks to bet- ply use the app to locate the item in another treslocated in 19 countries. ter sales of certain cosmetics brands, such as store nearby or offer to order the product online.” Turning to group-wide synergies, WBA No.7 and Sleek. Meanwhile, drivenbyhigher sales in Ireland said combined synergies from the Walgreens/ Following the close of the period, Boots and Thailand, Retail PharmacyInternational Boots merger had totalled US$947 million in UK rolled out to its stores across the UK a posted an operating income of US$258 million nine months ended 31 May 2016. mobile app which can be used by stafftohelp for the three months. The companynoted that following the close customers when making product selections As of 31 August 2015, the division wasop- of the period it had achievedits goal set in (OTC bulletin,30June 2016, page 6). erating 4,582 health and beauty stores across 2012 to reach at least US$1 billion in com- Boots teamed up with technology giant IBM Chile, Ireland, Lithuania, Mexico, the Nether- bined synergies in its financial year ending 31 to create the Sales Assist App which the retail- lands, Norway,Thailand and the UK. August 2016. er claims will “makeiteasier for customers to Meanwhile, WBA’sPharmaceutical whole- WBA’stotal operating income in the third get hold of the products theyneed”. sale unit –which mainly operates under the quarter wasUS$1.81 billion, after eliminations. Robin Phillips, director of omnichannel and Alliance Healthcare brand –posted sales up OTC

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OTC COMPANY NEWS

Mergers&Acquisitions Alibaba grabs Chinese pharmacy chain

libaba Health Information Technology –a able it to engage in the online retail pharmaceut- Asubsidiary of Chinese e-commerce giant ical business to provide more products and ser- Alibaba Group –isset to expand its presence vices to end consumers.” in its domestic market by acquiring for CNY16.8 Alibaba Health’sproposed acquisitionof million (C2.26 million) the Guangzhou Wu Qian Wu Qian Nian comes just overamonth after Nian pharmacychain. Completion of the deal its parent, Alibaba Group, told vendors on its is subject to regulatory approval. yao.tmall.com online pharmacymarketplace Wu Qian Nian, Alibaba Health said, was website to stop selling OTCmedicines. “mainly engaged in the retailing of pharmaceut- According to Reuters, the Hebei province ical products and traditional Chinese medicine branch of the China Food and Drug Adminis- (TCM) beverages” in China. tration (CFDA) issued an “urgent” directive in The companyoperated aretail pharmacy May halting OTCsales via third-party platforms. Alibaba Health Information Technology is set to chain, Alibaba Health pointed out, and held an Thedirective,Alibaba Group told the news acquirethe Guangzhou Wu Qian Nian pharmacy chain Internet Drug Transaction Service Qualification agencyatthe time, only applied to OTCsales whole medicine e-commerce business, includ- Certificate, “which entitles it to sell OTCdrugs on marketplace websites. However, Reuters ing yao.tmall.com,industry players are explor- and certain other regulated products online”. claims that such sites “generally provide the ingnew ways to use internet technology to help Commenting on the rationale behind the bulk of traffic topharmacies and drug manu- improve the traditional drug retail system,”the deal, Alibaba Health insisted that the acquisition facturers selling online”. spokesperson added. would support its efforts to “build an online Yao.tmall.com was“cooperating and com- Alibaba Group recently abandoned plans to community connecting participants in China’s plying with the government’snew policytostop transfer yao.tmall.com from its Tmall e-com- healthcaremarket”. online drug sales on third-party platforms”, a merce website to Alibaba Health, citing “sub- “The companybelieves,”Alibaba explained, spokesperson for the firm informed Reuters. stantial regulatory uncertainties” in relation to “that its acquisition of Wu Qian Nian will en- “While the policychange might impact the China’shealthcare market (OTC bulletin,8 April 2016, page 7). Announcing its decision to scrap the deal, OTC DISTRIBUTION IN EUROPE: 20 COUNTRY CONSULTANCY REPORT Alibaba Group said it would instead look to hand overtoAlibaba Health aportion of its diet- THE NEW GLOBAL AGENDA ary supplements, health food and nutritional products business, which is currently operated NOW IN ITS 10TH EDITION, OTC DISTRIBUTION IN by Tmall. EUROPE IS A COMPREHENSIVE STRATEGIC ANALYSIS OTC OF THE SUPPLY NETWORK SERVING EUROPE’S NON- PRESCRIPTION AND OTC SELF-MEDICATION SECTORS IN BRIEF A study of the factors driving change and presenting challenges and opportunities to manufacturers ■ PROBI –the Swedish probiotics firm – reported sales at its Consumer Healthcare An exploration of changes in retail customer and shopper needs and the unfolding strategies required unit up by 30% to SEK64.8 million (C6.85 to achieve competitive success million) in the second quarter of 2016. Large An in-depth source of current statistics, discussion and orders for probiotics from its partners in North opinions about the European consumer healthcare America had driventhe double-digit increase market – plus consumer insights, market sizes, sales trends in turnover, Probi said. The rise in Consumer and distributors’ market shares Healthcare sales helped to lift Probi’stotal A window into leading retail pharmacy chains and their group turnoverby24% to SEK73.3 million strategies for market share through digital innovation in the three months. The Functional Foods div- and new concepts in multi-channel shopping ision reported sales down by 6.6% to SEK8.5 million. During the period, Probi announced OVER 590 PAGES AND it wasset significantly to growits presence in 300 GRAPHS, TABLES & FIGURES North America by acquiring for US$105 mil- Markets covered are: Austria, Belgium, Bulgaria, Czech Republic, lion (C93 million) US-based contract-manu- Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, facturer and supplier Nutraceutix and its port- Norway, Poland, Romania, Slovak Republic, Slovenia, Spain, folio of probiotics (OTC bulletin,17June Sweden, Switzerland and the United Kingdom 2016, page 7). Describing the deal as “trans- formational”, Probi said at the time that gain- ingNutraceutixwould “dramatically enhance” Download Executive Summary and order online at ® JAMES DUDLEY ® its scale and geographic footprint. www.james-dudley.co.uk MANAGEMENT OTC

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COMPANY NEWS OTC

Legal Cases Mergers&Acquisitions Herbalife settles Japan’s Suntory picks up US FTCcharges GSK’s drinks in Nigeria erbalife has agreed to restructure its US Hoperations and to pay US$200 million laxoSmithKline (GSK) Consumer Nigeria (C180 million) to compensate its distributors Ghasentered into an agreement to divest its in amove which settles Federal Trade Com- Lucozade and Ribena drinks brands to Japan’s mission (FTC) charges that the companyhad Suntory Beverage &Food for around ¥7.0 bil- acted deceptively. lion (C60 million).The deal is scheduled to close “The settlement announced today requires in August, subject to regulatory approvals. Herbalife to revamp its compensation system While GSK sold the global rights to Luco- so that it rewards retail sales to customers and zade and Ribena to Suntory in 2013 (OTC eliminates the incentivesinits current system bulletin,27September 2013, page 1), the UK- that reward distributors primarily for recruit- based firm’sNigerian subsidiary continued to ing,”the FTC explained. “It mandates anew manufacture and distribute the brands under compensation structure in which success de- license from Suntory. pends on whether participants sell Herbalife Under the terms of the deal, Suntory will GlaxoSmithKline Consumer Nigeria has agreed products, not on whether theybuy products.” gain the rights in Nigeria to sell Lucozade and to divest its Lucozade and Ribena brands to Japan’s SuntoryBeverage &Food In its investigation into Herbalife –launch- Ribena –which generated combined sales of ed in 2014 (OTC bulletin,28March 2014, around NGN15 billion (C46.4 million) in 2015 – “GSK Consumer Nigeria will still be listed on page 4) –the FTC argued that the company’s and will acquire GSK’ssoft drinks manufactur- the Nigerian Stock Exchange (NSE) and will compensation structure wasunfair “because ing facility in Agbara. continue to manufacture, market, and distribute it rewards distributors for recruiting others to aportfolio of leading healthcarebrands in- join and purchase products in order to advance Refocus and invest cluding Horlicks, Panadol, Sensodyne, and, in in the marketing programme, rather than in re- “The divestment decision wasreached to future, the legacy Novartis brands, such as sponse to actual retail demand for the product”. enable GSK Consumer Nigeria to refocus and Voltaren and Otrivin.” “This settlement will require Herbalife to reinvest in the rapid expansion of the business’ GSK decided to offload the global rights to fundamentallyrestructure its business so that retained portfolio and to delivermore value Ribena and Lucozade back in 2013 as part of participants are rewarded for what theysell, to shareholders,”commented Edmund Onuzo, its strategy to concentrate only on brands that not howmanypeople theyrecruit,”comment- chairman of GSK Consumer Nigeria. hadscientific or professional endorsements and ed FTC chairwoman Edith Ramirez. “Despite this transaction,”continued Onuzo, the potential to growinemerging markets. OTC Must make truthful claims “Herbalife is going to have to start oper- BusinessStrategy ating legitimately,making only truthful claims about howmuch moneyits members are like- Romania’s Dona plansfranchise move ly to make,”Ramirez noted, “and it will have to compensate consumers for the losses they omania’sDona pharmacychain has an- panyina“real and balanced partnership”. have suffered as aresult of what we charge Rnounced plans to open franchise stores, “Partners will have access to avertically are unfair and deceptive practices.” in amove the firm claims will allowittosig- integrated system, with activities in procure- In response, Herbalife said the settlement nificantly “accelerate” its expansion. ment, wholesale distribution and marketing,” did“not change Herbalife’sbusiness model as Dona said it wasseeking entrepreneurs with Donaexplained, “subject to compliance with adirect-selling company”. industry experience that were interested in open- the strict rules that have led to the development “The settlements are an acknowledgement ing franchise stores and working with the com- and success of the Dona Pharmacybrand.” that our business model is sound and under- Noting that it wascurrently operating 286 score our confidence in our ability to move wholly-owned stores, Dona said it wasalready forward successfully,otherwise we would not workingwith partners on opening eight fran- have agreed to the terms,”insisted Herbalife’s chise outlets within the coming months. chief executive officer Michael Johnson. The companynoted that it hoped to be op- Herbalife explained that while it believed erating around 30 franchise outlets by the end that “many” of the accusations made by the of the year. FTC were “factually incorrect”, the company Dona reported sales up 11.5% to RON471 had concluded asettlement was“in its best million (C105 million) in the six months end- interest” because the “financial cost and dis- ed 31 June 2016. The firm operates the third- traction of protracted litigation would have largest pharmacychain in Romania, behind

been significant”. Romania’s Dona pharmacy chain is on the look out for Catena and Sensibu. OTC partners to open franchise stores OTC

