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10 February 2010

COMPANY NEWS 2 Novartis set to introduce ’s Mepha aims 2 at herbals and supplements Alliance Boots to establish 3 Swedish pharmacy venture Pantoloc in 14 countries Ta isho suffers as OTC market cools 4 J&J hit by comparison and currency 6 ovartis Consumer Health is set to in- the product is available without a prescription Ntroduce Nycomed’s proton-pump in- in . NBTY’s pre-tax profits soar 7 hibitor Pantoloc Control as a non-prescrip- Novartis said that it would introduce Panto- Demand for OTC specialties 8 tion medicine in 14 European countries. loc Control in the 14 countries “later in 2010” lifts annual sales at Boiron The 20mg pantoprazole tablets gained non- through a co-marketing agreement with Nyco- Prilosec OTC hit by Prevacid 9 prescription status across Europe in June of last med. “The launch will be backed by substan- MiraLAX rival drives Perrigo 10 year through the European Union’s centralis- tial investment to build consumer awareness Omega offsets tough 11 ed authorisation procedure (OTC bulletin,19 and demand,”the company commented, “as start to grow sales June 2009, page 1). well as pharmacy training to help pharmacy Cadbury’s shareholders agree 12 Nycomed has since introduced the medi- teams identify customers who will benefit most to Kraft takeover cine for frequent heartburn in Austria, Estonia, from Pantoloc Control and advise those cus- William Ransom agrees to 13 Finland, France, Germany, Hungary,Latvia, tomers appropriately.” divest Manuka Gold Lithuania, the Netherlands,Norway,Poland, Brian McNamara, head of Europe for Nov- GENERAL NEWS 14 Sweden and Switzerland. Outside of Europe, ■ Continued on page 26 UK intends to regulate more 14 nicotine products Europe looks into safety of 15 Combination pulled GSK’s Alli achieves topical bufexamac products out of central route £100 mn in Europe MARKETING NEWS 18 Benckiser creates 18 n application to license a non-prescrip- laxoSmithKline’s Alli was the third best- ‘magical’ Nurofen world Ation combination medicine has been with- Gselling OTC brand in Europe during 2009, FDA warns over counterfeit Alli 20 drawn from the European Union’s centralised according to chief executive officer Andrew authorisation procedure. Witty,as the weight-loss medicine achieved Novartis promotes speed 21 of German Voltaren Spray The soft capsules containing 200mg ibupro- sales in excess of £100 million (C115 million) FDA sends warning letter to McNeil 22 fen and 25mg diphenhydramine hydrochloride in the region. would have been indicated for short-term treat- In the nine months after its launch in 24 FEATURES 24 ment of mild to moderate pain in adults who ex- countries across the European Union in April perience sleeplessness as a result of the pain. 2009 (OTC bulletin,30 April 2009, page 1), Centralised procedure is a 24 The application was submitted by Wyeth Alli generated sales of £105 million in the re- tough nut to crack Consumer Healthcare – now part of Pfizer – on gion. By the end of the year,it was available REGULARS ■ Continued on page 13 ■ Continued on page 13 Consumer viewpoint 16 Nominations for OTC Marketing Awards – Anaemia is this month’s topic A supplement inside this issue lists all the nominations for OTC bulletin’s OTC Marketing Awards 2010. Events – Our regular listing 23 OTC10-02-10p2-3FIN.qxd 5/2/10 12:32 Page 2

OTC COMPANY NEWS

Mergers & Acquisitions Business Strategy/Annual Results SIA gains stake Switzerland’s Mepha aims in Russia’s 36.6 at herbals and supplements harmaceutical wholesaler SIA Internation- Pal has acquired a 25% stake in fellow Rus- ushing into its domestic market for herbal firm Biotan as an entry point into the broader sian company Pharmacy Chain 36.6 for an un- P remedies and food supplements is among consumer healthcare market. disclosed amount. the top priorities for Switzerland’s leading ge- Biotan – which is based in Baar near Zürich A spokesperson for Pharmacy Chain 36.6 nerics player,Mepha, as it prepares for life und- – was founded in 1992 by the biochemist Guido declined to comment on media reports that the er new ownership. Jutz. It markets a range of supplements based deal had been struck to settle its debts with SIA. US-based company Cephalon has agreed to on vitamins, minerals and natural extracts, in- SIA’s investment comes less than a month pay SFr623 million (C 423 million) for Mepha. cluding omega-3 fish oils and algae. after Pharmacy Chain 36.6 raised RUB2.3 bil- The Swiss firm’s owner – Mepha Holding, a A spokesperson for Mepha told OTC bul- lion (C54 million) through a new share placing company controlled by the Merckle family that letin that the company would look to build on to help pay the company’s debts and increase is currently selling Ratiopharm – had put the its strong position with Swiss pharmacists to working capital (OTC bulletin,20 January business up for sale last year (OTC bulletin, push into the herbal and supplements sectors. 2010, page 8). 30 September 2009, page 9). The firm did not plan to push into mass-mar- Artem Bektemirov, Pharmacy Chain 36.6’s “The acquisition,”stated Cephalon,“diver- ket channels, he added. chief executive officer,said at the time that the sifies the company’s business mix, doubles the Last year,Mepha increased its domestic successful placement of the additional 85.5 mil- size of its international business and provides an sales by 5.4% to SFr176 million. lion shares meant the company had “success- attractive platform [from which] to launch cur- International sales rose by 2.7% to SFr191 fully overcome” one of the “most complicated” rent and future products in new, developed and million on strong growth in the Middle East, periods in its history. emerging markets.”The firm now has interests while revenues from contract-manufacturing Cash-flow problems and a failure to refi- in brands, branded and unbranded generics. activities shot up by 57.0% to SFr41 million. nance the firm’s debt – which stood at RUB5.1 The purchase price is just over one-and-a- The prospect of mandatory price cuts for billion as of 30 September 2009 – have plagued half-times Mepha’s 2009 turnover, which ad- generics in Switzerland means Mepha is fore- Pharmacy Chain 36.6 over the past year as the vanced by 7.7% to SFr408 million. casting a 4.5% decline in domestic sales this rapidly-expanding retail business has suffered Mepha – which markets several non-pre- year to SFr168 million. However, group turn- from the economic slowdown. The company’s scription medicines, including the recently- over is expected to rise by 2.0% to SFr416 mil- Retail division accounted for RUB4.4 billion launched wart treatment Verrukill – recently ac- lion in 2010 by virtue of a 12.6% increase in of the debt, with the remainder held by its Vero- quired Swiss supplements and natural health international sales to SFr215 million. pharm manufacturing business. OTC Commenting on the 25% stake in Pharmacy Chain 36.6, Igor Rudinsky, general director of Joint Ventures SIA, said the partnership would strengthen the company’s position in the Russian pharmaceu- Sanofi-Aventis to form business tical market and help it develop relationships with manufacturers and distributors. The tie-up anofi-Aventis and Minsheng Pharmaceu- new consumer healthcare products. would also make Pharmacy Chain 36.6 more S tical have now agreed to form a joint ven- Commenting on the deal, Hanspeter Spek, competitive with consumers, Rudinsky said, as ture to produce vitamins and mineral supple- president of global operations at Sanofi-Aven- synergies would allow the retailer to cut costs ments for the Chinese OTC market. tis, said that entering the “world’s second larg- as well as reduce and stabilise prices. Subject to certain conditions, the French est consumer healthcare market” was a strate- Bektemirov said synergies created by the company said it would take a majority stake in gic move for the company that would “consol- partnership with SIA would move Pharmacy the new joint venture. This would give it access idate its position in consumer healthcare”. Chain 36.6 closer to its target of returning to to one of the largest categories in the Chinese The French firm recently announced that it profitable growth. OTC market, it noted. was entering the world’s largest OTC market, Pharmacy Chain 36.6 reported sales down The move follows an announcement in Oct- the US, by acquiring Chattem for US$1.9 bil- by 26.3% to RUB4.6 billion for the third quar- ober last year,when Sanofi-Aventis said it had lion.The deal was recently cleared by the Fed- ter of 2009. Retail turnover, which accounted signed a letter of intent with Minsheng to set eral Trade Commission (FTC) in the US and for 77% of total group sales, fell by 29.8% to up a joint venture company to gain access to is expected to close in the first quarter of 2010. RUB3.5 billion. Veropharm’s sales dropped by China’s US$10 billion (C 7.2 billion) vitamin, Chattem provided Sanofi-Aventis with the 13.6% to RUB868 million. minerals and supplements market (OTC bul- “ideal platform in the US consumer healthcare As of 30 September 2009, Pharmacy Chain letin,30 October 2009, page 10). market”, the firm said, and gave it a vehicle for 36.6 was operating 1,026 pharmacies across Minsheng – which has a strong presence in switching some of its medicines, such as the Russia. This was down from the 1,168 stores the vitamins, minerals and supplements cate- allergy medicine Allegra (fexofenadine hydro- the company was operating a year earlier,as goryin China through its 21 Super-Vita brand chloride), from prescription to OTC status in the it closed underperforming outlets. – said that it hoped the joint-venture business US (OTC bulletin,20 January 2009, page 1). OTC would provide it with a platform to develop OTC

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COMPANY NEWS OTC

Retailers Mergers & Acquisitions Alliance Boots to establish Martek grabs Swedish pharmacy venture Amerifit Brands artek Biosciences is set to acquire US- lliance Boots may soon establish Boots- A spokesperson for Alliance Boots com- M based Amerifit Brands from the private- Abranded pharmacies in Sweden through mented to OTC bulletin that it was too early equity firm Charterhouse Group in an all-cash a joint venture with the Swedish Association to give any further details of the potential joint- deal worth US$200 million (C 141 million), or of Pharmacists, Sveriges Farmacevtförbund. venture business. more than two-times sales. Farmacevtföretagarna – a company owned Farmacevtföretagarna said Alliance Boots Amerifit had a turnover of about US$81 mil- by Sveriges Farmacevtförbund – and Alliance shared its aim of “creating a professionally- lion in 2009, and its earnings before interest, Boots have signed a letter of intent for the “pot- managed, private alternative that will offer ex- tax, depreciation and amortisation (EBITDA) ential establishment of a jointly-owned busi- ceptional customer and patient care in Sweden”. were US$22 million. The deal is expected to ness” that will enable independent pharmacies Sverker Littorin, chairman of Farmacevtföre- close in the first quarter of 2010. in Sweden to operate as franchise stores under tagarna, pointed out that Alliance Boots was the Martek will gain a number of established the Boots brand name. best possible partner for the company and the natural-wellness brands in the US including “pharmacy entrepreneurs” it represented. the supplement Culturelle, the urinary Farmacevtföretagarna was formed by Sver- tract infection treatment Azo, and the meno- iges Farmacevtförbund to help protect “vital and pause symptom-relief supplement Estroven. OTC bulletin innovative small businesses” following the lib- Amerifit also recently extended its portfolio eralisation of the Swedish pharmacy market. with the fish-oil product Cardiostat. 10 February 2010 Number 336 Last year,Sweden ended the state-owned Quoting data from market researcher Niel- Apoteket pharmacy chain’s monopoly on the sen,Martek said Culturelle was the number two Editor & Publisher: Deborah Wilkes sale of medicines, and put nearly two-thirds of probiotic supplement in the US food, drug and Associate Editors: Aidan Fry the 945 pharmacies up for sale (OTC bulletin, mass merchandiser channel, excluding Walmart. Mike Rice 29 May 2009, page 1). Azo was the number one OTC product in Senior Assistant Editor: Matt Stewart Finland’s Oriola-KD and three private-equ- the urinary-tract infection diagnosis, preven- Assistant Editor: Jenna Lawrence ity investors snapped up 465 of the Apoteket tion and treatment market, the company point- Advertising Controller: Debi Minal pharmacies for a total of SEK5.9 billion (C0.6 ed out, while Estroven was the leading natural Marketing Manager: Val Davis billion). A further 150 were made available to symptom-relief brand in the US. small businesses, while Apoteket retained the Steve Dubin, chief executive officer of Mar- Editorial, Subscription and Advertising enquiries should be addressed to: OTC bulletin, remaining 330 pharmacies (OTC bulletin,16 tek, said: “Amerifit’s first-class sales and mar- OTC Publications Ltd, 54 Creynolds Lane, Solihull, November 2009, page 1). keting infrastructure and proven management West Midlands B90 4ER, UK. Neither Alliance Boots nor its rival pan- team for selling branded consumer health and Tel: +44 1564 777550. Fax: +44 1564 777524. European wholesaler and retailer,Celesio, ac- wellness products will provide Martek with a E-mail: [email protected]. quired any of the Apoteket stores. Celesio is platform for commercialisation of our nutrition- Subscriptions planning to establish an entirely new pharmacy al product pipeline.” Annual subscriptions to OTC bulletin in Europe are £595.00 for single copies and £345.00 for additional copies to the same ad- chain of more than 100 stores in Sweden under “This new capability will enable Martek dress, including delivery. Subscriptions to addresses outside Eur- its DocMorris brand (OTC bulletin,30 Septem- to move up the value chain by getting closer to ope are subject to an additional charge of £30.00 to cover postage. Subscription enquiries in Korea should be directed to Pharma ber 2009, page 2), with the first pharmacy set the consumer and should result in increased Koreana Ltd, 14th Floor,KTB Network Building, 826-14 Yeoksam- to open in the first quarter of 2010. revenue and more gross-profit opportunities,” dong, Kangnam-gu, Seoul 135-080, Korea (Tel: +82 2 554 9591; OTC Fax: +82 2 563 8289; E-mail: [email protected]). Dubin added. Advertising Martek reported total sales of US$345 mil- Advertising rates and data are available on request from the ad- lion in the year ended 31 October 2009 from its dress above or at www.otc-bulletin.com. IN BRIEF About OTC bulletin Life’sDHA products based on the omega-3 fat- OTC bulletin is published 20 times a year by OTC Publications ■ ALLIANCE BOOTS reported sales up by ty acid docosahexaenoic acid (DHA) and its Limited: twice monthly in February,March, April, May,June, Sep- tember,October and November; and monthly in December,Jan- 10.2% in the final quarter of 2009. Christmas Life’sARA products based on the omega-6 fatty uary,July and August. A subscription to OTC bulletin includes trading helped to drive sales at the Health & acid arachidonic acid (ARA). Its operating pro- the weekly electronic newsflash, news@OTCbulletin,which is published around 45 times a year. OTC bulletin is printed by the Beauty Retail division up by 6.1%, with the fit was US$63.6 million. Warwick Printing Company Limited, Caswell Road, Leamington Boots UK retail business posting turnover up Commenting on the deal, Cyrill Siewert, Spa CV31 1QD, UK. No part of this publication may be copied, reproduced, stored by 5.1%, or 4.6% on a like-for-like basis. At the chief executive officer of Amerifit, said the in a retrieval system or transmitted in any form without prior Pharmaceutical Wholesale division, sales in- combination of its sales and marketing expe- permission from OTCPublications Ltd. creased by 12.7% – 6.1% when adjusted for rience with Martek’s product pipeline, research ©OTC Publications Ltd. All rights reserved. Company registered in England No 2765878. Registered Office: acquisitions and disposals and at constant cur- and development capabilities and commitment 54 Creynolds Lane, Solihull, West Midlands B90 4ER, UK. rencies – with particularly good growth in to science-based products, would provide the OTC bulletin® is registered as a trademark in the European Norway,Russia and the UK. A division-wide combined company with “powerful opportu- Community. restructuring programme is 85% complete. nities for growth in the years ahead”. ISSN 1350–1097 www.OTC-bulletin.com OTC OTC

