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16 November 2010

COMPANY NEWS 3 Sanofi expands in Alliance Boots eyes 3 Chinese expansion Regulatory problems hit 4 Mucinex launch with BMP Sunstone deal plans future 5 of and Scholl Merck overcomes 6 anofi-Aventis is set to strengthen its pres- der exclusive multi-year licenses and provides Latin American drop Sence in the Chinese OTC market by ac- pharmaceutical distribution services through Sanofi-Aventis works on 7 quiring BMP Sunstone and its portfolio of subsidiaries in Beijing and Shanghai. consumer acquisitions OTC cough/cold and women’s health brands Sanofi-Aventis said the US$10.00 per share Energy drinks boost 8 for around US$520 million (C375 million). deal had been unanimously approved by BMP OTC sales at Taisho The price tag represents around 3.5-times Sunstone’s board of directors and had received Prilosec OTC holds back 9 BMP Sunstone’s 2009 sales of US$147 million the backing of shareholders representing 23% growth at P&G and 62-times its operating profit of US$8.4 mil- of the company’s stock. Perrigo sees longevity 10 lion. The company is based in the US and oper- Combining BMP Sunstone with its exist- in store-brands ates through subsidiaries in China. ing Chinese joint venture business, Hangzhou Pfizer benefits from 12 Almost 60% of BMP Sunstone’s sales were Sanofi Minsheng Consumer Healthcare, would Wyeth’s OTC brands generated by its OTC brands, Sanofi-Aventis turn Sanofi-Aventis into a “leading consumer Key brands boost 13 said, which included China’s leading paediatric healthcare company in China”, the French firm Bayer Consumer Care cough and cold product Hao Wa Wa (Good- said, with a strong position in China’s two largest Merck eyes global future 15 Baby) and the women’s hygiene brand Kang OTC categories of cough and cold and vitamin for Consumer Care division Fu Te (Confort). and mineral supplements, each of which is worth The company also markets a portfolio of around US$2.5 billion annually. GENERAL NEWS 16 third-party products – primarily focused on Sanofi-Aventis entered the Chinese OTC Benefits of self-care will 16 paediatrics and women’s health – in China un- ■ Continued on page 15 be highlighted in the UK MARKETING NEWS 17 Beiersdorf takes Nivea 17 Meda acquires three OTC brands to travellers worldwide eda has grown its OTC business for the pany announced it would be entering the US Award rewards non-pharmacy 19 Mthird time in just over two months by ac- OTC market after acquiring the speciality phar- performance quiring three OTC brands from Dutch firm Nor- maceutical company Alaven for US$350 mil- McNeil refreshes Sudafed 20 gine for SEK540 million (C57.6 million). lion (C257 million) (OTC bulletin,10 Septem- with new names in the UK Through the acquisition, the Swedish com- ber 2010, page 1). Prilosec OTC teams up 21 pany has gained Norgine’s Pyralvex for reliev- Acquiring Alaven provided Meda with a with NFL players in US ing the pain caused by mouth ulcers, Spasmon- “strategic OTC platform in the US”, the com- Actavis offers pharmacists 22 al for treating irritable bowel syndrome and pany said, through which it could commercial- “potent” First Resort in UK Waxsol ear drops. ise “strategic pipeline opportunities”. FEATURES 24 Meda is paying almost three times the com- Meda followed the Alaven deal by acquiring bined annual sales of the brands, which are ap- BioPhausia’s portfolio of Nordic OTC brands Regulators grapple with 24 proximately SEK190 million. The majority of for SEK190 million at the end of September non-prescription supply the brands’ sales are generated in Europe, the (OTC bulletin,29 September 2010, page 1). A look at Europe’s regulatory issues company said, adding that Pyralvex was the Meda’s OTC offering has grown steadily PepTcell pursues 26 biggest-selling of the three, with annual turn- over the past few years, and now accounts for OTC partners over of around SEK90 million. more than SEK2.0 billion of Meda’s total sales, REGULARS Commenting on the deal, Anders Lönner, which the company expects to reach SEK11.4 Meda’s chief executive officer,said the acqui- billion in 2010. Events – Our regular listing 23 sition further strengthened the firm’s presence The majority of the company’s OTC sales People – Reckitt tasks Sydow 27 in the growing OTC segment. are generated by its Betadine antiseptic brand, with growing Durex and Scholl The acquisition is Meda’s third in the OTC which had sales of SEK614 million in the open- arena in recent months. In September,the com- ing nine months of 2010. OTC Ad 2010:OTC Ad 1_07 5/1/10 14:16 Page 1

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COMPANY NEWS OTC

Business Strategy/Trading Update Alliance Boots eyes Chinese expansion

lliance Boots says it intends to become a ister David Cameron and a group of UK busi- supermarket chain Waitrose had been extended Aleading player in the Chinese market and ness leaders on a trade mission to China. during the period. A total of 12 Boots stores now has identified ways to increase its presence. Currently,Alliance Boots’ only presence in sell a combined Boots and Waitrose lunchtime A spokesperson for Alliance Boots told OTC China is the 50:50 wholesaling joint venture food offering, and a further seven incorporate bulletin that the pan-European wholesaler and with the Guangzhou Pharmaceutical Company, a larger range of lunchtime and convenience retailer was looking at “several opportunities” which was formed in January 2008 (OTC bul- foods. In addition, Waitrose is selling Boots and one might be “seized in the near future”. letin,15 February 2008, page 2). health and beauty products in 12 of its shops. No “significant” deals would be signed dur- Meanwhile, Alliance Boots reported total Sales by Alliance Boots’ international retail ing executive chairman Stefano Pessina’s two- sales by its wholesaling, retailing and contract operation increased by 8.2% – 6.7% at constant day trip to China, said the spokesperson, but manufacturing businesses up by 6.0% to £8.95 exchange rates – compared to the same period Alliance Boots planned to develop its presence billion (C10.4 billion) in the six months ended a year earlier,Alliance Boots noted, but the in China and become a leading player in the 30 September 2010 (see Figure 1). fragile state of the economy in Ireland and civil fast-growing market. unrest in had hampered trading. Pessina recently joined British Prime Min- Sales 2% ahead at Health & Beauty Turnover at the Pharmaceutical Wholesale The company’s Health & Beauty retail divi- division had grown by 7.7% to £5.91 billion sion posted turnover up by 2.0% – 1.8% on a over the period, Alliance Boots said, or 8.7% OTC bulletin constant currency basis – to £3.64 billion. Like- on a constant currency basis. for-like sales edged up by 0.3%. The company has recently expanded its 16 November 2010 Number 352 Health & Beauty’s Boots UK retail opera- wholesaling business by becoming the major- tion reported sales up by 1.8% on a like-for- ity shareholder in Turkish wholesaler Hedef Editor & Publisher: Deborah Wilkes like basis. The business had continued to grow Alliance Holding (OTC bulletin,13 August Associate Editors: Aidan Fry market share in its core health and beauty prod- 2010, page 3), and by snapping up a further Mike Rice uct categories, Alliance Boots said, thanks to 51.65% stake in Germany’s Andreae-Noris Business Editor: Matt Stewart its “strong product offering combined with ex- Zahn (Anzag) from German wholesalers Cele- Assistant Editors: Joanne Grew, Jenna Lawrence, cellent customer service”. sio, Phoenix and Sanacorp (OTC bulletin,29 David Wallace The company noted that its partnership with October 2010, page 1). Advertising Controller: Debi Minal Marketing Manager: Val Davis Division*First-half sales Change 2009/2010 (£ millions) (%) CER** Editorial, Subscription and Advertising enquiries should be addressed to: OTC bulletin, Pharmaceutical Wholesale 5,914+7.7 +8.7 OTC Publications Ltd, 54 Creynolds Lane, Solihull, Health &Beauty 3,637 +2.0 +1.8 West Midlands B90 4ER, UK. Contract Manufacturing 120 -3.2 – Tel: +44 1564 777550. Fax: +44 1564 777524. Intra-group -724 –– E-mail: [email protected]. Subscriptions Total Alliance Boots 8,947 +6.0 +6.6 Annual subscriptions to OTC bulletin in Europe are £595.00 for single copies and £345.00 for additional copies to the same ad- * Continuing operations ** CER is constant exchange rates dress, including delivery. Subscriptions to addresses outside Eur- ope are subject to an additional charge of £30.00 to cover postage. Figure 1: Alliance Boots’ sales in the six months ended 30 September 2010 (Source – Alliance Boots) Subscription enquiries in Korea should be directed to Pharma OTC Koreana Ltd, 14th Floor,KTB Network Building, 826-14 Yeoksam- dong, Kangnam-gu, Seoul 135-080, Korea (Tel: +82 2 554 9591; Fax: +82 2 563 8289; E-mail: [email protected]). Advertising Mergers & Acquisitions/Third-Quarter Results Advertising rates and data are available on request from the ad- dress above or at www.otc-bulletin.com. Valeant grabs Australian skin brands About OTC bulletin OTC bulletin is published 20 times a year by OTC Publications Limited: twice monthly in February,March, April, May,June, Sep- tember,October and November; and monthly in December,Jan- aleant Pharmaceuticals International is of quarterly results since its creation through uary,July and August. A subscription to OTC bulletin includes V set to acquire several pharmacy skincare the merger of US-based Valeant Pharmaceu- the weekly electronic newsflash, news@OTCbulletin,which is published around 45 times a year. OTC bulletin is printed by the brands in , including Hamilton’s Sun- ticals and Canada’s Biovail (OTC bulletin,30 Warwick Printing Company Limited, Caswell Road, Leamington care and Hamilton’s Skin Therapy, for an un- June 2010, page 3). Spa CV31 1QD, UK. disclosed sum. The enlarged business did not give combin- No part of this publication may be copied, reproduced, stored in a retrieval system or transmitted in any form without prior Michael Pearson, Valeant’s chief executive ed sales figures for the third quarter of 2010, permission from OTCPublications Ltd. officer,said that the brands – which generated but reported turnover of legacy Biovail prod- ©OTC Publications Ltd. All rights reserved. Company registered in England No 2765878. Registered Office: annual sales of around A$10 million (C7.3 mil- ucts down by 2% to US$208 million (C151 mil- 54 Creynolds Lane, Solihull, West Midlands B90 4ER, UK. lion) – expanded the company’s presence in lion). Sales of legacy Valeant products were re- OTC bulletin® is registered as a trademark in the European Australia’s pharmacy OTC market and fitted ported to have increased by 18% to US$259 Community. nicely with its existing suncare portfolio. million in the period. ISSN 1350–1097 www.OTC-bulletin.com Meanwhile, Valeant has reported its first set OTC

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OTC COMPANY NEWS

Nine-Month Results Regulatory problems hit Mucinex launch

eckitt Benckiser’s Mucinex cough and cold to improve,Becht said, following a poor cold Europe, Reckitt Benckiser said, while Personal Rmedicines will not be launched in Europe and flu season that had hit sales at the start of Care’s sales had also been lifted by the perform- before 2013. the year (OTC bulletin,14 May 2010, page 5). ance of the No-Touch Hand Soap system Explaining that regulatory problems had de- Growth had primarily been driven by in North America. layed authorisation in Europe, Reckitt Benc- in the Personal Care category and Gaviscon in Health & Personal Care accounted for 27% kiser’schief executive officer said , Becht noted. These gains had off- of Reckitt Benckiser’s total sales for the nine the medicines containing extended-release guai- set “softer” sales of Mucinex and ear- months, which increased by 9% – 6% at con- fenesin would now be introduced in 2013 at lier in the year. stant exchange rates – to £6.18 billion. Oper- the earliest. “You will see Mucinex in a num- Dettol’s personal-wash range had deliver- ating profit rose by 19% – 16% at constant ex- ber of markets outside Europe before you see ed excellent growth in developing markets and change rates – to £1.53 billion. it in Europe,”he commented. Becht pointed out, however, that the roll- Business Nine-month salesChange 2009/2010 (%) out of Mucinex in non-US markets was now (£ millions) £CER* underway. The brand had been launched in Health & Personal Care1,667 +10 +7 Malaysia and Singapore “very recently”, he Fabric Care1,206 ±0 -1 said, and would be introduced in “one more Surface Care1,039 +8 +4 market in the next six months”. Home Care842 +11 +7 Reckitt Benckiser gained the Mucinex brand Dishwashing 651 +4 +3 when it acquired Adams Respiratory Therapeu- Other Household 49 +17 +18 tics during 2008 (OTC bulletin,17 December Household and Health & Personal Care 5,454 +7 +4 2007, page 1). Meanwhile, turnover at Reckitt Benckiser’s Pharmaceuticals 505 +28 +27 Health & Personal Care division rose by 10% Food 217 +12 +11 – 7% at constant exchange rates – to £1.67 bil- Total Reckitt Benckiser 6,176 +9 +6 lion (C1.90 billion) in the first nine months of 2010 (see Figure 1). * CER is constant exchange rates The division’s performance had continued Figure 1: Reckitt Benckiser’s sales in the first nine months of 2010 by business (Source – Reckitt Benckiser) OTC

Mergers & Acquisitions The UK-based company said the purchase would increase its annual sales of health and Reckitt to divest SSL’s Anbesol personal care products by more than a third to about £2.8 billion. Reckitt Benckiser has eckitt Benckiser’s £2.54 billion (C2.99 bil- adult and infant mouth-pain-relief products in established a Sexual Wellbeing and Footcare Rlion) acquisition of SSL International has the UK and SSL’s brand for mouth-pain-relief category to manage Durex and Scholl. been given the go-ahead by the European Com- in Ireland”. Anbesol is part of SSL’s portfolio of locally- mission, after the company agreed to sell two Following the European Commission ruling marketed OTC brands – including Earex ear of SSL’s mouth-pain-relief products in the UK and approval from SSL’s shareholders, Reckitt drops, Full Marks head-lice treatments, Meltus and Ireland. Benckiser took control of SSL on 29 October. cough medicines, Mister Baby baby products, The European Commission noted Reckitt The brands were not disclosed by Reckitt and the Syndol and Cuprofen pain relievers – Benckiser had satisfied its competition con- Benckiser,but SSL’s Anbesol mouth-pain-relief which reported sales down by 14.1% to £65 cerns by offering to “divest SSL’s brands for products compete directly with Reckitt Benck- million in the year ended 31 March 2010. iser’s range in the UK and Ireland. Both the Anbesol and Bonjela lines include Future of smaller brands unclear adult versions for relieving the pain caused by The future of SSL’s local brands, such as mouth ulcers and denture irritation, as well as Full Marks and Meltus, remains unclear in the infant products to ease the pain of teething. wake of Reckitt Benckiser’s takeover, which In early October,Reckitt Benckiser said that was driven primarily by the strength of SSL’s it would sell “two relatively minor local SSL core Durex and Scholl brands. brands” to gain European Commission approval Bart Becht, Reckitt Benckiser’s chief execu- (OTC bulletin,15 October 2010, page 3). tive officer,said the “drag” on SSL’s sales caus- The news came two months after Reckitt ed by its locally-marketed brands and “other” Benckiser announced that it was acquiring SSL products was something that had to be dealt in a deal that would add the Durex and Scholl with, although he refused to say whether any of