22 July 2016 OTC bulletin 7 OTC22-07-2016p2-9_Layout 1 19/07/2016 12:57 Page 8

OTC COMPANY NEWS

Mergers&Acquisitions Mergers&Acquisitions Pharmacy2U Alphrema purchase grows agrees merger Urgo’s presence in Italy K-based internet-pharmacyfirms Phar- Umacy2U and Chemist Direct have merged rance’sUrgohas “strengthened its position minerals and plant-based products, as well as the in adeal worth £40 million (C48 million). Fin Italy and established itself as one of the Humexportfolio of cough and cold remedies. By joining forces, the companies claimed major players in the OTCand food supplements Urgo’spresident, Hervé Le Lous, said the to have created the “clear,digital-only leader arena” after striking adeal to buyItalian derma- firm had made international expansion a“key in the UK online pharmacysector,with acus- tology and supplements specialist Alphrema. growth driver”, with 45% of sales having been tomer base of 1.5 million people”. “Thanks to this newacquisition, Urgo has achievedoutside France in 2015. The deal for The combined business has receivedanin- reinforced its position in the Italian market, Alphrema “once again demonstrates the intent vestment of £10 million from the Business where the group has been present for many of Urgo to makeregular acquisitions to support Growth Fund, which is backed by five of the years,”the French firm stated. Financial terms the dynamism of our brands”, he insisted. UK’smain banking groups. Pharmacy2U and of the deal were not disclosed. Chief executive officer Pierre Moustial said Alphrema’sbusiness consists of “14 lead- the acquisition would “allowthe Urgo group to ing products, principallydermatology products strengthen its expertise and its brands”, while and supplements” –including Emortofine, Plur- at the same time demonstrating that “Europe ilac and Eupondile –inthe areas of proctology, still has significant growth potential for us”. gastroenterology and gynaecology.Based in Alphrema is the latest in aline of interna- Saronno in Italy’sLombardy region since its tional acquisitions by Urgo that includes Brazil’s creation in 2000, the companyachievedsales LM Farma in 2011, Poland’sBio-Profil in 2012 of C3.8 million in 2015. and PolfaLodz in 2013, and the 2014 inaugu- Having in 2013 acquired Italian food supple- ration of aTurkish subsidiary.And more re- ments firm Agave, Urgo said it expected the cently,inApril this year,Urgotook astrategic Pharmacy2U and Chemist Direct have merged to synergies between that companyand Alphrema stakeinIndian wound-treatment specialistEu- create what the firms claim is the “clear digital-only leader” in the UK online-pharmacy sector to act as a“springboard” to develop Urgo’sflag- care that allowed the French group to “enter ship brands in the country.These include the the Indian market and reinforce its international Chemist Direct said theyplanned to use the Juvamine range of supplements and vitamins, development strategy”. funds to support their “ambitiouslong-term OTC growth plans”. Chemist Direct’sMark Livingstone has been Mergers&Acquisitions named chief executive officer of the combined business, with Pharmacy2U’sDaniel Lee ap- Blistex boosts portfoliowith J&J’s Tucks pointed chief operating officer. “This is alandmark moment for internet listexhas bolstered its portfolio by ac- Blistexfamily of brands,”commented Justin pharmacyinthe UK,”commented Livingstone. Bquiring the Tucks range of haemorrhoid Arch, chief executive officer of Blistex. “Weare creating the leading ‘pure play’ busi- treatments from Johnson &Johnson for an “Givenits efficacious products and strong nessinthe sector,with unrivalled experience, undisclosed sum. heritage,”continued Arch, “Tucks is well-posi- facilities and scale.” Under the terms of the deal, US-based Blist- tioned to address growing consumer needs “It is the beginning of anew era of conve- ex has gained the Tucks portfolio in North within its category,and we expect the brand nience and choice for millions more patients,” America, as well as international trademark to respond positively to our focused model of Livingstoneinsisted, “as we open up the full rights to the brand. consumer advertising and promotional support potential of internet pharmacyfor the first time.” The Tucks range includes Medicated Cool- combined with thoughtful innovation.” The combined business would offer con- ing Pads, Take Alongs Medicated Cooling Tucks will sit in Blistex’ consumer health- sumers arange of “over6,000 health and well- Towelettes, Hemorrhoidal Ointment, Internal care portfolio alongside the Stridexacne treat- being products”, the firms said, and online Soothers Suppositories, and Fast Relief Spray. ment, Foille antiseptic, Glysomed skin-care doctor consultation servicesfor a“wide range “Weare delightedtowelcome Tucks to the brand, and the company’srange of lip balms. of common conditions including women’s OTC health, travelhealth precautions and skin conditions”. A“fully managed online home delivery prescription service for National Health IN BRIEF Service (NHS) patients” would also be offered. ■ USP ZDROWIE –the Polish consumer product, Maxivit multivitamin, Prolactiv pro- “Wenow plan to introduce even more con- healthcare company–has expanded its dietary biotic and the Slimastick weight-management venience and choice for existing customers, supplements portfolio by acquiring for an un- brand. Naturell markets its dietary supplements while offering our services to millions more disclosed sum Sweden’s Naturell.Led by the in anumber of European countries including people,”the companies added. Enzyvit digestive enzyme, Naturell’sportfolio Poland and Sweden. OTC also includes the Ginkgo Intensivginkgo biloba OTC

8 OTC bulletin 22 July 2016 OTC22-07-2016p2-9_Layout 1 19/07/2016 12:57 Page 9

GENERAL NEWS OTC

Communication Campaigns Switches Afipa sets out German experts against French agenda switchingmetronidazole rench industry associationAfipa has set Foutapublic information campaign to pro- majority of members on Germany’sex- Theywere also not swayed by evidence that mote self-medication “in the absence of any Apert committeeonprescription have ad- Sweden had switched metronidazole to OTC initiative from the political powers”. The cam- vised health ministersagainst switching metro- status in 2011, followed by Italy in 2012 and paign –which includes radio spots, internet nidazole from prescription to OTCstatus as a Finland and Norway ayear later. advertisements and on-screen communications treatment of papulopustular rosacea. Germany’sfederal institute for drugs and in 1,300 pharmacies –builds on amanifesto The experts had been asked to consider dur- medical devices, BfArM –which hosts the ex- published by the association earlier this year ingtheir meeting at the end of June whether pert committeemeetings –opposed the pro- (OTC bulletin,22April 2016, page 11). metronidazole should be made available with- posed switch, listing objections including the Afipa –which has just named Dominique out aprescription for use by adults. The maxi- importance of adoctor’sdiagnosis in monitor- Giulini as president (see page 23) –said the mum OTCstrength wastohavebeen 0.75% ing potential complications, determining the campaign would seek to address questions at amaximum pack size of 30g or 30ml. need for combination therapyand deciding the about the nature of self-medication, the cost, The recent decision follows asimilar verdict best delivery form for particular skin types. the patient benefits, and the effectiveness of last year (OTC bulletin,2February 2015, page The agencynoted that topical metronida- non-reimbursed medicines. 12), when the committee advised against switch- zole had been available as aprescription-only “It is an unprecedented operation that allows ing metronidazole 0.75% to OTCstatus. medicine in Germanysince 2001 under brand us to communicateapositive and educational Committee members then were unconvinc- names including MetroGalenand Rosiced. message,”Giulini said, “which will allowevery ed by arguments that the topical antibiotic The committee recently rejected an OTC French citizen to practise self-medication aut- could be used safely for self-medication over switch application for adapalene (OTC bul- onomously and responsibly.” Details have been aperiod of up to three months, following an letin,5February 2016, page 11). posted at Afipa’swebsite masantemonchoix.org. initial rosacea diagnosis by adoctor. OTC OTC

Industr yAssociations ASMI and NZSMI host world meeting

he AustralianSelf Medication Industry T(ASMI) and NewZealand Self-Medica- tion Industry (NZSMI) are set to co-host the World Self-Medication Industry (WSMI) Gen- eral Assembly 2017. The three-day event would be held on 17- 19 October 2017 in Sydney, Australia, the two associations said, while the theme of the conference would be the economic value of self- care and non-prescription medicines. Dean Schoombie, the ASMI’schief executive officer,said the conference would feature a“formidable line-up of local and international speakers”. Theywill discuss the “important elements of the economics of self-care, such as access to medicines, affordability and consumer empowerment”. “The conference will showcase evidence- based models supporting enhanced self-care, and the role of non-prescription medicines in individual and public health,”headded. Formore information on the WSMI Gen- eral Assembly and to register your interest visit wsmiga2017.com. OTC

