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28 February 2011

COMPANY NEWS 2 Meda adds Antula to its Merck KGaA backs 2 Consumer Health Care unit Futura signs up Ansell to 3 launch topical delay spray expanding OTC business BioGaia gets sales boost 4 from Nestlé formula deal Reckitt considers future 5 eda is set to make its sixth OTC ac- The Antula deal is the latest move by Meda of SSL brands Mquisition in less than six months by to expand its OTC business and is its second Sanofi-Aventis has 6 acquiring Antula and its portfolio of brands OTC buy in the Nordic region in the past six big plans for Allegra from Healthcare Brands International for months. In late September 2010, Meda acquir- Tough Russian markethits 7 SEK1.8 billion (C205 million). ed Swedish firm BioPhausia’s portfolio of six Oriola-KD’s operating profit Over the past five years, Meda pointed out, OTC brands for SEK190 million (OTC bul- Core OTC brands boost 8 Antula had built up a range of strong brands in letin, 29 September 2010, page 1). sales at Pharmstandard the Nordic region with annual sales of around Earlier in September, the firm had estab- Oxford Nutrascience can now 9 SEK500 million. Antula’s portfolio includes the lished an OTC platform in the US following taste-mask ibuprofen Anti aciclovir cream, Eeze diclofenac tablets its US$350 million (C259 million) Alaven buy and spray, Eox naproxen tablets, Recrea minox- (OTC bulletin, 10 September 2010, page 1). GENERAL NEWS 10 idil solution, and SB12 disinfectant mouthwash. Meda expanded its fledgling US OTC busi- Acquiring Antula gave Meda several prod- ness in December by acquiring the Geritol French pharmacies hit back 10 at Leclerc over distribution ucts that had the potential to become strong multivitamin, the Feosal iron supplement and international brands, claimed Meda, as well as another unnamed iron supplement from Glaxo- Watson wins Mucinex 12 patent case in the US access to Antula’s product pipeline that consist- SmithKline, and then again in January by ac- ed of “three to four new products annually”. quiring the Contac cold and flu line and the Counterfeit law may apply to 13 some non-prescription medicines Meda pointed out its expanded OTC busi- Vivarin caffeine supplement from GlaxoSmith- ness, including Antula’s OTC brands, would Kline (OTC bulletin, 21 January 2011, page 4). MARKETING NEWS 14 account for more than a fifth of group sales, The expansion in the US came shortly after which were SEK11.6 billion in 2010. Meda had snapped up three OTC brands from Teva wants wider access 14 Subject to closing requirements and the ap- Dutch company Norgine for SEK540 million to Plan B One-Step in US proval of competition authorities, the deal is (OTC bulletin, 16 November 2010, page 1). GSK to expand Alli with a 15 expected to close within a couple of months. ■ Continued on page 21 chewable tablet in Europe GlaxoSmithKline brings 16 Flixonase into Piri range Europe looks into Novartis raids J&J FEATURES 18 Consumers choose products 18 pholcodine safety for new OTC chief they trust Retail dynamics hold key 20 he safety of medicines containing phol- ovartis has recruited Naomi Kelman – to geographic expansion Tcodine is under review by the European Npresident of the Lifescan North America Union’s Committee for Medicinal Products for business within Johnson & Johnson’s Diabetes REGULARS Human Use (CHMP). Care division – as head of its global OTC busi- Events – Our regular listing 17 “The potential link between the use of phol- ness with effect from 2 March 2011. People – Bayer recruits Mann 23 codine-containing medicines and anaphylactic Kelman’s appointment coincides with key reactions in patients subsequently exposed to changes to Novartis’ Consumer Health divi- People – Boehringer confirms Wright 23 neuromuscular blocking agents (NMBA) used sion – which comprises the Animal Health, STOP PRESS in anaesthesia” is the focus of the review. CIBA Vision, and OTC businesses – follow- The CHMP will make recommendations on ing its acquisition of eyecare specialist Alcon Bayer names OTC head whether the marketing authorisations for phol- (OTC bulletin, 21 January 2011, page 4). The Bayer HealthCare has recruited Pfizer’s Erica codine-containing medicines should be main- OTC and Animal Health businesses will be- Mann to replace Gary Balkema as worldwide head of its Consumer Care business. Turn to tained, changed, suspended or revoked. Phol- come stand-alone divisions alongside the exist- page 23 for full details. codine-containing medicines, which are used ing Pharmaceuticals, Sandoz and Vaccines & ■ Continued on page 21 ■ Continued on page 23 OTC28-02-11p2-3FIN.qxd 23/2/11 14:14 Page 2

OTC COMPANY NEWS

Annual Results Merck backs Consumer Health Care unit

erck KGaA has no intention of selling Business Annual sales Change Operating profit Change Mits Consumer Health Care business, ac- (C millions) (%) (C millions) (%) cording to chief executive officer Karl-Ludwig Kley. However, Kley did admit that the com- Merck Serono 5,754 +8 565 +59 pany was “not satisfied” with the division’s per- Consumer Health Care472 +1 14 -71 formance in 2010. Total Pharmaceuticals 6,226 +7 579 +44 Kley’s comments came as the German firm Merck Millipore 1,681 +81 44 -59 blamed problems in China, impairment losses Performance Materials 1,384 +38 580 +166 in Mexico and a warehouse fire in the UK for Corporate and others ––-90 +14 a 71% drop in Consumer Health Care’s 2010 Total Merck 9,291 +20 1,114 +72 operating profit to just C14 million. The difficulties in China, Mexico and the Figure 1: Merck KGaA’s sales and operating profit in 2010 (Source – Merck KGaA) UK, Merck said, had been compounded by a 28% rise in research and development expen- Health Care division was for sale. The firm “did been for the problems in China. diture in the 12 months. not intend to sell” the business, he added. Commenting on China, Merck explained Meanwhile, the company said sales by Con- Maintaining a Consumer Health Care di- that Consumer Health Care had expanded too sumer Health Care had edged up by 1.1% to vision “made sense”, Kley insisted, adding that fast outside the four major Chinese cities of C472 million in 2010 (see Figure 1). As a result the division was “regionally very strong”, it was Beijing, Guangzhou, Shanghai and Shenzen, of the decline in operating profits, the division profitable and had a positive cash flow. and a considerable amount of stock had not recorded a return on sales of only 2.9%. This Kley said Merck wanted Consumer Health been sold to consumers. was down from 10.3% in 2009. Care to achieve critical mass on a global scale, Furthermore, continued Merck, the division Earlier this month, Kley threw the future of but this was “quite a difficult exercise”. had reached an exclusive agreement with the Merck’s Consumer Health Care business into Acquisitions were one way of reaching this Chinese Medical Doctors Association to offer doubt after saying in a newspaper interview that goal, Kley said, but the company felt that cur- its Diabion food supplement in major hospitals, the company had not ruled out selling the busi- rent prices in the OTC sector were not very but had not received government permission ness if it made “economic sense” (OTC bul- attractive. Merck could also look to form part- to allow doctors to prescribe the product. letin,11 February 2011, page 3). nerships, seek out individual brand acquisitions, The Consumer Health Care division entered Speaking at Merck’s annual press confer- do product swaps and invest in organic develop- the Chinese market in 2007 (OTC bulletin,29 ence, Kley sought to clarify his comments, in- ment to grow the division, he ventured. May 2009, page 20). sisting that he had never said the Consumer Kley refused to put a time line on Consumer Merck said the difficulties in China had re- Health Care’s development, saying that as long sulted in Consumer Health Care’s sales in Asia Europe as the business maintained a good level of prof- dropping by 4.8%. This in turn had hit growth 71% itability then it would get “all the time in the in the Asia, Africa, Australasia region, where world” to become a global player. sales had risen by just 1.8% to C57 million, or However, if profits remained at the level seen 12% of the division’s total (see Figure 2). in 2010, then Consumer Health Care’s devel- In Latin America, sales had fallen by 9.6% opment would “have to speed up”, Kley warned. to C81 million, Merck said, due to currency ex- Merck pointed out that Consumer Health change-rate losses in Venezuela. Asia, Africa, Latin America Australasia Care’s organic sales had advanced by 2.6% Europe remained Consumer Health Care’s 17% 12% worldwide in 2010, and the division had “ex- biggest region, with turnover rising by 3.8% to ceeded average market growth” in many coun- C331 million. In France – Consumer Health Figure 2: Sales by Merck KGaA’s Consumer Health Care business in 2010 – C472 million – by region tries. Organic growth would have been an even Care’s biggest individual market – sales had (Source – Merck KGaA) better 5.2%, added the company, if it had not increased by 1.8% to C101 million, pointed out Merck, while UK turnover had slipped back Brand Annual sales Change Proportion by 0.7% to C54 million after a poor perform- (C millions) 2009/2010 (%) of total (%) ance by the Femibion brand. Bion 54 +11 11 Turning to Consumer Health Care’s five strategic brands – Bion, Femibion, Kytta, Nasi- Nasivin 52 +23 11 vin and Seven Seas – Merck pointed out that all Seven Seas 44 +14 9 but one had posted a double-digit sales rise in Femibion 41 +24 9 2010 (see Figure 3), and had accounted for Kytta 15 -21 3 44%, or C206 million, of the division’s sales. Others 266 –56Merck blamed the 21% decline in Kytta sales on increased advertising by the brand’s Total Consumer Health Care472 +1 100 competitors in Germany. Figure 3: Sales of Merck KGaA’s five strategic Consumer Health Care brands in 2010 (Source – Merck KGaA) OTC

