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29 July 2011

COMPANY NEWS 2 RB expands Mucinex 2 decides to keep as generics loom Ransom sells contract 3 manufacturing arm Consumer Healthcare J&J’s US OTC sales 4 halve in two years Forest Laboratories buys 5 fizer has decided to keep its Consumer pharmaceutical products”, Read pointed out, six OTC brands from GSK PHealthcare business following a review and also had “strong connections with emerging Hi Capital acquires stake 6 of all its operations. markets and customers worldwide”. in Pharmacy Chain 36.6 However, the US-based pharmaceutical com- Read’s comments seem to bring an end to a looks to grow 7 pany is exploring the strategic alternatives, in- period of uncertainty for the Consumer Health- OTC business cluding divestment, for its Animal Health and care business, which Pfizer gained when it ac- Emerging markets to dominate 8 Nutrition businesses. quired in October 2009 (OTC bulletin, at GSK Ian Read, Pfizer’s president and chief exec- 30 October 2009, page 3). DocMorris keeps growing 9 utive officer,said the company believed it could In February of this year,Read – who took as new customers log on continue to “enhance the value” of the Con- the reins at Pfizer in December 2010 – chal- FDA files decree against 10 sumer Healthcare business, which he insisted lenged the Consumer Healthcare business to dietary supplement firm had a “strong connection” to the company’s prove its worth to Pfizer (OTC bulletin,11 Feb- core biopharmaceutical operations. ruary 2011, page 14). GENERAL NEWS 11 Consumer Healthcare had the potential to Read’s comments coincided with Consumer “extend the value of certain Pfizer legacy bio- ■ Continued on page 16 Commission plans repeal of 11 law covering dietetic foods Eisai moves to switch 12 rabeprazole in the UK EFSA releases fifth batch 13 Centralised switch rejected of opinions on health claims Counterfeit Directive leaves 14 alpharm’s bid to gain non-prescription sta- ient would increase the risk of cerebrovascu- much to do Gtus for the migraine medicine sumatriptan lar and cardiovascular side-effects, and poten- US court backs Watson 15 using Europe’s centralised procedure has been tial misuse”. in Mucinex patent case turned down. In addition, the CHMP felt that monitoring Germany defers 16 The rejection comes despite the fact that was essential because migraine as a condition decision sumatriptan is already a non-prescription med- changed over time, as did the patient’s cere- icine for treating migraine in some countries, brovascular and cardiovascular status. MARKETING NEWS 17 including New Zealand, Sweden and the UK. The measures proposed by Galpharm to re- Furthermore, medicines for treating the symp- duce these risks were “insufficient”, according Beiersdorf boosts Eucerin 17 toms of migraine are available without a pre- to the members of the CHMP. range for acne-prone skin scription in many countries. Sumatriptan Galpharm was developed as a Hedrin expands in the UK 18 Europe’s Committee for Medicinal Products generic version of GlaxoSmithKline’s Imigran. with ‘fuss-free’ treatment for Human Use (CHMP) decided Sumatriptan The CHMP accepted that it was bioequivalent FEATURES 20 Galpharm – containing 50mg sumatriptan – to Imigran. could not be approved in the non-prescription Overall, the CHMP concluded that the ben- Developing regions drive 20 setting. The CHMP maintained that “lack of efits of making Sumatriptan Galpharm avail- OTC growth medical supervision and monitoring of the pat- ■ Continued on page 13 A look at global OTC trends REGULARS Events – Our regular listing 19 Shotter to leave Germany’s Merck KGaA People – Brossard replaces Cotard 26 as head of France’s AFIPA eter Shotter will step down as worldwide Udit Batra, head of global public health and People – promotes Pane 27 Phead of Merck KGaA’s Consumer Health market access at Novartis’ Vaccines and Diag- to global healthcare position Care division on 1 September 2011 and leave nostics unit, has been named as his replacement. the German company by the end of the year. ■ Continued on page 13 OTC29-07-11p2-3FIN.qxd 29/7/11 08:55 Page 2

OTC COMPANY NEWS

Business Strategy/First-Half Results RB expands Mucinex as generics loom

eckitt Benckiser has expanded the reach cinex line until 28 April 2020 (see page 15). quired SSL International last November (OTC Rof its Mucinex brand into the US multi- Becht admitted that the case against Watson bulletin,30 July 2010, page 1) – added £344 symptom cold category,as the company pre- had been lost and that the generics firm would million, the company said. On a like-for-like pares for the impact of generic competition to be in a position to launch its own versions of basis, total sales had advanced by 11%. the brand’s core products. “pretty much the full line” of Mucinex guaife- The Healthcare business had benefitted from , Reckitt Benckiser’s outgoing nesin-based cough products once the generics the “very good growth” achieved by the Mu- chief executive officer,said the Mucinex Fast- had been approved by the US Food and cinex, Nurofen and brands, Reckitt Max range of liquid products had been devel- Administration (FDA). Benckiser pointed out, all of which had been oped to treat a variety of symptoms associated Reckitt Benckiser is also facing a Mucinex boosted by line extensions and a stronger cold with colds and would help mitigate the impact patent challenge from and has already and flu season. Gaviscon had also been a good of generic competition to Mucinex’ existing settled a case with URL/Mutual. contributor,the company noted. cough products. The new line of Mucinex products consists Looking ahead, the Strepsils brand would The US Court of Appeals recently upheld of four liquids: Mucinex Fast-Max Cold, Flu be extended in the second half of 2011, Kapoor a decision that Watson Pharmaceuticals’ guai- & Sore Throat; Mucinex Fast-Max Severe Con- said, with the launch of Strepsils Children 6+ fenesin tablets did not infringe the US patent gestion & Cough; Mucinex Fast-Max Cold & and Strepsils Sore Throat & Cough. 6,372,252, which protects the established Mu- Sinus; and Mucinex Fast-Max DM Max for Strepsils Children 6+ was the brand’s first Cough & Chest Congestion. lozenge specifically targeted at children, Kapoor ,Reckitt Benckiser’s chief pointed out, while Strepsils Sore Throat & Cough executive officer designate, pointed out that each was the first lozenge that tackled tickly cough, Business Strategy of the four variants contained the maximum which he claimed was the number one symp- strength of active ingredients – including para- tom of a sore throat. Alliance cetamol and phenylephrine – allowed for the In the Personal Care business, had symptoms each product was indicated to relieve. continued to grow in developing markets, Reck- The Mucinex brand would be entering a itt Benckiser said, as well as in Europe, where eyes deal market segment “two-to-three times the size the rollout of the No Touch Hand Soap Sys- of the cough category”, Kapoor pointed out, but tem had been “very encouraging”. lliance Boots is in talks to acquire a hold- one which was also much more competitive. The Dettol brand would be expanded in Aing in Nanjing Pharmaceutical Group, the To ensure Mucinex could compete in this the second half of the year with the Dettol largest shareholder in Chinese pharmaceutical segment, Reckitt Benckiser had combined Healthy Touch Moisturising Sanitiser,Kapoor wholesaler Nanjing Pharmaceutical. the brand equity Mucinex had built up in the revealed, and a line of male personal-care The pan-European wholesaler and retailer cough category,Kapoor noted, with maximum products aimed at the Middle East and other said it had signed a letter of intent with Nanjing strength ingredients and a liquid formulation developing markets. and both companies believed the potential col- that was the best-tasting in the category. Reckitt Benckiser had also launched its laboration would provide “substantial support Meanwhile, Reckitt Benckiser saw a 45% rise first condom product since acquiring to the Chinese government in its commitment in sales at constant exhcnage rates at its Health the brand, Kapoor noted. Durex Performax In- to healthcare reform over the next 10 years”. & Personal Care business to £1.54 billion (C1.74 tense, now available in France, had been de- Described as a “leading pharmaceutical billion) in the first half of 2011 (see Figure 1). signed to provide a “more intense experience wholesaler in China”, Nanjing reported sales Sales from the Durex and Scholl brands – for both men and women”, he said. of CNY15.3 billion (C1.7 billion) in 2010. which Reckitt Benckiser gained when it ac- OTC Nanjing’s primary customers were hospitals and chains, including its own stores, Al- Business First-half sales Change 2010/2011 (%) liance Boots pointed out, noting that the com- (£ millions) £CER* pany had established a strong position in its Health & Personal Care1,536 +44 +45 home province of Jiangsu as well as the key Fabric Care757 -6 -5 provinces of Anhui and Fujian, and had ex- Surface Care692 +1 +2 panded into seven further provinces. Home Care569 +1 +3 Alliance Boots announced in November Dishwashing 453 ±0 +1 last year that it intended to become a leading Other 105 –– player in the Chinese market and had identi- Household and Health & Personal Care 4,112 +14 +15 fied ways to increase its presence (OTC bul- letin,16 November 2010, page 3). Pharmaceuticals 360 +16 +22 At the time, a spokesperson for Alliance Food 149 +2 +8 Boots told OTC bulletin that the company was Total Reckitt Benckiser 4,621 +14 +15 looking at “several opportunities” and one might be “seized in the near future”. * CER is constant exchange rates OTC Figure 1: Reckitt Benckiser’s sales in the first half of 2011 by business (Source – Reckitt Benckiser)

2 OTC bulletin 29 July 2011 OTC29-07-11p2-3FIN.qxd 29/7/11 08:55 Page 3

COMPANY NEWS OTC

Business Strategy Ransom sells contract manufacturing arm

illiam Ransom & Son Holdings is set to creating a “focused, higher-margin, differenti- page 6) before announcing in September 2008 Wsell its Ransom Pharmaceuticals divi- ated natural consumer healthcare business”. that it was seeking buyers for the contract man- sion to OBG Pharmaceuticals for approximate- Earlier this year,Ransom completed a re- ufacturing division and various brands as part ly £350,000 (C398,352). structuring which divided the business into three of a strategy to simplify the business. The sale will bring to an end a lengthy search operating subsidiaries under the William Ran- for a buyer for the contract manufacturing busi- som & Son Holdings banner. This saw the Con- Continued to struggle ness, which Ransom has been trying to sell as sumer Healthcare division and Ransom Natural Despite implementing the turnaround plan, part of a turnaround plan since 2008 (OTC bul- Products division transferred into two newly- the company continued to struggle financially, letin,29 September 2008, page 6). created subsidiaries,leaving the William Ran- reporting an operating loss of £12.2 million Roger Jones, Ransom’s chairman, said the som & Son Limited (WRSL) unit to operate the in the year ended 31 March 2010. The major- company’s board believed that selling the Phar- Pharmaceuticals division. ity of the loss was blamed on a write-down of maceuticals division was in the best interests The reorganisation followed more than three the goodwill valuation of the Consumer Health- of both the company and its stakeholders. It years of upheaval at Ransom, which began at care business after it had sold six of its con- was also consistent with the firm’s strategy of the end of 2007 when the UK’s Medicines sumer healthcare brands (OTC bulletin,29 and Healthcare products Regulatory Agency September 2010, page 5). (MHRA) temporarily suspended the company’s Following the close of the company’s 2009- OTC bulletin manufacturer’s licence for certain products made 2010 financial year,Ransom secured a long- at its facility in Witham, Essex (OTC bulletin, term financing agreement after using the pro- 29 July 2011 Number 366 17 December 2007, page 5). ceeds from the brand divestments to reduce its Less than a month later,Tim Dye stepped bank debt and provide working capital (OTC Editor & Publisher: Deborah Wilkes down as Ransom’s chief executive following a bulletin,30 April 2010, page 3). Associate Editors: Aidan Fry “disappointing and unacceptable financial per- At the end of 2010, Ransom announced its Mike Rice formance” in the six months to 30 September intention to reorganise the business by estab- Business Editor: Matt Stewart 2007 (OTC bulletin,25 January 2008, page 21). lishing a new parent company – William Ran- Assistant Editors: Jenna Lawrence, In the wake of the poor financial results and som & Son Holdings – and cancel trading in David Wallace the action taken by the MHRA, Ransom under- the company’s shares on ’s Alternative Advertising Controller: Debi Minal took a review of its manufacturing business and Investment Market (AIM). The process to go product portfolio (OTC bulletin,17 March 2008, private was completed in February 2011. Marketing Manager: Val Davis OTC Editorial, Subscription and Advertising enquiries should be addressed to: OTC bulletin, OTC Publications Ltd, 54 Creynolds Lane, Solihull, Business Strategy West Midlands B90 4ER, UK. Tel: +44 1564 777550. Fax: +44 1564 777524. B+L partners with Micro Labs in E-mail: [email protected]. Subscriptions ausch + Lomb has signed a strategic al- ing ophthalmic pharmaceuticals market” in Annual subscriptions to OTC bulletin in Europe are £625.00 for B liance with Indian contract manufacturer India, which was expected to be worth US$300 single copies and £355.00 for additional copies to the same ad- dress, including delivery. Subscriptions to addresses outside Eur- Micro Labs to launch a range of prescription million (C213 million) by 2015. ope are subject to an additional charge of £30.00 to cover postage. Subscription enquiries in Korea should be directed to Pharma and OTC eye-health products in India. Harish Natarajan, the managing director of Koreana Ltd, 14th Floor,KTB Network Building, 826-14 Yeoksam- The US-based eyecare specialist said that Bausch + Lomb India, said the company was dong, Kangnam-gu, Seoul 135-080, Korea (Tel: +82 2 554 9591; Fax: +82 2 563 8289; E-mail: [email protected]). it would initially launch six prescription phar- “committed to improving the quality of eyecare Advertising maceutical eye-drop products – Aquasurge, in India”. It would help doctors grow their Advertising rates and data are available on request from the ad- Aquasurge Max, Bromvue, Ketovue, Moxi- practices by expanding the range of offerings dress above or at www.otc-bulletin.com. About OTC bulletin surge and Moxisurge-KT – in India and “ex- they provided. OTC bulletin is published 20 times a year by OTC Publications plore other areas of possible collaboration” In addition to launching new products, the Limited: twice monthly in February,March, April, May,June, Sep- tember,October and November; and monthly in December,Jan- with Micro Labs. partnership would give Bausch + Lomb access uary,July and August. A subscription to OTC bulletin includes These other areas of collaboration, Bausch to “world-class manufacturing capabilities”, the weekly electronic newsflash, news@OTCbulletin,which is published around 45 times a year. OTC bulletin is printed by the + Lomb pointed out, included manufacturing tech- the company noted, adding that it would estab- Warwick Printing Company Limited, Caswell Road, Leamington nology for producing eye drops. Sourcing of lish dedicated sales and marketing teams to Spa CV31 1QD, UK. ophthalmic-solution products from Micro Labs support the products and deliver practitioner- No part of this publication may be copied, reproduced, stored in a retrieval system or transmitted in any form without prior for sale by Bausch + Lomb in India and other and patient-education programmes. permission from OTCPublications Ltd. markets in the Asia-Pacific region would also Bausch + Lomb has had a presence in India ©OTC Publications Ltd. All rights reserved. Company registered in England No 2765878. Registered Office: be explored, as well as the joint development since 1992 through its contact lens and solu- 54 Creynolds Lane, Solihull, West Midlands B90 4ER, UK. of ophthalmic pharmaceutical products specif- tions business. About 15 years ago, the com- OTC bulletin® is registered as a trademark in the European ically for emerging markets. pany expanded its presence in India by launch- Community. Bausch + Lomb said that through the deal ing eye-related surgery products. ISSN 1350–1097 www.OTC-bulletin.com it aimed to capture part of the “rapidly expand- OTC