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OTC GENERAL NEWS

Regulatory Af fairs Regulatory Af fairs BAH wants EMA PRAC opens safety review to move to Bonn of modified paracetamol he European Medicines Agency(EMA) Tshould be relocated from London, UK, to he European Medicines Agency’s(EMA’s) general sale of paracetamol tablets after an in- Bonn, Germany, following the UK’sreferendum TPharmacovigilance Risk Assessment Com- crease in poisoning cases (OTC bulletin,22 vote to leave the European Union (EU), ac- mittee (PRAC) has opened areviewinto the May2015, page 15). The ban does not include cording to Germany’smedicines manufactur- benefits and risks of modified- and prolonged- liquids and effervescent tablets or suppositories ers’ association, the BAH. release paracetamol tablets. containing paracetamol. “We regret deeply the referendum result Unlike immediate-release paracetamol tab- Meanwhile, the PRAChas also opened a and believe it is both politically and economic- lets–which release the ingredient quickly and reviewofretinoid medicines –aclass of drugs ally disastrous,”stated the BAH’sdeputy direc- are not included in the review–modified- and predominantly used to treat skin conditions tor-general, Dr Hermann Kortland. “The British prolonged-release paracetamol tablets provided such as acne –toevaluate measures currently have unfortunately voted against Europe, against the active ingredient overaprolongedperiod in place to warn women using retinoids to the supposed ‘eurocracy’ and against the Euro- of time, the PRACpointed out. avoid getting pregnant, and to minimise the pean institutions,”he noted, adding that unified However, the standard procedures for as- possible risk of neuropsychiatric disorders. European standards had provedinvaluable in sessing and managing overdose and poisoning The move comes shortly after the US and the pharmaceutical sector. with paracetamol were designed for immediate- NewZealand both approvedprescription-to- Kortland called on German federal and release products, the committee said, and in OTCswitch applications for the retinoid ad- regional authoritiestopropose Bonn as the recent years there had been anumber of cases apalene to treat acne (see front page). EMA’s newhome, pointing out that the city on of overdose related to certain modified-release Retinoids could have aharmful effect on the banks of the Rhine already housed Ger- paracetamol tablets. unborn children, the PRACnoted, and while many’s federal institute for drugs and medical This indicated, the PRACpointed out, that pregnancyprevention programmes(PPPs) had devices, BfArM, and its workforce of around procedures might not be “entirelysuited to been set up across the European Union (EU), 1,100 regulatory and safety experts. treat overdoses with the latter modified-re- arecent analysis of PPPs raised concerns about “Furthermore,”the BAHpointed out, “many lease paracetamol products”. howwell the programmes were followed. medicines manufacturers are situated along PRAChas instigated the reviewfollowing The reviewwas instigated following are- the Rhine.” arequest from the Sweden’sMedical Products quest from the UK’sMedicines and Health- OTC Agency(MPA). In 2015, Sweden banned the care products Regulatory Agency(MHRA). OTC Regulatory Af fairs BfArM organises Market Research borderline meeting Fewer Spanish households buy OTCs alf amillion fewer Spanish households months. This wasthe same as in 2014. full-day conference organised by Ger- Hbought some form of non-prescription Mercedes Bardina, client manager at Kantar Amany’sfederal institute for drugs and medicine in 2015, according to anew report Worldpanel, said that the cause of the fall might medical devices, BfArM, on 19 September from Kantar Worldpanel. be due to consumers opting for “more natural alt- will discuss the borderline between medicines, According to the figures, sevenmillion Span- ernatives”, or more people making use of the medical devices, food and cosmetics. ish householdsbought at least one OTCmedi- state healthcare system to access medicines. “Medicines are long since established as cine last year,Kantar revealed, afall of around Around 64% of Spanish households said products that relieve,heal or prevent illnesses 500,000 on the previous year. that theyusually went through the national and complaints,”the agencystated. “But in the Those households that had bought anon- healthcare system for treatment, Bardina noted, past fewyears, more and more product groups prescription medicine,the companypointed while 63% said that theylooked for alterna- have emerged that display to consumers sim- out, bought an average of sevenproducts with tivestostandard medicines. ilar characteristics to medicines, and thus are an average total spend of C57.00 overthe 12 Looking at the categories impacted by the hard to differentiate from medicines.” decline, Kantar said that while the cough and As examples, BfArM cites substance-based coldcategory remained the largest in Spain, it medical devices with amedical purpose and wasproducts in this category of which people food supplements with health-related claims IN BRIEF had bought fewer. such as “maintains anormal cholesterol level ■ MINTEL –the market research agency– By contrast, analgesics and anti-inflamma- in the blood”. said that sales of sports-nutrition products torydrugs were growing in importance to Span- Registration costs C130.00 and participa- in the UK had risen by 27% in the past two ishhouseholds, Kantar noted, with brands like tion is limited to 230 people. More informa- years. Theywere £66 million (C79 million) in GlaxoSmithKline’s Voltadol and Ferrer’sGelo- tion can be found at bfarm.de. 2015, up from £52 million in 2013. catil becoming more popular. OTC OTC OTC

10 OTC bulletin 22 July 2016 OTC22-07-2016p10-12_Layout 1 19/07/2016 15:03 Page 3

GENERAL NEWS OTC

Switches Market Research OTC Differin German manufacturers approved in US anticipate consolidation ■ Continued from front page 0.1% as atopical acne treatment (OTC bul- ore than three-quarters of leading exec- pharmacyco-operativesorbanner groups. letin,22April 2016, page 1). MutivesatGerman pharmaceutical com- Just overfour-fifths of executivesexpected At the time, the committee said data in Gal- panies expect consolidation in the OTCmarket the importance of mail-order retailers to in- derma’ssupplemental newdrug application to pick up pace, according to asurvey conduct- crease, while nearly nine out of 10 said they (sNDA) for adapalene gel 0.1% supported an ed by Sempora Management Consultants. already had key-account relationships with acceptable benefit/risk profile for non-prescrip- When asked about their expectations for the six or more such retailers. tion use by consumers. number of companyacquisitions in the OTC “The importance of mail order is high and Amonth ago, NewZealand’sregulatory sector,77% of the 39 interviewed industry ex- rising,”commented Sempora’smanaging dir- authority Medsafe also approvedanapplication ecutivesbelievedthe number would increase. ector,Tobias Brodtkorb.“But consolidation to widen access to adapalene to treat acne The other 23% anticipated the rate to con- is to be expected, as the gulf in performance (OTC bulletin,30June 2016, page 12). tinue, with none expecting the rate of consoli- is spreading,”he added. The country’sMedicines Classification Com- dation to slow. In general, the executivesrated the overall mittee (MCC) reclassified adapalene as “a pre- Sempora pointed out that when it had asked performance of mail-order pharmaciesatthe scription medicine except in medicines con- the same question ayear earlier,5%ofexecu- same levelasin2015. But anotably strong taining not more than 1mg/g and when supplied tiveshad expected areduction in the number evaluation of shop-apotheke.com sawthe re- by apharmacistinapack of not more than 30g of transactions, while nearly athird had said tailer stretch its lead over euora-apotheek.com when indicated for treating acne vulgaris”. there would be no increase in the pace of take- and apo-rot.de. Responding to an application from phar- overs. The proportionofindustry leaders who Evaluating pharmacyco-operativesorban- macyretail group Green Cross Health and thought consolidation would speed up rose ner groups on the same basis, the executives switch consultant Natalie Gauld (OTC bulletin, by 14 percentage points to 77% this year. said Linda and EasyApotheke had performed 4March 2016, page 9), the MCC said that over- During interviews conducted in March and best, ahead of Migasa and GesundLeben. allthere were no outstanding risks that should April this year –the 13th time that Sempora Alittle under half –44% –ofindustry lead- prevent the availability of adapalene with a‘pre- had conducted such astudy –the management ers expected the importance ofpharmacyco- scription medicine except’ classification. consultancyalso sought industry executives’ operativestogrow. Three-fifths of the 267 Adapalene 0.1% is already available with- views on both mail-order pharmaciesand pharmacists questioned felt the same. out aprescription in Georgia, Russia and Thai- OTC land, while Germanyrecently rejected an application to switch adapalene mono preparations Industr yAssociations in concentrations of up to 0.1% with amaximum pack size of 25g (OTC bulletin,5Feb- ICH welcomes WSMI as amember ruary 2016, page 11). OTC he International Council for Harmonisa- is committed to continuing its active partici- Ttion (ICH) has welcomed global industry pation,”the association continued. “Full mem- Obituary association, the World Self-Medication Indus- bership provides an opportunity to fully en- try(WSMI), as amember at its recent Assem- gage in global regulatory discussions in the Obituary: Kirit Patel bly meeting in Lisbon, Portugal. future and to ensure specificities of non-pre- Announcing the membership, the ICH said scription medicines are taken into account in irit Patel, founder and chief executive that the addition of WSMI –aswell as the ICH guidelines.” Kofficer of the Day Lewis pharmacychain International Generic and Biosimilar Associ- WSMI added that it was“looking forward in the UK, has died. ation (IGBA) and 14 “observers”, including to working with all ICH members and observ- In aretail pharmacycareer spanning over Australia’sTherapeuticGoods Administration ers in advancing OTCregulation around the 40 years, Patel founded Day Lewis with his (TGA) –built on its objective to establish it- globe and enabling self care”. brother JC Patel in 1975. Today,the chain is self as a“truly global platform for harmoni- The ICH announced plans last year to ex- one of the UK’slargest multiple pharmacyplay- sation and better health”. pand its membershiptoallowfor more involve- ers with around 250 pharmacies and amajor Commenting on the decision, WSMI – ment from regulators around the world and presence in the South of England, from Corn- which recently appointed Suneet Varma, Pfizer “wider inclusion of global industry sectors af- wall to Greater London. Consumer Healthcare’spresident and general fected by harmonisation”. Aside from his position within Day Lewis, manager,asits chair (OTC bulletin,22April This reform, the council explained, was Patel held significant roles in various pharmacy 2016, page 23) –said it was“pleased” to be intended to “reinforce the foundations of ICH associations, such as the Royal Pharmaceuti- admitted as amember. to make itbetter-equipped to face the chal- cal Society of Great Britain (RPS) and the Asso- “WSMI has contributed as an interested lenges of global pharmaceutical development ciation of IndependentMultiple Pharmacies. party to various ICH working groups and in- and regulation”. OTC itiativessince the onset of the programme and OTC

