Q&A session Spotlight on Leading with Tim Lahurque Pfizer to a Templeman International newfuture page 21 page 7 page 24

Contents Retzlaff steps down 9September 2016 Issue Number 468 in Stada shake-up COMPANY NEWS tada’sHartmut Retzlaff has resigned J&J researching skin treatments 3 Sfrom his position as chairman of the man- George to lead Stada Brands 4 agement board at the German company “due Perrigo reviews options 5 to personal circumstances”. Sanofi prepares for6The move came shortly before Stada an- growth in Australia nounced the make-up of its newsupervisory Latin America lifts 8 board following aperiod of instability after minor- turnoveratMerck ity shareholder Active Ownership’sattempts to gain control of the committee (OTC bulletin, Boehringer reports OTCrise 9 27 May 2016, page 6). Amazon Dash enters EU 12 In June, Stada announced that Retzlaffhad taken leave from his role as chief executive officer GENERAL NEWS at the firm “due to aserious, long-term illness” (OTC bulletin,17June 2016, page 27). Hartmut Retzlaff Homoeopathygets 13 Executive board member Matthias Wieden- Following the vote, fivenew members joined trade body support fels has taken overthe chief executive officer the supervisory board, four of which had been FDAissues revised 16 role “until further notice”, along with responsi- nominated by Stada. Only Eric Cornut, Nov- supplement rules bility for corporate strategy and production. artis’ former chief ethics, compliance and poli- ASMI welcomes 17 Joining Stada in 1986 as sales and market- cy officer,was elected from the list of candi- labelling changes ing director for its Stadapharm division, Retz- dates drawn up by Active Ownership. laffbecame head of Stadapharm in 1991. He Joining Cornut on the board are Stada can- MARKETING NEWS stepped up to lead the German group two didates: Rolf Hoffmann, former senior vice- years later,and in September last year,Stada president of US commercial operations at Am- Lanes strengthens Earex in UK 19 extended Retzlaff’semployment contract by gen; Dr Birgit Kudlek, previously chief operat- Regaine adds foam 19 fiveyears until August 2021 (OTC bulletin, ing officer at Aenova;Tina Müller,chief mar- in Germany 25 September 2015, page 23). keting officer at car manufacturer Opel; and Awards reflect digital growth 22 Shortly after Retzlaffstepped down, Stada Dr Gunnar Riemann, previously head of En- thwarted attempts by Active Ownership to re- vironmental Science at Bayer Crop Science. REGULARS place the majority of the company’ssupervisory Stada’sCarl Oetker has been elected chair- board with its owncandidates. manofthe supervisory board, replacing Martin Spotlight on –Lahurque 7 Prior to avote at the company’sannual Abend, who wasremovedatthe meeting. Q&A –with Boehringer 21 general meeting, Stada had warned that Active Meanwhile, Stada announced that Dieno Ingelheim’sTim Templeman Ownership’sdesire to replace six supervisory George had been promoted to takecharge of Events –Our regular listing 23 board directors would be a“disruptive action”, the firm’sBranded Products unit as part of a People –Recordati changes 27 as well as “ill-considered and irresponsible” “fundamental change to the firm’sreporting management team (OTC bulletin,12August 2016, page 23). structure” (see page 4). OTC Connect with us on: Twitter LinkedIn OTC-bulletin.com Areyour challenges giving you sleepless nights?

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Licensing Agreements Business Strategy Mundipharma J&J is researching grows in MEA treatments for skin undipharma has broadened its OTC prod- Muct portfolio in the Middle East and Africa ohnson & Johnson (J&J) Consumer has by striking a licensing deal with Jordan-based Jpartnered with development company Xy- Munir Sukhtian group. crobe Therapeutics to research new treatments Under the terms of the agreement, UK-based for skin conditions. Mundipharma has gained the commercial rights Thepartnership, the US-based firm said, would for 10 years to market Munir Sukhtian’s HiGeen focus on “further understanding applications of consumer healthcare brand in more than 50 coun- Xycrobe’s platform technology developed for J&J will work with Xycrobe Therapeutics tries across the Middle East and Africa. the treatment of inflammatory skin diseases”. better solutions,” Hitchcock added. The HiGeen line includes foot creams and “The planned collaboration is intended to “The current paradigm for treating skin con- powders, as well as hand sanitisers and creams. provide both companies with information on how ditions, such as acne, completely disregards “The HiGeen range complements very well Xycrobe’s technology may be best applied to the importance of the commensal skin flora,” our consumer health portfolio, which includes future therapeutic and commercial applications,” Hitchcock argued. our Betadine range,” commented Raman Singh, J&J explained. “Overuse of antibiotics has led to a higher president of Mundipharma in Asia-Pacific, According to California-based Xycrobe, its prevalence of resistant strains of bacteria,” he Latin America, Middle East and Africa. “The platform technology “consists of a library of insisted, “and along with that comes less effi- partnership will also help Mundipharma build commensal [bacterial] strains from the skin cacy of conventional treatments.” on our strong leadership in the sector and help microbiome engineered to grow and secrete bio- “Wefeelthatthekeytobettertreatmentsolu- expand our presence.” therapeutics as needed to help treat an array of tions for skin disease lies in understanding our “Mundipharma’s expertise in emerging mar- skin issues”. body’s interaction with the skin microbiome,” kets,” continued Singh, “will increase access The company says it has developed “several Hitchcock explained, “and how we can leverage to these treatments for millions of people.” strains of commensal skin bacteria that show this information.” Deemah Sukhtian, Munir Sukhtian’s man- potential for the significant reduction of inflam- The partnership was facilitated by J&J In- ging director, claimed the “complementary na- mation, promising potential relief from a num- novation, the firm’s venture capital arm which ture” of HiGeen with Mundipharma’s products ber of ailments including acne, dermatitis, ec- aspires to find “the best science and technology, would “provide a stronger proposition to con- zema and psoriasis”. no matter where it is, to solve the greatest unmet sumers in the area of wound care and prevention Commenting on the partnership, Thomas needs of our time”. of infectious diseases”. Hitchcock, Xycrobe’s chief executive officer, Most recently, the Innovation unit partici- “We are confident that our alliance, leveraging said the company was “thrilled” to collabo- pated in a round of funding for the US-based Mundipharma’s expertise and global network,” rate with J&J Consumer. firm First Aid Shot Therapy (FAST) to help the Sukhtian added, “will enhance access to our inno- “It is our hope that this collaboration can fledgling company expand its portfolio of single- vative products and further improve the quality help expedite getting our therapies into the hands dose liquid OTC medicines (OTC bulletin, 27 of life of consumers.” OTC of physicians and their patients who truly need November 2015, page 4). OTC

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9 September 2016 OTC bulletin 3 OTC COMPANY NEWS

Business Strategy/First-Half Results George to lead Stada Brands

ieno George has been promoted to take Country Group sales Change Branded Products’ Change Branded Products’ Dcharge of Stada’s Branded Products as (€ millions) (%) sales (€ millions) (%) share in Stada (%) part of a “fundamental change” to the firm’s Germany247 +18 98 +48 40 reporting structure. Russia 110 -13 60 -29 55 In his new role, George – who is chief ex- ecutive officer of Stada’s UK subsidiary Thorn- Italy 101 +5 21 +23 21 ton & Ross – would be responsible for “inter- UK 94 +7 84 +12 89 nationalising” Stada’s brands and taking them Spain 62 +1 9 +22 15 into new markets, the firm explained. Claiming that there existed a “lot of un- Belgium 46 -34 5+811 tapped growth potential” in the Branded Prod- Other 375 –130 –35 ucts portfolio, with some of its biggest brands Total Stada 1,035 +1 407 +5 39 only available in one or two markets, Stada said George would ensure a more “centralised” ap- Figure 1: Sales by Stada and its Branded Products division in the opening six months of 2016, together with the proportion of group sales accounted for by Branded Products (Source – Stada) proach to its internationalisation strategy. The Branded Products business unit will sit brand names – moved ahead by 48% to C98 ing deal with Reckitt Benckiser (RB) for the alongside a Generics business unit, led by Stada’s million (see Figure 1). K-Y range of personal lubricants (OTC bulletin, regional director for Europe, Luc Slegers. As a “High seasonal orders”, in combination with 30 June 2016, page 3). result of this change, Stada said it would now successful efforts to “optimise” the firm’s OTC Stada has been granted the rights to market manage the firm by operating segmenther rat than offering in Germany, had been behind the double- K-Y in the country for an eight-year period. by both operating segment and market region. digit improvement, Stada said. Branded Products accounted for 89% of “This measure is primarily designed to take Branded Products’ turnover accounted for UK turnover in the first half, which increased account of our growth strategy, including central 40% of group sales in Germany, which ad- by 7% to C94 million. management of the core segments, increasing vanced by 18% to C247 million. In Italy, turnover from Branded Products internationalisationoftheproductportfolio,as Meanwhile, Branded Products’ sales had had improved by 23% to C21 million, Stada re- well as stricter cost control,” the firm explained. been held back, Stada noted, by a weaker per- ported, thanks to acquisitions. The change to Stada’s reporting structure formance in Russia. Branded Products accounted for 21% of to- follows the departure of Hartmut Retzlaff, who A “decrease in purchasing power” among tal turnover in Italy, which moved forward by has resigned from his position as chairman of consumers in Russia, due to the economic situ- 5% to C101 million. the management board at the German company ation, had caused sales of Branded Products to Branded Products generated 39% of Stada’s “due to personal circumstances”. decline by 29% to C60 million, the firm said. total sales in the first half of 2016. These moved Retzlaff had recently taken leave from his Lower sales had also been compounded by nega- forward by 1% to C1.04 billion (see Figure 2). role as chief executive officer at the firm “due tive currency effects related to the Russian rouble. Stada’s dominant Generics business accounted to a serious, long-term illness” (OTC bulle- Branded Products accounted for 55% of for the bulk of the remainder. OTC tin, 17 June 2016, page 27). group sales in Russia, which slipped back by A Stada spokesperson said that while George 13% to C110 million. Mergers & Acquisitions would remain in his present role at the UK In the UK, where Stada acquired Thornton subsidiary, Barry Draude would run the business’ & Ross in 2013 (OTC bulletin, 23 August “day-to-day” operations. 2013, page 1), Branded Products’ sales improv- Lonza grabs Stada announced the organisational changes ed by 12% to C84 million. as it reported turnover from Branded Products Acquisitions and good performances from InterHealth up by 5% to C407 million in the opening six key brands had driven the rise in sales, Stada witzerland’s Lonza has expanded its port- months of 2016, as sales improved in five of its said, adding that growth had been held back by Sfolio by acquiring dietary supplements ingre- six biggest markets. a “weak cold season” at the start of the year. dients manufacturer InterHealth Nutraceuticals In Stada’s home market, sales of Branded During the period, Stada expanded its Branded for C300 million. Products – under the Stadavita and Stada GmbH Products portfolio in the UK by striking a licens- Describing InterHealth as a “leader in the research, development, manufacture and mar- Business First-half sales Change Operating profit Change (€ millions) (%) (€ millions) (%) keting of value-added nutritional ingredients for dietary supplements”, Lonza said the deal rep- Generics 604 -2 104 +22 resented a step forward on its “strategic path”. Branded Products 407 +5 71 -1 “Lonza will leverage the successful product Commercial 23 +10 0.3 >100 portfolio of InterHealth on a global level, and in Group/Other 0.1 –-39 – turn will be able to benefit from InterHealth’s proven management and branding capabilities Total Stada 1,035 +1 136 +22 to promote Lonza’s existing product portfolio,” Figure 2: Stada’s sales and operating profit in the opening six months of 2016 (Source –Stada) commented the Swiss firm. OTC