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OTC COMPANY NEWS

Second-Quarter Results J&J’s US OTC sales halve in two years

S sales at Johnson & Johnson’s OTC& Meanwhile, international OTC & Nutrition- ties, Mehrotra warned that the extra quality con- UNutritionals business have halved over the als sales improved by 16.0% to US$753 mil- trols put in place by the consent decree meant past two years, as product recalls and the closure lion, as a 4.8% operational advance was boost- that volumes shipped from the two sites had of McNeil Consumer Healthcare’s Fort Wash- ed by an 11.2% positive currency effect. been hit. However, she added, they would start ington manufacturing plant have taken their toll. Commenting on the OTC business in the US, to ramp up later in 2011. OTC & Nutritionals’ US turnover was just Louise Mehrotra, Johnson & Johnson’s vice- Commenting on the products that had pre- US$330 million (C223 million) in the second president of investor relations, said McNeil viously been made at the Fort Washington facil- quarter of this year. This represented a fall of had made progress in meeting the conditions of ity,Mehrotra said McNeil was still in the pro- 32.9% compared with the same period last year a consent decree filed by the US Department of cess of transferring production and that only (see Figure 1), and a drop of 51.4% compared Justice and the Food and Drug Administration modest amounts of some brands would be made with the second quarter of 2009 when sales (FDA) (OTC bulletin,17 March 2011, page 1). available in 2011. stood at US$679 million. The decree was filed against McNeil for fail- Dominic Caruso, Johnson & Johnson’s chief The 2011 decline in the US pushed down ing to comply with current Good Manufactur- financial officer,added that the McNeil busi- worldwide sales at the OTC & Nutritionals ing Practice requirements at the Fort Washing- ness would ramp-up production in the first half unit by 5.1% to US$1.08 billion. The fall would ton plant, its facility in Las Piedras, Puerto Rico, of next year. He expected the majority of its have been worse if a positive currency impact and its Lancaster,Pennsylvania site. products to be back on retailers’ shelves by the of 6.4% had not partially offset an 11.5% oper- Although the company was still operating middle of 2012. ational slide. both the Las Piedras and the Lancaster facili- At the start of the quarter,Johnson & John- son implemented a shake-up of the Consumer Business Second-quarter Change Operational Currency division that isolated the McNeil business in the sales (US$ millions) (%) change (%) effect (%) US (OTC bulletin,15 April 2011, page 3). The company also appointed Pat Mutchler Medical Devices & Diagnostics 6,571 +7.2 +1.3 +5.9 as group chairman of US OTC, McNeil Nutri- Pharmaceutical 6,233 +12.2 +7.0 +5.2 tionals and the Wellness & Prevention business Consumer 3,793 +4.0 -1.8 +5.8 unit, as well as the Johnson & Johnson/Merck Consumer Pharmaceuticals joint venture. Total Johnson & Johnson 16,597 +8.3 +2.6 +5.7 The decline in US OTC sales was the pri- Figure 2: Johnson & Johnson’s sales in the second quarter of 2011 (Source – Johnson & Johnson) mary factor behind second-quarter sales at John-

Business Second-quarter sales ChangeOperational Currency (US$ millions) 2010/2011 (%) change (%) effect (%) OTC & Nutritionals – US 330 -32.9 -32.9 – OTC & Nutritionals – International 753 +16.0 +4.8 +11.2 Total OTC & Nutritionals 1,083 -5.1 -11.5 +6.4 Skin Care – US 449 +6.4 +6.4 – Skin Care – International 480 +14.0 +4.3 +9.7 Total Skin Care 929 +10.2 +5.3 +4.9 Baby Care – US 105 +6.1 +6.1 – Baby Care – International 493 +12.6 +5.0 +7.6 Total Baby Care 598 +11.4 +5.2 +6.2 Women’s Health – US 121 -11.7 -11.7 – Women’s Health – International 356 +8.2 -0.9 +9.1 Total Women’s Health 477 +2.4 -4.0 +6.4 Oral Care – US 158 +6.8 +6.8 – Oral Care – International 241 +7.6 -2.1 +9.7 Total Oral Care 399 +7.3 +1.5 +5.8 Woundcare/Other – US 176 +6.7 +6.7 – Woundcare/Other – International 131 +6.5 -3.3 +9.8 Total Woundcare/Other 307 +6.6 +2.8 +3.8 Total Consumer 3,793 +4.0 -1.8 +5.8 Consumer – US 1,339 -8.5 -8.5 – Consumer – International 2,454 +12.4 +2.8 +9.6

Figure 1: Breakdown of sales by Johnson & Johnson’s Consumer division in the second quarter of 2011 (Source – Johnson & Johnson)

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COMPANY NEWS OTC

son & Johnson’s Consumer division falling by Mergers & Acquisitions 1.8% at an operational level to US$3.79 billion (see Figure 2). However, a positive currency Forest Laboratories buys impact of 5.8% offset the operational drop, lift- ing the Consumer division’s sales by 4.0%. Consumer’s US sales declined by 8.5% to US$1.34 billion due to the problems at Mc- six OTC brands from GSK Neil, while international turnover jumped by 12.4% to US$2.45 billion thanks to a 9.6% orest Laboratories has acquired six brands positive currency effect. F in the UK from GlaxoSmithKline Consum- Consumer’s Baby Care business was the er Healthcare for an undisclosed sum. best performer of the division’s six categories, The package of brands includes the EarCalm with sales rising by 11.4% to US$598 million. anti-infective ear spray,Imigran Recovery mi- Mehrotra said the increase had been driven by graine treatment,Joyrides travel-sickness brand, double-digit growth in cleansers, wipes and oils. Otomize anti-infective ear spray,Wind-eze for US Baby Care sales improved by 6.1% to trapped wind and Veno’s cough line. US$105 million, while international turnover Forest has also gained the rights to Otomize grew by 12.6% to US$493 million. in Greece and Veno’s in Ireland. Skin Care – Consumer’s second-biggest Commenting on its plans for the newly-ac- category – posted sales up by 10.2% to US$929 quired brands, Forest said that it was working million, as Aveeno, Le Petit Marseillais and with Ceuta Healthcare to support the EarCalm Neutrogena all posted strong growth thanks brand in during the summer season.

to new product launches. International sales – Summer was the key trading period for Ear- EarCalm is one of six OTC brands Forest Laboratories boosted by a positive currency effect – jump- Calm, Forest noted, as the product was the only has acquired from GlaxoSmithKline in the UK ed by 14.0% to US$480 million, while US turn- general-sales list medicine indicated for treat- over advanced by 6.4% to US$449 million. ment of superficial infections of the external Commenting on the deal, a spokesperson for Women’s Health recorded a 2.4% rise in auditory canal, such as otitis externa, or ‘swim- GlaxoSmithKline told OTC bulletin that the worldwide sales to US$477 million. On an op- mer’s ear’. Swimmer’s ear was more common “local transaction” was “entirely separate” to the erational basis, however, turnover declined by in the summer,the company commented, espe- company’s plans to sell a basket of over 100 4.0%. Sales in the US dropped back by 11.7% cially amongst people who spent a lot of time non-core global OTC brands with a combined to US$121 million, while international turn- in the water. annual turnover of £0.5 billion (C0.6 billion) over increased by 8.2% to US$356 million Pharmacists were in “pole position to advise (OTC bulletin,29 April 2011, page 1). thanks to a positive currency effect of 9.1%. parents and recommend appropriate treatment Earlier this year,GlaxoSmithKline sold five Worldwide turnover for the company’s Oral in this area”, Forest added, noting that in the of its US OTC brands to Sweden’s Meda in Care products grew by 7.3% to US$399 mil- future EarCalm would benefit from more sea- two separate deals worth a total of SEK145 mil- lion, as a result of strong toothbrush sales and sonal marketing support. lion (C15.8 million). new Listerine products. In the US, turnover rose OTC by 6.8% to US$158 million, while international sales moved forward by 7.6% to US$241 mil- Business Strategy lion. The growth in international sales was sole- ly thanks to a positive currency effect of 9.7%. Omega Pharma admits delisting option Woundcare/Other reported worldwide sales up by 6.6% to US$307 million, with US and mega Pharma has admitted that delisting that Omega has been forced to deny it is on international turnover improving by 6.7% and Ofrom the Stock Exchange Euro- the verge of falling back into private hands. 6.5% respectively to US$176 million and next market is a strategic move open to the Bel- In June, the company refused to rule out a US$131 million. Again, the rise in international gian firm, but insisted that no decision to go delisting, but denied reports in the Belgian sales was driven by a positive currency effect, private had been taken. newspaper De Tijd that it was in talks over a this time of 9.8%. In response to reports in the Belgian press return to private ownership (OTC bulletin,10 The Consumer division accounted for 23% on 9 July that an offer price had been set ahead June 2011, page 3). of Johnson & Johnson’s total sales in the sec- of a possible delisting, Omega stated that al- Omega reported sales up by 5.3% to C857 ond quarter,which moved forward by 8.3% though a delisting scenario involving its con- million in 2010, beating its forecast of a 4% rise to US$16.6 billion. trolling shareholder,Couckinvest, had been an- (OTC bulletin,11 February 2011, page 12). The dominant Medical Devices & Diag- alysed,no decision had been made about de- Looking ahead, the firm said that with the nostics division reported turnover up by 7.2% listing or funding any possible return to pri- restructuring of its country operations now to US$6.57 billion, whiles sales at the Pharma- vate ownership and there was no certainty that complete and a “promising” product pipeline, it ceutical unit grew by 12.2% to US$6.23 billion. such a scenario would ever be executed. expected organic growth of at least 4% in 2011. Pre-tax profits fell by 18.9% to US$3.42 bil- Omega also noted that the offer price men- This internal growth, combined with a num- lion, due primarily to double-digit increases tioned in press reports had been higher than ber of recent acquisitions, would give the com- both in the cost of goods sold and research and the C37.00 per-share offer the company had pany an annual turnover of a least C927 mil- development expenses. assumed in its strategic planning. lion, the company forecasted. OTC This is the second time in less than a month OTC

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OTC COMPANY NEWS

Business Strategy Mergers & Acquisitions USANA meets Hi Capital acquires stake FDA standards in Pharmacy Chain 36.6 ietary supplements manufacturer USANA DHealth Sciences has been approved to nvestment firm Hi Capital Corporation has ability was currently at a “low level”. However, manufacture OTC medicines after obtaining Iacquired more than a fifth of Russia’s Phar- the company had shown positive growth, he Drug Establishment Registration from the US macy Chain 36.6 from pharmaceutical whole- added, and Hi Capital expected profitability to Food and Drug Administration (FDA). saler SIA International for an undisclosed sum. be in line with the average for the pharmaceuti- USANA said that while nutritional com- The move comes almost 18 months after cal retail market over the next two to three years. panies in the US were not expected to follow SIA took a 25% stake in Pharmacy Chain 36.6 Pharmacy Chain 36.6 – which operates a pharmaceutical Good Manufacturing Practice in a deal that media reports claimed had been chain of 990 pharmacies in Russia as well as (GMP), the firm believed it was an “important, struck to settle the retailer’s debts with the Rus- the Veropharm manufacturing business – re- logical step” to acquire government registra- sian pharmaceutical wholesaler (OTC bulletin, ported sales up by 16.6% to RUB5.29 billion tion as it proved its “long-standing commitment 10 February 2010, page 2). (C130 million) in the first quarter of 2011 (see to producing the highest quality products”. Figure 1). Earnings before interest, tax, depre- Based in the US, USANA produces 90% Good working relationship ciation and amortisation (EBITDA) more than of its nutritionals, personal-care, energy and Igor Rudinsky,SIA’s general manager,said doubled to RUB443 million. weight-management products in-house. The the wholesaler had developed a good business Sergey Krivosheev, chairman of Pharmacy company’s products are sold directly to prefer- relationship with Pharmacy Chain 36.6 and the Chain 36.6’s board of directors, said the work red customers and associates in , Can- two companies would continue to cooperate. done to improve the company’s efficiency had ada, , Japan, Malaysia, Mexico, the Alexander Zhdanov, a partner in Hi Capital, led to the new investment, which in turn would Netherlands, the Philippines, Singapore, South pointed out that Pharmacy Chain 36.6’s profit- attract further interest. Korea, Taiwan, the UK and the US. Dave Wentz, USANA’s chief executive offi- Business First-quarter salesChange EBITDA* Change cer,said that while few companies volunteer- (RUB millions) (%) (RUB millions) (%) ed to put themselves under more scrutiny, as Retail 3,713 +8.7 48 +8.0 USANA operated in 15 countries including Veropharm 1,383 +43.6 416 +109.1 Australia – where dietary supplements were Other 196 +23.9 7+189.0 highly regulated – the company’s manufactur- Corporate ––-28 – ing standards were extremely high. Total Pharmacy Chain 36.6 5,292 +16.6 443 +107.5 “So, while obtaining FDA registration won’t affect our day-to-day operations,”Wentz said, * Earnings before interest, tax, depreciation and amortisation