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OTC COMPANY NEWS TaNine-Monthisho Results suffers as OTC market cools

aisho Pharmaceutical said the OTC mar- Business Nine-month sales Change Forecast sales Change Tket in Japan had cooled sharply in the final (¥ billions) (%) (¥ billions) (%) three months of 2009, as the company report- ed a 3.0% decline in its OTC sales for the nine Livita brand 2.3 +17.1 3.1 +19.2 months ended 31 December 2009. Overseas drinks 4.2 -10.2 5.7 -5.0 Others1.4 ––– The company pointed out that sales of cold Foods for specified health use 7.9 +2.8 10.1 +1.8 remedies had slipped back after “comparatively OTC products 113.8 -3.0 144.8 -2.3 healthy sales” during the summer period. Fur- Others 2.9 +25.2 4.0 +33.7 thermore, sales of category 1 products – OTC Total Self- 124.7 -2.1 158.9 -1.4 medicines, such as switch products, deemed to hold the highest degree of adverse-event risk Prescription operations 78.3 +8.1 100.1 +5.3 – had been sluggish, Taisho said. Total for Taisho 202.9 +1.6 259.0 +1.1 Overall, the size of the Japanese OTC mar- ket had declined year-on-year,the firm added. Figure 1: Taisho Pharmaceutical’s sales in the nine months ended 31 December 2009. Forecasted sales are for the year ending 31 March 2010 compared with actual sales in the previous 12 months (Source – Taisho Pharmaceutical) The 3.0% sales fall came despite the Japan- ese company launching two OTC switch pro- Business Nine-month sales Change Forecast sales Change ducts: Stopan (tiquizium bromide) for treating (¥ billions) (%) (¥ billions) (%) gastrointestinal problems; and the Diclotect (di- Lipovitan D40.7 -6.8 49.3 -6.6 clofenac sodium) topical and anti-in- Other Lipovitan 17.3 -3.0 21.5 -2.3 flammatory range. Total Lipovitan brand 58.0 -5.7 70.7 -5.5 Taisho also introduced Meditreat Cream Zena brand 2.7 -11.2 3.5 -10.3 (miconazole nitrate), Japan’s first OTC cream Other drinks 1.1 ––– for the treatment of recurrent vaginal candida, Total tonics and nutrient drinks 61.8 -5.7 –– and boosted its hair-regrowth brand RiUP with Cold remedies (Pabron brand) 18.6 +2.1 25.5 +0.1 RiUP X5, which contains a minoxidil formula- Hair treatments (RiUP brand) 9.9 +9.6 12.7 +11.4 tion five-times stronger than the original. (Naron brand) 3.4 +3.4 4.5 +2.3 As a result of the lower OTC sales, nine- Gastrointestinal treatments 3.4 -2.1 4.4 ±0.0 month turnover by Taisho’s Self-Medication division decreased by 2.1% (see Figure 1) to Laxatives (Colac brand) 3.0 +1.3 4.0 +2.6 ¥125 billion (C993 million), while operating Cold remedies (Vicks brand) 2.4 +7.6 3.1 +6.9 income fell by 3.1% to ¥24.8 billion. Other OTC products 11.3 ––– Launching new OTC category 1 drugs con- Total OTC products 113.8 -3.0 144.8 -2.3 tinued to be a priority for the Self-Medication division, Taisho said, along with making an “all- Figure 2: Breakdown of Taisho Pharmaceutical’s OTC sales in the nine months ended 31 December 2009. out” effort to strengthen in-store promotions Forecasted sales are for the year ending 31 March 2010 compared with actual sales in the previous 12 months (Source – Taisho Pharmaceutical) highlighting the value of the firm’s products. Taisho has just introduced a powder spray 2009, page 17) – had helped drive up sales Nine-month sales Change containing terbinafine hydrochloride for treat- of its RiUP brand by 9.6% to ¥9.9 billion. (¥ billions) (%) ing athlete’s foot. It is called Dermarin Grande. Naron analgesics – boosted by a new Nar- A 5.7% decline in sales of its key Lipovi- on Ace R product – and Colac laxatives had Food channels 31.6 -3.3 tan brand of tonics and nutrient drinks to ¥58.0 posted “steady performances”, the company Drug channels 30.1 -8.1 billion was a significant reverse for the Self- said, with sales up by 3.4% to ¥3.4 billion and Total 61.8 -5.7 Medication division (see Figure 2). 1.3% to ¥3.0 billion respectively. Although sales of some Lipovitan products Meanwhile, the new topical analgesic Dic- Figure 3: Breakdown by distribution channel of Taisho Pharmaceutical’s sales of tonics and nutrient had grown, Taisho noted, those of the leading lotect – available as a tape, gel and lotion con- drinks in Japan in the nine months ended 31 December Lipovitan D product had dropped back due to taining diclofenac – was meeting its targets. 2009 (Source – Taisho Pharmaceutical) the economic recession, intensified competition In the foods for specified health use cate- and the impact of bad weather during the sum- gory,turnover increased by 2.8% to ¥7.9 bil- Tempra analgesic and Counterpain topical an- mer months. lion, driven by a double-digit rise in sales of algesic brands – meant the company could now Sales of tonic and nutrient drinks declined the Livita brand. enter the Asian OTC drug business “in earnest” by 8.1% through drug channels and by 3.3% Outside of Japan, the company expanded (OTC bulletin,30 September 2009, page 1). through food channels (see Figure 3). its Self-Medication division last November by Looking ahead, Taisho said Self-Medication In a market where category 1 drugs were acquiring Bristol-Myers Squibb’s OTC assets sales would decline by 1.4% to ¥159 billion in “generally struggling”, Taisho said its RiUP in the Asia-Pacific region, excluding China and the year ending 31 March 2010. It blamed a dete- X5 product for hair regrowth – launched in Japan. It paid US$310 million (C222 million). rioration in the OTC market since October. March of last year (OTC bulletin,17 March Taisho said the deal – which includes the OTC

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OTC COMPANY NEWS J&JFourth-Quarter/Annual hit Results by comparison and currency

orldwide turnover at Johnson & John- Introducing OTC Zyrtec boosted OTC& international operational growth of 4.7%. Wson’s OTC & Nutritionals business fell Nutritionals’ US sales in 2008 by 16.8% (OTC William Weldon, chairman and chief exec- by 4.5% in 2009, as it suffered from a tough bulletin,29 January 2009, page 4). Dominic utive officer of Johnson & Johnson, pointed out year-on-year comparison in the US following Caruso, Johnson & Johnson’s chief financial that more than half of Consumer’s sales now the launch of OTC Zyrtec, and from negative officer,warned a year ago the business would came from outside of the US. currency effects. face “tough comparisons” in 2009. Some of the company’s “most important ac- Negative currency effects wiped 3.4% off a International sales were curbed by a nega- quisitions and innovations” had been made in result that was already behind by 1.1% on an tive currency effect of 7.1%, which wiped out international markets, Weldon noted, such as the operational basis, driving down the worldwide operational growth of 1.9%. Overall, interna- addition during 2009 of the Vania cosmetics sales at OTC & Nutritionals to US$5.63 bil- tional sales fell by 5.2% to US$2.69 billion. and sanitary protection business in France. lion (C4.00 billion). OTC & Nutritionals accounted for 35.6% of In China, the Dabao skincare brand acquir- The damage on an operational basis was Johnson & Johnson’s worldwide Consumer ed in 2008 continued to thrive,Weldon added, caused by a 3.8% slide in US sales to US$2.94 sales, which declined by 1.6% to US$15.8 bil- while Johnson & Johnson’s Consumer research billion (see Figure 1), which Johnson & John- lion in 2009 (see Figure 2). and development centre in Shanghai was now son blamed on the negative comparisons with US Consumer turnover dropped back by developing ideas for well-established as well the previous year when the company launched 1.4% to US$6.84 billion, while international as developing markets. the OTC version of the allergy medicine Zyrtec sales decreased by 1.7% to US$8.97 billion. Johnson & Johnson’s Skin Care business ac- (OTC bulletin,15 February 2008, page 4). Negative currency effects of 6.4% offset the counted for 21.9% of Consumer’s sales, with worldwide turnover moving forward by 2.5% Business Fourth-quarter Change Annual sales Change to US$3.47 billion thanks to the Aveeno and sales (US$ millions) (%) (US$ millions) (%) Neutrogena brands as well as Dabao in China. US Skin Care sales finished ahead by 8.2% to Medical Devices & Diagnostics 6,309 +11.8 23,574 +1.9 US$1.58 billion, but international turnover drop- Pharmaceutical 5,993 +5.4 22,520 -8.3 ped by 1.8% to US$1.89 billion due to negative Consumer 4,249 +10.2 15,803 -1.6 currency effects. Weldon revealed that the Skin Care busi- Total Johnson & Johnson 16,551 +9.0 61,897 -2.9 ness would be boosted by the launch of a new Figure 2: Johnson & Johnson’s sales in the fourth quarter and full year of 2009 (Source – Johnson & Johnson) anti-ageing technology known as Cytomimic,

Business Fourth-quarter sales Change Annual sales Change (US$ millions) 2008/2009 (%) (US$ millions) 2008/2009 (%) OTC & Nutritionals – US 807 +5.9 2,944 -3.8 OTC & Nutritionals – International 767 +10.5 2,686 -5.2 Total OTC & Nutritionals 1,574 +8.1 5,630 -4.5 Skin Care – US 378 +10.2 1,582 +8.2 Skin Care – International 572 +14.2 1,885 -1.8 Total Skin Care 950 +12.6 3,467 +2.5 Baby & Kids Care – US 106 -2.8 414 -7.8 Baby & Kids Care – International 468 +13.0 1,701 -3.6 Total Baby & Kids Care 574 +9.8 2,115 -4.5 Women’s Health – US 135 -8.8 578 -6.5 Women’s Health – International 354 +22.9 1,317 +1.9 Total Women’s Health 489 +12.2 1,895 -0.8 Oral Care – US 167 -13.0 716 -8.2 Oral Care – International 241 +18.1 853 +1.1 Total Oral Care 408 +3.0 1,569 -3.4 Woundcare/Other – US 119 +17.8 603 +6.3 Woundcare/Other – International 135 +36.4 524 +13.2 Total Woundcare/Other 254 +27.0 1,127 +9.4 Total Consumer 4,249 +10.2 15,803 -1.6 Consumer – US 1,712 +3.4 6,837 -1.4 Consumer – International 2,537 +15.3 8,966 -1.7

Figure 1: Breakdown of sales by Johnson & Johnson’s Consumer division in the fourth quarter and full year of 2009 (Source – Johnson & Johnson)

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COMPANY NEWS OTC

First-Quarter Results NBTY’s pre-tax profits soar as cost-cutting takes effect

re-tax profits at NBTY more than quintu- September 2008, page 4). Pre-tax profits in- Ppled in the company’s first quarter ended creased by 32% to US$34.6 million. 31 December 2009, thanks to cost-containment The integration process had included con- initiatives, a drop in advertising costs and com- verting a number of Julian Graves stores into parison with a poor performance in the same Holland & Barrett shops and eliminating “re- period a year earlier. dundant” activities, NBTY pointed out, adding The US-based supplements manufacturer that the benefits of the acquisition would start Johnson & Johnson’s high-profile launch of Zyrtec and retailer reported pre-tax profits of US$116 to be felt in the company’s financial fourth quar- allergy remedies into the US OTC market in 2008 led to “tough comparisons” for the company last year million (C83.4 million), as the company slash- ter ending September 2010. ed US$10 million off its selling, general and As of 31 December 2009, the division was which would be used in three of its beauty administrative costs and its advertising costs. operating 1,033 stores, including 543 Holland brands beginning in February. Advertising expenditure fell from 5% to 4% of & Barrett shops, 351 Julian Graves locations Turnover at the Baby & Kids Care business sales. This had no repercussions, as sales rose and 32 GNC outlets in the UK, along with 25 tumbled by 4.5% to US$2.12 billion, as a 3.6% by 14% to US$751 million (see Figure 1). Nature’s Way stores in Ireland and 82 DeTu- slide in international sales to US$1.70 billion NBTY also benefited from the favourable inen outlets in the Netherlands. – caused by a negative currency effect of 5.3% comparison with the prior-year quarter,when NBTY also noted that it had 14 Holland & – was compounded by a 7.8% decline in dom- pre-tax profits tumbled by 70% as it wrote off Barrett franchises across South Africa, Singa- estic turnover to US$414 million. an “ineffective and uneconomical” information- pore and Malta. As part of Holland & Barrett’s A drop in US sales was the primary reason technology project, tackled higher raw-material “global expansion”, further franchises would behind the 0.8% fall in worldwide Women’s costs and was hit by adverse currency effects be opened in new locations during 2010. Health sales to US$1.90 billion. While inter- (OTC bulletin,12 February 2009, page 11). At the Direct Response/E-Commerce divi- national turnover grew by 1.9% to US$1.32 sion, pre-tax profits grew strongly to US$16.4 billion, sales in the US fell back by 6.5% to Initiatives to improve operations million on sales up by 7% to US$53 million. US$578 million. Scott Rudolph, chairman and chief executive In the prior-year quarter,the division’s pre-tax Sales of the Listerine antiseptic mouthwash officer of NBTY,said the significant increase profits had been hit by the written-off infor- boosted Oral Care’s international sales, which in sales and income reflected the “ongoing ini- mation-technology project. finished 1.1% ahead. However, an 8.2% fall in tiatives to improve operations, control costs and North American Retail – consisting of the the US, led to worldwide turnover sliding back expand our premier position as the leading nutri- Vitamin World stores in the US and the Le Nat- by 3.4% to US$1.57 billion. tional supplement company”. uriste chain in Canada – posted sales up by 6% Woundcare/Other was the Consumer divi- Three out of NBTY’s four divisions report- to US$51 million. Same-store sales had increas- sion’s best-performing business, with world- ed massive pre-tax profit growth, with the big- ed by 5%, according to NBTY,as its efforts to wide sales rising by 9.4% to US$1.13 billion. gest in terms of sales – Wholesale/US Nutri- modernise the Vitamin World stores had pro- International and US sales increased by 13.2% tion – reporting pre-tax profits up by 187% to duced a favourable impact. The pre-tax profit and 6.3% respectively to US$524 million and US$86.2 million. Private-label products gen- of US$2.1 million compared with a loss in the US$603 million. The business benefited from erated US$198 million of sales for the Whole- same period a year earlier. a wider wellness and prevention portfolio and sale/US Nutrition division, representing 42% The total number of outlets operated by the acquiring the Vania business in Europe. of total sales up by 16% to US$471 million. North American Retail business as of 31 Dec- Commenting on the Consumer division’s European Retail sales increased by 13% to ember 2009 was 534, consisting of 448 Vita- performance, Caruso pointed out that it had US$176 million, as the company continued to min World stores in the US and 86 LeNatur- battled against “economic headwinds” during integrate the Julian Graves stores acquired in iste stores in Canada. 2009, which had driven consumers to switch to the UK in September 2008 (OTC bulletin,29 OTC private-label products. The headwinds seem- ed to be “stabilising to slightly improving”, Business First-quarter Change Pre-tax profit Change Caruso said, but it was “too early to say that sales (US$ millions) (%) (US$ millions) (%) we are out of the woods”. Wholesale/US Nutrition 471 +16 86.2 +187 The Consumer division represented 25.5% of Johnson & Johnson’s worldwide sales in European Retail 176 +13 34.6 +32 2009, which fell by 2.9% to US$61.9 billion. Direct Response/E-Commerce 53 +7 16.4 +2,211 The decline was the first reported by the com- North American Retail 51 +6 2.1 – panyin 76 years, as generic competition cut Corporate/Others ––-23.4 – sales at the Pharmaceutical division by 8.3% Total NBTY 751 +14 115.9 +449 to US$22.5 billion. OTC Figure 1: NBTY’s sales and pre-tax profit in the firm’s first quarter ending 31 December 2009 (Source – NBTY)

10 February 2010 OTC bulletin 7 OTC10-02-10p8-9FIN.qxd 5/2/10 12:34 Page 2

OTC COMPANY NEWS

Third-Quarter Results Annual Results Matrixx boosts Demand for OTC specialties oral Zicam sales lifts annual sales at Boiron atrixx Initiatives said that driving con- M sumers towards oral versions of its Zi- trong seasonal demand for OTC specialties (OTC bulletin,27 February 2009, page 10). cam Cold Remedy was helping to stem the loss Sboosted sales at French homoeopathy spe- Turnover in Boiron’s home market improved of sales caused by withdrawing the key nasal cialist Boiron in the second half of 2009, driv- by 9.1% to C289 million in 2009, but this was products last year. ing the company’s turnover up by 12.7% to C526 behind the double-digit rises achieved outside The company’s total sales dropped by 26% million for the full year. of France as international sales moved forward to US$28.5 million (C 20.2 million) in the three Sales of OTC specialties finished ahead by by 17.4% to C237 million. months ended 31 December 2009. But Matrixx 22% to C253 million (see Figure 1). Fourth- In Europe – excluding France – turnover fin- said the decline would have been worse had it quarter sales grew by 35.6%, better even than ished ahead by 14.1% to C188 million, while the not been for a 62% increase in the volume of the 28.1% rise in the third quarter. growth in North America was even quicker at Zicam Cold Remedy oral products that had Meanwhile, sales of non-proprietary homo- 32.7% to C43.5 million. In other countries, sales been shipped over the period. eopathic medicines grew by 5.5% to C273 mil- increased by 28.0% to C5.9 million. Matrixx is trying to convert consumers to lion in 2009. This contrasted with the prior year, Given its sales performance in the second oral versions of the Zicam Cold Remedy aft- when they had fallen by 1.4%, a decline Boiron half of 2009, Boiron said it expected its oper- er it withdrew the core nasal versions in June blamed on the French government’s new regu- ating income to be “significantly” better than 2009 (OTC bulletin,19 June 2009, page 15). lations for reimbursing magisterial preparations it had been in 2008. The nasal versions had generated approximate- ly 40% of the firm’s total net sales in the pre- Business Fourth-quarter sales Change Annual sales Change vious financial year. (C millions) (%) (C millions) (%) William Hemelt, president and chief exec- France 84.4 +13.3 288.8 +9.1 utive officer of Matrixx, said that Nielsen data Europe* 63.5 +27.0 187.9 +14.1 for the 12 weeks ended 27 December 2009 North America 13.7 +29.1 43.5 +32.7 showed that retailers – excluding Walmart and Other countries 1.7 +61.9 5.9 +28.0 club stores – had sold approximately 16% more Zicam Cold Remedy oral products than in the Total Boiron 163.4 +19.9 526.1 +12.7 same period a year earlier. Meanwhile, the total Non-proprietary 77.0 +6.5 272.7 +5.5 volume of cough and cold remedies retailed in OTC specialties 86.3 +35.6 252.6 +22.0 the US had grown by around 5%, he noted. Other 0.05 -80.2 0.8 -30.8 A further US$10 million would be spent in the three months ending 31 March 2010 pro- * Excluding France

moting the oral products, Matrixx said. Figure 1: Breakdown of Boiron’s sales in the fourth quarter and full year of 2009 (Source – Boiron) Zicam Cold Remedy Nasal Gel and Zicam OTC Cold Remedy Gel Swabs were withdrawn after Matrixx received a warning letter from the US Trading Update Food and Drug Administration (FDA), which cited reports that the nasal products could cause SSL encouraged by and Scholl a loss of sense of smell. In November,the FDA informed Matrixx SL International said that its core consum- Meanwhile, Beleggingmaatschappij Lemore that it was “unwilling to reverse its position” Ser brands, Durex and Scholl, had perform- BV (BLBV) and Gainbridge Investments – the and that Matrixx should file New Drug Appli- ed encouragingly during the period from 1 Oct- two eastern European condom distributors that cations (NDAs) for the two products (OTC ober 2009 until 21 January 2010, despite the SSL took control of last year (OTC bulletin, bulletin,16 November 2009, page 12), a move difficult trading environment. 17 April 2009, page 2) – continued to perform Matrixx had previously claimed would be too The firm added that its geographic reach ahead of expectations. expensive to undertake. and the strength of the two brands – coupled A spokesperson for SSL told OTC bulletin Despite a US$1.8 million charge for legal with ongoing investment in innovation, adver- that the company was set to acquire the remain- expenses related to the product withdrawal, tising and promotion – meant SSL’s branded ing 49% stake in BLBV now it had established Matrixx reported a pre-tax profit of US$6.2 consumer business had built on the “encour- a £410 million banking facility. The facility million for the quarter. However, this was 21% aging” sales growth achieved in the first half allowed SSL to complete the BLBV acquisi- down on the same period a year earlier. of the company’s financial year. tion and still have substantial funds available, Matrixx said that it expected legal expenses Branded consumer sales were up by 10.6% the spokesperson added. to average between US$1.5 million and US$2.0 to £321 million (C 367 million) in the six months SSL said it was confident of achieving its million per quarter due to product liability cases, ended 30 September 2009 (OTC bulletin,30 target of increasing earnings per share by 50% securities litigation, and FDA matters. November 2009, page 2). Total group sales over the three years ended March 2012. OTC grew by 7.3% to £346 million. OTC