SSL International’s Anbesol range competes directly brands to its global health and personal care these brands would be divested (see page 5). with Reckitt Benckiser’s Bonjela brand portfolio (OTC bulletin,30 July 2010, page 1). OTC

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COMPANY NEWS OTC

Business Strategy Reckitt plans future of Durex and Scholl

nnovation, investment and stronger market- bility in the pharmacy channel, where the maj- I ing will enable Reckitt Benckiser to get the ority of SSL’s brands were distributed. best out of SSL International and its Durex and However, acquiring Boots Healthcare In- Scholl brands,according to the UK-based firm’s ternational in 2006 (OTC bulletin,17 October chief executive officer Bart Becht. 2005, page 1) and Adams Respiratory Ther- Acquiring SSL for £2.54 billion (C2.99 bil- apeutics in 2008 (OTC bulletin,17 December lion) (OTC bulletin,30 July 2010, page 1) was 2007, page 1) had made Reckitt Benckiser both “strategically and financially attractive”, much more capable in the pharmacy channel, Becht insisted, as it had given the company Becht pointed out, while SSL had acted to Big innovation projects will help Durex reach its two global ‘powerbrands’ with potential for condense its portfolio and switch its focus to potential, according to Reckitt Benckiser further growth. Durex and Scholl. Becht said the company’s growth strategy Looking ahead, Becht said that Reckitt Ben- 14.1% to £65 million in the year to 31 March for Durex and Scholl would focus on increas- ckiser wanted to raise SSL’s underlying growth 2010, while turnover generated by its “other” ing investment in brand support and brand- rate – which stood at 1.8% at constant exchange consumer products dropped by 26.9%. building initiatives, as well as developing a rates in the year ended 31 March 2010 (OTC The remainder of the portfolio was “not so “gradually improving pipeline”. “We do not bulletin,31 May 2010, page 8) – to match its bad”, Becht noted, describing sales growth by believe,” insisted Becht, “that the bigger ben- own average growth rate through a “step change” the Durex condom business as “so-so” and the efits will come from scale or distribution or in how SSL’s brands were handled. performance of the Durex Play line as “pretty white spots.” Innovations in existing and new categories good”. Scholl footcare was “ok-ish”, he con- SSL’s brands were already well distributed would need to be bigger,Becht insisted, while tinued, while Scholl footwear was “very good” and well merchandised in most countries, and brand support in certain countries would also in sales terms. there were only a limited number of “white need to be boosted. Adding SSL’s brands to its portfolio means spots” to be found, Becht pointed out, citing that health and personal care products will rep- China and Japan as examples. Key challenges going forward resent a third – approximately £2.8 billion – Combining the operations of the two com- There were some interesting projects in of Reckitt Benckiser’s annual group sales. panies in China and Japan would provide a SSL’s pipeline, Becht noted, but most were On a regional basis, the deal would primar- “material increase in scale”, he noted, which relatively small and this represented a key ily benefit the operations in China and Japan, Reckitt Benckiser hoped would make both challenge going forward. Becht claimed, where both Reckitt Benckiser businesses “substantially stronger and more “We are sitting on two brands – Durex and and SSL had only a limited presence. successful in the future”. Scholl – which have huge recognition in the In Japan, purchasing SSL would add the Reckitt Benckiser gained control of SSL on marketplace, but are relatively small in size,” Scholl brand to Reckitt Benckiser’s Airwick air 29 October 2010 after securing the backing of Becht pointed out. The challenge, he explain- fresheners, its skincare range, over 85% of SSL’s shareholders and agreeing ed, was translating that brand equity and brand dish-washing brand, Muse anti-bacterial prod- to sell two of SSL’s mouth-pain-relief brands recognition into brand sales. ucts and depilatory line, Becht noted. to satisfy competition concerns raised by the “It comes down to stretching these brands,” These six brands would give the company a European Commission (see page 4). Becht continued, “and that requires innova- “reasonable critical mass” in Japan, Becht said, The deal followed years of speculation link- tive thinking, and means we need some big but not a fully operational organisation. All ing Reckitt Benckiser with a takeover of SSL. projects and not lots of little ones.” these brands were at an “infant stage”, he add- Asked why Reckitt Benckiser felt the time To help achieve these goals, Reckitt Ben- ed,and the firm needed more scale before it was now right to acquire SSL, Becht explained ckiser has created a new Sexual Wellbeing and could have its own “fully-fledged go-to-mar- that in the past only a small percentage of SSL’s Footcare category containing both Durex and ket operation” in Japan, something that would sales had been generated by Durex and Scholl, Scholl. The new category will be led by for- come as it launched more of its powerbrands while Reckitt Benckiser had very little capa- mer SSL group marketing director Volker Sy- in the market. dow, who has been given responsibility for de- The two companies’ existing Chinese busi- veloping both brands (see page 27). nesses were even smaller,Becht said. Dettol Lifting growth rates would also be reliant was Reckitt Benckiser’s main franchise, with on dealing with the “drag” caused by SSL’s Veet as a smaller arm of the business; while local brands – including its portfolio of UK Durex served as SSL’s key brand. OTC brands – and its “other” products, Becht Highlighting the limited geographic pres- said, although he refused to say whether any ence of both companies in China, Becht point- of these brands would be divested. ed out that although Durex had a good market SSL’s locally-marketed brands – includ- presence, the brand was only available in a ing Earex ear drops, Full Marks head-lice treat- couple of Chinese cities. Combining operations ments, Meltus cough medicines, Mister Baby was a good step forward in China, Becht in-

Reckitt Benckiser aims to translate Scholl’s strong baby products, and Syndol and Cuprofen pain sisted, but was not the ultimate step. brand recognition into sales growth relievers – reported annual turnover down by OTC

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OTC COMPANY NEWS

Third-Quarter Results Merck overcomes Latin American drop

etter sales in Europe, as well as across Business Third-quarter sales Change Operating profit Change BAsia, Africa and Australasia, helped Merck (C millions) (%) (C millions) (%) KGaA’s Consumer Health Care business offset a double-digit decline in Latin America and Merck Serono 1,394 +6 210 +70 drive turnover up by 1.7% to C125 million in Consumer Health Care125 +2 16 -24 the third quarter of 2010. Total Pharmaceuticals 1,518 +5 226 +56 The devaluation of Venezuela’s currency, Merck Millipore 574 –10– Merck pointed out, had been behind the 34.6% Performance Materials 346 +23 152 +109 drop in Latin American sales over the three Corporate and others ––-24 – months to C17 million. However, an 8.3% rise in European sales to Total Merck 2,438 +25 364 +64

C91 million, combined with a 23.1% increase in Figure 3: Merck KGaA’s sales and operating profit in the third quarter of 2010 (Source – Merck KGaA) turnover across Consumer Health Care’s Asia, Africa, Australasia region to C16 million man- brands, now accounted for C72.5 million, or ucts declined by 6.6% to C25 million. Mobility aged to offset the poor result in Latin America. 58%, of the division’s total turnover. sales fell by 6.4% to C19 million, despite the Merck noted that the stronger British pound High demand in Germany and Poland had gains made by the category’s strategic brands. and Indonesian rupiah had helped negate the im- led to a 40% jump in global sales of the Fem- Consumer Health Care’s operating income pact of the Venezuelan currency devaluation. ibion vitamins and minerals supplement for had dropped by 24% to C16 million during the Latin America represented just 14% of Con- pregnant women and nursing mothers, Merck quarter (see Figure 3), Merck said, due to the sumer Health Care’s total third-quarter sales (see pointed out, while the Bion3 probiotic multi- start of restructuring activities in China. This re- Figure 1), down from 21% a year earlier. Europe vitamin brand posted sales up by 13% thanks structuring was expected to continue through- accounted for 73% – up from 68% a year ago to greater demand in France and the UK. out the fourth quarter,the company noted. – while Asia, Africa and Australasia’s contri- Worldwide sales of the Nasivin nasal spray Along with the restructuring in China, Merck bution increased from 11% to 13%. had increased by 24% in the quarter,driven by blamed the profit fall on a rise in marketing Commenting on Consumer Health Care’s the brand’s growing popularity in and Po- and selling expenditure on its strategic brands, performance, Merck said that sales of its inter- land, Merck noted. The company’s key mobil- and higher research and development costs. national strategic brands – Bion3, Femibion, ity brands, such as Flexagil, Kytta and Seven The decline in operating income meant Con- Flexagil (also known as Seven Seas and Kytta), Seas, posted turnover up by 7.5%. sumer Health Care recorded a return on sales and Nasivin – together with sales of the Cebion, In contrast, sales of Cebion vitamin C prod- of only 13.0% compared to 17.4% in the third Diabion and Kidabion “regionally driven” ucts slumped by 30%, the company said, due quarter of 2009. primarily to the problems in Venezuela. Consumer Health Care accounted for just Women’s and children’s health was the only 7% of Merck’s Pharmaceuticals operating in- Europe 73% one of Merck’s four OTC “health themes” – the come for the quarter – which finished up by others are everyday health protection; mobility; 56% to C226 million – and represented 8% of and cough and cold – to post a positive sales Pharmaceuticals sales, which improved by 5.3% result in the third quarter,as Femibion’s per- to C1.52 billion. formance drove turnover up by 11% to C19 mil- The Merck Serono prescription drugs busi- lion (see Figure 2). ness reported sales up by 5.7% to C1.39 bil- Everyday health protection remained the lion, representing 92% of the Pharmaceuticals Asia, Africa, Australasia Latin America largest health theme, despite a 13% drop in division’s turnover. Merck Serono’s operating 13% 14% sales to C40 million, caused by the double-digit income jumped by 70% to C210 million. decline in Cebion turnover. Merck’s total group sales increased by 25% Figure 1: Sales by Merck KGaA’s Consumer Health Care business in the third quarter of 2010 – C125 Meanwhile, although the Nasivin brand had to C2.44 billion. The majority of the rise – million – by region (Source – Merck KGaA) performed well, sales of cough and cold prod- 16% – was due to acquiring the Millipore life- science company in July for C5.1 billion. Op- Health theme Third-quarter sales Change Proportion erating income finished up by 64% to C364 (C millions) 2009/2010 (%) of total (%) million. Everyday health protection 40 -13 32 OTC Cough and cold 25 -7 20 Mobility 19 -6 15 IN BRIEF Women’s and children’s health 19 +11 15 ■ ORION said sales at its Specialty Products Others 22 +67 18 business – including generic, prescription and Consumer Health Care125 +2 100 self-care products – had risen by 10% to C222

Figure 2: Sales by Merck KGaA’s Consumer Health Care business in the third quarter of 2010, broken down by million in the first nine months of 2010. the company’s health themes (Source – Merck KGaA) OTC

6 OTC bulletin 16 November 2010 OTC16-11-10p6-7FIN.qxd 15/11/10 10:43 Page 3

COMPANY NEWS OTC

Third-Quarter Results Sanofi works on consumer acquisitions

anofi-Aventis is working towards consumer Business Third-quarter sales Change (%) Proportion S healthcare acquisitions in Asia-Pacific and (C millions) CER* of sales (%) Latin America,according to its president of global operations Hanspeter Spek, and has iden- Emerging Markets 277 +41.0 48 tified some “very interesting opportunities”. Western Europe 148 -2.0 26 Spek’s comments came as the French firm US 88 –15 reported an acquisition-driven 57.8% rise in Rest of World 63 +47.2 11 third-quarter sales at its Consumer Health Care Total Consumer Health Care576 +45.8 100 business to C576 million (see Figure 1). At con- stant exchange rates, sales grew by 45.8%. * CER is constant exchange rates Shortly after the results announcement, Spek Figure 1: Breakdown of Sanofi-Aventis’ Consumer Health Care sales in the third quarter of 2010 by region proved as good as his word as Sanofi-Aventis (Source – Sanofi-Aventis) revealed it was set to strengthen its presence Business Third-quarter salesChange 2009/2010 (%) in the Chinese OTC market by acquiring BMP (C millions) C CER* Sunstone and its portfolio of OTC cough/cold and women’s health brands for around US$520 Diabetes brands 1,097 -15.8 +6.7 million (C375 million) (see front page). Other prescription brands 3,022 –– The price tag represents around 3.5-times Other products 1,510 +4.6 -1.2 BMP Sunstone’s 2009 sales of US$147 million Consumer Health Care576 +57.8 +45.8 and 62-times its operating profit of US$8.4 mil- Generics 390 +29.1 +18.9 lion. The company is based in the US and oper- Pharmaceuticals 6,595 +3.8 -3.5 ates through subsidiaries in China. Vaccines 1,226 +17.2 +8.9 Acquiring BMP Sunstone is the latest de- monstration of Sanofi-Aventis’ aggressive acqui- Total Sanofi-Aventis 7,821 +5.7 -1.7 sition strategy in the consumer healthcare arena, * CER is constant exchange rates

which led to the double-digit rise in third-quar- Figure 2: Sanofi-Aventis’ sales in the third quarter of 2010 broken down by business (Source – Sanofi-Aventis) ter sales at its Consumer Health Care unit. Over the past 20 months, Sanofi-Aventis the US, where Sanofi-Aventis entered the OTC with turnover growing by 41.0% at constant ex- has expanded its Consumer Health Care busi- market by paying US$1.9 billion for Chattem change rates to C277 million. ness by acquiring Gramon in Argentina, Kern- (OTC bulletin,20 January 2010, page 1). The growth had been led by Latin Amer- pharm in the Netherlands, and Oenobiol in Acquiring Chattem added C88 million to ica, Poland and Russia, the company said, add- France (OTC bulletin,16 November 2009, Consumer Health Care’s sales in the third quar- ing that acquiring Nepentes in September had page 1), as well as Zentiva in the Czech Repub- ter,Sanofi-Aventis noted, as the US business further strengthened the business’ presence in lic and Nepentes in Poland (OTC bulletin,31 achieved double-digit organic growth. emerging markets. May 2010, page 1). Emerging Markets remained Consumer Consumer Health Care’s Rest of World sales The biggest acquisition, however, came in Health Care’s biggest region in terms of sales, grew even quicker than those in Emerging Mar- kets, with turnover up by 47.2% at constant ex- change rates to C63 million. In contrast, sales in Western Europe fell by 2% to C148 million. Business Strategy Although acquisitions had contributed the majority of Consumer Health Care’s third-quar- German chain targets 2,000 stores ter growth, Sanofi-Aventis noted the business had also benefited from strong organic growth erman drugstore chain dm-drogerie markt tic turnover by 8.7% to C4.07 billion. over the three months. On a constant-structure Gplans to invest C68 million in its current Sales in 10 other countries – largely in cen- and constant exchange rate basis, turnover had financial year ending 30 September 2011 to set tral and eastern Europe, including Croatia, increased by 9.5%. up 100 new outlets. This will take its total num- Hungary,Romania, Serbia and Slovakia – rose Consumer Health Care accounted for 8.7% ber of stores in Germany to 1,285. by 8.8% to C1.57 billion, moving group turn- of total sales by Sanofi-Aventis’ Pharmaceuti- “We believe there is potential for 2,000 dm over ahead by 8.7% to C5.65 billion. cals division, which increased by 3.8% to C6.60 stores in Germany,”the chain’s expansion head In total, dm intends to invest C170 million billion (see Figure 2). At constant exchange Markus Trojansky stated. in its current financial year to expand its Euro- rates, the division’s sales slipped back by 3.5%. The drugstore group claims to be Germany’s pean chain of 2,403 outlets. If the group hits Total group sales – including the Vaccines leading provider of healthcare products out- its sales growth goal of around 7%, turnover business as well as Pharmaceuticals – grew by side of the pharmacy channel. should exceed C6.0 billion, including a sales 5.7% to C7.82 billion. At constant exchange In its financial year ended 30 September increase of at least C200 million in Germany. rates, sales dropped by 1.7%. 2010, the German group increased its domes- OTC OTC

