Q&A with Spotlight France must Sanofi’s on beattimid Stephen Walker Welmedix growth page 17 page 8 page 20

Contents Stada primed for 17 February 2017 Issue Number 477 potential takeover COMPANY NEWS Sanofi movesintotop three 2 tadaArzneimittel has commenced“open- vate-equity firm, Advent International. Ipsen growswith 3 Sminded talks” with twoprivate-equity Noting that the potential bids “could offer in Sanofi brands firms after receiving separate, legally non- different ways attractive opportunities in the Pfizer posts operational rise 4 binding takeoverproposals. interest of the company”, Stada said its execu- Confirming news of the potential bids to tive board had movedforward with talks “to GSK sales hit by India move 5 dispel “market rumours”, the German player allowthe interested parties to explaintheir Taisho terminates 6 said UK-based CinvenPartners had made a strategic concepts and evaluate further value- Takeda deal proposed offer of C56.00 pershare to take full enhancing potential with regards to the poten- Prestige plots Fleet growth 9 controlofthe company,inadeal valuing the tial offer price”. firm at approximately C3.49 billion. GENERAL NEWS Cinven’sbid represented apremium of Questions overfuture ASMI wantsschedule 3ads 10 12.7% to Stada’s closing share price of C49.70 Questions overStada’sfuture have intensi- Sanofi expands with 11 on 12 February,the day before the potential fiedoverthe past 12 months following the firm’s Xyzal Allergy switch takeoveroffer wasannounced. As OTC bul- protracted dispute with activist investor Active letin went to press,Stada’s share price hadcrept Ownership Capital, which led to Stada’sshare- Australia rejects 14 up to C56.00 per share. holders removing supervisory board chairman vardenafilswitch Meanwhile, Stada declined to expose details Martin Abend (OTC bulletin,9September MARKETING NEWS of aproposed offer submitted by the other pri- 2016, page 23). OTC Flonase Sensimist launches 15 Alkem to push Tiger Balm 15 RB grabs Mead Johnson Galderma treats adult acne 16 eckitt Benckiser (RB) is set to acquire andamultipleof4.5-timesthe firm’ssales of Reckitt fined in NZ 18 RUS-based infant formula specialist Mead US$3.74 billion. Mead Johnson generated around overNurofen claims Johnson Nutrition in adeal worth US$17.9 50% of its 2016salesinAsia,withNorthAmer- REGULARS billion (C16.9 billion), including Mead John- ica/Europe accounting for33% and Latin Amer- son’snet debt. icathe remainder. Spotlight on –Welmedix 8 TheUK-based fast-moving consumer-goods Once the deal is confirmed, RB will gain a Consumer Healthcare (FMCG) giant said the US$90 per share deal portfolio of brands which includes the Enfa- Q&A –with Sanofi’s 17 wassubject to shareholder approvaland that grow, Enfamil and Enfapro infant formulas, the Stephen Walker it expected the transaction to close by the end Choco Milk, Lactum and Sustagen children’s Events –Our regular listing 19 of the third quarter of 2017. nutritionalmilksupplements,aswell as theNu- The proposed price represents amultiple tramigenformula for infants with foodallergies. People –Warnerytohead up 23 Beiersdorf CHC unit of 18.0-times Mead Johnson’s2016 earnings These brands would be housed in an infant before interest and tax (EBIT) of US$927 million Continued on page 7 Connect with us on: Twitter LinkedIn OTC-bulletin.com OTC COMPANY NEWS

Business Strategy/Annual Results Sanofi vemo sintotop three

anofi has taken up aglobal “leadership Region Annual sales Change (%) Proportion Sposition” in anumber of “attractive OTC (C millions) CER* of total (%) categories” followingits acquisition of Boeh- Emerging Markets 1,238 -7.9 37 ringer Ingelheim’s Consumer Health Caredivi- US 938 +3.8 28 sion,according to Alan Main,the firm’s execu- Europe 879 ±0 26 tive vice president of Consumer Healthcare. Rest of World 275 +9.9 8 Speaking as the French companyannounced its 2016results, Main said Sanofi’snewly-en- TotalConsumer Healthcare3,330 -1.6 100 larged Consumer Healthcare business wasthe *CER is constant exchange rates world-leader in OTCdigestive health- and femi- Figure1:Sanofi’s Consumer Healthcaresales in 2016 by region (Source –Sanofi) nine-care products, as well as number twoin pain relief. countryleadership,”Mainpointed out. Excluding Venezuela, and the “divestiture Acquiring Boehringer’sConsumer Health “Based on our plans,”hecontinued, “we re- of small products”,Consumer Healthcare’sturn- Careunithad added around C1.5 billioninan- main confident that the transaction will meet overhad advanced by 2.7%, Sanofinoted, driven nualsales to Sanofi’s ConsumerHealthcare opera- Sanofi’sfinancialobjectives, including the achieve- up by abetter performance in Russia, and a tion, he noted, and made it one of the world’s ment of around a30% business operating in- “strong cough and cold season”acrossEurope. top-three consumer healthcare businesses. come margin in 2018.” The problems in Venezuela –coupled with The transaction consisted of an exchange the“challenging” economicsituationinBrazil – Integration on track of Sanofi’sMerialanimal healthcare business – had left Consumer Healthcare’ssales in Emerging Noting that it had “only been one month” which has an enterprise value of C11.4 billion Markets down by 7.9% at constant exchange since the deal closed (OTC bulletin,13January –for Boehringer’sConsumer Health Care as- ratesto C1.24 billion (seeFigure1), thefirm said. 2017, page 1), Main said the integration of sets outsideofChina, which hold an enterprise In Europe, turnoverwas flatat C879 million, Boehringer Consumer Health Care was“on track” value of C6.7 billion. The German company Sanofipointed out, “reflecting the divestitures and work wasalreadyunderwayto“unlockthe also made acash payment to the French firm of small products”. potential of Boehringer’siconic brands”. of C4.7 billion to “reflect the difference in value On abrighter note,salesin theUShad grown “Todate, we have determined that the pri- of the twobusinesses”. by 3.8% to C938 million, Sanofi noted, while turn- mary global hubs for the combined business Meanwhile, Sanofireported Consumer Health- overin its Rest of World region had moved will be Paris, France and Frankfurt, Germany, care sales down by 1.6% at constant exchange forward by 9.9% to C275 million. and we have already made the keydecisions rates to C3.3 billion in 2016, due primarily to the Turning to Consumer Healthcare’sleading around management, as well as regional and macro-economic environment in Venezuela. brands, Sanofi reported amixed showing. The stand-out performer in the period had Business Annual sales Change Proportion been Doliprane, the companysaid, with sales (C millions) CER*(%) of total (%) of the pain-relief line up by 2.6% to C309 mil- Allegra417 -0.2 1 lion (see Figure 2). Doliprane 309 +2.6 >1 The onlyother brand to postariseinturnover Enterogermina 159 +2.5 >1 wasEnterogermina, withsales of the diarrhoea Essentiale 145 -20.9 >1 treatment up by 2.5% to C159 million. Allegra remained the unit’sbiggest-selling Nasacort108 -10.7 >1 brand in the 12 months, despite sales slipping Maalox85-8.2 >1 backby 0.2%to C417 million. An “increasingly No Spa 82 ±0 >1 competitive environment” in the US allergy cate- Lactacyd 80 -25.4 >1 gory wasblamed by Sanofi for the slight drop Dorflex75-2.5 >1 in the brand’sturnover. Consumer Healthcare is nowone of Sanofi’s Magne B6 73 -6.1 >1 Global business units, along with General Medi- Other 1,797 +1.7 5 cines and Emerging Markets, Genzyme, Vac- TotalConsumer Healthcare3,330 -1.6 10 cines, and Diabetes &Cardiovascular,following General Medicines and Emerging Markets 14,498 -3.3 43 achange to the company’sreporting structure Diabetes &Cardiovascular 6,397 -2.0 19 on 1January2017. “Thisstructuredrivesdeeper Genzyme/Specialty Care5,019 +17.3 15 specialisation, simplifies reporting andvides pro clearfocus on growth drivers,” Sanoficommented. TotalPharmaceuticals 29,244 +0.2 86 Consumer Healthcare accounted for9.8%of Vaccines 4,577 +8.8 14 Sanofi’stotal salesinthe period, which advanced TotalSanofi33,821 +1.2 100 by 1.2% at constant exchange rates to C33.8 bil- *CER is constant exchange rates lion.The company’s four other globalbusiness Figure2:Sanofi’s sales in2016brokendownbybusiness (Source –Sanofi) units accounted for the remainder. OTC

2 OTC bulletin 17 February 2017 COMPANY NEWS OTC

Mergers &Acquisitions Mergers &Acquisitions i-Health buys Ipsen growsreach probiotic line S-based i-Health –awholly-owned sub- with Sanofi brands Usidiary of Netherlands-based life sciences and material sciences firm Royal DSM –is psen is set to expand its consumer healthcare poised to grow its consumer healthcare portfolio Ioffering in Europe by acquiring abasketof by snapping up foranundisclosed sum theUP4 OTC brands from Sanofi for C83 million in cash. probiotic brand from UAS Laboratories. The deal –whichisexpected to close,subject Describing UP4 as a“successful consumer to regulatory clearances, in the second quarter brand”, i-Health pointed out the range com- of 2017 –will see Paris-based Ipsen gain Sanofi’s prised a“full line of probiotic products that Prontalgine analgesic,which is marketed only address abroad range of consumer healthcare in France. and wellness solutions”. Furthermore,Ipsenwill acquire the Busco- Above:Sanofi’s Buscopan antispasmodic line UP4 products incorporated “state of the art” panantispasmodic in the Czech Republic, Es- Below: Sanofi’s Prontalgine analgesic probiotic strains, the firm claimed, that were tonia, Hungary,Latvia, Poland and Slovakia. “supported by strong scientific research”. The rightstothe SuppositoriaGlycerinilaxa- tive in the Czech Republic are also included in Enhance leadership position the agreement, along with the Mucothiol and “Theacquisitionofthe successful,fast-grow- Mucodyne cold and flu products in Greece and ingand scientifically-supported UP4 brand of the Republic of Ireland respectively. probiotics will expand and accelerate i-Health’s Ipsen pointed out that by selling offthe leadership position in the probiotic category,” brands, Sanofi had satisfied anumber of com- panded thefirm’s OTCportfolio “and enhanc- commented WesParris, the company’schiefex- petition concerns raised by the European Com- es its value proposition to consumers”. ecutive officer. mission (OTC bulletin,12August 2016, page1) “Theproductsare fully synergistic with our “I am excited about the prospect of deliver- ahead of the firm’sacquisition of Boehringer existing infrastructure,”Fabre claimed, “and the ingevenmorenew growth platforms based on Ingelheim’sConsumer Health Care business keyasset,Prontalgine–awell-established and strong scienceand innovationintothe fast-grow- (OTC bulletin,13January 2017, page 1). growing market player for pain management ing probiotic category,” continued Parris. “In Commenting on the deal, David Meek, Ipsen’s in France,withamid-30% market share –will addition, the UP4 brand represents aperfect chief executive officer,said acquiring the Sanofi help us achieve criticalmassatthe pharmacy strategic complement to our category-leading brands would “immediately improve the profit- level, accelerating the development of our con- brand, Culturelle.” abilityprofile of Ipsen’sPrimaryCarebusiness”. sumer healthcare business.” Along with theCulturelleprobiotic, i-Health’s “It adds alimited portfolio of well-estab- Thefive Sanofi brands will join Ipsen’s ex- portfolio also includes the AZO yeast infection lished and market-leading brands,”Meekpointed isting line up of consumer healthcare products, treatment and the Estrovenand i-Cool meno- out, “in keymarkets such as France.” which includes theSmecta and Smectalia anti- pause relief supplements, as well as the Ovega- Jean Fabre, executive vice president of Ip- diarrhoea treatments, as well as the Forlax laxa- 3omega-3 supplement. OTC sen’sPrimary Care division, said the deal ex- tive range. OTC