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COMPANY NEWS OTC

Second-Quarter Results Prilosec OTC’s recovery hit by Prevacid

olume sales of Procter & Gamble’s Pri- Procter & Gamble’s total sales America and Asia, Procter & Gamble said, and V losec OTC omeprazole-based heartburn – including the Feminine Care and Oral Care a favourable comparison to the prior-year per- medicine slipped back in the company’s sec- businesses as well as Personal Health Care – iod, when trade-inventory reductions had hit ond quarter ended 31 December 2009, as Nov- increased by 5% to US$3.1 billion. sales. Overall, Oral Care posted volume sales artis Consumer Health’s Prevacid 24HR lanso- The rise was driven by a 3% increase in vol- growth in the mid-single digits. prazole rival hit the OTC market in the US. ume sales, a 3% positive currency effect and a Health Care’s pre-tax income from contin- Prilosec OTC has only recorded one quar- 1% positive price impact. These had been par- uing operations grew by 9% to US$790 million. ter of volume sales growth since it lost market tially offset by a negative mix impact of 2%, Net earnings from continuing operations fin- exclusivity in March 2008 and generic compe- Procter & Gamble pointed out, resulting from ished up by 8% to US$534 million, Procter & tition began eating into the brand’s sales (OTC a “disproportionate growth in developing re- Gamble noted, thanks to a pricing- and cost- bulletin,16 November 2009, page 9). gions and unfavourable product mix”. savings-driven expansion of the gross margin. Although Procter & Gamble posted a mid- However, this was partially offset by higher sell- single-digit improvement in sales of Prilosec Feminine Care makes gains ing, general and administrative costs as a per- OTC in the previous three months, the recov- The Feminine Care business reported low- centage of net sales caused by currency effects ery was short lived in the second quarter once single-digit volume sales growth over the three and business-development investment. Novartis Consumer Health launched Prevacid months, thanks primarily to gains in the central Procter & Gamble’s total group sales from 24HR on 12 November (OTC bulletin,16 Nov- and eastern Europe, Middle East and Africa continuing operations moved ahead by 6% to ember 2009, page 1). (CEEMA) and Asia regions, although this had US$21.0 billion for the three months, thanks Backed by a US$200 million (C143 million) been partially offset by “share losses” in Latin primarily to strong volume sales growth. Pre- consumer marketing campaign, Prevacid 24HR America caused by price increases. tax earnings from continuing operations im- – which has three years of market exclusivity Meanwhile, Oral Care benefited from “ini- proved by 19% to US$4.48 billion. – generated over US$100 million in sales on tiative-driven” growth in western Europe, Latin OTC its first day thanks to pre-launch stocking. Novartis claims Prevacid 24HR is the “first and only OTCproton-pump inhibitor for the treatment of frequent heartburn in its original prescription formulation”. The Swiss firm ex- pects Prevacid 24HR to be one of the “biggest prescription-to-OTC switches”,as well as a “top five OTC brand in the US”. Despite the decline in Prilosec OTC sales, Procter & Gamble’s Personal Health Care busi- ness posted a mid-single-digit rise in worldwide volume sales for the three months, driven by strong performances from the Vicks cold and flu brand as well as diagnostic products. Procter & Gamble pointed out that Vicks had posted a double-digit volume sales gain due to higher incidence of cold and flu.

IN BRIEF ■ BEIERSDORF said that it had “held firm” during the global economic crisis, despite sales at its Consumer business, which includes the Nivea and Eucerin brands, falling by 2.2% to C 5.0 billion in 2009. Double-digit gains in China and Latin America as well as growth in Germany, eastern Europe and the US were off- set by lower Consumer sales in western Eur- ope. Total turnover at the German group fell by 3.7% – or 0.7% on a like-for-like basis – to C5.75 billion. Earnings before interest and tax (EBIT) were down by 15.9% to C585 million. OTC

10 February 2010 OTC bulletin 9 OTC10-02-10p10-11FIN.qxd 8/2/10 07:45 Page 2

OTC COMPANY NEWS MiraLAXSecond-Quarter Results rival drives Perrigo forward

ntroducing a store-brand equivalent of Sch- Business Second-quarter Change Operating income Change Iering-Plough’s MiraLAX laxative helped to sales (US$ millions) (%) (US$ millions) (%) drive up Perrigo’s Consumer Healthcare sales by 7% to US$478 million (C350 million) in its Consumer Healthcare 478.4 +7 88.4 +57 second quarter ended 26 December 2009. Prescription Pharmaceuticals 55.6 +38 2.42 -66 Since its launch in the US in October,Per- Active Pharmaceutical Ingredients 37.0 +16 5.83 +448 rigo’s store-brand version of MiraLAX (poly- Other 12.2 -34 -12.2 – ethylene glycol 3350) had resisted competi- Total Perrigo* 583.2 +9 84.5 +39 tion from four rival store-brand products, said the US company, to take a 90%-plus share of * Excluding the discontinued Israel Consumer Products business the store-brand polyethylene glycol market. Figure 1: Perrigo’s sales and operating income in its second quarter ended 26 December 2009 (Source – Perrigo) Joseph Papa, Perrigo’s chairman and chief executive officer,said store-brands had taken until 9 January 2010, average volume sales of the cough, cold and flu season. New products a 26.9% volume share of the MiraLAX market Perrigo’s store-brand omeprazole product had that Perrigo expected to launch in the rest of by mid-December,and although the branded increased by 2.3% compared to the nine weeks the year were also in the forecast, he added. product had taken some of that back in Jan- prior to the launch, Papa noted. By contrast, A store-brand version of Reckitt Benckis- uary,he expected store-brands to take a 30% average unit sales of Prilosec OTC in the same er’s -based cough brand Mucinex share of the market in the next few months. period had fallen by 6.5%, he pointed out. would be launched before the end of Perrigo’s MiraLAX had annual sales of approximate- Papa was also unconcerned by the entry of financial year,Papa forecasted, noting that it ly US$220 million, Papa noted. a rival store-brand omeprazole product at the expected approval for its Mucinex equivalent He pointed out that the “strong start” to the end of 2009, claiming it would serve more as a from the US Food and Drug Administration cough, cold and flu season had seen the firm’s line-extension for retailers rather than a re- (FDA) within the next 30 to 60 days. He noted category sales jump by 19% compared to the placement for Perrigo’s own product. that Mucinex patent litigation with Reckitt Ben- prior-year period. Continued growth of the com- ckiser would go to court in March. pany’s omeprazole products and increased pen- Operating income rises by 57% The company’s store-brand equivalent of etration of its store-brands generally had also Consumer Healthcare’s operating income Johnson & Johnson’s Monistat-1 vaginal cream lifted Consumer Healthcare’s sales, Papa added. from continuing operations increased by 57% and suppository combination (OTC bulletin, Sales of new products accounted for five per- to US$88.4 million over the quarter (see Fig- 31 August 2009, page 10) was also expected to centage points of Consumer Healthcare’s 7% ure 1), thanks to a better product mix and high- come to market before the end of June. growth over the quarter; while increased sales er gross margins from new product sales. The Looking further forward, Papa said Perrigo of existing products, together with acquisitions, operating margin improved by 590 basis points planned to launch store-brand equivalents to contributed a further four percentage points. to 18.5%, as cost-improvement initiatives off- brands with annual sales totalling over US$650 Discontinuing certain products and adverse ex- set an increase in research and development ex- million in the year ending June 2011. change rates, however, cut two percentage points penditure and a rise in variable costs. The firm is lining up equivalents to Glaxo- from these gains. In the half year,Consumer Healthcare’ssales SmithKline Consumer Healthcare’s Commit Commenting further on Consumer Health- rose by 13% to US$916 million (see Figure 2). cinnamon-flavoured smoking-cessation coated care’sresults, Papa pointed out that its store- Looking forward, Papa said Perrigo still ex- gum, Novartis’ Zaditor antihistamine eye drops, brand OTC omeprazole product – the equiva- pected Consumer Healthcare’s sales to grow by Bayer’s Aleve Liquid Gels analgesic and Teva’s lent to Procter & Gamble’s Prilosec OTC heart- between 8% and 10% in the year ending June Plan B emergency contraceptive. burn medicine – had stood up well to the Nov- 2010, but operating margins would now im- Perrigo was also looking forward to the pot- ember launch of Novartis Consumer Health’s prove to between 16% and 17%. ential prescription-to-OTC switch of Sanofi- lansoprazole-based rival Prevacid 24HR (OTC He had allowed for the impact of a rival Aventis’ US$330 million allergy medicine Al- bulletin,16 November 2009, page 1). store-brand omeprazole product, he said, and legra (fexofenadine hydrochloride), Papa re- In the period from Prevacid 24HR’s launch assumed there would not be a second peak to vealed, and was working diligently to ensure the company was one of the first to launch a Business First-half sales Change Operating income Change store-brand equivalent when it happened. Papa (US$ millions) (%) (US$ millions) (%) expected Perrigo to introduce a store-brand ver- Consumer Healthcare 915.8 +13 159.8 +38 sion of OTC Allegra before June 2011. Sanofi-Aventis said in December that ac- Prescription Pharmaceuticals 102.7 +40 16.7 +86 quiring the US consumer healthcare products Active Pharmaceutical Ingredients 67.0 +1 9.58 +540 company Chattem for US$1.9 billion gave it Other 25.7 -36 -15.0 – a strong vehicle for switching some of its med- Total Perrigo* 1,111.2 +12 171.0 +43 icines from prescription to OTC status in the US, including Allegra (OTC bulletin,20 Jan- * Excluding the discontinued Israel Consumer Products business uary 2010, page 1). Figure 2: Perrigo’s sales and operating income in its first half ended 26 December 2009 (Source – Perrigo) OTC

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COMPANY NEWS OTC

Trading Update Omega offsets tough start to grow sales

mega Pharma’s strategy of reducing costs, Business Fourth-quarter Change Annual sales Change Oboosting innovation and expanding into sales (E millions) 2008/2009 (%) (C millions) 2008/2009 (%) new markets appears to be paying off, as the company overcame a difficult first half to post Western Europe 74.0 +5 327 -3 a slight rise in sales for 2009. Belgium 61.8 +12 228 +11 The Belgian OTC company reported sales France 39.4 -12 157 -9 up by 0.3% to C814 million. Turnover in the Emerging markets 38.5 +11 102 +4 second half of the year increased by 4%, off- Total Omega Pharma 214 +4 814 +0.3 setting the 3% decline recorded during the open- ing six months of the year. Figure 1: Omega Pharma’s sales in the fourth quarter and full year of 2009 (Source – Omega Pharma) Marc Coucke, Omega’s chief executive of- ficer,said the company had “reacted very alert- In September last year,Omega overhauled vers in Belgium, where sales grew in every quar- ly to the various challenges and opportunities” its executive committee by appointing Georges ter of 2009. The fourth-quarter sales rise of 12% thrown up by the economic crisis. “We have De Vos as chief operating officer (OTC bulletin, followed growth of 15% in the third quarter, been able to achieve substantial cost reductions, 16 September 2009, page 23). De Vos replaced 7% in the second quarter and 11% in the open- fine-tune our innovation and continue our geo- Jan Cassiman who is now head of innovation ing three months of the year. graphic expansion,”Coucke pointed out. and business development. In emerging markets – central and eastern Looking forward, Coucke said that action These changes, Omega said, coupled with Europe and countries outside of Europe – strong had been taken to improve the company’s prod- the company’s “highly promising brands with turnover in Australia, Russia and the Ukraine, uct range, its local organisations and its group high growth potential” and access to “a large as well as the first sales by the company’s Ind- structure, which meant the outlook for the com- number of growth markets”, had convinced it ian joint venture, lifted turnover by 11% in the pany in 2010 was“very promising”. that the 4% sales growth achieved in the second final quarter of the year. Commenting on the group’s organisation, half of 2009 could be maintained in 2010. Omega announced in May last year that it Coucke added that the company planned to re- As Figure 1 shows, the rise in Omega’s an- would launch three brands – Silence anti-snor- cruit regional managers and expand the depart- nual sales was driven by its performances in ing products, the Addax skincare range and the ment responsible for innovation and market- Belgium and in emerging markets, with sales Cellasene anti-cellulite remedy – in via ing. At the same time, however, Omega was also up by 11% to C228 million and 4% to C102 its Modi Omega Pharma (India) joint venture in the process of replacing its country managers million respectively. with Modi-Mundipharma (OTC bulletin,15 in France, Germany and Poland. Generic products were the main growth dri- May 2009, page 1). Western Europe – Omega’s biggest sales region – rebounded during the second half of Annual Results 2009 after a weak first six months, but this was not enough to stop sales dropping by 3% Galenica sales hit by fall in demand to C327 million for the year as a whole. While sales in Germany and the UK had re- teeply-declining contract manufacturing had remained static, Galenica said. mained weak, double-digit growth in Greece, Ssales in Switzerland – coupled with adverse The division’s export sales had fallen by Italy,Scandinavia and Spain had pushed fourth- currency effects – led to turnover by the Con- 24.6% year-on-year to SFr28.2 million, Gal- quarter turnover up by 5%, Omega noted, fol- sumer Healthcare operation of Galenica’s Vi- enica noted, due to tough market conditions in lowing a 4% advance in the previous three for Pharma division falling by 11.8% to SFr108 various countries and unfavourable exchange months. However, these performances could million (C73.7 million) in 2009. rates. When adjusted for these currency effects, not repair the damage done by the 6% decline However, once OM Pharma – which was export sales slipped back by 15%. in sales during the opening three months of the integrated into the business on 1 November Looking ahead, Galenica said that it would year and the 11% fall in the second quarter. 2009 (OTC bulletin,16 September 2009, expand its core Consumer Healthcare areas Looking ahead, Omega said that its West- page 3) – was included, Consumer Health- through “intensive lifecycle management” of ern Europe business would benefit fully from care sales had increased by 1.7% to SFr124 its key products. the company’s innovation projects during 2010. million, the Swiss firm pointed out. Vifor Pharma Consumer Healthcare gener- France recorded the worst performance of Domestic Consumer Healthcare sales drop- ated 24% of sales by Galenica’s Pharma divi- 2009, with sales down by 9% to C157 million. ped by 6% to SFr79.8 million, due mainly to sion, which grew by 1.6% to SFr441 million. Omega’s French business performed poorly a collaboration with 3M ending. The company Galenica’s total group sales for 2009 in- throughout the year,with sales dropping by noted, however, that it had extended its con- creased by 7.5% to SFr2.91 billion. Turnover 12% in the fourth quarter – 8% including the tract with IVF Hartman, but the income from by the dominant Logistics division rose by sale of a factory – 4% in the third, 10% in the that deal had been allocated to its operating 1.3% to SFr2.06 billion, while acquiring the second and 7% in the first three months. results and not accounted for as sales. Sun Store pharmacy chain pushed up Retail Omega said the recruitment of new manage- Adjusting for the loss of the 3M business, sales by 50.4% to SFr838 million. ment in France would help stabilise sales. Consumer Healthcare turnover in Switzerland OTC OTC