4 OTC bulletin 9 September 2016 COMPANY NEWS OTC

Business Strategy/Second-Quarter Results Perrigo reviewing its options

errigo is “beginning to explore strategic alter- Business Second-quarter Change Operating income Change Pnatives” for its Branded Consumer Health- sales (US$ millions) (%) (US$ millions) (%) care operations in Argentina, Russia and South Consumer Healthcare686 -8 134 -16 Africa, according to the firm’s chief executive Branded Consumer 394 -2 59 -24 officer John Hendrickson. Healthcare Speaking as the store-brand specialist an- Prescription Pharmaceuticals 293 +5 127 -8 nounced the results of its second quarter ended 2 July 2016, Hendrickson said Perrigo was re- Specialty Science/Other 108 –73– viewing its options in all three countries as part of Total Perrigo 1,481 -3 393 -10 a plan to “enhance value across the portfolio”. The company was taking “tangible actions Figure 1: Perrigo’s sales and operating income in the three months ended 2 July 2016 (Source – Perrigo) to address market structures in certain countries”, back by 2% to US$394 million (C354 million) experiencing problems at Branded Consumer Hendrickson noted. in the second quarter. Healthcare when the business posted fourth- These actions would “reduce operating costs “Lower sales in the lifestyle and natural health/ quarter results that recently-departed chairman and improve profitability”, he said, and allow vitamins categories” had been behind the drop and chief executive officer, Joseph Papa, de- the firm to “reinvest resources into the high-per- in sales, Perrigo said. scribed as a “personal disappointment” (OTC forming parts of our business”. Adjusted operating income was US$59 mil- bulletin, 4 March 2016, page 1). In Argentina, Russia and South Africa, Per- lion, giving the business an adjusted operating These problems continued into 2016, with rigo was reviewing how it could “change the margin of 14.9%. the company reporting in May that first-quarter way we’re doing things”, Hendrickson reveal- To improve Branded Consumer Healthcare’s sales at the unit had fallen “considerably short ed. “As we look at those [businesses] that are performance the company was “prioritising brand of top-line expectations” (OTC bulletin, 27 May not performing as well as we want, we’re saying strategies in core markets”, Hendrickson ex- 2016, page 4). ‘how do we get those performing well, or is there plained, and making “structural changes” to en- Lower Branded Consumer Healthcare sales another way to manage that asset or to do those sure the business was more efficient. in the second quarter, combined with a drop in things?’,” he explained. “There’s substantial work to be done,” Hen- turnover at the firm’s store-brand Consumer Perrigo revealed its decision to explore its drickson admitted, “but I am confident we can Healthcare unit, left Perrigo’s total sales in the options in Argentina, Russia and South Africa create greater shareholder value by improving three months down by 3% to US$1.48 billion as it continued to wrestle with problems at its and further leveraging this important Branded (see Figure 1). Branded Consumer Healthcare business. Consumer Healthcare platform.” Consumer Healthcare’s sales had dropped Sales at Branded Consumer Healthcare – “The path of steadily-improving margins is by 8% to US$686 million, Perrigo noted, due to comprising the Omega Pharma business and multifaceted and it will take time, but the team a “relatively weak allergy season” and lower the basket of brands the company snapped up has an actionable, multi-layered plan to improve orders in the contract manufacturing business. from GlaxoSmithKline (GSK) last year (OTC profitability,” he insisted. Perrigo’s Consumer Healthcare and Branded bulletin, 12 June 2015, page 1) – slipped Perrigo revealed earlier this year that it was Consumer Healthcare divisions accounted for 73% of group turnover in the second quarter. The remainder was generated by the firm’s Mergers & Acquisitions Prescription Pharmaceuticals and Specialty Sciences divisions, plus ‘other’ sales. Life Wear snaps up TriCalm Separately, Perrigo has expanded its US op- ports medicine firm Life Wear Technologies Commenting on its plans for TriCalm, Life eration by acquiring for an undisclosed sum Shas made its first foray into the consumer Wear said it intended to invest heavily in “brand distribution company Geiss, Destin & Dunn. healthcare market by acquiring the TriCalm anti- media and marketing programmes” to drive sales. A privately-owned distributor of OTC and itch brand from Cosmederm Bioscience for “We will continue to partner with Cosme- consumer goods to the non-chain retail and in- an undisclosed sum. derm,” Life Wear added, “as our ultimate goal is stitutional markets in the US, Geiss, Destin & “The TriCalm brand is an excellent fit for to deliver new and innovative products to our Dunn also owns the GoodSense range of OTC our company,” commented US-based Life Wear’s end consumers.” and personal-care lines. chief executive officer Brad Waugh. Cosmederm’s chief executive officer, Joseph Commenting on the deal, Hendrickson said “It is a natural extension of our product of- Pike, said it was the right time to offload TriCalm acquiring Geiss, Destin & Dunn would “further fering,” Waugh insisted, “and allows us to lever- to allow the firm to “focus on our strengths in strengthen and diversify” the firm’s US distri- age and strengthen our existing relationships with the field of drugve de lopment”. bution and retail network and provide it with national and regional retailers.” Established in 1974, Life Wear markets a “direct access to the non-mass retail market”. Comprising three products – TriCalm Hy- range of private-label and branded sports medi- “While we currently distribute products to drogel, TriCalm Clinical Repair Cream and cine products including elastic bandages, athletic this channel through Geiss, Destin & Dunn, I TriCalm Extra Strength Spray – the TriCalm tape, sports supports and heat packs. am pleased we will now bring the management range is sold across the US through retailers such The firm recently launched in the US its Flex- of this business completely in-house,” Hendrick- as Walgreens, Walmart and Rite Aid. Aid range of knee and ankle supports. OTC son added. OTC

9 September 2016 OTC bulletin 5 OTC COMPANY NEWS

Business Strategy Business Strategy Cold-EEZE Sanofi prepares for up for sale growth in Australia roPhase Labs has revealed its board is weigh- Ping up a “wide range of strategic initiatives anofi Consumer Healthcare is expanding and alternatives”, including the potential sale of Sits production facilities in Australia in re- its core Cold-EEZE brand, in an effort to “fur- sponse to increasing demand for its vitamins, ther enhance shareholder value”. minerals and supplements (VMS) in the Asia- Speaking as the US-based firm reported sec- Pacific region. ond-quarter sales up by 27% to US$2.8 mil- Noting that it had already invested A$30 lion (C2.5 million), chief executive officer Ted million (C20 million) this year in its Brisbane Karkus said ProPhase would listen to offers for manufacturing facility, Sanofi said it was com- its Cold-EEZE homoeopathic cold and flu range. mitted to spending a further A$5 million to grow Sanofi’s Nature’s Own supplement range “Everything is on the table,” Karkus revealed, the site, which produces the Cenovis, Nature’s that there was demand for “quality Australian “with the goal of increasing shareholder value.” Own and Ostelin VMS lines. products from all across Asia-Pacific”. Claiming that Cold-EEZE was a “growing Brett Charlton, general manager of Sanofi Sanofi’s growth in Australia was recently brand”, Karkus said the timing was right to ex- Consumer Healthcare Australia, revealed the firm highlighted by Vincent Warnery, global head of plore a potential sale. “There are lots of buyers was seeing “strong” and growing demand for its the French firm’s Consumer Healthcare unit. out there,” he insisted. “It’s a seller’s market.” Australian-produced VMS brands in China. Speaking to OTC bulletin, Warnery said Aus- However, ProPhase would only be open to A “large proportion” of Sanofi Consumer tralia had become a “success story” for Sanofi, selling Cold-EEZE to a buyer “willing to pay Healthcare’s sales growth in Australia was be- following an impressive turnaround in the country ing driven by Chinese consumers, Charlton (OTC bulletin, 19 February 2016, page 7). explained, who wanted “clean and green, qual- “We had some issues in Australia a few ity Australian products”. years ago,” Warnery admitted, “and we weren’t “Certain niche products and segments are equipped to run the business properly.” influencing this growth,” he noted, “in partic- “So we took the time to react,” Warnery said. ular vitamin D and fish-oil supplements, plus “We appointed the right leader, added capabili- women’s health and children’s health lines.” ties in OTC regulatory and industrial affairs, “Women’s health is a big opportunity,” Charl- and in 2015 Australia was, together with the US, ton insisted, noting that the firm’s Nature’s Own our top-performing business.” products in this category were especially pop- “We overachieved our objectives and grew ular with Chinese consumers. market share not only in VMS with brands like While Sanofi was currently experiencing Nature’s Own, but also in OTC, with Telfast, the ProPhase’s Cold-EEZE cold and flu brand strong demand from China, Charlton claimed local equivalent to Allegra.” OTC a significant price”, Karkus noted. “I am highly confident that the Cold-EEZE brand alone is worth significantly more than Mergers & Acquisitions the entire market capital of the company, which is around US$26 million,” he insisted. WBA ups stake in Amerisource In addition to weighing up the possible sale algreens Boots Alliance (WBA) has exer- firms have built together, and further strength- of Cold-EEZE, Karkus said ProPhase would Wcised warrants ahead of schedule to buy ens the long-term strategic relationship we launch- “explore a variety of acquisition opportunities” almost 22.7 million shares in US pharmaceuti- ed in 2013,” commented WBA’s chief executive to grow the business. cal wholesale firm AmerisourceBergen. officer Stefano Pessina. “We are searching for acquisitions of other Noting that the warrants were originally sched- “Since the beginning of the strategic rela- products,” he explained, “including brands both uled to be exercisable in March 2017, the US tionship,” Pessina noted, “we have worked to- inside and outside our industry.” wholesale and retail giant said it had come to gether with AmerisourceBergen to improve the “Smaller” acquisitions could be financed an agreement with AmerisourceBergen to ac- customer experience by delivering the right right away, Karkus noted, while larger deals tivate the option earlier than planned. products at the right time to ensure that we are would be dependent on first finding a buyer The US$1.19 billion (C1.05 billion) cash able to provide exceptional patient access and for Cold-EEZE. transaction gives WBA a 23.9% stake in Ameri- care in our US pharmacy operations.” Karkus indicated that ProPhase was not in- sourceBergen with nearly 56.9 million shares. Net earnings attributable to the investment tending to sell its TK Supplements brand, which WBA and AmerisourceBergen forged an alli- in AmerisourceBergen will be classified with- the firm launched earlier this year to diversify its ance three years ago as part of a 10-year long in the operating profit of WBA’s Pharmaceuti- portfolio into the dietary supplements category distribution agreement between the two com- cal Wholesale business. (OTC bulletin, 22 April 2016, page 5). Under panies (OTC bulletin, 29 March 2013, page 1). The deal marks the second time this year that the TK umbrella, ProPhase markets the Legendz “Today’s announcement builds on the strong WBA has grown its stake in AmerisourceBergen, XL male sexual enhancement supplement. OTC and collaborative working relationship our following a similar transaction in March. OTC

6 OTC bulletin 9 September 2016 COMPANY NEWS OTC

Spotlight on… Lahurque International

● ESTABLISHED: 2012 ● PRODUCTS: ● BASED: Valkenswaard, ITCHIE acne treatment the Netherlands ● MARKETS: ● SALES: Around €5 million Ecuador, Norway, Peru, (2017 forecast) Switzerland,Turkey, the Middle East ● LEADERSHIP: ● WEBSITE: lahurqueinternational.com

Peter van den Hurk, managing director

ABOUT KEY BRAND BUSINESS STRATEGY “Lahurque International’s main goal is to “ITCHIE is a serum for the treatment of “Our ambition for the coming years is to develop innovative OTC medical devices for acne and especially, but not limited to, itchy expand our products’ availability into new mar- skin problems that provide solutions for con- and irritated acne skin,” van den Hurk explained. kets,” van den Hurk stated. sumers worldwide,” according to managing There was a gap in the market for ITCHIE, “We would like to establish a presence in director Peter van den Hurk. “We are passion- he claimed, as no other OTC product could the major European countries, as well as in the ate about discovering gaps and opportunities treat itchy acne as “effectively and instantly”. US and the key Latin American and Asian within the dermatological OTC segment and “ITCHIE creates an invisible layer on the markets,” he pointed out. identifying consumer product needs.” acne skin which provides a direct cooling sen- “To achieve this, we are interested in en- The Netherlands-based company’s portfo- sation, rapidly soothes the itching and irritated tering into new partnerships with distributors lio currently comprises one OTC medical de- acne skin and effectively calms the acne in- who are enthusiastic about representing and vice, the ITCHIE acne treatment, which it re- flammation,” van den Hurk noted. “At the same selling our products in specific countries or mar- cently launched into a number of markets across time, the invisible layer acts as a barrier to kets,” van den Hurk noted. Europe, the Middle East, and South America. protect the acne skin against irritating environ- In addition to expanding into new markets, Lahurque markets its portfolio through a net- mental influences.” Lahurque was also “dedicated” to widening work of international distributors. ITCHIE was different from other acne prod- its portfolio, van den Hurk explained, noting Noting that the firm was currently investing ucts on the market containing benzoyl per- that the company was hoping to introduce a in innovation to expand its product offering, oxide and salicylic acid, he claimed, because “steady flow” of innovative products. van den Hurk said Lahurque’s greatest strength it was based on natural ingredients. “We already have several new and prom- was its ability to “create first-class OTC medi- “Part of the success we have already had ising products in the pipeline, which we plan cal devices that stand out in the market, have with ITCHIE is that it works rapidly and con- to launch over the next few years,” van den unique benefits and are highly effective”. sumers will see and feel direct results.” Hurk promised. OTC