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COMPANY NEWS OTC

Licensing Agreements Mergers & Acquisitions Futura signs up Ansell to Sinclair in talks launch topical delay spray with IS Pharma inclair Pharma and IS Pharma have an- utura Medical’s PET500 topical spray to 2009 so it complied with a US Food and Drug Snounced that they are in “advanced dis- Fdelay male ejaculation will be commercial- Administration (FDA) monograph and could cussions” over a possible merger to create Sin- ised by Ansell Limited – owners of the Mates be launched without any further clinical data clair IS Pharma. condom brand – after the two companies agreed (OTC bulletin,30 September 2009, page 5). The UK-based companies said the potential a worldwide licensing deal. Under the terms of the agreement, Futura merger would create a “fully-integrated pan- A launch strategy had already been develop- would receive a “significant royalty rate on sales European speciality pharmaceutical company” ed by Ansell, Futura noted, adding that the spray and a modest upfront payment”, the firm said. with access to “substantial growth opportunities would be on the market “as soon as practicable”. The branding of the product would be devel- in emerging markets through existing and new A topical spray that combines Futura’s Der- oped by Ansell, Futura noted, which would also regional strategic partnerships”. maSys AquaFree delivery system with a mild be responsible for the product’s manufacture Under the terms of the proposed merger,IS anaesthetic, PET500’s formula was modified in and for funding all regulatory work. Pharma shareholders would receive 2.6868 Sin- James Barder,Futura’s chief executive offi- clair shares for each IS Pharma share, the com- cer,said the company was looking forward to panies noted, valuing IS Pharma at around £54 OTC bulletin working closely with Ansell and making a suc- million (C64 million). cess of PET500. If the merger goes ahead, Sinclair share- 28 February 2011 Number 357 The agreement for PET500 brings a second holders would own 62.4% of the enlarged com- Futura product close to market. The company pany, with IS Pharma stock holders owning the Editor & Publisher: Deborah Wilkes is currently awaiting a CE mark award for its remaining 37.6%. Associate Editors: Aidan Fry CSD500 erection-maintaining condom, which The merger would bring together Sinclair’s Mike Rice Reckitt Benckiser is planning to launch under portfolio of speciality skincare, woundcare and Business Editor: Matt Stewart the Durex brand name. Futura said it expected oral-care products – including the Atopiclair Assistant Editors: Joanne Grew, Jenna Lawrence, CSD500 to receive its CE mark in early 2011 dermatitis brand, Decapinol oral-care range David Wallace (OTC bulletin,21 January 2011, page 9). and XClair wound-care line – with IS Pharma’s Advertising Controller: Debi Minal Meanwhile, Futura said its revenues – which range of late-stage pharmaceuticals and med- comprised payments from commercial partners ical devices focused on the oncology,critical Marketing Manager: Val Davis – increased from £50,000 (C59,316) in 2009 care and neurology sectors. Editorial, Subscription and Advertising to £125,000 in 2010, while the company’s pre- Sinclair IS Pharma would be headquarter- enquiries should be addressed to: OTC bulletin, OTC Publications Ltd, 54 Creynolds Lane, Solihull, tax loss had narrowed from £1.51 million to ed in the UK, the companies noted, with direct West Midlands B90 4ER, UK. £1.32 million. commercial operations in France, Germany, Tel: +44 1564 777550. Fax: +44 1564 777524. Over the 12 months, Futura had taken im- Italy,Ireland, Spain and the UK. E-mail: [email protected]. portant steps to becoming a profitable company, OTC Subscriptions Barder said, and was looking forward to having Annual subscriptions to OTC bulletin in Europe are £625.00 for two revenue-generating products in the fore- single copies and £355.00 for additional copies to the same ad- Mergers & Acquisitions dress, including delivery. Subscriptions to addresses outside Eur- seeable future. ope are subject to an additional charge of £30.00 to cover postage. During the year,Futura also licensed the Subscription enquiries in Korea should be directed to Pharma Massmart investors Koreana Ltd, 14th Floor,KTB Network Building, 826-14 Yeoksam- development rights to its TPR100 topical OTC dong, Kangnam-gu, Seoul 135-080, Korea (Tel: +82 2 554 9591; pain-relief product to GlaxoSmithKline (OTC Fax: +82 2 563 8289; E-mail: [email protected]). back Walmart offer Advertising bulletin,30 July 2010, page 7). The company Advertising rates and data are available on request from the ad- added that it expected to agree a commercial hareholders in South African retailer Mass- dress above or at www.otc-bulletin.com. distribution deal for the product with Glaxo- Smart have voted in favour of US retail giant About OTC bulletin OTC bulletin is published 20 times a year by OTC Publications SmithKline subject to clinical trials and regu- Walmart’s offer to acquire a 51% stake in the Limited: twice monthly in February,March, April, May,June, Sep- tember,October and November; and monthly in December,Jan- latory approvals. company for R148.00 (C15.06) per share. uary,July and August. A subscription to OTC bulletin includes OTC Walmart made its offer in November last the weekly electronic newsflash, news@OTCbulletin,which is published around 45 times a year. OTC bulletin is printed by the year,claiming the deal fitted with its strategy Warwick Printing Company Limited, Caswell Road, Leamington IN BRIEF of investing in high-growth markets and would Spa CV31 1QD, UK. enable it to accelerate Massmart’s growth and No part of this publication may be copied, reproduced, stored in a retrieval system or transmitted in any form without prior ■ NAVA MEDIC said sales through its Vitaflo expansion in South Africa. permission from OTCPublications Ltd. Scandinavia sales and distribution business had Operating in 14 countries across sub-Saha- ©OTC Publications Ltd. All rights reserved. Company registered in England No 2765878. Registered Office: increased by 4.8% to NKr55.1 million (C7.1 ran Africa, Massmart owns nine wholesale and 54 Creynolds Lane, Solihull, West Midlands B90 4ER, UK. million) in 2010. Vitaflow Scandinavia dis- retail chains and one buying group, each focus- OTC bulletin® is registered as a trademark in the European tributes the Glucomed brand in Denmark,Fin- ed on “high-volume, low-margin, low-cost dis- Community. land, Norway and Sweden. tribution of mainly consumer goods for cash”. ISSN 1350–1097 www.OTC-bulletin.com OTC OTC

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OTC COMPANY NEWS

Nine-Month Results Annual Results Consumer sales BioGaia gets sales boost grow at Takeda from Nestlé formula deal onsumer Healthcare turnover at Japan’s CTakeda Pharmaceutical increased by 2.8% ncreased deliveries of the probiotic Lacto- vakia and Ukraine, had also started to “reach to ¥48.4 billion (C426 million) in the nine Ibacillus reuteri for use in Nestlé’s infant for- significant volumes”. months ended 31 December 2010. mulas helped to drive up sales at Sweden’s Bio- In contrast, sales in Asia had declined sharp- The growth was attributed to better sales Gaia by 16% to SEK236 million (C26.9 million) ly over the year,BioGaia pointed out, as the of the Alinamin brand of vitamin tonic drinks in 2010. Excluding currency effects, turnover company stopped selling directly to Japanese and an increase in turnover from the Benza cold would have risen by 27%. retailers. During the year,it had signed a dis- remedies range. Peter Rothschild, BioGaia’s president, said tribution deal with wholesaler Nippon Access Four out of Takeda’s five best-selling Con- the partnership with Nestlé – which began in (OTC bulletin,17 March 2010, page 7). sumer Healthcare products reported a rise in 2008 (OTC bulletin,12 September 2008, page This had been compounded,BioGaia said, sales over the nine months. However, sales of 3) – had contributed an important share of its by one of its partners in China not taking de- Alinamin vitamin tablets – the division’s big- sales growth over the 12 months. livery of any of the company’s probiotic straw gest seller – dropped by 2.5% to ¥11.6 billion. A raft of launches in 2010 meant that Nestlé products, and other partners cutting back on In contrast, Alinamin tonics posted turnover infant formulas containing BioGaia’s patented their purchasing volumes. up by 5.8% to ¥10.3 billion, while Benza – ex- probiotic Lactobacillus reuteri were now avail- Negotiations with two of the company’s cluding drinks – reported a 9.7% jump in sales able in 19 markets around the world, Rothschild Asian partners regarding compensation for fail- to ¥7.6 billion. pointed out, adding that the Swiss consumer ing to meet their contracted volumes were un- The top five was completed by the Biofer- giant was happy with how “quickly and success- derway,BioGaia insisted. min and Borraginol brands which posted sales fully” the partnership had started. On the product side, sales of the company’s up by 5.9% to ¥5.3 billion and 3.6% to ¥3.2 “After only a short time,”Rothschild noted, probiotic drops and tablets had continued to billion respectively. “Nestlé is on its way to becoming one of our grow, BioGaia said, adding that BioGaia-brand- Consumer Healthcare’s top five brands ac- largest customers.” ed products now accounted for nearly 40% counted for 79% – ¥38 billion – of the divi- BioGaia’s sales growth had also been aided of its total finished product sales. sion’s total sales in 2010. by strong performances in its “relatively well- Operating profit grew even faster than sales, Operating income at Takeda’s Consumer established markets” in Europe, including Fin- rising by 18% – 51% excluding currency effects Healthcare business grew by 22.1% to ¥12.0 land, Italy and Spain, the company said, while – to SEK56.3 million, despite an increase in billion, thanks to a decline in expenses. Eastern European markets, such as Poland, Slo- selling costs. OTC OTC

Mergers & Acquisitions Dermapharm buys Germany’s Hübner erman skincare and allergy firm Derma- Gpharm has acquired natural products com- pany Anton Hübner for an undisclosed fee. Anton Hübner produces natural medicines, food supplements, medical devices and body- care products. The company claims to be Ger- many’s leading supplier of products to ‘Re- formhaus’ healthfood stores. Among Anton Hübner’s brands are the Arth- oro range of food supplements for arthritis suf- ferers, the iron supplement Eisen Vital F and the green-lipped mussel extract Grünlipp. The vendor,sugar producer Nordzucker, highlighted potential synergies in the supply chain. Ferber & Co – which advised Derma- pharm on the transaction – said the deal would offer the dermatology specialist a new distribu- tion route through the Reformhaus channel. OTC

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COMPANY NEWS OTC

Annual Results Reckitt considers future of SSL brands

eckitt Benckiser is considering the future Business Annual salesChange 2009/2010 (%) Rof a number of smaller OTC brands the (£ millions) £CER* company gained when it acquired SSL Inter- national in October last year. Health & Personal Care2,265 +9 +6 A spokesperson for Reckitt Benckiser told Fabric Care1,576 ±0 -1 OTC bulletin that some of SSL’s smaller brands Surface Care1,391 +8 +4 were “up for review as to whether we should Home Care1,152 +11 +8 retain them or not”, but that the company would Dishwashing 875 +4 +3 not disclose the names of these brands. Other Household 63 -3 +2 Bart Becht, Reckitt Benckiser’s chief exec- Household and Health & Personal Care 7,322 +6 +4 utive officer,said the company had already re- Pharmaceuticals 737 +25 +24 moved what he described as “discontinued busi- Food 304 +11 +9 nesses” from its sales growth forecast of 4% SSL 90 –– for SSL in 2011. Removing the discontinued businesses from Total Reckitt Benckiser 8,453 +9 +7 the forecast would have no impact on SSL’s * CER is constant exchange rates profit, Becht pointed out, which showed why Figure 1: Reckitt Benckiser’s sales in the year ended 31 December 2010 by business (Source – Reckitt Benckiser) they should be discontinued. “It’s a huge number of complex little crap, inex,Reckitt Benckiser pointed out, due to high romol would be available from all UK pharma- basically,which sits in that portfolio, which demand for cough and cold products in 2009 cies in March and would be rolled-out in further makes no money,”Becht insisted. caused by the H1N1 swine flu outbreak. markets over the next 12 months, Kapoor noted. “Yes, it takes the net revenue number down,” The Dettol powerbrand had continued to Another new addition to Health & Personal he added, “but it means nothing for the cash, if deliver “excellent growth” in developing mar- Care’s portfolio would be the Clearasil Ultra anything it is good for the cash, as [the discon- kets and Europe to the Personal Care business, Acne and Marks product, which helped reduce tinued businesses] tie up net working capital.” the company noted, adding that the Dettol/Ly- the appearance of visible marks left behind by Rationalising this portfolio had already be- sol No-Touch Hand Soap System had “con- acne and reduced redness and pimple size in up gun, Becht stated, adding that more brands tributed strongly” along with the Veet hair re- to four hours, Kapoor claimed. might be divested to make SSL – for which moval range. In December,Reckitt Benckiser expanded Reckitt Benckiser paid £2.54 billion (C3.03 bil- its Health & Personal Care business by acquir- lion) (OTC bulletin,30 July 2010, page 1) – a Powerbrands lift European sales ing the Indian OTC firm Paras Pharmaceuticals, “stronger,healthier,more focused business with In regional terms, the launch of the Dettol together with its D’Cold winter remedy and better profits”. No-Touch Hand Soap System boosted Health Moov topical analgesic, for INR32.6 billion The decision is not entirely surprising giv- & Personal Care’s European performance, along (C534 million) (OTC bulletin,16 December en that shortly after Reckitt Benckiser had ac- with contributions from the Gaviscon, Nurofen 2010, page 1). quired the company (OTC bulletin,16 Novem- and Strepsils lines. Commenting on the deal, Becht said that one ber 2010, page 5), Becht described SSL’s local Health & Personal Care’s turnover in North of the motivating factors behind the acquisition brands – including its portfolio of UK OTC America and Australia had been driven by the had been the success of the company’s Health brands – and its “other” products, as a “drag” Lysol No-Touch Hand Soap System, Reckitt Care business in Russia, which had shown what on SSL’s growth rates. Benckiser noted, while in developing markets a healthcare business could achieve in an emerg- Reckitt Benckiser had already agreed to sell the Dettol personal-care line of shower gels and ing market. two of SSL’s mouth-pain-relief products in the soaps had delivered excellent growth, along with Although Paras was relatively small, it had UK and Ireland to gain European Commission Gaviscon, Strepsils and Veet. some “very nice brands” and had been growing approval for its acquisition of SSL (OTC bul- Looking forward, Rakesh Kapoor,Reckitt consistently at 15% in a very buoyant market, letin,16 November 2010, page 4). Benckiser’s executive vice-president, category Becht noted, adding that this was the reason Meanwhile, Reckitt Benckiser’s Health & development, said the company would expand why Reckitt Benckiser had paid a “relatively Personal Care division posted sales up by 9% its Dettol/Lysol, Clearasil and Scholl lines over high price” for the company. – 6% at constant exchange rates – to £2.27 bil- the first half of 2011 and would roll out a new Reckitt Benckiser also added to its US lion in 2010 (see Figure 1), driven by “excel- combination pain reliever Nuromol in a num- healthcare business by acquiring a range of lent” growth of its powerbrands. ber of markets over the next 12 months. brands, including the Lanacane skincare line, This result excludes the £90 million gener- Nuromol was a “real breakthrough”, Kapoor from privately-owned Combe for an undisclosed ated by SSL in the short period from when it said, offering consumers a combination of para- sum (OTC bulletin,21 January 2011, page 1). was consolidated on 1 November 2010 to the cetamol and ibuprofen in one tablet that had Going forward, the firm would continue to end of the year,the company noted. been proven to give superior pain relief com- make add-on acquisitions in the healthcare sec- In Healthcare, strong performances from pared to codeine and paracetamol combinations. tor,Becht said, as it focused on “specific cap- the Gaviscon and Strepsils powerbrands had Already exclusively available at Boots stores ability gaps” and finding “strong powerbrands”. been partially offset by weaker sales of Muc- (OTC bulletin,21 January 2011, page 16), Nu- OTC

