Perrigoinvesting Poland limits GSK to in online EllaOne lead digital presence access revolution page 8 page 15 page 20

Contents Stada shareholders 30 June 2017 Issue Number 485 reject takeover bid COMPANY NEWS ain Capital and Cinven’sproposed take- introduced last year.“This will enable us to Private-equity firm3BoverofStada Arzneimittel has failed generate sustainable growth, guarantee Stada grabs Oystershell after the private-equity firms wereunable asuccessful future, and so live up to the trust Ceutaglobalising 4 to gain enough support forthe deal from our shareholders have put in us.” ‘brand fostering’ theGerman company’sshareholders. Gen- FerdinandOetker, chairman of Stada’ssuper- 36.6 plots growth in 5 erics and OTCspecialist Stada has vowed visory board, expressed his gratitude to the com- online pharmacy to “press ahead” with its growth strategy. pany’sshareholders “for the confidence they LetterOne snaps up 6 Supported by Stada, the offer wasfirst an- have placed in Stada”. Holland &Barrett nounced in April this year (OTC bulletin,28 “I am firmly convinced that, as an independ- April 2017, page 1). ent supplier of generics and branded products Mead Johnson buy 7 NiddaHealthcare –the acquiring company of with amarket-acclaimed growth strategy,Stada boosts RB offering Bain and Cinven–secured 65.5% of Stada’s will be able to lastingly enhance its market GENERAL NEWS outstanding shares by the 22 June deadline, value,”Oetker insisted. just short of the 67.5% minimum acceptance Despite the bid’sfailure, Stada said its Canada simplifies 10 threshold. The threshold had been “narrowly growth targets for 2017 remained in place. The labelling language missed”, Nidda said, “despite ahighly attrac- firmexpects that sales will reach between C2.28 Allergies lift German market11 tive offer price of C66.00 per share, the recom- billion and C2.35 billion. EBITDAisexpected Pharmacytraining 12 mendationsbyStada’smanagementand super- to be between C430 million and C450 million. needs highlighted visory board and aconcerted shareholder out- Stada saiditwouldhit these targets –and its Herbal approvals 13 reach by Bain and Cinven”. recently-adjusted medium-term targets for2019 hold steady Nidda’soffer valued Stada at around C5.32 (OTC bulletin,24March 2017, page 1) –by billion, or 12.3-times earnings before interest, implementing “various initiatives” under the MARKETING NEWS tax, depreciationand amortisation (EBITDA). Stada Plus programme. “Theaim of these initia- Commenting on the outcome,MatthiasWie- tivesistostrengthen the segments of Generics Prestige helps US 16 denfels, chairman of Stada’sexecutive board, andBranded Products, to tackle the potential of to #KeepMoving said the firm respected the “close vote of our newand existing markets, to reduce the complex- NutraPharma eases 17 shareholdersand understanditasamandate to ity of the firm’sportfolio and its organisational pain of high heels press head with our successful growth strategy”. structure,and to improve itscostbase,” it added. TheOTCLab offers 18 “However, we also regard this decision as a The biddingwar forStada beganinFebruary IBS maintenance mark of confidence in Stada’sabilities,”hein- when the firm started “open minded talks” with sisted, “whichour employeeshaveimpressively twopotential suitors, Cinvenand Advent (OTC REGULARS demonstrated, in particular overthe past months.” bulletin,17February2017, page 1). In order to “leverage the company’sgreat After conducting a“structuredbidding pro- Events –Our regular listing 19 potential”, Stada would, Wiedenfels promised, cess” (OTC bulletin,3March 2017, page 1), People –Galenica appoints 23 work to implement the “far-reaching measures” Stada voiced itssupportinApril for Bain and newhead of Retail of its ‘Stada Plus’ improvement programme Cinven’stakeo.veroffer OTC Connect with us on: Twitter LinkedIn OTC-bulletin.com

COMPANY NEWS OTC

Business Strategy Mergers &Acquisitions BioGaia adds Private-equity firm probiotic unit weden’s BioGaia has established asub- grabs Oystershell Ssidiary company to focus on the research and development of probiotic drugs. elgium-based OTCdevelopment company The subsidiary –BioGaia Pharma –would BOystershell Laboratories has been snapped allowthe firm, BioGaiasaid, to “takeadvantage up by European private-equity firm Gilde Buy of the opportunities to develop drugs identified Out Partners for an undisclosed sum. in the research and development conducted in Describing Oystershell as a“rapidly grow- the firm’snormal operations”. ing” consumer healthcare player “with core “Sincethe foundation of BioGaia, the com- competencies in research and development and panyhas focused its development efforts on the product commercialisation”, Gilde said it in- regulatory categories dietary supplements and tended as the firm’snew owner,to“further sup- foodfor special medicalpurposes,” the firm said. port the company’sgrowth trajectory”. “For certain target segments, these categories “The acquisition of Oystershellrepresents are limiting and in some cases BioGaia alsolacks an attractive investment opportunity in aplayer thedistribution channels for pipeline products,” with leading positions in select OTCniches,” JanCassiman it noted.“Forthis reason, the boardhas decided commentedNicolas Linkens, apartner at Gilde. peutic segments of consumer healthcare.” to also develop probiotic drugs through Bio- “Weare impressed with the waymanagement Asked if the deal would result in amanage- Gaia Pharma.” has been able to build astrong platform through mentshake-up of the company,Cassimanre- Noting that drug candidates would “pri- autonomous growth and are delighted at the vealed that he would continue in his role as chief marily be developed to be licensed to appro- prospect of working withmanagement in accel- executive,with his team “staying in place”. priate partners at relatively early stages”, the eratingthe execution of the company’sstrategy.” Oystershell’smanagement were, however, firm said its capital commitment to BioGaia Speaking to OTC bulletin about the deal, “immediately intensifying” their search for “pas- Pharma would be “initially limited”. Jan Cassiman, Oystershell’schief executive of- sionate and talented people”, Cassiman noted, “to However, if the subsidiary’scapital require- ficer,saidhewas “delighted” to have teamed strengthen our organisation in all departments”. ments were to increase significantly,“external up with Gilde. The deal with Gilde comes less than six funding” would be possible, BioGaia explained. Oystershell had chosen to partner with Gilde, months after Cassimantold OTC bulletin that Taking charge of BioGaia Pharma as chief he said, due to the private-equity firm’s“strong Oystershell wasseeking to triple its annual executiveofficer will be NigelTitford, BioGaia’s track record in developingmid-market companies”. sales from “less than C25 million to approxi- head of business development. Titford holds a “This deal will enable us to strengthen sig- mately C75 million by 2021” (OTC bulletin, 4% stakeinBioGaia Pharma. nificantly our innovation, research and develop- 3February2017, page 6). In addition to supporting BioGaia Pharma, ment and business development activities,” Cassiman said at the time he wasconfident BioGaia said it would continue to work on de- Cassiman insisted, “allowing us to serveour cur- thata“focusoninnovationand building brands” velopingnew products with MetaboGen,the rent and future clients better and faster,with would enable Oystershell to substantially grow research firm in which it holds a36% stake. OTC more game-changing innovations in all thera- its sales overthe next fiveyears. OTC

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30 June 2017 OTC bulletin 3 OTC COMPANY NEWS

Business Strategy Business Strategy J&J sureon Ceutaglobalising Consumer ohnson &Johnson (J&J) is feeling “very ‘brand fostering’ Jbullish” about its Consumer unit now it has overcome the manufacturing issues that have artnering withthe CeutaInternationalAlli- troductions to brands and businesses that an al- blighted the business in recent years, according Pance now gives manufacturing companies liance partner might not have otherwise had the to groupworldwidechairman SandiPeterson. access to aholistic ‘brand fostering’ model via opportunity to work with, Garrity noted. Speaking at the Goldman Sachs 38th An- the 13 specialist companies that form the wider “Webecome acentral point of contact,” Gar- nual Healthcare Conference in California, US, Ceuta Group. This model delivers the “most rity explained, “which makes the process easier Peterson said J&J had worked hard to “fix and effective,innovative and creative brandsolu- for both distribution partners and clients as they transform” Consumer to put it back on apath tionsavailable”, according to director of inter- are dealing directly with asingle organisation to “industry-leading growth”. national businessdevelopment Keith Garrity. that understands international business.” Speaking to OTC bulletin,Garrity pointed Ceuta International had built a“robust alliance Ready to grow share out that the Ceuta Group’sexistingclients were of provendistribution partners” which gave the “Wehad alot of challengesinthe [Consumer] nowbenefiting from the accessand expertise firm access to “over440,000 pharmacies and business, butwenow are very comfortable with of the International Alliance. 120 major retail chains globally”, he stated. our abilitytotakeshareinthe marketplace and “The CeutaInternational teamaddsvalue “Combe is agreat example of amanufacturer to growat, or above,[the rate of]our peers”. to our Group clients by offering them the op- that is experiencing thebenefits of working with “Wecurrently sit right smack in the middle, portunity to expand their brandsinternation- us” Garritysaid. “It is fullyutilisingour alli- at the median levelofprofitability for the in- ally.Our alliance of trusted partners can help ance to rapidly grow its brands,Justfor Menand dustry,” Petersonnoted, “but we’renot done.You us introduce, embed and growbrands, both Vagisil, internationally as it is in theUK.” will stillsee uscontinue to improve our mar- locally and globally,” he added. “Over the past three years, we’ve assisted gins in that business going forward.” Established 12 years ago to offer the out- Combe in developing and managing its Eu- Astring of recalls forOTC productsby J&J sourcing services CeutaHealthcarehad devel- ropean business through acentral manage- during 2010 and 2011 prompted agovernment oped in theUKto aglobal audience, Ceuta ment process, re viewing andstrengtheningits investigation and the closure of the firm’sFort International nowhad “access to over100 inter- existing relationships in Europeand introducing Washington plant in Pennsylvania. The Fort national markets” through its alliance of proven it to newmarkets using our pool of European Washington facility,along with twootherUS distribution partners, Garrity said. partners,”heexplained. plants, were re-certified by the Food andDrug “Wehavepartners covering Asia, Australa- “Wethenreplicatedthis model in Asia where Administration (FDA) in 2015,but willcontinue sia, Africa, Canada, Europe, the Middle East our teaminBangkokintroduced Combetoour to operate under aconsent decree –issued in and the US,”hepointed out, “but we are always local alliance partners,”Garrity said, “providing 2011 for failing to comply with good manufactur- looking to identify potential newpartnersinun- opportunities to develop the business in new ing practice (GMP) requirements –until 2020 tapped regions, particularly South America.” markets across Asia.” (OTC bulletin,11September 2015, page 11). Garrity explained that thegoal of Ceuta In- “Using our central management model, we’ve The recalls heavily impacted J&J’sOTC ternational wasto“support newand existing introduced efficiencies for Combe whilst en- sales in the US, costing the firm market share. brands across the health and beauty,OTC and abling growth through its base business as well fast-moving consumer-goods (FMCG) industries as via innovative newproducts,”heexplained. US$33 million settlement with their international strategy”. “Our rigour, thorough processes and know- Last month, J&Jagreedtopay US$33 mil- “The team can help companies with brands ledgeable team allowustodeliverexponential lion(C30 million) to 42 US statesand the District that are already established in their owndo- results for our clients in manymarkets around of Columbia to settle acase overthe product mestic market to expand into newmarkets,” the globe,”Garrity insisted, “and we spend alot recalls (OTC bulletin,16June 2017, page 13). he continued.“It can aid private-equity firmsthat of time getting to knowour alliance partners The companyhas agreed to pay the sum need aroutetomarket, and alsowork withinno- to ensuretheir values and capabilities arealigned to resolveallegations that its McNeil-PPC sub- vative companieslooking to turnanewproduct to ours and will deliverthe results our clients sidiary engaged in “deceptive practices” by idea into asuccessful commercial launch.” and their brands deserve.” marketing products such as Tylenol and Mo- Thecompany’s“central management pro- “Every year,webring together all our alli- trin produced in plants that did not comply cess”supported itsclientsfrom“initial market ancepartners, our clients, as well as brand owners, with FDAstandards. brief through to market launch and the ongoing innovators and thoughtleaders fromacrossthe In astatement, J&J told OTC bulletin at day-to-day managementoftheir brands,” Gar- health and beauty industry to our Internation- the time that it waspleased to have finalised a rity stated, “including identifying and develop- al Conference. Thisgives themanopportunity settlement agreement. ing newbusiness and retail opportunities”. to network, hear the latest on market and in- All of the product recalls had been “pre- In addition, Ceuta International’sreporting dustry trendsand createpotential newbusiness cautionary and not undertaken on the basis of capability allowed clients to “monitor and un- opportunities,”Garrity concluded. anyhealth and safety risks to consumers”, the derstand the performance of their brands,”he l The 12th Ceuta International Conference will statementnoted, addingthat“we remain com- added, “ensuring clarity on strategy” and that takeplace in Lisbon, Portugal between 28-30 November mitted to providing our customers with safe and agreed objectiveswere achieved. 2017.For more information, please contact Lorian Pit- effective OTCmedicines”. OTC Furthermore, the companycould facilitate in- man: [email protected]. OTC