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9 September 2016 OTC bulletin 7 OTC COMPANY NEWS

Second-Quarter Results First-Half Results Sales down Latin America lifts at Moberg turnover at Merck oberg Pharma reported a double-digit drop Min second-quarter sales to SEK71.3 mil- strong performance in Latin America “thereby generate future growth”. lion (C7.45 million), as turnover declined in all Ahelped drive up sales at Merck KGaA’s Outside Latin America Consumer Health had three of its global business regions. Consumer Health business by 3.2% operation- recorded “low single-digit growth” in Europe The Sweden-based firm’s sales fell back by ally in the opening six months of 2016. in the six months, Merck said. 23% overall, with Europe recording the biggest However, negative currency effects of 14.0% “Strong demand” for the Femibion women’s plunge in turnover. had wiped out the operational gain, the German health supplement had driven up sales in many Peter Wolpert, Moberg’s chief executive of- firm pointed out. Eastern European markets, the firm noted. ficer, explained that a 43% slide in sales in Eu- This left Consumer Health’s first-half sales Meanwhile, in Consumer Health’s Asia-Pa- rope had been due to “increased competition”. down by 10.8% at C427 million. cific region, the business had enjoyed growth “Going forward, we expect European sales The Neurobion and Dolo-Neurobion vita- in India, Indonesia, Thailand and Singapore, to be at a lower level,” he admitted. min B brands had boosted sales in Latin America Merck noted. Turning to the firm’s North and South Ameri- in the six months, Merck noted, along with a Indonesia remained the Consumer Health ca region, Wolpert reported turnover down by solid showing from ‘local brands’. unit’s “growth engine” in the region, the com- 21% to SEK53.9 million, as a result of “discon- During the period, Merck expanded its Con- pany pointed out, thanks to a strong showing tinued product variants” and lower sales of its sumer Health portfolio in Latin America with the from the Sangobion anaemia supplement. Kerasal Ointment line. Anemidox/Confer and Hepabionta brands, which During the six months, Merck expanded its “All other products” had delivered growth, were transferred from its Biopharma business portfolio in the Asia-Pacific region with three Wolpert pointed out, including the firm’s key (OTC bulletin, 5 February 2016, page 15). dietary supplements transferred from the Bio- Kerasal Nail antifungal product. Anemidox/Confer was for “the treatment pharma business. Widening distribution meant that Kerasal and prevention of iron deficiency-related anae- The Evion vitamin E product, Livogen iron Nail – known as Emtrix or Nalox in a number mia at every stage of life”, Merck explained, and folic acid supplement and the Polybion of markets – now accounted for over a quarter while Hepabionta was designed to support and vitamin D brand were all marketed in India, of sales in the US retail fungal-nail segment, protect the liver. Merck explained, and generated combined an- Wolpert explained. Commenting on the transfers, Uta Kemmer- nual sales of around C45 million. ich-Keil, chief executive officer of Merck Con- Consumer Health accounted for 5.7% of Expanded US portfolio sumer Health, said the brands had “great pot- Merck’s total sales in the opening six months Following the close of the period, Moberg ential for consumerisation”, adding that the com- of 2016, which moved forward by 19.3% to strengthened its US OTC portfolio by acquiring pany planned to “further develop” them and C7.47 billion. OTC three brands from Prestige Brands for US$40 million (C36 million). Business Strategy The three brands – Fiber Choice, New-Skin and PediaCare – had generated sales of around Vitamin Shoppe grows footprint US$24.4 million in the year ended 31 March 2016, Moberg noted, and were “well-estab- itamin Shoppe has expanded its footprint “Working with partners, such as Vita Vida,” lished” in the US OTC market (OTC bulletin, Vin Central America with the opening of continued Denker, “Vitamin Shoppe is able to 22 July 2016, page 2). three stores in Costa Rica. educate consumers about the supplements in- Commenting on the rationale behind the Located in the country’s capital, San José, dustry as well as how to live a health and well- deal, Wolpert said the acquisition was “in line the three franchise outlets were opened as part ness lifestyle.” with our strategy to add critical mass to our US of a partnership between Vitamin Shoppe and operations, as well as a leading topical brand local player Vita Vida. Expanding in Panama to our core dermatology franchise”. The partnership between the US-based natu- Separately, Vitamin Shoppe said it planned Turning to Moberg’s Rest of World business, ral products retailer and the local firm will see to open two new outlets in Panama to take its Wolpert reported turnover down by 13% to Vita Vida open a further eight Vitamin Shoppe total number of stores in the country to four. SEK10.5 million. stores in Costa Rica over the next five years. The company took its first steps into Central “Volume discounts”, in combination with Each store in Costa Rica would offer con- America earlier this year with the opening of a number of product divestments, had been to sumers a “curated selection of Vitamin Shoppe’s three stores in Guatemala (OTC bulletin, 5 Feb- blame for the drop in sales, Wolpert explained. proprietary brands”, the retailer said, as well ruary 2016, page 8). Despite the overall fall in sales in the region, as “other leading third-party brand products”. Located in Guatemala City, the three outlets Wolpert noted that Kerasal Nail was “reaching a “The Vitamin Shoppe brand continues to reso- were opened in collaboration with Swiss com- market leading position” in “most countries” nate with customers outside the US, and we are pany Grupo Unipharm. across Asia where Moberg had a presence. In pleased to be launching in another new country The partnership will see Grupo Unipharm addition, test launches of the product had been this year,” commented David Denker, the firm’s open a further 12Vitamin Shoppe stores in Guate- initiated in China and Japan, he said. OTC director of international development. mala over the next 10 years. OTC

8 OTC bulletin 9 September 2016 COMPANY NEWS OTC

Annual Results First-Half Results P&G suffers BI reports OTCrise tough year beforeSanofi deal rocter &Gamble’s (P&G’s) Personal Health PCare business endured a“difficult” year oehringer Ingelheim reported arise in first- vation for offloading Consumer Health Care. ended 30 June 2016 with several “headwinds” Bhalfsales at its Consumer Health Care unit Speaking in May,Andreas Barner,chairman holding back growth, according to the US firm’s as the privately-owned German firm prepares of firm’smanagement board, said Boehringer chairman David Taylor. to hand over the business to Sanofi. had decided to enter talks with Sanofi as the com- Personal Health Care had suffered through TurnoveratConsumer Health Care had im- panywould have had to “invest considerable a“very weak cough/cold season in the US”, provedby5%onacurrency-adjusted basis to amounts in acquisitions” in order to “survive Taylor pointed out, while also facing atough C750 million in the opening six months of the the consolidation process” in the OTCarena comparison with the prior year when anum- year,Boehringer said. In euro terms, sales were and “retain the critical mass required” (OTC bul- ber of line extensions to the Metamucil and down by 4%. letin,6May 2016, page 5). Vicks brands had been launched. “This is amarket in which, in the long run, Despite this, organic sales had movedforward Exit the OTCmarket Boehringer would no longer be competitive,” in the 12 months, he noted. In June,Boehringerreached adefinitive agree- Barner admitted. The Personal Health Care unit includes sales ment to swap its Consumer Health Care business Consumer Health Care accounted for just from P&G’swholly-owned US OTCbusiness for Sanofi’sMerial animal healthcare unit (OTC over atenth of Boehringer’stotal first-half sales, and the PGT Healthcare OTCjoint venture it bulletin,30June 2016, page 1). The deal will which movedforward by 2% to C7.3 billion. established with Teva in 2011 (OTC bulletin, seeBoehringer exit the OTCspace in all markets Thefirm’sPrescription Medicines business ac- 16 November 2011, page 1). around the world, except China. counted for the bulk of the sales, with turnover Personal Health Care is part of P&G’swider Announcing the definitive agreement, Boeh- rising by 4% to C5.5 billion, with the Animal Health Care business –along with the Oral Care ringer cited ongoing consolidation in the global Health and Biopharmaceuticals units respon- unit –which reported sales down by 5% to OTCindustry as the company’sprimary moti- sible for the remainder. OTC US$7.35 billion (C6.59 billion) in the 12 months. Negative currencyeffects and adjustments for acquisitions and divestments had been enough to offset 3% growth drivenbyincreased pricing and abetter product mix, P&G said. By contrast, Health Care’spre-tax profits rose by 7% to US$1.81 billion in the 12 months. Health Care accounted for 11% of P&G’s annual sales, which declined by 8% to US$65.3 billion, due mainly to negative currencyeffects. By contrast, total group pre-tax profits ad- vanced by 21% to US$13.4 billion, thanks to reduced costs.

Health Carenot apriority In February,P&G said that its Health Care business wasnot a“particular priority” for the US consumer giant (OTC bulletin,5February 2016, page 6). Jon Moeller,P&G’schief financial officer, made no mention at the time of the firm’sHealth Care business as he revealed that the firm had put a“particular priority” on strengthening its “four largest categories: Baby Care, Fabric Care, Grooming and Hair Care”. Despite this, Taylor revealed that the com- panyhad restructured its Personal Health Care sales team in the US to ensure that the average experience levelwas more than fiveyears of healthcare sales exposure. He also insisted that the team wassolely dedicated to selling the company’sOTC brands in the country. OTC

9September 2016 OTC bulletin 9 OTC COMPANY NEWS

Annual Results First-Half Results Blackmores OTCPharm boosted enjoys rise by demand for VMS ustralian natural health firm Blackmores Areported sales up by 52% to A$717 mil- ncreasing demand” for vitamins, minerals noted, helping to maintain its position as OTC- lion (C491 million) in the year ended 30 June “Iand supplements (VMS) in Russia lift- Pharm’s second-best selling brand. Launching 2016, driven by a double-digit rise in turnover ed turnover at OTCPharm by 68.4% to RUB11.3 a range of line extensions, such as Complivit in its core domestic market. billion (C155 million) in the opening six months Shine and Complivit Chondro, had driven the Sales in Australia advanced by 56% to A$495 of 2016, the company reported. double-digit rise, OTCPharm pointed out. million in the 12 months, accounting for just Sales of wholly-owned brands had risen by Meanwhile, OTCPharm said better sales of over two-thirds of Blackmores’ total turnover. 65.9% to RUB9.29 billion in the period, OTC- cold and flu products had also boosted turnover. Christine Holgate, Blackmores’ chief execu- Pharm noted, driven by an 86% rise in turn- Flu pandemics in January and March had tive officer, said “growing consumer demand for over from VMS products. lifted demand for Arbidol in the period, the high quality, natural wellness products” had been The stand-out performer in the period had company explained, with sales of the brand up behind the double-digit rise in domestic sales. been the Magnelis supplement, the company by 58.2% to RUB950 million. This rise in inci- “In addition,” continued Holgate, “the Aus- pointed out, posting sales of RUB643 million, up dences of flu had also benefitted Amixin, with tralian business continued to benefit from in- from RUB216 million in the prior-year period. sales growing by 63.9% to RUB949 million. creased sales to Chinese tourists and entrepre- This growth propelled Magnelis from tenth to In addition to the overall rise in sales of neurs shopping in Australia, as well as Chinese sixth position in the ranking of OTCPharm’s wholly-owned brands, OTCPharm also reported Australian consumers purchasing for relatives top-10 brands (see Figure 1). better turnover from products that the company and friends and shipping to China.” Introducing the Magnelis B6 Forte line ex- markets in Russia on behalf of other manufac- During the 12 months, Blackmores expand- tension, in combination with increased demand turers. Sales from these products advanced by ed its domestic operation by acquiring for A$23 for VMS products, had been behind the jump 80.7% to RUB2.05 billion in the six months. million traditional Chinese medicine manufac- in the brand’s sales, the firm explained. OTCPharm was established via a spin-off of turer Global Therapeutics (OTC bulletin, 27 Sales of Complivit vitamins had improved Pharmstandard’s branded OTC business in 2013 May 2016, page 4). by 43.9% to RUB1.09 billion, the company (OTC bulletin, 17 January 2014, page 6). OTC The firm claimed at the time that the deal Business First-half sales Change 2015/2016 Proportion would give Blackmores a “foothold in the rapidly- RUB millions) (%) of sales (%) growing Chinese herbal medicines market”. Pentalgin 1,502 +41.9 13.2 Turning to the company’s sales in Asia, Holgate noted that turnover in the region had Complivit 1,087 +43.9 9.6 improved by 54% to A$129 million. Arbidol 950 +58.2 8.4 Singapore, Hong Kong and Taiwan had deliv- Amixin 949 +63.9 8.4 ered “record growth” in the 12 months, Holgate said, thanks to “line extensions, increased dis- Aphobasolum 656 +55.6 5.8 tribution and further investment in our brand”. Magnelis 643 >100 5.7 China – Blackmores’ biggest Asian market – Acipol 508 +64.9 4.5 had also enjoyed a good year, she pointed out, Rinostop 441 +47.9 3.9 driven by a rise in e-commerce sales. Blackmores recently expanded its presence Codelac 359 +7.1 3.2 in Asia by establishing a joint venture with Kalbe Flukostat 357 +9.5 3.1 Farma to “facilitate” its entry into the Indonesian Other 1,841 –16.2 market (OTC bulletin, 6 November 2015, page 3). At the time, Blackmores said that establish- Wholly-owned brands 9,294 +65.9 81.9 ing a presence in Indonesia was an important Third-party products 2,054 +80.7 18.1 part of its “Asia growth strategy”. Total OTCPharm11,348 +68.4 100.0 Meanwhile, commenting on the BioCeu- ticals business – the Australian nutritional sup- Figure 1: OTCPharm’s sales in the first half of 2016 broken down by business (Source – OTCPharm) plements firm Blackmores acquired in 2012 (OTC bulletin, 29 June 2012, page 1) – Hol- IN BRIEF gate said its sales had advanced by 25% to A$69 million in the 12 months, driven by launches of NUGO NUTRITION – the US-based mented NuGo’s chief executive David Levine. “innovative new products”. sports-nutrition company – had expanded its “NuGo recognises the great potential of the Pro- BioCeuticals markets supplements to medi- portfolio by acquiring for an undisclosed sum max brand and will leverage its expertise in the cal practitioners, natural health professionals the Promax protein brand from Promax Nu- nutrition bar category, and its extensive sales and pharmacists, primarily in Australia and trition. “Promax has been a mainstay in the sports- network, to create a solid growth platform for New Zealand. OTC nutrition category for more than 20 years,” com- the brand under NuGo’s umbrella.” OTC