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OTC COMPANY NEWS

Business Strategy/Annual Results Sanofi-Aventis has big plans for Allegra

anofi-Aventis will back the US launch of Business Annual sales Change (%) Proportion Sthe OTC version of its allergy medicine Al- (C millions) CER* of sales (%) legra (fexofenadine hydrochloride) next month with a “massive”investment in advertising and Emerging Markets 1,050 +44.4 47 promotion, according to Hanspeter Spek, pres- Western Europe 630 +1.1 28 ident of global operations at the French phar- US 320 –14 maceutical company. Rest of World 217 +31.3 10 Spek said Sanofi-Aventis intended to make Total Consumer Health Care2,217 +55.0 100 Allegra into one of the top three brands in the US$1.5 billion (C1.1 billion) OTC allergy mar- * CER is constant exchange rates ket in the US. The firm was “very confident, and Figure 2: Breakdown of Sanofi-Aventis’ Consumer Health Care sales in 2010 by region (Source – Sanofi-Aventis) even optimistic”, that in a very short time Alle- gra would reach the same level of sales as the Sanofi-Aventis pointed out, while Chattem had ablished a majority-owned vitamin and miner- two leading brands in the category,he added. contributed C297 million to US turnover which als joint venture with Minsheng Pharmaceu- The Allegra portfolio of products – Allegra had reached C320 million in 2010. tical (OTC bulletin,10 February 2010, page 2) 12 Hour,Allegra 24 Hour,Allegra-D 12 Hour, In Western Europe, Consumer Health Care and had acquired BMP Sunstone and its port- Allegra-D 24 Hour and Children’s Allegra – sales had edged up by 1.1% to C630 million, folio of OTC cough/cold and women’s health was approved for OTC sale in the US by the the company noted, while turnover in the busi- brands (OTC bulletin,16 November 2010, page Food and Drug Administration (FDA) in Jan- ness’ Rest of World region had grown by 31.3% 1), Viehbacher noted. These buys had propelled uary of this year (OTC bulletin,11 February to C217 million. Sanofi-Aventis into fifth place in the Chinese 2011, page 16). Sanofi-Aventis said it would be Commenting on the Consumer Health Care OTC market, he claimed. launched in March. business, Chris Viehbacher,chief executive offi- During the year,Sanofi-Aventis also added Allegra was “extremely well-positioned to cer of Sanofi-Aventis, said that in the past three to its Consumer Health Care business in Can- be a leading consumer brand”, Spek claimed, years the company had gone from being no- ada by acquiring skincare specialist Canderm noting that it had “by far the least sedative where in the consumer healthcare sector to hav- (OTC bulletin,30 June 2010, page 1) and in effect” and a very strong brand name. In addi- ing a business with sales of over C2.0 billion Eastern Europe, where the company bought tion, Chattem – Sanofi-Aventis’ US OTC sub- and double-digit growth rates. Polish OTC company Nepentes (OTC bulletin, sidiary – had an “excellent record in switching Sanofi-Aventis had started 2010 with no 31 May 2010, page 1). products and making them a success”, he added. presence in the US or Chinese consumer mar- “We are building this business,”Viehbacher Spek’s comments came as Sanofi-Aventis kets, Viehbacher noted, but had finished the year concluded. “We are not a business with big glo- recorded a 45.7% rise at constant exchange rates having made significant progress in both. bal brands, but really Consumer Health Care is – 55.0% as reported – in sales at its Consumer In the US, the Chattem deal had been final- a local business, so we’ve got very strong posi- Health Care business to C2.22 billion in 2010 ised, Viehbacher said, giving the firm a “very tions in Europe, very strong positions in Latin (see Figure 1). strong consumer base”, which had now been America and now we are building good posi- Acquiring Chattem in February 2010 and complemented by the approval of OTC Allegra. tions in the US and Asia as well,”he added. a 44.4% rise in turnover in emerging markets Allegra was a “very exciting opportunity” OTC to C1.05 billion (see Figure 2) had driven the for the company, he added, noting that a head growth, the company noted. of one of the major US pharmacy chains had IN BRIEF Consumer Health Care’s sales in emerging called it the “most exciting OTC switch” the markets had benefitted from the firm’s perfor- market would see over the next five years. ■ SANOFI-AVENTIS is set to acquire US- mance in Latin America and Eastern Europe, Meanwhile, in China the company had est- based biopharmaceutical firm Genzyme in a deal worth US$20.1 billion (C14.7 billion). Business Annual salesChange 2009/2010 (%) Genzyme shareholders will also receive mile- (C millions) C CER* stone payments related to some products. The deal comes after Genzyme had turned down Diabetes brands 4,298 +14.2 +9.2 three bids from Sanofi-Aventis last year (OTC Other prescription brands 12,463 –– bulletin,15 October 2010, page 2). Other products 6,064 +2.0 -1.9 Consumer Health Care2,217 +55.0 +45.7 ■ PALADIN LABS has agreed to buy Bris- Generics 1,534 +51.6 +41.5 tol-Myers Squibb’s Tempra brand of paedi- Pharmaceuticals 26,576 +2.9 -1.6 atric acetaminophen – paracetamol – products Vaccines 3,808 +9.3 +4.8 in Canada for an undisclosed sum. The Cana- Total Sanofi-Aventis 30,384 +3.7 -0.8 dian company pointed out Tempra had ach- ieved sales of approximately CA$3.0 million * CER is constant exchange rates (C2.2 million) in 2010. Figure 1: Sanofi-Aventis’ sales in 2010 broken down by business (Source – Sanofi-Aventis) OTC

6 OTC bulletin 28 February 2011 OTC28-02-11p6-7FIN.qxd 24/2/11 10:14 Page 3

COMPANY NEWS OTC

Annual Results Annual Results Vemedia posts Tough Russian market hits growth in sales Oriola-KD’s operating profit emedia Pharma said excellent results in V the Netherlands and strong growth in riola-KD’s operating profit slumped by totalling C2.7 million related to the restructur- Spain and Portugal had driven up its sales by O81% to C9.8 million in 2010. The com- ing of the firm’s wholesaling business in Swe- 9.7% to C54.9 million in 2010. pany said one-off costs and a challenging mar- den and write-offs caused by the bankruptcy of Its Dutch sales and marketing business had ket in Russia had resulted in the decline. a Swedish pharmaceutical company, Oriola said. posted turnover up by 16%, the company add- In contrast, the Finnish wholesaler and re- Excluding the one-off costs in Russia and ed, as its Dagravit vitamin brand and Roxasect tailer’s net sales increased by 23% to C1.93 bil- Sweden, operating profit would have stood at insecticide reported record sales. The opera- lion, driven by “positive”performances in Fin- C22.5 million, Oriola noted, 57% down on 2009. tion had also benefited from new distribution land and Sweden. contracts, Vemedia noted. Commenting on the Russian market, Oriola- Entered Swedish retail market In Spain and Portugal, sales had increased KD said that slower than forecasted growth, During the year,Oriola-KD entered the by 34% and 35% respectively,Vemedia said, coupled with price regulation, had led to “very Swedish pharmacy market by acquiring 170 driven by product launches and new additions intense competition”, resulting in an operating pharmacies through a joint venture with retail- to its Valdispert plant-based sedative brand. loss of C18.1 million in the country. er Kooperativa Förbundet (OTC bulletin,16 During the year,Vemedia expanded its OTC This loss included C10.0 million in one-off November 2009, page 1). offering by acquiring the Sleepzz sleep-aid in costs, Oriola-KD said, related to the bankruptcy The company also expanded its Russian re- the Netherlands (OTC bulletin,10 September of a Russian pharmacy chain and the write- tailing business by completing the acquisition 2010, page 10) and the Podosan footcare line down of stock value due the “extremely tough of 70 stores in Moscow from the OOO 03 Ap- in Spain and Portugal (OTC bulletin,21 Jan- market conditions”. teka pharmacy chain (OTC bulletin,30 Nov- uary 2010, page 2). Compounding this loss, were one-off costs ember 2010, page 7). Excluding these acquisitions, the company’s OTC sales had increased by 8.5%, Vemedia noted. Vemedia’s earnings before interest, tax, de- preciation and amortisation (EBITDA) advanc- ed by 9.9% to C10.0 million,despite a 30% rise in advertising and promotional spend. Looking ahead, Yvan Vindevogel, Vemedia’s chief executive officer,said that the company would continue to expand into new regions and was “still actively looking for interesting ac- quisition opportunities”. OTC

IN BRIEF ■ ORION said sales of its Burana ibuprofen painkiller had increased by 8.2% to C21.5 mil- lion in 2010. The Finnish firm pointed out that its Speciality Products business – comprising generic prescription drugs and branded self-care products – had grown by 8.7% in the 12 months to C299 million. Speciality Products accounted for 37% of Orion’s total Pharmaceuticals sales, which grew by 10.7% to C806 million.

■ RECORDATI’ssales dropped by 2.6% to C728 million in 2010, with operating profit falling by 4.6% to C155 million. The Italian pharmaceutical firm recently expanded its prod- uct offering in central and eastern Europe by ac- quiring the Procto-Glyvenol OTC haemorrhoid cream from Novartis Consumer Health Care (OTC bulletin,11 February 2011, page 14). OTC

28 February 2011 OTC bulletin 7 OTC28-02-11p8-9FIN.qxd 24/2/11 10:18 Page 2

OTC COMPANY NEWS

Third-Quarter Results Annual Results Prestige lifted Core OTC brands boost by Blacksmith sales at Pharmstandard cquiring Blacksmith Brands Holdings and Aits range of OTC brands in September last year,helped drive up sales at Prestige Brands’ ales of Pharmstandard’s branded OTC prod- ume terms the growth had been 1.9%. OTC division by 44.9% in the company’s third Sucts moved forward by 5.3% to RUB15.6 Sales of Pharmstandard’s unbranded OTC quarter ended 31 December 2010. billion (C0.39 billion) in 2010, as eight of the products outpaced their branded counterparts, The US$190 million (C141 million) addition Russian company’s top 10 OTC brands report- growing by 5.7% to RUB2.25 billion in 2010. of Blacksmith (OTC bulletin,29 September ed a rise in turnover. Commenting on the performance of the 2010, page 1) had lifted OTC sales to US$67.5 As Figure 1 shows, Pharmstandard’s activat- company’s OTC brands, Igor Krylov, Pharm- million for the three months, the US-based ed charcoal products grew quickest, with sales standard’s chief executive officer,said they had company said. Excluding Blacksmith – which up by 37.7% over the 12 months to RUB247 managed to maintain what had been achieved had contributed US$15.2 million – OTC turn- million, while the anxiety treatment Afobazol in 2009 despite the weaker flu season. He claim- over finished up by 12.3%, Prestige noted. and the Terpincod brands also reported double- ed that the company had also managed to pro- Across Prestige’s five core OTC brands, digit rises of 14.4% to RUB607 million and vide antiviral drugs in a “timely fashion and sales increases for the Chloraseptic, Compound 17.8% to RUB1.05 billion respectively. without shortages” to help prevent and treat W, Clear Eyes and Little Remedies brands, The Arbidol flu brand remained the firm’s cold-related illnesses. Prestige pointed out, had been partially offset biggest-selling OTC brand, although turnover OTC products accounted for 53% of Pharm- by lower sales of The Doctor’s brand. only edged up by 1.6% to RUB5.59 billion, as standard’s total sales, which finished ahead by The company noted that its OTC division fourth-quarter sales dropped in comparison to 23.3% to RUB29.7 billion. Sales of third-party would have nine core brands to focus on in the prior year period, when turnover had been drugs contributed RUB9.86 billion, while pre- future, following the acquisition of Black- boosted by the H1N1 swine flu outbreak. scription brands were responsible for another smith’s Efferdent/Effergrip oral-care products, Only two of Pharmstandard’s top 10 OTC RUB3.31 billion. The rest was generated by the the PediaCare cough and cold remedy for in- brands reported a drop in sales. The Codelac medical equipment business and “other” sales. fants and children, Luden’s throat drops and cough and cold brand fell sharpest, with sales In January,Pharmstandard acquired a 55% Nasal-Crom allergy products. down by 8.1% to RUB692 million, while the stake in Ukrainian pharmaceutical firm Biolek. Following the close of the quarter,Prestige Pentalgin analgesic brand posted turnover down Its portfolio is said to include vaccines, serums, expanded its OTC offering further by acquir- by 5.3% to C1.99 billion. nutrient mediums, diagnostics products, and ing the Dramamine anti-sickness brand from The company’s top 10 best-selling OTC blood products, as well as immunobiological, McNeil Consumer Healthcare (OTC bulletin, brands in 2010 had reported growth of 2.4% in hormonal, antiviral and antibacterial drugs. 21 January 2011, page 7). value terms, Pharmstandard said, while in vol- OTC Matthew Mannelly,Prestige’s president and chief executive officer,said that the company’s Business Annual salesChange Proportion strategy of growing its core OTC brands was (RUB millions) 2009/2010 (%) of total (%) well underway. Increased investment in advert- Arbidol 5,589 +1.6 19 ising and promotion, coupled with new prod- Pentalgin 1,988 -5.3 7 uct introductions, had resulted in a “strong sell Complivit 1,228 +3.4 4 through during the quarter”. Terpincod 1,047 +17.8 4 “Our OTC segment now includes nine core OTC brands, which represent 90% of our OTC Codelac 692 -8.1 2 segment revenue,”Mannelly added, noting that Flukostat 653 +0.7 2 the company intended to continue to invest in Afobazol 607 +14.4 2 its core OTC brands so they would be position- Amixin 542 +6.9 2 ed for growth in the company’s fiscal 2012. Activated charcoal 247 +37.7 1 Prestige’s OTC division accounted for 74% Corvalol 230 +3.4 1 of the company’s total group sales, which ex- Other OTC brands 558 –– panded by 22.7% to US$90.6 million in the Unbranded OTC products 2,252 +5.7 8 quarter. The company’s Household Cleaning Total OTC products 15,633 +5.3 53 division generated the remaining 26%, or Prescription drugs 3,308 +41.5 11 US$22.8 million. Excluding the impact of the Third-party prescription drugs 9,860 +60.2 33 Blacksmith acquisition, turnover grew by 2%. Operating income fell by 44.0% to US$13.0 Medical equipment & disposables 630 -8.5 2 million. The majority of the decline was blam- Other sales 288 +303 1 ed on a US$10.5 million charge related to the Total Pharmstandard 29,719 +23.3 100 Blacksmith acquisition. OTC Figure 1: Sales by Pharmstandard’s top 10 OTC brands and other businesses in 2010 (Source – Pharmstandard)