4 OTC bulletin 30 June 2017 COMPANY NEWS OTC

Business Strategy/Annual Results Business Strategy Celesio sees 36.6 plots growth in opportunity elesio is convinced that the European online pharmacy Chealthcaremarket will “continuetobean environment of opportunity” over the next 12 ussia’sPharmacy Chain 36.6 has launched months, according to the pan-European whole- Ran online pharmacy in amove the com- saler and retailer. pany claims will expand significantly its fledg- Announcing its results for the year ended ling e-commerce operation. 31 March 2017, Celesio said that despite contin- Created in collaboration with Germany- uedpressure from governments across Europeto basedmultinationalsoftware corporationSAP, “contain therising costs of healthcare”, the in- the online pharmacy–366.ru –offered Russian dustry wasexpected to “outpace grossdomestic consumers arange of 15,000 products, the product (GDP) growth in our core markets”. firm pointed out,ve co ring OTCmedicines, vitamins, minerals and supplements (VMS), PharmacyChain 36.6’sonline pharmacy Concentrateonpriorities cosmetics and infant nutrition. Orders placed Celesio would “benefit” from this market through thewebsite, thecompany said,could before interest, tax, depreciation and amorti- growth, the company said,and plannedto“dif- be collected at anyone of 36.6’s1,728 retail sation (EBITDA) of RUB519 million. ferentiate itself from the competition” by focus- pharmacies across Moscow, St Petersburgand US-based wholesaleretail giant Walgreens ingon anumber of “key priorities” for its 2018 the Leningrad Oblast. Boots Alliance (WBA) holds aminority stake financial year. Noting that e-commerce sales currently ac- in 36.6 following aswapdeal last year.WBA Driving “operational excellence” and expand- counted for around 1% of its annualturnover, transferred its Alliance Healthcare Russia whole- ingthe firm’s“value proposition” to its custom- 36.6 said it hoped the launch of 366.ru would sale businessto36.6 in exchangefor a15% stake ers, manufacturer partners and patients were boost this contribution to about 10% by mid-2018. in the pharmacychain (OTC bulletin,22April top of the agenda, the companyexplained. 36.6 took its first steps into e-commerce 2016, page 1). Furthermore, Celesio would look to “take earlier this yearthrough adealwhich made avail- As part of the deal, WBAhas taken an option advantage” of the combined economies of scale ableasmallnumberofits productson the web- –which it can exercise in around four years’ it generates with its largest shareholder,Mc- site of Russian retailer Ozon. time –toacquire the remaining 85% stakein Kesson, to “optimise purchasing power” across Ivan Saganelidze, 36.6’schairman, said he 36.6 that it does not already own(OTC bul- the globe, the firm noted. hoped the launch of 366.ru would give Russian letin,22July 2016, page 4). McKesson acquired Celesio in 2014, after consumers a“simple and convenient” option Commenting at thetimeonthe rationale for striking deals with its European counterpart’s for ordering healthcare products. the swap deal, WBA’schief executive officer twobiggest shareholders (OTC bulletin,7Feb- “Weexpect asynergistic effect from the Stefano Pessina claimed that pharmacies were ruary 2014, page 1). operationofour online pharmacyand our col- “becoming the most profitablepart of thesup- laboration with Ozon,”Saganelidze added, “which ply chain” in Russia. Capital deployment in time will enable us to become the leader in “In the past, pharmacies were not particu- Finally,itadded, Celesio would “continue Russia’sonline pharmacyretail segment.” larly profitable because the cost of [building] to look for appropriate opportunities to invest Headquartered in Moscow, 36.6claims to rent wasreally very,very high,”Pessina ex- capital…to enable the companytoachieve greater be Russia’slargest pharmacychain by number plained. “Nowthe situation hasnormalised. You efficienciesinthe European healthcare market”. of stores. The firmgeneratedsales of RUB45.9 can have long- or medium-term rent with the In 2016, Celesiocontinued to expandits oper- billion (C689 million) in 2016 and earnings option of extending [the contract].” OTC ationswiththe acquisitionofUKsupermarket chain Sainsbury’spharmacybusiness (OTC Business Strategy bulletin,12August 2016, page 13). Celesioreported turnoverdownby2.6% to Strides Shasun denies fund raising C20.6 billion for the 12 month period, due to negative currency effects and the sale of its trides Shasun has denied reports of “raising abrief notice to theIndianstock exchange.“Nor Swedishand NorwegianoperationstoMcKes- Sfunds” or entering into afinancing agree- does it have plansfor enteringinto anyfinancing sonin February 2016. ment with global private-equity fund KKR. The arrangement with KKR, in anymanner.” Earnings before interest and tax (EBIT) de- Indianfirmsought to clarify an article published Strides invested heavily to bolster its OTC clined by 29.1% to C303 million in the period. online in India’s Mint publication,which had business last year,picking up four brands through Celesioblamed thedropinEBIT on the divest- reported that Strides had raised INR5.0 billion twoseparate transactions with Sweden’sMo- ments in Norway and Sweden, combined with (C69 million) from KKR, with plans to use the bergPharma. In March, Strides snapped up state-imposed price reductions in the UK. money to “restructure existing loans as well as Fergon, JointFlexand Vanquish from Moberg Looking ahead to its 2018 financial year, expand some of the businesses”. (OTC bulletin,25March 2016, page 2), and Celesio said it expected sales and earnings to “Wewish to clarify that StridesShasun has followed this acquisition later in the year with benefit from “market growth,wb ne usiness and not raisedfunds or entered into afinancing ar- the purchase of PediaCare (OTC bulletin,9 acquisition-related growth”. OTC rangement with KKR,”the companystated in December 2016, page 3). OTC

30 June 2017 OTC bulletin 5 OTC COMPANY NEWS

Business Strategy Mergers &Acquisitions Nestlé urged LetterOne snaps up to remodel wiss food and drinks giant Nestlé should Holland &Barrett Sundertake a“comprehensive”portfolio review and offload non-core businesses to turn around uxembourg-based private-equity firm Letter- its “long-term underperformance”, according LOneispoised to acquire for £1.77billion to major shareholder Third Point. (C2.02billion)natural products retailer Holland Investment firm Third Point,which holds &Barrett from TheNature’s Bounty Co –for- a1.3%stakein Nestlé worth overUS$3.5 billion merly NBTY –and The Carlyle Group. The (C3.13 billion), insists that “re-shaping the port- transaction is expected to close by September, folio” is among the changes needed at the com- subject to regulatory approval. panytoreverse“arecent history of meaning- Generating sales“in excess” of £610 million ful underperformance versus peers”. in 2016, Holland &Barrett had “grown to be Nestlé’soperating margin currently stands Europe’slargest health and wellness retail chain”, Holland &Barrett operates in 16 countries at around 15%, Third Point notes, which falls LetterOne claimed, with stores in more than short of peers such as Unilever and Kraft Heinz. 1,150 locations worldwide and a“significant, Commenting on the agreement, Aldis said “Itispasttimefor Nestléto undergo acom- rapidly growing online e-commerce capability”. Holland &Barrett was“delighted to be in part- prehensive portfolio review,”maintains Third Offering arange of vitamins, minerals and nership with L1 Retail”. Point in aletter to investors. “Nestléoperates to- supplements (VMS), specialist foods and natu- “Carlyle has been agreat partner for Holland day with over2,000 brands in Food &Beverage ral beauty products, the retailer is present in 10 &Barrett overthe past fewyears, investing and Health Science operations. Management European countries –including Belgium, the in the brand, our people, and next generation must determine which of these businesses are Netherlands and the UK –and sixAsian markets, technology,which has drivenour growth,”Aldis keypillars of growth for the future and then strate- such as China and India. insisted. “Welook forward to building on this gically reduce exposure to those that are not.” “Holland &Barrett is aclear leader in the track record as we enter the next chapter with Offloading non-core assets could “help ac- UK health and wellness retail market, with attrac- L1 Retail.” celerateorganic growth”, ThirdPoint says,and tive growth positions in other European and Marco De Benedetti, managing directorof “free up internal resources –both time and international markets, and an increasingonline Carlyle’sEuropean operation, noted the com- money–to increase focus on priority areas”. presence, with aleading customer loyalty pro- panyhad “invested heavily” in Holland & On this front, the time is right, the New gramme and 10 million active cardholders,” Barrett. “Wehavebuilt an innovation pipeline, York-based firm insists, for Nestléve todi st its commentedStephan DuCharme, managingpart- opened over300 newstores, built an industry 23% stakeinFrench cosmetics giant L’Oréal, ner at LetterOne’sL1Retaildivision. leading omnichannel platform, and expanded which is worth around US$25 billion. “Webelievethat the company is well posi- the business internationally,” Benedetti point- While L’Oréal has been a“superb invest- tioned to benefit from structural growth in the ed out. “This has delivered 32quarters of con- ment” for Nestlé, the business is “non strategic”, growing £10 billion health and wellness mar- secutive like-for-likegrowth and sustainable Third Point claims. “Shareholders should be ketand has multiple levers for long-term growth financial performance.” freetochoose whether theywant to invest in and value creation,”DuCharme insisted. “We Carlyle gained Holland &Barrett in 2010 Nestlé or some combination of Nestlé or L’Oréal.” look forward to working with Holland &Bar- as part of its US$3.80billion (C3.39 billion)ac- In addition to divestments, ThirdPoint calls rett’s chief executive officer,Peter Aldis, and quisition of the firm’sparent companyNBTY on Nestlé to improve productivity and return his strong management team.” (OTC bulletin,30July 2010, page 1). OTC capital to shareholders. While Nestlé has not responded directly to Mergers &Acquisitions Third Point’sletter,the investor notes that it has held “productive conversations” with the RoundTable takesDeerland stake Swiss firm’smanagement, “which we expect will continue”. rivate-equity company RoundTable Health- “The team hasbuiltamarket-leading, high- Third Point says it will continue to encour- Pcare Partners has acquired an undisclosed quality operation with significant capacity for age Nestlé’smanagement to “pursue change stake in US-based dietary supplement devel- future growth,”the private-equity firm com- with agreater sense of urgency”. OTC oper and contract manufacturer Deerland En- mented. “Welook forward to partnering with, zymes &Probiotics. and investing in, Deerland to expand its product Established in 1990 and headquartered in and manufacturing capabilities to better serve IN BRIEF Kennesaw, Georgia, Deerland specialises in cus- its customers.” HI-TECH PHARMACEUTICALS tomised enzyme and probiotic-based formu- “Our familiarity with the nutritional supple- has expanded its portfolio by acquiring Top lations for dietary supplements. ments industry,and experience with contract Secret Nutrition and its line of sports-nutri- Commenting on its investment –the terms development andmanufacturingorganisations,” tionproductsfor an undisclosed sum.“Thetrans- of which were not disclosed –RoundTable continued RoundTable, “will help us play avalue- action will bolster Hi-Tech’sleading sports-nu- said Deerland held a“unique position in the added role in supporting the growth of Deer- trition and weight-loss arsenal,”the firm said.OTC rapidly-growing probiotic and enzyme markets”. land going forward.” OTC