10 OTC bulletin 9 September 2016 COMPANY NEWS OTC

Mergers & Acquisitions/Annual Results Adcock to sell Ayrton

outh Africa’s Adcock Ingram is set partially Sto realise plans to withdraw from Ghana to focus more on its domestic market, after agreeing to sell a majority stake in its Ghan- aian Ayrton Drug Manufacturing business to local manufacturer and distributor Dannex for an undisclosed sum. Adcock has agreed to divest a 53.47% share of Ayrton, representing just over two-thirds of Adcock’s existing 78.57% Ayrton stake. Adcock first approached Ayrton with an offer to acquire at least 51% of the Ghanaian com- pany’s shares late in 2009, with an agreement for 65.59% of Ayrton tied up in April the fol- lowing year. No expected completion date for the trans- action was disclosed, with the deal “subject to a number of conditions precedent”. “The mode of payment for the shares will be cash,” Ad- cock revealed. Established in 1965, Ayrton manufactures a range of prescription and OTC drugs, includ- ing the Baby Paralex children’s pain-relief line, Clobet dermatology range, Medi-Keel A throat lozenges and the Samalin cough and cold brand. For more than 25 years, we In March this year, Adcock chief executive Andy Hall announced that the firm was actively have acted on behalf of our looking to exit both Ghana and India, the latter clients as advisors, doers and being partially achieved shortly after through the agreed sale of the sales and marketing arm a source of ideas for medicinal of Adcock’s Cosme Farma operation to a local and health products: private-equity company (OTC bulletin, 22 April 2016, page 8). Regulatory Affairs Adcock retained Cosme’s regulatory services business covering “quality control and assurance, Medical Affairs medical affairs, information technology support and research and development services”. Clinical Affairs Both Ghana and India were thus listed as Business Development discontinued operations in Adcock’s financial report for the year ended 30 June 2016, during Quality Management which time group sales improved by 7.5% to ZAR5.55 billion (C335 million), thanks to ad- vances by its Southern African OTC and Con- sumer businesses. During the 12 months, OTC sales had im- proved by 14.7% to ZAR1.67 billion, Adcock We rock pointed out, driven by “greater volume demand” for its Adco-Dol analgesic, Corenza C cold and flu line, and its Allergex allergy line. OTC turnover accounted for 31% of Adcock’s Southern Africa sales – which advanced by 7.3% to ZAR5.39 billion – with the firm’s Consumer, Hospital and Prescription businesses generating Diapharm GmbH & Co. KG · Muenster · London · Vienna · Shanghai · +44 203 178 2790 · www.diapharm.com the remainder. OTC

9 September 2016 OTC bulletin 11 OTC COMPANY NEWS

First-Half Results Business Strategy Krka posts Amazon brings its sales drop Dash service to EU urnover from Krka’s non-prescription prod- Tucts – including self-medication lines and onsumers in Europe can now buy OTC cosmetics – slipped back by 1.1% to C50.3 mil- Cproducts such as Durex and Nicorette at lion in the opening six months of 2016. the push of a button, after e-commerce giant The Slovenian firm said gains in its domestic Amazon launched its Dash instant-order service market and South-East Europe region had been in a number of markets across the region. offset by lower sales in East Europe. Launched in the US in 2015, the Dash ser- Krka blamed the overall decline in sales vice has been expanded to allow consumers in East Europe on the company’s performance in in Austria, Germany and the UK instantly to Dash Buttons for Durex and Nicorette Ukraine, where the non-prescription medicines order products – ranging from consumer health- one-click shopping from anywhere in the home,” market had shrunk dramatically in the six months. care lines to household goods – by pressing a commented Daniel Rausch, director of Amazon On a more positive note, Krka reported non- Wi-Fi connected physical device, known as a Dash. “They can be placed near those frequently- prescription turnover up by 22% to C4.2 mil- Dash Button. used items you don’t want to run out of, and lion in its domestic market, thanks to better Each Dash Button costs C4.99 and will order when you see supplies running low, the Dash sales of analgesics. a set item to the user’s home when pushed. Con- Button makes it easier than ever to order more. The naproxen-based product Nalgesin had sumer healthcare companies including Reckitt Just press the button and your item is on its way.” been the firm’s leading non-prescription prod- Benckiser (RB) and Johnson & Johnson (J&J) Taryn Mitchell, RB’s global vice-president uct in Slovenia in the six months, Krka said, have made a number of their products avail- of digital sales, claimed the Dash service made with the paracetamol brand Daleron also per- able through the service. it “even easier to stay stocked up on the essential forming well. Consumers in the UK can obtain Dash items you use every day”. Turning to South-East Europe, Krka said Buttons for numerous J&J products including “We’ve seen great engagement from our con- non-prescription sales had risen by 19%, thanks Aveeno, Listerine, Nicorette, and Regaine. Dash sumers in the US,” Mitchell noted. “In fact, a to growth in Romania and Croatia. Buttons are also available for RB’s Durex and significant number of orders we see through Ama- Better sales of Nalgesin and Septolete throat Glanbia’s Optimum Nutrition and BSN sports- zon today are placed via a Dash Button.” lozenges had helped to lift turnover in Romania nutrition lines. “It is a remarkably convenient way for con- by 31%, the firm noted, while sales hadve impro d Austrian and German consumers can also sumers to reorder everyday items,” she added, 23% in Croatia, driven by the performance of purchase a Dash Button for Durex, as well as “and it even adds a bit of fun to the process.” Ginkgo biloba-brand Bilobil. for Diadermine’s skin-care products. RB offers US consumers a wide range of Non-prescription products represented 9.2% “Dash Buttons offer the convenience of brands through the Dash service, including Air- of Krka’s Human Health sales in the first half borne vitamins, Mucinex cold and flu products of 2016, which slipped back by 1.6% to C550 and Schiff glucosamine supplements. Companies million. This accounted for 91% of Krka’s to- such as Church & Dwight, Procter & Gamble tal group sales, which edged up by 0.7% to (P&G) and Rexall Sundown also operate on the C604 million. platform in the US. Commenting on the US operation, Amazon said the Dash service was enjoying “continued IN BRIEF growth”, with the number of brands available “increasing at a rapid pace”. BIOGAIA reported sales down by 1% to “Dash Button orders have increased three- SEK270 million (C28.3 million) in the open- fold and orders take place at a rate of over twice ing six months of 2016, as turnover declined at Reckitt Benckiser’s Taryn Mitchell a minute,” Amazon revealed. OTC its dominant Paediatrics business. Paediatrics’ turnover had dropped by 4% to SEK215 million, the Swedish firm said, due to lower sales of IN BRIEF digestive-health tablets in Brazil and across Europe. This had been compounded, BioGaia CHURCH & DWIGHT reported turn- sumer division’s domestic sales, which moved said, by falling sales of cultures for infant formula. over at its US Personal Care Products business forward by 4.9% to US$670 million. The firm’s On a more positive note, BioGaia reported up by 9.9% to US$272 million (C244 million) US Household Products business made up the sales at it Adult Health business up by 11% to in the second quarter of 2016, thanks to higher remaining 59% of the Consumer division’s SEK46.8 million in the six months. Better sales sales of Vitafusion vitamins. The brand had domestic turnover. International Consumer sales of digestive-health tablets in Europe had been enjoyed a “solid quarter”, Church & Dwight improved by 4.2% to US$136 million, while behind the rise, the company revealed. Sales pointed out, with sales advancing at a “high- Specialty Products turnover fell by 8.6% to of oral-health tablets had also improved in all single digit” rate. US Personal Care Products US$71.2 million. Total group sales advanced regions except Asia, BioGaia noted. OTC accounted for 41% of Church & Dwight’s Con- by 3.6% to US$877 million. OTC

12 OTC bulletin 9 September 2016 GENERAL NEWS OTC

Research Pricing & Reimbursement Danes lack Homoeopathy gets knowledge trade body support anish consumers have “very little know- Dledge” about dietary supplements and in erman patients must be allowed to choose the BAH, said delisting homoeopathy from re- particular plant-based supplements, according Ghomoeopathic medicines as part of their imbursement would “endanger in an irrespon- to new research by the University of Denmark’s treatment through the country’s statutory health sible manner the range of medicines and thera- National Food Institute. insurance system, two leading pharmaceutical peutic options that are available”. As homoeo- Despite being among the highest consumers of associations have insisted. pathic remedies had pharmacy-only status in dietary supplements in Europe, most of the us- The associations have criticised comments Germany, patients had access to expert advice ers interviewed for the research did not know made to the Frankfurter Allgemeine Zeitung on such products, he added. what dietary supplements actually were, the (FAZ) newspaper by Professor Josef Hecken, Furthermore, Kroth argued, such suggestions study’s authors say, and had no precise know- chairman of Germany’s decision-making federal went against the wishes of empowered patients, ledge on nutritional recommendations. joint committee on reimbursement, the G-BA. as proven by a 2014 survey conducted for the The study – which focuses on the reasons Hecken argued in an interview with the FAZ that BAH by Demoskopie Allensbach that found why people take plant-based supplements – statutory insurance funds should not pay for that more than half of the German public had shows that 64% of the adult Danish population homoeopathic treatments because there was no evi- already used homoeopathy (OTC bulletin, 7 aged 18-75 years uses supplements, with 48% dence to show that such medicines were effective. November 2014, page 13). using multivitamin and mineral supplements. Since 2012, statutory insurance funds have Henning Fahrenkamp, chief executive of Supplements with various herbs and herbal been able to choose whether to fund certain the association of the German pharmaceutical extracts are used by about 5 % of the population. non-prescription medicines, such as homoeo- industry, the BPI, stressed the role that homoe- Those taking plant-based supplements are pathic remedies, as an optional service to attract opathy could play as a supportive therapy for the least educated about the products they are customers. Most OTC medicines were barred serious conditions that was typically without using, the study finds, with the majority stating from reimbursement by statutory funds in 2004. major side effects. “Homoeopathy is no in- that any information they receive comes from Dr Elmar Kroth, scientific director of Ger- effective hocus pocus, it is a recognised and magazines, newspapers or advertisments. many’s medicines manufacturers’association, proven form of therapy,” he insisted. OTC Despite this, many users want more docu- mented information on the effects of plant-based supplements, the study says. Regulatory Affairs