8 OTC bulletin 28 February 2011 OTC28-02-11p8-9FIN.qxd 24/2/11 10:18 Page 3

COMPANY NEWS OTC

Business Development Opportunities Distribution Agreements Oxford Nutrascience can Perrigo signs now taste-mask ibuprofen diabetes deal

xford Nutrascience is offering a drug-de- ed the proof-of-concept for taste-masking of errigo has entered into an exclusive agree- O livery technology that allows ibuprofen to ibuprofen, and was now developing “no burn” Pment to sell and distribute blood-glucose be incorporated into “next-generation” chew- chewable and liquid products for the OTC and monitors and test strips from AgaMatrix via able tablets and liquid suspensions with “no taste prescription sectors. He noted, for example, the store-brand channel in the US. or burn irritation issues”. that the company was working on 400mg ibu- Under the terms of the agreement, the US- The technology was applicable to a broad profen chewable tablets and 400mg/5ml ibu- based store-brand specialist said it would offer range of pharmaceuticals, the company pointed profen suspension. its customers certain products in the current out, including non-steroidal anti-inflammatory “We are looking to license our dossiers to AgaMatrix portfolio as well as certain future drugs (NSAIDs) and statins. partners for commercial launch of the prod- new products. Oxford Nutrascience said it had signed an ucts either in specific territories or globally,” Perrigo pointed out that it would start dis- exclusive worldwide licensing agreement for he added. “We are also making our taste-mask- tributing the blood-glucose monitors and test the technology with Isis Innovation, a technol- ing system available for other companies to strips in early 2011. ogy-transfer business wholly-owned by the Uni- develop dossiers for their own NSAID prod- The company added that it intended to ex- versity of Oxford. It noted that the technology uct concepts.” pand beyond blood-glucose monitoring and provided for “outstanding taste-masking, en- Isis’ technology is protected by patents in offer a full range of diabetes products. hanced drug stability and the potential for tun- France, Germany and the UK, and an applica- Perrigo estimated that more than US$2.8 able drug-release properties”. tion has been made for the US. Oxford Nutra- billion (C2.04 billion) was spent annually on Nigel Theobald, chief executive of Oxford science aims to file further patent applications blood-glucose monitoring meters and test strips Nutrascience, said the company had establish- during 2011. in the US. OTC OTC

Annual Results Launches lift sales at Slovenia’s Krka

rka said sales of its self-medication prod- Kucts had grown by 25% to C112 million in 2010, thanks to product launches and the rollout of existing brands into new markets. The Slovenian company pointed out that during the 12 months it had added to its key Septolete sore-throat brand by introducing a strawberry-flavoured Septolete Plus pastille and a Septolete Plus spray in Estonia, Latvia, Lithuania and Slovenia. Meanwhile, Krka said it had also gained approval for its Orsoslim weight-management capsules in Kazakhstan,Ukraine and some oth- er countries. In Russia, the Pikovit vitamin line had been expanded with the Pikovit Omega 3 and Pikovit Prebiotik products. Marketing authorisations had also been ob- tained in Ukraine for Bilobil intense ginkgo- biloba capsules and Herbion Ginseng capsules, the company noted. Self-medication products generated 11.1% of Krka’s total group sales for 2010, which im- proved by 6.0% to C1.01 billion. Sales outside of Slovenia were responsible for 90% of the company’s total turnover. OTC

28 February 2011 OTC bulletin 9 OTC28-02-11p10-11FIN.qxd 23/2/11 13:27 Page 2

OTC GENERAL NEWS

Regulatory Affairs Distribution Germany to curb French pharmacies hit back pseudoephedrine at Leclerc over distribution ompanies that market medicines contain- C ing pseudoephedrine in Germany have until campaign attacking French supermarket 1 May this year to sell off larger packs. Agiant Leclerc for claiming the right to sell Non-prescription medicines will be restrict- some non-prescription medicines through its ed to a maximum of 720mg pseudoephedrine parapharmacies has been launched by pharm- per pack from that date. Larger packs will be acy groups in France. prescription-only. Direct Labo, Global Pharmacie and Univers The pack-size restrictions for the pharmacy- Pharmacie – along with French pharmacists’ only medicines follow the recommendations union, UDGPO – are backing the campaign. made last year by Germany’s Expert Com- It follows Leclerc’s recent reiteration of its mittee for Prescription (OTC bulletin,30 July opposition to France’s pharmacy monopoly on 2010, page 13). the sale of non-prescription medicines (OTC Approving the change, Germany’s upper bulletin, 21 January 2011, page 15). house of parliament, the Bundesrat,noted that Campaign posters are based around a cari- McNeil Consumer Healthcare’s Reactine Duo cature of Michel-Edouard Leclerc, the head of and Rhinopront Combi would be affected. The Leclerc, depicted as Pinocchio. They challenge upper house insisted that restricting pack sizes his claims that the supermarket would sell medi- would reduce the risk of misuse of pseudoeph- cines more cheaply with the slogan: “As with edrine to illegally manufacture methamphet- medicines, perhaps tomorrow M.E. Leclerc will amine, also known as ‘crystal meth’. claim the right to sell plots of land on the moon Reactine Duo combines 120mg pseudoeph- more cheaply.” edrine with 5mg cetirizine and comes in 28-cap- Univers Pharmacie’s president, Daniel Buch- sule packs, while Rhinopront Kombi is sup- inger,has also written an open letter to Michel- plied as packs of 20 tablets, each providing 60mg Edouard Leclerc. It challenges the ability of Le- Campaign materials are based around a caricature pseudoephedrine and 2.5mg triprolidine. clerc’s parapharmacies to provide the same level of Michel-Edouard Leclerc, the head of French Several other countries and a number of US of customer service and care as pharmacies, supermarket chain Leclerc, which depicts him with a states have already taken steps to limit access and points out that Leclerc’s size allows it to long nose like Pinocchio to pseudoephedrine due to evidence that con- launch communication campaigns more widely sumers were converting the active ingredient than pharmacists. gers of selling medicines in supermarkets”. It into methamphetamine (OTC bulletin,10 Feb- Buchinger’s letter also claims that the fig- also provides a downloadable copy of the peti- ruary 2010, page 14). ures used in Leclerc’s campaign – which high- tion and the poster for use in pharmacies. The Bundesrat has also altered an entry in lighted price discrepancies of more than 200% Also highlighted at the website are two sur- Germany’s prescription order for triamcinolone between different pharmacies – prove that phar- veys comparing the prices of a basket of 25 as a non-prescripton treatment for mouth ul- macies already give effective price competition. products sold in pharmacies and in Leclerc’s cers. A prescription-to-OTC switch in 2003 The pharmacy groups have also launched a parapharmacies across five of France’s regional (OTC bulletin,10 February 2003, page 9) had parody of Leclerc’s website “Se soigner moins départments in 2009 and 2011. According to accidentally been listed as triamcinolone, in- cher” or “Heal yourself more cheaply”. Called the surveys, Leclerc was between 0.5% and stead of as triamcinolone acetonide as the ap- “Se moquer du monde” or “Laugh at the world”, 18.3% more expensive in each départment in plicant had requested. the site encourages visitors to sign an online 2009, and between 3.9% and 15.5% more ex- At the same time, the Bundesrat approved petition to “protect the French against the dan- pensive during 2011. changes to Germany’s general-sale order. From OTC 1 May this year,medicines made from arti- choke leaves will be available without a pre- IN BRIEF scription from non-pharmacy outlets in line with a recommendation by the Expert Com- ■ SALES OF PHARMACY-ONLY MEDI- ■ CHURCH & DWIGHT reported sales up mittee for Prescription (OTC bulletin,16 Oct- CINES in German community pharmacies de- by 2.7% to US$2.59 billion (C1.90 billion) in ober 2009, page 15). clined by 3.3% to C2.8 billion at ex-factory prices 2010. Organic growth was 3.0%,noted the The general-sale conditions for products last year,according to the market researcher US-based company, despite weak consumer de- containing valerian extract will be extended Insight Health. The volume decline was 4.1% mand and intense price competition. Church & to include those that combine the herb with to 650 million packs. Pharmacy-only medicines Dwight said growth had been aided by prod- lemon balm or passionflower extract. accounted for 11.0% of all value sales through uct launches – including Trojan Fire and Ice Minor changes will be made to general-sale pharmacies, which totalled C25.6 billion dur- condoms – and a steady increase in marketing listings for eucalyptus and mint oil. ing 2010. In volume terms, the figure was much spend throughout the year. OTC higher at 41.8%. OTC