“it will help further assure our users of the Figure 1: Pharmacy Chain 36.6’s sales and earnings before interest, tax, depreciation and amortisation in the quality of our products.” first quarter of 2011 (Source – Pharmacy Chain 36.6) OTC OTC

Trading Update IN BRIEF ProPhase faces ■ SINCLAIR IS PHARMA has forecast that ■ BIOPROGRESS said it had signed a sales its sales for the year ended 30 June 2011 and distribution agreement with Herbavim in will beat expectations and reach £32.7 mil- Poland for its Menoflavon range of products. A Nasdaq trouble lion (C37.4 million). However, as anticipated, first order for the Menoflavon supplements – the company would probably record a loss due which are claimed to relieve the symptoms of roPhase Labs – owner of the Cold-EEZE to ongoing investment to drive revenue growth, the menopause – had already been delivered Pcough and cold brand – said that it was no Sinclair noted. Sinclair IS Pharma was formed prior to the launch in Poland this month, Bio- longer in compliance with the Nasdaq stock through the merger of Sinclair Pharma and Progress noted. The brand was now available exchange rules, as its closing share price had IS Pharma on 20 May 2011 (OTC bulletin,15 in 15 countries, including Canada, Jordan and been below US$1.00 (C0.71) for 30 consecu- April 2011, page 6). Singapore, the company added. tive trading days. To regain compliance, the closing price of ■ RECORDATI is set to buy Turkish pharma- ■ ANZAG – the German wholesaler controlled the company’s shares had to stay above US$1.00 ceutical company Dr Frik Ilac in a deal worth by the Alliance Boots group – said margin for a minimum of 10 consecutive trading days, US$130 million (C92 million). The Italian firm pressure arising from healthcare reforms and ProPhase pointed out. said the deal would make Turkey its third most “intensive competition” in its domestic market The firm now had until 27 December 2011 important market after Italy and France, while caused its pre-tax profit to slump by 78% to to regain compliance, ProPhase said, noting that increasing its presence in Central and Eastern C10.8 million on a turnover of C2.5 billion in it would consider all options to achieve this. Europe, which offered much greater growth the seven months ended 31 March 2011. OTC rates than markets in Western Europe. OTC

6 OTC bulletin 29 July 2011 OTC29-07-11p6-7FIN.qxd 29/7/11 09:00 Page 3

COMPANY NEWS OTC

NovartisSecond-Quarter Results looks to grow OTC business

ovartis is looking to increase the scale of its Region Second-quarter sales Change 2010/2011 (%) NOTC business. The Swiss company wants (US$ millions) US$ Local currencies the unit to grow, and will put the resources in place for it to do so, according to chief execu- Europe 503 +14 +1 tive officer Joseph Jimenez. US 368 +5 +5 Speaking at Novartis’ second-quarter results Asia/Africa/Australasia 201 +23 +10 press conference,Jimenez said the company Canada and Latin America 115 +17 +15 considered both its OTC and Animal Health Total Novartis Consumer Health* 1,187 +13 +5 businesses – which form the Novartis Con- sumer Health division – “investment grade” * Continuing operations operations that were “growing nicely”. Figure 2: Breakdown of Novartis Consumer Health’s sales in the second quarter of 2011 (Source – Novartis) “They are not as big as some of the other businesses,”Jimenez pointed out, “so it would ed strong ahead-of-market growth in Canada, increase in local currencies to US$1.19 billion be nice to build scale in those two businesses.” Germany and the US, the company added, while (see Figure 1). Asked if Novartis could afford to bulk-up across its six key emerging markets – Brazil, Asia/Africa/Australasia was the best-per- the OTC and Animal Health businesses after China, India, Russia, Turkey and South Korea – forming region for Consumer Health, with sales paying US$12.9 billion (C9.1 billion) in April sales had increased by a fifth in local currencies. improving by 23% to US$201 million. In local to take full control of (OTC bulletin,15 The double-digit rise in emerging-market currencies, the increase was a slightly more April 2011, page 13), Jimenez said that given sales had been driven primarily by better OTC modest 10% (see Figure 2). the company’s current debt position and the fact sales in Brazil and Russia, Novartis pointed out, Consumer Health’s biggest region in terms it was generating around US$1.0 billion in cash where a focus on key brands and investment of sales – Europe – posted a 14% jump in sales a month, it would not take long to “create a into salesforces had supported growth. to US$503 million. However, in local curren- position where we could go after assets that In the US, the lansoprazole-based Prevacid cies, the rise was just 1%. would increase our scale in some of those div- 24HR had maintained a solid market share as In the US, Consumer Health’s performance isions that are smaller than others”. it continued to benefit from “normalised quarter- was held back by increased competition in the Novartis Consumer Health’s global OTC ly stock movement” compared to the prior-year animal health sector,with the division’s turn- business had grown ahead of the market in the launch period, Novartis noted. over rising by just 5% over the three months second quarter of 2011, the company said, as Investment behind the Voltaren pain-relief to US$368 million. Sales in Canada and Latin continued focus on its priority brands and mar- brand led to a double-digit increase in sales in America moved ahead by 17% – 15% in local kets had delivered “strong results”. Germany – Novartis’ second-biggest OTC mar- currencies – to US$115 million. A number of its priority brands had reported ket – the company noted, adding that Volta- Consumer Health’s operating income edged double-digit sales growth, Novartis noted, which ren was the “number one OTC self-medication up by 2% to US$225 million, although in local had helped offset a decline in turnover caus- product” sold in the country. currencies the rise was a more impressive 11%. ed by expired distribution contracts and the dis- A double-digit jump in OTC sales had also Operating income margin slipped back by 3.2 posal of non-core brands. been recorded in Canada, Novartis said, driven percentage points to 19.0%. A strong cough/cold season had lifted sales primarily by the business’ cough and cold fran- The Consumer Health division made up of the Theraflu brand by a quarter in local cur- chise and Voltaren. 7.9% of Novartis’ total sales, which finished rencies, Novartis revealed, while Otrivin nasal Sales at Novartis Consumer Health – which ahead by 27% – 19% in local currencies – to spray had reported an 18% jump in turnover. now consists of just the OTC and Animal Health US$14.9 billion. Novartis’ operating income The OTC business’ leading brand, Voltaren, units, after the CIBA Vision business was inte- advanced by 12% to US$3.32 billion. In local posted sales up by 9% in local currency terms. grated into the Alcon eyecare business – grew currencies, the rise was even bigger at 15%. Geographically,the OTC unit had report- by 13% in the second quarter. This was a 5% OTC

Division Second-quarter sales Change 2010/2011 (%) Operating income Change Operating (US$ millions) US$ Local currencies (US$ millions) 2010/2011 (%) margin (%) Pharmaceuticals 8,338 +10 +2 2,791 +23 33.5 Alcon 2,625 –– 371 –14.1 Sandoz 2,466 +25 +16 283 -2 11.5 Consumer Health* 1,187 +13 +5 225 +2 19.0 Vaccines and Diagnostics 299 -47 -50 -214 –-71.6 Corporate –––-134 –– Total Novartis 14,915 +27 +19 3,322 +12 22.3

* Continuing operations

Figure 1: Breakdown of the financial performance of Novartis in the second quarter of 2011 (Source – Novartis)

29 July 2011 OTC bulletin 7 OTC29-07-11p8-9FIN.qxd 29/7/11 09:02 Page 2

OTC COMPANY NEWS

Second-Quarter Results Emerging markets to dominate at GSK

laxoSmithKline Consumer Healthcare will Region Second-quarter sales Change 2010/2011 (%) Ggenerate around 60% of its sales in emerg- (£ millions) £CER* ing markets once its non-core brands have been divested, according to ,Glaxo- Rest of World 551 +12 +15 SmithKline’s chief executive officer. Europe 490 -1 -3 Work to sell the non-core OTC brands was US 236 -10 -2 ongoing, Witty noted, with the products expect- Total Consumer Healthcare1,277 +2 +4 ed to be divested by the end of 2011, subject to realising the best value for shareholders. * CER is at constant exchange rates

GlaxoSmithKline announced in April that Figure 1: GlaxoSmithKline Consumer Healthcare’s second-quarter 2011 sales by region (Source – GlaxoSmithKline) it would divest over 100 non-core OTC brands in Europe and the US – including the weight- ure 1), with “very strong” results recorded in would have been worse but for a very strong loss medicine Alli – with combined annual sales Africa – where sales increased by 23% – and quarter from the brand – which posted of around £500 million (C566 million) (OTC in India, where turnover advanced by 20%. turnover up by 19% – and sales of the Breathe bulletin,29 April 2011, page 1). By contrast, sales in Europe fell back by 3% Right line, which had jumped by a quarter,the to £490 million at constant exchange rates. company noted. Heavy exposure to emerging markets GlaxoSmithKline blamed the decline on lower Sales of OTC Medicines were flat at con- Witty pointed out in May that once the div- Alli sales, some retailer destocking and certain stant exchange rates in the second quarter at estments had been completed Consumer Health- interruptions to product supply. £581 million (see Figure 2). In actual terms, care would have “15 strategic brands and a very, One bright spot in Europe had been tooth- turnover dipped by 2%. very heavy exposure to emerging markets”, a paste sales, the company noted, with An 11% rise in sales of the Panadol analges- profile he described as “very exciting” (OTC delivering double-digit growth as Sensodyne ic brand – driven by “strong performances” bulletin,13 May 2011, page 4). Repair & Protect was introduced into new mar- in Australia and emerging markets – coupled Sales at the Consumer Healthcare division kets. Meanwhile Aquafresh had performed well with 28% and 15% increases in turnover from improved by 4% at constant exchange rates to in Central and Eastern Europe and had been the Tums and Eno gastrointestinal brands re- £1.28 billion during the second quarter. Around boosted by the launch of Aquafresh Ultimate spectively,GlaxoSmithKline said, had offset 43% of the second-quarter sales were generated in several markets. Alli’s weaker performance in both Europe and by the Rest of World region, which was also the Lower sales of Alli and withdrawing den- the US. division’s fastest-growing geographic area. ture adhesives containing zinc had led to a 2% Rest of World’s sales grew by 15% at con- drop in US sales to £236 million at constant Sensodyne drives Oral Healthcare stant exchange rates to £551 million (see Fig- exchange rates, GlaxoSmithKline said. The fall Oral Healthcare turnover improved by 5% at constant exchange rates to £425 million, driven Business Second-quarter sales Change 2010/2011 (%) primarily by the ongoing rollout of Sensodyne (£ millions) £CER* Repair & Protect. The Oral Healthcare busi- OTC Medicines 581 -2 ±0 ness had also benefitted, GlaxoSmithKline not- Oral Healthcare 425 +4 +5 ed, from good performances from the Aqua- Nutritional Healthcare 271 +8 +12 fresh brand in Europe and the launch of Aqua- fresh Ultimate. Total Consumer Healthcare1,277 +2 +4 Nutritional Healthcare was the stand-out per- * CER is at constant exchange rates former in the Consumer Healthcare division, with sales rising by 12% at constant exchange Figure 2: GlaxoSmithKline Consumer Healthcare’s second-quarter 2011 sales by business (Source – GlaxoSmithKline) rates to £271 million,as organic sales growth Second-quarter Change 2010/2011 (%) Proportion of 8% was boosted by the acquisition of the (£ millions) £CER* of total (%) Maxinutrition business late last year (OTC bul- letin,16 December 2010, page 1). Sales The organic growth at Nutritional Healthcare Pharmaceuticals 5,443 -6 -3 81 had been spurred by innovation and consumer Consumer Healthcare 1,277 +2 +4 19 marketing, GlaxoSmithKline said, with strong Total 6,720 -4 -2 100 results in emerging markets offsetting “poor Operating profit macroeconomic conditions” in a number of Pharmaceuticals 2,008 –-988other markets. Consumer Healthcare 263 –+15 12 Operating profit at the Consumer Healthcare division increased by 15% to £263 million in Total** 1,778 –– 100 the second quarter (see Figure 3), thanks pri- * CER is at constant exchange rates ** Including corporate costs of £302 million and restructuring costs of £191 million marily to product disposals. This lifted the oper- Figure 3: GlaxoSmithKline’s sales and operating profit in the second quarter of 2011 (Source – GlaxoSmithKline) ating margin from 20% to 21%.