Used for specific health problems SA widens supplement definition Looking at the reasons why plant-based sup- outh Africa’s Medicines Control Council the criteria they would have to be withdrawn plements are used, the study finds that most S(MCC) and Department of Health is con- from the market by 2019. people take the products for a specific health sidering broadening its definition of comple- However, the South African authorities are problem or as a preventive measure. mentary medicines to allow a number of natural now considering adding a new category – ‘health Users strongly believe the products work health products to remain on the market. supplement’ – to the legislation, which would for them, with long-term use often based on the In 2013, in an attempt to clean up the comple- enable many more natural products to be sold. perceived effect and the belief that plant-based mentary medicines market, the MCC proposed MCC registrar Joey Gouws said manufac- supplements are harmless and less dangerous a new definition of complementary medicines, turers wanting to sell products under the new than medicinal products, the study points out. which industry argued would lead to 60% of all category would still have to submit safety and Furthermore, long-term users claim that they natural products on the market being banned. quality data. take the products out of habit, the study finds, The law defined natural or complementary Previous dossiers for products such as slim- and that the products act as insurance against medicines as products making medicinal claims ming aids and sexual-health products submitted potential future health problems. that were linked to established healthcare tradi- under earlier legislation had all failed to meet the “The users do not know how healthy they tions such as herbal or Ayurvedis medicines. standard required, Gouws said, but in many would feel without taking plant-based sup- Manufacturers of such products had to sub- cases this was because the dossier was in- plements,” the study’s authors noted “and they mit evidence for the products’ claims by the complete, rather than the evidence did not meet have therefore chosen to believe that the supple- end of 2014. If the products did not fit with the right standard. OTC ments have a beneficial effect on their health.” Currently, there are no official recommenda- tions from the Danish health authorities on us- IN BRIEF ing plant-based supplements. Only certain at-risk population groups are CMDh – the European Medicines Agency’s out of a total of 120 procedures. Three of the recommended to use of dietary supplements Co-ordination Group for Mutual Recognition procedures related to herbal-based products. by the Danish Veterinary and Food Administra- and Decentralised Procedures – said 15 decen- Meanwhile, 28 mutual recognition procedures tion, but no plant-based supplements are rec- tralised procedures related to non-prescrip- had been started in June, but none were related ommended to those groups. OTC tion drugs had been started in June 2016 to non-prescription medicines. OTC

9 September 2016 OTC bulletin 13

OTC GENERAL NEWS

Research Regulatory Affairs US ignores FDA issues revised safety text fifth of US adults do not consider “key supplement rules Asafety factors” – such as pre-existing health conditions, current medicines and age – when he US Food and Drug Administration (FDA) quired; and the procedures for submitting an choosing an OTC analgesic, according to a sur- Thas released revised draft guidance to help NDI notification, theA FD said, along with the vey by pain charity the US Pain Foundation. dietary supplement companies improve the way types of data and information that manufactur- While 97% of the 1,300 participants said they provide pre-market safety notifications for ers and distributors should consider when evaluat- they were “confident” when selecting an OTC new dietary ingredients (NDI). ing the safety of a dietary supplement contain- painkiller, the survey – supported by Johnson Noting that while there were an estimated ing an NDI, and what should be included in & Johnson’s (J&J’s) McNeil Consumer Health- 55,600 dietary supplements on the US market an NDI notification. care unit – found that consumers placed more and that 5,560 new supplements came onto the Furthermore, the draft guidance contained emphasis on how quickly and effectively a prod- market each year, the FDA said that it had re- questions and answers about parts of the dietary uct would relieve their pain than whether it was ceived “fewer than 1,000 NDI notifications” supplement definition – section 201(ff) of the the most appropriate option for them, with 58% since the Dietary Supplement Health and Edu- Food, Drug & Cosmetic Act – that could affect failing to take into account their current ailments. cation Act (DSHEA) was passed in 1994. whether a substance might be marketed as an ingre- Many respondents were also unconcerned by An initial draft guidance was released in 2011, dient in a dietary supplement, the FDA said. potential interactions with other drugs they were but following feedback from the dietary supple- Steven Tave, acting director of the FDA’s taking, with nearly half – 45% – of those sur- ments industry, the agency had decided to issue Office of Dietary Supplement Programs, said veyed saying their choice of pain-relief product a revised version, the FDA pointed out, to “clarify the revised draft guidance was an “important was not influenced by their current prescription several important points” which had been mis- step forward” in the agency’s work to protect medicines, and around two-thirds stating that understood or not fully explained. the public from potentially dangerous new diet- they did not consider their consumption of other The draft guidance had several purposes, the ary ingredients. OTC products when choosing pain relief. FDA said. First, it was intended to “help dietary “Notification of new dietary ingredients Meanwhile, almost three-quarters – 73% – supplement manufacturers and distributors de- is the only pre-market opportunity the agency of participants aged 60 years and over said they cide whether to submit an NDI notification”. has to identify unsafe supplements before they disregarded their age when making a purchase. “In addition, the draft guidance is intended are available to consumers,” Tave pointed out. The US Pain Foundation’s founder Paul to provide recommendations on how to prop- “The revised draft guidance is intended to im- Gileno stressed that consumers should “always erly conduct a safety assessment for an NDI prove the quality of industry’s new dietary in- balance finding effective relief with important notification and what to include in the notifica- gredient reporting so the FDA can more effective- safety considerations”. OTC tion,” the agency continued. ly monitor the safety of dietary supplements.” In question and answer form, the draft guid- Comments on the revised draft guidance ance presented the FDA’s views on what qualified should be submitted to the FDA by 11 Octo- Market Research as an NDI; when an NDI notification was re- ber 2016. OTC Global market to rise by 6% Regulatory Affairs he global OTC market is expected to grow AESGP joins eHealth group Tby over 6% in the next four years, accord- he Association of the European Self-Med- ciation would give input on the advice given ing to a new report by Research and Markets. Tication Industry, the AESGP, is set to play to the EC on eHealth-related activities. Forecasting a compound average growth rate a role in developing European Union (EU) The eHealth Stakeholder group also covered (CAGR) of 6.19% in the 2016 to 2020 period, eHealth policy after becoming a member of the the area of mobile health, or mHealth, the asso- the firm said that the growing importance of self- European Commission’s (EC’s) eHealth Stake- ciation said. The group had closely followed medication to help control healthcare budgets holder Group. EU policy actions in the mHealth area, the would be a key driver of the rise in sales, espe- The eHealth Stakeholder Group had been AESGP pointed out, since the launch of the cially given the increased demand on healthcare established to contribute to the “development EU mHealth Green Paper in 2014. services from an ageing population. and implementation of eHealth policy at the EU Noting that the Green Paper raised issues However, one challenge for the market would level”, the AESGP pointed out. around data protection and reliability as well as be counterfeit medicines, Research and Markets As a selected member of the group for a the validity of collected data, the AESGP said claimed. The sale of counterfeit OTC medicines period of three years, the AESGP would give that these issues still needed to be addressed to was increasing, especially in emerging markets, its input into the “design, implementation and build consumer trust in mHealth technologies. it maintained, and was a problem that usually evaluation of eHealth policy activities” and com- Policy initiatives in the mHealth area were went unreported to the authorities. ment “in particular on the implementation of underway, including building a framework for “It is estimated that counterfeit drugs account the Digital Single Market Strategy and the eHealth health and wellbeing apps, such as an industry- for 10% of the global market, as compared to just Action Plan 2012-2020”. led code of conduct and mHealth assessment 1% in the developed world,” the firm said. OTC Furthermore, as part of the group, the asso- guidelines, the AESGP said. OTC

16 OTC bulletin 9 September 2016 GENERAL NEWS OTC

Market Research Regulatory Affairs Vits & tonics ASMI welcomes lead Korea itamins and tonics were the best-selling labelling changes Vlocal consumer healthcare products in Korea in the opening six months of the 2016, according hanges to the way non-prescription medi- Noting that the new labelling requirements to research by local news agency Yonhap. Ccines are labelled in Australia have been would “not change the overall appearance of well- Using data gathered from first-half reports welcomed by the Australian Self-Medication known non-prescription medicine brands”, the of local OTC players,Yonhap said that Ildong Industry (ASMI). ASMI said that this consistency was “important Pharmaceutical’s vitamin brand Aronamin was Following the conclusion of the Therapeutic for consumers”. the biggest seller in the period with sales of Goods Administration’s (TGA’s) review of medi- “Industry also welcomes the pragmatic tran- KRW33.5 billion (C27.2 million). cines labelling and packaging, the ASMI said it sition period of four years,” the ASMI added, Aronamin was followed by Daewoong Phar- was pleased that the regulator had approved “sen- “which allows adequate time for manufacturers maceutical’s liver supplement Ursa with sales sible” reforms to non-prescription labelling. to phase out current packaging before transition- of KRW30.9 billion. Dongwha Pharm’s digestive “For non-prescription medicines, the major ing to the new format.” health supplement Gas Whalmyungsu-Q and changes are an increase in the prominence of While the majority of non-prescription med- Kwangdong Pharmaceutical’s Cheongshimwon active ingredients on the front of the pack,” the icines would be able to accommodate the new both recorded turnover of KRW18.1 billion. ASMI explained, adding that the changes would labelling requirements, the ASMI warned that In the first half, nine OTC drugs reported also see a standardised format for critical infor- some products might “have difficulty meeting the sales of more than KRW10 billion, up from six mation on the back of the pack. requirements and need TGA exemptions”. in the prior-year period. Commenting on the labelling changes, the The labelling review began in 2012, but the Yonhap said the growth had been due to the TGA said its goal was to “make important in- initial changes were deemed impractical. The wider awareness of self-care. formation easier to find” on product packaging. ASMI said the original proposals would have Among local OTC medicines brands, Jeil Medicine labels would now be “clearer and “significantly impaired consumers’ ability to Pharmaceutical’s topical pain-relief plaster Ke- more consistent”, the regulator insisted, and recognise and select non-prescription medicines fentech reported the strongest growth, with sales provide users with “enough information to make as they did not take into account differences be- rising by 65% to KRW9.3 billion. OTC safe and informed decisions”. tween OTC and prescription products. OTC

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9 September 2016 OTC bulletin 17 OTC GENERAL NEWS