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OTC COMPANY NEWS

First-Half Results Energy drinks boost OTC sales at Taisho

aisho Pharmaceutical said robust sales of Business First-half sales Change Forecast sales Change Tenergy drinks helped drive up its OTC sales (¥ billions) (%) (¥ billions) (%) by 3.7% to ¥77.7 billion (C688 million) in the six months ended 30 September 2010, despite Livita brand 1.7 +19.0 3.5 +12.9 a “sluggish” Japanese OTC market. Overseas drinks 3.3 +15.1 6.2 +8.8 Japan’s largest OTC firm said the domestic Others1.2 –2.8 – Foods for specified health use 6.2 +18.3 12.5 +14.9 market had been impacted by lower sales of cold-prevention products compared to a year OTC products 77.7 +3.7 152.0 +4.8 earlier,when the category had spiked sharply Others 1.5 +3.7 2.7 -6.9 due to an outbreak of swine flu (OTC bulletin, Total Self-Medication 85.4 +4.6 167.2 +5.3 16 November 2009, page 11). Prescription operations 47.6 -1.0 98.3 -1.3 However, a hot summer period starting in Total for Taisho 133.0 +2.5 265.5 +2.7 July had benefited the company’s core energy drink brands,Taisho said, which had helped Figure 1: Taisho Pharmaceutical’s sales in its first half ended 30 September 2010. Forecasted sales are for the year ending 31 March 2011 compared with actual sales in the previous 12 months (Source – Taisho Pharmaceutical) push up OTC sales. As a result of the firm’s better OTC sales, Business First-half salesChange Forecast sales Change turnover at Taisho’s Self-Medication division (¥ billions) (%) (¥ billions) (%) increased by 4.6% to ¥85.4 billion in the six Lipovitan D28.3 +0.7 50.0 +1.2 months (see Figure 1). Other Lipovitan 12.5 +6.0 22.2 +3.7 Operating income at the division had jump- Total Lipovitan brand 40.8 +2.3 72.2 +2.0 ed by 30% to ¥20.9 billion, Taisho said, thanks Zena brand 1.5 -11.2 3.5 ±0.0 to a dramatic reduction in advertising expendi- Other drinks 0.9 ––– ture – which had peaked in the same period a year earlier due to the launch of new products, Total tonics and nutrient drinks 43.2 +2.0 –– including RiUP X5 – and efforts to contain sell- Cold remedies (Pabron brand) 10.0 -5.9 25.5 +2.4 ing, general and administrative costs. Hair treatments (RiUP brand) 7.4 +16.4 14.7 +15.7 To drive further growth in the stagnant Jap- Analgesics (Naron brand) 2.2 -1.9 4.6 +4.5 anese OTC market, the Self-Medication divi- Gastrointestinal treatments 2.0 -3.3 4.3 ±0.0 sion was focused on increasing the “provision Laxatives (Colac brand) 1.9 -1.5 3.9 ±0.0 of information” for its category 1 drugs – OTC Cold remedies (Vicks brand) 1.1 +1.6 3.1 +6.9 medicines deemed to hold the highest degree of Biofermin 2.8 +1.1 5.2 -1.9 risk – Taisho pointed out, as well as improving in-store promotional activities. Overseas OTC2.2 –4.3 – In May,the firm said it planned to broaden Other OTC products 4.9 –10.7 – its range of category 1 drugs by switching more Total OTC products 77.7 +3.7 152.0 +4.8 ingredients from prescription-only to OTC sta- tus, as well as “aggressively” developing new Figure 2: Breakdown of Taisho Pharmaceutical’s OTC sales in its first half ended 30 September 2010. Forecasted sales are for the year ending 31 March 2011 compared with actual sales in the previous 12 product categories (OTC bulletin,31 May months (Source – Taisho Pharmaceutical) 2010, page 6). Taisho expects these efforts to push up sales food channels, but dropped by 0.3% to ¥20.6 First-half sales Change at the Self-Medication division by 5.3% to ¥167 billion through drug channels (see Figure 3). (¥ billions) (%) billion in the year ended 31 March 2011. Despite category 1 drugs generally struggling Sales of the company’s core Lipovitan brand in the Japanese OTC market, the RiUP X5 min- Food channels 22.6 +4.2 of energy and tonic drinks increased by 2.3% oxidil product for hair regrowth – launched in Drug channels 20.6 -0.3 to ¥40.8 billion (see Figure 2), as the hot sum- March last year (OTC bulletin,17 March 2009, Total 43.2 +2.0 mer months lifted sales and offset a decline in page 17) – helped drive up sales of the RiUP the April-June period caused by “unseasonal brand by 16.4% to ¥7.4 billion. Figure 3: Breakdown by distribution channel of Taisho Pharmaceutical’s sales of tonics and nutrient weather in early spring” (OTC bulletin,13 Meanwhile, sales of the Pabron cold reme- drinks in Japan in its first half ended 30 September August 2010, page 11). dies brand dropped by 5.9% to ¥10.0 billion, 2010 (Source – Taisho Pharmaceutical) The brand’s leading Lipovitan D products due to the swine-flu driven rise in the same had posted a solid performance, Taisho noted, period last year. billion during the six-month period. while the low-calorie Lipovitan Fine and Lip- Outside of Japan, Taisho said that its OTC In the ‘foods for specified health use’ cate- ovitan Half, as well as the Lipovitan FB prod- assets in the Asia-Pacific region – excluding gory,sales grew by 18.3% to ¥6.2 billion, thanks uct, had grown “steadily” over the six months. China and Japan – acquired from Bristol-Myers to a double-digit rise in sales of the Livita brand Turnover by all of Taisho’s tonic and nutrient Squibb last year (OTC bulletin,30 September and the firm’s portfolio of overseas drinks. drinks rose by 4.2% to ¥22.6 billion through 2009, page 1) had contributed sales of ¥2.2 OTC

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COMPANY NEWS OTC

First-Quarter Results Prilosec OTC holds back growth at P&G

olume sales growth at Procter & Gamble’s Merck & Co’s Zegerid OTC – which combines the brand’s launch in China, and the growth of VPersonal Health Care business in its first 20mg of omeprazole with 1,100mg of sodium the Always brand in Africa, central and east- quarter ended 30 September 2010 was held back bicarbonate – and a national television cam- ern Europe and the Middle East. by Prilosec OTC’s battle in the US with rival paign in support of the newcomer,which urged Meanwhile, Oral Care posted a high-single- branded and store-brand heartburn medicines. consumers to “Discover the difference” (OTC digit gain in volume sales as Procter & Gamble Personal Health Care’s volume growth stall- bulletin,16 April 2010, page 14). rolled out the Crest Pro-Health Clinical line in ed in the low single digits in the three months, Merck & Co claims the product’s “unique North America and expanded the Oral-B tooth- as the omeprazole-based Prilosec OTC reported dual-ingredient formulation” protects the ome- paste range in Brazil, Belgium and the Nether- volume sales down for a fourth consecutive prazole from stomach acids and allows the lands. The category was also boosted by the quarter. This decline partially offset higher ship- medicine to be absorbed quickly. success of the Crest Pro-Health line in various ments of Vicks cold and flu products and PUR Net first-quarter sales at Procter & Gamble’s markets, the company noted. water filtration products across Africa, central overall Health Care division – including its Health Care’s net earnings had dropped by and eastern Europe and the Middle East. Feminine Care, Oral Care and Personal Health 10% to US$495 million, Procter & Gamble Prilosec OTC has been hit by the launch Care businesses – stood still at US$3.0 billion. stated, due to a lower operating margin caused of two branded competitors over the past 12 The static sales result was blamed on a neg- by higher marketing spending. months, as well as ongoing competition from ative 4% foreign exchange rate impact and a The Health Care division accounted for store-brand equivalents. 2% decline in pricing, which wiped out a 6% around 15% of first-quarter group sales. Includ- The launch of Novartis Consumer Health’s volume sales gain. ing beauty and grooming products, baby and lansoprazole-based Prevacid 24HR a year ago The Feminine Care business had achieved family care brands, snack and pet care lines, –backed by a US$200 million (C142 million) mid-single-digit volume growth during the three and household products – as well as the firm’s consumer marketing campaign (OTC bulletin, months, Procter & Gamble pointed out, as a re- healthcare offering – these advanced by 2% 16 November 2009, page 1) – led to a drop in sult of higher shipments of Naturella, thanks to to US$20.1 billion. Prilosec OTC’s volume sales in the second and OTC third quarters of the year ended 30 June 2010 (OTC bulletin,10 February 2010, page 9; OTC bulletin,14 May 2010, page 9). This was compounded in the company’s fourth quarter ended 30 June by the launch of

Second-Quarter Results OTC sales decline at Prestige Brands

ales at Prestige Brands’ OTC Healthcare di- Svision fell by 1.7% to US$50.8 million (C35.7 million) in its second quarter ended 30 September 2010. Prestige blamed the decline on lower sales of the Allergen Block and Chloraseptic brands, which had offset better sales of its Clear Eyes, Compound W and Little Remedies lines. The drop in OTC turnover, combined with a 5.3% fall in sales at the Household division to US$27.5 million, resulted in the US-based company’s total sales declining by 3.0% to US$78.3 million over the three months. Meanwhile, the company announced that it had completed its US$190 million acquisition of Blacksmith Brands Holdings from Charles- bank Capital Partners (OTC bulletin,29 Sept- ember 2010, page 1). OTC

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OTC COMPANY NEWS

First-Quarter Results Perrigo sees longevity in store-brands

tore-brand products remain strong in the Business First-quarterChange Operating income Change SUS and now represent around 29% of dol- sales (US$ millions) (%) (US$ millions) (%) lar sales of OTC and nutritional products at re- tail prices, according to Perrigo’s chairman and Consumer Healthcare 396 +4 71 -4 chief executive officer Joseph Papa. Nutritionals 123 +120 18 – The proportion of US retail sales taken by Prescription Pharmaceuticals 69 +47 18 – store-brand OTC and nutritional products had Active Pharmaceutical Ingredients 37 +14 10 – grown by 400 basis-points from 25% over the Other 16 +36 -6 – past two years, added Papa, noting a 4% rise in Perrigo’s Consumer Healthcare sales to US$396 Total Perrigo 641 +21 112 +55 million (C285 million) in the three months end- Figure 1: Perrigo’s sales and operating income in its first quarter ended 25 September 2010 (Source – Perrigo) ed 25 September 2010 (see Figure 1). Asked whether he agreed with other con- ers. The large retailers had developed “signifi- sation and contract-manufacturing turnover. sumer products companies that sales growth cant programmes and promotions” to drive Explaining the drop in contract manufactur- for store-brand products had started to flatten store brands, he claimed, and the company was ing sales, Papa said the decline had been caused out as the US economy recovered, Papa said that not seeing any reduction in that activity. by the company’s efforts to improve its produc- on the contrary he felt growth was accelerating. The 4% gain made by Perrigo’s own Con- tion facility in Allegan, Michigan, which had Quoting IRI data for the 52 weeks ended 26 sumer Healthcare division in its first quarter been subject to a Warning Letter from the US September 2010, Papa said that in the major US ended 25 September 2010 would have been Food and Drug Administration (FDA) (OTC OTC and supplements categories – analgesics; even greater but for a loss of contract manufac- bulletin,11 June 2010, page 1). cough, cold, allergy and sinus; gastrointestinal; turing sales due to problems at one of its man- Correcting the violations highlighted in the smoking cessation; and vitamins – store-brands ufacturing facilities and increased competition Warning Letter had led to a US$25 million had grown ahead of both their equivalent nat- in the smoking-cessation category. product back-log in the three months, Papa ional brands and the categories as a whole. said, which had been carried through and ship- “The overall OTC market was up just 1% New products add US$17 million ped early in the company’s second quarter. versus last year,with national brands down by New products contributed US$17 million These manufacturing problems had also nearly 4%,”Papa noted (see Figure 2), “but of Consumer Healthcare’s sales rise, to which been responsible for the 4% drop in Consumer store-brands had gained 15% on the strength was added a further US$18 million from exist- Healthcare’s operating income to US$71 mil- of new product launches, recalls of national ing products, primarily in the analgesics and lion, Perrigo noted. brand products and market-share gains.” cough/cold categories. Meanwhile, Perrigo’s newly-created Nutri- Papa said his views were further backed by These increases were partially offset by a tionals division – which houses its recently ac- the growing importance of store-brands to retail- combined US$20 million loss in smoking-ces- quired PBM infant formula business and its existing vitamin, mineral and supplement prod-