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COMPANY NEWS OTC

Mergers & Acquisitions Annual Results Perrigo sells to DocMorris keeps growing complete deal as new customers log on errigo has agreed to divest six generic prod- Pucts to Watson Pharmaceuticals as a condi- elesio’s DocMorris said an 18% increase year to make navigating the site easier had in- tion of completing its US$540 million (C373 Cin customer numbers had enabled it to raise creased sales of non-prescription medicines by million) takeover of Paddock Laboratories. its mail-order turnover by more than a tenth to around 30%,the Celesio subsidiary revealed. Watson has signed a definitive agreement C280 million last year. DocMorris’ 160 partner pharmacies in 100 to buy the six products, four of which have “Since our foundation, more than 1.5 mil- German towns and cities now offer a range of been approved by the US Food and Drug Ad- lion patients have placed orders with the mar- 20 own-label medicines, including high-demand ministration (FDA) – ammonium lactate 12% ket leader,” the company stated, adding that the lines such as the allergy remedy cetirizine and cream and 12% lotion; ciclopirox 1% shampoo; DocMorris green cross logo could also be seen the . and promethazine 12.5mg and 25mg suppos- on franchise pharmacies in Germany, Ireland, itories. The other two are a clobetasol 0.05% Italy and Sweden. DocMorris name boosts profits spray and a diclofenac 1.5% solution still at DocMorris noted that it had built on its pro- “If a pharmacy becomes a DocMorris phar- the development stage. motional agreement with drugstore chain Ross- macy, it can improve its gross profit by up to Perrigo will make the products for Watson mann by forming a joint venture with the mail- C60,000 per year,” claimed Andreas Engleder, under a manufacturing and supply agreement order specialist the Klingel group. This venture who leads the company’s German franchising until production is transferred to Watson or a focuses on general-sale and unlicensed health- programme. third party. care products, such as food supplements, under In Sweden, 50 DocMorris pharmacies open- A settlement order agreed between Perrigo the Wellsana brand name. It is aimed primar- ed during 2010. By the end of this year,Doc- and the US Federal Trade Commission (FTC) ily at Germans aged 50 years and older. Morris intends to have more than 300 pharma- said that Perrigo and Paddock would have held Relaunching its own website in October last cies operating under its banner across Europe. a combined 87% share of the US market for OTC ammonium lactate cream, and a 93% share of the lotion market, competing against just Taro. Given Paddock’s dominant position, the two firms would have controlled virtually all of the US market for ciclopirox shampoo, the FTC noted, while the combined firm would have held just over a third of the market for pro- methazine suppositories. Discussing generic clobetasol spray and diclofenac solution, the FTC said: “Perrigo and Paddock are among a limited number of sup- pliers capable of entering these markets.”The merger would have eliminated future competi- tion, leading to higher prices for US consumers. OTC

Consumer Healthcare accounted for 19% of GlaxoSmithKline’s total second-quarter sales, which slipped back by 2% at constant exchange rates to £6.72 billion. The fall in group sales was due to a 3% slide in turnover at the domi- nant Pharmaceuticals division to £5.44 billion. Group operating profit – including corporate and unallocated costs and disposal profits of £302 million, as well as major restructuring costs of £191 million – stood at £1.78 billion. This was significantly better than £51 mil- lion posted in the prior-year period, when the company was hit by corporate, legal, restruc- turing and other costs totalling £2.37 billion (OTC bulletin,30 July 2010, page 6). OTC

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OTC COMPANY NEWS

Mergers & Acquisitions Regulatory Affairs Stada finalises FDA files decree against Grünenthal buy dietary supplement firm tada Arzneimittel has agreed a deal to ac- Squire a portfolio of branded products in he Food and Drug Administration (FDA) spection had found that he had continued to Central and Eastern Europe and the Middle T in the US has filed a consent decree of make them on his website. East from fellow German firm Grünenthal for permanent injunction against Howard Sousa Under the terms of the consent decree, Sousa around C360 million. – trading as Artery Health Institute and De- has agreed to remove the drug claims from his The company announced in May that it was Sousa – prohibiting him from distributing pro- website. He has also agreed to hire an inde- in exclusive talks with Grünenthal to acquire ducts with claims on the labelling to cure, treat, pendent expert to review the claims he makes the basket of primarily prescription products mitigate or prevent diseases. for his product and to certify that he has omit- (OTC bulletin,30 May 2011, page 3). Prior to the filing of the consent decree, he ted all claims that violate the FFDCA. Under the terms of the deal, Stada will gain had distributed Advanced Formula EDTA Oral six of Grünenthal’s own brands and eight licens- Chelation capsules on his website at artery Unapproved claims are dangerous ed products, including the Flexove/Glucomed healthinstitute.com, the FDA said. Although Dara Corrigan, the FDA’s associate com- glucosamine brand, the Oekopharm range of represented as a dietary supplement, the cap- missioner for regulatory affairs, said that un- nutritional supplements,and a diclofenac patch. sules had been promoted as a drug through approved disease claims were dangerous be- Acquiring the Grünenthal brands is in line claims made on the website. cause they might cause consumers to delay or with Stada’s strategy of growing its Branded Under the Federal Food, Drug and Cosmetic avoid legitimate treatments. Products business and boosting its presence Act (FFDCA), the FDA explained, a product “The FDA will continue to take actions in Eastern Europe. was a drug if it was intended for use in the diag- against companies that do not meet federal Subject to regulatory approvals, the deal is nosis, cure, mitigation, treatment or prevention standards for safety,effectiveness, and quality expected to close in the fourth quarter of 2011. of disease. by placing unapproved products on the mar- OTC Sousa’s products had been promoted and ket,”Corrigan insisted. marketed for serious disease conditions, the If Sousa failed to comply with the consent FDA pointed out, such as cardiovascular dis- decree, the FFDCA or FDA regulations, the IN BRIEF ease and kidney stones. FDA noted it could order him to stop making ■ JOHNSON & JOHNSON affiliate Cilag A Warning Letter had previously been sent and distributing any product. Sousa would also International has completed its acquisition of to Sousa for violating the FFDCA by promot- have to pay US$1,000 (C694) per violation and JB Chemicals & Pharmaceuticals’ OTC busi- ing and distributing his product as a drug, the twice the retail value of each shipment of prod- ness in Russia and the Commonwealth of In- FDA revealed. Although Sousa had promised uct in the event he failed to comply with the dependent States (CIS) for around US$245 mil- to remove the claims, a subsequent FDA in- consent decree. lion (C175 million) in cash. The deal – which OTC was announced in May (OTC bulletin, 30 May 2011, page 1) – includes the worldwide rights Business Strategy to the Doktor Mom herbal cough brand, Fitovit vitamin range and Rinza cough and cold line. Dr Kade reveals expansion strategy ■ VA LEANT PHARMACEUTICALS is set erman company Dr Kade intends to ac- of the German company’s total turnover of just to acquire Sanofi’s Dermik dermatology busi- Gquire brands and in-license development over C70 million last year. Just under half came ness in a deal worth US$425 million (C300 mil- projects, the family-owned firm announced as from gynaecology products, including the non- lion). Dermik had a strong presence in the Can- it celebrates its 125th anniversary this year. prescription KadeFungin range of clotrimazole- adian and US medical dermatology market, Berlin-based Dr Kade said it was looking based thrush treatments. Prescription-only an- Valeant said, and would add to the firm’s grow- for deals in its core therapeutic categories of algesics made up the other 23% of turnover. ing dermatology operations in both countries. , gynaecology and proctology. Operations in the German firm’s domestic However, the company is confident it can, market – including its gynaecology joint ven- ■ FERO INDUSTRIES said that its Sucan- in the medium term, also introduce products ture with Belgium’s Besins – accounted for on OTC product for sufferers from type 2 dia- based on its own improvements to establish- three-quarters of Dr Kade’s turnover last year. betes was now available in over 2,500 outlets ed active ingredients. The company’s main export markets are Japan across Mexico after an expansion drive by its Highlighting its recent launch of Posterisan –where it has collaborated with local firm marketing partner Merck SA. The Mexican Protect – an ointment and suppositories con- Maruho since 1923 – and Poland, where the subsidiary of Germany’s Merck KGaA, Merck taining jojoba and beeswax that are classifi- German group operates through the Kade- SA had expanded Sucanon’s availability in ed as medical devices – Dr Kade said it would farm joint venture. Mexico from 900 points-of-sale to over 2,500 aim to protect its 50% share of Germany’s However, Russia and Scandinavia were in- outlets, Fero noted, including well-known re- haemorrhoid treatments market through further creasingly important markets for the company, tailers such as WalMart Supercenters. product innovation. Dr Kade commented. OTC Haemorrhoid treatments accounted for 29% OTC

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GENERAL NEWS OTC

Regulatory Affairs ferent lists of substances included in three dif- ferent legal measures, the Commission added Commission plans repeal of that it wanted to create a single legal measure that regulated lists of substances such as vit- amins, minerals and other substances that might law covering dietetic foods be added to the categories of food covered by its proposal. Similar products would be treated in the xisting dietetic food law in Europe is result- other two looked to improve the existing rules same way across the European Union, it not- Eing in such “considerable problems” that and their administration. ed, and rules would be removed that had be- the European Commission proposes to abolish In the event, the Commission has chosen come “unnecessary,contradictory and poten- the category and repeal the legislation. entirely to repeal Directive 2009/39/EC – the tially conflicting”. Referring to “distortions of trade”, the Com- “recast” version of the framework directive on mission commented: “Member states have re- dietetic foods, amended to include the rules of Simplifying the regulatory process ported that the legislation on dietetic foods is the new comitology procedure – and Directives “The emphasis is on simplifying the regu- being used by some operators to circumvent 92/52/EC on infant formulae and 96/8/EC on latory process,”the Commission commented, the rules.” foods intended for use in energy-restricted diets “thus reducing the administrative burden and This has distorted the notion of foods for for weight reduction. Regulation 41/2009 on improving the competitiveness of the Euro- particular nutritional uses, it added, and has foodstuffs for people intolerant to gluten will pean food industry,while ensuring the safety resulted “in certain cases, in confusion over also be repealed. of food, maintaining a high level of public- [the law’s] application”. This has created “un- “The proposal simplifies and clarifies legal health protection and taking global aspects into fair competition between businesses and dif- requirements applying to certain categories of consideration.” ficulties for enforcement”. foods and establishes a single list of substances The proposed text will now be submitted The Commission is convinced that more that may be added to the foods covered by this to the European Parliament and the Council, recent legislation would adequately cover “all proposal,”the Commission commented. which will start considering it under the co- products addressing nutritional benefits for the Noting that there were currently three dif- decision procedure. general population” – as well as certain pop- OTC ulation sub-groups – “with less administrative burden and more clarity”. Noting that the framework directive on diet- etic foods was originally adopted over 30 years ago in 1977, the Commission highlighted in par- ticular such recent measures as the food sup- plements directive 2002/46/EC, the regulation on adding vitamins and minerals to foods 1925/ 2006, and the nutrition and health claims reg- ulation 1924/2006. “The classification of many foods as diet- etic foods and the need for such a category of foods has been seriously questioned,”stated the Commission,adding that it would main- tain rules on certain specific categories of foods actually addressing nutritional benefits for cer- tain sub-groups of the population. The proposed regulation covers food intend- ed for infants and young children and food for special medical purposes.

Will not cover foods for diabetics However, the Commission rejected the need to single out foods for diabetic people. “There is no scientific basis on which to develop spe- cific compositional requirements for this cat- egory of food,”it stated, adding that diabetic people should eat “as healthily as possible, choosing a diet from a variety of food for nor- mal consumption”. Four options were considered by the Com- mission before it came up with its proposal. Two involved repealing the existing dietetic foods legislation entirely or partially; while the

29 July 2011 OTC bulletin 11 OTC29-07-11p12-13FIN.qxd 29/7/11 09:14 Page 2

OTC GENERAL NEWS EisaiSwitches moves to switch rabeprazole in the UK

eartburn sufferers could soon be able to of 14 tablets. If the user does not achieve sym- Hbuy the proton-pump inhibitor rabepra- ptomatic relief within two weeks, then he or she zole without a prescription in the UK. should visit a doctor. Eisai is seeking to switch 10mg rabepraz- The patient information leaflet will advise ole tablets from prescription-only to pharmacy consumers not to use Pariet Pharmacy as a pre- (POM-to-P) status in the UK as a once daily op- ventive medicine. tion for short-term symptomatic treatment of The leaflet will also inform them that the reflux-like symptoms,including heartburn, in tablets “will not provide immediate relief of sufferers aged 18 years and over. The P medi- symptoms”. “The slow onset of action of Par- cine would be called Pariet Pharmacy. iet Pharmacy relates to the fact that it takes Consultation document ARM 77, which has about three days to reach steady-state inhibi- just been released in the UK by the Medicines tion of acid secretion,”explains ARM 77. “Feel good 24/7” was the theme of the first-ever International Self-Care Day on 24 July 2011. and Healthcare products Regulatory Agency Discussing the potential for misuse, ARM Organised by the World Self-Medication Industry (MHRA), points out that another proton-pump 77 points out that rabeprazole has “relatively (WSMI), the initiative was started to inform inhibitor,10mg omeprazole, has been available limited contraindications and special precau- consumers and health officials about the importance of self-care in healthcare, and to encourage the as a P medicine from UK pharmacies for five tions for use”, “a notably low propensity for general public to practice self-care. According to the years “without apparent problems arising from drug interactions”, and is “very well tolerated industry association, there was a “limited this route of supply”. “Pariet Pharmacy has a even at doses greatly in excess of that propos- understanding” in many countries of the public health opportunities presented by responsible self-care and similar favourable adverse event profile to ome- ed for Pariet Pharmacy”. “The risk of masking self-medication with non-prescription medicines, food prazole, but lacks the potential for some drug serious underlying conditions as a result of ig- supplements and medical devices. interactions at the level of hepatic metabolism,” noring dosage instructions is no greater than “Society benefits from the people who practice self-care and who do not visit health professionals it continues. with existing non-prescription for heart- unnecessarily,” commented the WSMI. “Self-care ARM 77 highlights that rabeprazole was ap- burn,”adds ARM 77. helps people stay well and prevent chronic proved as a P medicine in Australia during 2010. non-communicable diseases, thus relieving pressure on a country’s healthcare system.” Australia was the first country in the world to ■ Comments on ARM 77 should be sent by 2 Septem- The WSMI noted that the date – 24 July or 24/7 – make the proton-pump inhibitor available with- ber 2011 to Clare Hedges, Medicines and Healthcare symbolised how the benefits of self-care were out a prescription (OTC bulletin,31 August products Regulatory Agency (MHRA) Area 3-0, 151 experienced 24 hours a day, seven days a week. International Self-Care Day was initiated by the 2009, page 18). Buckingham Palace Road, London SW1W 9SZ, UK WSMI’s Chinese member association, the CNMA. Pariet Pharmacy will be available as a pack (E-mail: [email protected]). OTC OTC