RegulatoryAffairs RegulatoryAffairs Brazil has FDArules against newcode antibacterial wash he Brazilian Food and Drug Administration T–ANVISA –has updated its OTC regula- onsumer antiseptic wash products con- the spread of germs, the agencyhad seen “no tion to help expand the number of OTC medi- Ctaining triclosan and triclocarban can no scientific evidence that theyare anybetter than cines available in the country. longer be marketed in the US after the Food plain soap and water”. Published in Brazil’s Official Gazette,the and Drug Administration (FDA) ruled that “In fact, some data suggests that antibacteri- newregulation has been designed to allow there was no evidence that they were safe for al ingredients may do more harm than good,” ANVISA simultaneously to reassess the status long-term daily use. she added. of currently available OTCdrugs while approv- Issuing afinal rule banning the products, the Proposing the rule at the end of 2013, the ingnew products. FDAsaid that as well as aquestionable safety FDApointed out that some data suggested that Thenew regulation is expected to increase profile, OTCproducts such as antibacterial hand long-term exposure to certain active ingredients competition in the OTCcategory and prompt a and body washes that contained either triclosan used in antibacterial products –for example, shifttowards consumer marketing rather than or triclocarban –aswell as another 17 other less triclosan in liquid soaps and triclocarban in bar physician detailing. widely-used ingredients –had not been proven soaps –could pose health risks, such as bacterial Under the newregulation, medicines must by manufacurers to be more effective than plain resistance or hormonal effects (OTC bulletin, meet sevencriteria to be approvedfor OTCsale: soap and water in preventing illness and the 17 January 2014, page 10). l The drug must have been commercially spread of certain infections. The other 17 ingredi- The widespread consumer use of antibacterial available for aminimum of 10 years –five ents have also been banned. products, the accumulated scientific information, years in Brazil –asaprescription drug. Alter- The ban did not impact consumer hand sani- andconcerns raised by healthcare and consumer natively,the drug must have been registered for tisers or wipes, the agencynoted. groups, the FDAsaid, had prompted are-evalu- fiveyears as an OTCdrug in countries where Janet Woodcock, director of the FDA’sCenter ation of what data wasneeded to classify the regulations are similar to ANVISA’s own. for Drug Evaluation and Research (CDER), said active ingredients in consumer antibacterial prod- l The drug must exhibit ahigh levelofsafe- thatwhile consumers might think that antibac- ucts as “generally recognised as safe and ef- ty: the causes of adverse reactions must be well terial washes were more effective at preventing fective”orGRASE. OTC known and easily reversed, the drug must have alow leveloftoxicity,asafe therapeutic win- dow, and alow levelofinteractions with other Research drugs and food. l The clinical condition treated by the drug PAGB defends paracetamol cannot evolverapidly,and its symptoms must be easily identifiable by the consumer. he Proprietary Association of Great Brit- ors of the study admitted that their findings l The drug must pose alow risk when used Tain (PAGB) has defended the use of para- were from an observational, rather than aran- off-label or in overdose scenarios. cetamol during pregnancy, after arecent study domisedcontrolled study,with the results based l The drug cannot be indicated for continu- claimed that using the pain-reliever while preg- on questionnaires completed at various intervals ous use; rather,itcan only be used for ashort nantmay be associated with an increased risk overalong period of time. period of time or afixedperiod of time, which of behavioural problems in children. The study also did not account for the amount must be identified in the drug’slabel (except for Donna Castle, PAGB’sdirector of commu- of paracetamol taken and duration of use, Castle drugs labelled for prevention). nications, pointed out that the UK National pointed out, and it wastherefore “impossible l The consumer must be capable of using Health Service (NHS) advised that paracetamol to understand whether paracetamol wastaken the drug without anyphysical assistance from could be used throughout pregnancytoreduce a within the guideline levels”. ahealthcare professional. high temperature and relieve pain. “Furthermore, the authors have also high- l The drug cannot cause chemical depend- “This is supported by alarge body of evi- lighted the potential risk of not treating fever or encyinconsumers. dencefrom over50years of paracetamol use,” painduring pregnancy,”Castle noted, “overany Furthermore, an application for OTCstatus Castle noted. potential harm that prenatal paracetamol use must be supported by arisk-reduction plan, Research recently published online by JAMA may cause to offspring.” OTC detailing howpost-marketing safety monitor- Paediatrics assessed questionnaires completed ing would be carried out. by 7,796 mothers at 18 and 32 weeks preg- Once switches to OTChavebeen approved nant, along with partners and children aged five IN BRIEF byANVISA and published in the Official Gazette, andseven years old. The questionnaires formed companies will have 180 days to amend packag- part of the Avon Longitudinal Study of Parents FDA –the US Food and Drug Administra- ing and labels. and Children carried out between 1991 and 1992. tion –has launched its Drug Safety Labeling Thenew regulation replaces the rules intro- The authors claimed the result showed an Changes(SLC)database.Theagencysaidthe duced in 2003, which established the drugs that increased risk of multiple behavioural prob- database would also enable healthcare technol- could be sold OTCaccording to their thera- lemsinchildren whose mothers had taken para- ogy firms to more efficiently gather,organise and peutic indications. OTC cetamol during pregnancy. However, the auth- distribute information to drug safety labels. OTC

18 OTC bulletin 9September 2016 MARKETING NEWS OTC

Digital Marketing Product Launches Nix helps US Lanes strengthens to track lice restige Brands is helping US parents and Earex range in UK Pschool nurses to prepare for head-lice out- breaks in their community with an online Lice anes Health has strengthened its Earex ear- Tracker tool on behalf of its Nix brand. Lcare brand in the UK with the launch of a Claimed by the firm to be the first data-driven Pain Relief Ear Spray and Olive Oil Ear Drops, tool of its kind, the Nix Lice Tracker works by following its acquisition of the brand from combining retail sales information with “crowd- Reckitt Benckiser (RB) last year. sourced outbreak reports” from parents and Earex Pain Relief Ear Spray is positioned as school nurses – as well as Google Trends data providing “first aid for common ear problems” – to develop a map of communitieswhere lice – such as pain, infection, irritation, and accumu- outbreaks are currently occurring. lated earwax – and is claimed by Lanes Health The Nix Lice Tracker could be found on the to contain “a carefully-selected blend of natural brand website, nixlice.com/lice-tracker, the firm plant extracts known for their antiseptic, anti- Two new products join the Earex range bacterial, and anti-inflammatory properties”. The “unique, advanced triple-action formula” Earex Pain Relief Ear Spray and Earex Olive includes olive oil, sesame oil, spearmint oil, sea Oil Ear Drops were currently being supported whip extract and a “phytosterol complex”. by consumer public-relations activity, Lanes Meanwhile, Lanes Health said Earex Olive Health pointed out, while a press campaign Oil Ear Drops contained “medicinal-grade ol- was planned for early next year. ive oil” to gently soften and remove ear wax, The brand website, earex.co.uk, had also been pointing out that general practitioners (GPs) updated to include the two new products, the recommended the ingredient as an effective firm added, while point-of-sale materials were treatment for ear wax build-up. available to pharmacists and retailers. The Nix Lice Tracker is available online Both the Earex Pain Relief Ear Spray and Marketing support was expected to continue pointed out, adding that the tool had been de- Olive Oil Ear Drops were suitable for children until April 2017, the company said. signed easily to be used on mobile devices. aged over five years, Lanes Health noted, adding In January last year, Lanes Health gained Ear- Prestige pointed out that the website also that they could also be used on those under five ex – along with the Derbac M head-lice treat- informed users of the location of the nearest when recommended by a medical professional. ment – from RB, which acquired the brands Nix stockist. Money-off coupons were avail- The two new products joined the existing when it bought SSL International in 2010 able online for the brand, the company added, Earex Advance ear drops – formulated with (OTC bulletin, 3 July 2010, page 1). which included the recently-launched Nix ingredients such as glycerin and urea peroxide The recommended retail price for Earex Ultra product (OTC bulletin, 6 May 2016, page – to provide consumers with a “variety of af- Pain Relief Ear Spray is £9.99 (C11.88) for a 16) and a Lice Elimination Kit containing a fordable, high-quality, tailored ear-care solu- 15ml bottle, while it is £3.99 for a 10ml pack Crème Rinse, Combing Gel, Lice Control Spray tions”, the company said. of Earex Olive Oil Ear Drops. OTC and comb. OTC

Product Launches Regaine adds foam in Germany nce-a-day application is the key product the foam into their daily beauty regimes. Obenefit of the latest option for German Available in pharmacies from this month, the women of Johnson & Johnson’s (J&J’s) Re- 5% foam has a recommended retail price of gaine hair-loss treatment brand. C59.90 for a pack of two 60mg bottles, each of Regaine Frauen Schaum is a 5% minoxidil which is sufficient for two months of treatment. foam that is applied to the scalp. J&J said wo- The firm – which is supporting the launch men could easily and quickly integrate applying with public-relations activity – said “visible Ricola claims it is providing US consumers with results” could be expected after 12 weeks of use. a “proactive approach to wellness” by adding immunity lozenges to its range of herbal drops. J&J – which also markets a twice-a-day Formulated to “meet the needs of today’s hectic 2% Regaine solution for women in Germany – lifestyle”, Ricola Herbal Immunity lozenges introduced its 5% minoxidil foam in the US combined a blend of 10 Swiss herbs with a purified form of panax ginseng – as well as vitamins B6, almost two years ago under the Rogaine brand B12 and C – to support the immune system and name (OTC bulletin, 28 November 2014, page fight fatigue, the Swiss firm pointed out. 15). In France, the 5% foam is sold under the The lozenges were available in Honey Herb and Citrus Herb flavours from CVS,Walgreens and Rite Alostil brand name (OTC bulletin, 8 Novem- Aid stores across the country, Ricola noted. OTC Regaine 5% is available to German women ber 2013, page 21). OTC

9 September 2016 OTC bulletin 19 OTC MARKETING NEWS

Advertising Complaints ASA raps TAKING A PILL IS AS EASY AS PIE? FW Medical 50% OF YOUR CUSTOMERS

WOULD DISAGREE… W Medical’s claims that Silicolgel can … WOULD DISAGREE Ftreat a range of gastrointestinal symptoms were unsubstantiated and misleading and must not appear again in their current form, the UK’s Advertising Standards Authority (ASA) has ruled. A national press advertisement for Silicolgel showed an image of a torso with a stomach and digestive tract superimposed over it, while text stated that the colloidal silicic acid gel – a class IIa medical device – provided “fast, effective treat- ment” for irritable bowel syndrome (IBS) symp- toms, as well as heartburn and reflux, diarrhoea, stomach ache, flatulence and nausea. Explaining its decision, the ASA said that consumers would understand the claim to mean that Silicolgel was proven to treat each of the individual problems listed. Furthermore, noting that all the symptoms mentioned – with the exception of heartburn and reflux – were common symptoms of IBS, the watchdog said there were “additional com- mon and associated symptoms” of the condi- tion, such as constipation, bladder problems and lethargy, which were not referred to in the advertisement. Consumers would expect the ef- ficacy claim regarding “IBS symptoms” to in- clude all indicators, the ASA added. ViGETsit A us FREE at CPhI COPY 2016 OF THE in Barcelona, STUDY stand 6D31 While FW Medical had provided evidence in response to the ASA’s investigation, this had not been “sufficiently robust” to support the claims A recent study proves that more than half of the population in the advertisement, the watchdog said. has problems swallowing tablets and capsules. From breaking As a result, the claims were found to be and dissolving to not taking them at all, people invent their own unsubstantiated and misleading, and must not strategies to cope with tablets – which may reduce efficacy and appear again in their current form. Addition- treatment success. ally, FW Medical must not claim in the future that Silicolgel can treat specific symptoms or We at HERMES PHARMA have over 40 years of experience in conditions unless the firm holds sufficient docu- making medicines easier to take – from product design through mentary evidence to support such statements. to manufacturing and packaging. Meanwhile, the ASA banned sports-nutrition company Science in Sport’s online advertise- ment for its energy gels, as it featured an unap- GET A FREE COPY proved nutrition claim. OF THE STUDY As the statement that the products worked Scan QR-code or visit “twice as fast as any other energy gel” was not www.swallowingtablets.com listed in the annexto the European Union’sregula- tion on nutrition and health claims made on foods, the watchdog said the advertisement must not appear again in its current form. OTC

IN BRIEF EMSER has grown in Germany its epony- mous range of pastilles for sore throats and cough with a sage-flavoured option. OTC

20 OTC bulletin 9 September 2016 MARKETING NEWS OTC

Marketing Campaign Q&A with ‘No drama’ Boehringer’s for Hedrin Tim Templeman o itch, or not to itch?” asks a young Head of Consumer “Twannabe thespian in Thornton & Ross’ latest UK television commercial for its Hedrin Health Care, Australia head-lice treatment brand. Created by Bray Leino as part of Hedrin’s and New Zealand “no drama”-themed multimedia campaign, the 30-second advertisement shows the boy’s recital ending abruptly when his mother turns on the bathroom light, before he drops to the ground What has been the biggest achieve- not become their only reference when they and begins furiously scratching his head. Q ment of your OTC marketing career? are faced with a self-selection decision. As the woman shakes her head in despair, a We continue to focus resources in phar- voiceover states: “Head lice causing drama in I am very proud of Boehringer Ingel- macy staff education in an effort to build know- your house? Bring the curtain down on it with A heim’s ‘Got Mucus’ campaign for Bisol- ledge about our brands and the benefits they Hedrin Once”, adding that the spray gel kills lice von and the ‘Rope’ campaign for Buscopan, offer when a recommendation is needed. and eggs in 15 minutes. which we developed locally and was then suc- The voiceover also points out that Hedrin “pro- cessfully adopted in many other countries. What has been the most important tects, detects, treats and clears”, as the entire Being part of a global team which initiated Q lesson of your career? product range – which also comprises a Treat the turnaround of our Japanese Consumer & Go Mousse, Head Lice Detection Comb, and Health Care unit a number of years ago is also A key mantra of mine has been not to the Stubborn Egg Removal Kit launched in June one of my most rewarding achievements. A get too caught up in the theory of mar- (OTCbulletin,30 June 2016, page 16) – is shown. keting. I try not to overcomplicate things. I “Taking the fuss and bother out of head lice”, What has been the biggest challenge trust my gut instincts and others around me the voiceover continues, before announcing: “no Q of your OTC marketing career? – especially our sales team, which is a terrific barometer for giving a ‘real world’ perspec- There have been many – but the biggest tive. Pharmacy staff can be a powerful ally A challenges have centred on managing the for your brand; they are the front-line link to changing environment we work in, whether it consumers, so I am a strong believer in pro- be from a market or regulatory perspective, or viding both brand and category information to from the growing globalisation of our business. this group and listening to their feedback. The so-called ‘digital revolution’ and the changing dynamic of the media landscape is How do you see OTC marketing dev- Hedrin’s latest campaign has a“no drama” theme a big challenge we are currently facing. Free- Q eloping in the future? drama”. The tagline also appears on screen. to-air television is simply not delivering the Public-relations activity in trade and con- reach it used to, although the costs keep rising. I believe that media will become in- sumer press also formed part of the “no drama” The relevance of digital media needs to be A creasingly difficult to manage. At some campaign, Bray Leino noted, as well as print carefully considered; the challenge is that while point, advertisers are going say ‘enough is advertising in trade titles. the digital space certainly provides new op- enough’ with regard to free-to-air channels. There was also digital promotion on websites portunities to build greater intimacy with consum- Mobile devices will become more impor- such as boots.com, netdoctor.co.uk, patient.co.uk, ers, it still lacks a bit of credibility around the tant, as they provide a great vehicle not only and the ‘Back to School’ digital magazine for measurement tools and post-activity data. to communicate, but also to build real intimacy parents with children in primary school, the com- with consumers. pany pointed out. How have consumers changed over Medical devices based around technol- Thornton & Ross is also targeting ‘influencer Q the course of your career, and how ogy, rather than medicines, will feature more blogs’ popular with the brand’s target audi- have you responded? and more in the OTC space in the future, and I ence of mothers. wouldn’t be surprised to see a freeing-up of the Hedrin’s new-look packaging – introduced The average consumer is definitely channel restriction currently in place for many earlier this year – is being highlighted to re- A more aware of prices these days. They OTC products, so multichannel marketing will tailers and pharmacies (OTC bulletin, 25 March are also more open to store brands and gen- become more prominent. I also live in hope that 2016, page 16). erics. Over the past few years we have set out to medicines switched to pharmacist-only status The refreshed livery – which includes colour increase awareness of our brands through can be advertised in Australia. The current coding and simpler, clearer on-pack instruc- consumer advertising. While recommend- regulations do not make sense to me as they tions – was designed to help parents better navi- ation is extremely important, if consumers are now, and I have no doubt they dampen gate the self-selection product range and improve are familiar with our brands then price does the desire of manufacturers to switch. OTC product compliance, Thornton & Ross said. OTC