10 OTC bulletin 28 February 2011 Facts advert V2 HR.pdf 1 18/02/2011 10:57

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OTC GENERAL NEWS

Regulatory Affairs Patent Disputes Diapharm registers Watson wins Mucinex herbal combination iapharm said it had obtained Europe’s first patent case in the US Dtraditional herbal registration for a fixed combination of St John’s wort and black cohosh. The traditional herbal medicine has just been atson Pharmaceuticals moved closer to The company is also facing a Mucinex pat- registered by the UK’s Medicines and Health- Wthe US launch of generic versions of ent challenge from store-brand specialist Per- care products Regulatory Agency (MHRA) using Reckitt Benckiser’s Mucinex cough medicines rigo.In February of last year,the Michigan dis- the simplified procedure established by Euro- when a district court threw out the UK-based trict court ruled that Perrigo’s ANDA for its pean directive 2004/24/EC. company’s patent infringement complaint. 600mg guaifenesin extended-release tablets did Dr Karim Sultan of Diapharm UK said the The court for the Southern District of Florida not infringe the Mucinex patent (OTC bulletin, German pharmaceutical services provider was ruled in favour of Watson in litigation over the 26 February 2010, page 13). applying for further registrations in countries company’s generic versions of the Mucinex, In August, however, Reckitt Benckiser won such as Austria, France and Hungary. Mucinex D and Mucinex DM guaifenesin-bas- an appeal against the ruling and the case was Each coated tablet of the traditional herbal ed medicines. It said that Watson’s generics did returned to the district court for further proceed- medicine contains 300mg hypericum extract and not infringe the Mucinex patent 6,372,252. ings (OTC bulletin,13 August 2010, page 7). 6.4mg cimicifuga extract. “It is the first time that Watson is waiting for Abbreviated New Drug In 2007, Adams Respiratory Therapeutics such a fixed combination of hypericum and cimi- Applications (ANDAs) for all three medicines – which is now part of Reckitt Benckiser – set- cifuga has been registered in Europe as a tradi- to be approved by the US Food and Drug Ad- tled a patent challenge to the Mucinex brand tional herbal medicinal product,”said Sultan. ministration (FDA). from URL/Mutual, which potentially kept URL/ The product is indicated for relieving symp- According to Watson, the Mucinex products Mutual’s 600mg guaifenesin product off the toms of the menopause, including hot flushes, had total US sales of approximately US$500 market in the US until 2012 (OTC bulletin,30 night sweats, slightly low mood and mild anx- million (C367 million) in 2010. March 2007, page 11). iety based on traditional use only. Diapharm Reckitt Benckiser sued Watson twice dur- Watson’s victory,however,means that URL/ said both active ingredients were used to relieve ing 2009 for allegedly infringing its US patents Mutual may soon be in a position also to in- the various symptoms of menopause, giving 6,372,252 and 6,955,821, which protect its Muc- troduce its 600mg guaifenesin product,as the inex range until 28 April 2020 (OTC bulletin, company’s settlement with Adams allowed it 30 April 2009, page 20; OTC bulletin,19 June to launch if a third party was in a position to 2009, page 12). The case involving the patent introduce its own generic guaifenesin prod- 6,955,821 was dismissed without prejudice. uct before 1 July 2012. OTC

Regulatory Affairs IN BRIEF

Denmark restricts ■ THE EUROPEAN COMMISSION has re- leased for public consultation a concept paper sales of painkillers on ways of revising the Clinical Trials Direc- tive 2001/20/EC. The concept paper builds on anish people under the age of 18 years will an initial public consultation held a year ago. Dsoon only be able to buy painkillers if they The Commission said it planned to put for- have been prescribed by a doctor. New rules, ward in 2012 a legislative proposal to revise which come into effect on 7 March 2011, also the Directive. mean they will only be able to obtain pain- A combination of St John’s wort and black cohosh for killers from a pharmacy. ■ EMA – the European Medicines Agency relieving menopause symptoms has been registered as a traditional herbal medicine in the UK by Diapharm The Danish Medicines Agency pointed out – has now published the final version of its that all retail outlets for non-prescription medi- ‘Road Map to 2015’, which sets out its vision the combination a synergistic effect. cines – including health and beauty stores, pet- for the strategic development of the agency Diapharm said the product would be launch- rol stations and supermarkets – would have to until 2015. There are brief references to non- ed in the UK and other markets by a third party. ensure young people buying painkillers were prescription and herbal medicines. “Approximately one quarter of all traditional over the age of 18 years. herbal medicinal products within the European The new rules had been introduced to “count- ■ AUSTRALIA’s Office of Complementary Union originate from Diapharm in this way,” er a rising number of suicide attempts from pain- Medicines has developed two new guidance the company added, noting that it had “prepar- killers”, the agency explained. documents. One covers equivalence of herbal ed and documented 35 of the 79 newly-regis- The rule that young people must be at least extracts in complementary medicines, while the tered traditional herbal medicinal products in 15 years of age to buy other OTCmedicines in other focuses on the use of modified unprocessed the UK”. non-pharmacy retail outlets still applies. herbal materials in complementary medicines. OTC OTC OTC

12 OTC bulletin 28 February 2011 OTC28-02-11p12-13FIN.qxd 23/2/11 13:33 Page 3

GENERAL NEWS OTC

Regulatory Affairs Counterfeit law may apply to some OTCs

on-prescription medicines will not gener- scription medicines in the new law “would have show the public they are linked to an autho- Nally be affected by measures aimed at coun- meant considerable additional costs to be paid rised pharmacy. terfeitprescription products in a new law passed by European citizens without any gain from a All authorised internet pharmacies will be by the European Parliament on 16 February. public health perspective”, Hubertus Cranz, connected to a central website in each mem- The draft directive – which still has to be ap- director-general of the Association of the Euro- ber state on which they will all be listed. These proved formally by the European Union’s Coun- pean Self-Medication Industry,the AESGP,said national websites will be linked to a European cil of Ministers – proposes safety features on that a good compromise had been found “in the Union-wide site. packs, such as individual serial numbers that can spirit of smart regulation”. The law also calls upon the authorities to be checked in pharmacies, but leaves the details “We are pleased to see that the European warn citizens about the risks involved in buy- for the European Commission to work out. Parliament agreed on a rational and propor- ing medicines via the internet. Only non-prescription medicines listed as tionate approach concerning the new system Pharmacists represented by the Pharmaceu- having been “assessed to be at risk of falsifica- of safety features,”he said. tical Group of the European Union (PGEU) tion” will have to bear the safety features. These The parliament voted 569 in favour and 12 pointed out that such logos could easily be safety features will make it possible for “whole- against the new law, which will come into force counterfeited. sale distributors and persons authorised or en- 20 days after it is published in the Official Jour- Facilities making active substances should titled to supply medicinal products to the pub- nal. Publication will happen once it is formally be inspected on the basis of risk analyses, as lic”to verify the authenticity of the products as adopted by the Council. Member states will well as on grounds of suspected non-compli- well as identify individual packs. have 24 months to adopt the directive into ance, the directive maintains. Furthermore, Such products will also have to carry a de- their own legislation. brokers and distributors will be required to vice “allowing verification of whether the outer Internet pharmacy websites will be required register with the local authorities in their packaging has been tampered with”. to display a common logo, recognisable through- home country,with the authorities conduct- Noting that systematically including non-pre- out the European Union. This is intended to ing risk-based inspections. OTC

28 February 2011 OTC bulletin 13 OTC28-02-11p14-15FIN.qxd 23/2/11 13:39 Page 2

OTC MARKETING NEWS

Switches Teva wants wider access to Plan B One-Step in US

sraeli generics company Teva has asked the of unprotected sex take place in the US every IUS Food and Drug Administration (FDA) to single night. grant full OTC status to its Plan B One-Step Plan B has been surrounded by controversy (levonorgestrel) emergency contraceptive. since its arrival on the OTC scene. After drag- The 1.5mg levonorgestrel tablets – which ging its heels for three years, the FDA finally Teva acquired through its takeover of US firm approved the switch from prescription to OTC Barr – are currently available without a pre- status in August 2006 (OTC bulletin,31 Aug- scription in the US for women aged 17 years ust 2006, page 1). and over. Women younger than 17 years of age The product was the first dual-label OTC/ can only obtain the product on prescription. prescription medicine in the US. Originally, it The supplementary new drug application was only available as an OTC medicine for sale (sNDA) filed by Teva would extend OTC ac- to women aged 18 years and over. Furthermore,

Chefaro has boosted its German portfolio by cess for younger women. the FDA imposed point-of-sale restrictions, in- introducing a “next generation” cold-sore patch In July 2009, the FDA approved single-use cluding distribution through pharmacies only. that dissolves itself. 1.5mg levonorgestrel tablets for OTC market- Two years ago, a federal district court judge According to the company, other cold-sore patches had to be torn off like normal plasters, ing (OTC bulletin,31 July 2009, page 24). ordered the FDA to make Plan B available OTC causing pain and running the risk of ripping open the Three years of new-product exclusivity gives to 17 year-olds as well as older women. Finding cold sore. By contrast, its Herpatch by Wartner Plan B One-Step protection from competition that the FDA had acted in a “capricious and product – which employs RemeSense film technology developed by Belgium’s Sylphar – dissolved after until 10 July 2012. arbitrary” manner during the five-year switch several hours, Chefaro said. The original Plan B emergency contracep- of the levonorgestrel product, Judge Edward The Omega Pharma subsidiary pointed out that tive – which comprises two 0.75mg levonor- Korman also remanded the matter back to the the patch contained beta-glucan and other polysaccharides derived from red algae which worked gestrel tablets – is already subject to OTC com- agency “to reconsider its decisions regarding with zinc sulphate to accelerate healing. petition from Perrigo and Watson. the Plan B switch to OTC use” (OTC bulletin, A 15-second television commercial shows a According to Teva,almost one million acts 31 March 2009, page 11). young woman using the patch to treat her cold OTC sore. “Beschleunigt die Heiling, löst sich selbst auf” or “Accelerates healing, dissolves itself” is the sign-off message. Line Extensions A pack containing eight of the two-a-day patches has a recommended retail selling price of C12.95. OTC Sanofi offers ready-to-drink Oralyte IN BRIEF anofi-Aventis is offering Britons a ready- Sto-drink version of its Dioralyte oral-rehy- ■ WORKS WITH WATER Nutraceuticals dration therapy. has secured distribution for its Help food sup- Called Oralyte, the newcomer contains the plements at 350 Boots stores in the UK. The same active ingredients – disodium hydrogen company said it had repackaged the range to citrate, glucose,potassium chloride and sodium enhance the premium positioning of the sup- chloride – in the same proportions as the exist- plements and communicate their benefits more ing Dioralyte. The two products will be sold effectively. New packaging highlights that the alongside each other. trio of products,which target specific health However, unlike Dioralyte, which is a lic- problems,contain “only natural ingredients”. ensed medicine, Oralyte is a food. Sanofi said The first product – Help: Blood Pressure – pro- it would appeal to a wider consumer reach. vides dairy peptides to “help maintain healthy “The key unique selling point is the pleas- blood pressure”. Meanwhile, Help: Clear Skin anttasting blackcurrant flavour,which is more Sanofi-Aventis says Oralyte’s unique selling point is contains lactoferrin from milk protein and is appealing to children, compared to standard its “great-tasting” blackcurrant flavour backed by the on-pack promise “to help clear Dioralyte,”said Sanofi, adding that its ease- blemishes and maintain a healthy complexion”. of-use would appeal to parents. material,trade-press advertising, and training The final supplement – called Help: Choles- Packaging states the “Ready to drink” new- for pharmacy staff. terol – contains barley beta glucan and is comer is a “Great tasting blackcurrant flavour Suitable for adults and children aged two claimed to help “maintain normal blood choles- hydration drink with sugar and sweetener”. years and over, Oralyte comes in a pack of three terol concentrations”. Sanofi is backing Oralyte with public rela- 200ml cartons that retails at £3.99 (C4.75). OTC tions activity,aconsumer leaflet, point-of-sale OTC