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OTC GENERAL NEWS

Regulatory Af fairs CHPAand FDA debate user-fee system

he US Consumer Healthcare Products As- that charging fees “could create certain incen- to marketing,”Kochanowski pointed out. Tsociation (CHPA) is set to begin detailed tivesordisincentives” for consumer health- “Manyofthese ingredientshave been mar- talks with the Food and Drug Administration care companies. keted for more than 40 years, with along (FDA) overhow apotential OTCmonograph “Fees for non-prescription medicines under history of safe use. There is no backlog of user-fee system could look. the monograph system could be adisincentive applications,”she noted. “Therefore we must de- Following an FDApublic meeting on OTC for innovation,”Kochanowski claimed, “or they fine value differently than industries subject monograph user fees in June, the process of re- could incentivise innovation, depending on how to FDAapprovalprior to marketing.” forming the US OTCmonograph system had now theyare applied.” In calling the June meeting, the FDAsaid entered the stage of discussion that would include “For example, today,very fewmanufactur- that it wanted to “gather input on the potential “detailed talks” between the CHPAand the FDA. ers are filing NewDrug Applications (NDAs) development of auser-fee programme for non- These would cover“the parameters of apoten- andpaying the Prescription Drug User Fee Act prescription monograph drugs” (OTC bulletin, tial user-fee framework”, the associationsaid. (PDUFA) fee to innovate with monograph in- 27 May 2016, page 15). Anysuch framework would require Con- gredients,”she pointed out. “A user-fee programme would provide fund- gressional action to be implemented, the CHPA Noting that the CHPAdid not want to “dis- ing to supplement Congressional non-user fee pointed out, adding that the FDAwould post courage activities that could benefit public appropriations,”the agencyclaimed, “and would public minutes of the talks on its website. health”, Kochanowski argued that anypotential support atimely and efficient FDAreviewof While the CHPAsaid it strongly supported user-fee programme needed to contain “mech- the efficacyand safety of ingredients in, or pro- the OTCmonograph system, the association anisms to support innovation”. posed for inclusion in, amonograph.” believedthat “policyreforms could make the “Interms of fees in general,”Kochanowski The FDAhas invited industry and public system more flexible, responsive and accom- added, “we would expect them to be justified comments on the potential user-fee programme modating to innovation”. and spending transparent.” and suggestions for the features such apro- “We recognise that resource constraints “Fees should not be disproportionately tar- gramme should include. would affect the ability of the FDAtoimple- geted to rebuilding and maintaining capability,” The June meeting waspart of awider re- ment anypotential monograph reforms,” the she insisted. “We would expect to see abalance viewofthe OTCmonograph system in the US, CHPAsaid, “and we are open to ways of ad- in the application of fees between long-stand- which beganin2014 (OTC bulletin,30May equately funding reforms, including consider- ing,needed actions under the monographs and 2014, page 12). ation of auser-fee programme for OTCdrugs.” acting on innovation.” Earlier this year,Patrick Lockwood-Taylor, However, speaking at the FDApublic meet- While the CHPAagreed that adiscussion the then chair of the CHPA, said that reform ing in June, the CHPAwarned that introducing on user fees for OTCproducts waswarrant- of the US OTCmonograph system wasabig an OTCmonograph user-fee system in the US ed, the association cautioned the FDAagainst opportunity for the industry to shape its future without “thorough discussion and study” could drawing too manycomparisons with the pre- rather than have its future decided for it. be a“disincentive for innovation” (OTC bul- scription medicines market. “Capitol Hill and the FDAwant to com- letin,17June 2016, page 14). “Unlike other drugs subject to user fees, plete the monograph system and modernise it,” The CHPA’svice-president of regulatory non-prescription drugs under the monograph he pointed out, “as do we.” affairs, Barbara Kochanowski, told the meeting system are not subject to FDAapprovalprior “But anyreform needs to create value for consumers, the FDAand for the manufacturers of the medicines within this system,”Lock- wood-Taylor insisted, referring to the FDA’s Regulatory Af fairs statement twoyears ago that it believedits OTCmonograph system needed a“critical ex- FDA proposesnew hand sanitiser rule amination at this juncture to determine whether and howtomodernise [the FDA’s] processes he US Food and Drug Administration zalkonium chloride; and isopropyl alcohol. andregulatory framework”. T(FDA) has proposed arule requesting addi- No consumer hand sanitiser products would The regulatory framework faced “significant tional scientific data to support the safety and be removedfrom the market at this time, the challenges” as it did not allowrapid responses efficacyofcertain active ingredients used in FDAsaid, butmanufacturers that wanted to to drug-safety issues or scientific advances, OTCtopical antiseptic rubs, including com- continue marketing these products under the the FDAclaimed, with the agencyquestion- monly-used hand sanitisers. OTCDrug Reviewwould be required to pro- ing whether the challenges facing the system While noting that millions of Americans vide the agencywith additional data on their “necessitated amore agile and responsive pro- used antiseptic rubs daily,the FDAsaid that active ingredients’ safety and effectiveness, cess than the OTCdrug reviewallowed”. it wasthe agency’sresponsibility to determine including data to evaluate absorption. This had presented an opportunity,Lock- whether such products were safe and effec- The proposed rule would be available for wood-Taylor said, to “push for asimplified, tive,and to do this it must “fill the gaps in public comment for 180 days, the agencysaid, more transparent rule-making process, which scientific data on certain active ingredients”. while companies would have one year to sub- offers amore effective waytoaddress safety Under the newrule, the agencywould re- mit newdata and information. issues around potential OTCproducts”. quire data on three ingredients: alcohol; ben- OTC OTC

12 OTC bulletin 22 July 2016 OTC22-07-2016p13-18_Layout 1 19/07/2016 16:11 Page 2

MARKETING NEWS OTC

ProductLaunches ProductLaunches French women Bayer addsTENS device get Palomacare to Aleve range in the US pain’sProcare Health has introduced its SPalomacare range of vaginal-health prod- ayer Consumer Health has expanded its ucts to the French market. Comprising avagi- BAleveanalgesics range in the US with the nal gel and a“sensitive mousse”, the range brand’sfirst transcutaneous electrical nerve is intended for use in “all situations that dis- stimulation (TENS) pain-relief device. rupt vaginal health”. Aclass II medical device, Aleve Direct Palomacare is “notably particularly effec- Therapyisindicated for the “temporaryrelief tive”inmenopause; postpartum episiotomy; of pain associatedwith sore and aching muscles following gynaecological surgery; during hor- in the lower back due to strain from exercise Aleve Direct Therapy is indicated for lower back pain monal contraception; while undertaking radio or normal household and work activities”. and is the first TENS machine under the Aleve brand or chemotherapy; or during repeated infections, The device provided safe, drug-free, “deep- Information on the device and instructions Procare pointed out. penetrating lower-back pain relief without a on howtouse it are available on the Aleve Based on “ingredientsofnatural origin”, prescription”, Bayer explained, by delivering website, aleve.com, and through videos on the the “original and patented formula” of Paloma- “stimulating pulses at the site of pain”. brand’sYouTube channel. care enabled the “penetrationofthe active in- These pulses blocked the body’spain sig- Bayer currently offers tablets, caplets, liquid gredients in the deepest layers of vaginal mu- nals and releasedendorphins in the targeted gels and gelcaps under the naproxen-based cus”, enhancing the efficacyofthe product. areas, Bayer maintained. Aleve umbrella brand, as well as an Aleve PM Hyaluronic acid “hydrates tissue and re- At 4.8 oz (136g), Aleve Direct Therapy product with naproxen sodium and diphenhy- stores elasticity to the vaginal mucus”, ac- weighed “about the same as most smartphones”, dramine hydrochloride. cording to Procare. Meanwhile, beta-glucans Bayer pointed out, adding that the “durable” The range also includes Aleve-D variants for contribute anti-inflammatory and anti-oxidant device could be worn “discreetly and comfort- Sinus and Cold, and Sinus and Headache, both properties, as centella asiatica stimulates col- ably throughout the day on the user’slower containing naproxen sodium and pseudoephe- lagen activation. back, even during some physical activities”. drine hydrochloride. OTC OTC

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22 July 2016 OTC bulletin 13 OTC22-07-2016p13-18_Layout 1 19/07/2016 16:11 Page 3

OTC MARKETING NEWS

ASAAdvertisingComplaint banss Nurofen Joint &Back spot

eckitt Benckiser’s(RB’s) television advert- fective at relieving, back and joint pain if this that it misleadingly implied the product directly Risement for its ibuprofen-based Nurofen wasnot the case. targeted muscles in the head –after the firm Joint &Back Pain Relief capsules has been The commercial must not be shown again pledged that it would not showthe television banned by the UK’sAdvertising Standards Auth- in its current form, the ASA ruled. commercial again (OTC bulletin,4March ority (ASA). The watchdog said the spot mis- Commenting on the case, the ASA said the 2016, page 15). leadingly implied that the product specifically ruling served as areminder to OTCcompanies RB had also “provided assurance”, the ASA targeted –and wasespecially effective at re- –including RB –of“the importance of being said at the time, that it would “not create an ad- lieving –joint and back pain. able to substantiate their claims and to avoid vertisement in the future that could imply that Explaining whythe commercial had been their advertisements containing anything that, the product has aspecial mechanism that makes banned, the ASA said that although the on- whether through exaggeration or otherwise, is it especially effective for headache pain”. screen text stated that Nurofen Joint &Back likely to mislead”. The companyalso recently came under fire was“also indicated for other aches and pains”, in Australia for making misleading claims about this was“not sufficiently prominent” to counter RB “disappointed” with ruling its Nurofen ‘Specific Pain’ products. imagery shown on screen that the product was Meanwhile, RB said in astatement that it was RB wasfined A$1.7 million (C1.0 million) tailored for back and joint pain. “disappointed” with the watchdog’sdecision. by the country’sFederal Court for making “mis- While avoiceoverstated that the product “Nurofen pain-specific products were intro- leading representations” on the packaging of the provided “constant targeted pain relief”, the duced to provide easy navigation of pain-relief products and on its website, nurofen.com.au, ASA said that in the context of an advertise- options for consumers experiencing aspecific that each variant –Back Pain, Migraine Pain, ment “focused on the alleviation of back pain”, type of pain, particularly within the grocery en- Period Pain, and Tension Headache –had been and“giventhe product name”, viewers would vironment where pharmacysupport isn’tavail- “formulated to treat aparticular type of pain” be likely to understand that Nurofen Joint & able,”the firm pointed out. and “solely or specifically treated aspecific type Back wasspecifically designed to relieve joint It added that all television advertising claims of pain”, despite them all containing 342mg and back pain, “rather than pain generally”. made in the UK were “supported by robust evi- ibuprofen lysine (OTC bulletin, 22April 2016, Viewers would also likely infer that the prod- dence and approvedbythe relevant indepen- page 16). uct had aspecial mechanism or contained an dent external agencies”. The case wasbrought by the Australian Com- active ingredient which made it especially effect- This is the second time in recent months petition and Consumer Commission (ACCC), ivefor joint and back pain, the watchdog noted. that the ASA has looked into complaints about which has appealed the amount of the penalty RB waswarned by the watchdog that it must misleading claims in advertising for Nurofen. for being too lenient (OTC bulletin, 27May makesure it did not imply that Nurofen Joint Earlier this year, the watchdog called off 2016, page 16). An initial fine of A$6 million &Back had aspecial mechanism which meant an investigation into RB’sNurofen Express ad- had been proposed by the Commission for it specifically targeted, and wasespecially ef- vertisement –which had sparked complaints the violations. OTC

ProductLaunches Remisens peps up Germans’ sex lives

ermany’s“first herbal medicine to treat Predominantly red packs bearing apink Gdeclining sexual desire” in women is how flower logo carry the claim that the tradition- Schaper &Brümmer is positioning its Rem- al medicine is for use “as an aphrodisiac for isens newcomer. declining sexual desire”. Apharmacy-exclusive traditional medicine, Herbal remedies specialist Schaper &Brüm- “The secret to your summer” is how Mentholatum Remisens is supplied as three-a-day coated mer cited research suggesting that one in five is positioning its Rohto Ice All-In-One Cooling Eye tablets, each containing 225mg dried extract women reported aloss of libido overtime. Rea- Drops to US consumers. The drops’ combination of “fast-acting and of damiana (Turneradiffusa)leaves. sonscould include taking certain prescription highly-effective” ingredients provided “fast, cooling medicines, hormonal changes, body image and relief for eight symptoms” – red, dry, itchy,irritated, relationship issues, the firm noted. burning, gritty,wateryand stinging eyes – for up to eight hours, the firmclaimed. “For the first time,”the companystated, “a The All-In-One Cooling Eye Drops variant joins the herbal medicine has been registered in Germany five-strong Rohto eye drops line, which includes products as an aphrodisiac.” for dryeyes, redeyes and a‘multi-symptom’ option. To promote the latest product, Mentholatum said Damiana had been used as an aphrodisiac it was currently partnering with ‘influencers’ such as for centuries, dating back to the Mayan culture, lifestyle bloggers, while other marketing initiatives Schaper &Brümmer commented. would take place “at alater date”. Rohto Ice All-In-One Cooling Eye Drops have a Recommended retail prices for 30-and 90- recommended retail price of US$5.99 (C5.40). The packaging for Remisens claims the product is for tablet packs are C18.98 and C39.89 respectively. OTC use as an “aphrodisiac for declining sexual desire” OTC