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17 February 2017 OTC bulletin 3 OTC COMPANY NEWS

Annual Results Pfizer posts operational rise

etter US sales helped topushupPfizer’s Business Annual sales Change Proportion BConsumer Healthcareturnover by 5% opera- (US$ millions) 2015/2016 (%) of sales (%) tionally in 2016. Internal medicine 8,858 +16 17 However, negative currencyeffects had com- Vaccines 6,071 -6 11 pletelywiped out the operationalgain, the US- based pharmaceutical giant pointed out. This Oncology 4,563 +54 9 left Consumer Healthcare’s2016 sales flat at Inflammation &Immunology 3,928 ±0 7 US$3.41 billion (C3.17billion) (seeFigure1). Consumer Healthcare3,407 ±0 6 Turnoverinthe US improvedby7%toUS$1.92 RareDiseases 2,369 -2 4 billion, Pfizer noted, thanks to better sales of InnovativeHealth 29,197 +9 55 the Emergen-C effervescent supplement, Robi- tussin cough and cold products and the Chap- Essential Health 23,627 +7 45 Stick skin-care line. TotalPfizer52,824 +8 100

Meanwhile, Internationalturnoverdeclined Figure1:Pfizer’ssales in 2016 broken down by business (Source –Pfizer) by 7% to US$1.49billion. Adjusted for currency effects, International sales actuallyadvanced by Consumer Healthcare, Read said the business (atorvastatin) fromprescription to OTCstatus 3%.Strong performances by theNexiumCon- remained a“valuable asset” for the company. in thTeUS(O C bulletin,14August2015, page 1). trol heartburn-relief brand and the Advil an- “Just like all of ourportfolioand all of our Speculation washeightened later that year algesics line had been behind this constant cur- assets,”Read stressed,“if there’s abettermix, when Reckitt Benckiser’s(RB’s) chief execu- rencyrise, Pfizer explained. we’realways open to it, butithas to be for strate- tive officer,Rakesh Kapoor,openly admitted Pfizer reported its 2016 results as chief execu- gic reasons rather than cash.” that the UK-based fast-movingconsumer-goods tive officer Ian Read reiterated his comments on Pfizer has continued to face questions about (FMCG) giant would be “interested” in acquir- the future of the Consumer Healthcare business. the future of Consumer Healthcare ever since ing the Consumer Healthcare business (OTC bul- Asked byanalysts if Pfizerwanted to offload the firmfailed with its attempt to switch Lipitor letin,11 December 2015, page 1). OTC

Mergers &Acquisitions Business Strategy/Annual Results Egis grabs brands in Russia C&D expects

ungary’s Egis Pharmaceuticals has expand- further deals Hed furtherits presence in the Russian OTC market by snapping up fourbrands from Cro- hurch&Dwightpromised it would con- atia’s Jadran-Galenski Laboratorij (JGL) for Ctinue to “aggressively pursue acquisitions” an undisclosed sum. in 2017 after it revealed the details of two re- The four brands –D-Panthenol, Feminal, Fol- centdeals. acin and Vagilac –had generated sales of around Announcing its 2016 results, the US-based

C12 million in 2015,Egis said, and were well- The Feminal menopause treatment firm reported that in December it had snapped established in Russia. up the Anusol and Rectinol haemorrhoid brands Wound-carelineD-Panthenol wasthe “sec- The dealwith JGL formed part of Egis’ long- from Johnson &Johnson (J&J) for US$130 ond-largestbrand by salesinthe Russian dexpa- termstrategy to “strengthen” its competitiveness million (C123 million). The brands had combined thenol market”, Egis claimed, and represented a in the non-prescription market, the company annual sales of US$24 million, Church &Dwight “strong fit” with the company’sexisting non- pointed out, through “strategic acquisitions in noted, and weremarketed inAustralia, Canada, prescription medicines portfolio in Russia. keycountries”. South Africa and the UK. Noting that D-Panthenolwould becomethe In linewiththatgoal, Egisgrewits OTCport- Thefollowing month, thecompany grabbed firm’ssecond-largest OTCbrand in terms of folio in 2015 by acquiring from Bayer the Biovital the Viviscal hair-care supplement brand from sales, Egis said it intended to help the product line of vitamins for adultsand children in Poland Lifes2Good Holdings for US$160 million. achieve its “full potential” by “improving its (OTC bulletin,14August 2015, page 4). Noting that Viviscal was“highly comple- availability for awider range of consumers”. Egisclaimed at the time thatthe deal would mentary” to the company’sBatiste and Toppik The Feminalmenopausesupplement, Folacin makeita“major player” in Poland’snon-pre- hair-care lines, Church &Dwight explained folic acid supplement for pregnant women and scription market, adding to the firm’sstrong that thebrand’sannualsalesofUS$44million Vagilac probiotic line would strengthen Egis’ positions in its domestic market and Russia. were “mainly” generated in the UK and US. “established presence” in the women’shealth Since closing the deal, Egis noted that it had Turning to its 2016 results, the companyre- OTCcategory,the companyinsisted.All three morethan doubled the annualsalesofBiovital ported turnoverupby2.9% to US$3.49 billion, brands had “unexploited distribution poten- by supporting the brand with anumber of suc- thanks to better sales at its Consumer Domestic tial”, Egis added. cessful marketing campaigns. OTC and Consumer International units. OTC

4 OTC bulletin 17 February 2017 COMPANY NEWS OTC

Annual Results GSK sales hit by India move

emonetisation of certain high-value bank Business Annual sales Change (%)* Dnotes in Indiahas heavily impacted sales (£ millions) £Proforma at GlaxoSmithKline’s (GSK’s)Consumer Health- Wellness 3,726 +15 +6 care operation in the country, according the UK- Oral health 2,223 +8 +8 based firm’s chief executive officerAndrew Witty. Nutrition 674 -8 -9 Speaking as thepharmaceuticalsgiant re- ported its 2016 results, Witty said the sudden Skin health 570 +4 -2 withdrawalofall INR500 (C7.03) and INR1,000 TotalConsumer Healthcare7,193 +9 +5 banknotes –said toaccount for over80% of *Changeisatconstant exchange rates the cashincirculation–bythe Indiangovern- Figure1:GSK Consumer Healthcare’ssales in 2016 by business unit. Proforma sales comparisons ment in November had “affected us very sig- include Novartis Consumer Health in Januaryand February2015 (Source –GSK) nificantly toward the end of the year”. flows of those families significantly.” 15% at constant exchange rates to £3.73 bil- Following the abolition of the banknotes, “Cash is beginning to be recycled into the lion (see Figure 1). The performance of Ex- newINR500 and INR2,000 notes were issued marketplace,”Witty noted, adding that GSK cedrin and Tums had been behind the double- on 8November,with the government claiming wasexpecting the issue to be resolved within digit rise, GSK said. that the move wasneeded to fight corruption a“couple more months”. Wellness sales had also been boosted, the and fraud financed by counterfeit notes. Witty made his comment on India as GSK firmnoted, by the continued growth of Flonase Reuters reported atthe time thatthe move had reported turnoveratits Consumer Healthcare AllergyReliefinthe US, which had been intro- disrupted the daily livesofIndians as banks strug- business up by 9% at constant currencies to duced into the market in 2015 (OTC bulletin, gled to expand circulation of the newnotes. £7.19 billion (C8.44 billion). 13 February2015, page 1).Launchinganumber “We’re probably abit moreexposed to this of line extensions to the Flonase range –in- compared to manyother Indian businesses,” Proforma growth of 5% cluding achildren’svariant (OTC bulletin,4 Witty explained, “inthe sense thatalot of our Proforma constant currencygrowth was5%, March 2016,page15) –had helped to drive up Horlicks business is distributed and consumed GSK noted, primarily drivenbysales of its sales of the brand, GSK explained. at avery lowlevel of the income pyramid.” ‘power brands’. Oral health turnoverimproved by8%incon- “These consumers don’thavebank accounts Reported turnoveratConsumer Healthcare’s stant currenciesto£2.22 billion,GSK report- and don’thavecredit cards,”henoted. “The Wellness category –which contains the bulk ed, withSensodynerecording “strong” results reality is this demonetisation affected the cash of the division’sOTC medicines –improved by in Europe and the US. Lineextensions and improved distribution Region Annual sales Change (%)* had driven Sensodyne’s growth in the12 months, (£ millions) £Proforma the companynoted. International 3,241 +8 +5 Turnoverinthe Nutrition category had de- Europe 2,191 +12 +4 clined by 8% in constant currencies to £674 US 1,761 +9 +5 million, the companysaid,due to adifficultyear TotalConsumer Healthcare7,193 +9 +5 for Horlicks. *Changeisatconstant exchange rates “Slower growth in the nutrition category”, particularly in the keyIndian market, had hit Figure2:GSK Consumer Healthcare’ssales in 2016 by region. Proforma sales comparisons include Novartis Consumer Health in Januaryand February2015 (Source –GSK) sales of the drinks brand, GSK explained. Meanwhile, Skinhealth sales had moved for- Annual sales Change 2015/2016 Proportion (£ millions) £CER* of total (%) ward by 4% to £570 million, GSK pointed out. Turning to the regional performance, the Coresales strong showing from Flonase helped lift pro- Pharmaceuticals 16,104 +3 +4 58 forma sales in the US by 5% –9%asreported –to Consumer Healthcare7,193 +9 +5 26 £1.76 billion (see Figure 2). Vaccines 4,592 +14 +12 16 In Europe, sales had advanced by 4% on a Totalcoresales 27,889 +6 +5 100 proforma basis, and 12% as reported, to £2.19 billion, GSKsaid, driven by the growth of Volta- Coreoperating profit ren and Sensodyne. Pharmaceuticals 5,491 +6 +8 68 International proforma sales had moved for- Vaccines 1,454 +38 +47 18 ward by 5% to £3.24 billion, arise of 8%asre- Consumer Healthcare1,116 +42 +40 14 ported, thefirm noted,thanks to the perform- Totalcoreoperating profit** 8,061 +16 +18 100 ance of power brands across the Wellness and *CER is constant exchange rates Oral health portfolios. ** Excluding corporateand other unallocated costs of £290 million Consumer Healthcare contributed 26% to

Figure3:GSK’s ‘core’ sales and operating profit in 2016.er Cor esults exclude amortisation, goodwill, GSK’stotal sales in 2016,whichroseby6% restructuring costs, legal charges and other items (Source –GSK) as reported to £27.9 billion (see Figure 3). OTC