6 OTC bulletin 30 June 2017 COMPANY NEWS OTC

Annual Results Mergers &Acquisitions Turnoverat Mead Johnson buy Weleda falls erman natural cosmetics and anthropo- boosts RB offering Gsophic medicines manufacturer and retailer, Weleda, saw worldwide sales at its Pharma- eckitt Benckiser (RB) said it had secured ceuticals division –which includes its OTC oper- Ra“globalmarket leadership positionin ation –fall by 4.8% to C190 million in 2016. consumer health” after completing its US$17.9 Thecompanyblamedthe drop in Pharma- billion (C16.9 billion) acquisition of US infant- ceuticals’turnoveronan11.5% decline in sales nutrition specialist Mead Johnson. in Germany, Austria and Switzerland. The main Thedealfor Mead Johnson –first announced reasonfor this declinewas the withdrawalof earlier this year (OTC bulletin,17February

Iscador from the German market, the firm added. 2017, page1)–had added to RB’s portfolio “two TheEnfaand Nutramigen infant nutrition range On amore positivenote, Weleda saidithad infant and child nutrition powerbrands” in Enfa enjoyed a2.6%rise in Pharmaceuticals’ sales in and Nutramigen, the UK-based fast-moving explained,under the leadershipofAditya Sehgal. France. As aresult of this growth, Weleda noted consumer-goods (FMCG) giant pointed out. Sehgal –who takes up therole ofexecutive that France had for the first time overtaken Ger- Mead Johnson’s infant andnutritionbusiness vice-president of Infant and Child Nutrition –was manyasits largest Pharmaceuticals market. would increaseRB’sconsumerhealthcare rev- previously RB’spresident of North America. Total group sales –includingturnoverfrom enues by around90%,the company noted. RB Commenting on the closing, James Cornelius, its Cosmetics business –advanced slightly by posted sales of £3.33 billion (C3.77 billion) at Mead Johnson’schairman, said the deal had 0.1%to C390 million. Earnings before interest its Health unit in 2016. returned to the firm’sshareholders “significant and tax (EBIT), however, weredownby27% Rakesh Kapoor,RB’schief executive of- and immediate value”. to C23.9 million. This wasdue to rising prices ficer,insisted that closing the deal marked an “The merger with RB is arecognition of the of rawmaterials and investments in interna- “inflection point in seRB’ volution to become strong growth and geographic expansion the tional markets, the companysaid. aleader in consumer health and hygiene”. MeadJohnsonbusiness achievedsincethe com- With plans to expand outside Europe “in order “Bycombining the best of RB’sglobal scale pany’ssplit-offfromBristol-Meyers Squibb to makebetter use of its potential in lesssaturated with Mead Johnson’sscience-based innovation, in 2009,”Cornelius insisted. markets,”Weleda predicted aslight increase RB is well positioned to deliverfurther value “Wewish our thousands of employees, in Pharmaceuticals’ sales for 2017. OTC for all stakeholders,”Kapoor noted. “Wecon- whose work and dedication enabled this suc- tinue to executeonour strategyofproviding in- cess, all the best in the next chapter of the Mead novative health solutions for healthier livesand Johnson story.Weexpect the business and Business Strategy happier homestomillions of people worldwide.” brands to continue to flourish as part of RB, Mead Johnson would initially operate as a with its larger scale and provenmarketing and Sanofi plots “separate division within RB”, the company innovation prowess.” OTC China growth Mergers &Acquisitions anofi Consumer Healthcare Australia is Slooking to take alarger share of China’s Xantis acquires Russia’sAlsi dietary supplementsmarket by expandingthe range of brands it offers on the local NetEase wiss-based pharma companyXantis Pharma neighbouring countries,” continued Ramneborn, Kaola e-commerce website. Shas snapped up Russian OTC and pre- “andlay astronger foundationfor future growth With its Nature’sOwn vitamins, minerals scription medicines manufacturer Alsi Pharma in the region.” and supplements (VMS) brand already avail- for an undisclosed fee. Xantis intended to distribute Alsi’sportfolio able through NetEase Kaola, the companywill Established in 2000, Russia’sAlsi operates “in selected Commonwealth of Independent nowalsomarkettoChineseconsumersits Cen- asales andadministration office in Moscow, as States (CIS) markets”, Ramneborn noted. ovis and Ostelin lines. well as amanufacturing facility in Kirovthat Foundedin2015 by Icelandic entrepreneur Sanofi explained the firm wasexpanding the Xantis intends to bring immediately to “full Thor Björgólfsson’sinvestment firm vaNo - line of brands offered through NetEase Kaola in capacity utilisation” and will consider expand- tor –which remains the primary owner –and response to growing consumer demand. ing in the future. former senior exectutivesfromgenerics special- Through NetEase Kaola, Chineseconsumers ist Actavis, Xantis has a“vision of building a can buyarange of imported products. The firm Solid trackrecord fully integrated pharmaceutical companyinthe claims to be China’s“leading cross-border e- “Our team has an impressive track record markets whereitoperates”,which are currently commerce platform” carrying “over5,000 brands in building profitable marketshare in the region Russia,Ukraine, the CIS andCentral and East- from 50 countries”. where we operate and we have strong aspirations ern Europe (CEE). Separately,Sanofi has penned adeal with the for this combination,”commented Xantis’ chief Thefirm has headquarters in Zug,Switzer- PharmacyGuild of Australia to offer a‘click-and- executive officer Lars Ramneborn. land, and operates aregional hub in Moscow, collect’ service for its Bio-Organics Glycemix “Byjoining forceswithAlsi,wesee an op- as wellasrepresentative offices across the CIS supplements brand. OTC portunitytoenhanceour positioninRussia and and CEE regions. OTC

30 June 2017 OTC bulletin 7 OTC COMPANY NEWS

Business Strategy Business Strategy GSK seeking Perrigo investing in genius ideas its online presence laxoSmithKline (GSK) Consumer Health- Gcare is looking to work more closely with errigo is targeting a“leadership position” US-based entrepreneurs who have “innovative Pin e-commerce as it works to “capitalise ideas that address some of the world’s most on this growing consumer channel”, according critical issues”. to Jeff Needham, head of the firm’s Consumer Launching its ‘Chasing Genius Challenge’ Healthcare Americas business. –inpartnership withthe National Geographic Speaking at the 17th Annual Oppenheimer Society –GSK saiditwanted to receive video Consumer Conference in Massachusetts, US, submissions describing “genius ideas” to address NeedhamsaidPerrigohad recognised the im- anyofthe company’sthree target areas: “mak- portance of masteringe-commercetohelp grow ing our planet more sustainable”; “addressing itsAmericas division, which comprises its OTC, Perrigo’sonline offering on Amazon growing needs for improving global health”; infant formulaand animal health operationsin retailers, Needham noted, including traditional and “ensuringwewill be able to feed nine bil- the US, Canada and Mexico. bricks-and-mortar firmsand online-only players, lionpeople by 2050”. Noting that the firm had spent the “past such as Amazon. On the environmental sustainability cate- couple of years” developing its online offering, “Aswelook at the increased importance of gory,GSK said humans needed to takere- Needhamsaidtheseinvestments hadbegun to e-commerce, we want to be the bricks-and-mortar sponsibility the damage theyhad done to the bearfruit,withe-commerce salesatConsumer retailers’ thought-leader and partner in helping planet. “Nowisthe time for everyone to be Healthcare Americas up by 50% to US$60 mil- them to drive their online sales,”heexplained. thinking about howwecan balance our own lion (C54 million) in 2016. “If you look at the major bricks-and-mortar human aspirations with the planet’sability to More than 81% of Perrigo’sproducts were retailers,”saidNeedham, “increasingly theyare sustain them,”the firm noted. nowavailable online, he noted, amounting to factoring e-commerce into howtheygotomar- more than 1,000 stock-keeping units (SKUs). ketwith newproducts, and we are working very Access to medicines E-commerce was, Needham admitted, still hard with them to help them accomplish this.” Turning to the healthcare category,the com- arelatively small part of the business –account- Perrigo had also partnered with Amazon, panysaidthat despite life expectancyincreas- ing for around 2% of Consumer Healthcare he revealed, to bolster the onlinepresence of ingacross the world, there were still manychal- America’sannual sales of US$2.51 billion. How- itsGood Sense brand, which covers OTCmedi- lenges to be addressed “from basic access to ever,thanks to the firm’sinvestments in the chan- cines, as well as infant nutrition and animal clean water,sanitation, medicines and vaccines, nel, Perrigo’se-commerceoperation was“poised health products. to newapproaches to fighting both infectious to growalot more going forward”, he claimed. “Wewanttodrive our Good Sensebrand as and non-communicable diseases”. To achieve “critical mass” for its online op- themostprominent consumer healthcare value Commenting on thefoodcategory,the firm eration, Perrigohad been working closely with brand at Amazon,”heexplained. said the time was“ripe for newsolutions that Perrigo’spartnership with Amazon waspoised strengthenour ecosystem”, andideasthat“en- to further expand, he revealed, withthe twofirms courage nutrition and prevent waste”. currently working to “establish and build an Noting that submissions would be judged own-brand OTCprogramme”. for their “creativity,viability,innovation and While he did notgiveany furtherdetails on inspiration”, GSK said four winners would the Amazon partnership, Needham said that receive US$25,000(C22,400) each“to expand Perrigo’se-commerce goal wasto“maximise upon their ideas, helping to further creative thesalesand market shareopportunity of all of solutions towards positive change”. our products acrossall digital sales channels”. Theresa Agnew,GSK ConsumerHealth- “Ultimately,” stated Needham, “we want to care’schief marketing officer for the US, said ensure that similar to our bricks-and-mortar strat- the firm wasexcited to work withthe National egy, Perrigo is the e-commerce leader in our Geographic Society to “providebudding ge- industry,and we will continue to work strate- niuses withaplatform to explore their curi- Jeff Needham gically with retailers to help drive that.” OTC osities, share their ideas, and turn those ideas into catalysts for global change”. “Problems aroundthe world,big and small, IN BRIEF global and local, can be solved by asingle idea from scientists and researchers as well as every- JACOBSON PHARMA reported turn- over of the HongKongcompany’sProprietary day geniuses,”Agnewinsisted. overupby15.9% to HK$1.26 billion (C144 Medicines –including the firm’sOTC brands Entries to the challenge can be submitted million) in its financial year ended 31 March –had advanced by 13.9%toHK$158 million, online –at natgeochasinggenius.com –until the 2017, thanks to higher sales at its Proprietary Jacobsonnoted,due to acquisitions and better closing date of 31 July 2017. OTC Medicines and Generic Drugs divisions. Turn- sales of its leading Po Chai Pills brand. OTC