Series1Store-brands Series2National brands Series3Total for category ucts, as well as oral electrolyte solutions – re- ported sales of US$123 million, up from US$56 30.030 million a year earlier. Operating income was +25.0% US$18 million, which compared with a loss. The sales growth had been driven by the ac- 20.020 quisition of PBM in March (OTC bulletin,17 +15.0% +13.6% +14.1% March 2010, page 3), Perrigo said, and partially +11.1% +10.2% +11.1% offset by a year-on-year decline in sales of vita- +8.7% 10.010 +6.4% mins, minerals and supplements.

th (%) +2.7% Looking ahead, Papa said the company was ow +0.1% +1.0% anticipating the switch of Sanofi-Aventis’ al- 0.00 lergy medicine Allegra (fexofenadine) from +3.9% +7.9%

Sales gr 1234567-2.1% -1.2% -1.3% -3.4% prescription-only to OTC status in the US -3.9% sometime in “early 2011”. -10-10.0 However, Papa cautioned that Perrigo’s -11.0% -11.5% store-brand version of Allegra would most like- ly not appear until after the close of the com- -20-20.0 pany’s current financial year in June 2011. Analgesics Cough, Cold, Gastrointestinal Smoking Total VMS* Total OTC Allergy,Sinus Cessation OTC&VMS* Perrigo acquired the exclusive rights to sell and market store-brand OTC Allegra from Teva * VMS is vitamins, minerals and supplements Pharmaceutical Industries in July (OTC bul- letin,30 July 2010, page 19). Figure 2: Retail sales growth of major categories in the US OTC medicines and vitamin, mineral and supplements markets in the 52 weeks ended 26 September 2010 (Source – Perrigo/IRI) OTC

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OTC COMPANY NEWS

Third-Quarter Results Pfizer benefits from Wyeth’s OTC brands

fizer said the Consumer Healthcare business sumer Healthcare generated worldwide sales Animal Health generated 40.0% of the divi- Pit gained when it acquired Wyeth a year ago of US$2.01 billion. The business reported US sion’s sales, while Nutrition was responsible for had contributed sales of US$673 million (C483 sales of US$1.02 billion and international turn- 20.5% and Capsugel the remaining 8.2%. million) to the company’s Diversified division over of US$998 million. In early October,Pfizer announced that it in the third quarter of 2010. Consumer Healthcare accounted for 31.3% was exploring strategic options, including di- The Consumer Healthcare business – which of the Diversified division’s third-quarter sales, vestment, for its Capsugel drug-delivery busi- includes the Advil, Centrum and Robitussin which more than doubled to US$2.15 billion ness (OTC bulletin,15 October 2010, page 1). brands – had posted international sales of (see Figure 1), thanks to the addition of Wyeth Asked if the Capsugel move signalled a US$299 million in the three months, Pfizer in October last year. Pfizer’s existing brands change in Pfizer’s attitude towards its Diversi- pointed out, while turnover in the US account- contributed just four percentage points of the fied businesses, Jeffrey Kindler,Pfizer’s chair- ed for US$374 million. division’s growth, with Wyeth accounting for man and chief executive officer,said the com- Over the opening nine months of 2010, Con- the other 147 percentage points. pany was “engaged in a continuous review” of the role of each of its businesses and not just the Business Third-quarter salesChange Proportion ones covered by the Diversified division. (US$ millions) 2009/2010 (%) of sales (%) The Capsugel decision had been the result of such a review, Kindler said, adding that every Biopharmaceutical 13,945 +31 86.2 business had to demonstrate on an ongoing Animal Health 860 +27 5.3 basis that it was creating shareholder value in Consumer Healthcare673 –4.2 “accordance with the strategic purpose of that Nutrition 441 –2.7 business” and that it was creating “more value Capsugel 176 -1 1.1 inside Pfizer than outside Pfizer”. Diversified 2,150 +151 13.3 Diversified businesses accounted for 13.3% Other 76 -15 0.5 of the firm’s total third-quarter sales, which grew by 39% to US$16.2 billion. All the growth Pfizer 16,171 +39 100.0 came from the Wyeth acquisition, with sales Figure 1: Pfizer’s sales in the third quarter of 2010 broken down by business (Source – Pfizer) of Pfizer’s legacy products dropping by 4%. OTC

Third-Quarter Results Regulatory Affairs Herbalife’s turnover Qualiphar addresses FDA’s concerns ualiphar said it had taken steps to resolve stopped manufacturing the product referred to improves by 14.7% Qthe manufacturing issues highlighted in in the Warning Letter some time ago. erbalife said its net sales had grown by a recent Warning Letter from the US Food and The company added that the product had H 14.7% to US$688 million (C491 million) Drug Administration (FDA). been made in “dedicated facilities”, which had in the third quarter of 2010, reflecting a dou- The Belgian company also drew attention to been completely separate to the main manu- ble-digit rise in volume sales. the fact that it had just received a satisfactory facturing plant. These facilities had now been Michael Johnson, chairman and chief exec- current Good Manufacturing Practice (cGMP) totally dismantled, Qualiphar noted. utive officer of the US-based direct-selling spe- Inspection Report from the Belgian authorities. Stressing that it was “committed to address- cialist, said the company had experienced vol- No critical observations were notified in the re- ing all concerns raised by the FDA”, Qual- ume sales growth across all regions, leading port dated 18 October 2010, said Qualiphar, iphar said it was supplying “all additional in- to a total rise in volume sales of 13.5%. which followed a four-day inspection during formation, documentation and rationale behind “Our distributors are driving momentum September of the company’s manufacturing the former manufacturing operations with re- around the world,”he commented, “by attract- facility in Bornem, Belgium. gard to the Warning Letter product”. This, it ing and retaining long-term customers for our said, would provide the FDA with assurance nutrition products.” Bornem facility was inspected that all products of Qualiphar “comply to all The net sales growth was driven by the Asia The FDA sent the Warning Letter dated 30 specifications that are critical to safety,efficacy Pacific and North America regions, where turn- September 2010 after its inspection of the and quality of the product”. over increased by 40.5% to US$182 million Bornem facility in May had identified “signif- Marc Van Diest, research and development and by 10.4% to US$156 million respectively. icant violations” of cGMP regulations for fin- manager of Qualiphar,said the Warning Letter Herbalife’s operating income improved by ished pharmaceuticals. A response from Qual- had “no impact on any other products”. “Sales 29.7% to US$101 million during the period. iphar dated 28 May 2010 had lacked “sufficient of all existing products included in Qualiphar’s Looking ahead, Herbalife said it expect- corrective actions”, said the regulatory agency product range and manufactured by Qualiphar ed a 16.5% to 17.0% net sales rise in 2010. (OTC bulletin,29 October 2010, page 11). may continue without restrictions,” he added. OTC Qualiphar told OTC bulletin that it had OTC

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COMPANY NEWS OTC

Third-Quarter Results Key brands boost Bayer Consumer Care

ouble-digit growth by five of Bayer’s six Business Third-quarter sales Change EBIT Change D key OTC brands helped drive up sales at (C millions) 2009/2010 (%) (C millions) 2009/2010 (%) the German firm’s Consumer Care business by 13.3% in the third quarter of 2010. Adjusted Pharmaceuticals 2,732 +7.2 412 +12.0 for currency and portfolio effects, sales increas- Consumer Care880 +13.3 –– ed by 4.7%. Medical Care375 +4.2 –– Consumer Care’s turnover in the three Animal Health 284 +13.1 –– months increased to C880 million (see Figure Consumer Health 1,539 +10.9 300 -4.2 1) as its Aspirin, Aleve,Bepanthen/Bepanthol, Bayer HealthCare4,271 +8.5 712 +4.6 Canesten and One-A-Day brands all delivered double-digit gains. Figure 1: Breakdown of Bayer HealthCare’s sales and earnings before interest and tax (EBIT) in the third quarter of 2010 from continuing operations (Source – Bayer) Substantial sales growth in the US, Bayer pointed out, had led to the painkiller Aspirin posted sales up by 16.3% – 9.6% on a constant only Supradyn failed to achieve a double-digit posting global turnover up by 11.1% to C110 exchange rate basis – to C57 million, due pri- gain, with the multivitamin supplement’s sales million and the Aleve analgesic reporting a marily to launches in Canada and higher vol- sticking at C37 million. At constant exchange 30.0% rise in sales to C78 million (see Figure umes in Italy. Bayer expanded its Canesten rates, the brand’s turnover declined by 4.9%. 2). At constant exchange rates, Aspirin’s and range in Canada earlier this year with the launch The six brands accounted for 43.3% – C381 Aleve’s gains were a more modest 3.4% and of CanesOral 150mg fluconazole oral tablets. million – of Consumer Care’s C880 million total 18.2% respectively. The Bepanthen/Bepanthol skincare brand for the third quarter. One-A-Day multivitamins had also been lift- also produced a double-digit rise, with sales Geographically,all regions had contributed ed by a strong US performance, Bayer noted, growing by 15.9% – 14.3% at constant ex- to Consumer Care’s performance, Bayer said, with worldwide sales rising by 33.3% – 20.3% change rates –to C51 million, following posi- noting that North America in particular had en- on a constant-currency basis – to C48 million. tive developments in Brazil, France and Russia. joyed a good quarter. Meanwhile, the Canesten antifungal line Of Consumer Care’s six best-selling brands, Consumer Care generated 57.2% of sales at Bayer’s Consumer Health division, which in- Brand (businessunit) Third-quarter sales Change 2009/2010 (%) creased by 10.9% – 2.6% on a currency- and (C millions) C CER* portfolio-adjusted basis – to C1.54 billion, with Contour (Medical Care) 147 -1.3 -6.5 the business reporting growth across all regions. Aspirin** 110 +11.1 +3.4 Asia/Pacific made the biggest gain, with turnover growing by 19.3% as reported to C167 Advantage (Animal Health) 103 +17.0 +7.5 million (see Figure 3). However, at constant ex- Aleve/naproxen 78 +30.0 +18.2 change rates, the rise was a more modest 3.6%. Canesten 57 +16.3 +9.6 In the Latin America/Africa/Middle East region, Bepanthen/Bepanthol 51 +15.9 +14.3 sales improved by 15.1% – 5.1% at constant One-A-Day 48 +33.3 +20.3 exchange rates – to C236 million. Baytril (Animal Health) 44 +18.9 +12.1 Consumer Health’s biggest region in terms Supradyn 37 ±0.0 -4.9 of sales, Europe, reported the smallest advance Breeze (Medical Care) 31 -8.8 +16.9 in the quarter,with turnover moving forward Top 10 706 +11.5 +4.2 by 5.7% – 3.5% on a constant exchange rate basis – to C576 million. Consumer Health 1,539 +10.9 +2.9 North America, meanwhile, posted sales of * CER is constant exchange rates C560 million, up by 12.4% as reported. At con- ** Total Aspirin sales – including Aspirin Cardio, which is part of the Pharmaceuticals division – were C204 million stant exchange rates sales edged up by 1.1%. Figure 2: Sales of the top 10 best-selling brands in Bayer’s Consumer Health division in the third quarter of Consumer Health’s earnings before interest 2010. Brands are part of the Consumer Care business unit unless stated (Source – Bayer) and tax (EBIT) fell by 4.2% to C300 million. Region Third-quarter sales Change 2009/2010 (%) The Consumer Health division accounted (E millions) C CER* for 36.0% of Bayer’s total HealthCare turnover, which improved by 8.5% to C4.27 billion. Ad- Europe 576 +5.7 +3.5 justed for currency and portfolio effects, the North America560 +12.4 +1.1 growth was 0.9%. Latin America/Africa/Middle East 236 +15.1 +5.1 Meanwhile, Bayer said that as a result of a Asia/Pacific 167 +19.3 +3.6 wider review of the Bayer brand, its pharma- Bayer Consumer Health 1,539 +10.9 +2.9 ceuticals business would no longer be known as Bayer Schering Pharma but simply as Bayer * CER is constant exchange rates HealthCare. Figure 3: Breakdown of Bayer Consumer Health’s sales in the third quarter of 2010 by region (Source – Bayer) OTC