Regulatory Affairs the proposal to have 48-tablet packs was im- practical, as most strips contained 10 tablets. Holland may modify paracetamol proposal “Participants therefore proposed increasing the tablet number to a multiple of 10 and suggest- oncerns about proposed controls on para- This proposal would have brought paracet- ed a maximum of 50,”added the MEB. C cetamol-containing medicines in the Neth- amol in line with the new pack size restrictions In addition, noted the MEB, participants in erlands may be taken into account by the auth- for the non-steroidal anti-inflammatory drugs the consultation meeting had asked for “sci- ority floating the change. (NSAIDS), which were introduced after a safe- entific substantiation and information” on the The country’s Medicines Evaluation Board ty review. For example, the maximum pack size “decision drivers” behind its proposal. “We (MEB) has reported that participants in its re- for 200mg ibuprofen tablets or capsules in the have taken note of the request for full infor- cent consultation meeting on the proposal sug- pharmacy/drugstore category is 48 (OTC bul- mation on what motivates our intended deci- gested that limits on pack sizes should be in- letin, 29 October 2010, page 20). sion to modify pack sizes and to share views creased. Pack sizes of 500mg paracetamol pro- At the time, Bernard Mauritz – director of with the MEB prior to the final decision,”re- ducts in the pharmacy/drugstore category,they Neprofarm, the Dutch OTC manufacturers’ as- marked the agency. insisted, should be limited to a maximum of 50 sociation – said the maximum pack size should The agency said it would “formulate a pro- tablets or capsules. be 50 rather than 48, as tablets and capsules posed and substantiated decision” at its meet- The MEB announced at the end of May came in standard strips of 10. Some brands are ing on 1 September 2011, and give interested that it intended to limit pack sizes of 500mg available in packs of 50 and some retailers’ parties an opportunity to share their views. A paracetamol products in the pharmacy/drug- own-label ranges include packs of 100. final decision would be taken on 24 Novem- store category to a maximum of 48 tablets or The MEB highlighted that participants in ber 2011, it added. capsules (OTC bulletin,10 June 2011, page 1). the consultation meeting had pointed out that OTC

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GENERAL NEWS OTC

Regulatory Affairs Regulatory Affairs EFSA releases fifth batch France unveils plan of opinions on health claims for a ‘major reform’ ew medicines will have to demonstrate N an improvement over existing treatments he vast majority of submissions for gener- cose after meals; and melatonin and sleep onset. to qualify for reimbursement in France under Tal-function health claims for foods, exclud- However, claims about “women’s health” measures outlined by the country’s health min- ing botanical claims, have now been evaluated or “mental energy” received negative opinions, ister,Xavier Bertrand. by the European Food Safety Authority (EFSA). said EFSA, because they were not sufficient- Furthermore, the “major reform” of France’s The fifth batch of scientific opinions, cover- ly specific. medicines system proposed by Bertrand will ing 536 health claims, has just been released by Other claims had received negative opinions, see the role of the country’s medicines agency, EFSA, which said it would soon publish opin- continued EFSA, because they referred to food AFSSAPS, made clearer through a new name. ions for the remaining 35 health claims. categories,such as “fruits and vegetables” or It will be known as the Agence Nationale de EFSA has now said no to the vast majority “dairy products”, that were considered to be too Securité du Médicament (ANSM) or National of the 2,723 general-function health claims as- broad to be linked to specific effects. Agency for the Safety of Medicines. sessed to date. Furthermore, some negative opinions were Bertrand indicated that tighter rules would Commenting on the fifth batch, EFSA said handed down because the submissions were be introduced to grant reimbursement only to positive opinions had been given to the relation- not supported by any relevant human studies. new products that could show they were at least ship between specific dietary fibres and blood The 1,548 submissions for claims on botan- as effective as similar products already on the cholesterol; cereal fibre and bowel function; icals have been placed on hold by the European market and had a “real benefit” for the patient. carbohydrate-electrolyte drinks and endurance Commission pending further consideration on A list of medicines that were subject to par- performance; low sodium and blood pressure; how to proceed with them (OTC bulletin,15 ticular post-marketing surveillance would also dietary fibre and reduced increase in blood glu- April 2011, page 15). be regularly updated by the ANSM and pub- OTC lished online, he noted. It was essential to regain trust in the French People system through greater transparency, Bertrand said, in the wake of the controversy over Ser- Shotter to leave Germany’s Merck KGaA vier’s Mediator (benfluorex) anti-obesity treat- ment in France. AFSSAPS had allowed the ■ Continued from front page had been instrumental in executing large re- drug to remain on the market until November Shotter has led Merck’s Consumer Health structuring programmes. 2009, despite longstanding safety concerns. Care division since October 2004, when he Batra’s key priority in his new role would be OTC replaced Volker Keidtel (OTC bulletin,15 Oct- to redefine and reshape the Consumer Health ober 2004, page 23). Shotter had previously Care business, Oschmann said. Switches served as managing director of Seven Seas, He pointed out that Batra’s strategic objec- Merck’s Consumer subsidiary in tives would be to expand the unit’s international Sumatriptan rejected the UK. He joined Seven Seas in February 2002 presence – particularly in emerging markets from Boots the Chemists (OTC bulletin,15 and the US – continue to grow its strategic ■ Continued from front page February 2002, page 27). brands, and develop a promising pipeline to -able without a prescription did not outweigh Commenting on Batra’s appointment, Stef- ensure future success. the risks of such a move. an Oschmann – executive board member of Meanwhile, the Consumer Health Care divi- The European Medicines Agency (EMA) Merck with responsibility for the Pharmaceu- sion had achieved sales up by 3.9% to C118 mil- noted that Galpharm could request a reexam- tical business – noted that over the past 15 years, lion in the second quarter of 2011, Merck re- ination of the CHMP’s negative opinion within the Novartis man had successfully led the trans- ported, driven by “solid demand in European 15 days of receipt of the notification. formation of global and local businesses and markets”. To date, only two non-prescription medi- cines – GlaxoSmithKline Consumer Health- Peter Shotter Udit Batra care’s Alli weight-loss medicine containing 60mg and ’s 20mg pantopra- zole tablets under several brand names – have been authorised through the European Union’s centralised procedure. Galpharm’s parent Perrigo told OTC bul- letin earlier this year that the generics firm had an ambitious regulatory strategy in Europe en- compassing the centralised, decentralised and mutual-recognition licensing procedures (OTC bulletin,21 January 2011, page 22). OTC OTC

29 July 2011 OTC bulletin 13 OTC29-07-11p14-15FIN.qxd 29/7/11 09:15 Page 2

OTC GENERAL NEWS

Regulatory Affairs Counterfeit Directive leaves much to do

any questions remain unanswered follow- Commission based on five criteria: macies must display a common logo, recognis- Ming publication of the European Union’s ■ The price and sales volume of the products able throughout the European Union. This is Falsified Medicines Directive in the Official ■ The number and frequency of past incidents intended to show the public they are linked to Journal on 1 July. of falsification an authorised pharmacy. Implementation of the Directive,which came ■ The specific characteristics of the product All authorised internet pharmacies will be into force on 21 July,will be through a series of ■ Severity of conditions treated by the product connected to a central website in each member delegated acts, implementing acts, guidelines ■ Other potential risks to public health. state on which they will all be listed. These nat- and an awareness campaign. Practical details of The Association of the European Self-Med- ional websites will be linked to a European some key measures in the Directive still have ication Industry,the AESGP,said it understood Union-wide site. to be decided through delegated acts. that the European Commission would require The law also calls upon the authorities to Non-prescription medicines will not gener- all five criteria to be fulfilled for a non-pre- warn citizens about the risks involved in buy- ally be affected by the measures aimed at coun- scription medicine to be included on the list. ing medicines via the internet. terfeit prescription products in the Directive, The Directive also provides for member Facilities making active substances will have which European Union member states should states to notify the Commission when they be- to be inspected on the basis of risk analyses, as transpose into national law within 18 months. lieve a non-prescription medicine is at risk of well as on grounds of suspected non-compli- The Directive requires safety features on falsification based on the five criteria. ance. Furthermore, brokers and distributors will packs, including a unique identifier,but leaves Dr Hubertus Cranz, director-general of the have to register with the local authorities in the details for the European Commission to AESGP,called for “smart implementation” of their home country. work out by means of delegated acts. These the Directive. Commenting on new import requirements safety features will make it possible for “whole- Cranz said the new law took into account from third countries for active pharmaceutical sale distributors and persons authorised or en- particularities of non-prescription medicines, ingredients, the AESGP said better coordina- titled to supply medicinal products to the pub- which normally will not need to bear specific tion of inspections and closer cooperation be- lic” to verify the authenticity of the products safety features. “It is important that a rational tween European Union and non-European Union as well as identify individual packs (OTC bul- and proportionate approach concerning the new authorities would help achieve smooth imple- letin,10 June 2011, page 9). system of safety features is maintained and that mentation. The AESGP also called on the Euro- Only non-prescription medicines listed as non-prescription medicines remain in principle pean Commission to establish rapidly the list having been “assessed to be at risk of falsifi- exempt from the obligation to bear safety fea- of foreign countries with a system of Good cation” will have to bear the safety features. tures,”added Cranz. Manufacturing Practice equivalent to that of The list will be compiled by the European According to the Directive,internet phar- the European Union. OTC

Product Recalls Germany’s BfArM recalls fenugreek

edicines containing fenugreek seeds that Mwere imported from Egypt between 2009 and 2011 have been recalled by the federal in- stitute for drugs and medical devices, BfArM, in Germany. The regulatory agency, which is coordinat- ing the recall of the gastrointestinal medicines through regional authorities, said there was “a high probability” that fenugreek seeds import- ed from Egypt had caused recent Escherichia coli bacteria outbreaks in France and Germany. Emergency measures recently issued by the European Commission – following an inves- tigation by the European Food Safety Author- ity(EFSA) –have placed a ban on importing a wide range of seeds from Egypt until 31 Oct- ober 2011. OTC

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GENERAL NEWS OTC

Regulatory Affairs Patent Disputes EMA opens up US court backs Watson side-effect data in Mucinex patent case he European Medicines Agency (EMA) T has released plans for giving public ac- cess to information on the potential side-effects atson Pharmaceuticals’ guaifenesin tab- million (C359 million) last year. of medicines held in its EudraVigilance and W lets do not infringe US patent 6,372,252 Reckitt Benckiser sued Watson twice dur- EudraVigilance Veterinary databases. protecting Reckitt Benckiser’s Mucinex range ing 2009 for allegedly infringing its US pat- For human medicines, the EMA plans to of cough remedies until 28 April 2020, the US ents 6,372,252 and 6,955,821, which protect its produce monthly reports summarising the in- Court of Appeals has ruled in upholding a Flor- Mucinex range (OTC bulletin,30 April 2009, formation held in EudraVigilance for all med- ida district court’s decision from earlier this page 20; OTC bulletin,19 June 2009, page 12). icines authorised centrally via the agency by year (OTC bulletin,28 February 2011, page 12). The case involving patent 6,955,821 was dis- the end of this year. This will be extended to However, Watson cannot yet launch the ex- missed without prejudice. searchable reports by the end of 2012. tended-release products, as it has not obtained The EMA said it intended to make further approval from the US Food and Drug Admin- Challenge from Perrigo improvements to the search and data-output istration (FDA). The company is also facing a Mucinex patent functions and to supply the pharmaceutical in- Watson has submitted Abbreviated New Drug challenge from store-brand specialist Perrigo. dustry with access to tools allowing the detec- Applications (ANDAs) for generic versions of In February of last year,the Michigan district tion and analysis of signals on adverse reac- Mucinex (guaifenesin), Mucinex D (guaifen- court ruled that Perrigo’s Abbreviated New tions to human medicines by 2015, subject to esin/pseudoephedrine) and Mucinex DM (guai- Drug Application (ANDA) for its 600mg guai- budget being available. fenesin/dextromethorphan). fenesin extended-release tablets did not infringe For both human and veterinary medicines, The panel of three appeals judges said the the Mucinex patent (OTC bulletin,26 Febru- the Agency will consider providing access to Florida court had not erred by construing the ary 2010, page 13). data for research purposes on a case-by-case term ‘portion’ in the patent claims to mean “a A few months later in August, however, Rec- basis, in line with its objective of protecting discrete part of the product”. The ‘252 patent’s kitt Benckiser won an appeal against the ruling public health. specification explicitly stated that the modi- and the case was returned to the district court The EMA said the changes were part of its fied-release tablets described contained “two for further proceedings (OTC bulletin,13 Aug- ongoing drive to increase its levels of trans- discrete portions”, they pointed out. ust 2010, page 7). parency. “They aim to contribute to the pro- Noting that Reckitt had, in the process of ob- In 2007, Adams Respiratory Therapeutics – tection of human and animal health, by provid- taining the patent, disclaimed sustained-release which is now part of Reckitt Benckiser – set- ing the agency’s stakeholders – including other guaifenesin tablets without discrete portions, the tled a patent challenge to the Mucinex brand medicines regulatory authorities, healthcare appeals judges said “Watson’s products do not from URL/Mutual, which potentially kept URL/ professionals, patients, consumers,the pharma- infringe because they are non-layered, single- Mutual’s 600mg guaifenesin product off the ceutical industry and research organisations formulation polymer matrix tablets that do not market in the US until 2012 (OTC bulletin,30 – with as much information as possible from contain the claimed ‘first portion’ or ‘second March 2007, page 11). these databases,”it explained. portion’. Watson’s need to prove bioequivalence Watson’s victory,however,means that URL/ EudraVigilance and EudraVigilance Veteri- did not equate to infringement under the doc- Mutual may soon be in a position also to intro- nary are the central databases for reports of sus- trine of equivalents, they added. duce its 600mg guaifenesin product, as the pected adverse reactions related to medicines Quoting IRI data, Watson said the Mucinex settlement with Adams allowed it to launch if authorised in the European Economic Area and line – including Mucinex D and Mucinex DM a third party was in a position to introduce its medicines being studied in clinical trials. – had generated US sales of around US$500 own guaifenesin product before 12 July 2012. OTC OTC