8 OTC bulletin 30 June 2017

OTC GENERAL NEWS

RegulatoryAffairs RegulatoryAffairs UK’sMHRA Canada simplifies backs PSE labelling language estrictions designed to curb the misuse Rof pseudoephedrine (PSE) and ephedrine ew regulations to ensure all non-prescrip- similar fashion to their prescription counterparts, (EPH) in theUKare continuing to workeffi- Ntion medicines carry clear, understandable with high levels of evidence needed to prove ciently, accordingtothe Medicines and Health- labels have come into force in Canada. safety,efficacyand quality. care products Regulatory Agency (MHRA). Commenting on the Plain Language Label- Meanwhile, natural healthproductsare regu- Introduced in 2007, the restrictions limited ling Regulations, the country’sregulator Health lated in asimilar fashion to OTCmedicines, but pack sizesofmedicines containingPSE or EPH Canada saidthat the newcode wouldhelpcon- the levelofevidence required can vary and non- to amaximum of 720mg of the active ingredi- sumers makeinformed decisions anduse non- scientific data is accepted tove pro efficacy. ent, which is equivalent to 12 tablets or capsules prescription medicines appropriately and avoid By contrast, cosmetics are managed through of 60mg-strength products and 24 tablets or cap- potentially dangerous errors. apost-marketing system, with manufacturers sulesof30mg-strength products (OTC bulletin, Under the newregulations, manufacturers simply having to notify Health Canada within 14 September 2007, page 1). must ensure that labels and packaging feature 10 days of the first sale and provide information Furthermore, productsales can only be car- “clear,understandable and plain language”, on the nature and quantity of the ingredients. riedout by apharmacist, and customers are Health Canada said, along with a“standardised If the proposedchanges come intoforce, all only able to purchase one pack. table format” for outer labels and mandatory self-care products of asimilar profile will be Noting that arecent rise in sales of PSE and contact information. treated in the same way. This will ensure that EPH products wasdue to the high levelofcoughs Manufacturers must alsoprovide mock-ups the rules for bringing products to market will and colds at the end of 2016, the MHRA said of labels for Health Canada to review. be consistent and easier to understand, Health that the measures continued to be effective. The regulations had come into force on 13 Canada claims. However, thesuccess of thesemeasures con- June, Health Canada said, and by June 2021 Furthermore, anynew health claim will be tinued to depend on the “vigilance of the phar- labels and packaging of all non-prescription drugs reviewed by the government no matter what type macyprofession in notingand reportingrelevant on the market must reflectthe newrequirements. of product it is, and the manufacturer will have incidents”, the agencyadded. Health Canada is currently consulting on to provide scientific evidence to support the claim. Prior to themeasures being introduced, the proposedchanges to simplify itssystem for clas- Labelling changes have also been outlined, MHRA hadthreatened to reverse-switchPSE sifying non-prescription products (OTC bul- with an authorisation number giventoproducts and EPH products to prescription-only status letin,28April 2017, page 12). which have beenreviewed and approvedand (OTC bulletin,16March 2007, page 1). Fol- Theconsultationdocument – whichisopen forwhich the claim is based on scientific evidence. lowing theintroductionofthe restrictions,the until 24 October – proposes bringing all self- Forthose products not approved, an on-pack MHRA warned that if the measure did not curb careproductsunder asingleset of rulesand regu- disclaimer must be displayed. themisuse of the medicines, the products could latingthembasedontheirrisk to the consumer. These changes will provide “more clarity still be reverse-switched. OTC Currently,all three types of self-care prod- and transparencytothe rules for bringing prod- uct –OTC medicines, natural health products ucts to market”, HealthCanada says, “and allow and cosmetics – are regulated differently. the reviewofhealth claims that are supported IN BRIEF OTCmedicinesare currently regulatedina only by scientific proof”. OTC

EFSA – the EuropeanFood Safety Authority – RegulatoryAffairs has rejected ahealth claimapplication by UK retailer Marks &Spencer that consump- Glucose health claims barred tion of afixedcarbohydrate-to-protein ratio of less than 1.8 could help reduce body weight. ermany’s DextroEnergy has beenbarred link” couldbeestablishedbetweenthe consump- Publishingits opinion on theapplication, EFSA’s Gby the European Court of Justice, the tion of glucose andnormal energy-yielding met- Panel on Dietetic Products, Nutrition and Al- CJEU, from making health claims about the abolism, the European Commission (EC) re- lergies statedthatacause-and-effect relationship benefits of glucose contained in its tablets. fused to authorise the health claims. had not been established. In 2011, the companyrequested authorisa- “Theuse of suchahealth claimwould con- tion for fivehealth claims relating to glucose, veyaconflicting and confusing message to PAGB – the Proprietary Association of Great including that it “is metabolised within the consumers, because it would encourage con- Britain – willexplore whethersafetywarnings body’s normalenergymetabolism”, “supports sumption of sugars for which, on the basis of should be applied to paraffin-basedemollients. normal physical activity”, “contributes to nor- generally accepted scientific advice, national The move comesafter BBC Radio 5Live linked mal energy-yielding metabolism”, to “normal andinternational authorities inform theconsum- anumber of fire-related deaths to paraffin-based energy-yielding metabolism during exercise” er thattheir intakeshould be reduced”,the Com- skin creams. Noting that some products already and to “normal muscle function”. mission concluded. carried fire safety warnings, the PAGB said that Despite the positive outcome of an assess- Dextro Energy appealed to the CJEUafter the incidents reported by the BBC involved ment by theEuropean Food Safety Authority theEuropean UnionGeneral Courtbackedthe use of asignificant amount of product. OTC (EFSA), which foundthat a“cause-and-effect EC’sdecision in 2015. OTC

10 OTC bulletin 30 June 2017 GENERAL NEWS OTC

Market Research Allergies lift German market

ild temperatures and early sunshine Category First-quarter sales Mail-order Total sales Mhelped hayfever and allergy remedies (€ millions) proportion (%) change (%) boost sales of respiratory medicines and ex- Respiratory668.3 9.4 +9.5 tend the strong growth of the German OTC market through pharmaciesintothe firstquar- Analgesics 339.4 15.8 +3.0 terof2017, according to data from market re- Digestive305.3 14.8 +5.1 search company QuintilesIMS. Vitamins,minerals and supplements 243.2 18.3 +7.4 Compared to the same periodlast year,the Skin care193.2 13.3 +7.2 value of the OTCmarket throughpharmacies – licensed medicines and selected unlicensed Heart/circulatory126.0 22.2 +0.4 healthcare products – movedforward by 6% Eyecare94.6 16.2 +4.3 to C2.4 billion (see Figure 1) in the first quar- Blisters 85.1 19.2 +6.8 ter of 2017, while volumesales rose by 3% to around 255 million packs. Sleeping/calming aids 68.6 18.2 +0.8 Sales through community pharmacies in- Tonics and geriatrics 56.2 23.3 +5.8 creased in value by 5% to C2.0 billion, while Mouth/dental care25.5 9.0 +4.7 mail-order sales continued last year’strend, Anti-nausea 18.1 9.1 ±0.0 advancing by 13% to C349 million. Three major health “themes” of the first Cessation aids 16.7 24.6 +5.9 quarter were colds, hayfeverand weight loss, Weight-loss aids 16.4 40.9 +42.6 QuintilesIMS reported. Non classified 11.4 7.9 +5.9 Respiratory medicines – which include cough, cold, hayfeverand other allergy remedies – Ear care7.8 6.7 -3.1 accounted for the largest part of the German Other 76.2 20.6 +3.7 OTCmarket, with first-quarter sales of C668 Germany’sOTC market2,351.9 14.8 +6.1 million, accounting for 28% of the total market. Figure1:Pharmacysales in Germany’sOTC market–licensed medicines and selected unlicensed Wavesofcolds and flu in Germany, begin- healthcareproducts –inthe first quarterof2017 broken down by category(Source –QuintilesIMS) ning in thelastquarter of 2016 (OTC bulletin, 24 March 2017, page10), continued to influence “In cases of acute need and in connection this year,GlaxoSmithKline (GSK) launched the sales growth of respiratory medicines. with adoctor’svisit, thecommunity pharmacy its Otri-Allergie Nasenspray Fluticason prod- In January, sales of coldremedieswere 33% is still apopular place to go”, QuintilesIMS uct, joining the Otrivenrange of nasal sprays above those of theprevious year.Theygrewby argued. “Mail order,however,iscatching up, anddrops in Germany (OTC bulletin,3March 35%incommunitypharmaciesand 27% through due to ever shorter delivery times,”itadded. 2017, page 14). themail-order channel. “Deliveries within aday or,inmetropolitan areas, Turning to other categories, weight-loss Total cold sales were 10% higher in Febru- on the same day,will accelerate this trend.” products showed by farthe strongest growth ary,although there wasan extra working day As the contribution of cold remedies to in sales in the first quarter at 42.6%, yet ac- in 2016, QuintilesIMS said. Both pharmacy respiratory sales fell, the demand for hayfever counted foronly 0.7% of the total OTCmarket channels shared the same increase. products grew, according to QuintilesIMS. at C16 million. Sales of weight-loss products Mail-order sales of cold remedies were static Weather conditions led to increases in pollen dropped back by 6.6% in 2016 (OTC bulletin, in March, butsales through community phar- counts, such that in the first quarter of 2017, 24 March 2017, page 10). macies were reduced by 14%, the market re- sales within the hayfeversegment increased Sales of vitamins, minerals and supplements searcher reported. by 14% to C36 million. (VMS) and skin-care products also slightly First-quarter salesofcold remedies roseby The market researcher said that the pre- outpaced the overall pharmacyOTC market, almost10% overall, representing avolume increase scription-to-OTC switches of mometasone and showinggrowth of 7.4%and 7.2% respective- of 6%, compared with the same period in 2016. fluticasone drove higher hayfeversales. Earlier ly.Only ear care failed to increase sales, reporting adrop of 3.1% compared to the same period last year,finishing at C7.8 million. IN BRIEF Last year,Germany’spharmacymarket for non-prescriptionmedicinesfinallyrecovered AUSTRALIA’s government is set to provide to patients in instalments medicines paid for by more than 10 y earsafter most of these medi- A$600 million (C406 million) in funding to the state if requested;DoseAdministration Aids, cines were taken out of the statutory health- continue and expand arange of pharmacypro- which package all apatient’smedications in sealed carereimbursement systemin2004 (OTC grammes. Programmes that will benefit from blister packs; and Home Medicines Reviews, bulletin,26May 2017, page 24). Pharmacy the funding include:the MedsChecks andDia- where apharmacists reviews all themedications sales of all non-prescription medicines finish- betesMedsChecksservices; the Staged Supply inapatient’shome.Funding for these programmes ed 2016 at C6.58 billion, a2.6%increase from offering, which enables pharmacists to provide is expected to increase in future years. OTC the previous year. OTC