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COMPANY NEWS OTC

Mergers & Acquisitions Third-Quarter Results Sanofi-Aventis Merck eyes global future grows in China for its Consumer Care unit ■ Continued from front page market a year ago, when it agreed to establish erck & Co’s Consumer Care division is Claritin (loratadine) allergy brand to US$92 a joint venture with Minsheng Pharmaceuticals Man important part of the US company’s million, the firm said, along with “strong per- to produce vitamin and mineral supplements future and is a business for which it has global formances” from Coppertone suncare products (OTC bulletin,30 October 2009, page 10). ambitions, according to chief executive officer and the Dr Scholl’s footcare line. Christopher Viehbacher,chief executive offi- Richard Clark. This growth had been partially offset by the cer of Sanofi-Aventis, said the deal – which will Asked about Merck & Co’s strategic plans impact of generic versions of the MiraLAX be structured as a merger of BMP Sunstone and for the Consumer Care division, which was laxative brand, Merck & Co noted. In October a wholly-owned subsidiary of Sanofi-Aventis – gained by acquiring Schering-Plough, Clark last year,store-brand specialist Perrigo and ge- represented “another strategic move”that rein- said the business contained “good brands” that nerics firm Mylan both received the go-ahead forced the firm’s leadership position in China. would “last a long time” and were a “natural to launch their equivalents to the polyethylene Acquiring BMP Sunstone would “not only fit” with its core pharmaceuticals operations. glycol 3350-based product (OTC bulletin,16 leverage our consumer healthcare business in Schering-Plough had done a “tremendous October 2009, page 17). China”, Viehbacher noted, but would also give job” of growing Consumer Care’s brands in the The third-quarter sales rise, coupled with the the company “unique access to expanding dis- US, Clark said, pointing out that Merck & Co 11% gain in the previous quarter,offset the 2% tribution channels,which are expected to ac- now wanted to do the same thing globally. decline reported for the opening three months count for a third of the pharmaceutical mar- “We’re putting resources behind the growth of 2010. This led to a 4% increase in Consum- ketin China in the coming years”. of Consumer Care from a global standpoint,” er Care’s turnover to US$1.09 billion for the Sanofi-Aventis said that BMP Sunstone had Clark insisted, “and so from a distribution and first nine months of the year. access to retailers, county hospitals and com- customer standpoint we are looking at grow- Despite the combination of strong single- munity clinics in Tier III and Tier IV markets. ing it organically as we move forward.” digit growth during the third quarter and a dou- Tier III and Tier IV markets are classified as ble-digit advance in the second quarter,Clar- cities with a population of less than 500,000. Backing for Consumer Care itin’s sales finished down by 2% to US$334 There are approximately 200 Tier III county- Clark has continually backed the Consumer million, following a 26% fall in the first three level cities, the company pointed out, and 400 Care division in the year since Merck & Co ob- months of the year. Tier IV towns, which are the capitals of the tained the business by acquiring smaller rival International sales of Schering-Plough’s con- counties they are in. Schering-Plough for US$41 billion (C29.3 bil- sumer healthcare brands are now included in China was now the world’s second-largest lion) (OTC bulletin,17 March 2009, page 1) Merck & Co’s Global Human Health division, consumer healthcare market after the US, San- together with its portfolio of OTCbrands. which also includes its prescription, vaccines and ofi-Aventis claimed, with an estimated size of In August, Clark said expanding the Con- biologics business units. C12 billion in 2010 and a compound annual sumer Care business in Europe and emerging Consumer Care is one of the “five primary growth rate of 11% since 2005. markets represented an exciting opportunity for divisions” in the enlarged Merck & Co. The Merck & Co (OTC bulletin,13 August 2010, other four are Global Human Health, Animal Plans for Chinese business page 1), while in May,he said that the business Health, Merck Manufacturing and Merck Re- As well as growing its Chinese Consumer had a “critical part” to play in the company’s search Laboratories. Health Care business via acquisitions, Sanofi- strategy going forward (OTC bulletin,14 May Consumer Care generated 3% of Merck & Aventis said it would drive organic growth by 2010, page 11). Co’s total adjusted third-quarter sales, which launching several legacy products – such as Consumer Care reported sales in the US declined by 4% to US$11.1 billion. For the first the Lactacyd feminine hygiene products and and Canada up by 3% to US$291 million in nine months of 2010, group turnover edged up Essentiale vitamin and mineral supplements the third quarter of 2010 (see Figure 1). The by 0.4% to US$33.9 billion. – and by introducing products that met con- growth reflected an 8% uplift in sales of the OTC sumer needs, such as food supplements, car- diovascular products and anti-ageing lines. Business Third-quarter salesChange Proportion Sanofi-Aventis announced the BMP Sun- (US$ millions) 2009/2010 (%) of total (%) stone deal just hours after reporting an acquisi- Human Health* 9,660 -4 87 tion-driven 45.8% rise in sales at its Consumer Animal Health 687 +3 6 Health Care division during the third quarter of 2010 to C576 million (see page 7). Claritin OTC92+81 Hanspeter Spek, president of global oper- Consumer Care** 291 +3 3 ations at Sanofi-Aventis, said the company was Other 487 +1 4 working on more consumer healthcare acqui- Merck & Co 11,125 -4 100 sitions in the Asia-Pacific region and in Latin America. * Includes international Consumer Care sales outside of the US and Canada ** Sales in US and Canada only OTC Figure 1: Merck & Co’s sales in the third quarter of 2010 broken down by business (Source – Merck & Co)

16 November 2010 OTC bulletin 15 OTC16-11-10p16-17FIN.qxd 15/11/10 07:14 Page 2

OTC GENERAL NEWS

Government Initiatives Regulatory Affairs Benefits of self-care will HMA finalises its be highlighted in the UK five-year strategy ost of the comments made by Europe’s M OTC industry have been incorporated enefits of self-care will be highlighted in into the final version of the five-year strategy Bthe UK during Self Care Week running that has just been published by the Heads of from 15-21 November 2010. Medicines Agencies (HMA). The aim of Self Care Week 2010, said the The strategy document now acknowledged Department of Health (DoH), was “to get peo- the different economic setting for the non-pre- ple, especially those with a long-term condi- scription sector,noted the Association of the tion, learning about how they could look after European Self-Medication Industry,the AESGP, their own health better”. and had a dedicated section on improving the The DoH pointed out self-care meant “look- decentralised and mutual recognition autho- ing after yourself in a healthy way, whether it’s risation procedures. brushing your teeth, taking medicine when you Put out for consultation in July (OTC bul- have a cold or doing some exercise”. letin,30 July 2010, page 12), the strategy high- A wide range of materials have been pro- lights three areas in which the HMA “can make duced for the week, including a communica- “Learning to live well” is the theme of Self Care Week a real difference” in the coming years. These 2010 in the UK tion pack containing tips on how to support the are in safeguarding public and animal health, campaign, statistics, and key messages. Posters advise general practitioners on shared decision- supporting innovation, and further improving and leaflets are also available. making in consultations. the operational efficiency of medicines autho- The DoH promised there would be “lots of Nigel Sparrow, chair of the professional de- risation by the decentralised and mutual-recog- events and activities around the country to pro- velopment board of the RCGP,said that “giv- nition procedures. mote and explain the benefits of self-care”. ing patients the information and support need- Speaking recently at a meeting in Antwerp ed to make informed decisions about their own organised by the AESGP,Kent Woods, chief People must be active partners health and the healthcare they receive is vital executive of the UK’s Medicines and Health- Self Care Week 2010 was launched earlier to improving the public’s general health”. “Many care products Regulatory Agency (MHRA),said this month by Paul Burstow, minister of state general practitioners and nurses already do this,” the strategy would be rolled out from 2011. for care services, at a Self Care Symposium org- he added, “but I hope this module will provide OTC anised jointly by the Royal College of General clinicians with more opportunities to develop Practitioners (RCGP) and the Proprietary Asso- and enhance their consultation skills.” ciation of Great Britain (PAGB). Commenting Gopa Mitra, the PAGB’s director of health on the initiative,Burstow said: “I believe that policy and public affairs, said the module was if we want people to be active partners in all as- essential to end the culture of dependency in pects of self-care, we need to ensure that they the National Health Service (NHS). have access to information, education and sup- The e-learning module, which will be deliv- port to help them do that with confidence.” ered through the RCGP’s online learning envi- At the symposium, the RCGP and the PAGB ronment, will be developed, piloted and deliv- announced plans for an e-learning module to ered over the next 12 months. OTC GlaxoSmithKline Consumer Healthcare’s NiQuitin Minis smoking-cessation aid is now available in a Trade Associations Switches cherry flavour as well as the original mint. The company said the new 1.5mg nicotine Association set up Big ibuprofen pack lozenges would provide “an alternative fruity taste option for smokers attempting to quit”. Supplied in packs of 20 or 60 lozenges, the new in Asia-Pacific area larger pack of topical ibuprofen will soon addition has respective recommended retail selling Abe available on general sale in the UK, prices of £4.99 (C5.70) and £13.99. GlaxoSmithKline launched mint-flavoured n OTCindustry association for the Asia- if a switch consultation from the Medicines NiQuitin Minis in the UK a year ago backed by the A Pacific region has been set up. and Healthcare products Regulatory Agency claim “Not big. But very clever” (OTC bulletin, The chairperson of the Asia-Pacific Self- (MHRA) is given the go-ahead. 16 October 2009, page 15). NiQuitin Minis are also available in a number of Medication Industry (APSMI) is Seiichi Sato, Consultation document ARM 71 says Thorn- other countries including Australia, Belgium, France, president of Japan’s Sato Pharmaceutical Co. ton & Ross is seeking to switch a 100g pack of Germany, the Netherlands, Poland and Sweden Sato said several member associations of 5% w/w ibuprofen gel from pharmacy to gen- (OTC bulletin, 14 May 2010, page 6). Earlier this year, GlaxoSmithKline launched the product in the World Self-Medication Industry (WSMI) eral-sales list (P-to-GSL) status. GSL status al- the US as the Nicorette Mini Lozenge (OTC bulletin, wanted a regional body for Asia-Pacific. ready applies to 30g and 50g packs. 14 May 2010, page 21). OTC OTC OTC

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MARKETING NEWS OTC BeiersdorfBusiness Strategy takes Nivea to travellers worldwide

eiersdorf has unveiled a global travel retail airports in Copenhagen,Istanbul and Vienna,” Bstrategy for its Nivea skincare brand, which said Beiersdorf. People who have difficulty swallowing capsules will see more than 65 products plus exclusive Beiersdorf pointed out that around 70% of and tablets are the target audience for the latest travel sets available from aeroplanes, airports, travellers made no purchases in travel retail addition to Hexal’s omeprazole-based medicine border shops, cruise lines and ferries. shops inside airports because they were unable Omep in Germany. Omep is now available not only as capsules but The German company, which is setting up to find products that met their needs and bud- also as enteric-coated tablets, which can be either the Beiersdorf Travel Retail Division to oversee gets. “We will offer a very attractive range of swallowed or dissolved in water before swallowing. the strategy,said the range would initially be Nivea products for both men and women, with Each tablet contains more than 1,000 ‘micro-pellets’, which pass directly into the intestines before available in Europe, the Middle East and Africa, the particular needs of two target groups – fam- releasing the active ingredient, 20mg omeprazole. followed by Asia, and then the Americas. ilies and charter travellers – in mind,”the com- Hexal, which is part of Novartis, noted that Travellers will be able to buy products from pany added. the one-a-day tablets could also be divided for ease of swallowing. They are free from gelatin, gluten the Nivea Body,Nivea for Men, Nivea Lipcare Inken Menck, director of purchasing for and lactose. and Nivea Visage ranges, as well as personal perfumes and cosmetics at Gebr Heinemann, The pharmacy-only medicine has recommended care products such as sunscreen, deodorant and commented: “With this selection of Nivea prod- retail selling prices of C5.90 for seven tablets and C9.90 for a pack of 14. shower gel. Recommended retail selling prices ucts, we will be able to meet the demands of a A television advertising campaign for the brand is will range from C2.00-C49.00. previously under-served need and price seg- ongoing (OTC bulletin, 31 August 2009, page 21), ment, and we see great potential for attracting while current trade-press advertising highlights the tablet newcomer. Successful in the Middle East new buyers to our stores.” OTC Beiersdorf noted that it had successfully ex- Beiersdorf said it would back Nivea in the panded Nivea’s travel retail presence in the Mid- travel retail channel with point-of-sale material. dle East over the past three years. “Much of this It added that the travel range would also benefit experience has played a role in our internation- from multimedia advertising campaigns for the al strategy,” the company added. brand in many countries. In Europe, Beiersdorf is working with Gebr Nivea products are currently sold in more Heinemann, which has retail outlets in 49 inter- than 50 countries. national airports. “Our first step will be to est- The Beiersdorf Travel Retail Division will ablish a presence inside German airports such have its headquarters in , and will as Frankfurt, Hamburg and Munich, as well as be led by Ilka Schütte.

“Wherever your pain your answer is Anadin” is Pfizer Exclusive Nivea travel sets are among the products on offer from the new Beiersdorf Travel Retail Division Consumer Healthcare’s promise to consumers in OTC press advertising for its Anadin brand in the UK. Based around a computer game, the advertisement highlights that Anadin has IN BRIEF “developed a whole range of different formulations to effectively tackle pain”. ■ SEVEN SEAS is supporting its Halibor- supplements, with a significant boost to men- Joint-pain sufferers are advised to take Anadin Joint Pain, for example, while Anadin Extra is ange food supplements in the UK with a public tal and physical health in babies and children. suggested for people with a headache. relations campaign based around research that Seven Seas is also highlighting a separate sci- Pfizer is also backing Anadin with radio found fewer than one in ten children ate enough entific review, which found that omega-3 was advertising, an iPhone ‘app’ and a website at www.anadin.co.uk. Television advertising based fish to meet health guidelines. The firm said needed for development of babies in the womb around the computer game concept is scheduled to there was “strong evidence” linking omega-3 and infants’ brain, eyes and immune systems. begin in December. fatty acids, which are found in fish and fish oil OTC OTC

16 November 2010 OTC bulletin 17 OTC16-11-10p18-19FIN.qxd 15/11/10 07:15 Page 2 OTC16-11-10p18-19FIN.qxd 15/11/10 07:15 Page 3

MARKETING NEWS OTC

OTC Marketing Awards 2011 Award rewards non-pharmacy performance

as one of your OTCproducts put in a strong ■ OTCBrand of the Year The OTC Marketing Awards 2011: Hperformance this year in UK non-pharm- ■ OTCLaunch of the Year acy retail outlets? If it has, then make sure you ■ OTC Brand Revitalisation of the Year OTC Company of the Year Sponsored by IMS Consumer Health and put it forward for OTC bulletin’s OTCMarket- ■ Best OTCPharmacy Support Package SymphonyIRI Group ing Awards 2011. ■ Best OTCPharmacy Salesforce Your product could win our new Award for There is no entry fee for these six Awards, OTC Brand of the Year Best OTCPerformer Outside Pharmacy,which and no supporting information is required. Win- Sponsored by Euro RSCG Life is sponsored by SymphonyIRI Group. The Award ners are decided either by our Super Retail Pan- OTC Launch of the Year is aimed at OTCproducts wholly or partially el or by independent market research. Sponsored by Tena selling outside the pharmacy environment in Twelve other Awards do require an entry OTC Brand Revitalisation of the Year supermarkets, grocery stores, garage forecourts fee and supporting information. To obtain an Sponsored by Spink and other non-pharmacy outlets in the UK. Entry Information Pack for these Awards – cov- The Award is open to both new and exist- ering advertising, product innovation, packag- Most Innovative New OTC Product ing OTCproducts. It is aimed at individual pro- ing design, public relations campaigns and phar- Best OTC Marketing Campaign on a Big Budget ducts or product lines sold under an umbrella macy training – visit the Awards website at brand rather than the umbrella brand itself. For www.otc-bulletin.com/awards. Best OTC Marketing Campaign on a Small Budget Sponsored by Bounty & Bounty Health Network further guidance contact Deborah Wilkes, Edi- Meanwhile, retailers could win the Award tor & Publisher of OTC bulletin,by sending an for Best OTC Multiple Retailer of the Year. Best OTC Consumer Advertising on Television e-mail to [email protected]. The entry deadline for OTC bulletin’s OTC Sponsored by Pegasus