14 OTC bulletin 28 February 2011 OTC28-02-11p14-15FIN.qxd 23/2/11 13:39 Page 3

MARKETING NEWS OTC

Line Extensions GSK to expand Alli with a chewable tablet in Europe

laxoSmithKline Consumer Healthcare said that losing weight was challenging and Alli Ga chewable version of its Alli weight-loss wanted to encourage people to adopt a sensi- medicine would be introduced in Europe this ble approach to weight loss. “We are pleased year. However, the company declined to give that we will soon be able to offer people an alt- further details of the launch timetable. ernative way to take Alli,”she added, “comple- The chewable tablets containing 27mg orli- mented by our personalised online support.” stat will be sold alongside the existing 60mg The company is currently backing Alli with orlistat capsules, which became the first non- a global advertising campaign that urges slim- prescription medicine to be licensed through mers to eat right, take some exercise and use the European Union’s centralised procedure the weight-loss medicine (OTC bulletin,21 Jan- around two years ago (OTC bulletin,29 Jan- uary 2011, page 17). uary 2009, page 1). GlaxoSmithKline noted that Alli had help- GlaxoSmithKline described the new addi- ed more than 120,000 people in the UK lose tion to the Alli brand as “discreet, pleasant- weight since it was launched. A devil with a bent trident is the arresting image Bayer HealthCare has chosen for launch trade-press tasting and easy to take”. The company also plans to introduce the advertising for the latest addition to its Bepanthen Alli brand manager Ruth Irving pointed out chewable tablet in the US, but not this year. skincare range in Germany. OTC The bent trident symbolises the way Bepanthen Sensiderm Creme helps to stabilise the skin’s protective barrier, thereby reducing itching and inflammation. Retailers Legal Cases Beneath an image of the devil standing on a young woman’s elbow runs the headline “Harte Lloydspharmacy Perrigo settles Zeiten für den Kratzteufel!”, which translates as ‘Hard times for the infernal itch!”. The pharmacy-exclusive medical device contains dexpanthenol to moisturise and lipids to complement offers magazine Rogaine lawsuit the skin’s own defences. It is free from cortisone, emulsifiers, fragrances, colourings and preservatives. loydspharmacy is launching a free custom- errigo has been given the go-ahead to in- Suitable for all the family, a 20g tube of Bepanthen Sensiderm Creme has a recommended Ler magazine called All of You,which will P troduce a generic version of McNeil’s Men’s retail price of C7.49. be available from the pharmacy chain’s 1,650 Rogaine Foam in the US after agreeing to set- OTC stores in the UK from March. tle patent litigation. Published in collaboration with Axon Pub- The store-brand specialist said that it could lishing, the magazine, which is primarily aim- launch the foam on 1 March 2012, or earlier ed at women, is said by the retailer to build on under certain circumstances. its ethos “to provide healthcare for life”. Stiefel Research Australia – the patent own- Noting that the magazine comprised three er of the 5% minoxidil formulation – had filed sections – Healthcare, Beauty and Lifestyle – suit in 2009 after Perrigo applied for an Ab- the retailer said each edition would include “top- breviated New Drug Application (ANDA) for ical features and expert advice along with ser- the aerosol foam (OTC bulletin,30 October vice and product information to support the 2009, page 10). health and wellbeing needs of all the family”. Quoting data from Information Resources, A pain-relief patch that combines diclofenac and In addition,it will include an “Ask the Ex- Perrigo said that Men’s Rogaine Foam, which heparin to reduce inflammation and swelling has just pert” column where customers can submit their is used to regrow hair on top of the scalp, had been introduced in France by Laboratoires Genévrier. The company said it was supporting the launch own health questions, as well as beauty prod- annual sales of US$60 million (C45 million). of Flector Tissugel Héparine with pharmacy-press uct pages, recipes to support healthy eating Joseph Papa, Perrigo’s chairman and chief advertising. Clinical studies involving 430 patients and competitions. executive officer,said this was “another exam- had demonstrated the effectiveness of the product, the company claimed. Steve Gray,trading director at Lloydsphar- ple of Perrigo’s commitment to bring prod- Each Flector Tissugel Héparine patch – measuring macy,said: “New and even regular customers ucts to market”. “The company continues its 10cm x 14cm – contains 140mg diclofenac and may not be familiar with the wide range of focus on bringing quality,affordable health- 5,600 IUs of heparin. One patch should be applied every day for a maximum of three days before affordable products and healthcare services care to consumers,”he added. consulting a doctor if the pain does not improve. we now offer.” Meanwhile, McNeil Products has just intro- Flector Tissugel Héparine joins Genévrier’s Further editions will follow in May and duced the foam in the UK, where it is available existing 1% diclofenac Flector patch, as well as a 1% diclofenac Flector topical gel and sachets of 50mg September,and it will become a quarterly pub- under the Regaine brand (OTC bulletin,11 Feb- diclofenac granules for oral solution. lication from January of next year. ruary 2011, page 22). The retail price is C13.90 for three patches. OTC OTC OTC

28 February 2011 OTC bulletin 15 OTC28-02-11p16FIN.qxd 23/2/11 13:43 Page 2

OTC MARKETING NEWS

GlaxoSmithKlineRelaunches brings Flixonase into Piri range

laxoSmithKline Consumer Healthcare has Gchanged the name of its Flixonase Allergy Nasal Spray to Pirinase Hayfever 0.05% Nas- al Spray in the UK. The fluticasone propionate spray joins the company’s Piriton and Piriteze allergy products under the Piri umbrella brand. The company said the simplified offering – which comprises Piriteze Allergy Syrup, Piri- teze Allergy Tablets, Pirinase Hayfever 0.05% Nasal Spray,Piriton Allergy Tablets and Piri- ton Syrup – had been repackaged in designs with a “stronger”Piri logo. A “unique three-dimensional mode of action” is The new look provided a “distinct Piri iden- Omega Pharma’s promise for the Dermalex skincare tity across the range”,commented GlaxoSmith- Pirinase is the new name in the UK for creams that it has introduced in Germany. GlaxoSmithKline Consumer Healthcare’s Flixonase In launch trade-press advertising, Omega says Kline, “whilst clearly differentiating between Allergy Nasal Spray (pictured above), which is now that aluminium silicate helps to create a protective the different ingredients”. The pack design in- part of the Piri umbrella brand together with the barrier on the skin, while a ceramide complex corporates blue for Pirinase, green for Piriteze Piriteze and Piriton allergy remedies (below) supports healing. The aluminium silicate and alkaline minerals also stimulate the skin’s own repair products based on cetirizine hydrochloride and mechanisms, the company claims. orange for Piriton products containing chlor- Two cortisone-free formulations are available: phenamine maleate. one for neurodermatitis; and the other for contact eczema. Each 30g tube has a recommended retail GlaxoSmithKline said it would back the Piri price of C9.95. range with a “major” television campaign and OTC a new website. The company will also offer pharmacy staff training materials at its website www.MyPharmAssist.co.uk. Commenting on the renaming of Flixonase, GlaxoSmithKline said the move would capi- talise on the “strong Piriton brand heritage” and strengthen the Piri offering. Furthermore, Packaging highlights that the pharmacy (P) it would assist pharmacy staff in the task of rec- medicine “For adults” is supplied as a “Once ommending an appropriate product to consum- a day dose”. Bulletpoints claim the spray “Pre- ers, the company added, as well as easing cus- vents and relieves symptoms of airborne aller- tomer recognition. gens including: pollen (hayfever), pet hair,dust GlaxoSmithKline explained there would be mite and mould spores”, while a strapline states a “strong focus” on Pirinase Hayfever 0.05% that it “Also relieves nasal congestion”. Nasal Spray in the coming months. The product comes in a bottle containing 60 Reliv International said its new energy shot was the “first product created specifically to address the Noting that it aimed to boost pharmacy sales, sprays with a recommended retail selling price entire fatigue cycle”. the company said it hoped to “trade consum- of £7.14 (C8.50). According to the direct-selling specialist, Reliv ers up to an effective nasal spray that goes fur- The Piri umbrella brand replaces “The Piri 24K “delivers healthy energy and mental focus” and “relieves stress”. ther than antihistamine tablets to relieve more Team”, which was created last year and com- The caffeine-free dietary supplement is said to symptoms, including that blocked up groggy prised the Piriteze and Piriton brands (OTC contain 24 ingredients based on clinical research, feeling”. bulletin,31 March 2010, page 18). including B vitamins, coenzyme Q10, omega-3 fatty OTC acids, resveratrol and valerian root. “Most energy shots on the market today rely on caffeine to provide a quick jolt, but those shots can cause jitters and an unhealthy spike in heart rate,” ” IN BRIEF explained Reliv, adding that Reliv 24K’s “comprehensive formula provides the fuel for healthy, ■ BAYER CONSUMER CARE is investing is running until 27 March. The 20-second ani- natural energy”. £1.5 million (C1.8 million) in a burst of nation- mated commercial focuses on Canesten Duo, Reliv 24K will initially be sold in the US, but the company plans to introduce the product into al television advertising for its Canesten thrush and is based around a woman fidgeting while international markets. medicines in the UK. The campaign features her dog looks on in mild bemusement. OTC the established “fidgety” commercial, which OTC

16 OTC bulletin 28 February 2011 OTC28-02-11p17FIN.qxd 23/2/11 13:52 Page 3

EVENTS OTC

MARCH 17 March Forum Institut für Management. MAY ■ Building a Regulatory Tel: +49 6221 500 680. 7 & 8-9 March Strategy for Marketing Fax: +49 6221 500 555. 5 May ■ Pharmacovigilance Food Supplements E-mail: [email protected]. ■ Basics of and Risk Management in Europe Website: www.forum-institut.com. Regulatory Affairs Frankfurt, Germany London, UK Brussels, Belgium 28-30 March A pre-conference workshop entitl- A one-day course from The Org- Subtitled ‘The key steps to a suc- DIA Annual ed ‘How to write a successful risk ■ anisation for Professionals in Reg- cessful product launch’, this two- EuroMeeting management plan’ will accompany day event will focus on the regu- ulatory Affairs (TOPRA). Geneva, Switzerland this two-day conference. latory framework for food supple- Contact:TOPRA. A three-day conference organis- Contact: Informa UK. ments in the European Union. Tel: +44 20 7510 2560. ed by the Drug Information As- Tel: +44 20 7017 7481. Contact:EAS. Fax: +44 20 7537 2003. sociation (DIA). Wider access in- Fax: +44 20 7017 7823. Tel: +32 2 218 1470. E-mail: [email protected]. cluding generics and self-care med- E-mail: [email protected]. Fax: +32 2 219 7342. Website: www.topra.org. icines will be one of the 15 paral- Website: www.informa-ls.com. E-mail: [email protected]. lel sessions at the conference. 5-6 May Website: www.eas.eu. 10-12 March Contact: DIA European Office. ■ 2011 Regulatory & ■ CHPA Annual 17 March Tel: +41 61 225 51 51. Scientific Conference Executive Conference ■ Variations to Marketing Fax: +41 61 225 51 52. London, UK Aventura, Florida, US Authorisations in the E-mail: [email protected]. A two-day regulatory and scien- The Annual Meeting of the US European Union Website: www.diahome.org. tific conference organised by the US Consumer Healthcare Prod- Consumer Healthcare Products London, UK APRIL ucts Association (CHPA). Association (CHPA) is only open This one-day meeting will cover Contact:Maria Sarabia, CHPA. to members. mutual recognition, decentralised, 4 April Tel: +1 202 429 3545. Contact: Phyllis Taylor,CHPA. centralised and national variations. ■ An Essential Guide to Fax: +1 202 223 6835. Tel: +1 202 429 9260. Contact: Management Forum. Pharmacovigilance E-mail: [email protected]. Fax: +1 202 223 6835. Tel: +44 1483 730071. E-mail: [email protected]. London, UK Website: www.chpa-info.org. Fax: +44 1483 730008. Documentation to be supplied to Website: www.chpa-info.org. E-mail: registrations@management- regulatory authorities will be dis- 6 May forum.co.uk. ■ Marketing Authorisation 17 March cussed at this one-day event. Website: www.management- Contact: Management Forum. in the CIS Countries ■ Phytopharmaceuticals forum.co.uk. in Europe Tel: +44 1483 730071. Frankfurt, Germany Belarus, Kazakhstan, Russia and Bonn, Germany 22-23 March Fax: +44 1483 730008. Ukraine will be the main focus of A one-day meeting run by Ger- ■ Regulatory Affairs in E-mail: registrations@management- this one-day conference, but other many’s medicines manufacturers’ India and China forum.co.uk. Website: www.management- countries will be covered. association, the BAH. The meet- Frankfurt, Germany forum.co.uk. Contact:Henriette Wolf-Klein, ing will be conducted in the Ger- Day one of this two-day seminar Forum Institut für Management. man language. will discuss regulatory affairs, clin- 11 & 12-13 April Tel: +49 6221 500 680. Contact:BAH. ical trial regulation and variations ■ Regulatory Affairs in Fax: +49 6221 500 555. Tel: +49 228 957 45 0. in India, while day two will focus Central and Eastern E-mail: [email protected]. Fax: +49 228 957 45 90. on China. Each day can be book- Europe Website: www.forum-institut.com. E-mail: [email protected]. ed separately. Website: www.bah-bonn.de. Contact:Henriette Wolf-Klein, Prague, Czech Republic 10-12 May A pre-conference symposium on ■ Vitafoods ‘Regulatory affairs in the CIS re- Geneva, Switzerland gion’ will accompany this two- 8-10 June A three-day exhibition and confer- day meeting. ■ 47th AESGP Annual Meeting ence focusing on nutraceuticals, Contact: Informa UK. Rome, Italy cosmeceuticals, functional foods Tel: +44 20 7017 7481. ‘A new treaty for self-care’ will be the theme of the 47th Annual Meeting and functional drinks. Fax: +44 20 7017 7823. of the Association of the European Self-Medication Industry,the AESGP. Contact: Chris Lee,IIR Exhibitions. E-mail: [email protected]. The three-day meeting will include a session entitled ‘Self-medication Tel: +44 20 7017 7036. Website: www.informa-ls.com. industry quo vadis?’, featuring presentations from Cavan Redmond, pre- Fax: +44 20 7017 7818. sident of Pfizer Diversified Businesses, and Emma Walmsley, world- 13 April E-mail: [email protected]. wide president designate of GlaxoSmithKline Consumer Healthcare. Website: www.vitafoods.eu.com. Speakers at the meeting will also include: John Dalli, European com- ■ Health Supplements missioner for health and consumer policy; Ferruccio Fazio, Italian min- and Functional Foods 30-31 May ister of health; Dagmar Roth-Behrendt, vice-president of the European Singapore ■ EuroPLX 46 Parliament; Andreas Pott of the European Medicines Agency (EMA); Subtitled ‘Secrets of successful Vienna, Austria Vittorio Silano of the European Food Safety Authority (EFSA); Basil regulatory strategies in Europe, A two-day partnering and licens- Mathioudakis of the European Commission; June Raine from the UK’s Latin America and Asia’, this one- ing forum focusing on OTC medi- Medicines and Healthcare products Regulatory Agency (MHRA); Andy day workshop will overview dif- cines, nutraceuticals, branded pre- Tisman, senior principal, Consumer Health at IMS Management Con- ferent regulations and practices. scription drugs and generics. sulting; and Stefano Maruzzi, country manager at Google Italy. Contact:EAS. Contact:RauCon. Contact:Association of the European Self-Medication Industry,the AESGP. Tel: +65 68 38 12 70. Tel: +49 6222 9807 0. Tel: +32 2 735 51 30. Fax: +32 2 735 52 22. Fax: +65 68 35 95 36. Fax: +49 6222 9807 77. E-mail: [email protected]. Website: www.aesgp.be. E-mail: [email protected]. E-mail: [email protected]. Website: www.eas.eu. Website: www.europlx.com.