14 OTC bulletin 22 July 2016 OTC22-07-2016p13-18_Layout 1 19/07/2016 16:11 Page 4

MARKETING NEWS OTC

SocialResearch data canback product claims

ocial media can offer a“pertinent and Slow-cost” wayofcollecting ‘real world evidence’ to support abrand’slicensed indications and efficacyclaims, according to Peter Brady, chief executive officer of UK social- media marketing firm Orbital Media. Healthcare brands were increasingly under pressure to provide up-to-date, credible evidence to support their product-licensed indications and claims, Brady explained, as well as to support general product safety throughout aproduct’slifecycle. But until now, there had been “no system- atic collection of data from non-prescription Orbital Media has developeda‘seven-step’ process of collecting real-world evidence through social media. This healthcareinterventions” in a“structured way”. includesestablishingwith afirmthe product claims it wants to investigate and consulting key opinion leaders Social media presented away of collecting To bring Goldman’sconcept to life, Brady Repetition of the data collection wasalso user evidence and supporting anecdotal com- noted, Orbital Media had developed a‘seven- possible, Brady noted, to “confirm validity ments, Brady maintained. In the past, the only step process’ of collecting evidence through and add to the baseline information”. waytoobtain this kind of information would social media, in collaboration with an “experi- Data for the Sudocrem “real-world retro- have been through aclinical trial, he claimed, enced medical research team”. spective study” had been obtained using the which would have been time-consuming, ex- Allergan’sSudocrem zinc-oxide-based anti- ‘SurveyGizmo’ online survey platform, through pensive, and unrepresentative of use in every- septic healing cream had been the first product which participants confirmed their use of Sudo- day real-world situations. for which real-world evidence had been col- crem to treat an episode of nappyrash on a The real world evidence collected through lected through social media, Brady claimed, child. The ‘bespoke’ questionnaire asked peo- surveying social media users about their prod- adding that the method was“nowbeing rolled ple for details of howthe product wasused uct experience could be used to “enhance out to wider industry”. and the outcome experienced. old or weak evidence”, he said, as well as to Step one of the process had involved est- The next step of the process had been col- “strengthen product claims for marketing pur- ablishing with Allerganand its medical advisor lating and reviewing the data before it appear- poses and generate extra-value propositions the objectivesofthe study and the product ed in an appropriate medical or other “influen- for products”. claims that the firm wished to investigate. tial” publication, Brady said, to “establish its sta- This “breakthrough”method of data collect- The next step had been consulting keyopin- tusasindustry-accepted, real-world evidence”. ion also allowed research to takeplace “in ion leaders, including Allergan’smedical offi- Completed in the spring of this year, the areas of conventional healthcarethat would cers, to ensure that the process “complied with resulting Sudocrem Real World Evidence traditionally be difficult or not possible”, Brady the standards required for collecting, analys- (SURE) Study –authored by Goldman and Dr noted. Baby healthcare products or the societal ing and presenting data findings for medical Imran Lodhi, medical director at Allergan– impact of conditions that might not generate peer review”. It could then also “form the had been published in the British Journal of adoctor’svisit, likeminor skin ailments, were basis for securing anyfuture claims”. Nursing,Brady noted. good examples of such areas. Participants were recruited according to the The study had successfully supported Sudo- Furthermore, the data collection was“not social-media and digital communities of the crem’sclaim for treating infantile nappyrash governed by clinical-trial regulations”, he main- brand in question, Brady pointed out. by showing rapid skin healing and reduced tained, giving brands “greater control”. It could These communities comprised “manythou- signs of inflammation, he added. also potentiallysavethe consumer healthcare sands” of participants, Brady noted, adding Four observed signs had been rapidly re- industry “millions of pounds”. that the Sudocrem study had obtained 2,159 duced, according to the SURE study: redness; Brady pointed out that the data-collection respondents within nine days. swelling; heat; and discomfort. process took approximately four-to-six months Around 45% of participants were recruited The results of the study meant that Allergan and cost “a tinyfraction” of aclinical trial. through Sudocrem social-media channels, while could potentiallyclaim that 99.3% of users Quoting real-world evidence pioneer Dr around 55% of parents or carers were signed sawnappyrash improve with using Sudo- Martin Goldman, chief medical officer at health- up through parenting website Bounty’son- crem, Brady noted, and that overhalf of users care consultancy firm Iatros Consulting, Brady line community. experienced an improvement in nappyrash noted that previous routes of collecting real- Thestudy had been “pilot-tested” on asam- the same day. world evidence had involved “extracting infor- ple number of participants, Brady explained. These were findings that had neverbeen mation from pre-existing large-scale health An advantage of the study’smethodology, demonstrated, he added. While the efficacyof records or disease registers”. These were not he noted, wasthat it collected data “on a Sudocrem had been established in two‘legacy’ available in the cases of self-treatment by large scale with high levels of detail”, suffi- studies, these had not specifically addressed users of OTCmedicines or alternative health cient to support keyproduct indications and the healing of infantile nappyrash. interventions, he maintained. credible promotional claims. OTC

22 July 2016 OTC bulletin 15 OTC22-07-2016p13-18_Layout 1 19/07/2016 16:11 Page 5

OTC MARKETING NEWS

AESGPMeeting Start engaging with consumers digitally

TC companies need to stop speaking to through monitoring –and reacting to –con- Opeople and start engaging with them –and sumer conversations on social media around digital is the best channel through which to do being ill –from the first signs through to when this, according to Laurent Faracci, senior vice- the symptoms were in full force. president, global marketing and digital excel- Data-drivenmarketing allowed firms to lence at Reckitt Benckiser (RB). knowhow, where and when to engage with the Addressing delegates at the 52nd Annual consumer,Faracci said. While it wasa“very Meeting of the European Self-Medication In- simple” concept, he noted, it wasimportant to dustry, the AESGP, inAthens, Greece, last “delivertothe right target at the right time and month, Faracci used the Mr Mucus character in the right place with the right message”. –who personifies RB’sMucinexdecongestant, Quoting the Greek physician Hippocrates, the “number one OTCbrand in the US” –as Faracci pointed out that it was“more important an example of howdigital platforms and tools to knowwhat sort of person has adisease than could be used to help “brand building” by cap- to knowwhat sort of disease aperson has.” RB’s Laurent Faracci explained to delegates how the Mr Mucus character had gone from speaking to turing consumerinterest in away that wasrel- Most importantly of all, it wascrucial to consumers to engaging with them digitally evant to them. “embrace creativity as amultiplier”. Mr Mucus –who first appeared in advert- While data offered the contextual relevance, changing world of digital and its “short cycles”, ising for Mucinexin2002 –had undergone a Faracci noted, it needed to be used creatively he noted, as the rate of adoption of anynew dig- “digital transformation”, he pointed out, where to engage consumers and increase brand-build- ital platform or innovation was“very fast”. asimple picture of broadcasting and pharmacy ing, or it would not have the desired effect. Faracci also acknowledged the presence and had been amplified into acomplexmodel that “You can’tjust talk to people,”hereiterated. impact of large technologycompanies in the leveraged “what digital brings to you”. What RB realised with earlier advertising healthcare field and beyond. This “digital innovation” had only been pos- for Mucinex, he said, wasthat it was“essential- “Wemust be humble,”Faracci maintained. sible, he maintained, thanks to the rise and rise ly abroadcast message”. The companyhad told “Wemust realise that we are not in the driving of the smartphone. consumers what it wanted them to know, “and seat as newdigital platforms emerge.” “It’snot about changing what you do,”Far- this is not really agood waytoengage with “Wehavestrengths as an industry in prod- acci told the audience. Digital innovation meant the consumer”. uct development and regulatory affairs, butcom- taking advantage of the benefits offered by dig- panies likeGoogle are building platforms and ital platforms, he said, to help consumers People do not engage to see your brand investing at alevel that is orders of magni- “through the customer journey” and assisting “Consumers will engage with platforms for tude greater than we can,”hesaid. them in choosing “the best medicine for the specific reasons, not to see your brand,”he However, as OTCfirms reacted to this digi- ailment they’re facing”. maintained. “If you interact with them on those tal “wave”, Faracci warned, there wasarisk of To meet this “newlevel” of consumer ex- platforms, you need to ask: ‘What are you “fragmentation”. He foresawproblems if “every- pectation, firms needed to transform their brand adding to that ecosystem?’” one goes their ownway and does small things”, assets so that theywere “digitally enabled”, This wasanimportant point to consider, when industry should be working together. Faracci noted. Faracci insisted, because digital devices and Companies could leverage digital develop- Faracci shared with delegates some learnings platformsmade it easy for advertising to be dis- ments and advances in technology internally RB had made from developing Mr Mucus, after missed if it did not engage –orwas not relevant for their ownbenefit, Faracci said, butthe OTC the firm gained the Mucinexbrand through the for –consumers. industry as awhole should “steer developments acquisition of Adams Pharmaceuticals in 2007 “You may actually pay for [the advertising],” and be seen as aforce for good”. (OTC bulletin, 17December 2007, page 1). he continued, “but you will not be seen.” “When you look at consumers and con- Firstly, hesaid, digital media should be em- Furthermore, social-media platforms present- sumers’ usage online,”henoted, “it is an app ployed to “bring brand purpose to life”. Aclose ed adifferent “clutter” to cut through than ad- world today.80% of consumers’ time is spent second, he added, wasthat “consumers should vertising breaks on television, Faracci pointed on five apps.” be at the heart of everything”. out. On television, firms would go up against “Weneed to think about our role as an in- Furthermore, communications should be their competitors and other brands, butinthe dustry not to let those five apps dictate engage- “channel deliberate”, and “big data” –such as digital world, brands were competing with per- ment. We must also ensure that we do not be- detailed information on illness prevalence and sonal and viral posts to get noticed. cometoo dependent on big players,”hesaid. distribution from analytics and predictive mod- “When your benchmark is the latest cat Instead, the consumer healthcare industry els –should be used to “gain contextual rele- video on the internet,”hesaid, “or your sister’s should collaborate with large technology com- vance” and “maximise your impact”, and get newbaby, the bar is much higher.” panies to ensure that its “philosophy” –ofpro- closer to consumers. “Howdoyou deliverinanenvironment that viding the best information and providing the Showing examples of howMrMucus was is very different to television broadcasting or right choice for apatient’scare –“is actually nowactive on Facebook and Twitter, aswell print?” he asked. “You need to think about that.” carried through properly”. as interactive out-of-home,Faracci said it had Companies also had to be aware of –and “This is the biggest call for us,”Faracci said. been vital to get “as close to sick as possible” be able quickly to react to –the constantly- OTC