17 February 2017 OTC bulletin 5 OTC COMPANY NEWS

Distribution Agreements/Nine-Month Results Taisho terminates Takeda deal

aisho Pharmaceutical is set to take back Business Nine-month Change Forecast sales Change Tdistribution of its Biofermin subsidiary’s sales (¥ billions) (%) (¥ billions) (%) OTC products in Japan after terminating its Japan 115.7 +1.1 152.0 +2.6 agreementwith fellow JapanesefirmTakeda. International OTCdrugs 12.6 -7.5 17.1 -7.0 Noting that Takeda had distributed products International energy drinks 7.2 -8.8 9.4 -9.4 manufactured by Biofermin since 2013, Taisho said it would start distributing Biofermin’sOTC International other 0.5 –0.9 – portfolio from 1October 2017. International 20.3 -8.4 27.4 -8.3 Despite this change,Biofermin’s prescription Others 2.1 -0.9 2.5 -8.1 medicines would continue to be distributed by TotalSelf-Medication 138.2 -0.4 181.9 +0.7 Takeda, the companyadded. Prescription operations 78.3 -9.2 99.6 -9.0 “Taisho will work to further solidify the posi- tion of the Biofermin brand by directly distri- TotalTaisho 216.4 -3.8 281.5 -3.0 buting its OTCproducts from 1October,” the Figure1:Taisho Pharmaceutical’ssales in the nine months ended 31 December 2016. Forecasted sales arefor the year ending 31 March 2017 compared with actual sales in the year ended 31 firm explained. “Atthe same time, Taisho will March 2016 (Source –Taisho Pharmaceutical) work to maximise the value of the Biofermin brand by implementing measures that takefull tension to the Pabron cold and flu brand. International sales of the division’sOTC advantageofits brand power,includingstrength- Following the close of the period, Taisho drugs slipped back by 7.5% to ¥12.6 billion, ening the product portfolio.” expanded further itsdomesticoffering by launch- while international turnoverfromenergy drinks Taisho announced the changes to its agree- ing in January the Claritin EX allergy-relief declined by 8.8% to ¥7.2 billion. Other sales ment with Takeda as it reported domestic turn- tablets following the product’srecent switch from generated ¥2.1 billion. overatits Self-Medication division up by 1.1% prescription to OTCstatus (OTC bulletin,3 Meanwhile, domestic sales of Taisho’score to ¥116 billion(C955 million)inthe ninemonths February 2017, page 16). Lipovitan brand of tonics and nutrient drinks ended 31 December 2016 (see Figure 1). In Julylastyear,Taishosignedalicensing fell back by 3.2% to ¥47.4 billion during the Agood performance from the Biofermin and commercialisation agreement for an OTC nine months (see Figure 2). range and Pabron cold remedieshad offsetlower version of Claritin in Japan with Bayer (OTC Turnoverfrom Lipovitan Ddropped by 3.5% sales of Lipovitan tonics and the RiUP hair- bulletin,12August 2016, page 10). to ¥30.5 billion, while sales of other Lipovitan regrowth brand, Taisho noted. Meanwhile, overall turnoveratTaisho’sSelf- products slipped by 2.6% to ¥17.0 billion. During the nine months, Taisho had con- Medication division slipped back by 0.4% to Sales of Lipovitan had been hit by “weak tinued toexpand itsOTC offering in itsdomestic ¥138 billion in the nine months, as the single- demand” during the “peak summer sales sea- market by rollingout anumber of newproducts, digit rise in domestic sales failed to offset an son”, Taisho explained. the company pointed out,including the Natural- 8.4% drop in international turnoverto¥20.3 Meanwhile, sales of RiUp hair-regrowth care functional food, Cobarasapoto appetite- billion. Other sales accounted for the remain- productsdropped by2.7%to¥12.3billion, while suppressant, and the Jiyounaifukueki line ex- der of the unit’sturnover. turnoverfromthe Naron range of pain and fever products declined by 7.1% to ¥2.6 billion. Business Nine-month Change Forecast sales Change By contrast, turnoverfromPabroncold rem- sales (¥ billions) (%) (¥ billions) (%) edies had advanced by 4.6% to ¥18.8 billion, Lipovitan D30.5 -3.5 37.9 -1.7 Taisho said, thanks to better sales of mainstay Other Lipovitan 17.0 -2.6 21.8 -0.5 general cold remedies. The Zena brand of en- TotalLipovitan 47.4 -3.2 59.7 -1.3 ergy drinks had also performed well, the firm added, with sales up by 8.0% to ¥2.3 billion. OTC Cold remedies (Pabron brand) 18.8 +4.6 25.8 +4.2 Hair treatments (RiUP brand) 12.3 -2.7 16.4 -1.2 Biofermin 6.7 +24.5 8.2 +10.2 IN BRIEF Livitaseries 2.9 -1.6 3.9 -0.8 Gastrointestinal treatments 3.0 -3.3 4.0 -2.3 BOIRON –the French homoeopathyspecial- ist–isset to acquire LaboratoireFerrier from Analgesics (Naron brand) 2.6 -7.1 3.5 -5.1 privately-held Arkopharma for an undisclosed Laxatives (Colac brand) 2.5 -0.1 3.4 +1.3 sum.The transaction is expected tocloseon1 Cold remedies (Vicks brand) 2.9 +0.5 3.6 +1.4 March.Boironpointed outthatFerriermarketed Zena brand 2.3 +8.0 3.0 +12.0 homoeopathic medicines within French phar- Other Self-Medication products 2.1 -0.9 2.5 -8.1 macies and generated sales of C2.4 million in TotalDomestic Self-Medication 115.7 +1.1 152.0 +2.6 2015. Ferrier’sportfolio includes the Contusium pain-relief line and the Urtikium treatment for Figure2:Breakdown of Taisho Pharmaceutical’sSelf-Medication sales in Japaninthe nine months insect bites. “The acquisition is in the process of ended 31 December 2016. Forecasted sales arefor the year ending 31 March 2017 compared with actual sales in the financial year ended 31 March 2016 (Source –Taisho Pharmaceutical) being finalised,”Boiron noted. OTC

6 OTC bulletin 17 February 2017 COMPANY NEWS OTC

Mergers &Acquisitions/Annual Results RB set to grab Mead Johnson

Continued from front page Business Annual sales Change 2015/2016 Proportion and children’snutrition division within RB, the (£ millions) £CER* of total (%) companypointed out. Hygiene 4,066 +13 +4 41 Rakesh Kapoor,RB’schief executive officer, Health 3,332 +13 +4 34 said the dealwas a“significantstep forward in Home 1,828 +7 -1 18 RB’sjourneyasaleader in consumer health”. Portfolio Brands/Food 665 +6 -5 7 “With the Enfafamily of brands, which is the TotalRB9,891 +11 +2 100 world’s leading franchise in infantand child- *CER is constant exchange rates ren’snutrition, we will provide families with Figure1:RB’ssales in 2016 broken down by business (Source –RB) vital nutritional support,”heclaimed. Acquiring Mead Johnson wasa“naturalex- panysaid, while the Enfafranchise –lead by Fast Max and Sinus Max franchises, the firm said. tension” to RB’s consumer healthcare‘power- Enfamil –would be the firm’slargest power- RB’svitamins, minerals and supplements brands’, Kapoor said, adding that Mead Johnson’s brand, ahead of the Air Wick, Dettol, Durex, (VMS) portfolio had also performed well, the geographic footprint would strengthen “signifi- Harpic, Lysol, Nurofen, Scholl and Vanish brands. company noted,with its keybrands–Airborne, cantly” RB’sposition in developing markets. At an operational level, RB’s“extensive Digestive Advantage, MegaRed and Move Free – Oncethe deal is closed, developingmarkets multi-channel go-to-market and global brand- all growing. Move Free had had astrong year, would account for 40% of RB’sglobal sales, ing capabilities across consumer health”, the the firm said, following its launch in China. Kapoor pointed out,with China becoming the companysaid, would “add value to the Mead On amore negative note, RB pointed out firm’ssecond-largest market. Johnson business by enhancing its position in that Health’sperformance in 2016 had been sig- Expanding on the rationale forthe deal,RB keymarkets”. nificantly impacted by weakness in the Scholl/ said that adding Mead Johnson’s “deep under- Meanwhile, RB’sretail scale and “whitespace Amopé franchise, which had experienced a standing of anew mother’sjourney”, along expertise” would accelerate the launch of Mead double-digit decline in sales. with its “well-established relationships with Johnson’sbrands into newmarkets,the firm add- This had been due, commented RB, to the healthcare professionals”, would enhance RB’s ed, and bothcompanies would benefit from their combination of ahigh comparative with the reputation with the “millions of mothers” it cur- “complementary e-commerce expertise”. prior year and the failure of the Wet&Dry in- rently reaches through its hygiene education RB announced the Mead Johnson dealshort- novation to meet expectations. programmes and withthe children’svariations ly before reporting2016 sales that had increased RB’sHealth businessaccounted for34% of of its Nurofen and Mucinexbrands. by 11% to £9.89 billion. At constant exchange thecompany’stotal 2016 sales, while the firm’s Furthermore, the deal gave RB aleading rates, turnovermoved forward by 2%. Hygieneoperationgenerated 41% and its Home position in the global infant and children’s Sales at the firm’sHealth business improved category 18%. The remainder came from Port- nutrition category,the companyadded, which by 13% –4%atconstant exchange rates –to folio Brands and Food products. wasexpected to growatbetween 3%-5% per £3.33 billion (see Figure 1). On aregional basis, overall group sales in annum in the medium-to-long-term. Health’slike-for-likegrowth of 4% for the Europe and North America (ENA) –which also Growth in the category wasunderpinned by year represented an “average result versus the includes Australia/NewZealand, along with demographic trends, particularly in develop- market”, RB said, and fell short of its ambi- Russiaand the Commonwealth of Independent ing markets, RB pointed out, such as economic tion to outperform the consumer healthcare States(CIS) –increased by 10% to £6.41 billion growth,urbanisation, increasing spend on pre- market globally. (see Figure 2). miumnutrition and special nutritional needs, Durexhad exceeded expectations, RB point- Commenting on the regional performance, ahigher proportion of mothers choosing to ed out, with better sales of the Invisible extra- RB said growth in ENAhad been hit by aflat work while their children were young, as well thin condom line in anumberofmarkets and the performance in the US and adouble-digit de- as changes to China’sone child policy. launch of the K-Y Duration spray in the US. cline in Russia. This had been offset by amore Mead Johnson’sinfant and children’snutri- Furthermore, Mucinexhad enjoyed agood robust performance across Australia, France, tion business would increase RB’sconsumer year,which had included the successful launch Germany, Spainand the UK. healthcare revenues by around 90%, the com- of the Clear and Cool range of liquids into the RB’sDeveloping Markets, or DvM, report- ing region–consisting of the Middle East, Region Annual sales Change 2015/2016 Proportion (£ millions) £CER* of total (%) North Africa and Turkey,Sub-Saharan Africa and Latin America, as well as North Asia and Europe and North America** 6,410 +10 ±0 65 South and South-East Asia –posted sales up Developing Markets*** 3,070 +14 +8 31 by 14% to £3.07 billion, thanks to growth in Food**** 411 +18 +5 4 China and India. TotalRB9,891 +11 +2 100 While RB recorded growth in most DvM *CER is constant exchange rates ** Europe and North America region also includes Australia/NewZealand, along with Russia and the Commonwealth countries, the firm noted that the competitive of Independent States (CIS) market remained challenging in Brazil, while *** Developing Markets region consists of the Middle East, North Africa and Turkey,Sub-Saharan Africa, and Latin America, as well as North Asia and South and South-East Asia the geopolitical environment in Saudi Arabia **** Food is notreportedaspartofany region and Turkey had somewhat impacted sales in Figure2:RB’ssales in 2016 broken down by region (Source –RB) those countries. OTC

17 February 2017 OTC bulletin 7 OTC COMPANY NEWS

Spotlight on… Welmedix Consumer Healthcare

l ESTABLISHED: 2009 l PRODUCTS: First DegreeMaximum l BASED: New Jersey, US Strength Burn Care pain- and l SALES: US$7.0 million itch-relief treatment, (€6.8 million) (2017 estimate) SunBurnt Advanced After Sun l LEADERSHIP: Recovery sun-care line, Welmedix HomeCare PRO skin-care regimen Avani Kanubaddi, president and chief l MARKETS: India, the US executive officer l WEBSITE: welmedix.com