28 February 2011 OTC bulletin 17 OTC28-02-11p18-19NEW.qxd 24/2/11 10:22 Page 2

OTC MARKET RESEARCH Consumers choose products they trust

When British consumers choose an OTCmedicine, their own experience they “mostly buy OTC products when they are of the product and the views of healthcare professionals, particularly on special offer”. Interestingly,consumers are of the view that doctors, are at the forefront of their minds. Deborah Wilkes reports prices of OTCproducts have increased in the on the findings of a survey by Sempora Consulting. UK recently. As can be seen from Figure 5, 62% of consumers believe that OTCprices have risen, f you want to make sure that consumers day’s role for general practitioners in recom- 26% think they have remained the same, and select your OTC medicine, then you had mending OTCproducts, only half replied that 13% feel they have decreased. better make their experience of using your it was important or very important. The rest Pharmacists have a similar opinion. Around Iproduct a good one. It would also be wise felt it was only fairly important or not impor- 71% of them believe that OTCprices have in- to ensure that healthcare professionals, partic- tant (see Figure 2). creased, 21% feel they have stayed the same, ularly doctors, are likely to recommend your However, the majority of manufacturers be- and 7% think they have fallen. product to consumers. lieved that recommendations by general prac- Manufacturers, however, have a very differ- These are two of the findings of a recent sur- titioners would become increasingly important ent perception. Only 13% of them believe that vey of the UK pharmacy market conducted by over the next few years. As can be seen from OTCprices have increased, while 41% think management consultancy Sempora Consulting. Figure 3, 62% of manufacturers expect the im- prices have remained constant, and a further The survey,which was conducted in October portance of general practitioners to increase. 41% feel prices have decreased. and November 2010, involved 237 consumers, The remaining 38% expect to see no change, In terms of own-label products, only around 42 pharmacists and 51 OTCindustry executives. and none expect the importance of general prac- a third of consumers, 32%, agreed that they As can be seen from Figure 1, nearly eight titioners to decrease. “usually buy own-label products of pharmacy out of 10 consumers surveyed by Sempora said Manufacturers were also questioned about chains and supermarkets”. previous experience of the product was an im- the influence of pharmacists on the choice of When Sempora asked consumers whether portant or very important criterion when choos- OTC products made by consumers. Around 65% they were “a regular buyer of OTCmedicines”, ing an OTC medicine, and seven out of 10 felt said this had stayed the same, 13% felt it had around one in two, 49%, said they were. the same way about ease-of-use. increased, and 18% thought it had decreased Looking at branding, Sempora found that Consumers were also likely to be influenced (see Figure 4). a “positive brand image” and a “well-known by recommendations from healthcare profes- When it comes to pricing, only around one brand” were important criteria when choosing sionals. A recommendation by a doctor was an in three consumers, 32%, said the “lowest price” an OTCmedicine for 51% and 40% of con- important or very important criterion for nearly was an important or very important factor when sumers respectively (see Figure 1). three-quarters of those surveyed, while around choosing an OTC medicine (see Figure 1). This However, the survey found that consumers two-thirds felt the same way about an endorse- was in line with the findings of a similar survey were not prepared to pay more for well-known ment from a pharmacist. However, only 38% re- carried out by Sempora during 2008 (OTC bul- OTCbrands. As can be seen from Figure 6, garded a recommendation by a friend as impor- letin,17 March 2008, page 20). only a third of consumers agreed that they were tant or very important. Furthermore, when consumers were present- usually “prepared to pay more for a medicine By contrast, manufacturers were divided on ed with statements about pricing for OTCmed- if it is a well-known, quality brand”. This was the importance of recommendations by general icines, just 21% agreed that they “always buy down from 44% in 2008 (see Figure 7). practitioners. When they were asked about to- the cheapest product” and only 13% agreed that Manufacturers, meanwhile, rate the impor-

TODAY’S ROLE OF GENERAL PRACTITIONERS Previous experience with the product10 77% IN RECOMMENDING OTC PRODUCTS IS.....

Recommendation by doctor9 72% Important or very important Ease-of-use8 70% 50% Recommendation by pharmacist7 65%

Positive brand image6 51%

Well-known manufacturer5 47%

Well-known brand4 40%

Recommendation by friend3 38%

Lowest price2 32%

Packaging design1 15% Fairly or not important 020406080100 50% 020406080100 Proportion of consumers who rate as an important or very important criterion when choosing an OTCmedicine (%) Figure 2: Response of manufacturers in the UK when asked to rate the importance currently of the Figure 1: Proportion of consumers in the UK who rate various criteria as “important” or “very important” when role of general practitioners in recommending OTC choosing an OTC medicine (Source – Sempora Consulting, 2010) products (Source – Sempora Consulting, 2010)

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MARKET RESEARCH OTC

PHARMACISTS’ INFLUENCE ON CONSUMER THE PRICES OF OTC PRODUCTS HAVE.... CHOICE OF OTC PRODUCTS HAS..... 8080 8080 71%

62% 65% 6060 6060 Series1Consumers 41% 41% 4040 Series2Manufacturers 4040 26% Series3Pharmacists 21% 20 Proportion who say (%) 20 18% 13% 13% 2020 13% 7% Proportion of manufacturers (%) 00 Risen Remained constant Fallen 00 123 12 3 Figure 5: Response of consumers, manufacturers and pharmacists in the UK when they were asked about recent changes in retail prices of OTC products in the UK pharmacy market (Source – Sempora Consulting, 2010) Increased Decreased Stayed same

Figure 4: Response of manufacturers in the UK I AM USUALLY PREPARED TO PAY MORE I AM USUALLY PREPARED TO PAY MORE when asked how pharmacists’ influence on consumer FOR AN OTC MEDICINE IF IT IS A FOR AN OTC MEDICINE IF IT IS A choice of OTC products had changed WELL-KNOWN, QUALITY BRAND WELL-KNOWN, QUALITY BRAND (Source – Sempora Consulting, 2010) 2010 2008

tance of brands much more highly than con- Disagree Disagree sumers. When Sempora questioned manufac- 67% 56% turers, 85% said strong brands were important in the OTCmarket. However, this figure was down from 93% two years ago (see Figure 8). One other interesting finding of the Sem- pora survey was that 57% of consumers agreed that they could avoid unnecessary visits to the doctor by using OTC medicines. Agree Agree ■ For more information on the survey contact Francis 33% 44% Prosser,Sempora Consulting, 33 St James’s Square, Figure 6: Proportion of consumers in 2010 Figure 7: Proportion of consumers in 2008 London SW1Y 4JS, UK (Tel: +44 20 3178 4612; Fax: who said they were usually prepared to pay more for who said they were usually prepared to pay more for +44 20 7661 9400; E-mail: [email protected]). a medicine if it was a well-known, quality brand a medicine if it was a well-known, quality brand OTC (Source – Sempora Consulting, 2010) (Source – Sempora Consulting, 2008)

OVER THE NEXT FEW YEARS, THE STRONG BRANDS IN THE OTCMARKET ARE..... IMPORTANCE OF GENERAL PRACTITIONERS IN RECOMMENDING OTC PRODUCTS WILL..... 100100 8080

78% 8080 62% 6060 64% 6060 2008Series1 38% 40 2010 40 4040 Series2

21% 2020 14% 15% 20 20 Proportion of manufacturers (%) 5%

Proportion of manufacturers (%) 3% 0% 00 0% Not Fairly Important Very 00 1234 12 3 important important important

same Increase Stay Decrease Figure 8: Response of manufacturers in the UK when asked to rate the importance of strong brands in the OTC market (Source – Sempora Consulting) Figure 3: Response of manufacturers in the UK when asked how the importance of general practitioners in recommending OTC products will change over the We also publish Generics bulletin – www.generics-bulletin.com next few years (Source – Sempora Consulting, 2010)

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OTC DISTRIBUTION

macy ownership and the sale of non-prescrip- Retail dynamics hold key tion medicines in non-pharmacy outlets. The pace of change will be different for these two aspects of distribution, he says. to geographic expansion Liberalisation of pharmacy ownership will be relatively slow in the wake of the European Court of Justice (ECJ) ruling, predicts Coles, If manufacturers want to take their products into new territories, adding that the debate has “ebbed and flowed over the years”. In 2009, the ECJ ruled that such as Europe, then a detailed understanding of local distribution systems European Union member states could ban third is a must, says David Coles, chief executive officer of the Ceuta Capability parties from owning and operating pharmacies Group. OTCbulletin reports. (OTC bulletin,29 May 2009, page 1). The rul- ing was a blow to pan-European retailers and wholesalers, which had expected a different out- n “intimate understanding”of the In 2009, the weight-loss product became the come that would have paved the way for large retail dynamics of individual coun- first non-prescription medicine to be authoris- pharmacy chains in major markets like France, tries is essential for OTC manufac- ed through the European Union’s centralised Germany and Spain. Aturers considering entering new re- procedure and gain immediate access to all Currently,Alliance Boots claims to be Eur- gions, says David Coles, chief executive officer member states. Alli was launched in more than ope’s leading pharmacy chain with around 3,000 of the global consulting business the Ceuta Cap- 20 countries in the space of a few weeks (OTC pharmacies in Ireland, Italy,the Netherlands, ability Group (CCG). “Even markets that you bulletin,30 April 2009, page 22). Norway,Russia and the UK. would expect to have similar distribution sys- Coles draws attention to the fact that as a Celesio, meanwhile, owns around 2,300 re- tems – such as the former Eastern Bloc coun- pan-European wholesaler and retailer Celesio tail pharmacies in nine European countries, in- tries in Central and Eastern Europe – have de- now has a Manufacturer Solutions division tar- cluding Belgium, the Czech Republic, Germ- veloped along different lines,”observes Coles, geting pharmaceutical firms. “Celesio did not any, Ireland,Italy,the Netherlands, Norway, who is also a non-executive director of virtual have this division three years ago,”he observes, Sweden and the UK. These pharmacies oper- pharmacy chain Avicenna and former manag- “but it is now a major division within Cele- ate under a number of banners such as Doc- sio’s organisation.” Morris, Lloydspharmacy, Unicare Pharmacy The big difference between an owned Announcing the formation and Vitusapotek. pharmacy chain and a virtual chain is the of the division in 2008, Cele- sio said the move was a res- Working with virtual pharmacy chains level of compliance. There is more adherence ponse to changes in the phar- Although large pharmacy chains are not per- to central policies in an owned chain maceutical market that had mitted in France or Germany, says Coles, sig- seen manufacturers “increas- nificant cooperatives and virtual chains of inde- ing director of wholesaler Unichem. “Countries ingly demand tailor-made solutions for the dis- pendent pharmacies do exist in these two maj- manage their healthcare systems in different tribution and marketing of the drugs they pro- or markets. “Such groupings allow manufactur- ways and that creates challenges,”he observes. duce”. The company maintained that adopting ers to gain scale and points-of-contact without Coles points out that smaller players trying a systematic approach towards pharmaceutical the need for a massive sales effort that reaches to break into Europe, such as US companies or manufacturers – also on the European level – the fragmented and dispersed independent sec- development firms, need to decide which coun- was absolutely essential to secure its success tor,”he explains, “and there are opportunities tries present the biggest opportunity,and then in the future (OTC bulletin,12 September to introduce products to the market as part of assess how easy it will be to realise that poten- 2008, page 23). own-label ranges.” tial. “In some of Europe’s bigger,more attrac- Celesio’s Manufacturer Solutions division That said, Coles warns that getting all mem- tive markets, such as France, there are signif- comprises the Movianto logistics business oper- bers of a pharmacy grouping on board can be icant barriers to realising that potential,”he ating in 13 countries, the Pharmexx contract an issue. “The big difference between an owned warns. “Smaller players need to be a lot more sales organisation with a presence in 22 coun- chain and a virtual chain is the level of com- pragmatic than the multinationals, and they tries,and the Evolution Homecare business pro- pliance,”he remarks. “There is a lot more ad- should focus on the quick and easy wins.” herence to central policies in The process for multinationals is the same, Retail dynamics in Europe are changing, an owned chain.” continues Coles, but they also need to be aware both in terms of pharmacy ownership and “One manufacturer might that leading international retailers,such as Ger- decide not to enter the French many’s Celesio, are increasingly taking a multi- the sale of non-prescription medicines in market because there are no country approach to many aspects of their busi- non-pharmacy outlets pharmacy chains, while anoth- ness, including their propositions, their brands er might go ahead because of and their formats. “Similar trends are affecting viding medical care at home in the UK. The the presence of virtual chains,”comments Coles, both retailers and manufacturers,”he notes, add- division reported a gross profit of C255 mil- adding that sales, marketing and distribution ing that regionalisation and globalisation have lion in 2009. partners, like the Ceuta International Alliance been on the agenda for many years but are now According to Coles, one of the most impor- that now extends to over 80 markets, can act gathering pace. tant issues in Europe is the role of pharmacy in on behalf of manufacturers. “One of the keys GlaxoSmithKline Consumer Healthcare’s distribution. He points out that retail dynamics to success is to have a detailed understanding Alli (orlistat) is cited by Coles as an example. in Europe are changing, both in terms of phar- of the retail dynamics of the market.”