IN BRIEF Regulatory Affairs ■ EMA – the European Medicines Agency ing. Champix has been authorised in the Euro- Australia scrutinises – has confirmed that the benefit-risk balance pean Union since September 2006, and its pro- for Champix (varenicline) remains positive, duct information already includes information labelling regulations despite a recent meta-analysis finding that the on cardiovascular side-effects. The meta-an- prescription-only smoking-cessation medicine alysis was published in the Canadian Medi- ustralia’s Therapeutic Goods Administra- affected the heart and blood vessels. The EMA’s cal Association Journal. Ation (TGA) is reviewing the regulatory Committee for Medicinal Products for Human framework for labelling and packaging of pre- Use (CHMP) and Pharmacovigilance Work- ■ MHRA – the UK’s Medicines and Health- scription, OTC and complementary medicines. ing Party concluded that the slightly increased care products Regulatory Agency – has launch- The regulatory agency said that it was pre- risk of cardiovascular events reported by the ed a feed on Twitter about herbal remedy saf- paring consultation documents for release “in study’s authors did not outweigh the benefits ety. Go to @staysafeherbals. due course”. of Champix in helping people to stop smok- OTC OTC

29 July 2011 OTC bulletin 15 OTC29-07-11p16-17FIN.qxd 29/7/11 09:16 Page 2

OTC GENERAL NEWS

Switches Germany defers paracetamol decision

eliberations on whether to reverse-switch pointed out, the Pharmacovigilance Working because of concerns about misuse. Dparacetamol in Germany have been post- Party within the European Medicines Agency During its July meeting, the expert commit- poned until early next year. Germany’s federal (EMA) had found that the available evidence tee voted against recommending prescription- institute for drugs and medical devices, BfArM, did not support a causal link between paracet- to-non-prescription switches for rizatriptan 10mg has decided to conduct a thorough review of all amol and asthma in children after exposure dur- formulations and sumatriptan 20mg nasal sprays analgesic ingredients including paracetamol. ing pregnancy or use in early infancy. as treatments for migraines. Reverse-switching paracetamol was remov- In a move aimed at reducing liver damage, The committee had previously recommend- ed from the agenda of points to be considered the US Food and Drug Administration (FDA) ed switching sumatriptan oral forms, but Ger- by Germany’s Expert Committee for Prescrip- recently cut the maximum prescription dose of man legislators have yet to act on that advice. tion shortly before it met earlier this month. paracetamol – or acetominophen as it is known McNeil recently launched 12.5mg almotrip- When the original agenda was announced, locally – to 325mg. However, it left unaffect- tan tablets as a non-prescription migraine rem- a spokesperson for Germany’s medicines man- ed non-prescription medicines containing the edy under the Dolortriptan brand name, while ufacturers’ association, the BAH, told OTC bul- active ingredient (OTC bulletin,21 January GlaxoSmithKline introduced Germany’s first letin that he was not aware “of any new evid- 2011, page 1). non-prescription triptan in 2006 with its For- ence” that would support removing paraceta- Also postponed was a committee decision migran () brand. mol-containing medicines from non-prescrip- on reverse-switching certain dextromethorphan The expert committee backed raising the tion use (OTC bulletin,15 April 2011, page 1). formulations. The cough medicine had been maximum non-prescription single dose for nic- Earlier this year,the BAH spokesperson placed on the original agenda for the meeting otine from 10mg to 15mg. Furthermore,the committee said that top- ical ketoprofen products should be reverse- Business Strategy switched from non-prescription to prescription- only status “without limitation”. Following a Pfizer to keep Consumer Healthcare safety review of topical ketoprofen due to seri- ous photosensitivity reactions, the EMA rec- ■ Continued from front page “Animal Health and Nutrition are strong ommended last year that the non-steroidal anti- Healthcare posting 2010 sales of US$2.77 bil- businesses with attractive customer bases and inflammatory drug (NSAID) should only be lion (C1.97 billion), representing 4.1% of Pfiz- solid fundamentals,”Read insisted, “but are used in topical formulations when it had been er’s total of US$67.8 billion (see Figure 1). distinct enough from our core businesses that prescribed by a doctor (OTC bulletin,30 July At the time, Read said he wanted to evaluate their value may be best maximised outside 2010, page 1). all Pfizer’s non-pharmaceutical businesses – of the company.” Meanwhile, all 60mg orlistat doses will Animal Health, Consumer Healthcare and Nut- Exploring these options would give Pfizer an have non-prescription status in Germany from rition – and give them an “opportunity to show idea about what would best drive future growth 1 August 2011, after the country’s upper house how strongly” they could perform for Pfizer. opportunities and expansion at both businesses of parliament, the Bundestag,ratified proposals Commenting this month on Animal Health and enable shareholders potentially to realise made by the expert committee at the start of this and Nutrition, Pfizer said it was “considering higher value for them both, Read added. year (OTC bulletin,21 January 2011, page 15). options that may include, among others, a full Pfizer said it expected to complete any trans- OTC or partial separation” from Pfizer through a actions involving its Animal Health and Nutri- “spin-off, sale or other transaction”. Given the tion businesses in “12 to up to 24 months”. separate and distinct nature of Animal Health The company does not anticipate making any and Nutrition, the company noted, a differ- further announcements on the futures of the ent strategic alternative might be pursued for two businesses until sometime in 2012. each business. OTC

Business Annual sales Change Proportion (US$ millions) 2009/2010 (%) of sales (%) Biopharmaceutical 58,523 +29 86.3 Animal Health 3,575 +29 5.3 Nelsons has enlisted actress Gaynor Faye to front Consumer Healthcare2,772 –4.1 a celebrity-endorsement campaign for its Bach Emotional Eating Kit in the UK. Nutrition 1,867 –2.8 “I’ve found the Bach Emotional Eating Kit has 752 +2 1.1 really helped me to take control of my cravings in the lead up to the summer, so I feel happy and confident Diversified 8,966 +114 13.2 with my body,” said Faye. “When I am having one of Other 320 -14 0.5 those worry days where I’m feeling body conscious, instead of eating a bar of chocolate to cheer myself Total Pfizer 67,809 +36 100.0 up I grab the Bach Emotional Eating Kit to help me keep on the right track.” Figure 1: Pfizer’s sales in 2010 broken down by business (Source – Pfizer) OTC

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MARKETING NEWS OTC

Line Extensions Beiersdorf boosts Eucerin range for acne-prone skin

eiersdorf is expanding its Eucerin Dermo- BPURIFYER range of products for acne- prone skin in Germany and several other coun- tries in Asia, Europe and Latin America. Four new products will bring the total num- ber of formulations in the Eucerin DermoPURI- FYER range to eight. The concentrate, day care, night care and SPF30 formulations join the exist- ing cleanser,cover stick, scrub and toner. Noting that “acne-prone skin comes in many A high-strength, flavourless way to combat dry varieties”, Beiersdorf maintained that one prod- Beiersdorf is expanding its Eucerin DermoPURIFYER is how Boehringer Ingelheim is positioning the uct did not solve the problem for everyone. “The range in Asia, Europe and Latin America latest addition to its Silomat brand in Germany. Silomat DMP Intensiv contains 30mg different symptoms of acne-prone skin require ciplined use of the appropriate Eucerin Dermo- dextromethorphan hydrobromide per hard different active ingredients,”explained Stefanie PURIFYER products, the skin of the partici- gelatine capsule, which is almost three-times the Conzelmann from Eucerin Skin Research. pants showed significant improvement of their strength of the firm’s existing Silomat DMP Lutschpastillen lozenges. Beiersdorf pointed out that the eight prod- acne symptoms,”Beiersdorf claimed. The pharmacy-only medicine, which is indicated ucts in the Eucerin DermoPURIFYER range Beiersdorf said that the product range was for adults and children aged 12 years and older, is were based on active ingredient combinations ideal for use both as medical skincare for those supplied as a pack of 12 capsules with a recommended retail price of C5.25. containing lactic acid, l-carnitine, decandiol and suffering from acne-prone skin and adjunctive Boehringer Ingelheim also markets pentoxyverine licochalcone a. The company maintained that skincare for dermatological patients undergo- drops and syrup under the Silomat brand name. the range of products addressed “all four fac- ing medical treatment. OTC tors that contribute to the development of the Marketing activity for the Eucerin Dermo- symptoms of acne-prone skin”. PURIFYER range highlights that the “clinical- According to Beiersdorf, the Eucerin Dermo- ly-proven, patent-pending formula combats all PURIFYER range created a “foundation for the four factors of acne-prone skin”. The campaign improvement of acne-prone skin and the heal- message – “Acne-prone skin? Fight all 4 fac- ing of acne”. The cleanser,moisturiser and night tors! Come in for a consultation!” – aims to en- care products were “must haves to effectively courage acne sufferers to discuss their condi- combat acne symptoms”, said the firm, while tion with a dermatologist. the concentrate was “an extra for those who want In addition to products for acne-prone skin, to intensify the effect of the products”. the Eucerin range includes formulations for sen- Clinical studies showed clear results, the sitive skin, options for dry and atopic skin, and company added. “After four to 12 weeks of dis- products with anti-ageing properties. OTC

Actavis is backing its Sominex sleep aids in the UK with a £1.0 million (C1.1 million) burst of television British Olympic athlete Marilyn Okoro is fronting a advertising during August and September. public relations campaign for Mentholatum’s Deep The initiative sees the return of the sheep-themed Heat and Deep Freeze brands in the UK. commercial that made its debut in the UK a year ago The 800m and 400m runner said the topical (OTC bulletin, 13 August 2010, page 17). Angela analgesics helped her during intensive training and Lloyd, OTC marketing manager at , said competition time as “the range fits easily into the Sominex had achieved year-on-year sales growth of training day and provides relief when needed”. 93% as a result of the commercial, according to The campaign also includes a “Love your muscles IRI data for the 52 weeks to 22 January 2011. MOT” initiative from physiotherapist Sammy Margo, Two versions of the commercial – the full who is offering consumers 10 top tips to keep 30-second execution and a cut-down 10-second spot muscles in good shape. These include warming up – will run nationally from 1 August. correctly before exercise, using the right equipment, Created by the advertising agency Sudler London, getting regular check-ups and treating injuries the humorous commercial is based around the plight promptly and correctly. of imaginary sheep who become redundant when According to Mentholatum, one in four of all Sominex helps people sleep without counting them. consultations with general practitioners in the UK The redundant sheep are forced to take up knitting, relate to musculoskeletal problems. fishing and other activities. Furthermore, the company notes that Actavis is also offering pharmacy staff an 22 million sporting injuries are suffered in the UK educational module on sleep problems as part of its each year, of which the most common are sprains and Customer Care Programme. pulled muscles. OTC OTC

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OTC MARKETING NEWS

Line Extensions Marketing Campaigns Hedrin expands in the UK Sanofi puts Oralyte on television in UK with ‘fuss-free’ treatment he importance of keeping children hydrat- Ted when they are on-the-go is the theme of uss-free head lice treatment” is Thorn- Sanofi’s first television advertising for its new “Fton & Ross’ on-pack promise to con- Oralyte hydration drink in the UK. sumers for a new addition to its Hedrin brand The commercial focuses on a young girl in the UK. taking part in a range of activities, including Thornton & Ross described Hedrin Treat & a sponsored bike ride, a game of football with Go as a “revolutionary” water-based head-lice friends,and a walk along a beach with her fam- treatment that had been specially developed to ily. Meanwhile, a visual gauge indicates how be “easy-to-use and fuss-free for parents”. her hydration level is decreasing. Hedrin Treat & Go featured Activdiol tech- At the end of the commercial, the girl is nology based on 1,2 octanediol, Thornton & seen drinking a carton of Oralyte, with the re- Ross explained, which stripped away the waxy sult that her hydration level rises. cuticle on the louse causing it to dehydrate. Sanofi said the commercial highlighted the “This physical action prevents head lice from key brand message that Oralyte hydrated bet- developing resistance,”the company noted, add- ter and faster than water,and compared the ing that this was “a common problem associat- product with other popular drinks in terms of ed with traditional pesticide treatments”. hydration benefits. Sanofi is investing £1 million (C1.1 million) Acquired worldwide rights in the campaign. Three versions of the commer- Thornton & Ross acquired the worldwide cial, lasting 10, 20 and 30 seconds, are running rights, excluding China and the US, to use the on a number of channels, including ITV and technology from EctoPharma last year. At the Sky 1, until 26 August. time, it said head-lice treatments based on the The company is also backing Oralyte with technology would be launched “firstly in Eur- Thornton & Ross is backing the launch of Hedrin a “hydrate right” public relations campaign. Treat & Go with a £3 million “television-led” ope and then in emerging markets around the marketing campaign in the UK Launched earlier this year,Oralyte is a ready- world” (OTC bulletin,10 September 2010, to-drink version of Sanofi’s Dioralyte oral-rehy- page 12). A medical device, Hedrin Treat & Go is dration therapy. A study involving 520 patients found that available in lotion, spray and mousse formats. Both products contain the same active in- Activdiol was clinically proven to kill lice and Recommended retail selling prices begin at gredients, but Oralyte is a food while Diora- eggs without pesticides, pointed out Thornton £5.49 for 50ml. lyte is a medicine (OTC bulletin,28 Febru- & Ross, adding that it was “significantly supe- Caroline Wheeler,marketing manager for ary 2011, page 14). rior to malathion over two treatments”. Hedrin, maintained that the newcomer was a Thornton & Ross is backing the launch dur- “completely hassle-free way for parents to treat ing the back to school period with a £3 mil- head lice”. “Sitting alongside our existing pro- lion (C3.3 million) “television-led” campaign. duct range,”added Wheeler, “it will also offer This will include a “heavyweight” public rela- parents greater choice in the battle against tions initiative from the agency Pegasus PR. head lice.” OTC

Spain’s Cinfa has expanded its Be+ line of skincare treatments by launching a range of sunscreens with anti-ageing properties. The nine products include body and face creams A young girl keeps her hydration level up by drinking as well as emulsion and fluid sprays aimed at specific Oralyte in Sanofi’s launch television commercial for skin types. the hydration drink in the UK There is also a soothing after-sun emulsion and a OTC sunscreen formulated for children. Cinfa pointed out that the products contained the Be+ Cell Protection Complex, which provided “innovative active filters”. These filtered harmful IN BRIEF UVA and UVB rays as well as protecting against infrared radiation. ■ MCNEIL Consumer Healthcare has an- The Be+ face cream for dry skin is priced at nounced another product recall in the US. The C16.95 for 50ml. A 250ml bottle of the sunscreen Johnson & Johnson subsidiary said it involv- spray for vulnerable and delicate skin costs C21.95, whilst the children’s spray is priced at C22.50 for a ed one product lot of Extra Strength 250ml bottle. Caplets 225 count bottles. OTC OTC