30 June 2017 OTC bulletin 11 OTC GENERAL NEWS

RegulatoryAffairs Market Research EU outlines Pharmacytraining EMA criteria he new host city of the European Medi- needs highlighted Tcines Agency (EMA) will be announced in November2017 now the heads of 27 Euro- ecent prescription-to-OTC switches of mo- stitute for drugs and medical devices, BfArM. peanUnion (EU)stateshave agreedthe criteria Rmetasone and fluticasone in Germany – both As allergic rhinitis could coincide with other to choose the agency’s next home. active ingredients for the treatment of seasonal serious long-term illnesses such as asthma Currentlybased in London, the EMAisseek- allergic rhinitis – have created aknowledge- andsleep apnoea, the authors argued,pharma- inganew home following the UK’sdecision deficit forpharmacists, arecent study has claimed. cists would benefit fromanadditionalpharmacy to leave the EU. Both substances were switched in 2016, protocoltodetermine acustomer’ssuitability. Member states interested in accommodating allowing them to be sold without aprescription At this time, the Federal Association of Ger- the agency–which has nearly 900 staffand for treating the symptoms of seasonal allergic manPharmacists,ABDA, only supplies apro- welcomes around 36,000 visitors annually – have rhinitis in adults, provided the condition has tocol for colds, which does not deal explicitly until 31 July to submit their offer,which must been diagnosedbeforehandbyadoctor (OTC with allergies. meetaseriesofcriteriadrawn up by theEuro- bulletin,21October 2016, page 11). Pharmacists were also asked if theyknew peanCouncil and the European Commission. Newproducts with these active ingredients about allergic rhinitisand itsimpactonasthma These criteria include: have since been launched. First, Hexal’sMo- (ARIA) guidelines, published in conjunction l Assurances that the EMAcouldbeset up metaHexalmometasone-based nasalspray at with the World Health Organization (WHO). andoperate on asite with adequate office space the end of last year (OTC bulletin,25 Novem- Atotalof72% of respondents said “no”, yet andITinfrastructure at th edateofthe UK’s ber 2016, page 19) and most recently GlaxoSmith- overthree-quarters claimed that existingsources withdrawalfrom the EU. Kline’s(GSK’s) Otri-AllergieNasenspray Fluti- of information were adequate. l Transport links that allowthe volume and casone(OTC bulletin,3March 2017, page 14). intensityto continueofcurrentmeeting activi- Accordingtothe results of asurvey of just Knowledge ofbioavailability ties of the EMA, along with enough hotel ca- over100 German pharmacies published in “Themostimportant outcome of this sur- pacity to hostexperts and visitorsfromthe EU Pharmazeutische Zeitung,most pharmacists are vey wasthatthe majority of pharmacistsdo and elsewhere. not sure about the safetyofthese newproducts, notknowthe bioavailability of thethree treat- l Adequate education facilities for the child- anddonot use all the sources of information avail- ments for allergic rhinitis: beclometasone, flutica- ren of agencystaff. abletothem when giving advicetocustomers. sone and mometasone,”the article concluded. l Appropriate access to the labour market, The majority of pharmacists rated the drug When asked if theyknewthe definition of social security and medical care forboth child- safety ofmometasone andfluticasoneas“med- seasonal allergic rhinitis, only 56% of pharma- ren and spouses of agencystaff. ium”, with 80% saying that long-term use was cists said yes. l The ability to meet the above criteria with- of particular concern. The lowbioavailability “Considering that beclometasone has been in the timeframe of the UK leaving the EU, of bothmedicines,however,meantthatlong- available as non-prescription since 1997, and along with the capacity to ensure asmooth term usewas not aproblem, unlike with gluco- fluticasoneand mometasone arenow alsonon- transition and the ability to retain and attract corticoid-based drugs thateventually destroyed prescription,arange of training should be con- talent to the agency. the nasalmucous membrane,the article said. sidered,”the authors added. l Fulfil the desire veto ha EU agencies When asked whatsources of information they When asked,pharmacistssaidthattraining fairly spread across the 27 member states. relied on when giving advice, close to three- should last 10-30 minutes and be offered in-house. Furthermore, memberstates biddingfor the quarters of pharmacists said theyused the “expert This training should include information on indi- EMA must also supply aplan for when and information”–summaryofproduct characteris- cation, dosage and side effects, as well as the dif- howthe relocation willtakeplace and give de- tics (SmPc) supplied by Germany’s federal in- ferences between the twoactive ingredients. OTC tails of the premises where the EMA will be based, along with the financial terms for the Market Research agency’suse of the premises. The competition to host the EMA is taking Germans trust homoeopathy place at the same time as the race to host the European Banking Authority (EBA), which is lmost three quarters of German people “very important” that homoeopathic medicines also based in London. Aare“satisfied” or “very satisfied” with their were supported by government alongside con- Votesto confirmthe location of bothagencies experienceofhomoeopathic medicines, asur- ventional remedies, while over80% said that will takeplace in November,with the first voting vey by the Federal Pharmaceutical Industry As- theywould be in favour of such medicines be- session deciding where the EMA will move to. sociation, the BPI, has found. ing reimbursed. While memberstates canapply to hostboth “Homoeopathicremedies are highly valued People integrated homoeopathyalongside agencies, the member state selected as the EMA’s by German patients”,Norbert Gerbsch, deputy other treatments withinaholisticapproach to newhome following the first voting session cannot chair of the BPI said. “If therapists and patients wellness, Gerbsch added. “Those who wish be consideredacandidate to host the EBA. If the use them correctly and responsibly,theycan to curtail therapeutic freedom and diversity, member state has also applied for the EBA, its support therapeutic success.” patronise numerous patients in Germanywho offer will be withdrawn. OTC Two-thirds thought it was“important” or can benefit from it.” OTC

12 OTC bulletin 30 June 2017 GENERAL NEWS OTC

RegulatoryAffairs Herbal approvals hold steady

he number of traditional-use registrations Monocomponent products Combination products T(TURs) and well-established use (WEU) 400 374 marketing authorisations remained steady in 2016,according to figuresfromthe European 296 Medicines Agency (EMA). 300 128 270

The EMA compiled the figures using data 223 collectedfromnational competentauthorities 154 200 104 on the number of TURs for traditional herbal 61 140 141 medicinal products granted in 2016, along with 125 95 246 46 36 thenumberofmarketauthorisations grantedto 100 53 29 162 166 142 products that met the well-established use criteria. 33 105 15 94 Across the European Union (EU), 141 TURs 0 2 5 66 72 0 for traditional herbal medicinal products had 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 been granted overthe 12 months, the EMA Number of traditional-use registrations Figure1:Numberoftraditional use registrations broken down by year (Source –EMA) pointed out, just one more than in 2015 (see Figure 1). Of these approvals, 105 had been Monocomponent products Combination products formonocomponent products, the agencysaid, 100 andthe remaining 36 for combinations. 94 100 85 88 71 73 27 75 11 7 67 57 21 Slight decline 52 11 14 17 5 44 46 17 7 Marketing authorisations for WEU products 8 9 73 83 81 64 58 slipped back slightly from 94 in 2015 to 88 in 52 60 59 50 7 36 45 37 2016, with approvals for both monocomponent 0 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 and combinationproductsfalling back slightly Number of well-established use marketing authorisations (see Figure 2). Figure2:Numberofwell-established use marketing authorisations by year (Source –EMA) Although the number of approvals through both registrationschemes has beenrelatively This wasfollowed by Germanywith 285 and Breaking down the TURs andmarketingau- stable for the past three years, go-aheads for Poland with 215. thorisations for WEU products, cough and cold TURs remain well belowthe numbers seen in However, whenitcametogranting market- wasbyfar themost common in both cases 2011, 2012 and 2013. ing authorisations for WEU products, Germany (see Figures 4and 5). In the 2004-2016 period, 1,719 TURs for wasthe clear leader,havingapproved286 be- Mental stress and mood disorders wasthe sec- traditionalherbal medicinalproductshad been tween 2004 and 2016. ond most common indication grantedinTURs granted, the EMA noted, and 803 marketing Looking at approvalscompared to totalap- fortraditional herbal medicinal products, the authorisations for WEU products. plications in the 2004-2016 period, the EMA EMA said, while for WEU products ‘other’ indi- TheUKhad grantedthe greatest numberof pointed out that of the 2,730 TURapplications cations – including cardiovascular,improved TURs for traditional herbal medicinal products received,574 remainedunder assessment, 240 liverfunction and mildcerebral insufficiencies – 348 – overthe 13-yearperiod, theEMA said. had beenrefusedand 197 had beenwithdrawn. – were the second most common. OTC

Monocomponent products Combination products Monocomponent products Combination products

Cough and cold 392 Cough and cold 246 Mental stress and mood disorders 282 Other 216 Gastrointestinal disorders 270 Mental stress and mood disorders 110 Urinary-tract disorders 267 Urinary-tract disorders 93 Sleep disorders/temporary insomnia 209 Constipation 74 Pain and inflammation 161 Sleep disorders/temporary insomnia 68 Other 152 Circulatory disorders 58 Mouth and throat disorders 94 Pain and inflammation 47 Skin disorders 92 Gastrointestinal disorders 40 Circulatory disorders 84 Loss of appetite 7 Fatugue and weakness 78 Skin disorders 6 Loss of appetite 27 Mouth and throat disorders 4 Constipation 14 Fatugue and weakness 2 Eye discomfort 3 Eye discomfort 1

Figure3:Number of traditional-use registrations broken down by indication Figure4:Number of well-established use marketing authorisations broken in the period 2004-2016 (Source –EMA) down by indication in the period 2004-2016 (Source –EMA)

30 June 2017 OTC bulletin 13 DEVELOP WINNING DISTRIBUTIONSTRATEGIES MARKET REPORTS FROM JAMESDUDLEYMANAGEMENT

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

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

Advertising Complaints RegulatoryAffairs ASA raps Access to EllaOne Vype ad limited in Poland icoventures’ website advertising its Vype Nbrand of e-cigarettes went beyond thepro- omen in Poland can no longer access vision of factual information and must not appear Wan emergency contraceptive without a again in its current form, the UK’s Advertising prescription after the country’sultra-conserv- Standards Authority (ASA) has ruled. ative government reverse-switched HRA Phar- Vype’swebsite showed an image of its ma’s EllaOne product. newPebble e-cigarette with the caption “a Ulipristal acetate-based EllaOne wasthe small and mighty vaping device”. Johnson & only emergencycontraceptive available in Poland Johnson(J&J)–which sells theNicorettelineof without aprescription, following the product’s smoking-cessation products –saidthe claim successful switch from prescription to OTC waspromotionaland therefore in breach of the status via the European Union’s(EU)central- UK CodeofNon-broadcast Advertising and Di- ised procedure in 2014 (OTC bulletin,28 Nov- Poland has reverse-switched EllaOne rect &Promotional Marketing,the CAP Code. ember 2014, page 11). Promotionalclaims are prohibited on e-cig- Theswitchforced major Europeanmarkets of the Polish HealthMinistry in November 2015. arette marketer’swebsites according to 2016 such as Germany, Italy and Poland –which At the end of May 2017, the Polish parlia- Tobacco and Related Products Regulations, hadresisted theswitchdue to political and relig- ment –the Sejm –backed abill limiting access to which the CAP Code reflects. Only factual claims ous opposition –tomakeanemergencycon- emergencycontraception, which wassubse- about unlicensed nicotine-containing e-ciga- traceptive available on anon-prescription ba- quently passed by the Polish senate on 1June. rettes are permitted. sis for the first time. On 23 June, PiS-friendly President Andrzej Responding to the challenge, Nicoventures Commenting on the Polish government’s Duda signed offonthe ban, despite protests said that “small and mighty” wasan“objective, move,HRA said that the decision wasa“back- from numerous women’srights groups and human factual description”, as the Vype Pebble was wardsstepfor women’sreproductive health rights associations –including AmnestyInter- “significantly smaller than most pen-style e- rights”inthe country. national –aswell as Europe’sscientific and cigarettes on the market, and wasable to sit in medical community. the palm of the hand”. Despite its small size, Reverse switchisapolitical move As aresult, EllaOne would only be available the Pebblewas more powerful than some larger “The decision to makeEllaOne prescription- from adoctor,HRA said, by the end of July. products, and therefore could be described as only is apolitical decision made against the Frédérique Welgryn, HRA’s chief operating “mighty”, the companyadded. recommendation of the European Medicines officer, said the companywas “concerned” about J&J’schallenge wasupheld in part, as the Agency(EMA),which advocates pharmacyac- the impact that this decision wouldhaveon ASA concluded that although the claim “small” cesstothis treatment,”HRA noted. “timely and affordable access to this important wasnot in breach of the code, the claim “mighty” In Poland,EllaOne became availabletowomen treatment forwomenduringtheir time of need”. was, as it did not provide anyinformation about without aprescription in 2015. The Polish Par- “Women have justasmall windowofop- the product, and wastherefore promotional. liament –dominated at the time by acentre- portunity to avoid an unplannedpregnancyand it Other claims madeonthe website were also rightparty –approvedthe switchfollowing its is therefore important that thereare no barriersto deemed unacceptable, the ASA pointed out, endorsementbythe EuropeanCommission. accessing emergency contraception,”she added. one offeringthe VypeePen Starter Kit for a The EMA’s switch recommendation was “It is HRA’s view that availability of emer- limited time at £19.98 (C22.71), and another based on information which found that Ella- gencycontraceptionwithout aprescriptionfrom offering “buy fiveget one free” on cartridges and One could be usedsafelyand effectivelywith- pharmacyisan essential service,”Welgryn in- e-liquid bottles for various Vype e-cigarettes. out prescription, HRA said. Since the central- sisted, “particularly as manydoctors’ surgeries These claims went beyond the provision of factual ised switch wasannounced, EllaOne has been are not open at the weekend, during public holi- information, and were presented as an “incen- made available without prescription in atotal days or at unsociable hours.” tive”tobuy the product, the watchdog ruled. of 23 EU countries. As products such as EllaOne were most Furthermore, theASA said avideo featured on “The Polish governmentisthe only country effective when taken as soon as possible after the website with the caption “vaping rocks” to reverse EllaOne’snon-prescription status,” unprotected sex, availability in pharmacywas wasalso promotional, as it was“stylised” and the companystated. critical, she explained, to enable timely access showed “unrelated imagery” accompanied by The move follows the victory in Poland’s to oral emergencycontraceptivesfromhighly bursts of colour and background music. October 2015 general election of the ultra- trained healthcare professionals. Commenting on the case, theASA “welcomed conservative andEuroscepticLaw andJustice “A number of highly inaccurate statements the amendments Nicoventures had already made party,known more commonly as PiS. have beencirculated as part of this debate around to their website”, butreminded the company Theban on non-prescription emergencycon- emergencycontraception in Poland,”Welgryn “not to use stylised videos, unrelated significant traceptiveswas prompted by the Polish Health pointed out. “HRAwishes to stressthatall cred- imagery or music” or “present information Minister,KonstantyRadziwiłł, who has made ible scientific bodies worldwiderecognise emer- about pricing offers in amanner that went be- several hostile statements regarding emergency gencycontraception to be asafeand important yondthe provision of factualinformation”. OTC contraception since he wasinstalled as the head back-up contraceptive option.” OTC