16 OTC bulletin 22 July 2016 OTC22-07-2016p13-18_Layout 1 19/07/2016 16:11 Page 6

MARKETING NEWS OTC

AESGPMeeting Digital media promotes health literacy

igital platforms are keytools for educat- wasablog about health and nutrition written Ding consumers about their ownhealth and in “plain language”, Riu pointed out. encouraging self-care, according to Inma Riu Originally set up to “fight against Dr Torrens of the social media and pharmacycon- Google”, the website wascreated by a“mum- sultancy, Saludability. my blogger”, Riu explained, who decided to Speaking to delegates at the 52nd Annual start blogging about healthcare once she had Meeting of the Association of the European finished her doctorate.Todate, it had had over Self-Medication Industry, the AESGP, inAthens, fourmillion page views, and 7,749 followers. Greece, last month, Riu pointed out that 8.7 The “mummy bloggersphere” wasamas- outof10Spaniards had smartphones, and that sive world, she noted, with alarge audience to 22 million people –78% of the population – be discovered. connected daily to the internet. Videos on howtouse medication were pre- “Digital is part of daily life, and we need sented by pharma20.es, said Riu, which had to be there because it’swhere the consumer is,” started life helping mothers with breastfeed- she insisted. ing and other subjects related to motherhood. Inma Riu Torrens, of social media and pharmacy Noting that 80% of Spaniards searched the Social media had helped the website’scre- consultancy Saludability,presented five ways in which pharmacies wereusing digital tools to provide internet for healthcare information, butfar few- ators –based at apharmacyinthe town of Llie- high-quality health information er understood what theyfound, Riu said digital da –gain further insight into consumer needs, platformscould be used by healthcareprofes- she pointed out. improving advice to patients and increasing sionals –such as pharmacists –topromote Once it had expanded onto Facebook –where product sales. self-care by improving consumers’ health liter- it had gained over10,000 followers –the site’s This pharmacist-to-pharmacist channel en- acy. This in turn gave people the ability better owners had abetter idea of the kinds of ques- couraged pharmacies to focus on self-care by to treat their ailments by themselves. tions to which consumers wanted answers, she posing ascenario and asking pharmacists what “Pharmacies and their institutions should stop said, noting that the most prevalent queries were theywould recommend. looking inward and start redirecting energies those based on using medication. The creator of the @susitravel handle also towards the greater social good,”she insisted. Around 300 questions amonth were sent posted atable featuring the answers from con- Developments in the digital channel were through social media and the website, Riu noted, tributors, which suggested cross-selling oppor- making more people more conscious of them- adding that now, instead of providing content tunities for products. selves and their health, Riu pointed out. it thought consumers wanted, Pharma 20 pro- Riu pointed out that the keytothe success “People likesharing experiences,” Riu said. vided content consumers actually needed. of these different digital approaches and initia- “Theyalso want to knowiftheyare well, if they The site had also recently started offering tiveswas that theyoffered “independent and are going to get sick, and howtheycan prevent companies amonthly test-marketing service, trusted advice online”. getting cancer or diseases,”she continued. she pointed out, for products such as vitamins Theywere also good at creating commu- Riu introduced to delegates five examples and supplements. nities around their brand, as well as adapting in which pharmacyinSpain wasusing digital Pharma 20 had both an online strategy and “quickly” to what consumers needed and to tools to drive self-care. an offline approach through the pharmacy offering specific advice. One such example was quemedaspara.es, owned by the site’screators, Riu said. Additionally, theywere reactive, she point- avideo blog set up by twopharmacists. The When acustomer –who wasregistered on ed out. It sometimestook pharmaceutical com- website took as its motivation that “information the pharmacy’semail database –bought aprod- panies around aweek to react –tosomething is the best drug for our patients”, Riu explained. uct, Riu explained, theywould receive alink in the news, for example. “What people want The site focused on the questions most fre- to avideo about it that provided further ad- is for someone to give them immediate ad- quently asked by consumers, Riu pointed out, vice and information. vice,”she insisted. noting that there were over4,000 subscribers Infographics wasthe point-of-difference of Taking advantage of the opportunitiesthat to the site’sYouTube channel. These asked ques- the medicadoo.es site, noted Riu, which pro- the digital world presented didn’tnecessarily tions as diverse as the differences between vided answers to questions pharmacists had require huge amounts of money, Riu pointed out. paracetamol and ibuprofen and the symptoms encountered in-store, such as: “Howmuch ibu- Noting that there were over21,000 inde- of urine infections. profen shall Igivetomychildren?” pendent pharmaciesinSpain, Riu said that they Meanwhile, the website boticariagarcia.com Created by pharmacistsinAndalucia, the did not have the budgets that large pharma- site had an international reach, Riu continued, ceutical companies had. pointing out that while the majorityofvisitors Nevertheless, by using social-mediaand to the site were Spanish, there wasalso afollow- tools such as Google Trends, pharmacyhad ing in Latin America. gained an insight into what consumers want- Riu’sfifth example wasthe Twitter profile ed and the current state of the market, she ex- created by apharmacist under the username plained. These insights could then be used to Boticariagarcia.com was originally set up to “fight against Dr Google” and provide health information @susitravel, who Riu explained had instigated react to consumers’ needs. “in plain language” aweekly conversation between pharmacists on OTC

22 July 2016 OTC bulletin 17 OTC22-07-2016p13-18_Layout 1 19/07/2016 16:11 Page 7

OTC MARKETING NEWS

ProductRelaunches ProductLaunches Stada renames PharmaFGP spends C5mn Hoggar Balance on Neodolor television push tada Arzneimittel has relaunched in Ger- Smanyits Hoggar Balance herbal calming ermany’sPharma FGP will spend C5mil- aid under the PassioBalance name better to Glion overthe next year on atelevision cam- highlight the product’scharacteristics and sep- paign to promote its Neodolor homoeopathic arate it from the brand’schemical option. analgesic in its domestic market. The newname, the firm pointed out, com- Indicated for headaches, migraines and neu- municated “perfectly” the pharmacy-only medi- ralgia, Neodolor is formulated with extracts cine’sbenefit of aiding a“balanced lifestyle” from five plants: cimicifuga racemosa, cycla- while highlighting the product’sactive ingred- men purpurascens, gelsemium sempervirens, ient, passionflower extract. iris versicolor and spigelia anthelmia. Stada added that the rebranding differenti- Claiming that most headache sufferers were Pharma FGP is spending C5million on atelevision ated clearly the PassioBalance tablets –which looking for an “innovative headache therapy campaign to promote Neodolor in Germany.The advertisement focuses on two women, one of which each contain 425mg of dried extract of passion- without anyknown risks of side effects or in- is suffering from aheadache flower –from the doxylamine-based Hoggar teractions”, the firm said Neodolorwould “help Night sleep aid. people protect their health by fighting head- It would also makeiteasier for pharmacists aches without chemicals”. to recommend PassioBalance to consumers for The television advertisement for Neodolor “nervous restlessness”, the companynoted. shows twowomen sitting on apark bench. Stada added that the product wasnow sup- As one complains that she has aheadache, plied as packs of 30 and 60 coated tablets, in- she is handed Neodolor by her friend, who states stead of the 40 previously.This wasintended that it is “the first natural headache pill”. to offer “the ideal quantities of pills for trial Avoiceoverpoints out that Neodolor has Other products in Pharma FGP’sportfolio in- usage and continuous usage”, the firm explained. “the power of five herbal ingredients”, and adds clude the Kijimea range of dietetic foods and sup- The launch of PassioBalance would be sup- that it is “effective and well-tolerated”, before plements and the Rubax painkiller line, which ported by aprint campaign, Stada said, as well the suffering woman announces that her head- also comprises ajoint-nutrition supplement. as “strong” public-relations activity and anew ache has gone. Available exclusively in pharmacies, a20- interactive website. Pharma FGP told OTC bulletin that it was tablet pack of Neodolor has arecommended Social-media campaigns were also being planning “further campaigns in other media” retail price of C9.95. The price is C14.95 for a planned, the companynoted. to support Neodolor. pack of 40 tablets. OTC OTC

ProductRelaunches GSK returns Polytar to UK shelves laxoSmithKline (GSK) says it will launch good manufacturing practice (GMP) standards”. Ga“full marketing campaign”in“acouple Formulated with 4% coal tar solution, the of weeks” to support the return to UK shelves general-sale list (GSL) Polytar Scalp Shampoo of its Polytar coal-tar brand for scalp conditions, is indicated to treat scalp disorders including following afour-year absence. psoriasis, seborrhoeic dermatitis and eczema. The brand wasremovedfrom retailers in Consumer-facing promotional activity for 2012 before GSK discontinueditcompletely Polytor Scalp Shampoo comprised point-of-

Urgo has launched in France apen aimed at eliminating twoyears later, after the firm was“unable to sale materials and “partnership marketing with “persistent verrucas” on feet and hands. Branded as source asupply of the rawmaterials which met retailers”, GSK said, as the product “continues Urgo Verrues Persistantes, the pen device is based to roll out nationwide”. on 40% trichloroacetic acid. A“precision brush” and ablue-coloured tint to the Adigital campaign wasalso planned, the substance allows for “precise treatment” of the affected companynoted. area, Urgo maintains. It also allows for accurate dosing, Meanwhile, marketing activity geared to- helping to overcome “the most tenacious verrucas”. Suitable for use by sufferers aged over four years wards pharmacists included trade-press activ- old, the product is contra-indicated for diabetics and ity, detailing, display units and apresence at for pregnant or breastfeeding women. Each verruca pharmacyshows, GSK added. should be treated once aday for up to aweek. The pen allows for 28 applications, meaning that one pen Polytar Scalp Shampoo has arecommended can treat up to four verrucas. retail price of £5.49 (C6.45) for a150ml bottle. OTC Polytar has not been available in the UK since 2012 OTC