BUSINESS FOCUS Aid in 2016. Last year it became the fastest- bringing afull range of hospital-grade skin- “Welmedix Consumer Healthcare is afast- growing product in the US after-sun category,” care to the consumer in their home.” growing skin- and wound-care company, provid- he pointed out. ing high quality products in speciality non-pre- Notingthatthe firm had recently expanded FUTURE STRATEGY scription categories,”according to the firm’s the range with aDaily After-Sun lotion and “Weaim to generate US$10-US$20 mil- president and chief executive officer Avani Ultra-Hydrating Face Mask product, Kanubaddi lion (C9.4-C18.8 million) in sales within the Kanubaddi. “Our company is proficientinde- said Welmedix had plans to add further line next twoyears,”Kanubaddi stressed, “although signing, developing and marketing OTCbrands extensions and hoped to takethe brand into with acquisitions we could become signifi- that are uniqueand fill unmet consumer needs.” markets outside the US, such as Australia, cantly larger than that.” Based in Princeton, NewJersey, Welmedix Europe and South America. “Wewill be brand acquirers,”heinsisted. had been set up to help address underserved In addition to its success with SunBurnt, “Wecontinuously look out for good assets consumer healthcare needsinfirstaid, sun-care Welmedix was“incredibly bullish” about its that will help our portfolio become stronger. and elderly-care, Kanubaddi noted. Welmedix HomeCare PROskin-care range, We are very good at marketing and building “Weworked for years developingthree pro- Kanubaddi said. brands –that’sacore skillset for us.” prietary brands and recently started rolling them “Welmedix HomeCare PROisspecially Welmedix would also “grow organically”, out nationally,” he said. The firm’sportfolio designed for skin affected by incontinence, Kanubaddipointed out,byentering newmar- includes First Degree Maximum Strength Burn scleroderma, disability, reduced mobility and kets through partnerships, and by rolling out Care products, the SunBurnt Advanced After drying, thinning or hardening,” Kanubaddiex- newproducts. Sun line, and the Welmedix HomeCare PRO plained.“Ourhospital-grade products are ac- “Wewill be extending our HomeCare PRO skin-care regimen to aid family caregivers. companied by patient information to teach a elderly-care platform to design solutions for “Welmedix is helping to open up import- provenregimen –asused by nurses –tohelp the ageing population around the world,”Kan- ant OTCcategories in home healthcare, sun clean, protect and treat fragile skin at home.” ubaddi revealed. recovery and first aid with its vainno tions. The Sold in CVS and online through Amazon, The firm wasalso “actively seeking” new companyispassionate about developing and these products could “help to maintain skin technologies that it could “embed” into its marketing products for the special needs of integrity in elderly consumers”, Kanubaddi said. brands,hesaid. “Wewant thatinnovation en- adults with fragile skin–skinaffected byage, “Webelieve we are one of akind in the US, ginetobesomething we’re known for.” OTC disability or health conditions.”

KEY BRAND “Our fastest-growing brand is SunBurnt Advanced After Sun,”Kanubaddi revealed. “SunBurntisapatented combinationofnatural ingredients –including aloe –inaunique non- stickyformula thatinstantly cools,rehydrates and helps reduce itching and peeling.” “Welaunched SunBurntinWalmart in 2015, and then expanded into Walgreens and Rite

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

8 OTC bulletin 17 February 2017 COMPANY NEWS OTC

Business Strategy/Third-QuarterResults Prestige plots Fleet growth

cquiring CB Fleet represented “a mile- “When you compare the Fleet opportunity Astoneinthe evolution”ofPrestigeBrands, to the other acquisitions that we’ve done,”Lom- according to the company’s chief executive bardi noted, “this business has more momentum officer Ron Lombardi. and has avery strong history of being well Speaking as the firm reported the results managed and heavily invested behind.” of its third quarter ended 31 December 2016, “We’re stepping into the shoes of avery Lombardi said closingthe Fleetdeal–announc- strong-performing business,” he insisted. “Our ed in December last year (OTC bulletin,13 intent is to continue to invest behind that and January 2016, page 3) –“strengthens Prestige’s we expect thesolid trendsthat Fleet has realised platforms in women’shealth, gastrointestinal in the lastcouple of years to continue into 2018.” and dermatology”. Turning to Prestige’sthird-quarter results, Prestige’sSummer’sEve brand With annual sales of around US$205 million Lombardi reported North American OTCturn- (C191 million),Fleet’sUSportfolio includes the overupby7.4%toUS$177 million. Away from DenTek, Lombardi said Pres- Summer’sEve feminine-hygiene range, Pedia- Better sales of core OTCbrands and the tige’score OTCbrands had enjoyed “continued Lax paediatric laxatives, Fleet gastrointest- acquisition of DenTek Oral Care had helped gains in consumption” during the three months. inaltreatments, and the Boudreaux’sButt Paste driveupsales in the three months, Prestige said. International OTCturnoverhad advanced by nappy-rash line. Prestige was“very pleased” with the per- 33.6% to US$18.5 million, Prestige noted, driv- “Summer’sEve has becomeour largest brand formance of DenTek, Lombardi said, noting en by the additionofDenTekand “high single- and fits wellwith our women’shealthcare focus that the brand had generated sales of US$17.3 digit” growth at its Australian Care business. and efforts,”Lombardi insisted. “Weplan to million in the three months. The firm snapped OTCsales accounted for 90% of Prestige’s quickly integrate Summer’sEve and work with up DenTek and its range of oral-care products total third-quarter turnover, whichincreased by retailers to introduce newproduct innovation, for US$225 million in late 2015 (OTC bul- 8.3% to US$217 million. The remainder wasgen- supported by effective marketing.” letin,11December 2015, page 5). erated by the Household Cleaning unit. OTC Lombardi also highlighted the Fleet brand, which heclaimed would “becomeour largest brand in thegastrointestinal category and help to anchor our efforts in the space”. “Fleet holdsthe number-oneposition in the OTCenema and suppository subcategories in Leading Innovation and Vision the US,”Lombardipointed out, “and similar to Summer’sEve,wesee clear innovation pipe- line opportunities.” Noting that the integration of Fleet was“al- readyoff to aswift start”, Lombardisaid Prestige was“excited about the opportunities ahead” for the business.

IN BRIEF

TAKEDA reported turnoveratits Japanese Consumer Healthcaredivision up by 2.5% to ¥65.5 billion (C541 million) in the nine months ended 31 December 2016, thanks to im- proved sales of keyproducts. Alinamin tonics –the unit’ssecond-best-selling brand –had been the stand-out performer in the period, Takeda 1 Pharmacy Sales, Marketing & Distribution 5 Brand Strategy pointed out, with sales up by 7.2% to ¥13.3 bil- lion. Sales of the Biofermin range of gastroin- 2 Global Grocery H&B Sales, Marketing & Distribution 6 Creative Design testinal treatments advanced by 5.5% to ¥7.1 3 Category Management & Shopper Insight 7 Data Insight billion, while turnoverfromthe Borraginol haem- orrhoid brand improved by1.3%to¥3.5bil- 4 Field & Experiential Marketing 8 Advisory lion.Onamorenegative note, the unit’s best- selling brand, Alinamin vitamin tablets, had en- Get in touch today! dured adifficultnine months, Takeda noted, with Visit www.ceutagroup.com - Call +44 (0)1202 449763 - email [email protected] sales slipping by 6.8% to ¥19.1 billion. OTC

17 February 2017 OTC bulletin 9 OTC GENERAL NEWS

RegulatoryAffairs ASMI wants schedule 3ads

llowing advertising for schedule 3–phar- volvingalmost1,300consumers, 500pharma- Amacist-only –medicines in Australia would cistsand 500 pharmacy assistants to assess the enhancethe roleofpharmacists, lead to better impact of amock television advertisement. This health outcomes for consumers and save the followed the ASMI’sproposed infomercial for- government money, accordingtothe Australian mat for apharmacist-only product. Self Medication Industry (ASMI). The researchersselected aproductcategory Launching newresearch which it claims –cold-sore antivirals –which does not have shows that enabling firms to advertise phar- an AppendixHexemption, andused a‘test and macist-only medicines would improve health control’ environment with choice modellingto outcomes, the ASMI argues current laws that isolate the impact of the advertising model on “prohibit consumer advertising of schedule 3 consumers, pharmacists and pharmacyassistants. ASMI has produced amockadvertisement medicines are out of step with international practice and delivernopublic health benefit”. Positiveimpact on use Vineyclaims, “and that theywere quite com- Currently,pharmacist-only medicines cannot Commenting on the research –which was fortable referring people [to GPs].” be advertised to consumers, exceptthrough an designed to determine the impact of the pro- These findings, the ASMI insists, dispel AppendixHexemption, the ASMI points out, posed model on the Quality Use of Medicines mythsthatrecommendations from pharmacists which has made such products “largely invis- (QUM) provision within Australia’snational andtheir staff are “influencedbyconsumer ad- ible to the wider public”. medicines policy–Rosalie Viney, professor of vertising, and that pharmacists and pharmacy To demonstrate thatpharmacist-only prod- health economics and director of CHERE, points assistants buckle under the pressure of custom- uctscan be advertised safely and that doing so out that the evidence suggests that the ASMI’s ers demanding branded products after seeing will benefit consumers, the ASMI is propos- model“could have apositive impact on theQUM”. them advertised”. ing an “alternative model” for advertising the “Unfortunately,there is limited consumer DeonSchoombie,the ASMI’s chiefexecu- product. Thismodel,itasserts, has beentested awareness around pharmacist-only medicines,” tive officer,saysthe study highlights “poten- by the Centre for Health Economics Research Vineystates, “so manypeople don’tthink to go tial health benefitsofrelaxing advertisingre- and Evaluation (CHERE) at the University of to apharmacist for aminor ailment that could be strictions for schedule 3medicines”. Technology Sydney(UTS). treated fairly easily,without the need for adoctor.” “Importantly,the advertisement createdmore “Our research,”she adds, “showed that the awareness about health conditions and encour- Three coreelements proposed advertising model significantly in- aged consumerstoopen up aconversationwith The proposed model, the ASMI explains, creased the likelihood of consumers engaging their pharmacist,”headds. “This hasthe poten- comprises three core elements: in conversations with pharmacists about their tial to free up GPs’ time for the treatment of l Education on the condition/disease health conditions and treatment options.” more serious conditions while reducing costs l Branded product information Importantly,Vineysays, pharmacists and phar- to the healthcare system.” l The roleofthe pharmacist in determin- macyassistantsinvolved in the study “were not ing whether the medicine is appropriate for influenced by the consumer advertising and regu- Discourage innovation the consumer. larly chose the most appropriate treatment for “The current advertising restrictions discour- Furthermore, the proposed model advocates the consumer”. ageinnovation in the medicines sector because distributing clinical protocols and productin- “The pharmacists’ responsesindicated that theyare an obstacle to switching medicines formation to allpharmacies prior to the start of theywere not likely to recommend an anti- from prescription to non-prescription,”heargues, consumer advertising. viral to someone whose condition indicated “and they leave Australia out of stepwithcoun- CHERE conducted arandomised study in- that they should seeageneralpractitioner(GP),” tries such as NewZealand.” Included in the proposed advertising model is aclearly-defined “non-advertisable”list for Promotional Campaigns pharmacist-only products whichhaveahistory of misuse, abuse or diversion for illegaluse, Afipa starts Frenchcampaign Schoombie adds. If implemented, the default rench self-medication industry association Underthe slogan ‘selfcare et automédication advertising position will become one which FAfipa is seeking to generate debate over ne sont pas desgrosmaux’ –or‘self-care and allows advertising for all schedule 3products, the value of self-care with apromotional cam- self-medication are not bad things’, the asso- he notes. Those which feature on the “non-ad- paign launched on 13 February. ciation’s advertisement callsonFrenchPresi- vertisable”list will be theexceptions. Through advertisements in national news- dential candidates to note that self-medication The association is planning to propose its papers, promotional activitiesonradio stations is “largely adopted by French citizens”, but alternative model for advertising pharmacist- and an open letter being sent to “political deci- could save afurther C1.5 billion annually for only medicines at an upcoming government sion-makers” in France,the association is aiming health insurers. reviewofmedicines in March. To seethe full to “makeour policy-makers aware that self-care “Developing self-medication is an appropri- CHERE study on the ASMI’sproposed ad- should be integratedinto future health strategy ateresponse to the current challenges facing our vertising model for schedule 3products visit: by our next government”. healthcare system,”Afipa insists. OTC https://tinyurl.com/jo27cxn. OTC