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OTC COMPANY NEWS

IN BRIEF Mergers & Acquisitions

■ CHATTEM reported sales up by 1.9% to US$463 million (C 333 million) in the year end- Cadbury’s shareholders ed 30 November 2009, as the US firm prepares to be taken over by Sanofi-Aventis ( OTC bul- letin,20 January 2009, page 1). Domestic turn- agree to Kraft takeover over – excluding sales generated in 2008 by the discontinued Icy Hot Heat Therapy product – grew by 4.2%, while international sales drop- raft Foods is set to acquire Cadbury – own- was flatly rejected (OTC bulletin,16 Septem- ped by 22.9%. Operating profit fell by 4.6% to Ker of the world’s leading medicated con- ber 2009, page 3). However, on 9 November, US$119 million, due to an impairment charge fectionery,the 100 year-old Halls cough and Kraft took the same offer directly to Cadbury’s related to the firm’s brands. cold brand – after its improved cash and share shareholders (OTC bulletin,30 November deal worth £11.9 billion (C13.6 billion) was 2009, page 3). ■ NEUTRAHEALTH said that it expected accepted by the UK firm’s shareholders. Cadbury advised shareholders to reject the its sales to exceed £18 million (C 21 million) in As of 2 February 2010, shareholders repre- offer as it “fell well short of reflecting the value the second half of 2009,thanks to increased senting over 70% of Cadbury’s shares had ac- of the firm”. The company also pointed out that consumer demand driven by a focus on prod- cepted Kraft’s offer of £5.00 in cash and 0.1874 due to a 5% decline in Kraft’s share price since uct innovation and core customers. Meanwhile, new Kraft shares for every Cadbury share ten- the initial offer,the value of the deal had fallen the UK-based firm said it had disposed of the dered. The value of the deal represents 2.0-times to £9.8 billion. loss-making Nutrigold business that it acquir- Cadbury’s 2009 sales of £5.98 billion and 14.8- Carr urged shareholders not to let Kraft “steal ed four years ago (OTC bulletin,28 February times its operating profit of £808 million. your company with its derisory offer”, insisting 2006, page 9). Irene Rosenfeld,chairman and chief execu- that the takeover would expose Cadbury’s share- tive officer of Kraft, said that the combination holders to Kraft’s “low growth” business model ■ MEDICE said that the portfolio of brands of Kraft and Cadbury created a “global pow- as well as its “long history of under performance it had acquired from Rentschler Arzneimittel erhouse in snacks, confectionery and quick and its track record of missed targets”. But Kraft in 2006 (OTC bulletin,31 March 2006, page meals” with “impressive global reach and an came back with a better offer that the Cadbury’s 4) produced double-digit sales growth last unrivalled portfolio of iconic brands, with tre- board was able to accept. year. Brands including Dorithricin sore-throat mendous growth potential”. Cadbury returned the Halls brand to UK lozenges, the skincare range Soventol and the Cadbury’s board recommended the improv- ownership when it bought the Adams confec- diarrhoea treatment Tannacomp – as well as ed offer to shareholders in January. Roger Carr, tionery business from Pfizer in 2003, following its own Meditonsin homoeopathic remedy – chairman of Cadbury,said the US group’s bid the US drug firm’s acquisition of Warner-Lam- had captured “above-average market shares”, was “good value for Cadbury shareholders”. bert (OTC bulletin,24 January 2003, page 4). claimed the German firm. Following the recommendation, the US-bas- Todd Stitzer,Cadbury’s chief executive offi- ed chocolate maker Hershey and Italian firm cer,said Halls was one of the firm’s most prof- ■ KRKA said sales of its self-medication pro- Ferrero both said they did not intend to make itable brands and had been expanded into new ducts had fallen by a tenth in 2009 to C 89.6 an offer for Cadbury. Swiss company Nestlé functional areas and refresh segments. This had million, accounting for 9.4% of the group’s had announced at the start of January that it enabled the brand to move beyond its traditional total sales, which edged up by 0.1% to C 951 would not bid for the firm. cough and cold niche to a more mainstream set million. Central Europe was the company’s big- Kraft’s pursuit of Cadbury began in Septem- of consumers, Stitzer pointed out, and had driv- gest region, generating 28.1% of group sales ber 2009, when its original £10.2 billion offer en the brand’s annual sales to £450 million. with turnover up by 6% to C 268 million. In OTC the Slovenian firm’s home market, sales in- creased by 1% to C 106 million, representing Mergers & Acquisitions 11.1% of total group turnover. Hypermarcas responds to media reports ■ BOSNALIJEK said that despite the diffi- cult economic conditions in Russia and eastern ypermarcas has dismissed media reports material binding agreement, instrument or con- Europe its sales in 2009 had remained static Hthat it was about to acquire fellow Brazil- tract in connection with occasional funding and at BAM107 million (C 54.7 million). The Bos- ian company Laboratório Teuto Brasileiro and capitalisation instruments”. nia and Herzegovina-based firm noted that 37% was in talks to buy some brands or business units In December,Hypermarcas announced it of its 2009 sales had been generated outside of from Johnson & Johnson. would expand its Dorsay Monange OTC busi- its home market. However, Brazil’s leading OTC company ness and enter the generics market by acquir- may be set to obtain funding of BRL1.50 bil- ing fellow Brazilian firm Neo Química in a cash ■ NUTRACEUTICAL INTERNATIONAL lion (C0.58 billion) from the state-owned Brazil- and share deal worth BRL1.29 billion (OTC reported sales up by 13% to US$44.8 million ian development bank, BNDES. bulletin,18 December 2009, page 3). ( C 32.1 million) in its first quarter ended 31 Dec- Hypermarcas said in a statement that it was Founded in 2002, Hypermarcas’ business ember 2009. The US-based supplement com- “constantly in negotiation and dialogue with strategy is built on an aggressive acquisitions pany’s net income grew even faster,rising by several market players, including the BNDES, policy, which has seen the firm make numer- 26% to US$3.9 million. in the regular course of its business”. The com- ous purchases across all of its business areas. OTC pany added that to date it had “not signed any OTC

12 OTC bulletin 10 February 2010 OTC10-02-10p13-15FIN.qxd 8/2/10 07:47 Page 3

COMPANY NEWS OTC

Annual Results Mergers & Acquisitions GSK’s Alli achieves William Ransom agrees £100 mn in Europe ■ Continued from front page to divest Manuka Gold to buy in all 27 member states of the Euro- pean Union plus Norway and Switzerland. Europe accounted for the majority of Alli’s oney New Zealand (International) is set 2008 that has seen the firm put various brands worldwide sales in 2009, which more than dou- H to acquire the honey-based Manuka Gold and its UK contract manufacturing operation bled at constant exchange rates to £203 mil- brand from troubled UK natural products spe- up for sale (OTC bulletin,29 September 2008, lion. US sales increased by 14% at constant cialist William Ransom & Son for £0.56 mil- page 6). exchange rates to £96 million, with the Rest lion (C 0.69 million). Ransom has already divested its Metanium of the World region contributing the remain- Ransom said Manuka Gold generated sales nappy-rash brand and Radian B topical pain ing £2 million. of approximately £0.3 million and a gross pro- reliever to Thornton & Ross for a total of £5.4 The brand made its debut outside of Eur- fit of £0.15 million in the year ended March million (OTC bulletin,20 January 2010, page ope and the US in October when it was launch- 2009. The brand comprises a range of honey- 3; OTC bulletin,18 December 2008, page 3). ed in the Philippines. GlaxoSmithKline said it based products – primarily imported from New And the company’s Pavacol-D cough medicines would be rolled out across the rest of the world Zealand – to help maintain a healthy digestive brand was acquired by Alliance Pharma for during 2010 and 2011. system as well as general health and wellbeing. £0.6 million (OTC bulletin,28 August 2008, Alli’s performance helped drive up world- Commenting on the reasons for the divest- page 3). wide turnover by GlaxoSmithKline Consumer ment, Ransom said that sales of the brand had Despite making some progress with the Healthcare’s OTC Medicines business by 8% grown in the year to date but the “changing turnaround plan, David Suddens,Ransom’s at constant exchange rates to £2.32 billion in distribution channel mix” had led to significant non-executive chairman, said recently that the 2009. Actual sales rose by 20%. margin erosion. Ransom noted that it antici- future of the company remained uncertain as The biggest-selling brand in the OTC Med- pated continuing to distribute the products for it continued to implement its new strategy und- icines business, the Panadol pain reliever, re- a fee to some of its customers following the er “very testing business and economic condi- corded sales up by a tenth at £393 million. completion of the deal. tions” (OTC bulletin,20 January 2010, page 4). Meanwhile, GlaxoSmithKline announced Proceeds from the sale would be used to re- His comments came after Ransom posted that it would include a dermatology unit in its duce Ransom’s borrowings, the company said. an operating loss of £2.7 million during the Consumer Healthcare division, which com- Ivor Harrison,chief executive officer of Ran- six months ended 30 September 2009. Sales prises the Oral Care, Nutritional Healthcare som, said the deal released “significant work- declined by 3% to £16.7 million, due mainly and OTC Medicines businesses. The new unit ing capital” and was consistent with the com- to the sale of Radian B and Pavacol-D. would cover the acne, dry skin, sun-protection pany’s strategy of creating “a focused, higher Based in New Zealand, Honey New Zeal- and anti-ageing categories, explained the com- margin, differentiated natural consumer health- and offers a range of “honey bee products that pany,and would bring together its existing care business”. are pure and contain naturally-occurring health- OTC dermatology brands and the consumer The sale of Manuka Gold is part of Ran- giving properties found in the native plants and dermatology brands gained through acquir- som’s turnaround plan launched in September trees of New Zealand”. ing Stiefel Laboratories last year (OTC bul- OTC letin,30 April 2009, page 1). OTC Regulatory Affairs Publications Combination pulled out of central route BPI’s compact Kodex ■ Continued from front page The EMA said in a question-and-answer convenient overview of German laws and 4 December 2008. At the time of withdrawal, document that the CHMP felt the applicant Aregulations affecting medicines – includ- it was under review by the European Medi- had not shown enough evidence that there was ing rules covering their production and promo- cines Agency’s Committee for Medicinal Pro- a relevant advantage of using the combination tion – is the latest addition to the Pharma Ko- ducts for Human Use (CHMP). over ibuprofen alone. dex publications offered by the association of In its official letter to the European Medi- In the US, the company already markets a the German pharmaceutical industry,the BPI. cines Agency (EMA), Wyeth said its decision 200mg ibuprofen/25mg diphenhydramine hyd- The 560-page paperback Pharma Kodex to withdraw the application was due to “the rochloride combination as the OTC medicine Kompakt guide costs C29.90 plus postage, or CHMP’s view that the data provided would not Advil PM Liqui-Gels. It is indicated for relief C24.90 plus postage if bought together with allow the committee to conclude on a positive of occasional sleeplessness when associated the comprehensive Kodex with 3,800 pages. benefit-risk balance”. with minor aches and pains. OTC ■ Contact BPI Service, Friedrichstrasse 148, 10117 Berlin, Germany. Tel: +49 30 279 09 136; Fax: +49 30 We also publish Generics bulletin 279 09 336; E-mail: [email protected]. Find out more at www.genericsbulletin.com OTC

10 February 2010 OTC bulletin 13 OTC10-02-10p13-15FIN.qxd 8/2/10 07:47 Page 4

OTC GENERAL NEWS

Regulatory Affairs is difficult to obtain. It has evidence, however, that their nicotine content and its release over time can vary; they can contain widely-differ- UK intends to regulate ing amounts of nicotine in the same format; and they may contain toxic ingredients. Three options are suggested by the MHRA, more nicotine products of which the third is to maintain the current ap- proach. The agency says it prefers the more dra- conian first option of considering all nicotine- ll nicotine-containing products – except to include harm reduction by presentation, the containing products to be medicines by function Atobacco – could soon come under the con- MHRA says it has legal advice that it is obliged and – in line with existing legislation – demand- trol of the Medicines and Healthcare products to consider the regulation of unlicensed nico- ing that all unlicensed nicotine products be re- Regulatory Agency (MHRA) in the UK. tine-containing products currently on the mar- moved from the market within 21 days. Describing the move as a “major shift in ap- ket by presentation. The second option would be to set a date in proach in medicines regulation”, the MHRA Meanwhile, however, the MHRA has also the future, such as June 2011, for manufacturers has started a public consultation about requir- “taken the opportunity” to review its current of unlicensed products to cease marketing, after ing all nicotine products that are currently unli- policy on applying the definition of a medicine which time the MHRA would take enforcement censed, such as electronic cigarettes, to be for- in the context of nicotine. “Legal advice is that action. The suggested date would give manu- mally assessed by the agency. prima facie nicotine falls within medicines leg- facturers a year from the end of the public con- Consultation letter MLX 364, dated 1 Feb- islation in terms of its pharmacological action sultation to obtain a marketing authorisation, ruary 2010, explains that the agency was oblig- (medicinal by function),”says the agency. the MHRA notes. The consultation is due to be ed to take the step once it had decided to grant “[But] if all products containing nicotine completed by 4 May. on 11 December 2009 a ‘harm reduction’ indi- were to be regulated by function, [that means] Meanwhile, licensed NRT products will be cation to a licensed nicotine-replacement ther- presentation and the indications for such prod- able to claim harm reduction as well as their apy(NRT) product, McNeil Products’ Nicor- ucts would automatically be regulated as well.” existing indications: smoking cessation, cut ette Inhalator,which is also marketed by Boots Explaining further,the agency says that de- down to quit, and temporary abstinence. as NicAssist Inhalator. ciding on whether a nicotine-containing prod- The full indication approved by the MHRA Other companies marketing the six different uct should be considered as a medicine by func- is as follows: “Nicorette inhalator relieves and/ forms of licensed NRT medicines in the UK – tion depends on factors going beyond the prod- or prevents craving and nicotine-withdrawal gum, patch, nasal spray,inhalator,sublingual uct having an appreciable effect on metabolism. symptoms associated with tobacco dependence. tablet/microtablet and lozenge/pastille – are The manner in which the product is used is also It is indicated to aid smokers wishing to quit or being invited by the MHRA to add the harm- relevant, as is the extent of its distribution, con- reduce prior to quitting,to assist smokers who reduction indication to their NRT products. sumers’ familiarity with it, and the risks which are unwilling or unable to smoke, and as a safer Noting that any nicotine-containing product its use may pose. alternative to smoking for smokers and those that claims or implies that it can assist in smok- “Regulating nicotine in this way, by its func- around them. Nicorette inhalator is indicated ing cessation is a medicine, the MHRA points tion, represents a major departure from regulat- in pregnant and lactating women making a quit out that this has allowed other nicotine prod- ing products by claims made – and not regulat- attempt. Nicorette inhalator should preferably ucts not making such claims to be marketed as ing them if no claim is made,”notes the agency. be used in conjunction with a behavioural sup- substitutes or partial substitutes for smoking. In practical terms, the unlicensed products port programme.” Such items include electronic cigarettes, top- “purporting” to contain nicotine are widely and When it considered McNeil’s application, ical gels and oral products. readily available, the MHRA says, but infor- the working group of the Commission on Hu- But by extending the inhalator’s indication mation on their quality,safety and/or efficacy man Medicines (CHM) advised that NRT use in pregnancy “must be better than continuing to smoke”. It also advised that the product infor- mation should have “more emphasis and clar- Regulatory Affairs ity” on the positive indication for use in preg- Mississippi reverse-switches pseudoephedrine nancy, as well as advice about the concurrent use of NRT while continuing to smoke. ttempts in the US by consumers and the ers access some of their medicines,”she said, The CHM’s working group on harm re- A Consumer Healthcare Products Associ- also pointing out the additional cost to the duction and NRT also suggested that the early ation (CHPA) to dissuade Mississippi legisla- healthcare system. advertising concepts provided by McNeil re- tors from reverse-switching pseudoephedrine The CHPA has been promoting electronic quired more work on the images and concepts, to prescription control failed on 2 February tracking as the best solution for stopping the including more coverage of the issues related when the state’s Senate voted for the move. sale of illegal amounts of pseudoephedrine. to pregnancy. “Mississippians have spoken out that this Legal amounts were established by the fed- It also noted that the MHRA should clearly is not the right way to address methamphet- eral Combat Methamphetamine Epidemic Act, and effectively communicate its licensing re- amine abuse,”commented the CHPA’s presi- which pushed all pseudoephedrine-containing quirements as well as adopt a flexible and sup- dent, Linda Suydam. “We are disappointed that non-prescription medicines behind the counter portive approach to the innovative NRT products the Mississippi Senate chose to overlook con- ( OTC bulletin,17 March 2006, page 9). Eight that companies were developing with new for- sumer sentiment and passed a bill that will sig- states have adopted electronic tracking. mulations and delivery systems. nificantly impact how cold and allergy suffer- OTC OTC

14 OTC bulletin 10 February 2010 OTC 09-02-10 pS1-S8.qxd 8/2/10 10:35 Page 1 OTC 09-02-10 pS1-S8.qxd 8/2/10 10:35 Page 2 OTC 09-02-10 pS1-S8.qxd 8/2/10 10:35 Page 3

NOMINATIONS OTC

Park Lane Hotel, Piccadilly, Thursday,4th March 2010

ompetition for the 19 categories that make up ◆ OTC Company of the Year OTC bulletin’s prestigious OTC Marketing Awards Sponsored by IMS Consumer Health and IRI C ◆ OTC Brand of the Year has been fiercer than ever this year,with the number of entries racing past the 2009 total. Sponsored by Euro RSCG Life Our judges have now selected the nominations in each ◆ OTC Launch of the Year category for the OTCMarketing Awards 2010, and these are Sponsored by Tena listed in this special eight-page supplement. The award ◆ OTC Brand Revitalisation of the Year Sponsored by Spink winners will be announced on 4 March 2010 at the Gala Dinner & Awards Presentation in London. ◆ Most Innovative New OTC Product Sponsored by SourceOTC To find out which companies and brands are nominated ◆ Best OTC Marketing Campaign on a Big Budget for the four awards judged by our Super Retail Panel Sponsored by IRI – OTC Company of the Year,OTC Brand of the Year, ◆ Best OTC Marketing Campaign on a Small Budget OTC Launch of the Year,and OTCBrand Revitalisation of ◆ Best OTC Consumer Advertising on Television the Year – turn to page S4. Sponsored by Pegasus Nominations for the 12 entered awards – assessed by our ◆ Best OTC Consumer Advertising in the Press Expert Judging Panel – are on pages S5, S6 and S7. And ◆ Best OTC Consumer Advertising Out-of-Home nominations for Best OTCPharmacy Support Package and ◆ Best OTC Consumer Advertising on the Internet Best OTCPharmacy Salesforce are on page S7. Sponsored by OTC bulletin The winner of the award for Best OTCMultiple Retailer ◆ Best OTC Public Relations Campaign for a Medicine of the Year – judged by our Industry Executive Panel – will ◆ Best OTC Public Relations Campaign for a Non-Medicine also be announced on the night. Nominations are on page S4. ◆ Best New OTC Packaging Design OTC bulletin would like to thank our co-hosts ◆ Best OTC Trade & Professional Advertising – IMS Consumer Health and IRI – and our award Sponsored by OTC Magazine sponsors Euro RSCG Life, OTC Magazine, the Company ◆ Best OTC Pharmacy Training Chemists’Association, Spink, Pegasus, Tena and ◆ Best OTC Pharmacy Support Package SourceOTC – for making the OTCMarketing Awards 2010 Sponsored by the Company Chemists’Association possible. Many thanks also go to our judges for their ◆ Best OTC Pharmacy Salesforce valuable time and expertise. Sponsored by IMS Consumer Health ◆ Best OTC Multiple Retailer of the Year Sponsored by the Company Chemists’Association and OTC bulletin

Deborah Wilkes Editor & Publisher OTC bulletin

10 February 2010 OTC bulletin Nominations Supplement S3 OTC 09-02-10 pS1-S8.qxd 8/2/10 10:35 Page 4

OTC NOMINATIONS

SUPER RETAIL PANEL OTC COMPANY OF THE YEAR The first four awards on this page – OTC Company of the Year, OTC Brand Ceuta Group of Companies of the Year, OTC Launch of the Year and OTC Brand Revitalisation of the Year GlaxoSmithKline Consumer Healthcare – were judged by our Super Retail Panel McNeil Products/Johnson & Johnson made up of representatives from Novartis Consumer Health multiple and independent retailers. For each of these awards, judges on the Reckitt Benckiser Healthcare panel were presented with a shortlist of SSL International contenders drawn up by OTC bulletin. Thornton & Ross The results from the 13 judges were Award sponsored by combined to determine seven nominations, including the highly-commended candidates and, of course, the winner.