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In France, for instance, Alliance Boots’ co- Mergers & Acquisitions operative Alphega Pharmacy is playing an in- creasingly important role. It claims to support Meda adds Antula more than 2,700 independent pharmacy mem- bers in six countries – the Czech Republic, Italy, to OTC operation Russia, Spain and the UK as well as France. Members have access to pharmacy-management ■ Continued from front page resources, increased buying and negotiating pow- Healthcare Brands International acquired er, and exclusive retail brands. Sweden’s Antula for an undisclosed sum just In Germany, Celesio’s Gesund Leben-Apo- over three years ago (OTC bulletin,25 Janu- theken claims to be the largest co-operative with ary 2008, page 1). around 2,600 pharmacy partners. Celesio also Announcing its annual results earlier this has the DocMorris virtual chain in Germany. month, Meda said that after three years of in- In the UK, meanwhile, the leading virtual vestment the company’s OTC portfolio had groups – Avicenna and Phoenix-owned Numark grown from a marginal part of its operations to – each have over 1,000 members. contributing around SEK2.0 billion in sales. OTC products generated around 17% of Very powerful arguments Meda’s total sales in 2010, which fell back by Moving on to the sale of non-prescription 12.1% to SEK11.6 billion due to negative cur- medicines in non-pharmacy outlets, Coles says rency effects and generic competition to two there are “very powerful arguments” for mak- of its prescription brands. ing these products more widely available in non- Expanding the OTC business, the company pharmacy outlets, as well as more accessible International pharmacy chains are increasingly noted, was a deliberate move to help Meda re- within pharmacies. Greater price competition able to take a multi-country approach to their duce its reliance on one or two larger prescrip- and easier access to medicines are just two of dealings with manufacturers, says David Coles, tion products. It also pointed out that the OTC chief executive officer of healthcare consulting the reasons cited by Coles. business, the Ceuta Capability Group portfolio lacked any “future patent risks”. A pharmacy monopoly on the sale of non- A large proportion of the company’s OTC prescription medicines still exists in several Eur- free-access medicines across a range of ther- turnover was generated by its Betadine antisep- opean countries, including Belgium, France, apeutic categories. Prices were monitored at 118 tic brand, which posted sales down by a tenth Greece and Russia. But Denmark, Hungary, pharmacies in five different regions of France to SEK807 million in the 12 months. Exclud- Italy,the Netherlands, Norway,Portugal, Swe- over a 10-day period in December. ing currency effects, Betadine’s sales had been den,Switzerland, and the UK are among the flat, Meda noted. countries that allow non-prescription medicines Disparate rules on selling products OTC to be distributed in non-pharmacy channels. As well as highlighting the patchwork of Coles points out that there is pressure for lib- rules on pharmacy ownership and non-pharmacy eralisation in some key markets. In France, for distribution across Europe, Coles draws atten- Regulatory Affairs instance, the supermarket giant Leclerc is lead- tion to the disparate rules on selling products ing the push for change, he says, noting that within pharmacies. The “quite heavy” restric- Europe looks into mass-market retailers are testing the bound- tions on product sales in some countries in East- aries to see what happens. ern Europe seem “inappropriate”, he says, ob- pholcodine safety Leclerc recently reiterated its opposition to serving that transactions are “over-supervised” France’s pharmacy monopoly on the sale of by pharmacists and, in some instances, prod- ■ Continued from front page non-prescription medicines by publishing a sur- ucts are kept away from consumers. to treat cough in children and adults, have non- vey that highlighted wide discrepancies between On top of that, adds Coles, some countries prescription status in some countries. the prices of ‘free access’ medicines across the have rules preventing branded manufacturers The review follows the publication of stud- country (OTC bulletin,21 January 2011, page from giving “full expression” to marketing com- ies suggesting that pholcodine induces immun- 15). The retailer has repeatedly campaigned for munications for non-prescription medicines. ologic stimulation in exposed individuals. Fur- the right to sell certain non-prescription medi- Coles also notes that there are wide varia- thermore, in some member states where phol- cines through its parapharmacies. tions in VAT rates for non-prescription medi- codine is no longer marketed, a decrease in According to Leclerc, the free-access law, cines, extending from as low as 2.5% up to as the reports of NMBA-related anaphylaxis has allowing self-selection displays for certain non- high as 20%. been observed. prescription medicines, should have encourag- Although there are big incentives for com- The CHMP said it would review thorough- ed competition between pharmacies and reduc- panies to move into new markets, concludes ly all available data – including published data, ed the differences in prices of these medicines. Coles, there are also some huge caveats. “If non-clinical and clinical data, post-marketing Instead, Leclerc’s survey found that, on aver- you are looking at a large geographic region, reports and pharmacoepidemiological studies age, the highest price for each medicine cover- such as Europe, there is a temptation to assume – and would assess their impact on the balance ed by the survey was more than twice the low- commonality as you try and simplify the busi- of risks and benefits of these medicines. est price. This figure rose to more than three- ness environment,”he says. “Giving in to this The pholcodine review was initiated on 31 times for certain therapeutic categories. temptation will lead to costly mistakes and mis- January 2011 by France under Article 31 of Dir- The survey,which was carried out by mar- sed opportunities.” ective 2001/83/ EC as amended. ketresearcher BIPE, compared the prices of 30 OTC OTC

28 February 2011 OTC bulletin 21 In association with OTC Marketing Awards Recognising2011 the achievements of the British OTC industry Gala Dinner & Awards Presentation Park Lane Hotel, Piccadilly, London Thursday, 10th March 2011 Take Centre Stage at the Awards that Really Matter

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PEOPLE OTC

Manufacturers Manufacturers Boehringer confirms Bayer recruits Mann to Wright as OTC head oehringer Ingelheim has appointed David take over from Balkema BWright as senior vice-president and glo- bal head of its Consumer Health Care business. Wright, 46, had been acting global head of ayer HealthCare has recruited Erica Mann Erica Mann the privately-owned German company’s Con- B– president and general manager of Pfiz- sumer Health Care business since early 2010, er Nutritional Health – as the new president of following the departure of Hans Regenauer its global Consumer Care division and a mem- to Sanofi-Aventis (OTC bulletin,20 January ber of its executive committee. 2010, page 22). Mann will join Bayer’s Consumer Care divi- After starting his career at Boots Healthcare sion on 14 March 2011, and take over leader- International – where he held a variety of sales ship of the business on 1 April following Gary and marketing positions – Wright moved in Balkema’s departure at the end of March. 1992 to Novartis, where he served as sales dir- Balkema announced at the start of February ector and general sales manager. that he would be stepping down as worldwide In 1997, Wright joined Boehringer Ingel- head of Bayer’s Consumer Care division after heim as divisional director for the UK and Ire- more than a decade in the role (OTC bulletin, land, before he was named global marketing 11 February 2011, page 27). facturers’Association and Medicines Australia, director in 2004. Mann joined Pfizer upon the company’s ac- as well as the International Association of In- Wright is a board member of both the Asso- quisition of Wyeth in October 2009 (OTC bul- fant Food Manufacturers. ciation of the European Self-Medication Indus- letin,30 October 2009, page 3). Prior to that, Earlier in her career,Mann worked at Led- try,the AESGP,and the World Self-Medica- she had served as Wyeth’s senior vice-presi- erle Laboratories, Johnson & Johnson and Eli tion Industry (WSMI). dent, Nutrition, where she had helped estab- Lilly & Company. OTC lish the shape and strategic direction of the Jorg Reinhardt, chairman of Bayer Health- business, Bayer noted. Care’s board of management and executive com- IN BRIEF Previously,Mann had led Wyeth’s opera- mittee, said that over the past 25 years Mann tions in Australia and New Zealand, Bayer said, had become “noted in the industry for her strong ■ OMEGA PHARMA said its country man- and had spent over a decade in charge of the record of delivering business results”. “Her ager for Belgium, Bart Meermans,was leav- company’s Pharmaceutical business in South outstanding experience and insights will drive ing the company in March to take up a post in Africa, where she was the first female chief ex- Consumer Care to take advantage of the sus- London at “a major global company in the fast- ecutive officer of a pharmaceutical company. tained growth forecast for the OTC market,” moving consumer goods and OTC sector”. In addition, Mann has held executive posi- he commented. tions in several industry organisations, includ- Bayer Consumer Care reported worldwide ■ EFSA – the European Food Safety Author- ing the South African Pharmaceutical Manu- sales of C3.08 billion in 2009. ity – has announced that its management board OTC has renewed the mandate of its executive dir- ector, Catherine Geslain-Lanéelle. Her sec- Manufacturers ond term in the position will run for five years from 1 July 2011. Geslain-Lanéelle took up the Novartis raids J&J for new OTC chief post on 1 July 2006. ■ Continued from front page of Novartis’ OTC business after only eight ■ PROCTER & GAMBLE said Meg Whit- Diagnostics divisions, while the CIBA Vision months in the role (OTC bulletin,30 April man,54, had rejoined its board of directors. business will be integrated into the new Al- 2010, page 23). Whitman – who was president and chief exec- con eyecare division. Financial results for the OTCand Animal utive officer at eBay for a decade until her re- As a result, Kelman will be a member of Health divisions would continue to be report- tirement in 2008 – first served on Procter & Novartis’ executive committee, and report dir- ed under the umbrella of Novartis Consumer Gamble’s board from 2003 to 2008. She ran ectly to chief executive officer Joseph Jimenez. Health, the company noted. for Governor of California in 2010 in the US. George Gunn,worldwide head of Novartis’ Novartis pointed out that Kelman had held Consumer Health division, will take control of several leadership roles within Johnson & John- ■ ETHYPHARM has promoted Bruno Delie the Animal Health business on 2 March. Gunn son’s Consumer and Medical Devices & Diag- to executive vice-president of business devel- will remain a member of the executive commit- nostics divisions, and had demonstrated a strong opment. Delie – who joined the drug-develop- tee, and will also take charge of corporate social focus on innovation which had delivered strong ment specialist in 2000, and was previously its responsibility at Novartis. financial results. vice-president of sales and marketing – reports Gunn has been in day-to-day control of the Before joining Johnson & Johnson, Kelman to chairman and chief executive Hugues Lecat. worldwide OTC business since April of last worked for Bristol-Myers Squibb. OTC year,when Dirk Van de Put resigned as head OTC

28 February 2011 OTC bulletin 23