10 OTC bulletin 17 February 2017 GENERAL NEWS OTC

Market Research Switches Germans need Sanofi expands with moreadvice Xyzal Allergy switch third of the Germanpopulation would like Amoreadvice on howto usemedicines cor- rectly, according to the country’s medicines anofi is set to expand further its reach into 2013 (OTC bulletin,25October 2013, page 1). manufacturers’ association, the BAH. StheUSOTC allergy market after the US “The FDAapprovalofXyzal builds on our her- The results of the BAH’s‘Health Monitor’ Foodand Drug Administration (FDA) approved itage of successful prescription-to-OTC switches, survey – carried out by market researcherNiels- its prescription-to-OTC switch of thelevocetirizine and adds another trustedoption to our existing en with 1,000 people in the final quarter of dihydrochloride-based Xyzal Allergy 24HR. portfolio of OTCallergy medications,”saidRob- 2016 – showed that 90% of those wanting more Xyzal Allergy – which will be available as ert Long, head of Sanofi’sNorth America Con- information about medicines in general would 5mg tablets for ages six and over, as well as sumer Healthcare business. prefer to receive it from their doctor. 0.5mg/ml oral solution for ages twoand over– “Welook forward to making Xyzal available joins Allegra Allergy and Nasacort Allergy 24HR to allergy sufferers across the country,asthe lat- Morepharmacist advice in Sanofi’sgrowing US OTCallergy portfolio. est product in our growing Consumer Health- Around 70% expected more advice from Sanofi launched the fexofenadine-based Al- care business,”headded. their pharmacist, 45% wanted more from the legra Allergy in early 2011 after asuccessful Sanofi gained the OTCrightstoXyzal in the product packaging, 35% from the manufacturer switch application (OTC bulletin,11Febru- US from UCB. and 27% from the internet. ary 2011, page 16). The company took full controlofthe brand When it came to minor ailments,peoplegen- It followed that up with the switchofthe tri- in 2010,having co-promotedXyzal in the US erally appreciated the advice givenbypharma- amcinoloneacetonide-based Nasacort Allergy in with UCB since 2006. OTC cists, the BAHsaid, no matterwhattype of medi- cation theywere looking for. Over 80% of those surveyed said that the ex- IN BRIEF pert adviceprovided by pharmacists wasimport- ant to them, whether theywerebuying astandard CHPA – the US Consumer Healthcare Prod- healthcare choices” and that theywanted “more medicine or aherbal or homoeopathic drug. ucts Association – has welcomed the appoint- self-care choices, including OTCmedicines”. One ment of TomPrice as SecretaryofHealth and of Price’sfirstpriorities will be to propose an FDA Industrytoprovide more Human Services (HSS), the US department Commissioner.The CHPA urged Price to choose Hermann Kortland, deputy chief executiveof thatoversees the Food and Drug Administra- an FDAchiefwiththe “abilitytodeal with com- the BAH, said that the results showed that the tion (FDA). The CHPAsaiditwas confident plexity; decisiveness andarespectfor risk; medi- industryand other stakeholdersshould provide that Price believedthatAmericanswanted to cal and scientific knowledge; and apassion for the more information to consumers about the drugs be “empowered to makesmart and effective FDA’smission, vision and accountability”.OTC theywere taking and howtotakethem correctly. An informed patient, he claimed, wasmuch more likely to takethe medicine correctly and recoverfaster. OTC

IndustryAssociations AESGP meeting venues revealed

msterdam in the Netherlands will be the Avenue forthe 54th annualmeeting of the Association of the European Self-Medication Industry, the AESGP, which will be held on 5-7 June 2018. The following year,the 55th AESGP annual meeting will takeplace in Geneva,Switzerland on 4-6 June. This year,the annual gathering of Europe’s keyleaders in consumer healthcare will take placeon30May-1 JuneinVienna, Austria. More details on this year’smeeting can be found on our Events page (see page 19) or on the web- site: aesgp.eu/events/Vienna53/. OTC

17 February 2017 OTC bulletin 11

OTC GENERAL NEWS

RegulatoryAffairs Switches PASMI backs Australia rejects GSL access he Polish government’s proposed reduc- vardenafil switch Ttions in packsizes and dosagesfor com- monOTC medicines by the end of 2017 will ustralia’s Therapeutic Goods Adminis- preparations containing 10mg or less of vardena- spell the end of non-pharmacy sales of such Atration (TGA)has rejected an application fil in packs of no more than eight dosage units products,according to the Polish Association from Bayertoswitchthe erectile-dysfunction to be switched to pharmacist-only status. of the Self-Medication Industry (PASMI). drug vardenafil from prescription to pharma- In support of the move,Bayer argued that Commenting on the government’splans to cist-only status. the switch would improve access to safe and reduce the maximum dosage and levelofac- Explaining its reasons for rejecting the applica- effective treatments for erectile dysfunction and tive ingredients in general-sale list (GSL) an- tion, the TGA noted that theswitch waspredi- reduce the stigmasurroundingthe conditionthat algesics, cough, cold and gastrointestinalprod- cated on providing pharmacists with additional prevented men from going to the doctor. ucts, PASMI said that the newrequirements training and introducing anew supply protocol. Rescheduling vardenafil up to 10mg in- “dis would lead to the end of non-pharmacysupply, However, additionaltraining forpharmacists tinctively-labelled packs of up to eight dosage as it would not be economically viable for manu- andthe useofaspecific supplyprotocol could units as schedule 3medicines,when supplied facturers to produce lower-dose products and not be “mandated for the supply of pharma- by trained and accredited pharmacists accord- smaller pack sizes. cist-only schedule 3medicines”, theTGA said. ing to astrict screening protocol”, the appli- 90% of the OTCmedicinal products avail- Furthermore, erectile dysfunction could be a cation claimed, would “provide better access able for sale outside of pharmacywould “dis- marker of an underlying cardiovascular disease, to effective treatmentfor men with erectiledys- appear”, the association claimed, if the changes diabetes or endocrine disorder,the TGA said, function and alow-risk cardiovascular status”. were implemented. andmen should be assessedbyamedical practi- “More broadly,the proposed treatment al- tioner before using an erectile-dysfunctiondrug gorithm could be seen as apatient screeningpro- Reduce access to OTCdrugs such as vardenafil. gramme focused on cardiovascular risk indica- Ahuge swathe of the Polish population – There were also concerns around the mis- tors,”itadded, “that can identify at-risk patients particularly those in small towns or rural areas use of erectile-dysfunction drugs, especially earlier and thus improve health management – wouldhavenoeasy access to basic medica- when used in combination withotherdrugs such and wellbeing for Australian men.” tions, the association warned. Manydid not live as MDMA, the agencysaid, and the switch of Furthermore, offering an erectile-dysfunction withinareasonable distance of apharmacy or, vardenafil to pharmacist-only statuswould most drug such as vardenafil gale lly without apre- if theydid live close by,the pharmacydid not likely not reduce illegalinternet sales of such scriptioncould help combatthe growing trend open at weekends. drugs or access to overseas supplies of the drug. of men buying unapprovederectile-dysfunction Taking the example of the government’splans The switch application had called for oral drugs on the internet, it pointed out. OTC to reduce the maximum dose of paracetamol in GSL productsfrom500mg to 300mg, PASMI RegulatoryAffairs said thatmanymanufacturers did not produce the druginsuch alow strength,asthe standard Industry tackles EU shortages dose for treatingpainand feverwas 500mg. Only one manufacturer in Poland currently he Association of the EuropeanSelf-Medi- parts of the supply chain, improveddata infra- produced a300mg paracetamolproduct, PASMI Tcation Industry, the AESGP, has teamed structure and collaborative governance processes, said, and this wasnot enough to guarantee supply. up with other European healthcare industry the trade bodies claimed, would help with early If the government wasdetermined to push associations to publish aseries of recommen- detection and assessment of potential shortages. through thechanges,industry must be giventime dations on how bettertotackle medicinesshort- The recommendations aimed to “mitigate to adjust, PASMI insisted. ages in the European Union (EU). the impact of shortages on patients”, the asso- Under the current proposal, manufacturers Noting that evidence suggested that medicines ciations said, and provide patients and health- would be givenjust 30 days to implement the shortages were becoming an increasingproblem care professionals with “up-to-date, meaning- changes, the association said, whichwould cause acrossthe EU, theassociations said that it was fulinformation and improve theabilityofhealth ashortage of supply for manyproducts. imperative that there was“greater transparency systems to diagnoseand solvesupply issuesas Instead, the government should allowcurrent and availability of medicines shortage data”. theyarise”. stocks of affected products to be sold overasix- Ensuring consistencyofreporting, increased To viewthe recommendations in full visit: monthperiod. Thiswould give manufacturers accesstothe information available across all https://tinyurl.com/gogf3gt. OTC time to change theirproduction activities to meet the newrequirements, PASMIsaid,while also enabling wholesalerstoreduce inventory. IN BRIEF The governmentshould alsore-thinkthe pro- FDA – the US Food and DrugAdministration aresult, the agencyhas requested that manu- posed changes to aspirin and paracetamol, the – has issuedawarning thatithas receivedan facturers of OTCantiseptic products containing association added, and leave the allowed dose increasing number of reports of rare butserious chlorhexidine gluconate add awarning about at 500mg, which wasthe dosage that had been allergic reactionstoantiseptic skin-care prod- rare butserious allergic reactions to the prod- provento be most effective. OTC ucts containing chlorhexidine gluconate.As ucts’ Drug Facts label. OTC

14 OTC bulletin 17 February 2017 MARKETING NEWS OTC

Product Launches Flonase Sensimist launches

entle mist, powerful relief” is Glaxo- gies. It is said to relieve nasal allergy symptoms, “GSmithKline (GSK) Consumer Health- such as nasal congestion, runnyoritchynose care’smessageto US consumers to support its andsneezing, in sufferers aged overtwo years. Flonase Sensimist allergy-relief nasal spray. It is also indicatedfor itchy, watery eyes in those The launchofFlonaseSensimist–whichpro- over12years old. vides 27.5µg per spray of the glucocorticoid Flonase Sensimist wasswitched last year. fluticasone furoate –comes around sixmonths Expands Flonase range The spray (below)has an “ergonomic” design after the US Food and Drug Administration The spray joins the Flonase Allergy Relief (FDA)approvedthe prescription-to-OTC switch product launched twoyears ago following its of the product, which waspreviously available switch to OTCstatus (OTC bulletin, 13Feb- on prescription carrying the name Veramyst ruary 2015, page 1) and the Children’sFlo- (OTC bulletin, 12August 2016, page 1). nase Allergy Reliefproductthatrolled outlast Flonase Sensimist –which GSK noted was March (OTC 4bulletin, March 2016, page 15). scent-free and alcohol-free –used “unique ‘Mist- Both of these Flonase products provide 50µg Pro’technology”, the firm said, todelivera“fine, fluticasone propionate per spray. gentle, yet incredibly powerful mist spray” that Likethe earlier launches, the Sensimist vari- consumers could “barely feel”. ant is said to help block six inflammatory sub- The spray featured an “ergonomic” and “user- stances: chemokines; cytokines; histamine; leuko- friendly” packaging design that “fits perfectly trienes; prostaglandins; and tryptases. viapromotional links on the brand’s Facebook in your hand”, GSKadded, witha“side-actuated The spray is also claimed by GSK to provide and Twitter profiles, which directed them to pumptrigger” to “deliverconsistent dosing every “40% more powerfulrelief” fornasalsymptoms the flonase.com website. time”. It alsohad a“less invasive”shortnozzle than“aleading non-drowsy allergy pill” contain- GSK said the spray would be promoted and offered “virtually no drip”. ing 180mg fexofenadine. through website content, social-media activity, FlonaseSensimist is indicated for symptoms Consumers have been able to pre-order Flo- video assetsand “exciting campaigns plannedto associated with seasonal and perennial aller- nase Sensimist since the beginning of the year coincide with the allergy season this spring”.OTC