OTC BRAND OF THE YEAR OTC LAUNCH OF THE YEAR

Alli GlaxoSmithKline Alli GlaxoSmithKline Benylin McNeil Products Benylin Mucus Cough McNeil Products Calpol McNeil Products Calpol Saline Spray McNeil Products Nicorette McNeil Products Feminax Express Bayer Consumer Care Nurofen Reckitt Benckiser Nicorette Invisipatch McNeil Products Award sponsored by OptrexReckitt Benckiser Optrex Actimist Reckitt Benckiser Voltarol Novartis Consumer Health Handy Tube Reckitt Benckiser

Award sponsored by

OTC BRAND REVITALISATION OF THE YEAR

Benylin McNeil Products Calpol McNeil Products Clearblue Procter & Gamble NicoretteMcNeil Products Award sponsored by OptrexReckitt Benckiser Panadol GlaxoSmithKline Voltarol Novartis Consumer Health

INDUSTRY EXECUTIVE PANEL BEST OTC MULTIPLE RETAILER OF THE YEAR The award for Best OTC Multiple Retailer of the Year was judged by our Boots Industry Executive Panel made up of top executives from the UK OTC industry. Co-operative Pharmacy Judges on the panel were Day Lewis presented with a shortlist of Lloydspharmacy 10 contenders drawn up by the Company Chemists’ Association and Rowlands Pharmacy OTC bulletin. The results from the Sainsbury’s 13 judges were combined to determine Tesco seven nominations, including the highly-commended candidates and, of Award sponsored by course, the winner. bulletin

S4 OTC bulletin Nominations Supplement 10 February 2010 OTC 09-02-10 pS1-S8.qxd 8/2/10 10:35 Page 5

NOMINATIONS OTC

MOST INNOVATIVE NEW OTC PRODUCT EXPERT JUDGING PANEL The 12 awards on pages S5, Alli GlaxoSmithKline S6 and S7 were judged by an Expert Judging Panel made up of Care Virasoothe Thornton & Ross independent experts experienced in Centrum Cardio Pfizer the disciplines involved and/or knowledgeable about the OTC market. Life’s-Biotic Ratiopharm Award sponsored by For each of these awards, the judges Oxy Shaving The Mentholatum Company on the panel were presented with the PediTech ActiFreeze Passion for Life Healthcare entries submitted by companies and/or their agencies. Results from Rohto Dry Eye Relief The Mentholatum Company the six judges for each award were combined to determine nominations, the highly-commended candidates and, of course, the winner.

BEST OTC MARKETING CAMPAIGN ON A BIG BUDGET

Alli GlaxoSmithKline Bezier,Hive Health, Mediacom, PAA, Virgo Health, WCRS Benylin McNeil Products Carat, Junction 11, JWT,Redbox, Weber Shandwick Freederm Dendron Bray Leino Award sponsored by Nurofen Reckitt Benckiser Euro RSCG London, Lexis, OMD OptrexReckitt Benckiser Alchemy,Euro RSCG London, Hive Health, OMD, Sound, Spink Scholl SSL International McCann Manchester,Universal McCann Voltarol Novartis MEC, MS&L, Saatchi & Saatchi

BEST OTC MARKETING CAMPAIGN ON A SMALL BUDGET

Bassetts Soft & Chewy Ernest Jackson Bray Leino Daily Energiser Cerumol Thornton & Ross Jane Stevenson Communications, Network Design & Marketing Deep Freeze The Mentholatum CompanyAcumen, Concentric, Tony & Lesley Keen PR Eurax Novartis MEC, MS&L Full Marks SSL International McCann Manchester,National School Partnership, Universal McCann Kaloba Schwabe Pharma UK Experience Engine, Fluid Waves, Lavery Rowe, Pegasus Sanatogen Bayer Consumer Care i-Level, JWT,Mindshare

BEST OTC CONSUMER ADVERTISING ON TELEVISION

Benadryl McNeil Products Carat, JWT Award sponsored by Benylin McNeil Products Carat, JWT Calpol McNeil Products Carat, JWT Durex Play SSL International McCann Manchester,Universal McCann Full Marks SSL International McCann Manchester,Universal McCann NicoretteMcNeil Products AMV BBDO, Carat Motilium 10 McNeil Products Carat, 7Beaufort

BEST OTC CONSUMER ADVERTISING IN THE PRESS

Benylin McNeil Products Carat, JWT Clamelle Actavis Woolley Pau Cymalon Actavis Woolley Pau ExorexForest Laboratories DDB Health SanatogenBayer Consumer Care JWT,Mindshare SominexActavis Woolley Pau Zantac GlaxoSmithKline/Ceuta Mediacom, Spink, tF7

10 February 2010 OTC bulletin Nominations Supplement S5 OTC 09-02-10 pS1-S8.qxd 8/2/10 10:35 Page 6

OTC NOMINATIONS

BEST OTC CONSUMER ADVERTISING OUT-OF-HOME

Appesat Goldshield/Ceuta tF7 Durex Play SSL InternationalMcCann Manchester

BEST OTC CONSUMER ADVERTISING ON THE INTERNET

Benylin McNeil Products Carat, JWT Redbox Clarityn Schering Plough Euro RSCG Life, Golly Slater,Just:: Health PR, Zenith Optimedia Dentyl pH Mouthwash Dendron Bray Leino Full Marks SSL International McCann Manchester Nicorette McNeil Products Carat, Redbox Award sponsored by Nitty Gritty Ceuta Next Door,tF7 Sanatogen Bayer Consumer Care i-Level bulletin

BEST OTC PUBLIC RELATIONS CAMPAIGN FOR A MEDICINE

Alli GlaxoSmithKline Virgo Health Covonia Thornton & Ross Pegasus CymexActavis Lexis Emla AstraZeneca Munro & Forster Nasacort Sanofi-Aventis Pegasus Nurofen Reckitt Benckiser Lexis Oilatum Junior Stiefel Laboratories, a GSK companySpink

BEST OTC PUBLIC RELATIONS CAMPAIGN FOR A NON-MEDICINE

Appesat Goldshield Pegasus DurexSSL International Halesway,Myriad Public Relations Life’s-Biotic Ratiopharm Nexus PR Lloydspharmacy Online Doctor LloydspharmacyCitigate Dewe Rogerson Savlon Novartis MS&L Scholl Party Feet SSL International McCann Manchester,Myriad Public Relations The Co-operative Pharmacy Clinical Services The Co-operative PharmacyFuel PR

BEST NEW OTC PACKAGING DESIGN

Deep Freeze Cold Spray The Mentholatum CompanyImage Works Earex Ear Drops SSL International The Market Creative Consultants Own-Label Vitamins and Minerals The Co-operative PharmacyPentagram Design PediTech ActiFreeze Passion for Life Healthcare Seymourpowell Rohto Dry Eye Relief The Mentholatum CompanyImage Works Scholl SSL International Bobcat, Rare Design Agency Strepsils Handy Tube Reckitt Benckiser In-house team

About OTC bulletin OTC bulletin is a subscription newsletter published 20 times a year by OTC Publications Ltd: twice monthly in February,March, April, May,June, September,October and November; and monthly in January,July,August and December. OTC bulletin is printed by Warwick Printing Company Limited, Caswell Road, Leamington Spa, Warwickshire CV31 1QD, UK. Editorial, Subscription and Advertising enquiries should be addressed to: OTC bulletin, OTC Publications Ltd, 54 Creynolds Lane, Solihull, West Midlands B90 4ER, UK. Tel: +44 1564 777550. Fax: +44 1564 777524. Website: www.OTC-bulletin.com. No part of this publication may be copied, reproduced, stored in a retrieval system or transmitted in any form without prior permission from OTCPublications Ltd. ©OTC Publications Ltd. All rights reserved. Company registered in England No 2765878. Registered Office: 54 Creynolds Lane, Solihull, West Midlands B90 4ER, UK. OTC bulletin® is registered as a trademark in the European Community.

S6 OTC bulletin Nominations Supplement 10 February 2010 OTC 09-02-10 pS1-S8.qxd 8/2/10 10:35 Page 7

NOMINATIONS OTC

BEST OTC TRADE & PROFESSIONAL ADVERTISING

Alli GlaxoSmithKlineHive Health Award sponsored by Benylin McNeil Products Junction 11, JWT,MMS Calpol McNeil Products Junction 11 Full Marks SSL International McCann Manchester Nasacort Sanofi-Aventis Cherry NiQuitin GlaxoSmithKline TBWA\Paling Walters Nurture Heinz TBWA\Paling Walters

BEST OTC PHARMACY TRAINING

30-Minute Tutor Boots CIG Healthcare Partnership Alli GlaxoSmithKline Hive Health (with logistics support from Precision Direct Marketing and AHA Sales & Marketing) Brand Portfolio McNeil Products In-house team Diprobase Schering Plough Halesway Frontline Merial CIG Healthcare Partnership Retail Skills Made Easy Procter & Gamble Mediapharm Your Counter Assistant Alliance Healthcare CIG Healthcare Partnership

PHARMACY AWARDS BEST OTC PHARMACY SALESFORCE The nominations – including the highly-commended candidates and Actavis the winner – of our two pharmacy awards were primarily decided by GlaxoSmithKline Consumer Healthcare market research conducted using McNeil Products/Johnson & Johnson IMS’ Intr@PharmQ. The Reckitt Benckiser Healthcare support-package award was also based on input from the Company Seven Seas Award sponsored by Chemists’ Association (CCA). SSL International Thornton & Ross

BEST OTC PHARMACY SUPPORT PACKAGE

Alli GlaxoSmithKline Bezier,Hive Health, Gold-standard launch of the brand and the Mediacom, PAA, weight-management category into pharmacy Virgo Health, WCRS Benylin McNeil Products Junction 11 Pharmacy cough centre training and merchandising programme Canesten Bayer Consumer Care CIG Healthcare Partnership Pharmacy support package ClamelleActavis Lexis, Mediapharm Clamelle Chlamydia Service pharmacy and MCA training Golden Eye Golden Eye Bray Leino Branded pharmacy training suite and C&D training guide McNeil/NPA/C&D McNeil Products In-house team Responsible Pharmacist training Award sponsored by programme, with C&D features and handy pocket guide distributed to pharmacists Nurofen Reckitt Benckiser Hive Health, Precision Nurofen Academy Direct Marketing

Kantar Health will be a sponsor at the Gala Dinner & Awards Presentation in London on 4th March 2010

10 February 2010 OTC bulletin Nominations Supplement S7 OTCAd2010:OTC Ad 1_07 5/1/10 14:16 Page 1

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GENERAL NEWS OTC

Regulatory Affairs Regulatory Affairs Reckitt denied Europe looks into safety of in FDA petition topical bufexamac products eckitt Benckiser has suffered another blow Rin defending the US market exclusivity of oncerns about allergic contact reactions tact had led the regulatory agency to the con- its Mucinex cough brand with the Food and C have prompted Europe’s Committee for clusion that bufexamac had a negative risk- Drug Administration’s (FDA’s) decision to deny Medicinal Products for Human Use (CHMP) benefit profile. the firm’s citizen petition. to start a safety review of topical medicines con- Noting that it had started assessing bufexa- The British company – which acquired Mu- taining the active ingredient bufexamac. mac in 2002, the agency said it planned to re- cinex along with Adams Respiratory Therapeu- The move comes soon after Germany’s fed- voke licences for all medicines containing the tics two years ago – had insisted the FDA en- eral institute for drugs and medical devices, active ingredient that had dermatological or sure that any generic rivals to its modified-re- BfArM, proposed withdrawing haemorrhoid proctological indications, such as eczema, chro- lease guaifenesin brand meet the same bio- treatments and dermatological medicines con- nic dermatitis and anal fissures. equivalence requirements. taining bufexamac (OTC bulletin,18 Decem- In particular,BfArM pointed to 445 reports Noting that Perrigo’s Lara FitzSimmons ber 2009, page 13). of adverse bufexamac reactions detailed in its had also commented on the petition, the FDA’s Europe’s CHMP said it would assess the database as of 30 September 2009. The major- Janet Woodcock told Reckitt Benckiser that it benefit-risk balance of the non-steroidal anti- ity of these reports, it added, concerned aller- had not presented “compelling evidence that inflammatory drug, and recommend whether gic skin reactions. FDA’s current recommendations for approval its marketing authorisations should be main- Furthermore, BfArM said a scientific review of generic modified-release guaifenesin are in- tained, changed, suspended or revoked. Bufex- had found that “the efficacy of medicines con- appropriate to establish bioequivalence”. amac has non-prescription status in many coun- taining bufexamac in the given indications has Reckitt Benckiser had wanted generics to tries for treating dermatological and proctolog- not been adequately proven”. The agencymain- demonstrate an early Cmax – maximum plas- ical diseases. tained that corticosteroids with better side-ef- ma concentration – and efficacious concentra- The CHMP’s safety review was triggered fect profiles offered suitable alternatives. tions throughout the 12-hour dosing interval. by Germany under Article 107(2) of European The agency noted that during its review pro- Directive 2001/83/EC as amended. cess, Germany’s medicines manufacturers’ asso- No clinically-meaningful evidence Germany’s BfArM gave companies until ciation, the BAH, had suggested text to be add- However, the FDA retorted in response to mid-January to respond to its proposal. Several ed to listed contraindications. But such warn- the firm’s “several brief arguments” that as the well-known OTC haemorrhoid treatments in ings that people with a history of allergic reac- petition contained no evidence that an early Germany – including Nycomed’s Faktu Akut, tions or atopic dermatitis should ask a doctor Cmax was “clinically meaningful”, and as the Stada’s Mastu Akut and Dr Mann’s Rectosel- before using bufexamac products were “not suit- agency was not aware of any evidence, “we de- lan – contain bufexamac. able to increase medicinal safety”, BfArM felt, cline to revise the current recommendations to BfArM said several publications and spon- especially as such products were typically used require a demonstration of early Cmax”. taneous reports of allergic reactions upon con- for self-medication. Moreover, the FDA argued that it was rea- OTC sonable to expect the branded product and its bioequivalent generic would deliver “approx- Regulatory Affairs imately the same effective dose throughout the dosing interval”. Traditional filings to MHRA top 100 “If the branded product is effective during the entire dosing interval,”the agency said, “the ver 100 applications had been made to the mid-January 2010, according to the agency. generic product will also be effective during OUK’s Medicines and Healthcare products Of this total number of applications since the the entire interval.” Regulatory Agency (MHRA) under its tradi- scheme started in October 2005, almost half – Mucinex and Mucinex DM are currently be- tional herbal medicines registration scheme by 48 – had been granted a registration, the MHRA ing defended against two US patent challenges. said, with 19 having gone through since April One lawsuit against Perrigo, filed by Adams in Applications* Registrations last year (see Figure 1). 2007, is set to come to trial in March (see page March 2006 80Three of the applications, the MHRA noted, 10). More recently Reckitt Benckiser sued Wat- March 2007 11 3 had been the result of products entering the son after it had filed two abbreviated new drug March 2008 16 9 review of herbal product licences started in applications (ANDAs) covering four products April 2009. None of these products had yet March 2009 32 17 (OTC bulletin,30 April 2009, page 20). been registered, the agency added, but it also January 2010** 38 19 Adams settled a Mucinex patent challenge pointed out that all applications not shown from URL/Mutual in 2007. This keeps URL/ *Including transfers from full product licences as granted were still undergoing assessment. ** April 2009 to 14 January 2010 Mutual’s rival generic off the market until July The MHRA’s traditional herbal medicines 2012, but it could be introduced sooner if an- Figure 1: Applications and registrations under the UK’s registration scheme is the UK’s response to traditional herbal medicines registration scheme since other generic were to be launched. October 2005. The numbers are for the year until the European Union directive 2004/24/EC. OTC dates shown unless stated otherwise (Source – MHRA) OTC