30 June 2017 OTC bulletin 15 OTC MARKETING NEWS

Marketing Campaigns Marketing Campaigns Ratiopharm Prestige helps US gets ad ban atiopharm has been prohibited from advert- to #KeepMoving Rising that its ASS+C effervescent pain medi- cation with added vitamin C“supports the im- restige Brands is harnessing thepower of mune system” by the Higher Regional Court Ponline influencers in the latest campaign in Stuttgart, Germany. forits Dramamine Non-Drowsy Naturals mo- In ajudgement on 8June 2017, the Regional tion-sickness brand in the US. Court ruled in favour of the plaintiff, “an associa- Running fromJune until the end ofAugust, tion whose tasks include the enforcement of the#KeepMoving campaign wasled by “three the rules of fair competition for its members”. influencer families”,the companysaid,and was Ratiopharm’sadvertising hadbreachedthe designed to encourage families to “embark on German ‘Act against Unfair Competition’, the summeradventureswithout the fearofmotion Prestige is urging people to #KeepMoving Court said,asitreferred to an area of application sickness and the unwanted drowsy side-effects, plans, especially in the summer months. beyondthatfor which the product had been ap- thanks to Dramamine Non-DrowsyNaturals”. “#KeepMoving is about enjoying summer proved.ASS+C has only been approvedfor “mild- Primarily using the Instagram platform, the adventures and creating amazing memories that to-moderatelyseverepain”,“colds” and“fever”. threefamilies woulddocumenttheir adventures, don’tincludemotion sickness,”she added.“We “Consumers would understand thestatement Prestige said, using the #KeepMoving hashtag. are excited to partner with Denise Boveefor as designatingafurtherfield of applicationand Consumers would also be encouraged to use the first goftle he campaign, as she understands not merely as an indication of further effects #KeepMovingtoshare their summer adventures first-hand howmotion sickness caninterrupt a of the drug,”the Court commented. OTC with friends and family,the companyadded. day of fun and memory making.” Those that shared their “#KeepMoving mo- Thethree influencer partners hadbeencho- ment” would have the opportunitytoberepost- sen as theyall had “active family lifestyles” ed on Dramamine’ssocial-media channels. and an “affinity for adventure”, Prestige not- The first #KeepMoving adventure takes Den- ed. All three families would be provided with iseBovee –who posts as @deniseboveeonInsta- asupply of Dramamine Non-Drowsy Naturals, gram and has 115,000 followers on the platform the companyadded. –and her family on an Alaskan cruise in July. Dramamine Non-Drowsy Naturals contained Aspokesperson for Prestige told OTC bul- the “clinically-tested dosage of ginger required letin thatdetails of the other two#KeepMoving for preventing and treating motion sickness,” adventures would be announced in the near future. Prestige pointed out. The productispart of the Catherine Badillo, Dramamine’sbrand manag- wider Dramamine portfolio, which includes er,saidthat as the “number-one OTCtreatment Dramamine Original Formula,Dramaminefor for motion sickness”, Dramamine understood Kids and Dramamine Chewable –all of which thefearand anxiety of motionsickness andthe contain dimenhydrinate –and Dramamine All disappointment that came when it disrupted Day Less Drowsy,which contains meclizine.OTC

Product Launches

Mylan has launched its Flamigel cuts and burns treatment in anew 100g tube format in France. Innovus Pharmajoins allergy fray Billing Flamigel as the “number-one hydrocolloid gel enriched with arginine”, roduct development specialist Innovus erted anti-allergic activity spread overtime”. PPharma has entered the US OTC allergy Bassam Damaj, Innovus’president and chief pharmacy-press advertising highlights uses of the remedy during the summer,suchas market with its AllerVarx supplement. executive officer,saidlaunching AllerVarx sunburn, superficial wounds from sporting activities, and minor burns from barbecues. Described as a“clinically provensupplement, strengthened the firm’srespiratory franchise. Benefits of the treatment highlighted by scientifically formulatedfor the reliefofallergy “Wecurrently believe the product could the advertisement include “accelerating symptoms”, AllerVarx had been exclusively generate at least an additional US$1.0 million healing”,“rapidsoothing” and reducing the risk of scarring. OTC in-licensed for the US and Canada from Italy’s (C0.9 million) per year in revenues from the NTC, Innovus said, and utilised NTC’spatented launch date,”Damaj claimed. “Inaddition, we formulation and bilayer tablets which included arelooking to furtherexpand ourrespiratory IN BRIEF technology that allowed acontrolled release franchisethrough thein-licensingofotherprod- of the ingredients. ucts in this field,”headded. STORK –the only at-home conception assist- Noting that in Europe, AllerVarx wassold Innovus is currently awaiting approvalfrom ance device approvedbythe US Food and Drug underthe Lertal name, Innovus pointed out that theUSFoodand Drug Administration(FDA) for Administration (FDA)–is nowavailable to buy the bilayer tablet’ssustained-release layer “en- its fluticasone propionate-based nasal spray in 1,292 Target stores in the US. Previously,the hanced quercetin and vitamin D3 bioavaila- FlutiCare, which will compete withGlaxoSmith- product wasonly available in pharmacies. OTC bility”, thanks to its “lipidic matrix” and “ex- Kline’sFlonase. OTC

16 OTC bulletin 30 June 2017 MARKETING NEWS OTC

Product Launches NutraPharma eases pain of high heels

oall the ladies out there who feel pain tion caused by your favourite footwear.” “Tafter aday in heels, relief is just around Pointing out that 72% of US women wore the corner,” is the message to US women from high heeled shoes,and overhalfreported suf- Nutra Pharma as it launches its Luxury Feet fering from foot pain afterwearingthem,Nina OTC topical homoeopathic pain reliever. Goldstein, Nutra Pharma’smarketing manager, Designed specifically to treat foot and ankle said that the companyhad “begun the pre-mar- pain in women that couldbecaused by wear- keting process” for Luxury Feet and had seen ing high heels,pumps or stilettoshoes, Luxury “a lot of excitement in the marketplace from Feet wasatopical roll-on gel, the companyex- consumers and retailers”. plained, that “relied on natural cobra venom’s ability to alleviate pain and inflammation”. Available online Rik Deitsch, Nutra Pharma’schief executive “Luxury Feet will be available to purchase Lactalis Nutrition Santéhas expanded its Delical officer,pointed out that women who “chroni- fromNutra Pharma’s websiteinthe near future,” range of food supplements in France by launching cally” wore high heels were prone to a“variety Goldstein revealed, “followed by aroll out into alactose-free vanilla liquid, Delical Concentré. Billed as “concentrated in protein”, the 200ml of foot problems, including pain, bunions, ham- retail stores later in the year.” liquid presentation offers 29g of protein and 452 mer toe and plantar fasciitis”. Nutra Pharma already markets ahomoeo- kcals.Pharmacy-press advertising emphasises that “Weknowthat women spend upwards of pathic pain relieverbased on cobra venom for the product’sformat allows “maximum efficacy formalnourished and weakened patients”. US$600 (C536) for apair of shoes andcertain- chronic neck, back, wrist or knee pain under its Other products in Lactalis’ Delical range include ly would liketowear them without the fear Nyloxinbrand name. oral liquids, powders, cream desserts, fruit drinks, of pain,”Deitsch said. “Luxury Feet is anew Nyloxin is available as atopical gel, topical instant cereals, biscuits and soups, with specific lactose-free and sugar-free lines.Sister ranges product that can be used safely every day and roll-on or oral spray in both standard and extra- include Gelodiet, Fibreline and RealDiet. OTC can prevent or treat the pain and inflamma- strength versions. OTC

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30 June 2017 OTC bulletin 17 OTC MARKETING NEWS

Product Launches TheOTCLab offers IBS maintenance

nsure the symptoms of irritable-bowl syn- Edrome(IBS) do not reoccur is TheOTCLab’s Germany’sDrLoges has expanded its Omega3- message to consumers with the launch of its Loges range toinclude aproduct aimed at Detoxner IBS Maintenance product. children.The new“junior”supplement is “the first vegan omega-3-product with eicosapentaenoic Anatural product intended for adults and acid (EPA) and docosahexaenoic acid (DHA) children aged 16 years and over, Detoxner IBS aimed at children”, the companyclaimed. Maintenance wasdesigned as a30-day pro- Developed to aid cognitivedevelopment, the tablets were also “lactose-free,gluten-free and gramme to help sufferers of IBS to better con- without the addition of artificialdyes”. trol their symptoms, the Dutch firm said, and Omega3-Loges junior is designed forchildren should be used after tackling IBS with the De- aged overfour years, with up to twotablets Detoxner IBS Maintenance helps control symptoms to be takendaily.Itisrecommended that the toxner IBS Intense five-day programme. capsules be chewed with meals. Along with controlling symptoms, the line Dextoner IBS Maintenanceisjustone of a Recommended retail prices of 60 and 120 extension could alsoalleviateissues related to number of line extensions TheOTCLab plans to tablet packs are e19.95 and e37.95 respectively. However, Dr Loges is offering asmaller pack IBS, TheOTCLabsaid, including constipation roll out this year. size foralimited time at areduced price of and/ordiarrhoea, abdominal painand/or cramp- In the autumn, the companyintends to add €9.95 through its website. OTC ing and flatulence and/or bloating. abrush format to its Bitener line of products TheOTCLab’sfounder and owner,Albert designed to help people stop biting their nails. Swane, told OTC bulletin thatDetoxner IBS While the existing Bitener Pen wasan“easy Maintenance had recently been introduced in to use and unique offering to the market”, the Belgium and would be rolled out in the Nether- brush variation offered consumers the option lands at the end of June. of using amore traditional method of applica- tion, Swane said. Launches in sevenmarkets Containingthe sameingredients as the pen Launches were also plannedinPoland, Portu- –isopropyl alcohol,aqua, ethyl lactate, hydroxy- gal, Spain and four other European countries, propyl cellulose, and denatonium benzoate – he added, noting that the brand would be sup- Bitener Brush would be launched in “several ported by television and print activity. European markets”inSeptember,headded,and Supplied in a30-day pack, consumers are would also be backed by television and print directed to mix one Detoxner IBS Maintenance marketing activity. sachet with waterorfruitjuiceevery second day TheOTCLab wasalso extending its Meno- and drink on an empty stomach. Relax menopauselinewith MenoRelax Symbio, Each sachet of powder contained a“high- acombination product to tackle anumber of grade mix” of 2QR-complex–anoveland pat- issues related to the menopause. ented ingredient that consists of natural poly- MenoRelax Symbio wasdesigned to relieve saccharides (galactoarabinan polyglucuronic vaginal itch, odourand unpleasant discharge, acid crosspolymer) –fructo-oligosaccharides, TheOTCLabsaid,and consisted of a100mlgel PierreFabrehas initiated a“broad media psyllium and inulin, the companysaid. and fiveprobiotic capsules to be used together. campaign” to promoteits Cicatryl ointment forcuts and burns in France. Forthe best results, consumers are advised Supported by television and print promo- Atelevision commercial forthe product – which to avoid alcohol, eat light meals and drink up tional activity,MenoRelax Symbio would be is available in packs of 14 sachets of 2g – will be to 1.5 litres of water aday.Consumers are also rolled out in anumber of European markets in supportedbyadvertising on television streaming services M6 Replayand My TF1. warnednot to usethe product formorethan 30 October, Swanerevealed, pointing out that the Pharmacy-press advertising boasts that Cicatryl consecutive days, allowingthe user’sintestinal original MenoRelax vaginalmoisturisergel was was“number one in sales in 2015”, with a78% flora and bowel systemt osettle into its renewed, already available in six countries including the shareofthe product’smarket. It also highlights Netherlands and Poland. OTC Cicatryl’s“unchanged formula” and “practical natural balance. and hygienic” sachet format. OTC