Marketing Campaigns Alkem to push Tiger Balm

ndia’s Alkem Laboratories has signed adeal billion (C279 million) at retail as of 2015, ac- Iwith Haw Paw Healthcarefor the exclusive cording to Euromonitor figures. Topical OTC rights to market, sell and distribute the Tiger products accounted for more than 70% of the Balm herbal pain-relief brand in its home market. market, Alkem added. Under the terms of the agreement –struck Alkem also noted that 90% of total OTC with Singapore-based HawPar’sIndiansub- analgesic sales took place in pharmacies, where Homoeopathic oral drops to treat rheumatic sidiary–the products will be promoted through the companyhad a“strong reach”. complaints have been added by German Alkem’s OTCdivision, Alkem Healthcare, which Commenting on the partnership, Prabhat natural-products companyHeilpflanzenwohl to its domestic product portfolio. plans to start marketing activity for TigerBalm Agrawal, Alkem’schiefexecutiveofficer, point- Formulated with“sevennatural active ingredients” during the firm’scurrent quarter. ed outthat Tiger Balm –which has been avail- – berberis (barberry); colchicum; ledum (wild The deal marks Alkem Healthcare’s first entry able in India for overadecade –was “a very rosemary); Thuja occidentalis; Phytolacca americana (pokeweed); Spiraea ulmaria into the Indian OTCanalgesics market, which well-known OTCanalgesic brand worldwide (meadowsweet); and sulphur –Gelencium the companyclaimed waswortharound INR20 with ahigh consumer recall”. targeted “all types” of rheumatic joint ailments, “Combined with Alkem’sstrong sales and the companyclaimed, including osteoarthritis, rheumatism and gout. distribution infrastructureand robustexecutional Claiming that joint wear wasthe cause of capabilities in India,”headded, “we believe it is recurring joint complaints in 12 million Germans, abefitting alliance which can not only grow Heilpflanzenwohl said 90% of sufferers repeatedly used only chemical analgesics to relieve the Tiger Balm’sfranchise in India butalso add pain, meaning that cartilage wear and resulting significant thrust to Alkem’sOTC business.” joint inflammation usually remained untreated. TheTiger BalmlineinIndia comprises a The firmsaid that Gelencium’s‘three-way’formula relievedpain,enabled the regeneration of cartilage red balm for sore and aching muscles, and a in the joint, and fought joint inflammation. white balm for tension headaches. Both prod- Five drops should be takendaily foracute ucts can also be used for insect bites and are complaints, and three formild chronic symptoms. Gelencium is suitable foradults over18years of formulated with cajuput oil, camphor, clove oil age,except pregnant or breastfeeding women. OTC The Tiger Balm line in India and menthol. OTC

17 February 2017 OTC bulletin 15 OTC MARKETING NEWS

Product Launches/Marketing Campaigns Galderma treats adult acne

Sadult acne sufferers are“underserved” troducing under the Differin brand anon-foaming, Ubelieves Galderma, which is targeting this fragrance-free Balancing Cleanser and “gentle” group with its recently-switched Differin 0.1% Balancing Moisturiser.Neither of these two adapalene gel. products contains anymedicated ingredients. “People thinkthatacne is aproblemfor teen- Galdermawas recommendingathree-step agers, andtheydon’tknowwhy theystill have skin-care regimen to complement the gel, Risser it in their 20s and 30s,”commented June Risser, explained. This avoided or reduced‘retinisation’ vice president for marketing at the firm’scon- –mild irritation and dry skin, experienced by sumer business unit. 50% of users of retinoid-based acne products. “It’simportanttousthatpeople understand “Tominimise retinisation and really helpthe what causes their adult acne, and howtosolveit,” patient go through the [treatment] process, we she added, noting howawidearrayofdigital and recommend agentle cleanser, and then ada- social-media platforms were among those being June Risser palene. This shouldbeappliedoncedailywith used to educate Differin’sintended audience. amoisturiser, and that’swhy the launch port- When the US Food and DrugAdministration seeamajor opportunitytohelp adultswithacne, folio includes those three stock-keeping units (FDA) approvedthe switch of adapalene in July mainly because it’ssuch afrustrating issue,” (SKUs),”she explained. 2016 (OTC bulletin, 22July 2016, page 1), Risser insisted. While the cleanser and moisturiser would the US became one of the first countries in the “Our bullseye [target] is females in their form part of the launch marketing campaign world to allowOTC sale of the retinoid, which late 20s suffering from mild-to-moderate acne,” for Differin –which uses the slogan: “Do things is currently available without aprescription in Risserexplained, adding that Differinwas posi- Differin”–the main focus wouldbeon the medi- Georgia, Russia and Thailand. tionedprimarily forall consumers agedbetween cated gel, Risser noted. NewZealand reclassified adapalene at about 25 and 35 years. A30-secondnational television commercial the same time as theUSlastyearinmedicines At the time that the adapalene switch was for Differin ge lshows awomancomparing prod- “containingnot more than1mg/gand when sup- announced last year,Galderma pointed out that ucts in the skin-care aisle of ashop. Avoice on plied by apharmacist in apack of not more 99% of the US OTCacne market –worth US$748 the tannoycalls out for her attention, before than 30g” (OTC bulletin, 30June 2016, page 12). million (C703 million)inthe 52 weeks ending stating that almost all the acneproducts on the Differin is not only the first retinoid-based 21 January2017, according to Nielsen figures shelves “have had the same twoingredients acne treatment to be made available OTCinthe –was dominated by benzoyl peroxide- and for the past 30 years” and there is now“some- US, italsocontains thefirstnew ingredient for salicylic acid-based products. thingcompletely different”. treating acne to be switched in the country since “If you look at the competition, the tradi- Avoiceoverthen introduces Differin gel, the 1980s. tional brands are targeting teens –Clearasil is pointing out that it “contains aprescription- Noting that research had shown 50 million clearly an iconic teen brand, Clean and Clear strength retinoid that you could only get from people in the US suffered with acne, Risser also targets teens, and Neutrogena is for teens adoctor –until now”. told OTC bulletin that while the skin condition andyoung adults,” Risser pointed out.“Butwe It goes on to note that Differin “clears and wasoften thoughttobeanaffliction experienced found there is more of amarket opportunity preventsacne, while restoring your skin’snatural mainlybyteenagers, themajorityofthose affect- [with adults].” toneand texture”. This information is reiterated ed were in fact aged over18years old. “There’sareal chance for us to differentiate by on-screen text. Consumer insight had shown that because Differinfromthe kindsofproductsthatare al- The advertisement then cuts to the woman sufferers had experienced acne for so long, they ready in the marketplace,”Risser maintain- hugging the packasshe walks away, before the hadentered a“cycleofexasperation”, she said, ed. “Adapalene is athird-generation retinoid creative instructs consumers: “When it comes whereby theyhad tried “multiple products, many and an ingredient that dermatologists have been to your adult acne, do things Differin.” times”, none of which had worked. This had prescribing formanyyears–the efficacytruly Marketing support for Differin would also led themtogiveupon thecategory, Risser main- is there.” include print anddigital activity,Risser noted. tained, and exit it altogether. Galderma’schallenge goes beyondeducat- The print campaign –which would feature in “While the FDA-approvedinstructions on ing acnesufferers thatanew ingredient is avail- consumer publications such as Allure, Glamour the label are for 12 years and above, wereally able OTCthat could meet their needs. It also and US Weekly –included both traditional ad- hastoget across the idea that the acne treatment vertising and ‘advertorial’ content, she noted. should be part of awider skin-care regimen. Meanwhile, as part of the digital activity, “It is important that the adults we target have Galderma wasexploring campaigns on different agoodsenseofwhataretinoid is and howto social-media platforms, Risser said, including – apply it,”Risser explained. “It is very different butnot limited to –Facebook and YouTube. from what they’re used to. Where theymight Pointing outthat acne wasa“highly-searched have putanacne treatment on an individual category”, Risseradded thatthe productwould spot, this is atreatment for the full face.” be backed by search-engine promotion through- In addition to launching the non-prescription out the year. Galderma’sDifferinacne gel gel, the Nestlé Skin Health subsidiary is also in- Risser stressed that alot of the marketing for

16 OTC bulletin 17 February 2017 MARKETING NEWS OTC

Differin went“beyond creating mass awareness” Q&A with of the product’sOTC availability and focused on education through online videos and articles about acne. Sanofi’s Galderma wasforging “digital partnerships” withcompanies likemusic service Spotify and Stephen Walker lifestyle and entertainment website Popsugar to develop “custom content”, Risser explained. This would enable the firm to “build abrand Head of Marketing and story in away that is really relevant for how millennials –thosebornbetween the early 1980s Innovation, Consumer and the late 1990s –consume media today”. There would also be aseriesof‘howto’ HealthcareAustralia videos on the brand website, differin.com, she noted, which already houses videos featuring What has been the biggest achieve- wasrelatively linear; now it is an ever-evolving advice from adermatologist. Q ment of your OTC marketingcareer? ecosystem with consumers seeking health infor- Consumers would discoverthe cleanser and mation andreviewsonline before entering a moisturiser productspredominantly through on- In aformer role Iled aglobal OTC pharmacy or general practitioner’s(GP’s) office. line search, on the website andvia in-store dis- A category foramajor healthcare organi- plays promoting the three-step Differin range. sation for over five years, and in this time Whathas been the most important Noting that moisturisers were “a relatively achievedanaveragesales compoundannual Q lesson of your career? small sub-category within acne”, Risser said growth rate (CAGR)of10%, while the global emphasis on using amoisturiser with aretinoid category average was 3%. Newhealthcare technologies have arole –aspartofaskin-care routine –was especially A in improvingthe consumer experience important in the fight against acne. What hasbeenthe biggest challenge and health outcomes within OTC, but unless “Competitive moisturiser brands are more Q of your OTC marketing career? the innovation is anchored by astrong con- medicated, and so are meant to be used sepa- sumer needorinsight, it can be very difficult rately, but we thinkit’sanexciting opportunity,” Understanding the dynamics of the to build lasting, significant success. Risser continued. “There’sabit of amyth that A ‘daigou’ market in Australia –where acnesufferershaveoily skin, and theydon’twant overseas buyers purchase goods to send to How do you see OTC marketing dev- to use –orfeel liketheyshouldn’tuse –amois- Chinese consumers –and how this is translat- Q eloping in the future? turiser,” she added. ing into agrowing e-commerce business in Lookingto the future, Rissersaid Galderma’s China is high on my list of marketing and There willbefurther tailoring in the long-term ambition wasfor Differin to become business challenges. The learning is constant A OTCmarket to meet the specific needs “the number-one player in OTCacne”. and the marketplace ever-changing. of individuals. This will involve designer health Meanwhile, however, the firm was“focused programmes, not just products, and will be on driving trial and awareness” of Differin How have consumers changed over monitored by wearable or consumable digital –which is available in 15g and 45g packs – Q thecourseofyour career, and how diagnostic devices. Digital communications with the goal of making the twopresentations have you responded? will continue to develop to allow us to have the “number-one and number-twoSKUsindol- more engaged, real-time conversations with lar sales by the end of our launch year”. OTC Themajorchange is how the consumer our consumers. Meanwhile, marketeers will A interacts with our categories and brands operate in faster, more agile cycles to adapt to using digital media and social platforms. At market needs more quickly and efficiently IN BRIEF theoutsetofmycareer, the consumer journey than they typically do today. OTC

BLACKMORES has created a Probiot- For the opportunity to feature in the Q&A section, ics+ supplement line in its domestic market. email [email protected] Claimed to be the “first comprehensive pro- biotics range for the Blackmores brand”, the Probiotics+ selection includes aDaily Health FortéPhama’s Spanish armhas signed productwith five“specifically selected” probiotic actorMiguel Ángel Muñoz as an ambassador strains and inulin –aswell as a‘multi-action’ forits Énergie range of food supplements in Kids Daily Health option with four probiotic the country. As partofthe collaboration, Muñoz will feature strains, aprebiotic and vitamins Cand D, and the brand throughout the year in posts and an ImmuneDefenceoption withvitaminCand videos on his social-media pages.He would also zinc. Also featured in the range is an Eczema be the face of acampaign within pharmacies and parapharmacies, FortéPhama said, and Relief variant with lactobacillus rhamnosus GG take partinpress events forthe brand. and inulin, aBowel Support offering that in- The FortéPharma Laboratoires Énergie line cludes twotypesofprebioticfibre, and aWomens includes aMultivit Adult product –aswell as a Junior variant forthose aged between seven Flora Balanceproductwith a“specific combi- and 15 years –along with Memorex and Vitalité nation of probiotics for vaginal health”. OTC 4options, and atourine-based offering. OTC