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EVENTS OTC

19-22 October SEPTEMBER 18-19 October ■ CRN’s Annual ■ How Can the Availability of 7-9 September Symposium for the Non-Prescription Medicines ■ Vitafoods Asia Dietary Supplements be Improved? Hong Kong, China Industry London, UK A three-day exhibition and con- California, US ference covering dietary supple- Speakers at this two-day conference – organised by the Association of the European Self-Medication Industry,the AESGP – will include: Noël Wath- This four-day meeting is organised ments, nutraceuticals, functional by the US Council for Responsible foods and functional drinks. ion of the European Medicines Agency (EMA); Irene Sacristán Sánchez of the European Commission; and Peter Bachmann of Germany’s federal Nutrition (CRN). Contact: Chris Lee,IIR Exhibitions. Contact:Erin Hlasney, Tel: +44 20 7017 7036. institute for drugs and medical devices, BfArM. Contact:Association of the European Self-Medication Industry,the AESGP. Council for Responsible Nutrition. Fax: +44 20 7017 7818. Tel: +1 202 204 7684. E-mail: [email protected]. Tel: +32 2 735 51 30. Fax: +32 2 735 52 22. E-mail: [email protected]. Website: www.aesgp.be. Fax: +1 202 204 7701. Website: www.vitafoodsasia.com. E-mail: [email protected]. Website: www.crnusa.org. 22-23 September Products Association (CHPA). London, UK ■ Compliant PIL Contact: Maria Sarabia, CHPA. A two-day symposium organised 31 October User Testing Tel: +1 202 429 3545. by the UK Medicines and Health- ■ The Borderline Between London, UK Fax: +1 202 223 6835. care products Regulatory Agency Medicines and Foods This two-day course will provide E-mail: [email protected]. (MHRA). London, UK practical solutions on filing a user- Website: www.chpa-info.org. Contact:MHRA. Topics to be covered at this one- tested patient information leaflet Tel: +44 20 3080 6903. day seminar focusing on Europe in the European Union. 6-9 October E-mail: mhraconferences@mhra. will include health claims, tradi- Contact: Informa UK. ■ Expopharm 2011 gsi.gov.uk. tional herbal medicines, labelling Tel: +44 20 7017 7481. Düsseldorf, Germany Website: www.mhra.gov.uk. and advertising. Fax: +44 20 7017 7823. A four-day international pharma- Contact: Management Forum. E-mail: [email protected]. ceutical trade fair and conference. 13 October Tel: +44 1483 730071. Website: www.pti-europe.co.uk. Contact:Gabriele Stadler, ■ Food Supplements Fax: +44 1483 730008. Werbe- und Vertriebsgesellschaft Brussels, Belgium 27 September E-mail: registrations@management- Deutscher Apotheker. This one-day conference promises forum.co.uk. ■ Marketing Authorisation Tel: +49 6196 928 411. to provide the secrets of success- Website: www.management-forum.co.uk. in the Balkan States Fax: +49 6196 928 404. ful regulatory strategies for food Frankfurt, Germany E-mail: [email protected]. supplements in Europe, Asia and NOVEMBER This one-day seminar will focus Website: www.expopharm.de. Latin America. on licensing medicines in the Bal- Contact:EAS. 21-22 November 8-9 October kan states, including Bosnia, Croa- Tel: +32 2 218 14 70. ■ EuroPLX 47 tia, and Kosovo. ■ Pharmaceutical Fax: +32 2 219 73 42. Geneva, Contact: Dr Henriette Wolf-Klein, Regulatory Affairs E-mail: [email protected]. A two-day partnering and licens- Forum Institut für Management. in the Middle East Website: www.eas.eu. ing forum focusing on OTC medi- Tel: +49 6221 500 680. Dubai, United Arab Emirates cines, nutraceuticals, branded pre- Fax: +49 6221 500 555. A two-day conference. 13-14 October scription drugs and generics. E-mail: h.wolf-klein@forum- Contact: Management Forum. ■ The 8th TOPRA Contact:RauCon. institut.de. Tel: +44 1483 730071. Annual Symposium Tel: +49 6222 9807 0. Website: www.forum-institut.com. Fax: +44 1483 730008. Rome, Italy Fax: +49 6222 9807 77. E-mail: registrations@management- A two-day conference run by The E-mail: [email protected]. OCTOBER forum.co.uk. Organisation for Professionals in Website: www.europlx.com. Website: www.management- Regulatory Affairs (TOPRA) to- 5-6 October forum.co.uk. gether with the Italian Medicines 24 November Marketing Authorisation ■ Agency, AIFA. ■ The Nutrition and Health in Asia 11-12 October Contact:TOPRA. Claims Regulation Frankfurt, Germany ■ Good Manufacturing Tel: +44 20 7510 2560. Brussels, Belgium Countries to be discussed at this Practice and Good Fax: +44 20 7537 2003. A one-day conference on nutrition two-day seminar include China, Distribution Practice E-mail: [email protected]. and health claims in Europe. Indonesia, and Vietnam. 2011 Symposium Website: www.topra.org. Contact:EAS. Contact: Dr Henriette Wolf-Klein, Tel: +32 2 218 14 70. Forum Institut für Management. Fax: +32 2 219 73 42. Tel: +49 6221 500 680. 27-28 October E-mail: [email protected]. Fax: +49 6221 500 555. ■ 17th WSMI General Assembly Website: www.eas.eu. E-mail: h.wolf-klein@forum- Puerto Vallarta, Mexico institut.de. ‘Achieving the self-care future’ is the theme of the 17th World Self-Medi- 24-25 November Website: www.forum-institut.com. cation Industry (WSMI) General Assembly. ■ Joint TOPRA/EMA Day one of this two-day meeting will include a session on ‘Self-care Annual Review 6-7 October and self-medication contributions to public health’, while day two will look London, UK ■ Product Quality at Latin America. Contact:TOPRA. and Operations Contact:Sophie Durand-Stamatiadis, World Self-Medication Industry (WSMI). Tel: +44 20 7510 2560. Bethesda, Maryland, US Tel: +33 450 28 47 28. Fax: +33 450 28 40 24. Fax: +44 20 7537 2003. A two-day workshop, organised E-mail: [email protected]. Website: www.wsmi.org. E-mail: [email protected]. by the US Consumer Healthcare Website: www.topra.org.

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OTC AESGP MEETING Developing regions drive OTC growth

The developed world still generates the bulk of the global non-prescription ket was worth C74 billion at manufacturers’ sell- market, but the developing regions are driving sales growth. Deborah Wilkes ing prices in the 12 months to the end of the first quarter of 2011, Tisman said that it rep- reports on the latest global market data from IMS Consumer Health. resented 11.5% of the global pharmaceutical market worth C641 billion (see Figure 2). he developing regions of Central and the operation, while searching for growth op- IMS Consumer Health’s non-prescription Eastern Europe, Latin America and portunities,”he remarked. market figures cover both prescription-generat- South-East Asia/China are driving the By contrast, he added, Central and Eastern ed and self-medication or OTC sales of non- Tgrowth of the global non-prescription European markets continued to provide strong- prescription products. Growth rates use the lat- market, according to Andy Tisman, senior prin- er growth potential. “The challenge is to place est exchange rate for all countries across all cipal for Consumer Health at IMS Health. Fur- the investment bets, and then drive effective time periods. thermore, they will continue to do so over the market entry and growth strategies,”he said. The trend was unlikely to change in the fore- next five years. Strong sales growth in the developing regions seeable future, according to Tisman. A number Speaking recently at the 47th Annual Meet- meant the global non-prescription market per- of “significant structural factors” were behind ing of the Association of the European Self-Med- formed well during the 12 months to the end falling sales growth for the pharmaceutical mar- ication Industry, the AESGP,Tisman said Eur- of the first quarter of 2011. Tisman pointed out ket and rising sales growth for the non-prescrip- ope and the US were struggling to keep up with that the recent trend for non-prescription sales tion market, he said, adding that IMS Consum- the global picture. He also pointed out that Jap- to outperform pharmaceutical sales had contin- er Health did “not expect to see the situation an was having “a bad time after a couple of years ued. Indeed, the differential in growth between change anytime soon”. of performing moderately well”. non-prescription and pharmaceutical sales had Tisman said growth of the global pharma- Within Europe, pointed out Tisman, the pic- increased, he said. ceutical market had been constrained by a num- ture was mixed. Central and Eastern Europe led As can be seen from Figure 1, growth of the ber of factors, including the low quality output the way for sales growth, he said, with the result global non-prescription market speeded up from from research and development operations, the that companies faced different strategic chal- 1.8% in the 12 months to the end of the first dominance of generic drugs in major therapy lenges in different parts of the region. quarter of 2001 to 7.0% in the equivalent period areas,and the demands placed on pharmaceu- Tisman noted that key Western European for 2011. Over the same period, growth of the tical companies by healthcare payers. “In the markets were slower growing or static. “The global pharmaceutical market slowed down from developed world, pharmaceutical players are challenge is to sustain revenue and profit by 11.3% to 4.6%. suffering from cost constraints imposed by pay- optimising the efficiency and effectiveness of Noting that the global non-prescription mar- ers,”he stated. “In the developing world, pay- ers are learning from the experience of the de- Series1Pharmaceutical Series2Non-prescription veloped world.” By contrast, the global non-prescription mar- 16.016 ket was benefitting from a number of important 12.1% 12.012 11.3% growth drivers, observed Tisman. Healthcare 9.7%

th (%) payers were keen to promote self-medication, 7.7% 7.7% 7.5% 7.5% 7.1% ow 8.08 6.9% 5.5% 6.6% 6.5% 7.0% consumers had greater access to products via 5.9% 5.1% 5.3% 4.8% 4.4% 4.6% new distribution channels, and emerging mar- 4.04 Sales gr 2.5% 1.8% 2.2% kets had the critical mass to influence growth. Furthermore, key players were exploiting op- 0.00 200112345678 2002 2003 2004 2005 2006 2007 2008 200991 2010011 2011 portunities to switch medicines from prescrip- tion-only to non-prescription status. Figure 1: Development of global pharmaceutical and non-prescription markets in terms of growth of audited and estimated unaudited sales in euros at manufacturers’ selling prices. Figures are for the 12 months to the end of the first quarter of each year (Source – IMS Audits plus estimates) A more consumer-focused approach Tisman also highlighted a tendency for firms to take a more consumer-focused approach in 15.015 13.7% 12.6% the marketplace. “The key players are building 11.9% 11.5% 11.4% 11.1% 11.2% 12.012 11.0% 10.8% 10.9% 11.1% strong brand identities,”he said, “and consumer- driven brands are performing strongly.” 9.09 Discussing geographic regions, Tisman said

6.06 Europe – encompassing Central, Eastern and Western Europe – had remained the most im- 3.03 portant in terms of global non-prescription sales in the 12 months to the end of the first quarter 0.00 200112 2002 2003 34 2004 200556 2006 200778 2008 200991 2010011 2011 of 2011, accounting for 33.8% of the total. North Share of pharmaceutical market (%) America was second with a 20.8% share, fol- Figure 2: Change in share of global pharmaceutical market held by non-prescription products in terms of audited lowed by Japan with 13.2% (see Figure 3). and estimated unaudited sales in euros at manufacturers’ selling prices. Figures are for the 12 months to the end of the first quarter of each year (Source – IMS Audits plus estimates) Looking at the contribution to global sales

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AESGP MEETING OTC

growth, however, the picture was very different. South-East Asia/China was the most important 4040.0 region, contributing more than a third of global 34.2%

sales growth. Central and Eastern Europe gen- 30th (%) 30.0 erated a further 18.1% and Latin America add- ow 24.6% 20.8% ed another 16.1%. 18.1% 17.5% 2020.0 16.1% Series1Non-prescription Tisman observed that the developed world 13.5% 13.2% 13.1% sales 9.5% 9.2% 9.6% Non-prescription still accounted for the bulk of the global non- 1010.0 Series2growth prescription market, but the developing world 3.8% – Central and Eastern Europe, Latin America, 00.0 and South-East Asia/China – was driving sales 1234567-3.1%

growth. “Although developing regions only ac- -10Proportion of sales-10.0 or sales gr Western North Japan South East Latin Central and Others count for about a third of sales,”he added, “they Europe America Asia/China America Eastern Europe generate around two-thirds of sales growth.” Analysing the sales increases in the main Figure 3: Contribution to global non-prescription sales and sales growth by region of the world in the year to the end of the first quarter of 2011. Figures are based on sales in euros at manufacturers’ selling prices. Growth geographic regions, Tisman said the global non- figures are based on local-currency comparisons (Source – IMS Audits plus estimates) prescription market had recorded cumulative growth of 39% over the past five years. Cen- of 13%, 9% and 6% respectively. responsible for 20 percentage points. Further- tral and Eastern Europe and Latin America led Tisman pointed out that innovation – in the more, in the South-East Asia/China area, new the way with cumulative growth of 106% and form of both new products and line extensions products had contributed 11 percentage points 80%, while Western Europe lagged behind with – had fuelled the growth of the global non-pre- to the 59% growth, while line extensions had 6% (see Figures 4, 5, 6, 7, 8 and 9). scription market over the past five years. “Inno- been responsible for 33 percentage points. The global base business had declined by vation accounted for 33 of the 39 percentage Tisman drew attention to the fact that inno- 6% during the past five years. Western Europe points of global growth,”he noted. vation had even been the main driver of growth fared particularly badly with a 21% drop in base He added that innovation had driven sales in Central and Eastern Europe and Latin Amer- business, and North America experienced a fall growth in all regions of the world. In Central ica, where changes in prices had played a sig- of 12%. However, Central and Eastern Europe, and Eastern Europe, for example, new prod- nificant role. South-East Asia/China and Latin America buck- ucts had contributed 33 percentage points to the “Innovation is still the biggest single growth ed the trend, with increases in the base business 106% growth, while line extensions had been driver in our industry,” he remarked. “Without