IN BRIEF STRIDES SHASUN has receivedapprov- al from the US Food and Drug Administration (FDA)for its200mg ibuprofen tablets. The prod- uct will be marketed under its Nuprin name.OTC Bitener Brush uses atraditionalapplication method MenoRelax Symbio is acombination treatment

18 OTC bulletin 30 June 2017 EVENTS OTC

AUGUST 10-11 October 8August AESGP Conference Basics of Pharmaceutical Brussels,Belgium Regulatory challenges for consumer health products will be the focus of this two-day meet- Regulatory Affairs ing, which is organised by the Association of the European Self-Medication Industry,the London, UK AESGP.The conference will provide an update on political and regulatory developments in Aone-day seminar run by The Organisation for this sector with afocus on substance based medical devices, herbal medicinal products and Professionals in Regulatory Affairs (TOPRA). botanical supplements. Contact:TOPRA. Contact: AESGP.Tel:+32 273 55130. Tel: +44 20 7510 2560. Email: [email protected]. Website: aesgp.eu/events/brussels2017. Email: [email protected]. Website: topra.org. 13-14 September Contact:Management Forum. 30 August Meet the Manufacturer Tel: +44 20 7749 4730. OTCMedicines Advertising NewJersey, US Email: [email protected]. London, UK Dr Reddy’s, Johnson &Johnson and Perrigo Website: management-forum.co.uk. This one-day workshop on the promotion of will speak at this one-day event, hosted by OTCmedicines has been organised by the Propri- the Consumer Healthcare Products Associa- 17-19 October etary Association of Great Britain (PAGB). tion (CHPA). This seminar is only open to WSMI General Assembly Contact:PAGB. CHPAmembers. Sydney, Australia Tel: +44 20 7242 8331. Contact: CHPA. ‘The Economics of Self Care’ is the theme of Email: [email protected]. Tel: +1 202 429 9260. the World Self-Medication Industry’s(WSMI’s) Website: pagb.co.uk/events-training/. Email: [email protected]. three-day conference. Website: chpa.org/mtm/. Contact: Arinex. 30 August-1 September Tel: +61 29265 0700. Natural &Organic Email: [email protected]. Products Asia OCTOBER Website: wsmiga2017.com. WanChai, Hong Kong Athree-day tradeshow. 2-3 October 18-21 October Contact:Diversified Communications. Pharmaceutical Regulatory CRN’sAnnual Symposium forthe Tel: +852 3958 0502. Affairs in Africa Dietary Supplement Industry Email: [email protected]. London, UK Arizona, US Website: divcom.com.hk/events/nopa-2/. Countries to be covered at this two-day meet- Afour-day event organised by the US Council inginclude Ghana, Kenya, Malawi, Mozam- for Responsible Nutrition (CRN). bique, Nigeria, South Africa and Tanzania. Contact:CRN. SEPTEMBER Contact:Management Forum. Tel: +1 202 204 7700. Tel: +44 20 7749 4730. 5-6 September Email: [email protected]. Email: [email protected]. Vitafoods Asia Website: crnusa.org/2017events. Website: management-forum.co.uk. Singapore 24 October Atwo-day exhibition and conference. 2-4 October Global Generics & Contact: Informa UK. TOPRA Annual Symposium Biosimilars Awards Tel: +20 3377 3616. London, UK Frankfurt, Germany Email: [email protected]. Medicines, medical devices and Brexit are These awards, organised by Generics bulletin, Website: vitafoodsasia.com. among topics to be discussed at this three-day recognise ‘best practice’ in the global generics event run by The Organisation for Profession- 13 September and biosimilars industries. als in Regulatory Affairs (TOPRA). Food Supplements Workshop Contact: Generics bulletin. Contact:TOPRA. London, UK Tel: +44 1564 777550. Tel: +44 20 7510 2560. The regulatory environment and nutrition and Email: [email protected]. Email: [email protected]. health claims will be discussed at this one-day Website: generics-bulletin.com. Website: toprasymposium.org. workshop run by the Proprietary Association of Great Britain (PAGB). 5October Contact:PAGB. Pharmacovigilance NOVEMBER Tel: +44 20 7242 8331. London, UK Email: [email protected]. This one-day course will look at pharma- 27-28 November Website: pagb.co.uk/events-training/. covigilance and regulatory requirements. EuroPLX 65 London, UK This two-day meeting will provide aforum 29-30 November for business development decision makers CeutaHealthcareInternational Conference for discussing and negotiating collaborative Lisbon, Portugal agreements in licensing, marketing, and dis- ‘Creating sustainable growth and increasing brand equity for manufacturers and retailers’ tribution of patented medicines, generics, bio- is the theme of this two-day conference, which will bring together manufacturers, retailers, similars, OTCproducts, medical devices and brand owners, global outsource solutions providers and keyopinion leaders in the health and food supplements. beauty industries to explore global growth opportunities. Contact:RauCon. Contact:Ceuta Healthcare. Tel: +44 1202 780 558. Tel: +49 6221 426 2960. Email: [email protected]. Website: ceutaalliance.com/2017_conference-lisbon.html. Email: [email protected]. Website: europlx.com.

30 June 2017 OTC bulletin 19 OTC BUSINESS STRATEGY

Having significantly expanded its OTC presence globallythrough its joint venture with Novartis, GlaxoSmithKline (GSK) Consumer Healthcare is keen to conquer thedigital space, according to itsnew worldwidehead Brian McNamara. MattStewart reports.

GSK to lead digital revolution

here are real opportunities need to be where our consumers are.” claimed. “Amazon is the largest product search to advance in consumer “Weknowthat returnoninvestment(ROI) engine in the world,”hesaid, “with consumers not healthcare in the digital on ourdigital marketing is higher than our ROI just using Amazon to buyproducts, buttosearch “Tspace,” according to Brian on traditionalmarketing because we can be more forthemand getinformation about them too.” McNamara, chiefexecutiveofficer of targeted,”McNamara revealed. Turning to social media, McNamara pointed GSK Consumer Healthcare. “This is an “I don’twatch much television anymore, but out that this had changed the wayindustry area where Iwant GSK Consumer my daughter is 20 years oldand Idon’t think she thought about the content it created. Healthcare to lead the industry.” has turned on atelevision in overthree years. Content had to be relevant to the online Speaking to OTC bulletin earlierthismonth, Everything is watched on her laptop through communities that companieswanted to engage McNamara –who took overashead of GSK streaming services likeNetflix,”heexplained. with, McNamara stated, using the example of Consumer Healthcare in October last year (OTC “My daughter’sgeneration do not engage likebe- GSK’s‘ What does aMigraineFeel Like?’online bulletin,7October 2016, page 23) –insisted fore, so as theygrowup, we need to be with them.” campaign for its Excedrin migraine product. that the companywas fullycommitted to ex- Using aconsumer insight gleaned from mi- ploiting the benefits of digital, and would ac- Use datatoinnovate grainesufferers –that theyfeltthatnoone un- celerate its activities in the area. Digital innovation through the best use of derstood what theywent through and dismissed “One of the first things Idid wastohire a data wasalso akey factor in succeeding in migraines as justheadaches –GSK had created global chief digital officer in Marc Speichert, the digital world, McNamara said. It waskey amigraine simulator using augmented reality whoisverywellknown in the consumergoods to learn howbest to incorporate that into the technology that friends and family members and technology industries, having worked at firm’sinnovation activities going forward. of migraine sufferers then used to experience L’Oréal andGoogle,”McNamara pointed out. “A second big fundamental in allofthiswill what their lovedones went through. Speichert wasleading an “external digital be data analytics,”hesaid. “You can have allthe The video had had amajor impact, McNa- advisory board”, McNamara said,designedto big data in the world, butweneed to learn how mara said, both in making migraine sufferers bringtogether top external digital and technology to better leverage that data to get insights, drive feel liketheyhad been listened to, and in edu- experts to “really challenge us and our strategic innovation and growour brands.” cating people about what amigraine really was thinking and makesure we are thinking about Questions around data privacy would also have and the impact it had on people. this in the right way”. to be answered, especially in such asensitive field “Success on social media really does have Explaining howGSK thought about digital, as healthcare, McNamaraadmitted, buthewas con- to start with the content,”heinsisted. “If you McNamara said that the “base fundamental” fident that GSKhad allthe systems and processes get the right content out there, then people will of the area wassearch, which he claimed might in place to handle consumer data appropriately. access it in anynumber of ways. But it has to be notbeas“sexy” as social media,but wascrucial “Lastly –but of no less importance –there meaningful and add value. If it does, then it will to online success. is e-commerce,”hepointed out. allowyou to engage in aconversation.” “Tobesuccessful in search you have to have “E-commerce is where you can really see a “Digital and technology will be behind the the right content,”heclaimed, “and then we blurringofthesedifferent factors,”McNamara growth of alot of categories,not justconsumer

20 OTC bulletin 30 June 2017 BUSINESS STRATEGY OTC

healthcare,”McNamara pointed out. “People have access to amassofdata,soifyou are not proactivelyunderstanding howyou meetthose needs, then someone else will.” Going it alone would alsonot be wise, McNa- mara cautioned,adding that partnerships would be crucial, noting GSKalready worked closely withGoogleand otherdigital technology firms. There wasalso aneed for industry to partner with the regulators, he insisted, to ensure that the regulatory environment wasright for the OTCindustry to takeadvantage of the oppor- tunitiesin the digital space. The OTCindustry had been alittle slowto Excedrin’sfirstaugmented reality migraine simulator really engagewith the digitalworld,McNamara cludes the bulk of the firm’sOTC products – “But if you get into something likeTheraflu, a admitted, butthe space wasstill evolving and which generated overhalf of Consumer Health- cough/cold brand,”hecontinued, “the regula- industry needed to get on board. care’ssales in the 12 months (see Figure 2). toryenvironment for cough/coldproductsisvery Away from innovation in the digital world, In terms of geographies, countries outside different countrybycountry, plus we have some McNamara said that GSK’sstrategic priorities the US and Europe accountedfor over£3billion tremendous local cough/cold brands.” –announced shortly after the joint venturewith in sales(see Figure 3), butthe traditional Euro- “Wewould notintroduce Theraflu into the Novartiswas finalised (OTC bulletin,22May pean markets, together with the US, were still UK whenwehaveBeechams,”McNamara said. 2015, page 1) –remained in place. responsible for overhalf of total sales in 2016 “What we do is use Theraflu as aplatform. As “Overall, the vision we laid out remainsintact (see Figure 4). one of our powerbrands we invest heavily in with little things on the fringes changing on certain Strategically,the companywas committed innovation to drive Theraflu’sgrowth in the brands through market dynamics,” McNamara to its focus on its sevenglobal powerbrands – markets where it is present, then leverage that said. “This whole vision of focusing on seven Otrivin, Panadol, Parodontax, Polygrip, Sen- innovation to growBeechams in the UK.” ‘powerbrands’ has been extremely successful for sodyne, Theraflu and Voltaren/Voltarol –and “It’ssmart to not be global for the sake of it,” us and it will continue to be,” he maintained,“as its 12 core regional brands, McNamara said, McNamara insisted. “There are some really these are thebrandswith aright-to-win,strong whichaccount for approximately 90% of Con- important regional/local brands in our portfolio,” consumer benefits and strong gross margins.” sumer Healthcare’sgrowth. he added, “Horlicks in India is amassive health- McNamara –who led GSK Consumer Health- Expanding on howthe firm balanced its global care brand, while in China we have Bactroban care’s Europe and the Americas unit prior to ambitions with the need to cater for local tastes, and Contac. Those are brands that have been taking overfromEmmaWalmsley, nowGSK’s McNamara said it operated twomodels. there for along time and we are not going to chiefexecutive officer.Heinheritedabusiness “Voltaren and Sensodyne are unbelievable change those strong brand equities.” which posted salesupby9%to£7.19 billion global brands,”heexplained, “in the sense that However, McNamara warned,you could not (C8.19 billion) in 2016 (see Figure 1). the same packaging, products and advertising focus on everything, which waswhy the com- Turnoverwas split between four core cat- justworksall overthe world and theyhavebeen pany had made aclear decisiononthe brands on egories.These wereled by Wellness–which in- incredibly successful worldwide.” which to concentrate and in which to invest. Business Annual sales Change (%)* Skin health (£ millions) £Proforma 8% Wellness 52% Wellness 3,726 +15 +6 Nutrition Oral health 2,223 +8 +8 9% Nutrition 674 -8 -9 Skin health 570 +4 -2 TotalConsumer Healthcare7,193 +9 +5 Oral health *Changeisatconstant exchange rates 31%