18 OTC bulletin 22 July 2016 OTC22-07-2016p19Events_Layout 1 19/07/2016 16:21 Page 2

EVENTS OTC

SEPTEMBER Email: info@management- forum.co.uk. 1-3November 14-16 September Website: management-forum.co.uk. ■ Ceuta HealthcareInternational Traditional and Alliance Conference ■ 24-25 September Alternative Medicine Athens,Greece ■ Camexpo ‘A newgeneration’ is the theme of this three-day health and beauty Amsterdam, theNetherlands London, UK global conference,which will bring together manufacturers, global out- Athree-day conference and exhi- Acomplementary,natural and inte- source solutions providers and keyopinion leaders in the health and bition focusing on promoting and grative health event. beauty industries to explore global growth opportunities. navigating the future of tradition- Contact:Diversified Communications. Contact:Ceuta Healthcare. al medicine. Tel: +44 1273 645119. Tel: +44 1202 449 709. Email: [email protected]. Contact:Conference Series. Email: [email protected]. Website: ceutahealthcare.com. Tel: +40 805 080 048. Website: camexpo.co.uk. Email: traditionalmedicine@ insightconferences.com. 28-29 September Tel: +44 1564 777 550. Contact:ASMI. Website: traditionalmedicine. ■ Marketing Authorisation Email: natalie.cornwell@ Tel: +61 1300 878 815. conferenceseries.com. and Market Access generics-bulletin.com. Email: asmiconference@ in Iran, the Middle East Website: generics-bulletin.com/ nectarcc.com.au. 19 September and Turkey generics-biosimilars-awards.aspx. Website: asmi.com.au/events/. ■ BfArM discusses Frankfurt, Germany 5-7October 27 October Borderline This two-day conference will dis- ■ Health Ingredients ■ Food Supplements Bonn, Germany cuss the export of pharmaceutical Japan 2016 Brussels,Belgium This one-day meeting –organ- products to Iran, the Middle East Tokyo,Japan ‘Trading more effectively through- ised by Germany’sfederal insti- and Turkey. Athree-day health ingredient and out the European Union (EU)’ is tute for drugs and medical devices, Contact:Forum Institut service exhibition and conference. the theme of this one-day work- BfArM –will discuss the border- für Management. Contact:UBM Media. shop which will look at consumer line between medicines, medical Tel: +49 6221 500 500. Tel: +81 35296 1017. trends as well as market access. devices, food and cosmetics. Email: [email protected]. Email: [email protected]. Contact:European Federation of Contact: BfArM. Website: forum-institut.com. Tel: +49 228 99 307 0. Website: hijapan.info. Associations of Health Product Email: [email protected]. 28-30 September Manufacturers(EHPM). 13-14 October Website: bfarm.de. ■ TOPRA Annual Tel: +32 2721 6495. WSMI/APSMI Symposium 2016 ■ Email: [email protected]. 21 September Amsterdam, theNetherlands Conference Website: ehpm.org. ■ OTC and Prescription Both medicines and medical dev- NagoyaCity, Japan Atwo-day conferencerun by the Communications ices will be discussed at this three- NOVEMBER World Self-Medication Industry Bonn, Germany day event run by The Organisa- (WSMI) and the Asia-Pacific Self- 15 November Digital communication techniques tion for Professionals in Regula- Medication Industry (APSMI). ■ Advertising of for OTCand prescription medi- tory Affairs (TOPRA). Contact:Japan Federation of Self- Medicinal Products cines will be the subject of this Contact:TOPRA. Medication Industries (JSMI). Bonn, Germany one-day seminar organised by Ger- Tel: +44 20 7510 2560. Tel: +81 35657 0789. Advertising and competition law many’smedicines manufacturers’ Email: [email protected]. Email: [email protected]. and misleading and comparative association, the BAH. Website: toprasymposium.org. Contact:BAH. Website: jfsmi.jp/apsmi/index.html. advertising will be among topics to be addressed at this one-day event Tel: +49 228 957 4556. OCTOBER 26-29 October Email: [email protected]. runbyGermany’smedicines manu- 4October ■ CRN’s Annual facturers’ association, the BAH. Website: bah-bonn.de/widi-services/ Symposium for the fachseminare. ■ Global Generics Contact:BAH. &Biosimilars DietarySupplement Tel: +49 228 957 4556. 21-22 September Awards 2016 Industry Email: [email protected]. ■ Medical Device Barcelona, Spain California, US Website: bah-bonn.de/widi-services/ Regulations in These Awards will recognise the Afour-day conference organised fachseminare. Asia-Pacific Markets by the US Council for Responsi- achievements of the global gen- 21-22 November London, UK erics and biosimilars industries. ble Nutrition (CRN). ■ EuroPLX 62 Atwo-day conference offering Organised by Generics bulletin, Contact:CRN. Nice,France practical advice on howregula- theywill reward business develop- Tel: +1 202 204 7700. This two-day meeting will pro- tions are being applied. ment initiatives, cleverlicensing Email: [email protected]. vide aforum for business devel- Contact:Management Forum. deals and smart legalmanoeuvres. Website: crnusa.org/2016events. opment decision makers for dis- Tel: +44 1483 7300071. Contact: Generics bulletin. 27 October cussing and negotiating collabor- ■ ASMI Annual Conference ative agreements in licensing, mar- 9March Sydney,Australia keting, and distribution of patented ■ OTC Marketing Awards 2017 Subtitled ‘Advancing consumer medicines, generics, biosimilars, London, UK health through responsible self- OTCproducts, medical devices Formore information on the Awards visit care’, this one-day conference, org- and food supplements. OTC-bulletin.com/Awards,call Natalie Cornwell on +44 1564 777550, anised by the Australian Self-Med- Contact:RauCon. email [email protected],orfollowuson ication Industry (ASMI), will be Tel: +49 6221 426 2960. Twitter LinkedIn Facebook YouTube accompanied by the ASMI’sDia- Email: [email protected]. mond Awards. Website: europlx.com.

22 July 2016 OTC bulletin 19 OTC22-07-2016p20-23_Layout 1 19/07/2016 13:57 Page 2

OTC BUSINESS STRATEGY Perrigooffers ‘total healthcare’ in the UK

By acquiring Omega Pharma in 2015, Perrigo added abranded consumer healthcare business to its European presence. Nowthe store-brand giant aims to become the UK’sfirst ‘total healthcare’ provider,according to Perrigo’sUK&Ireland head Neil Lister.Matt Stewart reports.

errigo is the biggest consumer Although the prescription business had an healthcare business in the UK important role, Perrigo’sUKoperation thought by volume and is in the top of itself more as aconsumer healthcarebusi- “Pthree in terms of value,”ac- ness, Lister said. “But in line with our belief in cording to Neil Lister, head of the US firm’s offering total healthcare, we won’tbestymied UK and Ireland operation. by the molecule. We will think more about the Add the company’sprescription operation consumer condition and work back from that, to that consumer healthcare business –consist- and see if it’sanOTC solution or prescription ing of abranded consumer healthcare arm in solution that is needed.” Omega Pharma, acontract-manufacturing busi- Breaking down the business, Lister said that ness and an extensive own-label unit –and in terms of sales, the UK operation wassplit Perrigo wasunique in the UK and Ireland in roughly 50/50 between the Branded Consum- Neil Lister,Perrigo’s head of UK &Ireland, wants to being able to provide the supply chain with a er Healthcare arm –consisting of Omega Phar- make the company ahousehold name in the region “total healthcare” solution, Lister said. ma, which Perrigo acquired in April last year “Wehavefivestrategies,”heexplained. “The Previously head of Perrigo’sUKand Ireland as its European platform (OTC bulletin, 17April first one is about putting the customer first. I Branded Consumer Healthcarebusiness, Lis- 2015, page 3) –and the legacy Perrigo assets. believe the companies that try to understand ter is nowafew months into his newrole, lead- Of those legacy assets, two-thirds of the their customers and their needs are the most suc- ing asingle management team overseeing the salescame from the consumer healthcare busi- cessful. The ones that don’tcease to exist after Branded business and Perrigo’sformer Gal- ness –comprising Galpharm, own-label and afew years.” pharm and Wrafton consumer healthcare oper- contract manufacturing –and the remaining “Wewill push the bar even higher at our ations, and Rosemont generic prescription unit third came from the company’sprescription Branded Consumer Healthcarebusiness to really (OTC bulletin, 8 April 2016, page 23). arm, Rosemont. putthe customer first, and emulate the very best “The mission of Perrigo globally is to offer fast-moving consumer-goods (FMCG) com- Largest consumerhealthcarebusiness quality, affordable healthcareproducts,”Lister panies,”heclaimed. “Weshall match the cate- Combining the three business entities under said. “It is about democratising healthcareand gory insight and innovation theyoffer.” asingle leadership team had created, Lister broadening accessibility.” “The second strategic goal is about pro- claimed, the largest consumer healthcare com- “In the UK, our mission as acombined com- viding the right customer service,”Lister panyinthe UK by volume and an “OTC pow- panyisabout making adifference to health,” said. “This starts with the basics –on-time erhouse” in the market. he maintained. “Wewant to understand the deliveries and keeping the shelves full –but The combined business, however, went be- trends within healthcare and howwecan part- then it’sabout creating asupply chain for our yond afocus on just OTC, Lister insisted. ner with customers and consumers.” customers that is the best in the industry.” Speaking to OTC bulletin at Perrigo’sLon- “Companies that have been successful really “Weare unique in the product offerings we donoffice, Lister said: “Wehaveaprescription listen to their customers and their consumers,” have,” he pointed out, “and we can always division, Rosemont, which makes liquid medi- Lister insisted, “and then at alocal levelbring guarantee the highest levels of quality and ef- cines, the Galpharm business which offers products and services together that can deliver ficacy. But it’sabout howwedeliverthose to company-branded healthcare products, acon- 360-degree solutions.” customers in away that delights them.” tract-manufacturing business and an own-label “The fact we have aprescription division business, all on top of the branded OTCbusi- and aconsumer healthcare business means we Partnerships arekey ness,”heexplained. canlook at those needs and address them much Partnership wasthe third keystrategic pillar, “When we started looking at that structure,” more broadly,” he explained. “Weare combin- Lister said, with the firm planningto“amplify” he added, “we found that we are more of atotal ing the agility and entrepreneurial spirit that what Omega had done historically in supporting healthcare companythan anyone else.” the branded consumer division brings, with the pharmacists across all areas of healthcare. Having positioned itself as offering total global scale, discipline and commitment to qual- “Our prescription division already calls healthcare, the UK companyhad looked at how ity products that Perrigo has always had.” on hospitals and general practitioners,”Lis- it could leverage its assets, Lister explained. “Weare not lookingtochange healthcare,” ter pointed out, “and we have agreat under- “Westarted looking at it holistically, not as he stated, “we are looking to understand it much standing about howthose things work.” separate divisions within Perrigo, butmuch better, and to offer the products we manufac- “But by knitting all those relationships more as an integrated healthcare firm. We lis- ture in amore integrated way.” together and understandinghealthcare as a tened to our customers and consumers about What the business had started to think about whole,”Lister added, “we can offer our prod- what theyneeded, rather than deciding what in the past fewmonths wasits core mission ucts and services in amuch better waytocon- each individual division would offer.” and strategies, Lister said. sumers and to our customers.”