17 February 2017 OTC bulletin 17 OTC MARKETING NEWS

Legal Cases Reckitt fined in NZ overNurofen claims Teva is offering trampolining clubs in the UK the chance to win £1,000 (e1,178) through a social-media competition on behalf of its eckitt Benckiser (RB) has been fined to NewZealand customers”. Sudocrem Antiseptic Healing Cream. RNZ$1.08 million(C735,400) afteradmit- “Without the misleading statements, the rea- To be inwith achance of being named ‘Sudocrem’sTrampolining Team of the Year’, tingtomisleading consumers in New Zealand sonfor the products’ existencedisappears,” the participants can upload avideo of their routine over its Nurofen ‘Specific Pain’ products. court added, notingthat there was“no reason” to YouTube and paste the link intoadedicated The firm wasgiven the penalty by the Auck- to choose one product overthe other. application on the Sudocrem Facebook page. Theycan also upload their video to Facebook, land District Court after it pleaded guilty to 10 In December 2015, RB agreed to re-label the Twitter or Instagram using the hashtag chargesbrought by theNew ZealandCommerce Specific Pain products in NewZealand, after the #SudocremTrampolineChallenge. Commission relating to the packaging of the Commission took action against the firm fol- Entries can be submitted until 19 March, after whichdateavideo montage of the three fourproducts–BackPain, Migraine Pain, Period lowing asimilar case in Australia (OTC bul- competition finalists will be promoted.The Pain and Tension Headache –and messages letin, 15January 2016, page 15). winner –whichwill be decided by apanel of on the nurofen.co.nz website. judges –will be announced on 29 March. Fined in Australia The competition is partofSudocrem’slatest RB wasaccused by the Commission of mis- “give itall you’ve got”-themed campaign, the leading consumersabout the “nature, charac- RB wasoriginally finedA$1.7 million (C1.2 aim of which,Teva said, wasto“make the product teristics and suitabilityofthe products”bygiving million) in April 2016 by the Federal Court of synonymous with the wider benefits of treating sore skin caused by minor cuts and grazes”. the overallimpressionthat each of the variants Australia for misleading customers. This was Campaign activity includes atelevision had been formulated to relieve aspecific kind recently increased to A$6 million following an advertisement showing adults and children of pain, despite themall containing 342mg ibu- appeal by the Australian Competition and Con- jumping on beds, beforeachild falls offand grazes its knee.The next ‘burst’ of advertising profen lysine. sumer Commission, whichinitially tookthe fast- would air from 20 Februaryto5March,Teva In delivering the verdict, the court said RB’s movingconsumer-goods(FMCG) giant to court said, and again later that month. behaviour had been “highly misleading”, add- (OTC bulletin, 13January2017, page 17; OTC The contest would be promoted to trampolining clubs, the firmnoted, as well as through targeted ingthat it was“blatantly apparent” that the firm bulletin, 20March 2015, page 10).RBisset to Facebook and Twitter advertising. OTC had been in breach of its “lawful obligations appeal the increased fine. OTC

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18 OTC bulletin 17 February 2017 EVENTS OTC

MARCH 20-21 February AESGP Conference 2-3 March Malta Driving OTCGrowth ‘Defining the priorities for the futureve de lopment of self-care’is the theme of this two-day event Through Innovation and organised by the Association of the European Self-Medication Industry,the AESGP,with the Business Development European Union (EU) Heads of Medicines Agencies (HMA) during the Maltese EU Presidency. London, UK There will be sessions on ‘Howtofacilitate moving medicines from prescription to non- This two-day conference and networking event prescription status’ and ‘The future of self-care in aconnected world’. is organised jointly by OTCToolbox and the Described as a“unique opportunity to interact with keypeople in the regulatory environment”, Pharmaceutical Licensing Group (PLG). There speakers will include: June Raine and Guido Rasi of the European Medicines Agency(EMA); will be presentations by Bayer,GlaxoSmith- Andrzej Rys of the European Commission; Ian Hudson of the UK’sMedicines and Healthcare Kline (GSK) and PGT Healthcare, as well as products Regulatory Agency(MHRA); and Xavier de Cuyper of Belgium’sFederal Agency atechnology perspective from Google. for Medicines and Health Products (FAMHP). Contact:OTCToolbox. Contact:AESGP.Tel: +32 273 55130. Email: [email protected]. Website: aesgp.eu. Tel: +44 121 314 8757. Email: [email protected]. Tel: +1 202 429 9260. 19-21 .. Website: plg-group.com/events/2nd-otctoolbox- Email: [email protected]. Pharmaceutical Regulatory plg-otc-conference-and-networking-event/. Website: chpa.org/aec. Affairs in Asia 6-7 March 22-24 March London, UK Countries including India, Japan, Korea, Sing- EuroPLX 63 Health Ingredients Lisbon, Portugal apore, Taiwan and Thailand will be discussed at South-East Asia this three-day conference. This two-day meeting will provide aforum Jakarta, Indonesia for business development decision makers Contact: Management Forum. Athree-day trade showcovering health, func- Tel: +44 20 7749 4730. for discussing and negotiating collaborative tional food and drink and supplements. agreements in licensing, marketing, and dis- Email: [email protected]. Contact:UBM. Website: management-forum.co.uk. tribution of patented medicines, generics, bio- Tel: +31 20 4099 554. similars, OTCproducts, medical devices and Email: [email protected]. food supplements. Website: figlobal.com/hisoutheastasia/. MAY Contact:RauCon. Tel: +49 6221 426 2960. 29-31 March 10 May Email: [email protected]. DIA 29th Annual EuroMeeting Regulatory Summit Website: europlx.com. Glasgow, UK Maryland, US ‘Translational Healthcare, from bench to bed- The Council for Responsible Nutrition (CRN) 8March side – and back’ is the theme of this meeting OTCMedicines Advertising will participate with other industry trade asso- runby the Drug Information Association (DIA), ciations in presenting aone-day event. London, UK which will covertopics such as globalisation, Organised by Proprietary Association Of Great Contact: CRN. innovation, eHealth, pharmacovigilance and Tel: +1 202 204 7700. Britain (PAGB), this one-day workshop will medical devices. look at howthe advertising and promotion Email: [email protected]. Contact: DIA. Website: crnusa.org. of OTCmedicines is controlled and howthe Tel: +41 61 225 5151. rules can be interpreted to demonstrate that Email: [email protected]. 11-12 May effective advertising is still possible in this Website: diaglobal.org/em2017. CHPARegulatory,Scientific complexregulatory environment. &Quality Conference Contact:PAGB. Maryland, US Tel: +44 20 7242 8331. APRIL Atwo-day event run by annual meeting of Email: [email protected]. the US Consumer Healthcare Products Asso- Website: pagb.co.uk. 2-3 April Natural &Organic ciation (CHPA). Contact:CHPA. 19-22 March Products Europe CHPAAnnual Tel: +1 202 429 9260. London, UK Email: [email protected]. ExecutiveConference This two-day event is claimed to be Europe’s Website: chpa.org/rsq. Florida, US biggest trade showfor natural products. The annual meeting of the US Consumer Contact: Diversified Communications UK. 30 May-1 June Healthcare Products Association (CHPA) is Tel: +44 1273 645126. 53rdAESGP Annual Meeting open to members only. Email: [email protected]. Vienna,Austria Contact:CHPA. Website: naturalproducts.co.uk. ‘Self-care in achanging world’ is the theme of this three-day annual meeting of the Association 9March of the European Self-Medication Industry,the OTCMarketing Awards 2017 AESGP.Sessions will include: ‘Global changes and their implications on consumer healthcare’; London, UK ‘Performance of the self-care industry’; and These Awards, organised by OTC bulletin,recognise the best of ‘Digital revolution – self-care revolution’. the British OTCindustry.Followthe OTCMarketing Awards on Contact: AESGP. Facebook, Instagram, LinkedIn and Twitter. Tel: +32 273 55130. Contact: OTC bulletin. Email: [email protected]. Tel: +44 1564 777 550. Email: [email protected]. Website: otc-bulletin.com/awards. Website: aesgp.eu/53.

17 February 2017 OTC bulletin 19 OTC MARKET RESEARCH

Self-medication sales increasedinFrance in 2016, but thereisstill plentyof room forimprovement if the countryisto catch upwith its Europeanneighbours, accordingtothe latest study publishedbylocal industry association Afipa.David Wallace looksatthe data. France must beat timidgrowth

espite reporting French self- Moreover, the most recent data from 2014 areavailable in otherEuropean countries,”thus medication turnover that ad- cited by Afipa showed that self-medication in depriving French citizens of self-care opportuni- vanced by 3.3% to e2.33 France enjoyed one of the smallest volume shares ties.Inparticular,categories such as allergic Dbillion in 2016 –helping to of the overall medicines market compared to those rhinitis, asthma, acne, nausea and vomiting were drive overall self-care sales by 4.8% of its European neighbours.Ashare of just 15.4% lacking moleculesthat wereavailable as self- to e3.88 billion–local industryasso- in France compared to 37.5% in the Nether- medication in other territories, Afipaobserved. ciation Afipa believes the country is lands,38.0% in Belgium, more thantwo-fifths Salesoffood supplements rosebyalmosta failing to achieve its potential. in Swedenand Germanyand 57.8%inthe UK. tenth to C736 million and medical devices turn- Theself-medicationsector had experienced Only Italy and Spain were lower than France, over grewby5.0%to C817 million in 2016. By only “timid” growth in 2016, Afipa declared. with 12.3% and 11.7% respectively. contrast, French self-medication sales reported This wasdespite alow average price per pack for In terms of its self-medication market, “France by Afipa–incollaboration with marketresearch- self-medication, the association said, comparing lags behind on aEuropean scale,” Afipa lament- er OpenHealth –comprised non-prescription France’s C4.74 average retailprice in 2016 to a ed. “Too manytreatmentsremain inaccessible turnoverfromnon-reimbursable treatments that European average of C6.20 in June 2015. to French patients in self-medication while they grewby4.6%to C1.85 billion, while non-pre- scription sales of reimbursable drugs slipped by Category Sales value Change Proportion (€ millions) 2016/2017 (%) of total (%) 1.3% to C476 million (see Figure 1). Reimbursable self-medication 476 -1.3 12 Examined by therapeutic category,respir- Non-reimbursable self-medication 1,854 +4.6 48 atory and analgesic OTCremedies remained dominant in France in 2016(see Figure 2), al- Self-medication 2,331 +3.3 60 though Afipa noted that the digestive segment had Medical devices 817 +5.0 21 been boosted by an “epidemic of gastroenteritis Food supplements 736 +9.3 19 in December”, which the association said had Totalself-care3,883 +4.8 100 demonstrated consumers’willingnesstouse self- Figure1:Breakdown by categoryofFrench self-caresales –self-medication, medical devices and medication to treat benign pathologies. While food supplements –through pharmacies by value in 2016 (Source –Afipa/OpenHealth) dermatology andcirculatory treatments sawtheir Product category Sales value Change 2016/2017 sales dip slightly in 2016, homoeopathywas (€ millions) (%) (€ millions) boostedbymore than atenth,translatingtoan Respiratory534 +1.0 +5 absolute rise of around C12 million. Analgesics 491 +9.7 +44 In Afipa’sranking of the top-10 self-medi- Digestive315 +6.2 +18 cation companies by sales in 2016, the front- runners maintained their positions compared Dermatology 220 -0.3 -1 to 2015, with Boirontakingthe top spot ahead Circulation 130 -5.0 -7 of Sanofi, followed by BMS-UPSA, Johnson & Homoeopathy126 +10.6 +12 Johnson and Bayer (see Figure3). The only change Vitamins,minerals and supplements 116 -4.0 -5 to the top10was Merck Medication Familiale Smoking cessation 84 +9.2 +7 creeping into tenth place (OTC bulletin,19Feb- Sedatives 81 +2.4 +2 ruary 2016, page 20). Others 232 -0.3 -1 Asimilar storycould be seen among the top- 10 brands ranked by sales in 2016. Boiron’sOscil- Total2,331 +3.3 +75 lococcinum continuedtolead the table,followed Figure2:Breakdown by categoryofFrance’sself-medication market–self-medication sales of by Urgo’sHumex, Reckitt Benckiser’s(RB’s) both reimbursable and non-reimbursable non-prescription medicines –through pharmacies in 2016 (Source –Afipa/OpenHealth) Strepsils and Boehringer Ingelheim’sLysopaine,