Figure1:GSK Consumer Healthcare’ssales in 2016 by business unit. Proforma sales comparisons Figure2:GSK Consumer Healthcare’s2016 sales include Novartis Consumer Health in Januaryand February2015 (Source –GSK) of £7.19 billion by category(Source –GSK)

Region Annual sales Change (%)* US International (£ millions) £Proforma 25% 45% International 3,241 +8 +5 Europe 2,191 +12 +4 US 1,761 +9 +5 TotalConsumer Healthcare7,193 +9 +5 Europe *Changeisatconstant exchange rates 30%

Figure3:GSK Consumer Healthcare’ssales in 2016 by region. Proforma sales comparisons include Figure4:GSK Consumer Healthcare’s2016 sales Novartis Consumer Health in Januaryand February2015 (Source –GSK) of £7.19 billion by region (Source –GSK)

30 June 2017 OTC bulletin 21 OTC BUSINESS STRATEGY

Growing these brands, however, remained “really drivenbyconsumerneeds and trends”. diversity we need as aglobal company.” difficult, McNamara pointed out, asva “inno - McNamara also agreed that there wasaneed Meanwhileinthe US, McNamara welcomed tion in the OTCspace is hard”. for more categories to transfer overinto the non- the movestowards reforming the OTCmono- Whilemuchofthe innovation in OTCmedi- prescription space, citingthe successofthe al- graph system. cines might look simple, McNamara argued, the lergycategory in the US. GSKsupported establishing auser-feesys- science behind products likethe firm’sVoltaren “It wasn’tuntil Claritin wasswitched over tem, McNamara revealed, as it would help fos- 12hr line wascomplexand difficult to achieve. adecade ago in the US that allergy became a ter innovation. “With Voltaren 12hr,people may have thought consumer healthcare category,” he pointed out. Elsewhere, McNamara saidthatrecent issues ‘what is the big deal, it nowhas 2% diclofenac “Now it is akey driverofthe consumer health- that had cost the companysales in India and instead of 1%?’,”heexplained. “But from an in- caremarket, helping both consumers andhealth- Latin America were simply the cost of doing novation perspectiveitwas incredibly challenging. care systems.” business in developing economies. It wasnot just about adding more diclofenac, “I do think that for self-care to continue to The demonetisation of 500 and 1,000 rupee it wasabout getting more skin penetration and evolve, more and more categories need to come bank notes in India had abig impact on Con- to do that we had to create atechnology that into the self-care space,”McNamara argued. sumer Healthcare’ssales in the country,Mc- allowed diclofenac molecules to penetrate the Non-organic growth ofthe businesswas also Namara admitted, butthe thinking behind the skin faster and get to the site of pain faster.” on the agenda, McNamara revealed, although he move –tocrack down on the black market econ- Voltaren 12hr wasnot created merely as an waskeentopoint out that anybuy out of Novartis’ omy –wouldinthe long-term help the economy. exercise in getting more skin penetration, he 36.5% stakeinthe OTCjoint venture wasa “I think this short interruption is agood thing pointed out, butasaway of addressing areal decision for the Swiss firm first and foremost. as it’sworking to clean up the market in the consumer need. Applying the product once Novartis could choose to exit the joint ven- longterm,” he maintained,notingthat theIndian every 12 hours instead of four times aday was ture as earlyasMarch 2018 whenits put option government wasnow set to tackle the country’s ahugebenefit, especially foratopicalproduct. kicks in,withWalmsleyadmittinginMay this “extremely fragmented tax structure”. The lesson, McNamara said, wasthat while year that its partner’spotential exit wasthe “This tax restructure will also impact us as innovation washard,placing consumer insights “first item on the agenda” when it came to merg- what wasonce taxed at cost of goods level and unmet needs at the centre of the innovation ers and acquisitions in the consumer healthcare will nowbetaken offthe top line of the busi- strategy made it easier to find the opportunities space (OTC bulletin,12May 2017, page 5). ness,”McNamara pointed out. “But in the long- to expand abrand. term it will helpfurther simplify do- Furthermore, innovation no longer ingbusiness in India.” had to mean just innovating on the “ Idothink that forself-caretocontinue Meanwhile, the instability in some physical product, McNamara said. to evolve, moreand morecategories need Latin American markets would be “I think opportunitiesaround pack- overcome, McNamara said. GSK aging innovationare also important, to come intothe self-carespace ” would keep people on the ground and Ilook at that Excedrin viral and keep focusing on winning in the video. While you could dismiss it as market- Away from anypotential deal with Novartis, company’sproduct categories. ing,Isee it as innovation,”hemaintained. “We McNamara said the companywas, as expected, “You need local people on the ground that found an unmet need –that migraine sufferers keeping akeen eyeonthe market and wasready understand the market,”heexplained. “In the found theyhad to explain to people what they to move on interesting opportunities. end, what is important is that you win in the go through –and used technology and video “Wehaveour targetsofbrand/countrycom- marketplace. Youcan win in adeclining mar- content to address it.” binations,”McNamarasaid. “Even thoughwe ketorwin in agrowing market.” Akey area of innovation for GSK remained are abig player,westill only have a5%share Aregion where theGSK wascertainly look- prescription-to-OTC switches. McNamara point- of the global OTCmarket. If anythingcame ing for strong growth wasAsia, with McNa- ed out that switches were crucial, not just to on the market that we felt would add value to mara highly enthusiastic about the company’s drivegrowth in his ownbusiness, butthat of the our business, we would be highly interested newregional headquarters in Singapore as a industry as awhole. in evaluating and pursuing it.” platform to drive growth in Asia. There wasaneed for simplification in the Turning to the global environment, Mc- “Singapore is our base for emerging mar- switch environmentinEurope, McNamara said. Namara –who nowhas his home in London kets in Asia and it is spectacular,” he said. “It He welcomed recent comments by Karl Broich, where GSK is based –noted that the company givesthe companyanevengreater capability director general of Germany’sfederal institute wasnot clear on howthe UK’sexit from the to gather local insights and address the spe- for drugs and medical devices, BfArM, that a European Union (EU) would impact the Con- cific needs of the region.” “mind set change” wasneeded to ensure work sumerHealthcare business.However,GSK, at The days of taking an expensive Western aimedatsimplifying andformalising approval acorporate level, was“very involved in trying product and “just rolling it out in these markets” processesfor switching products in Europewas to influence wBho rexit goes”. were over, McNamara claimed, highlighting asuccess (OTC bulletin,16June 2017,page13). “I think the keything is maintaining astable pollutionasabig issue inmanydeveloping mar- On GSK’sswitchplans –the companyan- and predictableregulatory environment between kets and the need for GSK’sfuture portfolio to nouncedinMay 2015 that it wanted to achieve theUKand EU,”hestated,“and aharmonised address this issue. aprescription-to-OTCswitchevery fiveyears regulatory and legalstructure for OTCmedicines.” GSK’srefusal to address consumers as one (OTC bulletin,22May 2015, page1)–McNa- “Ease of movement of people is alsocritical,” homogeneous group, McNamara explained, mara said that while he could not reveal details of McNamara added. “The best and brightest added to the company’sgrowing capability in whatthe firm waslookingat, it did have a“dedi- talent around the world is what aglobal com- digital technologies to access local insights, cated switch team” reviewing opportunities “both pany likeGSK needs,”hepointed out, “not just would ensure the business wassuccessful in the inside and outside” its current categories and on atechnical level, butalso to fosterthe cultural coming years. OTC

22 OTC bulletin 30 June 2017 PEOPLE OTC

IndustryAssociations Retailers PGEU elects Galenica appoints president newheadofRetail he Pharmaceutical Group of the European TUnion (PGEU) –the European association wiss wholesaler and retailer Galenica has of community pharmacists –has elected Jesus Sappointed Daniele Madonna as head of Aguilar Santamaria as its 2018 president. its Retail businessunit. Currently presidentofthe GeneralPharma- He will assume this role during the fourth ceuticalCouncil of Spain, Aguilar Santamaria quarter of 2017, and will also become amem- waspreviously president of the region chamber ber of the corporate executive committee of of Castilla-Leon and vice-president of Spain’s the Galenica Group. General Pharmaceutical Council. Madonna is currently chief executive offi- Aguilar Santamaria will be supported by Es- cer of Coop Vitality,ajoint venture between tonia’s Kristiina Sepp,who waselected the asso- Galenica and the retailer Coop. He joined Gal- ciation’s 2018 vice-president. Sepp had served enica in 2004, as manager aCoop Vitality phar- on thePGEUexecutivecommittee for the past macyinTenero. He later took overrespon- three years, the organisation noted. OTC sibility for pharmacies in Ticino and Central Daniele Madonna Switzerland, eventually becoming chief execu- tive in 2014. commented. “He has also expanded his retail “Madonna has an excellent knowledge of knowledge overthe years and is therefore ide- the operational pharmacybusiness and the Swiss ally equipped for his newrole and to drive the pharmacyand healthcare market,”Galenica growth of our retail business.” OTC

IndustryAssociations Oschmann leads EFPIA

Jesus Aguilar Santamaria erck KGaA’s Stefan Oschmann has Mbeen elected as president of theEuropean Federation of Pharmaceutical Industries and Distributors Associations (EFPIA), replacing outgoing pres- DKSH promotes ident Joe Jimenez, chief executive of Novartis. Oschmannjoined Merck in 2011 as amem- business lead ber of the executive boardand wasresponsible forthe Healthcarebusinesssectoruntil the sian market expansion specialistDKSH end of 2014. In 2016, he wasnamed chairman Ahas appointed Bijay Singh to lead its and chief executive officer of the entire Merck Healthcare business unit. Singh replaces Andrew group with responsibility for group strategy. Frye,who the firm said had left “to take on a Olivier Brandicourt,chief executive of Stefan Oschmann senior position at ahealthcare client company”. Sanofi,and Jean-Christophe Tellier,chief ex- to “address the opportunities that arise for the Singh, who has led DKSH’sBusiness De- ecutive and chairman of the executive committee industry in Europe”, the association commented. velopment section for the past twoyears, had of UCB, have been named vice presidents. EFPIA represents 33 national associations over25yearsofexperienceworking in interna- These newappointments would help EFPIA and 43 pharmaceutical companies. OTC tional healthcare positions,the firmsaid. OTC Manufacturers GSK makes amarketing change

laxoSmithKline (GSK) Consumer Health- Before joining GSK, she worked at Danone Gcarehas appointed Cornelia Heiser as as marketing manager for the Activia brand, director of marketing for Austria, Germany following marketing roles at Reckitt Benck- and Switzerland. iser (RB) and Ferrero. Heiserpreviously worked as marketing man- Heiserreplaces Thomas Maurer –who had agerfor GSK’spain-relief category across the held the position since 2015 –who has been three markets, looking after keybrands such as promoted to general manager of thecompany’s BijaySingh Panadol and Voltaren. Nordics region. OTC

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