10 February 2010 OTC bulletin 15 OTC10-02-10p16-17FIN.qxd 5/2/10 12:36 Page 2

OTC GENERAL NEWS

CONSUMER viewpoint ...... anaemia

Anaemia is the subject of this month’s Consumer viewpoint survey France 3.4% of ailments suffered by Europe’s Germany 0.8% consumers. The survey appears Italy 1.6% exclusively in OTC bulletin courtesy Spain 4.3% of Ipsos MORI. UK 1.7% 0.0 1.0 2.0 3.0 4.0 5.0 paniards are more likely to say they have Proportion of consumers who say they have suffered from anaemia (%) Ssuffered from anaemia during the past year than their counterparts in France, Germany, Italy Figure 1: Proportion of consumers in France, Germany, Italy, Spain and the UK who say they have suffered from or the UK, according to our Consumer view- anaemia within the past year (Source – OTC bulletin 2010/Ipsos MORI) point European survey. Proportion of sufferers (%) Index Of the five countries covered by the Ipsos Fra Ger Ita Spa UK Fra Ger Ita Spa UK MORI survey,Spain has the highest proportion of people who say that they have suffered from Male 5.8 7.4 10.6 21.1 10.7 12 15 22 44 22 anaemia during the past year at 4.3%, follow- Female 94.2 92.6 89.4 78.9 89.3 180 180 175 151 174 ed by France at 3.4%, the UK at 1.7%, Italy at 18-24 13.0 –30.4 8.2 31.6 113 – 334 68 253 1.6% and Germany at 0.8% (see Figure 1). 25-34 35.5 –13.9 14.6 9.0 187 –797154 The low incidence of anaemia in most coun- 35-44 20.5 36.3 18.3 28.0 16.0 106 181 92 147 81 tries means that the following results should be 45-54 18.4 6.0 2.9 16.4 17.9 119 33 18 101 105 treated with caution. 55-64 8.3 17.4 14.2 6.8 6.7 49 121 96 54 46 In all five of the survey countries, women 65+ 4.3 40.3 20.3 25.9 18.7 24 161 109 133 96 are far more likely than men to say they have suffered from anaemia (see Figure 2). Figure 2: Consumers in France, Germany, Italy, Spain and the UK who say they have suffered from anaemia in the past year, analysed by sex and age. The index indicates the likelihood that a consumer in a specific population As can be seen from Figure 3, prescription group will have suffered from anaemia, and is the ratio of the proportion of total sufferers in a population group remedies are the most popular treatment option to the proportion of that group in the population as a whole (Source – OTC bulletin 2010/Ipsos MORI) for the condition in all five countries with OTC products in second position. Ipsos MORI and the ailments survey Spain has the highest proportion of suffer- ers who have treated the condition with an OTC ur Consumer viewpoint ailments survey appears exclusively in OTC bulletin courtesy product at 67.8%, followed by Germany at Oof Ipsos MORI. The survey is based on research conducted in February 2009 using Capi- 56.2% (see Figure 4). bus, the market researcher’s weekly European omnibus service. Ipsos MORI carried out face- OTC treaters are more likely to be women to-face interviews with 1,000 plus adults in each of the survey countries – France, Germany, than men in all five countries (see Figure 5). Italy,Spain and the UK. An OTCremedy was defined as a product purchased over-the-counter Spain also has the highest proportion of pre- from a pharmacy or off a shop shelf. scription treaters at 95.3% (see Figure 6). France has the highest proportion of herbal ■ For more information on the research supplied by Ipsos MORI, please contact Susan Purcell (Tel: +44 208 treaters at 10.1% (see Figure 7). 861 8000; Fax: +44 208 861 5515; E-mail: [email protected]). OTC OTC

100.0

80.0 Product type

60.0 OTC Prescription 40.0 Herbal

20.0

0.0

Proportion of sufferers treating with..... (%) France GermanyItaly Spain UK

Figure 3: Proportion of consumers in France, Germany, Italy, Spain and the UK who say they have suffered from anaemia who have treated the condition with an OTC, prescription or herbal remedy (Source – OTC bulletin 2010/Ipsos MORI)

16 OTC bulletin 10 February 2010 OTC10-02-10p16-17FIN.qxd 5/2/10 12:36 Page 3

GENERAL NEWS OTC

Patent Challenges ...... anaemia Schwabe loses its pelargonium patent 16.2% France r Willmar Schwabe’s patent covering a Germany 56.2% D method for deriving extracts from pelar-

Italy 16.2% gonium plants has been revoked by the Euro- pean Patent Office (EPO) following an oppo- Spain 67.8% sition hearing on 25 and 26 January. UK 10.1% The German company, which makes and

0.0 20.0 40.0 60.0 80.0 markets the popular pelargonium-based res- piratory medicine Umckaloabo, indicated that Proportion of consumers suffering from anaemia who have treated the condition with an OTC remedy (%) it would appeal for the decision to be review- Figure 4: Proportion of consumers in France, Germany, Italy, Spain and the UK who say they have suffered from ed by an EPO technical board of appeal. anaemia who have treated the condition with an OTC remedy (Source – OTC bulletin 2010/Ipsos MORI) The patent at issue – EP 02777223 B1 – Proportion of sufferers treating with OTC(%) Index relates to a method for extracting substances Fra Ger Ita Spa UK Fra Ger Ita Spa UK with medical properties from Pelargonium sid- oides and Pelargonium reniforme,plants which Male 20.4 ––14.8 –43– –31–originally came from southern Africa. Female 79.6 100 100 85.2 100 152 194 195 163 195 After hearing the parties, the EPO’s oppo- 18-24 40.8 –10.3 60.6 355 ––86 485 sition division concluded that the patent should 25-34 –42.1 19.0 39.4 ––239 92 236 be revoked because it did not fulfil the inven- 35-44 41.7 44.3 40.1 27.7 – 216 220 203 146 – tive-step requirements of the European Patent 45-54 ––17.8 13.8 –––109 85 – Convention. The reasons for its decision – in- 55-64 17.5 31.0 –10.1 – 104 215 –80–cluding a full assessment of the facts and argu- 65+ –24.7 –19.1 ––99 –98–ments – will be published in the near future. In 2008, several companies and non-gov- Figure 5: Consumers in France, Germany, Italy, Spain and the UK who have used an OTC remedy to treat ernmental organisations – including the Afri- anaemia, analysed by sex and age. The index provides a measure of the likelihood that a consumer suffering from anaemia in a specific population group will have treated the condition with an OTC remedy, and is can Centre for Biosafety – brought a challenge the ratio of the proportion of total OTC treaters in a population group to the proportion of that group in the to Schwabe’s ‘223 patent, which the EPO had population as a whole (Source – OTC bulletin 2010/Ipsos MORI) granted in September 2002 (OTC bulletin, 13 June 2008, page 16). Schwabe stressed that the EPO’s decision France 55.5% had not upheld the accusation of biopiracy by

Germany 65.2% unlawfully appropriating traditional knowledge. Furthermore, the German company insist- Italy 69.5% ed that the patent was “in no way directed at 95.3% monopolising the plant Pelargonium sidoides”. Spain The decision, the firm said, had confirmed UK 57.0% that Schwabe’s production process was new

0.0 20.0 40.0 60.0 80.0 100.0 and not based on traditional knowledge. Addi- tionally,the company’s harvesting process had Proportion of consumers suffering from anaemia who have treated the condition with a prescription remedy (%) been shown to be sustainable and no threat to Figure 6: Proportion of consumers in France, Germany, Italy, Spain and the UK who say they have suffered from the environment, Schwabe maintained. anaemia who have treated the condition with a prescription remedy (Source – OTC bulletin 2010/Ipsos MORI) OTC

France 10.1% IN BRIEF ■ FDA – the US Food and Drug Administra- Germany 0.0% tion – said MuscleMaster.com was voluntar- Italy 5.7% ily recalling seventeen dietary supplements. The regulatory agency believes that the body- Spain 8.0% building products sold by the internet retailer UK 0.0% contain ingredients that are steroids.

0.0 2.0 4.0 6.0 8.0 10.0 12.0 ■ FDA – the US Food and Drug Administra- Proportion of consumers suffering from anaemia who have treated the condition with a herbal remedy (%) tion – has sent out a warning letter to Sunrise

Figure 7: Proportion of consumers in France, Germany, Italy, Spain and the UK who say they have suffered from Pharmaceutical. anaemia who have treated the condition with a herbal remedy (Source – OTC bulletin 2010/Ipsos MORI) OTC

10 February 2010 OTC bulletin 17 OTC10-02-10p18-19FIN.qxd 5/2/10 12:39 Page 2

OTC MARKETING NEWS

Marketing Campaigns Reckitt Benckiser creates a ‘magical’ Nurofen world

n animated character called Nuro is used mind,”he added, “we have created a brand Ato get across the message that Nurofen goes world that will set Nurofen apart from every- right to the source of pain in Reckitt Benckiser’s body else and allow us to tell all sorts of ex- new marketing campaign for the brand. traordinary pain-relief stories in an imagina- The £11.0 million (C12.6 million) multi- tive and engaging way for the first time.” media campaign has just made its worldwide Nuro provides Reckitt Benckiser with an- debut in the UK, and will soon be extended to other creative magnifier for its OTC brand port- other countries. folio. Firemen are the consistent link across mar- Reckitt Benckiser said the 30-second televi- keting for the Gaviscon brand, Lemmies are the sion commercial at the heart of the campaign creative magnifier for , and Strepsils has was set in a “simple and magical brand world”. the quirky Mr T cartoon character. The animated spot opens with a white image Speaking exclusively to OTC bulletin last

of a woman against a white background. The year,Camillo Pane, Reckitt Benckiser’s UK An animated character called Nuro is the hero of only colour is a throbbing red patch in her head. general manager,said creative magnifiers were Reckitt Benckiser’s new international marketing The action then moves inside her head, where useful because they allowed “consumers to en- campaign for its Nurofen pain relievers the peaceful white world is disrupted by a black gage much more with the brand”. He said the bird pecking repeatedly and noisily at a branch company was keen to find creative magnifiers of a tree. for its other healthcare brands, particularly the Fortunately,Nuro – a white caplet-shaped Nurofen pain relievers (OTC bulletin,18 Dec- character with a Nurofen target logo for a face ember 2009, page 20). – comes to the rescue. Nuro sets his sights on The £11.0 million campaign in the UK in- the black bird, and the target logo then engulfs cludes television, print and outdoor advertis- the bird and renders it harmless. ing; a new-look website; online advertising; public relations activity; packaging; and in- Not all painkillers work the same way store activity. “Not all painkillers work in the same way,” Stefan Gaa, marketing director of Reckitt states a voiceover, adding that “Nurofen goes Benckiser,commented: “We expect the invest- right to the source of pain”. The sign-off mes- ment to enhance our position in the analgesics sage to consumers is: “Nurofen. Targeted relief market globally, to modernise our brand and from pain.” reinforce the role and relevance of Nurofen in Stephen Butler – creative director of Moth- consumers’ lives.” er,the advertising agency behind the campaign Nurofen was available in 90 countries, not- – maintained that the pain-relief category had ed Reckitt Benckiser,adding that the top five The new television commercial for Nurofen, which has “talked itself into an unnecessarily prosaic cre- markets were the UK, Australia, France, Rus- just made its debut in the UK, is set inside the head ative approach over the years”. “With this in sia and Belgium. of a woman with a headache OTC

IN BRIEF Marketing Campaigns ■ DENDRON has extended its Freederm Deep Heat changes to female voiceover skincare brand in the UK with Freederm Sen- sitive Facial Wash for people with sensitive ew television commercials for The Men- the patch for back pain and ends with a shot skin that is prone to spots. It joins the exist- N tholatum Company’s Deep Heat topical of the two patches. ing Freederm range comprising Exfoliating pain relievers in the UK have a female voice- The actress Anna Chancellor – who played Facial Wash, Facial Cleanser,Treatment Gel over for the first time ever. Duckface in the film Four Weddings and a Fun- and Zone Balancing Moisturiser. The two advertisements, which are running eral – invites viewers to “Feel the Deep Heat for four weeks until 14 February,feature the heat” and tells them that with Deep Heat patch- ■ NOVOGEN has changed the name of its familiar glowing outlines of people playing es “You’ve got pain covered”. Novogen Redclover food supplement to Pro- golf, playing tennis and dancing. Lynn McGinness – Mentholatum’s senior mensil Menopause in the UK. The company The 30-second version, which highlights brand manager for topicals – said it was quite said the move aligned the UK brand name with both Deep Heat Patch and Deep Heat Patch for a departure for the company to use a female that used in the rest of the world. Back Pain, ends with a shot of the patches, rubs after so many years of deep, male voices. OTC and sprays. The 10-second version focuses on OTC

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OTC MARKETING NEWS

FDACounterfeiting warns over counterfeit Alli in US

mericans have been warned by the Food oratory tests on the counterfeit product show- Aand Drug Administration (FDA) to watch ed that people might be taking three-times the out for a counterfeit and potentially-harmful usual daily dose of sibutramine – or twice the version of GlaxoSmithKline Consumer Health- recommended maximum dose – if they were care’s non-prescription weight-loss medicine following the dosing directions for Alli. Healthy Alli (60mg orlistat). people could experience anxiety,nausea, heart The regulatory agency said that preliminary palpitations, tachycardia, insomnia and small laboratory tests carried out by GlaxoSmithKline increases in blood pressure, warned the FDA, had shown that the counterfeit version – being adding that this amount of sibutramine could sold over the internet as an Alli 120-count re- be dangerous for people with a history of car- Authentic Alli capsules (pictured above left) contain the active ingredient orlistat in the form of white fill kit – contained the controlled substance sib- diovascular disease. pellets, while the counterfeit version (right) contains utramine rather than orlistat. Counterfeits are a rarity in the OTC sector, sibutramine as a white powder Sibutramine is the active ingredient in Abb- mainly because the relatively low retail prices ott Laboratories’ prescription-only,weight-loss of non-prescription medicines are unattractive chased from reputable retailers, consumers can medicine Meridia capsules C-IV. It should not to counterfeiters. However, the Alli pack in ques- have confidence the product is genuine and they be used in certain patient populations or with- tion generally sells for between US$60.00 and should continue use,”the company added. out physician oversight, the FDA warned, add- US$70.00 (C42.50 and C49.50). The FDA warned Americans to check and ing that it could also interact in a harmful way Consumers began reporting suspected coun- make sure that they were not taking counter- with other . terfeit Alli to GlaxoSmithKline in early Decem- feit Alli. Although the counterfeit Alli product ber 2009, the FDA pointed out, adding that looked similar to the authentic version, said the Sibutramine suspended in Europe the company had determined that the product agency, it had a few notable differences: The European Medicines Agency (EMA) was being sold over internet auction websites, ■ The outer cardboard packaging is missing a recently recommended that marketing autho- such as ebay. “lot” code. risations for sibutramine should be suspended There was currently no evidence, the agency ■ The expiration date includes the month, day in all markets of the European Union – where stressed, that the counterfeit Alli products had and year,whereas on the authentic Alli prod- it is sold under the Reductil, Reduxade and been sold through other distribution channels, uct the expiration date includes only the month Zelium brand names, among others – after it such as retail stores. and year. was associated with an increased risk of car- GlaxoSmithKline said consumers should ■ The plastic bottle is slightly taller and has a diovascular events. only buy Alli from reputable retailers or from wider cap with coarser ribbing than the gen- The FDA pointed out that its additional lab- retailers’ branded online websites. “When pur- uine product. ■ The plain-foil inner safety seal under the plas- tic cap does not have anything printed on it, un- like the actual product which has “sealed for your protection” printed on it. ■ The capsules are larger and contain a white powder instead of small white pellets. Launched in the US in June 2007, Alli is the only FDA-approved weight-loss medicine available to overweight adults, aged 18 years or over, without a prescription. The brand re- corded sales of £96 million (C110 million) in the US in 2009. Alli was launched in Europe last year,after it became the first medicine licensed through “Help your body help itself” is Brunel Healthcare’s The range now comprises five products: on-pack promise for its revamped range of Vertese a 60-capsule pack of Vertese Omega Oils 3.6.9; the European Union’s centralised procedure to food supplements in the UK. a 30-capsule pack of Vertese Omega Oils 3.6.9; be switched from prescription to non-prescrip- The company has replaced the brightly-coloured a 30 capsule pack of Vertese Evening Primrose Oil; tion status (OTC bulletin,29 January 2009, packaging with a predominantly-white design, and a 30-capsule pack of Vertese Flaxseed Oil; and a discontinued some formulations. However, Brunel said 30-capsule pack of Vertese Glucosamine and page 1). the Vertese range would be extended later this year Flaxseed Oil (pictured above). with new products. The company noted that Vertese Cardiovite Warning issued in the UK The new-look packaging highlights that Vertese would be relaunched with the new packaging capsules are gelatin-free and are approved by the later this year. In the UK, the Medicines and Healthcare pro- Vegetarian Society. The packaging also carries some Recommended retail selling prices range from ducts Regulatory Agency (MHRA) has warn- information in Braille. £3.99 for a 30-capsule pack of Vertese Omega ed consumers about the dangers of buying med- Brunel is backing the relaunch with a £0.25 million Oils 3.6.9 or Vertese Flaxseed Oil up to £7.49 for a (C0.29 million) marketing campaign, including public 30-capsule pack of Vertese Glucosamine and icines from unregulated websites following the relations activity and consumer-press advertising. Flaxseed Oil. discovery of counterfeit Alli in the US. OTC OTC