20 OTC bulletin 17 February 2017 MARKET RESEARCH OTC

whichmaintainedtheirrespectivesecond, third Rank Company Sales change Self-medication and fourth positions. But Sanofi’sDoliprane- (%) market share (%) Tabs –introduced in October 2015 –upset the 1Boiron +7.4 12.4 rankings,entering in fifth place (see Figure 4). 2Sanofi+4.0 11.8 AndasFigure5shows, the sales lift of al- most atenth for food supplements in 2016 was 3BMS-UPSA +6.0 6.3 driven by rises across several categories.Rem- 4 Johnson &Johnson SantéBeauté+3.5 6.0 edies for digestivecomfortstoodout with arise 5Bayer SantéFamiliale -1.0 5.5 of morethan aquarter,or C24 million. Having almost ayear ago launched a‘Mani- 6Reckitt Benckiser +4.3 4.6 festo’for developingself-medicationinFrance 7Cooper +4.2 3.9 (OTC bulletin,22April 2016, page 11),Afipa 8PierreFabre-4.1 3.3 maintained that itsthreekey goals weretode- finealistofbenign pathologies andswitchmore 9Boehringer Ingelheim +7.5 3.2 molecules; to inform and educate patients through 10 Merck Medication Familiale -2.4 2.5 promotional campaigns involving healthcare Totaltop 10 +3.8 59.5 professionals; and to “ensure affordability to all” by applying to self-medication products a Figure3:Top-10 firms by sales value in France’sself-medication market–self-medication sales of reimbursable and non-reimbursable non-prescription medicines –worth e2.3 billion in 2016 more favourable tax rate. (Source –Afipa/OpenHealth) “The current context is favourable to the Brand Company Rank 2016 Rank 2015 emergence of self-care as asustainable response to public healthissues,”Afipa said, citing“struc- Oscillococcinum Boiron 11 turalchallenges” facinghealthcare that included HumexUrgo22 ahealth insurance deficit, a‘saturation’of doctors’ Strepsils Reckitt Benckiser 33 surgeries and the emergencyservices, and the increase in chronic and long-termillnesses amid Lysopaine Boehringer Ingelheim 4 4 an ageing population. DolipraneTabs Sanofi5– “The challenge for the pharmaceutical in- Berocca Bayer65 dustry today is therefore to demonstrate that self-care is asuitable response” to such problems, NurofenFlash Reckitt Benckiser 77 and a“lasting solution” to fundingissues, Afipa Fervex BMS-UPSA 89 declared, suggesting that proper development Daflon Servier 96 of self-medicationwould generate additional an- nual healthcare systemsavings of C1.5 billion. NicoretteJohnson &Johnson 10 8 To this end, the association has launched a Figure4:Ranking by sales value of France’stop-10 self-medication brands in 2016 and their rankings major press campaign in France to promote self- in 2015 (Source –Afipa/OpenHealth) medication (see page 10), urging French decision- Product category Sales value Change 2016/2017 makers to include self-care as akey aspect of (€ millions) (%) (€ millions) the country’shealthcarepolicy, especiallyinlight Immune system/vitality 156 +3.9 +6 of the imminent FrenchPresidential elections. Digestivecomfort115 +26.8 +24 “Giventhe current health context, the 2017 electionsrepresent amajoropportunity to pro- Sleep/relaxation 110 +17.1 +16 mote self-careasapublic healthasset,”insisted Muscular/articulation 44 +20.5 +8 Afipa’spresident, Dominique Giulini, urging Slimming 43 -10.3 -5 a“change of orientation and aconsideration of self-care –through the development of self-med- Respiratory38+19.7 +6 ication –aspartofthe government’shealthstrat- Vision 36 +1.2 ±0 egy”. “Weintend to call on the Presidential can- Extremeties 34 -1.4 ±0 didatestoaddress this issue,”Giulini maintained, “and, likethem, we will be campaigning!” Urinary30-5.7 -1 Moreover, healthcareprofessionals were on Circulatory20+9.7 +2 boardwith the association’soverall approach, Feminine comfort19-2.8 -1 Afipa attested, “considering that self-medica- tion is acredible levertorelieve medical practices Sun 16 -6.6 -2 and reduce healthcare costs”.Professionalswere Cardiovascular 16 +10.6 +2 “readytosupport itsdevelopmentand want self- Pregnancy 13 +10.6 +1 medication to be supported by public information Other 44 +17.1 +6 campaigns”, the associationemphasised.“Afipa is pleased, because this fits perfectly with the Totalfood supplements 736 +9.3 +63 measures that the association has been advocating Figure5:Breakdown by categoryofFrance’sfood supplements marketthrough pharmacies for many years,” Giuliniconcluded. OTC in 2016 (Source –Afipa/OpenHealth)

17 February 2017 OTC bulletin 21 FOR 2017NEW

MAIL ORDER AND INTERNET PHARMACYINEUROPE 2017 REAPING THE BENEFITS OF AN OMNICHANNEL PRESENCE

AStudy of Mail Order And Internet Pharmacy In 17 European Countries Plus Key Learnings From The US And China

Mail Order and Internet Pharmacy in Europe shows how e-commerce is reshaping the pharmacy landscape and playing a key role in the omnichannel strategies of leading healthcare retailers. The European mail order and Internet pharmacy landscape has continued to evolve since the last edition of this study in 2015, driven by the growth of mobile technologies, smartphones and the consequent changes in how consumers want to shop. Major pharmacy multiples have been using their considerable reach in consumer healthcare to develop complex omnichannel strategies at the expense of ‘pure play’ online pharmacy companies. But in other markets, these entrepreneurial and disruptive firms continue to shake the foundations of traditional retailing, as the study explains.

Mail Order and Internet Pharmacy in Europe covers: Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Slovak Republic, Spain, Sweden, Switzerland, UK and US.

® JAMES DUDLEY® Download study at www.james-dudley.co.uk MANAGEMENT

FV -MAIL ORDER A4ad 2017 A4.indd 1 11/01/2017 09:35 PEOPLE OTC

Manufacturers Manufacturers Teva hunts Warnery to head up forachief Beiersdorf CHC unit eva has begun searching for anew per- Tmanent leader after its president and chief incent Warnery,the former head of executive officer, Erez Vigodman, steppeddown VSanofi’s globalConsumer Healthcare divi- with immediateeffectby“mutual agreement”. sion, has been appointed to the executive board He hasalsoleftthe Israeli firm’sboard of directors. of German personal-care giant Beiersdorf, effect- On an interim basis, chairman Yitzhak Peter- ive from 15 February 2017. burg has beennamed president and chief execu- In his newrole, Warnery would “oversee” tive officer,stepping down from his roleaschair- Beiersdorf’s Eucerin and La Prairie skin-care maninaccordancewithIsraelicompanies law. lines andits Hansaplast wound-carebrand,the companyexplained. Comprehensivesearch “For Eucerin,Hansaplastand La Prairie we “Weintend to conduct acomprehensive search see lots of growth potential in the future that to identifythe best person to leadthe company we intend to leverage through investments and for yearstocome,” stated Teva’s newchairSol innovation, helped by newmanagement and new Vincent Warnery Barer,who has served onthe board since 2015. business opportunities,”commented Beiersdorf’s Peterburginsisted the firm was“focusing chief executive officer Stefan Heidenreich. ation (OTC bulletin,25October 2013, page 23). on executingits strategic priorities to transform “With Warnery’sappointment, we are add- He left Sanofi inve No mber 2016 after the Teva,with immediate focus on realising the cost ing amanager to our executive board who has French firm appointed Alan Main to lead its synergies and strategic benefits of the Actavis the expertise and international experience we expandedConsumer Healthcarebusiness, which Generics acquisition”, following completion need in this area,”headded. nowincludes BoehringerIngelheim’sConsumer of theUS$38.8 billion (C36.4 billion) deal around Warnery joined Sanofi in 2011, serving as Health Care unit (OTC bulletin,13January six months ago (OTC bulletin,12August 2016, vice-president for ConsumerHealthcare Europe 2017, page 1). page 13). He pledged to work with “the entire and global development. In 2013, he waspromot- Prior to joining Sanofi, Warnery held positions Teva team” to “conduct athorough reviewof ed to leadthe global Consumer Healthcareoper- at L’Oréal and Procter &Gamble (P&G). OTC the business to find additional opportunities to enhance value for shareholders”. Manufacturers Having most recently served on Teva’s board since 2012, Peterburgwas previously vice-pres- ident in charge of Global Branded Products Perrigo reshuffles its board from 2010 to 2011. Prior to this, he wasaboard errigohas reshuffled its board of directors Furthermore, Starboard would be recom- member from 2009 to 2010. Pafter reaching aagreementwithone of its mending twoadditional independent directors, largest shareholders, Starboard Value. Perrigo pointed out, while current directors No impact on strategy Under the terms of the deal, Perrigo has placed MichaelJandernoa, Gary Kunkle, Herman Citing the firm’s“deep bench of talented JeffreySmith, chief executive officer dcan hief Morris and Shlomo Yanai would step down leaders”, he said the management change would investment officer of Starboard –which owns from the board immediately. Ellen Hoffing have “noimpact on our abilitytoexecutegoing 6.7% of Perrigo’sshares –onits board with im- wouldleave her role when the final Starboard- forward”, giventhe “strength of our generics mediate effect, along with Bradley Alford,an recommended member wasappointed, it added. pipeline, uniqueresearchand development capa- operating partner at Advent International, and Laurie Brlas,chairman of Perrigo’sboard of bilities and unparalleled footprint”. Jeff Kindler,aventure partner at Lux Capital directors, said the firm wascommitted to bringing Meanwhile, Barer emphasised that Teva’s and chief executive officer of Centrexion. “newenergy and fresh perspectives” to the board. board, with its “decades of collective pharma- “Weare pleasedto have reached this agree- ceutical industry experience”, would “continue to ment with Starboard,”she added, “and look play an active role in drivingthe firm’sstrategy”. forward to working closely with the newdirectors Teva’s search for Vigodman’sreplacement to create value for our shareholders.” comes soon after the firm appointed Dipankar The deal with Starboard comes after the in- Bhattacharjee as president and chief executive vestment firm washighly critical of Perrigo’s officer ofits GlobalGenericMedicines Group, performance since it rejected Mylan’stakeover succeeding Siggi Olafsson. bid (OTC bulletin,23September 2016,page 5). At the time of Bhattacharjee’sappointment, In aletter to thecompany,Starboardrecom- Vigodman insisted the companywould“con- mended Perrigo sell its non-core Prescription tinue to focus on integrating and realising the generics business and also accused the firm of value of the Actavis Generics transaction”, and “severely”mismanaging theintegration of Ome- driving “efficiencies” across the sgfirm’ lobal ga Pharma, which it acquired in 2015 (OTC generics organisation. OTC Jeffrey Smith bulletin,17April 2015, page 3). OTC

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