9 September 2016 OTC bulletin 21 OTC MARKETING NEWS

OTC Marketing Awards Awards reflect digital growth

igital and social media offer OTC com- the Award for Best OTC Audio-Visual Advertis- Dpanies more ways than ever before to ing. Sponsored by IRI, the co-presenter with promote their brands to consumers. Mobile apps, OTC bulletin of the OTC Marketing Awards interactive websites and social media are just 2017, this Award encompasses television and some of the myriad channels and platforms now video advertising campaigns, including television available to marketers, but they will all be cap- commercials, videos created for social media, tured by OTC bulletin in its OTC Marketing and YouTube channels and videos. Awards 2017. Social media now have their own Award. Since 2014, when the Digital and Social The Award for Best OTC Social Media Cam- Media Award was first introduced to reflect its paign will reward the most creative and ef- The OTCs reflect the changing digital landscape increasing importance, there has been a rapid fective social media campaigns aimed at con- Spanning 19 categories in total, OTC bul- increase in the Award’s popularity. This has re- sumers, patients or healthcare professionals. letin’s prestigious OTC Marketing Awards 2017 sulted from both more use of digital and social These could be on platforms like Facebook, also embrace other marketing communications media by OTC firms and the rapid expansion Twitter and LinkedIn, or use other social net- activities like public relations, sponsorship and of the channels and platforms available. works such as Instagram and Snapchat. advertising in more traditional types of media. Such is the number and variety of choices Meanwhile, the third new Award – for Best The Awards will be presented at a Gala Din- now facing OTC marketers that OTC bulletin OTC Digital or Mobile Marketing Campaign ner &Awards Presentation on Thursday, 9 March has created three new Awards fully to cover the – is open to all types of marketing activity in- 2017 at London’s Park Lane Hotel, Piccadilly. markedly different types of campaign. volving such platforms as mobile device apps, A detailed breakdown of criteria for each Television advertising now forms a part of games, websites and email. Award can be found in the Entry Information Pack at otc-bulletin.com/awards. The deadline for entries is Friday, 9 December 2016. Sponsorship packages are now available to OTC DISTRIBUTION IN EUROPE: 20 COUNTRY CONSULTANCY REPORT suit all budgets. There is no better way to present your name, THE NEW GLOBAL AGENDA your business and your contribution to the Brit- ish OTC industry than to sponsor an OTC Mar- keting Award. Before, during and after the Gala NOW IN ITS 10TH EDITION, OTC DISTRIBUTION IN Dinner & Awards Presentation, your brand will EUROPE IS A COMPREHENSIVE STRATEGIC ANALYSIS enjoy the highest of profiles in the industry OF THE SUPPLY NETWORK SERVING EUROPE’S NON- PRESCRIPTION AND OTC SELF-MEDICATION SECTORS through coverage in OTC bulletin and involve- ment on the night. • A study of the factors driving change and presenting Find out more about the OTC Marketing Awards 2017 challenges and opportunities to manufacturers by contacting Natalie Cornwell at OTC bulletin. Call • An exploration of changes in retail customer and +441564 777 550 or email [email protected]. shopper needs and the unfolding strategies required Alternatively, visit the OTC Marketing Awards website to achieve competitive success at otc-bulletin.com/awards. OTC • An in-depth source of current statistics, discussion and opinions about the European consumer healthcare market – plus consumer insights, market sizes, sales trends and distributors’ market shares • A window into leading retail pharmacy chains and their strategies for market share through digital innovation and new concepts in multi-channel shopping OVER 590 PAGES AND 300 GRAPHS, TABLES & FIGURES

Markets covered are: Austria, Belgium, Bulgaria, Czech Republic, Beiersdorf has expanded its ABC local pain Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, therapy products in Germany with a smaller Norway, Poland, Romania, Slovak Republic, Slovenia, Spain, version of its capsaicin-containing heat plaster. Sweden, Switzerland and the United Kingdom The latest ABC Wärme-Pflaster contained 4.8mg of the active ingredient – extracted from cayenne pepper – Beiersdorf noted, compared with the 11mg capsaicin plaster currently in the range. Download Executive Summary and order online at ® It also featured “thinner backing material for JAMES DUDLEY ® optimal wearing comfort”, the firm claimed. www.james-dudley.co.uk MANAGEMENT Other products in the line include a capsaicin- based heat cream and a patch for sensitive skin with nonivamide and “soft fleece” fabric. OTC

22 OTC bulletin 9 September 2016 EVENTS OTC

OCTOBER 1-3 November 4 October Ceuta Healthcare Global Generics & International Alliance Conference Biosimilars Awards 2016 Athens, Greece Barcelona, Spain ‘A new generation’ is the theme of this three-day health and beauty global conference, These Awards will recognise the achievements which will bring together manufacturers, global outsource solutions providers and key opinion of the global generics and biosimilars industries. leaders in the health and beauty industries to explore global growth opportunities. Contact: Generics bulletin. Contact: Ceuta Healthcare. Tel: +44 1564 777 550. Tel: +44 1202 449 709. Email: [email protected]. Email: [email protected]. Website: ceutahealthcare.com. Website: generics-bulletin.com/generics- biosimilars-awards.aspx. Email: [email protected]. consumer health technology, digital, well- Website: asmi.com.au/events/. being and lifestyle. 5-7 October Contact: Kisaco Research. 27 October Health Ingredients Japan Tel: +44 203 696 2920. Tokyo, Japan Profitable owGr th in Email: [email protected]. A three-day health ingredient and services Consumer Healthcare Website: consumerhealthinvest.com. exhibition and conference. Frankfurt, Germany Contact: UBM Media. ‘Growing your business in times of constrained 15 November Tel: +81 3 5296 1017. markets’ is the theme of this one-day workshop. Advertising of Email: [email protected]. Contact: Simon Kucher & Partners. Medicinal Products Website: hijapan.info. Tel: +49 89 544793. Bonn, Germany Email: [email protected]. Advertising and competition law and mis- 13-14 October Website: simon-kucher.com/consumer leading and comparative advertising will be WSMI/APSMI Conference healthforum. among the topics addressed at this one-day event Nagoya City, Japan run by Germany’s medicines manufacturers’ A two-day conference run by the World Self- 31 October-1 November association, the BAH. Medication Industry (WSMI) and the Asia- Health and Nutrition Contact: BAH. Pacific Self-Medication Industry (APSMI). in Russia and CIS Tel: +49 228 957 4556. Contact: Japan Federation of Moscow, Russia Email: [email protected]. Self-Medication Industries (JSMI). A two-day exhibition and forum based on last Website: bah-bonn.de/widi-services/ Tel: +81 3 5657 0789. year’s ‘Vitafoods in Russia and CIS’. fachseminare. Email: [email protected]. Contact: Adam Smith Conferences. Website: jfsmi.jp/apsmi/index.html. Tel: +44 20 8004 5707. 21-22 November Email: [email protected]. EuroPLX 62 26-29 October Website: nutritionrussia.com. Nice, France CRN’s Annual Symposium This two-day meeting will provide a forum California, US NOVEMBER for business development decision makers This four-day meeting is organised by the for discussing and negotiating collabora- US Council for Responsible Nutrition (CRN). 7-8 November tive agreements in licensing, marketing, and Contact: CRN. The Future of Pharmacy distribution of patented medicines, generics, Tel: +1 202 204 7700. Frankfurt, Germany biosimilars, OTC products, medical devices Email: [email protected]. ‘Growth in supposedly mature markets’ and and food supplements. Website: crnusa.org/2016events. ‘Pharmacies with added value’ will be among Contact: RauCon. the sessions at this two-day conference. Tel: +49 6221 426 2960. 27 October Contact: Inspirato. Email: [email protected]. ASMI Annual Conference Tel: +49 151 624 179 41. Website: europlx.com. Sydney, Australia Email: [email protected]. Subtitled ‘Advancing consumer health through Website: inspirato-zukunft-apotheke.de. responsible self-care’, this one-day conference, MARCH organised by the Australian Self-Medication 15 November Industry (ASMI), will be accompanied by the Consumer Healthcare 9 March 2017 ASMI’s Diamond Awards. Investment OTC Marketing Contact: ASMI. London, UK Awards 2017 Tel: +61 1 300 878 815. A one-day showcase of innovations in OTC, London, UK These Awards recognise the best of the British 19 October OTC industry. Organised by OTC bulletin, AESGP Conference new categories include Best OTC Social Me- dia Campaign, Best OTC Digital or Mobile Bucharest, Romania Marketing Campaign and Best OTC Audio- ‘The role of self-care in healthcare’is the theme of this one-day event run by the Association Visual Advertising. Entries close 9 Decem- of the European Self-Medication Industry, the AESGP, and the Romanian Assocation of the ber. Follow the OTC Awards on Facebook, Self-Care Industry (RASCI). LinkedIn, Twitter and YouTube. There will be sessions on: ‘The value of self-care’; ‘The importance of adequate communi- Contact: OTC bulletin. cation rules in self-care’: and ‘European Union regulation of health and nutrition claims’. Tel: +44 1564 777 550. Contact: AESGP. Email: [email protected]. Tel: +32 2 735 51 30. Email: [email protected]. Website: aesgp.eu. Website: otc-bulletin.com/awards.

9 September 2016 OTC bulletin 23 OTC BUSINESS STRATEGY

Technological change, and the greater economic power of growing urban populations in emerging markets will shape the OTC market in coming decades, but Pfizer’s Suneet Varma insists his firm is grasping these disruptive trends. Matt Stewart reports.