20 OTC bulletin 10 February 2010 OTC10-02-10p20-21FIN.qxd 5/2/10 12:47 Page 3

MARKETING NEWS OTC

Line Extensions Novartis promotes speed of German Voltaren Spray

apid relief from painful joints is the prom- the skin, quickly to the site of pain”. Rise behind Voltaren Spray,the latest addi- The bottle and droplets appear below the tion to Novartis Consumer Health’s diclofenac- headline “Das erste Voltaren zum Sprühen ist based brand in Germany. da”, or “The first Voltaren for spraying is here”. Launch pharmacy-press advertising for the A pharmacy-only medicine, Voltaren Spray 40mg/g diclofenac sodium spray shows drop- is indicated for treating acute pain and inflam- lets of spray coming out of a Voltaren Spray bot- mation around small- to medium-sized joints. tle. Three large droplets contain messages that Novartis says a typical treatment is four to that the newcomer is “Schnell zur Hand, schnell five pumps of spray delivered three times per durch die Haut, schnell am Schmerz”, which day,up to a maximum of 15 pumps per day. Pharmacy-press advertising for Nycomed’s Pantozol Control in Germany claims that the translates as “Quickly to hand, quickly through Each pump of spray delivers 8mg of diclofen- 20mg pantoprazole tablets were “the most ac sodium together with peppermint oil for a successful OTC launch for heartburn in 2009”. pleasant cooling effect. Nycomed supports this claim, which is based on IMS Health sell-out data for the 12 months ended A 25g bottle of spray has a recommended November 2009, by referencing a GfK study that retail price of C12.95. found the brand had a 92% repurchase rate. Germany was the only concerned member The advertising (pictured above) reminds pharmacists that Pantozol Control – which Nycomed state (CMS) in a decentralised European auth- launched in Germany last year following its orisation procedure for the diclofenac 4% spray pan-European authorisation as a non-prescription that was submitted by German firm Economed. medicine – enjoys “massive television support”. The company’s international campaign that uses jellyfish The UK’s Medicines and Healthcare prod- to symbolise the burning sensation of heartburn is ucts Regulatory Agency (MHRA) acted as the currently on air in Germany (OTC bulletin, 30 reference member state (RMS), and granted a September 2009, page 20). However, Pantozol Control now faces competition marketing authorisation under the brand name from generic heavyweights such as Hexal, KWIS Spray Gel. Ratiopharm, Stada and Tad. Having seized on the In Germany, the diclofenac-based Voltaren prescription-to-non-prescription switch of all 20mg pantoprazole heartburn formulations from 1 range includes Voltaren Schmerzgel gel as well January this year (OTC bulletin, 18 December 2009, as Voltaren Dolo 12.5mg and 25mg tablets, and page 11), several generics companies are offering a Voltaren Wirkstoff-Pflaster patch. packs of seven tablets with recommended retail prices below C 5.00. A similarly-sized pack of Pantozol In 2007, Novartis capitalised on the brand’s Control retails at C 7.85. popularity to introduce glucosamine capsules OTC under the name Voltaflex (OTC bulletin,12 October 2007, page 14). And just over a year Switches ago, the company introduced liquid diclofenac Launch pharmacy-press advertising for Novartis Consumer Health’s Voltaren Spray in Germany puts capsules as Voltaren Dolo Liquid (OTC bul- Motilium 10 gains the emphasis on speed letin,18 December 2008, page 16). OTC nausea indication cNeil Products’ Motilium 10 is now in- IN BRIEF M dicated in the UK for relieving symp- ■ GLAXOSMITHKLINE Consumer Health- in the UK. Starting in early February,the nat- toms of nausea and vomiting of less than 48 care is investing £0.5 million (C 0.6 million) in a ional campaign from the agency Grey includes hours duration. burst of national television advertising for Pan- a four-week burst of the established “gorgeous/ The additional indication for the pharmacy- adol Advance in the UK. The company said missing tooth” television commercial. This is only medicine containing 10mg domperidone its “visible man” commercial had been updat- based around an attractive woman with an un- was approved by the Medicines and Health- ed to highlight that Panadol Advance had been sightly gap in her teeth and focuses on Cor- care products Regulatory Agency (MHRA) fol- voted pain-relief product of the year at the Pro- sodyl Mint Mouthwash. A 10-second tag at the lowing an application from McNeil Products duct of the Year Awards 2010. Created by the end of the commercial highlights Corsodyl ( OTC bulletin,31 March 2009, page 15). agency Ogilvy,the commercial is on air from Daily Gum & Tooth Paste. The television ini- Motilium 10 was previously only indicated 1 February until 7 March. tiativewill be reinforced by an eight-week burst for “relief of post-prandial symptoms of exces- of consumer-press advertising with executions sive fullness, nausea, epigastric bloating and ■ GLAXOSMITHKLINE Consumer Health- based on “simple, yet compelling messages to belching, occasionally accompanied by epi- care is backing Corsodyl with a £1.95 million inform and educate people about gum health”. gastric discomfort and heartburn”. ( C 2.25 million) spend on consumer advertising OTC OTC

10 February 2010 OTC bulletin 21 OTC10-02-10p22FIN.qxd 5/2/10 12:48 Page 2

OTC MARKETING NEWS

Regulatory Affairs US FDA sends warning letter to McNeil

he Food and Drug Administration (FDA) ber 2009, page 17). The recall was extended was aware of the complaints made to McNeil, Thas sent McNeil Consumer Healthcare a shortly afterwards (OTC bulletin,20 January as well as the sequence of events and the ex- warning letter about its Las Piedras manufac- 2010, page 15). tent of the company’s follow-up measures dur- turing facility in Puerto Rico, where a number McNeil said it had now determined that the ing the period after the contamination was first of the company’s OTC medicines are made. uncharacteristic smell had been caused by trace noted in 2008 and recurred in 2009. The letter The US regulatory agency said the manufac- amounts of a chemical called 2,4,6-tribromo- said the FDA had concluded McNeil had not turing, processing, packing or holding of OTC anisole (TBA). This can result from the break- conducted a timely,comprehensive investigation. drugs at the facility deviated from current Good down of a chemical that is sometimes applied The initial investigation into the root cause Manufacturing Practice (cGMP) regulations. As to the wood that is used to build wooden pal- of the odour was “unjustifiably delayed and ter- a result, added the FDA, the OTCdrugs were lets that transport and store product packag- minated prematurely”, said the warning letter, adulterated within the meaning of the Federal ing materials. adding: “Numerous complaints were received Food, Drug and Cosmetic Act. Commenting on the TBA, McNeil said the over a four-month period in 2008 before they News of the FDA’s warning letter came as “health effects of this chemical have not been were considered a trend and before actions were McNeil announced a voluntary recall of certain well studied, but no serious events have been initiated to determine the root cause.” lots of its Benadryl, Motrin, Rolaids, Simply documented in the medical literature”. The warning letter added that the investi- Sleep, St Joseph Aspirin and Tylenol products McNeil pointed out that a small number of gation had been closed after microbiological made at the Las Piedras facility. The recall ap- the recalled product lots were associated with testing in August 2008 had not supported an plies to the Americas, the United Arab Emirates the complaints of an unusual odour,and some initial speculation that microbial contamination (UAE) and Fiji. of these lots had been found to contain trace was the root cause of the odour. No other root McNeil said the recall had been initiated fol- amounts of TBA. causes were pursued, said the letter,telling Mc- lowing an investigation into consumer reports Neil that “your firm lacked adequate justifica- of “an unusual mouldy,musty or mildew-like Investigation is still ongoing tion for this decision”. odour that, in a small number of cases, was as- An investigation was still ongoing, McNeil Complaints of uncharacteristic odour had sociated with temporary and non-serious gas- said, adding that it had ceased shipment of pro- been reported again in April 2009, stated the trointestinal events”. ducts made using materials shipped on the pal- warning letter,and 112 similar complaints had The latest action follows a number of recalls lets and that it had required suppliers who ship- been received by 3 August 2009. Although test by McNeil last year. In October,for instance, ped materials to its plants to discontinue the results indicative of contamination with TBA the company recalled selected Tylenol prod- use of the pallets. had been available since September 2009, add- ucts in Canada and the US for different reasons Nevertheless, the FDA’s warning letter said ed the letter,they had not been shared with the (OTC bulletin,16 October 2009, page 16). that the company had failed to investigate thor- FDA until the inspection of the Las Piedras The following month, the company recalled oughly the problem and had failed to extend plant began and several requests for the infor- some lots of Tylenol Arthritis Pain in the US the investigation to other batches of the same mation had been made. after a small number of consumers reported an product and other products that may have been Furthermore, said the warning letter,after uncharacteristic odour along with nausea and associated with the problem. concluding in October 2009 that the most prob- related symptoms (OTC bulletin,16 Novem- The warning letter pointed out that the FDA able root cause of the odour in Tylenol Arthri- tis Relief caplets was the exposure of drug pro- duct bottles to wood pallets chemically-treated A food supplement containing key vitamins, minerals with the chemical that breaks down to TBA, and nutrients for women who are pregnant, McNeil did not expand the scope of the inves- breast-feeding or trying for a baby is the latest offering from German firm Jenapharm. tigation to other lots and products that could The women’s health specialist said its GynVital have been affected. Gravida supplement provided key nutrients for McNeil’s quality management should have children’s development in one-a-day, softgel capsules. ensured the start of chemical testing far earlier, According to Jenapharm, the pharmacy-exclusive supplement’s formulation was based on the findings said the FDA’s warning letter,and failure to do of a national nutrition study conducted by Germany’s so had prolonged identification and resolution ministry of nutrition, agriculture and consumer of the problem. This had resulted in continued protection. Each capsule provides 400µg folic acid, 200mg docosahexaenoic acid from fish oils, consumer exposure, stressed the FDA. 120mg and 100µg iodine, as well as 45mg The FDA also complained about a lack of magnesium, 15mg niacin and a range of vitamins. response from McNeil’s parent company, John- A month’s supply of 30 softgel capsules has a recommended retail price of C 25.50. son & Johnson, when it was made aware of the Launch pharmacy-press advertising FDA’s concerns. “Neither upper management (pictured left) describes the product as “the at Johnson & Johnson nor at McNeil Consum- gynaecological essential-nutrient concept that er Healthcare assured timely investigation and encompasses pregnancy”. Jenapharm has also set up a telephone helpline resolution of the issues,”the FDA’s warning and a brand website at www.gynvital.de. letter concluded. OTC OTC

22 OTC bulletin 10 February 2010 OTC10-02-10p23FIN.qxd 5/2/10 12:49 Page 3

EVENTS OTC

FEBRUARY 2 March Postfach, 4002 Basel, Switzerland. MAY ■ Variations Regulation Tel: +41 61 225 5151. 22 February Cologne, Germany Fax: +41 61 225 5152. 18-19 May ■ The Borderlines Between Peter Bachmann and Susanne Win- E-mail: [email protected]. ■ Regulatory Affairs Cosmetics and Drugs terscheid from the German federal Website: www.diahome.org. in Africa London, UK institute for drugs and medical de- London, UK This one-day event will be chaired vices, BfArM will speak at this one- APRIL This two-day event will focus on by Ronald Marks, emeritus profes- day conference. 16 April pharmaceutical regulatory affairs sor of dermatology at the Univer- Contact:Forum Institut für ■ Medicines Variations in Africa, including South Africa. sity of Wales in the UK. Management, Postfach 10 50 60, Regulation Contact: Management Forum, 69040 Heidelberg, Germany. Contact: Management Forum, London, UK 98-100 Maybury Road, Woking, Tel: +49 6221 500 680. 98-100 Maybury Road, Woking, This one-day conference is organ- Surrey GU21 5JL, UK. Fax: +49 6221 500 555. Surrey GU21 5JL, UK. ised by the UK’s Medicines and Tel: +44 1483 730071. E-mail: [email protected]. Tel: +44 1483 730071. Healthcare products Regulatory Fax: +44 1483 730008. Website: www.forum-institut.com. Fax: +44 1483 730008. Agency (MHRA). E-mail: registrations@management- E-mail: registrations@management- 4 March Contact:Conferences and forum.co.uk. forum.co.uk. Website: www.management- ■ Variations to Marketing Learning Centre, MHRA, Website: www.management- Authorisations 16th Floor,Market Towers, forum.co.uk. forum.co.uk. London, UK 1 Nine Elms Lane, 18-20 May London SW8 5NQ, UK. 23 February A one-day conference focusing on ■ Vitafoods Tel: +44 20 7084 2903. ■ Marketing Authorisation mutual recognition, decentralised, Geneva, Switzerland in the European Union centralised and national variations Fax: +44 20 7084 3522. A three-day exhibition and confer- E-mail: [email protected]. Bonn, Germany to marketing authorisations with ence focusing on nutraceuticals, Website: www.mhra.gov.uk. Topics to be covered at this one- emphasis on the UK and Ireland. cosmeceuticals, functional foods day meeting will include: mutual Contact: Management Forum, 19, 20-21 & 22 April and functional drinks. recognition; variations; and the cen- 98-100 Maybury Road, Woking, ■ Regulatory Affairs in Contact: IIR Exhibitions, tralised procedure. Surrey GU21 5JL, UK. Central and Eastern 5th Floor,29 Bressenden Place, Contact:Forum Institut für Tel: +44 1483 730071. Europe London SW1E 5EW,UK. Fax: +44 1483 730008. Tel: +44 20 7017 7026. Management, Postfach 10 50 60, Budapest, Hungary E-mail: registrations@management- 69040 Heidelberg, Germany. A pre-conference symposium en- Fax: +44 20 7017 7818. forum.co.uk. Tel: +49 6221 500 680. titled ‘Regulatory affairs in the CIS E-mail: [email protected]. Website: www.management- Fax: +49 6221 500 555. region’ and a post-conference work- Website: www.vitafoods.eu.com. E-mail: [email protected]. forum.co.uk. shop on ‘Practical application of 30-31 May Website: www.forum-institut.com. 8-10 March pharmacovigilance in regulatory ■ Pharmaceutical ■ DIA Annual EuroMeeting affairs’ led by Lívia Stankovics Regulatory Affairs MARCH from Sanofi-Aventis will accom- Larvotto, Monaco in the Middle East ‘ The challenges of switching from panythis two-day meeting. 1 March Dubai, United Arab Emirates prescription to non-prescription sta- Contact:Informa UK, PO Box 406, ■ Marketing Authorisation Regulatory activities in Bahrain, tus through the centralised proced- Byfleet KT14 6WL, UK. in the CIS Countries Kuwait, Saudi Arabia and other ure’ is one of 13 themes at the an- Tel: +44 20 7017 7481. Berlin, Germany countries in the Middle East will nual EuroMeeting of the Drug In- Fax: +44 20 7017 7823. This one-day meeting will focus be discussed at this two-day event. formation Association (DIA). E-mail: [email protected]. on Belarus, Kazakhstan, Russia, Contact: Management Forum, Contact:DIA, Elisabethenanlage 25, Website: www.informa-ls.com. and the Ukraine, but will also cov- 98-100 Maybury Road, Woking, er Azerbaijan, Armenia, Mongo- Surrey GU21 5JL, UK. lia, and Uzbekistan. 9-11 June Tel: +44 1483 730071. Contact:Forum Institut für ■ 46th AESGP Annual Meeting Fax: +44 1483 730008. Management, Postfach 10 50 60, Dubrovnik, Croatia E-mail: registrations@management- 69040 Heidelberg, Germany. ‘Connecting with self-care. The future of self-medication in the new Eur- forum.co.uk. Tel: +49 6221 500 680. ope’ will be the theme of the 46th Annual Meeting of the Association of Website: www.management- Fax: +49 6221 500 555. the European Self-Medication Industry,the AESGP. forum.co.uk. E-mail: [email protected]. The three-day meeting will include a session entitled ‘How to be suc- Website: www.forum-institut.com. cessful in self-care’, featuring presentations from Manfred Scheske, pres- JUNE ident of GlaxoSmithKline Consumer Healthcare for Europe; Etienne de 1-2 March Laroullière, vice-president and head of global business unit OTC at Ny- 14-15 June ■ EuroPLX 42 comed; Cavan Redmond, senior vice-president and group president of ■ EuroPLX 43 Valletta, Malta Pfizer Diversified Businesses; and Dirk Van de Put, president and chief Berlin, Germany A two-day partnering and licens- executive officer,global OTC, at Novartis Consumer Health. A two-day partnering and licens- ing forum focusing on OTC med- Speakers at the meeting will also include: Martin Terberger and Basil ing forum focusing on OTC med- icines, nutraceuticals, branded pre- Mathioudakis of the European Commission; Thomas Lönngren of the icines, nutraceuticals, branded pre- scription drugs and generics. European Medicines Agency (EMEA); Dagmar Roth-Behrendt of the scription drugs and generics. Contact:RauCon, Kurfürstenstrasse 1A, European Parliament; and Catherine Geslain-Lanéelle and Vittorio Sil- Contact:RauCon, Kurfürstenstrasse 1A, 69234 Dielheim, Germany. ano of the European Food Safety Authority (EFSA). 69234 Dielheim, Germany. Tel: +49 6222 9807 0. Contact:AESGP,7Avenue de Tervuren, 1040 Brussels, Belgium. Tel: +49 6222 9807 0. Fax: +49 6222 9807 77. Tel: +32 2 735 51 30. Fax: +32 2 735 52 22. E-mail: [email protected]. Fax: +49 6222 9807 77. E-mail: [email protected]. Website: www.aesgp.be. E-mail: [email protected]. Website: www.raucon.com. Website: www.raucon.com.