The winner of the Award for Best OTCPer- Marketing Awards 2011 is fast approaching. Fri- Best OTC Consumer Advertising in the Press former Outside Pharmacy will be determined day,3December is less than three weeks away, by a panel of non-pharmacy retailers put to- so now is the time to make sure your best work Best OTC Consumer Advertising Out-of-Home gether by SymphonyIRI Group and OTC bul- is in the running to win one or more of the UK Best OTC Consumer Advertising on the Internet letin. Judges will be looking for OTCproducts OTCindustry’s most prestigious Awards. that have not only performed well but have con- Winners will be announced at a Gala Din- Best OTC Public Relations Campaign for a Medicine tributed to overall category growth in non-phar- ner & Awards Presentation on Thursday,10 Best OTC Public Relations Campaign for a macy retail outlets. March 2011 at ’s Park Lane Hotel. Non-Medicine For this Award, there is no entry fee and no OTC bulletin is pleased to announce that supporting information is required. Applicants the OTC Marketing Awards 2011 will be joint- Best New OTC Packaging Design simply have to e-mail their proposals to Deb- ly co-hosted this year by IMS Consumer Health Best OTC Trade & Professional Advertising orah Wilkes at [email protected] with and SymphonyIRI Group. Sponsored by Doctors.net.uk OTC Marketing Awards 2011 as the subject. Many thanks also go to our Award spon- Best OTC Pharmacy Training The Award for Best OTCPerformer Outside sors.These are Euro RSCG Life, the Company Sponsored by Mash Health Pharmacy is open to all consumer healthcare Chemists’Association, Spink, Pegasus, Tena, companies operating in the UK or their agen- SourceOTC, Bounty & Bounty Health Network, Best OTC Pharmacy Support Package Sponsored by the Company Chemists’Association cies or associates. Entries are restricted to OTC Doctors.net.uk and Mash Health. products – general-sales list (GSL) medicines, Best OTC Pharmacy Salesforce unlicensed food supplements, herbal and homo- ■ Find out how to enter,attend or sponsor the OTC Sponsored by IMS Consumer Health eopathic remedies, medical devices and other Marketing Awards 2011 by contacting Jenna Lawrence Best OTC Performer Outside Pharmacy selected unlicensed healthcare products – mar- or Val Davis at OTC bulletin (Tel: +44 1564 777550; Sponsored by SymphonyIRI Group keted in the UK. Fax: +44 1564 777524; E-mail: jenna.lawrence@otc- Best OTC Multiple Retailer of the Year You can also put forward proposals for six bulletin.com or [email protected]). Or visit Sponsored by the Company Chemists’Association other Awards by e-mail to Deborah Wilkes: the Awards website at www.otc-bulletin.com/awards. and OTC bulletin ■ OTCCompany of the Year OTC AWARDS ENTRY DEADLINE Friday,3rd December 2010 Get your Entry Information Pack from the Awards website at www.otc-bulletin.com/awards

16 November 2010 OTC bulletin 19 OTC16-11-10p20-21FIN.qxd 15/11/10 07:16 Page 2

OTC MARKETING NEWS

Relaunches/Marketing Campaigns McNeil refreshes Sudafed with new names in the UK

cNeil Products has relaunched its Suda- Mfed cough and cold medicines in the UK with new names and updated packaging. The company has added Blocked Nose to the name of the majority of its general-sales list (GSL) medicines and Decongestant to some of its pharmacy-only (P) lines. A company spokes- person said the revamp would make the range more “consumer friendly”. McNeil Products has added the words Blocked Nose The rebranded GSL range includes Suda- to the name of most of the general-sales list (GSL) medicines in its Sudafed range in the UK fed Blocked Nose & Headache Capsules, Suda- fed Blocked Nose & Sinus Capsules, Sudafed commercial featuring a man on a tube train suf- Blocked Nose Capsules, and Sudafed Blocked fering from a cold. He takes Sudafed and is A cartoon explorer who finds relief from his Nose Spray. able to breathe clearly again. haemorrhoids is the star of television advertising for Nycomed’s Faktu lind herbal medicine in Germany. Meanwhile, the repositioned P medicines The television campaign will run until the The 25-second commercial opens with a line include Sudafed 12 Hour Decongestant Tablets, end of the year on satellite channels Dave,E4, drawing of an explorer driving a jeep across a rough Sudafed Decongestant Liquid, Sudafed Decon- Film4, Fiver, Gold, Living, More4, and Sky1. savannah landscape. When he stops due to the pain of his gestant Tablets, Sudafed Chesty Coughs with In addition, McNeil is running three bursts haemorrhoids, a hand appears and draws a Decongestant, and Sudafed Dry Coughs with of digital advertising on escalator panels at tube curved line of Faktu lind ointment. The explorer Decongestant. stations in London until January. sits down in the curve, which turns out to be the trunk of an elephant. “Faktu lind. Wenn’s juckt und McNeil has updated the packaging to in- Sudafed is also sponsoring the Sky and Dis- brennt”, or “Faktu lind. When it itches and burns”, clude an illustration of airwaves that flow to covery Home & Health channels. The deal in- is the sign-off message. and from the graphic of a face. cludes creatives broadcast daily,as well as an Current trade-press advertising highlights the television support and cites an online survey of The company is backing Sudafed with an online banner that reads “Sponsored by Suda- 52 brand users that found 85% were satisfied updated version of its established television fed” on the Discovery Home & Health website. with the pharmacy-only medicine and 86% would OTC buy it again. Faktu lind ointment contains 6.25% witch-hazel distillate. It follows on from the Faktu Akut brand that Nycomed withdrew following the decision of Germany’s federal institute for drugs and medical devices, BfArM, to ban bufexamac (OTC bulletin, 18 December 2009, page 13). OTC

IN BRIEF ■ MATRIXX INITIATIVES is backing its Zicam brand in the US with a public relations campaign highlighting that pharmacists need to educate consumers about treating colds. The company said research had found that 93% of pharmacists believed early treatment of a cold could prevent a visit to the doctor. Further- more, more than half of pharmacists recom- Two vitamin supplements for teenagers have been sporty and active lives. Supplied as “delicious citrus mended zinc – an active ingredient in Zicam – added to Ernest Jackson’s Bassetts Soft & Chewy flavour pastilles”, the newcomer is a multivitamin brand in the UK. product with Coenzyme Q10. in the initial stages of a cold. However, a sep- Aimed at young women, Bassetts Soft & Chewy A pack of 30, one-a-day pastilles retails at £4.99. arate survey found that the majority of Amer- Healthy Balance is a multivitamin product with Both products carry the strapline “for young icans were misinformed about the causes of evening primrose oil and starflower oil. Straplines on adults” on the packaging. the packaging point out that the “one-a-day” pastilles Ernest Jackson noted that the “easy-to-take” colds and how to treat them, with almost three- provide “skin health and hormone balance”. pastilles contained the recommended daily quarters believing that there was not much they A month’s supply of the “delicious orange & allowance of vitamins, as well as natural colours could do except mask the symptoms and wait passion fruit flavour pastilles” has a recommended and flavours. retail selling price of £6.99 (C7.99). The Bassetts Soft & Chewy range also includes it out. Only 12% took zinc-based products, The second new addition – Bassetts Soft & Active Health, Daily Energiser, Early Health, Everyday while 41% tried chicken soup. Chewy Sport Health – is for teenagers who lead Health and Vitamin Cvariants. OTC OTC

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MARKETING NEWS OTC PrilosecMarketing Campaigns OTC teams up with NFL players in US

he “toughest offensive linemen” in the Nat- The 30-second television commercial – creat- T ional Football League (NFL) highlight that ed by the advertising agency Publicis – shows Prilosec OTC is the “best protection available” the players taking part in a gruelling training for frequent heartburn in a new consumer cam- regime. The sign-off message is “Heartburn paign from Procter & Gamble in the US. gone, power on”. The Prilosec OTC Living Proof campaign, A voiceover explains that Prilosec OTC has which runs until February,includes television travelled to the “front lines of the NFL train- and digital advertising as well as online videos. ing camp to put our 24-hour frequent heart- Procter & Gamble said it had chosen New burn protection to the test for two weeks”. York Giants player David Diehl and Minnesota Diehl and Herrera then tell viewers about Vikings member Anthony Herrera to front the the negative impact that heartburn has on their Prilosec OTC campaign, because they were performance, despite people thinking that they Procter & Gamble is urging Americans to take a 14-day challenge for its Prilosec OTCfrequent “living proof that heartburn can happen to even are “indestructible”. “Prilosec OTC is the one heartburn medicine the toughest people”. These players would show thing I can count on to block my heartburn,”ex- that Prilosec OTC “blocked frequent heart- plains Diehl, while Herrera adds that “Prilosec to receive a US$10.00 (C7.20) coupon for their burn for the toughest blockers in the NFL”, OTC is protecting me”. next pack. the company added. The voiceover then urges consumers to take Visitors to the website can also view videos Noting that the players “can’t afford to let their own 14-day challenge through the Pri- from Diehl and Herrera,who will share their anything undercut their fierce concentration”, losec OTC website at www.prilosecotc.com. stories about heartburn. Procter & Gamble said their appearance in the The challenge involves consumers buying The campaign comes soon after Procter & campaign would “help people understand that and taking a two-week supply of Prilosec OTC, Gamble reported that sales of the 20mg ome- frequent heartburn doesn’t have to get in the filling out a log, and sending the receipt, prod- prazole tablets had declined in the three months way of their daily activities”. uct barcode and a form to Procter & Gamble ended 30 September 2010 because of increased competition. Sales were hit by the introduction of two branded competitors in the previous 12 months, as well as ongoing competition from store-brand equivalents (see page 9). A year ago, Novartis Consumer Health in- troduced the lansoprazole-based Prevacid 24HR (OTC bulletin,16 November 2009, page 1). Then earlier this year,Merck & Co intro- duced Zegerid OTC, a combination of 20mg “Heartburn gone, power on” is the theme of Procter & Gamble’s new television commercial for Prilosec OTC omeprazole and 1,100mg sodium bicarbonate in the US, which highlights that the medicine has blocked frequent heartburn for the toughest blockers in the National Football League (NFL) (OTC bulletin,16 April 2010, page 14). OTC

IN BRIEF Marketing Campaigns ■ VERLA-PHARM has added a raspberry Nelsons backs Bach with online course flavour to its Magnesium Verla Direkt phar- macy-exclusive food supplement in Germany. elsons is backing its Bach Original Flower their own pace, learning about a selection of The orodispersible granules – which provide NRemedies, including Bach Rescue Rem- remedies in detail and completing a number 150mg magnesium per sachet – are already edy, with an online course giving Britons an of fun, interactive quizzes and exercises,”the available in a citrus flavour. A pack of 30 sachets insight into the “system” of products. company added. “We hope that those who take has a recommended retail price of C9.15. The company said the course – available at the course will be inspired to go on and learn www.bachintro.com – would advise consumers more about the remedies.” ■ BRUNEL HEALTHCARE said sales value on how natural healthcare could help them, their The course covers Dr Bach’s philosophy, the for Vertese had increased by 58% in the UK families and their friends when they were feel- system of 38 Bach Original Flower Remedies, health food trade during the first month after ing under pressure. The free course would en- and the Bach Rescue Remedy. It explains that the relaunch of the brand earlier this year (OTC able consumers to “explore their emotions on- the products are made from natural flower es- bulletin,10 February 2010, page 20). line”, commented Nelsons. sences, and tells people how to use them. OTC “Users can progress through the course at OTC

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OTC MARKETING NEWS

Launches Actavis offers pharmacists “potent” First Resort in UK

n advanced professional range for phar- “A macists” is how Actavis is positioning its new First Resort umbrella brand in the UK. The generics and OTCcompany has initial- ly launched two “potent” non-steroidal anti-in- flammatory drugs (NSAIDs) under the First Resort brand. Further additions to the range of “expert first-choice solutions” are planned. One newcomer is called Double Action Pain Relief and comprises oral 12.5mg diclofenac Two oral non-steroidal anti-inflammatory drugs (NSAIDs) potassium tablets. – diclofenac and naproxen – are Actavis’ first offerings under its First Resort umbrella brand in the UK Actavis is positioning the pharmacy-only (P) medicine as “an advanced product that effec- Actavis noted that Period Pain Reliever was

Reckitt Benckiser will extend its Scholl range of tively targets backache, rheumatic pain, and a “powerful NSAID that provides effective re- footcare products in France with a fungal nail muscular pain”. The company notes that it is lief from period pain and cramps”. A strapline treatment in February. also effective for headache, dental pain, period on the packaging states that the tablets are “For Pharmacy-press advertising (pictured above) states that the medical device – which was recently pain, fever and symptoms of cold and flu. period pain and cramps”. launched in the UK (OTC bulletin, 15 October 2010, Double Action Pain Relief competes with Period Pain Reliever competes with Bayer page 14) – will be available exclusively in pharmacies Novartis Consumer Health’s Voltarol Pain-eze Healthcare’s Feminax Ultra, which was launch- and parapharmacies. Pointing out that the newcomer can be ordered Tablets, which were the first diclofenac tablets ed in 2008 after oral formulations containing by pharmacists immediately, the advertising claims to be sold without prescription in the UK (OTC 250mg naproxen were switched from prescrip- the product has “exceptional efficacy” and is precise bulletin,29 September 2008, page 10). tion-only to pharmacy status (OTC bulletin,31 and easy-to-use. Straplines on the product packaging claim that The Actavis product comes in packs of 18 March 2008, page 10). the fungal nail treatment is “scientifically proven”, tablets with a recommended retail selling price Period Pain Reliever retails at £3.99 for a “eliminates 99.9% of nail fungus”, and “helps prevent of £3.99 (C4.65). pack of nine tablets. the spread and recurrence” of fungus. The effect of the treatment is demonstrated by ‘before’ and ‘after’ The second product available under the First Actavis said launch marketing activity for photographs on the pack. Resort brand is a P medicine called Period Pain the two First Resort products would focus on Reckitt Benckiser will support the launch with Reliever and consists of oral gastro-resistant tab- the trade. It added that there were no immediate television advertising in the second quarter of 2011, as well as point-of-sale displays in pharmacies. lets containing 250mg naproxen. plans for consumer advertising. OTC OTC