20 OTC bulletin 22 July 2016 OTC22-07-2016p20-23_Layout 1 19/07/2016 13:57 Page 3

BUSINESS STRATEGY OTC

“The fourth strategic arm is about innova- “I want customers and consumers to see sarily through product offerings, butwith ser- tion and growth,”Lister continued. “Wehave the Perrigo name and knowthat theyare get- vice offerings. had some amazing successes overthe past five ting aquality, affordable healthcareproduct.” “Weneed to look at weight-loss services years in the branded consumer healthcarespace Looking at the opportunities ahead, Lister and howwedeliverthem,”Lister said. “This that has seen us become the fastest-growing said that innovation would be akey growth may require partnering with communities to consumer healthcare companyinthe UK and driverfor the business. help people lose weight, initiating online activ- Ireland market.” ities, or linking with dietitians and local ser- “Toensure that continues, we need to keep Engine of innovation vices in pharmacy.” the agility, entrepreneurial spirit and quality of “Branded Consumer Healthcare has been a While switch opportunities would also be execution that the Branded Consumer Health- great engine of innovation and we need to en- looked at, Lister said Perrigo wasnot relying care business brings to the table,”Lister ex- courage this innovative spirit across the whole on moving products from prescription to plained, “while at the same time leveraging the organisation,”heinsisted. “Wemust listen to OTCstatus. It wasmore interested in looking scale we have from Perrigo.” consumers and not get ourselves pigeon-holed, at partnering with companies that had innova- The fifth and final strategic pillar wasabout while being flexible and open to embrace new tive products butperhaps not the scale to bring the people who worked for Perrigo, Lister claim- trends and categories. At the same time, we those products to newmarkets. ed. “I want our people to inspire each other,” must makethe most of the huge portfolio to “Wehaveastrong record of bringing prod- he maintained. “I want to give our people aut- which we have access through Perrigo.” ucts to market,”hepointed out, highlighting onomy, allowing them to lead and makedeci- Expanding on his strategic vision, Lister theUKoperation’swork with the herbal cough sions locally.” said the companywas “very interested in dif- medicine Bronchostop, which Perrigo had roll- “Wewant to build aspirit and culture that ferent approaches and ways of tackling big en- ed out across Europe with Quizda’shelp to attracts and retains the top talent in the in- trenched OTCcategories, whether by claims great success. dustry.With the top talent and the right cul- or by product innovation”. “Wehope other companies that want access ture, customers will be delighted to work with Societal opportunities in categories likehay- to the UK see us as agreat partner to do that us,”Lister noted. fever, weight loss or quitting smoking, for ex- type of work with,”Lister maintained. Plans were in place to expand in the UK “In the UK, we have done well and Ireland, Lister said, with the aim of turning in an environment where the big Perrigo into ahousehold name. “Creating acompany that inspires people, brands are struggling to find new “Asweexpand into newareas and seg- that promotes autonomy and drives ways to innovate,”Lister said. “I ments,”headded, “we will need to makesure believe that if we continue to be growth, will build aplatformthat enables we have the best talent in those areas too.” flexible, and continue to understand Realising these five strategic pillars over us to become ahousehold name.” trends, there is stacks of opportu- thenextfiveyears would enable Perrigo to be- nity for growth.” come ahousehold name that was“uttered in ample, were being evaluated and tackled in a “Niche operators are winning as theycan the same breath as Procter &Gamble, Uni- much more holistic way, he added. be alot more flexible,”hesaid. “Rigid com- lever, Reckitt Benckiser and GlaxoSmithKline”, “Niche categories are also being examined panies will be found wanting.” Lister claimed. to find ways the firm can really champion a Partnerships would also play akey role in “Perrigo is one of the biggest companies cause,”Lister said, adding that “a lot of success- the UK in howPerrigo approached the growing in the UK that you have neverheard of,”Lister ful innovation overthe past fewyears has been influence of digital technology in healthcare, said. “Creating acompanythat inspires people, in that area”. Lister pointed out. that promotes autonomy and drivesgrowth, “Weintend to pick the best ideas and marry will build aplatform that enables us to be- them to our customers’ needs in away which our Digital is ahuge opportunity come ahousehold name,”heinsisted. competitors will struggle to do,”Lister claimed. “Digital is ahuge opportunity, but the win- Taking weight-loss as an example, Lister ners will not go into it alone,”heinsisted. “Part- said Perrigo had had great success, not just in nerships will be important in this space.” the UK butacross Europe with XLS Medical, Perrigo would takeapioneering approach which he said wasnow “Europe’sleading when it came to utilising digital technology weight-loss brand”. to growthe UK business, Lister maintained. If Recently, the companyhad augmented XLS- theright opportunity presented itself that would Medical’soffering by acquiring the rights to give the company“meaningful scale” in the Naturwohl Pharma’sYokebe meal-replace- space, it would invest heavily. ment brand, Lister pointed out. “By partnering in this space, you may have “Wethink this is Europe’sbest meal-re- to accept having asmaller voice, butyou will placement brand, built on natural ingredients,” have apresence. By doing somethingonyour Lister said. “It is the antithesis of the high- own, you will have no scale, butitwill cost sugar meal-replacement products of the past. you alot of money.” Theynolonger understand what the modern With the combined Perrigo business all head- consumer wants from weight-loss products.” inginthe same direction in the UK, Lister said Combining XLS Medical with Yokebe had he wasconfident about what the future held. givenPerrigo astronger base in the weight- “The next five years are going to be even Neil Lister said that acquiring the Yokebe meal-replacement brand had given Perrigo a loss category,Lister maintained. This had al- more exciting than the previous five,” he insisted. stronger base in the weight-loss category lowed it to innovate even further, not neces- OTC

22 July 2016 OTC bulletin 21 GGB 2016 Full Pg 18-7-16 V3_Layout 1 18/07/2016 10:21 Page 1

Recognising the best in the global generics and biosimilars industries Presented by Generics bulletin in association with IMS Health

CocCocktktailail Reception Reception && AwAwardsards Presentation Presentation TuTuesdaesday4Oy4Octoberctober 2016 2016 Hotel PortaFira,The Gran Via complex, Barcelona, Spain

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PEOPLE OTC

Manufacturers Manufacturers HRA promotes Stada makes boardpicks Vuillet to CEO to counter activist investor rance’sHRA Pharma has promoted its chief Foperating officer François Vuillet to the tada has put forward four candidates for Rolf Hoffmann role of chief executive officer. Selection to its supervisory board as it seeks He succeeds Erin Gainer, who remains on to counter amove by an activist investor to in- the company’sboard as anon-executive direc- stall its owncandidates. tor and advisor. Frédérique Welgryn, pre- The German firm made its nominations less viously global director for Women’sHealth, than aweek after the investor –Active Owner- is nowchief operating officer. ship Capital –called on fellowshareholders Since joining in 2002 as international prod- to “propose independent candidates for election uct manager,Vuillet had held anumber of roles to the supervisory board”. within the company, HRA Pharma pointed Martin Abend, chairman of Stada’ssuper- the board with Active Ownership’scandidates. out, including head of endocrinology as well visory board, said the firm wasproposingfor However, shortly after the twofirms agreed the as international operations director, when he election to its nine-member board four “highly deal, Stada announced it would put forward “at was“instrumental in the inception of the com- suitable” and “outstanding”candidates. These least three” of its owncandidates for election pany’sEuropean footprint”.Inhis previous are: Rolf Hoffmann, senior vice-president of (OTC bulletin, 27May 2016, page 6). position, which he had held since 2011, Vuillet US commercial operations at Amgen; Dr Birgit “Stada has breached awritten agreement had overseen global corporate operationsin Kudlek, previously chief operating officer at with Active Ownership,”the activist investor over80countries worldwide, the firm noted. Aenova; Tina Müller, chief marketing officer claimed, “by not putting forward for election at Commenting on the change of leadership, at car manufacturer Opel; and Dr Gunnar the shareholder meeting on 9June the jointly- Thierry Timsit, chairman of HRA’s board of Riemann, previously head of Environmental approvedcandidates.” directors, said that Vuillet’s“provenoperation- Science at Bayer Crop Science. “Wetherefore no longer have anyfaith in al experience and great relationship-building If the candidatesare approvedatStada’s the ability of the current management to con- skills” made him a“great fittofurther dev- annual general meeting on 26 August –which duct the process to select newcandidates to elop the company’sleading position”. is the newdate for the postponed 9June meet- propose to the shareholder meeting on 26 Aug- ing –each will servefor afive-year term. The ust in atransparent, due and proper manner,” Exceptional leader 9June meeting waspostponed following Active Active Ownership stated. Gainer had been “an exceptional leader” Ownership’sproposal. “Weare therefore inviting all shareholders during her 16-year career at the firm, Timsit PriortoStada’sannouncement, Active Own- with asignificant equity holding in the com- said, and was“credited with putting patient ership said it would put to the company“on panytoensure that, by means of aprofession- needs at the centre of the company’sstrategy, or around” 11 July a“joint shareholder pro- ally conducted process, the best possible com- which has filled the company’sportfolio with posal” for newboard candidates. position of the company’ssupervisory board new, innovative products”. Active Ownership had originally come to is safeguarded going forward.” HRA Pharma was“confident” that Vuillet an agreement with Stada on 13 May to let share- Active Ownership said it had hired consult- would continue the company’s“track record of holders vote on aproposal to replace athird of ancyfirm Spencer Stuart to assist in the selection. success”, Timsit added. Meanwhile, Vuillet said OTC that he was“honoured” to “lead HRA Pharma into its next phase of growth”. Industr yAssociations Private-equity firm Astorgand its co-investor Goldman Sachs acquired the business from its founders and investment group, The France’s Afipa names Giulini as chief Riverside Company, earlier this year (OTC rench self-medication industry body Afipa “French exception”, he insisted. bulletin,4March 2016, page 7). Fhas named Dominique Giulini, head of “It is important today that politicians and The firm secured last year the centralised GlaxoSmithKline (GSK) Santé Grand Public, health authorities recognise the unprecedented switch of its EllaOne emergencycontraceptive as president of the association. He replaces situation of France in the self-medication arena,” in Europe (OTC bulletin, 16January 2015, Zambon’s Pascal Brossard in the role. Giulini stated, suggesting that forthcoming page 8) and has launched the product in a “I am committed to continuing the efforts French Presidential elections in 2017 would number of markets. made in recent years by Pascal Brossard to provide a“strong opportunity to convey our Other products in the company’swomen’s- enhance and develop responsible self-medica- message loud and clear”. health portfolio include the NorLevo emer- tion, and more widely self-care,”Giulini said. Having started his career at Unilever, Giulini, gencycontraceptive–which is available OTC “Thissector is largely underdeveloped in France 47, has also previously served in various roles in anumber of European countries –the Ci- compared to our European neighbours.”Afipa at Novartis Consumer Health, includingaspres- catridine intimate-health line and the Clar- would build on awide-ranging manifesto it ident for France, Belgium and the Netherlands. eva herpes treatment. published earlierthis year (OTC bulletin, 22 He will oversee a12-strong board at Afipa. OTC April 2016, page 11) to bring an end to this OTC

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