Leading Pfizer to a new future

sking whether an OTC company May 2016, page 7) – Varma believes that the fingertips. Now with smartphones and wear- wants to be a train company or a company’s senior management have noticed ables, people have the tools to track their own transportation company might seem the opportunities in consumer healthcare and health,” Varma points out. “But these technolo- Aan odd question, but to Suneet Var- how they may be “beneficial not only to Pfizer, gies have also led to a shift towards e-com- ma, president and general manager of Pfizer but beneficial to consumers, and beneficial to merce and omni-channel retailing. Consumers Consumer Healthcare, it is one the OTC industry healthcare systems”. now demand access to products and services needs to answer if it wants to survive and thrive However, performance also matters, Varma wherever they may be.” in a rapidly changing healthcare environment. is quick to point out. “If we look at 2015, the Ensuring Pfizer is able to give consumers Explaining the analogy, Varma points out major players in the OTC market and in every information and access to products on demand is that if you are a train company, you offer just region in which we operate – Asia-Pacific; crucial, Varma explains, offering up the example one solution: the train. However, if you are a Europe, Middle East and Africa; Latin America; of how people – especially millennials – are transportation company, you offer every possible and North America – we are first, second or moving away from television to online streaming. travel solution to consumers. This, he says, is third in terms of growth,” he claims. “I had a conversation with a colleague the something OTC companies need to do. Within Pfizer, he adds, there is a sense that other day,” he notes. “He had been working on The industry cannot just be about “pills in Consumer Healthcare is “well run and contrib- a new television commercial when he real- bottles” any more, he insists. “Our mission at Pfiz- uting to the group overall, not just internally, ised that the previous evening he had watched er Consumer Healthcare is to discover how we but also in the wider marketplace”. a film and some shows on Netflix. He hadnot can bring to market a broader array of solutions Having joined Pfizer when the company been exposed to any advertising at all during to positively impact consumers’ daily lives,” acquired Wyeth in 2009, Varma took over those programmes.” Varma maintains. global leadership of the Consumer Healthcare “We, as a company and an industry, have Speaking to OTC bulletin, Varma is en- business in May 2015. Since then, he has been to connect with consumers where they are search- thusiastic about not only macro-trends driving plotting how the firm will take advantage of ing for solutions and information about our the OTC industry – technological change, and the key macro-trends he believes will define products,” Varma maintains. the greater economic power of growing urban not only the future of Pfizer Consumer Health- “There is a massive convergence happening populations in emerging markets – but also the care, but the industry as a whole, the latter in between healthcare, technology and consumer sometimes-questioned future of the Consumer his capacity as chair of the World Self-Medi- behaviour,” Varma insists. “The potential to Healthcare business he leads within the wider cation Industry (WSMI). have disruption in a positive way for the con- Pfizer group. High on the agenda is the pace of techno- sumer exists. As an industry, we are obligated Bolstered by a series of positive statements logical development at the consumer level, an to engage with this convergence.” from the US-based group’s chief executive officer issue Varma claims is fundamentally changing Asked what Pfizer Consumer Healthcare Ian Read – who, in May, described the business how consumers shop. was doing to engage with faster-moving tech- as a “very valuable asset” (OTC bulletin, 27 “The internet put information at people’s nology, he points to the company’s decision to

24 OTC bulletin 9 September 2016 BUSINESS STRATEGY OTC

find and help develop innovative start-ups spe- border online marketplace. beneficial to the system.” cialising in health and wellness. “Companies such as Tmall Global give us a “Our products cost pennies per pill,” he ex- In February, Varma notes, Pfizer launched its great platform quickly to introduce new prod- plains, “but on the prescription side, they can ‘Health and Wellness Innovation Program’ in ucts from outside of the Chinese market and test be substantially more expensive.” partnership with the US education company consumer response,” Varma continues. “The more products that are readily availa- Galvanize (OTC bulletin, 19 February 2016, “E-commerce is important to our overall ble at an affordable price, the more people are page 8). This has already successfully worked strategy and we’ve driven substantial growth shifted into the self-care part of the healthcare with and supported 12 start-ups. through it over the past several years. We are spectrum,” Varma maintains. “This frees up More recently, the company announced it putting increased resources against it on a glob- more resources within a country’s healthcare would help a second cohort of firms access al basis,” he adds. system, and those extra resources can be real- Galvanize’s network of technical talent and inves- Changes like this may, of course, lead to a shift located to the most innovative, breakthrough tors to develop innovations targeting ageing, in the products Pfizer Consumer Healthcare solutions in the marketplace.” energy, improved sleep, nutrition or stress man- offers in those markets. While this shift has been at the forefront of agement (OTC bulletin, 30 June 2016, page 7). “These new urban areas present new health- the minds of governments for some years, Varma “In the past six months, we have brought in care challenges to consumers,” Varma explains. says he believes that consumers now also un- a dozen ‘entrepreneurs-in-residence’ to the Gal- “Let’s take allergy. Allergy would traditionally derstand that healthcare resources are finite. vanize incubator space in San Francisco,” Var- be thought of together with cough and cold. They are ready to take control of their own health ma says. “The solutions they are developing But what you are seeing now is the rise of other and wellbeing when it is appropriate. really are at the frontiers of technology, cov- respiratory challenges that the consumer is seek- While reluctant to speculate on what indi- ering all different areas from apps, to devices, ing solutions for.” vidual governments should do to drive this shift to the cloud. What they all have in common “Mass urbanisation is leading to pollution further,Varma is insistent that the more successful is that the solutions are all aimed at driving levels rising in certain markets, leading to high- countries have managed to position the shift as consumer self-selection and empowerment.” er levels of inhaled irritants,” he continues. an expansion of choice, rather than as having The Galvanize incubator project is “specifi- “The solutions these consumers are seeking are something taken away. cally geared to tapping into the entrepreneurial now different to the ones provided within the Taking the switch in the US of Pfizer’s atmosphere” of San Francisco, he adds, while traditional cough, cold and allergy category.” leading pain-relief brand Advil in 1984 as an plugging Pfizer into the “ecosystem of inno- Drawing on his own experience in the mar- example, Varma points out that it worked be- vation” that exists there. ketplace, Varma points out that, on a visit to cause both consumers and healthcare profes- A focus just on Silicon Valley sionals felt the move was right. would not be enough, Varma con- Consumers believed they could tinues, adding that the firm is also “ Pfizer is engaged with the tech self-manage minor pain and physicians looking for innovation in other tech- world, and it is crucial that as an industry believed the same, Varma adds. nology hotspots such as China, Ire- we engage with it. Widening access does not mean land and Israel. ” preventing someone from going to “Pfizer is engaged with the tech world,”Var- one of China’s leading online retailers, the screens their physician for a headache, Varma notes. ma insists, “and it is crucial that as an industry dotted around the workspace showed that sur- What it does is give more choice to the consumer. we engage with it.” gical and neoprene masks were among the best- It also allows a physician to start someone Staying in tune with technology to ensure a selling products. on an appropriate path to safe self-care, he adds. constant connection with the consumer also plays “Is this different to what we used to see “We know many of our Consumer Healthcare into another of Varma’s key macro-trends: the with traditional cough, cold and allergy because products are recommended by physicians when changing make-up of the world’s population. of mass urbanisation? The answer is yes. The it is appropriate for a patient to self-care.” People are living longer, Varma points out, solution is different, and in this case it was a “The path to purchase and journey to self- and becoming more urban. This is thanks to the device, not a pill in a bottle.” care is different for each person. It’s about giv- mass-urbanisation of previously rural popula- “As an industry, we have to be on top of that ing people the choice. When you do it that way, tions in emerging markets. shift, and at Pfizer Consumer Healthcare we are,” it is successful,” Varma maintains. Mass-urbanisation is already playing as big he insists. “We are considering these changes.” Bringing together his picture of the future a role as technology in disrupting distribution The economic impact of the population of the Pfizer Consumer Healthcare business and channels, Varma declares. While the traditional trends has also opened up an opportunity for that of the industry as a whole, Varma says that model of distributing through pharmacy will re- the OTC industry, Varma maintains, pointing it is crucial that all concerned “open up their main a key component, he maintains, Pfizer and out that governments around the world – and minds” to the opportunities ahead. other OTC firms need to be flexible enough to payors in general – are focused on the cost of “Companies tend to play in areas where take advantage of new opportunities. providing healthcare. they can add value. While that remains Pfizer’s Citing UN figures that forecast that 90% of “The role of consumer healthcare within a criterion, we have to remain expansive in our urban population growth to 2050 will take place country’s healthcare system is changing,” he in- thinking and ensure we are in the right places in Africa and Asia, Varma says that this trend sists. “Consumer healthcare has a more import- to fulfil our mission,” Varma states. is already “changing the way we operate”. ant economic role to play than ever before.” “Our management understands this and the The company is constantly addressing “the “We know that if consumers have more in- dynamics in play,” he adds. “We are able to ex- channels we market and sell in”, he says, cit- formation they can make better choices,”Varma pand our consideration of opportunities beyond ing the access Pfizer has gained to China’s grow- states. “We know that consumers have a desire what may have been the case 20 years ago. And ing and increasingly affluent urban consumer to take control of their own health and wellness, that is an exciting place for Pfizer Consumer base through Tmall Global, Alibaba’s cross- and we know that, if they do, it’s economically Healthcare to be.” OTC

9 September 2016 OTC bulletin 25 GGB 2016 Full Pg 28-7-16 V3_Layout 128/07/2016 10:49 Page 1

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Industry Associations Manufacturers CHPA gets Recordati changes Brikman management team he US Consumer Healthcare Products Asso- Tciation (CHPA) has named Anita Brik- ecordati has appointed Andrea Recordati man to the dual role of vice-president of communi- R– formerly its chief operating officer – cations and public affairs and executive director as vice chairman and chief executive officer, of the CHPA Educational Foundation. and Alberto Recordati as chairman of its board Over the past two decades Brikman worked of directors. as a news anchor and health reporter in the The changes to the Italian firm’s leadership major television markets of Philadelphia and were announced following the death last month Washington DC, the association pointed out. of chief executive Giovanni Recordati, who Following her time in broadcast journalism, had held the position for over 25 years. He had Brikman had moved into the association world, also chaired the privately-owned company’s the CHPA said, working as senior vice-president board of directors since 1999. Andrea Recordati of communications and outreach at the National Prior to his new appointment, Andrea Re- Hospice and Palliative Care Organization. cordati was promoted in 2013 to the newly- Commenting on her new role, Brikman said created role of chief operating officer, Recor- thatthroughout her career she had been passionate dati pointed out, after spending just over two about educating consumers on “all their health- years as general manager of its international care options to aid them in making informed pharmaceuticals division (OTC bulletin, 11 October 2013, page 22). Alberto Recordati had been responsible for coordinating the firm’s “drug discovery” and “drug development” activities since 2008, it noted, and had handled its licens- ing-in activities since 2011. Meanwhile, in a statement announcing Gio- Giovanni Recordati vanni Recordati’s passing, the company pointed 2014, the firm announced the creation of a new out that the group had grown “vigorously” Spanish subsidiary – Casen Recordati – fol- under his management, “becoming a well-known lowing the completion of its acquisition of Ma- international pharmaceutical player with sub- drid-based Laboratorios Casen Fleet (OTC sidiaries in Europe, North America, South Amer- bulletin, 24 October 2014, page 8). Anita Brikman ica and North Africa, as well as developing a Commenting on his new position, Andrea Re- presence in the rare-disease segment”. cordati said his priority would be to “proceed choices for themselves and their families”. Recordati recently snapped up Italian phar- along the lines of the development strategy “I am thrilled to have the opportunity to lead maceutical company Italchimici for C130 mil- outlined by Giovanni Recordati with the objective the communications team at CHPA,” she added, lion (OTC bulletin, 17 June 2016, page 5). In of continuing the growth of the group”. OTC “and spearhead the critically important consumer education programmes of the foundation.” Manufacturers Scott Melville, CHPA’s chief executive officer, said Brikman’s experience made her the ideal Valeant reshuffles leadership leader for the association’s communications function and its educational foundation. roubled Canadian company Valeant has realigned executive committee. “It is an exciting time for self-care,” Mel- Tappointed Paul Herendeen as chief finan- Further changes include the appointment of ville added, “and Brikman brings a lifetime of cial officer and executive vice-president of finance. investor and analyst Scott Hirsh as senior vice- communicating about healthcare issues that will Herendeen replaces Robert Rosiello, who will president for business strategy and communi- make the CHPA an even more effective voice remain at the firm as executive vice-president cations, while Pavel Mirovsky, president and for consumer healthcare.” OTC of corporate development and strategy. general manager of the firm’s Europe operation, The move is part of a broader series of lead- will retire “later this year”. ership and organisational changes aimed at creat- IN BRIEF ing “the new Valeant”. Expanded roles The company – which has been led by Valeant has also expanded the roles of joint BAH – Germany’s medicines manufacturers’ former Perrigo chief executive officer Joseph group chairmen Ari Kellen and Anne Whi- association – has appointed Christof Weingärt- Papa since May (OTC bulletin, 6 May 2016, taker, and elevated to the role of company group ner as press spokesman. He is part of the BAH’s page 1) – has promoted six people: Dennis chairman, Tom Appio, who will now have re- public relations department that relocated to Asharin, Joe Gordon, Barbara Purcell, Tage sponsibility for “all of Valeant’s markets out- Berlin at the end of last year. OTC Ramakrishna and Kelly Webber, to the firm’s side the US and Canada”. OTC

9 September 2016 OTC bulletin 27 06A_osmrLqie_T.nd1 2016_Ad_Consumer-LiquiGel_OTC.indd

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