Launches Herbalife debuts trio of products in US

nergy for the heart” is Herbalife’s on- ment” with allergen-free and pumpkin spice- “Epack promise for one of three new nut- flavoured variants in the US. ritional products in the US. The company said the allergen-free variant The US-based direct-selling specialist said was a “perfect nutritional solution for those the CoQ10 Plus dietary supplement was an “ex- with common food allergies, as it is soy, dairy clusive blend” of coenzyme Q10, vitamin D, and gluten free”. It noted that the product con- and non-fish docosahexaenoic acid (DHA) from tained 20 vitamins and minerals; non genetical- algae. The company noted the product worked ly-modified protein from rice, pea and sesame in the body to convert fats and carbohydrates sources; and more than two servings of fruit

into energy for the heart, adding that it was also and vegetables. Vaseline Lip Therapy products are now available in known to help regenerate essential antioxidants The pumpkin spice variant is a limited edi- the UK in sticks as well as the original tins. such as vitamin E. tion for the festive season. Unilever has also extended the range with a cocoa butter variant, which will be available in both A month’s supply of the one-a-day CoQ10 Both products provide 30 servings. The al- the stick and tin formats. It joins the existing aloe Plus softgel capsules has a suggested retail sell- lergen-free variant has a suggested retail sell- vera, original and rosy lip versions. ing price of US$39.95 (C28.95). ing price of US$37.85, while the pumpkin spice The launch will be backed by a £1.3 million (C1.5 million) marketing campaign. Meanwhile, Herbalife has extended its For- version retails at US$34.40. Consumers should Sticks have a recommended retail selling price of mula 1 Healthy Meal Nutritional Shake Mix take up to two servings a day. £1.99 for 4g, while the tins retail at £1.89 for 20g. range “for healthy nutrition and weight manage- OTC OTC

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EVENTS OTC

NOVEMBER 6-7 December JANUARY two-day conference,include Bah- ■ EMA/TOPRA rain, Israel, Syria and Yemen. 24 November Joint Review of the Year 26 January Contact: Management Forum. ■ Basics of and Look to the Future ■ Marketing Authorisation Tel: +44 1483 730071. Regulatory Affairs London, UK in Turkey Fax: +44 1483 730008. Brussels, Belgium This two-day conference is organ- Frankfurt, Germany E-mail: registrations@management- A one-day course from The Org- ised by the European Medicines Classification and pharmacovig- forum.co.uk. anisation for Professionals in Reg- Agency (EMA) and The Organ- ilance in Turkey are on the agenda. Website: www.management- ulatory Affairs (TOPRA). isation for Professionals in Reg- Contact:Henriette Wolf-Klein, forum.co.uk. Contact:TOPRA. ulatory Affairs (TOPRA). Forum Institut für Management. 28 February-1 March Tel: +44 20 7510 2560. Tel: +49 6221 500 680. Contact:TOPRA. ■ EuroPLX 45 Fax: +44 20 7537 2003. Tel: +44 20 7510 2560. Fax: +49 6221 500 555. Lisbon, Portugal E-mail: [email protected]. Fax: +44 20 7537 2003. E-mail: [email protected]. A two-day partnering and licens- Website: www.topra.org. E-mail: [email protected]. Website: www.forum-institut.com. ing forum focusing on OTC medi- Website: www.topra.org. 25 November 26 January cines, nutraceuticals, branded pre- scription drugs and generics. ■ Building a Regulatory 7 December ■ Homoeopathic Strategy for Marketing Medicines Contact:RauCon. ■ Labelling Food Tel: +49 6222 9807 0. Food Supplements Bonn, Germany Supplements Fax: +49 6222 9807 77. Speakers from Germany’s federal in Europe London, UK E-mail: [email protected]. institute for drugs and medical de- Brussels, Belgium Topics to be discussed at this two- Website: www.raucon.com. Subtitled ‘The key steps to a suc- day conference, organised by the vices, BfArM, will be at this one- cessful product launch’, this one- UK’s Health Food Manufacturers’ day conference run by Germany’s MARCH day meeting will look at the reg- Association (HFMA), will include medicines manufacturers’ associ- ulatory challenges of marketing the foods/medicines borderline, ation, the BAH. 10-12 March food supplements in Europe. routes to market, definitions and Contact: BAH. ■ CHPA Annual Contact:EAS. compositional requirements. Tel: +49 228 957 45 0. Executive Conference Tel: +32 2 218 1470. Contact:Linda Phillips, Health Food Fax: +49 228 957 45 90. Aventura, Florida, US Fax: +32 2 219 7342. Manufacturers’Association (HFMA). E-mail: [email protected]. This three-day conference is the E-mail: [email protected]. Tel: +44 20 8481 7100. Website: www.bah-bonn.de. Annual Meeting of the US Con- sumer Healthcare Products Asso- Website: www.eas.eu. Fax: +44 20 8481 7101. 27-28 January E-mail: [email protected]. ciation (CHPA), and is only open ■ Latest Developments DECEMBER Website: www.hfma.co.uk. to members. in Pharmacovigilance Contact: Phyllis Taylor,CHPA. 2 December 13-15 December London, UK Tel: +1 202 429 9260. ■ Marketing Authorisation ■ Pharmacovigilance This two-day event will focus on Fax: +1 202 223 6835. in Latin America London, UK European developments. E-mail: [email protected]. Düsseldorf, Germany A three-day course for those work- Contact: Management Forum. Website: www.chpa-info.org. A one-day event looking at Arg- ing on drug safety monitoring in Tel: +44 1483 730071. entina, Brazil, Chile, Colombia, Europe, Japan and the US. Fax: +44 1483 730008. 22-23 March Mexico and Peru. Contact: Management Forum. E-mail: registrations@management- ■ Regulatory Affairs in Contact:Henriette Wolf-Klein, Tel: +44 1483 730071. forum.co.uk. India & China Forum Institut für Management. Fax: +44 1483 730008. Website: www.management- Frankfurt, Germany Tel: +49 6221 500 680. E-mail: registrations@management- forum.co.uk. Day one of this two-day seminar Fax: +49 6221 500 555. forum.co.uk. will discuss regulatory affairs, clin- E-mail: [email protected]. Website: www.management- FEBRUARY ical trial regulation and variations Website: www.forum-institut.com. forum.co.uk. in India, while day two will focus 10 February on China. Each day can be book- ■ The Pharma ed separately. Summit 2011 Contact:Henriette Wolf-Klein, 1-2 February London, UK Forum Institut für Management. What Regulation for Food Supplements & Herbal ■ ‘Reinventing pharma for a new Tel: +49 6221 500 680. Medicinal Products in Europe? generation’ is the theme of this Fax: +49 6221 500 555. Brussels, Belgium one-day meeting. E-mail: [email protected]. This two-day meeting is organised by the Association of the European Contact:Economist Conferences. Website: www.forum-institut.com. Self-Medication Industry,the AESGP. Tel: +44 20 7576 8116. There will be sessions entitled: ‘Implementation/enforcement of the Fax: +44 20 7576 8472. 28-30 March nutrition and health claims regulation’; and ‘A single market for herbal E-mail: weurope_customerservice@ ■ DIA Annual medicines in Europe?’. economist.com. EuroMeeting Speakers will include: Dagmar Roth-Behrendt of the European Par- Website: www.economistconferences. Geneva, Switzerland liament; Basil Mathioudakis and Paola Testori-Coggi of the European com. A three-day conference organis- Commission; Vittorio Silano of the European Food Safety Authority ed by the Drug Information As- (EFSA); and Ioanna Chinou of the European Medicines Agency’s Com- 17-18 February sociation (DIA). mittee on Herbal Medicinal Products (HMPC). ■ Pharmaceutical Contact: DIA European Office. Contact:AESGP. Regulatory Affairs Tel: +41 61 225 51 51. Tel: +32 2 735 51 30. Fax: +32 2 735 52 22. E-mail: [email protected]. in the Middle East Fax: +41 61 225 51 52. Website: www.aesgp.be. London, UK E-mail: [email protected]. Countries to be covered at this Website: www.diahome.org.

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OTC AESGP MEETING

For druggists, a key concern was the qual- Regulators grapple with ity of professional advice offered at the three types of retail outlet for non-prescription medi- cines in the Netherlands – drugstores, pharma- non-prescription supply cies and general-sale outlets. Maintaining that there was a low health literacy among consum- ers, druggists had mentioned the need for fur- Initiatives in Belgium and Holland, experience with Europe’s centralised ther safeguards to protect consumers, he said. authorisation procedure, and other regulatory developments at the European Moving on to health insurers, ten Have said they saw the potential for cost savings. How- level were discussed at a recent meeting organised by the Association of the ever,they also appreciated that the current sys- European Self-Medication Industry,the AESGP. Deborah Wilkes reports. tem meant their clients had easy access to gen- eral practitioners, he added. here was good news for companies tion’, the AESGP’s study calculated the annual The work by Ecorys had suggested a num- operating in Belgium at a recent gath- savings that could be achieved for public funds ber of ways to reform the system in the long- ering of the European OTC industry and national economies if just 5% of prescrib- term, according to ten Have,including ‘assist- Tin Antwerp. From next year,comp- ed medicines were shifted to self-medication. ed’ self-medication, closer cooperation between anies will have regular meetings with the Bel- According to the AESGP’s study,the annual pharmacies and drugstores, correct incentives gian Federal Agency for Medicines and Health savings across the seven countries would have for health insurers, and better inspection and Products. Xavier de Cuyper,the agency’s chief been C11.5 billion and the average annual per enforcement by regulatory bodies. executive officer,told the meeting organised by capita saving would have been C35.78. The the Association of the European Self-Medica- seven countries were Austria, France, Germany, Consumers need better health literacy tion Industry,the AESGP,that the “platforms” Italy,Portugal, Spain and the UK (OTC bul- If self-medication and self-care were to play would provide an opportunity to address issues letin,16 June 2004, page 22). a greater role in healthcare, concluded ten Have, affecting self-medication products. Ten Have said a second preliminary quan- then the “self-reliance and health literacy” of The Belgian OTCmanufacturers’ associa- titative analysis by Ecorys had taken its lead consumers needed to be improved. Furthermore, tion, BACHI, said there would be three or four from the Proprietary Association of Great Brit- the quality of advice had to be better,he said. platforms a year,with the first taking place in ain’s (PAGB’s) work on general practitioners Noting that Ecorys was refining its method- January 2011. The platforms would initially be and minor ailments carried out in 2008 (OTC ology,ten Have said there was currently a politi- attended by the agency and industry,but doc- bulletin,15 February 2008, page 13). A recent cal window of opportunity for self-medication tors, insurers, pharmacists and other relevant survey of general practitioners in the Nether- to play a greater role in healthcare. The govern- stakeholders might also take part at a later date. lands found that they considered 29% of con- ment was seeking to cut its expenditure by C18 sultations to be unnecessary,he said, adding that billion over the next few years, he added. Study progresses in the Netherlands the analysis suggested an annual per capita sav- At the European level, Eric Abadie – chair- Next door in the Netherlands, meanwhile, ing of C57.00. person of the Committee for Medicinal Prod- the OTC industry is working with research and The work was still at a “preliminary” stage, ucts for Human Use (CHMP) at the European consultancy group Ecorys to work out the sav- stressed ten Have. Neither of the quantitative Medicines Agency (EMA) – offered advice to ings that could be achieved with greater self- analyses were “fully satisfactory”, he added, firms considering using the centralised proce- medication and self-care by people suffering noting that a better way of defining minor ail- dure to authorise a non-prescription medicine. from minor ailments. The Dutch OTC industry ments was needed. According to Abadie, the sparsity of suc- association, Neprofarm, is hoping to capitalise In addition to the quantitative work, Eco- cessful outcomes was not due to the regulatory on the new coalition government’s stated inten- rys has carried out a preliminary qualitative an- framework but how it was interpreted by the tion of encouraging people to take greater re- alysis following meetings with general practi- CHMP. There was a need for more rapporteurs tioners, pharmacists and drug- and peer reviewers with knowledge of non- A preliminary quantitative analysis found gists, and some interviews with prescription medicines, he accepted,and appli- that annual savings of aproximately C680 health insurers. cants should seek scientific advice for techni- Ten Have said that general cal issues. Abadie also maintained that switch- million could be achieved in the Netherlands practitioners had reported a ing medicines from prescription to non-prescrip- heavy unnecessary workload, tion status might require a “rethink” about the sponsibility for their own healthcare (OTC bul- but were reluctant for patients to visit pharma- role of the pharmacist. letin,29 October 2010, page 20). cists or druggists – especially druggists – as an Abadie reminded the meeting that non-pre- Arthur ten Have,apartner at Ecorys, told alternative. Both commercial and professional scription medicines had two entry points to the the meeting that one preliminary quantitative reasons had been cited by the general practi- centralised procedure. The first was automatic analysis had found that annual savings of ap- tioners for this reluctance,he added. entry for switching centrally-authorised pre- proximately C680 million could be achieved in General practitioners had acknowledged the scription medicines. The second was non-auto- the Netherlands. This represented an annual per importance of providing good information on matic entry for medicines that had not been auth- capita saving of C41.00, he noted. medicines, continued ten Have,but they had orised through the centralised procedure. The analysis, explained ten Have,was based also noted that patients seemed to become more GlaxoSmithKline Consumer Healthcare’s on methodology used by the AESGP in 2004 insecure when they had access to more infor- Alli – based on the active ingredient orlistat – is for a seven-country study. Entitled ‘The eco- mation. The issue of who should provide in- the only medicine to have gained non-prescrip- nomic and public health value of self-medica- formation had also been raised, he commented. tion status using the first entry point (OTC bul-