10 February 2010 OTC bulletin 23 OTC10-02-10p24-25FIN.qxd 8/2/10 07:48 Page 2

OTC AESGP MEETING Centralised procedure is a tough nut to crack

Opening up Europe’s centralised procedure to non-prescription medicines is proving a tough nut to crack for both industry and regulators. Two products have now have been authorised but two others have been withdrawn. Deborah Wilkes reports.

hen a second non-prescription shown enough evidence that there was a rele- medicine was pulled out of Eur- vant advantage of using the combination over ope’s centralised authorisation ibuprofen alone. The committee also maintain- The role of the pharmacist had been a “breaking Wprocedure a few weeks ago, it ed that there was “insufficient information on point” in one centralised procedure for a highlighted the problems facing applicants from the safety of the medicine compared with med- non-prescription medicine, said Patrick Le Courtois, the OTC industry. icines containing only one of the active sub- head of the human medicines development and evaluation unit at the European Medicines Agency, Although two medicines have now obtained stances”. Furthermore, it requested additional adding that this issue must be addressed non-prescription status in all 27 member states information on how the combination would in- using the centralised procedure, points out Eric teract with other medicines. “open” to non-prescription medicines, but it was Abadie, chairperson of Europe’s Committee for Wyeth had supported its application with the not “wide open”. Medicinal Products for Human Use (CHMP), results of three main studies involving around According to Scheske, the centralised pro- two applications have been withdrawn by the 900 adults in mild to moderate pain. The stud- cedure was “absolutely critically important to sponsor. Furthermore, several applications und- ies compared the combination with a placebo the OTCindustry”. “If we talk about compet- er the ‘interest of patients’ clause in the legis- and a medicine containing ibuprofen alone. The itiveness, then we have to talk about European lation have been rejected, Abadie adds. company stressed in its official letter to the business and we have to talk about European The second withdrawal involved an applica- EMA that there were currently no ongoing clin- brands,”he said. “If we want more pan-Euro- tion from Wyeth Consumer Healthcare – now ical trials with the product. pean brands in the self-medication industry, part of Pfizer – to licence a new combination The first withdrawal of a non-prescription then the centralised procedure is the pathway of existing non-prescription medicines. The soft medicine from the centralised procedure hap- to get there.” capsules containing 200mg ibuprofen and 25mg pened just over a year ago. Pfizer pulled the diphenhydramine hydrochloride would have plug on its application to switch the erectile dys- Procedure can be very rewarding been indicated for short-term treatment of mild function drug Viagra (sildenafil citrate) from There was no question, continued Scheske, to moderate pain in adults who experience sleep- prescription to non-prescription status, remark- that the centralised procedure could be very re- lessness as a result of the pain (see front page). ing that it wanted “to fully consider” comments warding. In the US, the company markets a combina- from the CHMP (OTC bulletin,28 Novem- Just over a year ago, GlaxoSmithKline Con- ber 2008, page 1). sumer Healthcare’s Alli became the first non- Three main issues had been prescription medicine to be licensed through The CHMP is learning by doing, so if raised by the CHMP. It was con- the centralised procedure (OTC bulletin,29 there are more applications, there cerned that switching Viagra January 2009, page 1). Following its consumer will be more progress could lead to a lack of medical launch in April, the weight-loss medicine con- supervision, which could delay taining orlistat recorded sales in excess of £100 diagnosis of underlying condi- million (C115 million) in Europe during the rest tion of 200mg ibuprofen and 25mg diphenhy- tions. Furthermore, the committee felt that the of 2009 (see front page). The successful launch dramine hydrochloride as the non-prescription complexity of the proposed patient information of Alli should help tackle the obesity problem medicine Advil PM Liqui-Gels. It is indicated could lead to unintentional misuse of Viagra, in Europe, for relief of occasional sleeplessness when as- and non-prescription availability could result Nevertheless, Scheske warned that the cen- sociated with minor aches and pains. in abuse of Viagra for recreational purposes. tralised procedure was a “high maintenance Responding to the latter point, Pfizer drew route” with some “severe hurdles”. He urged No positive benefit-risk balance attention to the widespread and illegal supply all stakeholders to help make it the default At the time of the withdrawal, the applica- of erectile dysfunction drugs over the internet. pathway for non-prescription medicines in the tion was under review by the CHMP. In its of- Speaking in London recently at a gathering same way that it had become the default path- ficial letter to the European Medicines Agency of the European OTC industry,organised by way for prescription drugs. (EMA), Wyeth put its decision down to “the the Association of the European Self-Medica- Outlining some of the most important issues CHMP’s view that the data provided would not tion Industry,the AESGP,Manfred Scheske, that the OTC industry would like to see addres- allow the committee to conclude on a positive European president of GlaxoSmithKline Con- sed, Scheske stressed that there was a need to benefit-risk balance”. sumer Healthcare, told delegates that the door resolve problems with access to the central- According to the CHMP,Wyeth had not to the centralised authorisation procedure was ised procedure.

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AESGP MEETING OTC

Patrick Le Courtois – head of the EMA’s that the recital states: “Allowing access for pro- pharmacist,”he observed, adding that “the human medicines development and evaluation ducts although non-innovative.....that may be practice is different, the culture is different, the unit – reminded delegates that non-prescrip- of benefit to society or to patients....such as perceptions are different, and the healthcare tion medicines had two possible entry doors to medicinal products that can be supplied with- systems are organised differently”. the centralised procedure. The first was auto- out prescription.” Le Courtois said the concept of pharma- matic entry for switching centrally-authorised “Clearly it should allow for a broader und- cist intervention could be introduced into the prescription medicines, and the second was erstanding of what is meant by availability,and marketing authorisation. However, implemen- non-automatic entry for switching medicines what is meant by the interests of consumers in tation would be a challenge, he said, and the that had not been authorised through the cen- terms of choice and aspects such as afford- issue had not been solved. tralised procedure. ability of the product,”he said. “There is room According to Le Courtois, “important re- Commenting on the first door,Le Courtois for improvement, and it is something that we flection is needed to tackle this issue”. He re- said there had been two cases to date. A pos- will have to work on in the coming years.” called that the ‘blue box’ had provided a way itive outcome had been achieved for Alli, but Abadie, meanwhile, suggested that non-pre- of solving a similar blockage for prescription the outcome for Viagra had been negative. scription status could be trialled in one or a few medicines in the centralised procedure 15 years Moving on to the second option, Le Cour- member states to gain experience. The CHMP’s ago. The blue box would provide some flexi- tois said there had been 11 requests for eligi- chairperson also thought that a third rapporteur bility at the national level, he said, and could bility,of which only five had been accepted. might be helpful in the case of a centralised be a way to move for the future. Of these five,only two had so far reached a switch application. Another issue raised by Scheske was data conclusion. Nycomed’s 20mg pantoprazole tab- Another important issue raised by Scheske exclusivity,which he said had been treated in lets had been authorised as a non-prescription was the OTC industry’s question mark over a very defensive way. Neither GlaxoSmithKline’s heartburn medicine last year (OTC bulletin, whether decision-makers had sufficient under- Alli nor Nycomed’s 20mg pantoprazole tablets 27 February 2009, page 1), and Wyeth’s com- standing of the particularities of non-prescrip- ■ Continued on page 27 bination had been withdrawn. tion medicines. “Are all countries ready and willing to accept the centralised procedure for CHMP still has little experience non-prescription medicines?” he asked, adding With just 11 requests to date, stressed Le the role of the pharmacist was also an issue. Courtois, the CHMP still had little experience Acknowledging the CHMP’s lack of expe- of eligibility for non-automatic entry in the rience when it came to non-prescription medi- ‘interests of patients’. cines, Le Courtois said the committee had only He said four situations had been identified dealt with four applications for marketing auth- as acceptable by the CHMP: orisations and a small number of requests for ■ Class of product not yet available as non- eligibility. “Nevertheless,”he said, “the CHMP prescription medicines at the European level. is the only forum at the European Union level One request had so far been accepted. where key issues for non-prescription medi- ■ Availability as a non-prescription medicine cines are discussed.” in a few member states. Three requests had Le Courtois believed there was “clearly a been accepted. need for more experience at the centralised ■ Innovative non-prescription medicines, such level for non-automatic entry”. He added that as new combinations of existing non-prescrip- experience of automatic switches would come tion medicines, new fixed-dose combinations, naturally,as most new medicines were autho- Eric Abadie, chairperson of Europe’s Committee for Medicinal Products for Human Use (CHMP), or new modes of administration. The only re- rised through the centralised procedure. suggested non-prescription status could be trialled in quest accepted so far had been the application Thomas Lönngren, the EMA’s executive one or a few member states to gain experience prior by Wyeth that has since been withdrawn. director,has previously stated that the central- to an application for a centralised authorisation ■ Different decision taken by member states ised procedure will be a “primary source of based on identical safety/efficacy. No requests future switches” in Europe (OTC bulletin,30 had been accepted. June 2008, page 25). Le Courtois said all other claims had been Le Courtois highlighted a number of pro- rejected and the CHMP had advised compa- posals that were under discussion. “There is a nies to use the mutual-recognition or decen- clear need to enrich the CHMP with experi- tralised procedures. Requests, he noted, based ence of member states and of experts in non- on cost for the company, cost for patients, or prescription areas,”he said. “And to address wider access when identical products were al- the composition of the rapporteurs, co-rappor- ready on the market, had all been refused. teurs and peer reviewers.” Le Courtois acknowledged that “availab- Discussing the role of the pharmacist, Le ility as a non-prescription medicine in a few Courtois said this had been “a main issue for member states” was a tricky question. “You the small number of products that have been could ask what is more than a few?” he asked. looked at by the CHMP”. “The role of the According to Le Courtois, Recital 9 of Reg- pharmacist has been a breaking point in one ulation EC/726/2004 was very clear about how of the procedures,”he remarked. Manfred Scheske, president of GlaxoSmithKline Consumer Healthcare Europe, said the door to the the centralised procedure could be used for non- “There is little harmonisation at the Euro- centralised procedure was “open” to non-prescription prescription medicines. He reminded delegates pean Union level in terms of the role of the medicines, but it was not “wide open”

10 February 2010 OTC bulletin 25 OTC10-02-10p26-27FIN.qxd 8/2/10 10:36 Page 2

OTC COMPANY NEWS

Licensing Agreements/Annual Results Novartis to offer Pantoloc in 14 countries

■ Continued from front page Animal Health 19%, 2009 Change -artis’ OTC business, said that the goal was to OTC 52%, US$1.1bn US$3.0bn (US$ millions) 2008/2009 (%) make Pantoloc Control a leading OTCbrand in Europe. Net sales 5,812 ±0 The announcement about Pantoloc Control Gross profit 3,804 -1 comes soon after Novartis launched the pro- Marketing & sales -2,054 -1 Ciba Research & development -346 +11 ton-pump inhibitor Prevacid 24HR into the US Vision OTC market on 12 November. The company is 29%, General & administration -376 -2 backing the 15mg lansoprazole delayed-release US$1.7bn Other income & expenses -12 -64 capsules with a massive US$200 million (C135 Figure 1: Novartis Consumer Health’s Operating income 1,016 -3 million) consumer campaign (OTC bulletin, sales in 2009 –static at US$5.81 billion 16 November 2009, page 1). – broken down by business unit Figure 4: Novartis Consumer Health’s continuing operations in the (Source – Novartis) full year of 2009 (Source – Novartis) “With both these launches that bring high- ly-effective medicines to frequent heartburn the global market with a share of 3.18%. switches on a country-by-country basis. sufferers,”said the company, “Novartis Con- Commenting on Novartis’ acquisition strat- Sales by Novartis’ Consumer Health divi- sumer Health is committed to a long-term strat- egyfor its OTC business, George Gunn, world- sion – which includes the Animal Health and egy in the gastrointestinal health arena.” wide head of Novartis Consumer Health, told Ciba Vision businesses as well as the OTC op- Announcing its annual results, Novartis said OTC bulletin that the company intended to eration – were flat at US$5.81 billion in 2009. Prevacid 24HR had recorded sales of more than “have a look at virtually anything that comes In local currencies, however, sales improved US$100 million on day one. The company add- up”. “We are looking for deals that will be com- by 5% (see Figure 2). ed that it had taken a 20% share of the US OTC plementary to our existing business, either on The US was the best performing region for market for proton-pump inhibitors in the first asegment basis or a geography basis,”he added. Consumer Health, with sales rising by 10% to two months on the market. Gunn noted, however, that these sort of deals US$1.89 billion (see Figure 3). Launching Prevacid 24HR in the US help- did not come up very often and when they did Novartis noted that all three of its Consum- ed push worldwide sales at the company’s OTC multiples were high. er Health businesses had achieved faster under- business up by 5.2% in local currency terms to Commenting on switches, Gunn said Nov- lying growth than their respective markets de- US$3.0 billion in 2009. artis was constantly reviewing its own portfo- spite the difficult economic conditions. As can be seen from Figure 1, the OTC busi- lio and was also looking at potential switches Operating income at the Consumer Health ness accounted for 52% of sales by Novartis’ for third parties. As regulatory systems around division dropped by 3% to US$1.02 billion in Consumer Health division. Novartis said its the world were “completely uncoordinated”, 2009 (see Figure 4). OTC business held a number four position in he noted, OTC companies had to approach Fourth-quarter turnover by the Consumer

Division Annual sales Change 2008/2009 (%) Operating income Change Operating (US$ millions) US$ Local currencies (US$ millions) 2008/2009 (%) margin (%) Pharmaceuticals 28,538 +8 +12 8,392 +11 29.4 Sandoz 7,493 -1 +5 1,071 +1 14.3 Consumer Health* 5,812 ±0 +5 1,016 -3 17.5 Vaccines and Diagnostics 2,424 +38 +39 372 –15.3 Corporate –––-869 -33 – Total Novartis 44,267 +7 +11 9,982 +11 22.5

* Continuing operations

Figure 2: Breakdown of financial performance of Novartis in 2009 (Source – Novartis)

Division Fourth-quarter sales Change 2008/2009 (%) Operating income Change Operating (US$ millions) US$ Local currencies (US$ millions) 2008/2009 (%) margin (%) Pharmaceuticals 7,773 +21 +13 1,906 +22 24.5 Sandoz 2,143 +19 +10 221 +11 10.3 Consumer Health 1,623 +20 +13 207 +9 12.8 Vaccines and Diagnostics 1,387 +182 +166 583 –42.0 Corporate –––-280 +16 – Total Novartis 12,926 +28 20 2,637 +57 20.4

* Continuing operations

Figure 5: Breakdown of financial performance of Novartis in the fourth quarter of 2009 (Source – Novartis)

26 OTC bulletin 10 February 2010 OTC10-02-10p26-27FIN.qxd 8/2/10 10:36 Page 3

COMPANY NEWS OTC

Health division jumped up by 20%, or 13% in Joe Jimenez local currencies, to US$1.62 billion (see Fig- Centralised procedure ure 5). Growth was led by OTCexpansion at a double-digit rate in local currencies on the is tough nut to crack strength of the Prevacid 24HR launch and strong ■ Continued from page 25 demand for cough and cold products. were granted the one-year period of data ex- Novartis also announced that its chairman clusivity available to innovative switches und- and chief executive officer Daniel Vasella was er European legislation. handing over his role as the Swiss group’s chief Scheske said the question of incentives for executive officer on 1 February to Joe Jimenez, the OTC industry must be addressed. “The pro- the former worldwide head of the company’s cedure is a long-lasting road, a winding road Pharmaceuticals division. Jimenez is also a Daniel Vasella and an expensive road,”he remarked. “It ab- former worldwide leader of the Consumer sorbs huge resources and not every stakehold- Health division. er – particularly small- and mid-sized entities Novartis highlighted that Jimenez had “in- –can afford to do this.” ternational experience in pharmaceuticals and Le Courtois noted that “specific innovative consumer businesses”. research for non-prescription products is nec- Jimenez leads a Novartis executive com- essary and should be stimulated”. mittee that has been reduced from 12 to nine Stressing the importance of continuous dia- members, including Jeff George as head of logue, he said the EMA-AESGP platform set Sandoz. Former Sandoz head Andreas Rum- up in 2007 had been “a very successful tool melt has left the group, as has chief operat- for the mutual understanding of problems, col- ing officer Jörg Reinhardt, who had been up focus on strategic priorities as chairman. laboration, and sharing of information”. In- against Jimenez for the role of the group’s chief Noting the planned acquisition of Alcon deed, Le Courtois wanted to see the EMA- executive officer. (OTC bulletin,20 Janury 2010, page 5), Vas- AESGP platform extended to members of The firm said Vasella, who had been chief ella said it would “propel Novartis to the global the CHMP. executive officer of Novartis for 14 years, would leadership position in eyecare”. The EMA would continue its dialogue with healthcare professionals such as the Pharmaceu- Region Annual sales Change 2008/2009 (%) tical Group of the European Union (PGEU), (US$ millions) US$ Local currencies he added. Europe 2,541 -7 +2 US 1,892 +10 +10 CHMP is learning by doing Asia/Africa/Australasia 883 +2 +2 According to Le Courtois, there was a clear Canada and Latin America 496 -1 +7 need for broader experience of non-prescrip- Novartis Consumer Health* 5,812 ±0 +5 tion medicines at the centralised level through more applications. “The CHMP is learning by * Continuing operations doing,”he commented, “so if there are more Figure 3: Breakdown of Novartis Consumer Health’s sales in 2009 (Source – Novartis) applications, there will be more progress.” OTC OTC

10 February 2010 OTC bulletin 27 Te ll the right people what you want to buy and

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