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AESGP MEETING OTC

letin,29 January 2009, page 1). Pfizer’s appli- already had non-prescription status in one or cation to switch Viagra (sildenafil citrate) was two member states. withdrawn from the procedure (OTC bulletin, Commenting on benefits and risks, Abadie 28 November 2008, page 1). said that question marks surrounding the non- The second entry point was used success- prescription setting posed difficulties for reg- fully by Nycomed to obtain non-prescription ulators. “The more you have uncertainty,the status for pantoprazole tablets. An application more you are in trouble,”he remarked. “For from Wyeth Consumer Healthcare – now part some colleagues, the non-prescription setting of Pfizer – to licence a new combination of revealed a number of uncertainties that could

existing non-prescription medicines was pull- have led to a negative opinion.” The uncertainty of the non-prescription setting ed out of the procedure (OTC bulletin,10 Feb- Offering advice to potential applicants,Aba- poses difficulties for regulators, according to Eric ruary 2010, page 1). die said they should give most prominence to Abadie, chairperson of Europe’s Committee for Abadie noted that there had been 13 requests “cumulative safety data from pre-existing non- Medicinal Products for Human Use (CHMP) for eligibility through the second entry point, prescription usage”, including experience out- educated to ensure the safe use of non-prescrip- of which only five had been accepted. Rejec- side of the European Union. If the experience tion medicines. tions often involved “old” products that were was within the European Union, he added, “pro- Abadie also touched upon the fact that non- already available as non-prescription medicines active participation of the member state with prescription medicines were available from non- in a number of member states, he noted. the experience is probably the way forward”. pharmacy outlets in some European countries. He said the CHMP would probably have a Potential applicants should also consider in- He pointed out that the CHMP had the right positive view on eligibility for a “first in class” correct use of the product, he noted, and could to set criteria for non-prescription medicines, product that was not available as a non-prescrip- identify co-morbidities. They could, for exam- such as “supervised by pharmacists”. tion medicine in any member states or was only ple, identify the proportion of people who were Europe’s mutual-recognition and decentral- available in two or three member states. He aware of the link between obesity and cardio- ised licensing procedures were also discussed stressed that experience in these two or three vascular problems, he suggested, and mention at the Antwerp meeting. An AESGP study re- member states had to be “satisfactory”. this link on the product labelling. leased earlier this year showed that companies However, “second in class” products – in the Furthermore, the role of the doctor in the using the two procedures for non-prescription same pharmacological class as a previously- product’s use should be examined. Abadie high- medicines faced distant starting times and long adopted non-prescription product – were less lighted that the involvement of a doctor before review periods (OTC bulletin,26 February likely to be viewed positively,he said. or after a person purchased a non-prescription 2010, page 20). Abadie added that the CHMP might have medicine could solve some of the problems in Truus Janse-de Hoog – chairperson of the the non-prescription setting. Coordination Group for Mutual Recognition The CMDh is open to starting a dialogue He also encouraged poten- and Decentralised Procedures, Human (CMDh) with the self-medication industry to discuss tial applicants to provide act- –claimed at the Antwerp meeting that the pro- ual-use studies and surveys of cedures had been successful with some sub- how its concerns can be addressed patient-behaviour patterns. The stances, notably paracetamol, nicotine and xylo- latter should be linked to the metazoline. Nevertheless, she acknowledged a positive view about a product for which the disease rather than a specific medicine, he noted. that both procedures were “underutilised” by legal status varied across Europe. Moving on to the role of the pharmacist, Aba- the self-medication sector. To date, there have been five applications to die maintained that this varied across the Euro- Noting that the CMDh had addressed the authorise a non-prescription medicine through pean Union. “The way pharmacists do their job specific needs of the innovative,generics and the centralised procedure. Two of these have is different in different member states,”he said. herbals sectors, she accepted that the CMDh been successful, two have been withdrawn, and This issue was explained in more detail ear- needed to have “procedures that facilitate entry one is ongoing. lier this year by Patrick Le Courtois,head of of OTC products to the market”. Abadie pointed out that the CHMP had been the EMA’s human medicines development and split over most of these applications, with two evaluation unit. It had been “a main issue for Potential for creating disharmony main issues causing concern. Firstly,he said, the small number of products that have been Janse-de Hoog said there were a number of the impact of the CHMP’s opinion on health- looked at by the CHMP”, he said, adding that points for discussion with regard to non-pre- care systems within each member state had been the role of the pharmacist had been “a break- scription medicines. She highlighted the dif- raised. Secondly, he added, the role of the reg- ing point” in one of the procedures (OTC bul- ferences in legal classification of medicines, ulator in assessing benefits and risks in the non- letin,10 February 2010, page 25). food supplements and borderline products from prescription setting had been a problem. “There is little harmonisation at the Euro- one member state to another,as well as the dif- Discussing the first of these, Abadie said a pean level in terms of the role of the pharma- ferent procedures for switching medicines from positive CHMP opinion could cause concern cist,”observed Le Courtois, adding that “the prescription to non-prescription status. She also for a member state that did not want the med- practice is different, the culture is different, the drew attention to the potential for creating dis- icine to have non-prescription status. “I had this perceptions are different and the healthcare sys- harmony with products that were already pre- discussion when Alli received a positive opin- tems are organised differently”. sent in national markets. ion,”he recalled. “I had a phone call from a These reservations about pharmacists were “The CMDh is open to starting a dialogue good friend in one member state, saying the challenged by John Chave,secretary-general with the self-medication industry to discuss CHMP had made the wrong decision.” of the Pharmaceutical Group of the European how its concerns can be addressed,”concluded Conversely,added Abadie, a negative CHMP Union (PGEU). He told delegates attending the Janse-de Hoog. opinion could cause concern when a medicine Antwerp meeting that pharmacists were well OTC

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OTC BUSINESS STRATEGY PepTcell pursues OTC partners

PepTcell is seeking global partners to develop and market a cough suppressant and a medicine to treat inflammatory flare. Deborah Wilkes asked Manfred Scheske, head of the drug-discovery company’s Consumer Health division, about the two OTC prospects.

here has been “little innovation” for all the boxes for safety and efficacy with an in- decades in the two biggest categories dication that is suitable for OTC use,”com- in the global OTC market, according ments Scheske. Tto Manfred Scheske, chief executive PepTcell is seeking regulatory and market- officer of the Consumer Health division at Pep- ing partners for both prospects. Scheske says Tcell. Extended-release guaifenesin formula- that the company would prefer to talk to global tions have had a big impact in the cough and players with a presence in both the prescrip- cold category in the US, observes Scheske, and tion and non-prescription sectors, but has not Manfred Scheske, chief executive officer of the switch of oral naproxen from prescription- ruled out working with regional players. Part- PepTcell’s Consumer Health division, wants only to non-prescription status has been impor- ners must view the prospects as “strategic” rath- regulatory and marketing partners who will take a tant in the pain-relief category in a number of er than “opportunistic”, stresses Scheske, adding “strategic” rather than an “opportunisitic” approach to its OTC prospects countries. Other than that, he says, there has that they must bring “passion” for the projects been very little innovation since ibuprofen was to the table. under prescription control (OTC bulletin,29 released from prescription control nearly 30 According to Scheske, PepTcell’s cough sup- September 2010, page 9). years ago. pressant could be authorised in Europe and the Scheske believes that the potential to abuse The opportunity to bring substantial innova- US as soon as 2013, subject to gaining regu- existing cough medicines could even lead some tion to these two categories was what attracted latory approval. regulatory agencies to fast-track the authorisa- Scheske to the drug-discovery company Pep- The product is already available in South tion of PepTcell’s cough suppressant. Tcell. “There is more innovation in this rela- Korea, where it was authorised as a prescrip- He also points out that there is a lot of safety tively small company than in the OTC portfo- tion-only medicine in 2009. South Korea is the data on theobromine, which is present in choco- lios of most global players,”he remarks. only country where PepTcell does not have the late, tea leaves and other foods and beverages. The former European president of Glaxo- rights to the product, he states, adding that the Moving onto the small-molecule drug for SmithKline Consumer Healthcare (OTC bul- company does have access to the Korean data inflammatory flare, Scheske says this is at an letin,16 April 2010, page 1) has just joined the including a Phase III clinical trial and a Post- earlier stage in the development process than the London-based firm, which has mid- to late-stage Authorisation Safety Study (PASS). cough suppressant. He declines to name the act- drugs in development, including vaccines, anti- Scheske notes that PepTcell will soon start ive ingredient, but says the patented product is inflammatories, and respiratory and cancer treat- another pivotal Phase III clinical trial for reg- an “adjuvant for a well-established and wide- ments. Announcing Scheske’s appointment, Pep- istration purposes in Europe. ly-used analgesic”. “Much of the safety data Tcell’s chief executive officer Gregory Stoloff The product is based on theobromine, which exists,”he adds, “so we hope to move directly said consumer health was an important part of has previously been used in medicines for oth- into Phase III clinical trials and subsequently the company’s business (OTC bulletin,15 Oct- er indications, such as hypertension, but is a proceed on a truncated regulatory pathway to- ober 2010, page 1). new active ingredient for suppressing coughs. wards authorisation.” Scheske’s “superb industry knowledge and Scheske points out that the Phase III clinical Scheske maintains that his experience with insight” would be invaluable, Stoloff stated, trial found that theobromine was equivalent to co- GlaxoSmithKline Consumer Healthcare’s Alli “for guiding our groundbreaking consumer as- deine as a cough suppressant, and did not have will be extremely valuable at PepTcell. Last sets to market”. the negative effects of codeine. year,the weight-loss medicine containing orli- Two prospects caught Scheske’s eye. One stat became the first product to be switched is described as a “first-in-class” cough suppres- A better risk/benefit profile from prescription-only to-non-prescription sta- sant with clinically-proven efficacy and a good Discussing the risk/benefit profile, Scheske tus throughout the European Union using the safety profile. The other is a small-molecule maintains that theobromine has advantages com- centralised authorisation procedure. drug for inflammatory flare, which has a clin- pared with existing cough suppressants, such as He adds that PepTcell is “uniquely position- ically-proven analgesic profile and is entering codeine and dextromethorphan, which are nar- ed” to provide breakthrough products in the two Phase III trials. cotics. Some teenagers and young adults in the largest consumer health categories, which have Scheske points out that both prospects have US intentionally abuse large amounts of med- long needed the kind of innovation that Pep- the potential to be non-prescription medicines, icines containing dextromethorphan to get high. Tcell is promising. but he says regulatory agencies may initially As a result, the non-prescription status of med- keep them under prescription control. He adds, icines containing dextromethorphan was recent- ■ For more details contact Manfred Scheske, chief exec- however, that the “surprising level of past expo- ly reviewed by advisory committees to the US utive officer of PepTcell’s Consumer Health division, by sure and safety data” should speed their transi- Food and Drug Administration (FDA), which e-mail at [email protected]. tion into the non-prescription market. “We tick voted against bringing the active ingredient OTC

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PEOPLE OTC

Manufacturers Manufacturers Krebs succeeds Reckitt tasks Sydow with Roberts at Merz growing Durex and Scholl ndreas Krebs,52, is the new chairman A of the supervisory board at Merz, follow- eckitt Benckiser has given Volker Sydow Volker Sydow ing the retirement of Edward Roberts,76, aft- R– formerly SSL International’s group mar- er more than 12 years in the post. keting director – the job of growing its recently- The German company pointed out that Rob- acquired Durex and Scholl powerbrands. erts had stepped down after reaching the age Sydow has been appointed global category limit for the role. director for the newly-created Sexual Wellbe- In addition to being elected chairman at the ing and Footcare category at Reckitt Benckiser. company’s meeting of the shareholders on 16 This houses the Durex condom and Scholl foot- September,Krebs was appointed deputy chair- care brands, which the company gained through man of the shareholders’ board and company its £2.54 billion (C2.99 billion) acquisition of counsellor. SSL (OTC bulletin,30 July 2010, page 1). Krebs previously spent 19 years at Bayer. Reckitt Benckiser said Sydow would lead He has also headed Wyeth’s business in Ger- “global new product development” and “equity many,and been an executive board member at development” for Durex and Scholl, and would Wyeth’s US headquarters with responsibility work with teams from key local markets for the to SSL International’s chief executive officer for overseeing Africa, Canada, Europe and the brands, including the UK. He reports to Rakesh Garry Watts. near East. Kapoor,Reckitt Benckiser’s executive vice-pre- Following Reckitt Benckiser’s acquisition Following Pfizer’s takeover of Wyeth, Krebs sident of category development. of SSL on 29 October,Watts and SSL’s chief supported the company’s integration before Sydow’s appointment is part of Reckitt Ben- finance officer Mark Moran have left the com- setting himself up independently as manag- ckiser’s growth strategy for Durex and Scholl, pany. In addition, Ian Adamson,the company’s ing partner of CologneInvest. which is based around innovation, investment group commercial director,has stepped down OTC and marketing (see page 5). as an executive director but will remain with Sydow began his career in 1995 as a junior the company until the end of December to as- brand manager at Reckitt Benckiser in Ger- sist with the transition. Regulatory Agencies many. He moved to Henkel in 1999, where he SSL’s non-executive directors – Gerald Cor- EMA searches for was international brand manager and then group bett, Peter Read, Richard Adam and Peter marketing manager. In 2002, he joined Molk- Johnson – have also stepped down. Lönngren successor erei Muller as international marketing director. Reckitt Benckiser has appointed four new Since moving to SSL in 2005, Sydow’s posi- directors at SSL International: William Mor- he management board of the European tions have included managing director for Ger- dan,Reckitt Benckiser’s vice-president and gen- TMedicines Agency (EMA) is looking for many,regional managing director for central eral counsel; Manish Dawar,its senior vice- a new executive director to replace Thomas Europe, and regional managing director for president and group controller; Martin Keeley, Lönngren,who will leave the agency at the northern Europe. He was made group mar- its senior vice-president of corporate planning; end of this year following the expiry of his keting director in April of this year,reporting and Simon Edwards. second five-year mandate. OTC The EMA said it had recruited Andreas Pott – the agency’s current head of adminis- IN BRIEF tration – to serve as acting executive director for an interim period of around six months ■ BAUSCH + LOMB has recruited Mariano of Oriola-KD’s Pharmaceutical Retail business with effect from 1 January 2011. García-Valiño to take the newly-created role in Russia, has taken on Knyazev’s role until According to the EMA, Pott – who became of corporate vice-president and president, Latin a replacement is found. head of administration in 2000 – was its long- America. Most recently,García-Valiño was an est-serving senior manager at the right grade. operating partner at private-equity group Ad- ■ IMS HEALTH has appointed Sebastian In addition, Pott had served a similar role to vent International, where he focused on health- Lempfert as head of its health insurance de- that of executive director 10 years ago, the reg- care investment opportunities in Latin Amer- partment in Germany. Lempfert, 42, spent 12 ulatory agency added. ica. He has also held positions at Pfizer,Mc- years at statutory health insurance funds and Lönngren became executive director of the Kinsey & Company, and Eli Lilly. joins from Steria Mummert Consulting. EMA in October 2000 (OTC bulletin,31 Oct- ober 2000, page 27). He began his first five- ■ ORIOLA-KD said Vladimir Knyazev – ■ THE NATURAL PRODUCTS ASSOCI- year term in January 2001, and was reappoint- general director of its Pharmaceutical Whole- ATION in the US has elected Mark LeDoux, ed to the role in October 2005 (OTC bulletin, sale business in Russia and a member of the chairman and chief executive officer at Natu- 17 October 2005, page 23). Finnish firm’s group management – had left ral Alternatives International, to its board. OTC the company. Henry Fogels,general director OTC

16 November 2010 OTC bulletin 27 Gen 4-COL Ad FOR OTC Promo Flash -Oct 2010.qxd 19/10/10 07:09 Page 1

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