WORLDWIDE WESTERN EUROPE NORTH AMERICA

-6% 5 Base value change -21% 5 Base value change -12% 5 Base value change

Price change4 +12% Price change4 +4% Price change4 +10%

New products3 +16% New products3 +12% New products3 +17%

Line extensions2 +17% Line extensions2 +11% Line extensions2 +9% +39%

Total change1 Total change1 +6% Total change1 +26%

Figure 4: Breakdown of growth in non-prescription Figure 5: Breakdown of growth in non-prescription Figure 6: Breakdown of growth in non-prescription sales worldwide over the past five years to the end of sales in Western Europe over the past five years to sales in North America over the past five years to the the first quarter of 2011 (Source – IMS Consumer the end of the first quarter of 2011 (Source – end of the first quarter of 2011 (Source – Health’s Elements of Growth) IMS Consumer Health’s Elements of Growth) IMS Consumer Health’s Elements of Growth)

CENTRAL AND EASTERN EUROPE LATIN AMERICA SOUTH-EAST ASIA/CHINA

Base value Base value 5 +13% 5 +6% Base value change5 +9% change change

Price change4 +40% Price change4 +34% Price change4 +4%

New products3 +33% New products3 +21% New products3 +11%

Line extensions2 +20% Line extensions2 +18% Line extensions2 +33% +106%

Total change1 Total change1 +80% Total change1 +59%

Figure 7: Breakdown of growth in non-prescription Figure 8: Breakdown of growth in non-prescription Figure 9: Breakdown of growth in non-prescription sales in Central and Eastern Europe over the past five sales in Latin America over the past five years to the sales in South-East Asia/China over the past five years to the end of the first quarter of 2011 (Source – end of the first quarter of 2011 (Source – years to the end of the first quarter of 2011 (Source – IMS Consumer Health’s Elements of Growth) IMS Consumer Health’s Elements of Growth) IMS Consumer Health’s Elements of Growth)

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110 120120 (+2%)

89 87 100100 (-2%) (-4%) 75

) 72

C (+3%) 8080 (+4%) 67 65 (+4%) 62 54 (±0%) (-2%) 51 (-3%) 49 48 48 6060 (-10%) 41 39 38 (+4%) (+9%) (-1%) 37 38 38 36 (-2%) (+1%) (+18%) 33 (-2%) (+8%) (+5%) 30 (+6%) 4040 (+2%) (+11%) 19 (+9%) r capita expenditure ( 2020 Pe

0 0 12 34 56 78 91011121314151617181920212223 UK kia ary Italy va Spain erage Russia France Finland Austria Ireland Norway Greece Poland Belgium Germany Portugal av Slo Republic Hung Bulgaria Romania erage Switzerland ope Av The Netherlands Czech n Eur Europe ster Central and Eastern We

Figure 10: Per capita expenditure in euros on non-prescription products at public prices in selected European countries in the 12 months to the end of the first quarter of 2011 (Source – IMS Consumer Health’s OTCims) innovation, the non-prescription markets in West- the first quarter of 2011, continued Tisman, add- nomic recession, Tisman said the situation was ern Europe and North America would be going ing that Italy had “continued to perform quite now improving. backwards.” strongly”. However, France, Germany and the In Russia – the largest market in Central Within the European non-prescription mar- pharmacy sector in the UK had all seen non- and Eastern Europe – non-prescription sales ket, all the sub-regions had experienced “slow- prescription sales slip back, and were holding increased by more than a tenth during the 12 ing growth”, Tisman pointed out. Non-prescrip- back growth for Europe as a whole, he said. months to the end of the first quarter of 2011, tion sales in Europe had moved ahead by 3.4% Discussing the UK, Tisman explained that compared with three-year average growth of in the 12 months to the end of the first quar- IMS Consumer Health’s figures only included more than a fifth. ter of 2011, compared with three-year average the pharmacy sector,but the rest of the mar- growth of 4.8%. ket was also “pretty depressed”. “The heavy Trends in Russian market Trends within the region continued to sug- presence of generics and retailers’ own-label Tisman said Russia’s very strong growth of gest “a tale of three Europes”, according to Tis- ranges in the UK is not doing any favours to recent years could not be sustained indefinitely. man. Central and Eastern Europe was “driving the branded OTC industry,” he remarked. He also noted that the figures for the previous growth in the region”, while Western Europe’s Commenting on Central and Eastern Europe, year had been boosted by the strong perform- dereimbursed markets – France and Germany Tisman said most countries in the sub-region ance of cold and flu immunostimulants in the – had declined. Other Western European mar- had shown a “positive recent trend”. Two big 2009/2010 winter season. kets sat between the two extremes with sales markets – Poland and Russia – had recorded According to Tisman, the economic crisis ap- growth of around 2.0%. strong sales growth, as had the smaller mar- peared to be holding back the annual per cap- Many Western European countries had re- ket of Bulgaria, he added. ita expenditure on non-prescription products in corded stable growth around the average for the Noting that short-term growth in Central and Europe, particularly in some countries in West- European Union in the 12 months to the end of Eastern Europe had been curbed by the eco- ern Europe. As can be seen from Figure 10,

Weight loss Other 1.8% 8.08 Anti-varicose 18.6% 6.7% 6.0% 2.3% 6.06 5.3% Eyecare Cough/cold 3.8% 20.3% 4.04 3.4% 3.5% 2.2% Skin 1.6% 1.7% 8.7% 2.02 1.3% Weight loss th (%)

ow 0.00 European12Cough/ Analgesics345678 Digestive VMS* and Skin Eyecare Anti- 910Other market cold tonics varicose VMS* and -2.0-2 Sales gr tonics 13.9% Analgesics -4.0-4 16.2% Digestive 14.4% -6.0-6 -5.9% * Vitamins, minerals and supplements -8.0-8 Figure 11: Sales of non-prescription products in Europe in the 12 months to the end of the first * Vitamins, minerals and supplements quarter of 2011, broken down by product category. Figures are based on sales in euros at Figure 12: Growth in sales of main non-prescription product categories in Europe in the 12 months to the manufacturers’ selling prices end of the first quarter of 2011. Figures are based on sales in euros at manufacturers’ selling prices (Source – IMS Consumer Health’s OTC Review Plus) (Source – IMS Consumer Health’s OTC Review Plus)

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OTC AESGP MEETING

per capita expenditure dropped back in Ger- back slightly or showed little growth. many, France, Switzerland, Ireland, Norway, Tisman noted that proton-pump inhibitors 20.020

Greece and the UK. held “decent” shares of the antacid category 15.8% Tisman put the falls down to price pressure in some European Union countries, although 15.2% 15.015 and an increase in generics and own-labels in there was “a mixed picture” overall. The shares

some key markets. “Consumers responded to in Finland, Poland, Czech Republic and Ger- th (%) 10

ow 10.0 the economic situation by cutting back on ex- many were 41%, 32%, 24% and 22% respec- 7.9% 7.0% penditure,”he said, adding that volume decreases tively,although the share for the European

had been less important. Union as a whole was only 11%. Sales gr 5.05 IMS Consumer Health’s annual per capita Novartis, Nycomed and had emerged 2.4% expenditure figure for the UK only covers the as the key players in the European Union’s non- 0.00 pharmacy sector. Tisman noted that the figure prescription market for proton-pump inhibitors, 123456 for the UK’s total non-prescription market was he added, with shares of 32%, 26% and 16% Global Europe South-East similar to that for Ireland or Norway. respectively. North America Latin America Asia/China Looking at categories, cough/cold products Only one of the main product categories in led the way in Europe in terms of both value Europe’s non-prescription market went back- Figure 14: Forecasted sales growth for the global non-prescription market and the key regions of the sales and sales growth. As can be seen from wards. Sales of weight-loss products fell by world over the five years from 2010 to 2014 Figures 11 and 12, the category accounted for 5.9%, as GlaxoSmithKline Consumer Health- (Source – IMS Consumer Health’s OTC Review 2010) 20.3% of total non-prescription sales in the 12 care’s Alli weight-loss medicine (orlistat) strug- months to the end of the first quarter of 2011, gled during the 12 months to the end of the first Novartis was the leading company with a and recorded growth of 6.7%. Tisman noted that quarter of 2011. 6.7% value share of the total non-prescription cough/cold products had “rebounded” from the Alli is one of a basket of more than 100 non- market in Europe,and sales growth of 5.5%. poor growth for the 2009/2010 winter season. core OTCbrands that GlaxoSmithKline is seek- Stada and Reckitt Benckiser were the fastest- ing to divest (OTC bulletin,29 April 2011, page growing firms, with sales growth of 8.2% and Driven by probiotic products 1). Its potential sale comes around two years 8.0% respectively (see Figure 13). The digestive category also did well, achiev- after it was launched in Europe, after becom- Tisman drew attention to the fact that half ing sales growth of 5.3%. Digestive growth had ing the first non-prescription medicine to be of the top 10 players had matched or beaten been driven primarily by probiotic products, authorised through Europe’s centralised proce- the average market growth across Europe of said Tisman, adding that switches to non-pre- dure. Alli achieved sales of £105 million (C120 3.4%. This was a more positive picture than in scription status for the proton-pump inhibitors million) in the nine months after its launch ac- previous years, he said, when most of the big pantoprazole and omeprazole had also been a ross the European Union, making it the third players had failed to keep up with the average contributing factor. best-selling OTC brand in Europe. market growth. Proton-pump inhibitors had achieved “some The poor performance of Alli during the 12 With a couple of exceptions, added Tisman, early success”in driving growth in the Euro- months to the end of the first quarter of 2011 all of the big players had managed to achieve pean Union antacid category,said Tisman. They took its toll on GlaxoSmithKline Consumer short-term growth that matched their long- contributed 5.6 percentage points to the total Healthcare, and the company’s total non-pre- term picture. sales growth of the antacid category in the 12 scription sales in Europe dropped back by 7.8%. Looking ahead, Tisman said the developing months to the end of the first quarter of 2011, Tisman noted the firm had been the “biggest regions would continue to provide the majority while sales of all other product types slipped loser” of the top 10 players in the region. of growth in the global non-prescription mar- ket. IMS Consumer Health is forecasting a com- Change in sales pound annual growth rate (CAGR) of 7.9% for Nova10rtis 6.7% +5.5% the global non-prescription market over the next five years. South-East Asia/China and Latin Ame- Sanofi9 4.9% +3.8% rica are expected to lead the way with CAGRs Bayer8 4.6% -2.5% of 15.8% and 15.2% respectively (see Figure 14). Within Europe, which is forecasted to have Johnson & Johnson7 4.1% -1.3% a CAGR of 7.0%, Central and Eastern Europe GlaxoSmithKline6 3.3% -7.8% would continue to drive growth, said Tisman. Western Europe’s CAGR is expected to be 4%, Reckitt Benckiser5 2.5% +8.0% while the forecast for Central and Eastern Eur- Boehringer Ingelheim4 2.2% +6.1% ope is 14%. Commenting on key markets in Western Eur- Te3va 2.2% -2.4% ope, Tisman said France was expected to return Bristol-Myers Squibb2 1.7% -1.7% to modest growth with a CAGR of 2.5%, and Germany should remain stable with no growth Stada1 1.5% +8.2% over the medium term. “Italy has the most opti- 0.0 1.0 2.0 3.0 4.0 5.0 6.0 7.0 01234567 mistic outlook with a CAGR of 6%,”he added. Share of European market for non-prescription products (%) In Central and Eastern Europe, forecasted Tisman, Russia would be the main driver with Figure 13: Top 10 companies in Europe ranked by sales of non-prescription products in the 12 months to the a CAGR in excess of 15%. end of the first quarter of 2011, together with sales growth for the year. Figures are based on sales in euros at manufacturers’ selling prices (Source – IMS Consumer Health’s OTC Review Plus) OTC

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Industry Associations Pascal Brossard Brossard replaces Cotard as head of France’s AFIPA

rance’s OTC industry association, AFIPA, tic value’, which Brossard said was damaging Fhas elected Zambon France’s managing dir- to the industry. Educating healthcare profes- ector Pascal Brossard as its president. sionals and providing patients with informa- He replaces Vincent Cotard,who has vacat- tion about self-medication was also high on ed the role halfway through a two-year term, the agenda, according to Brossard, as well as Vincent Cotard following his appointment as GlaxoSmithKline gaining data protection for switched products. Consumer Healthcare’s president for Australia Cotard, 47, was re-elected as AFIPA’s pres- and New Zealand. Cotard had previously led ident for a second, two-year term a year ago the New Zealand business from 2001-2003. (OTC bulletin,30 July 2010, page 24). He has Brossard, 52, previously held positions at more than 16 years of experience in the pharma- Warner Lambert Consumer Healthcare,Ther- ceutical industry,including serving as president aplix, and Nycomed before joining of GlaxoSmithKline Consumer Healthcare’s Zambon. He has managed brands including French business for the past seven years. Actifed, Doliprane, Fluimucil, Hextril, Maalox, AFIPA’s leadership team also includes Toni- and Solutricine. pharm’s director general and former AFIPA Brossard acknowledged Cotard’s contribu- president Eric Maillard and Sanofi-Aventis’ tion to AFIPA during the past three years, but director of general medicine and pharmacies said the association still had much work to do. Pascal Regen as vice-presidents. This work included eliminating references to Christophe de la Fouchardière,president general of the association, whilst Bayer Santé OTC products as having ‘insufficient therapeu- of Merck Médication Familiale, is secretary- Familiale’s Michael Kloss is treasurer. OTC

Retailers Regulatory Agencies Lloydspharmacy Hamburg reorganises FDA management he commissioner of the US Food and Drug tion at Children’s Mercy Hospital in confirms Wilton TAdministration (FDA), Dr Margaret Ham- City,and previously served as dean of Dart- burg,has reorganised the agency’s programmes mouth Medical School in New Hampshire. loydspharmacy has confirmed Peter Wil- into “directorates” that “reflect the core func- In addition, Hamburg has appointed Deb- Lton as head of its brand and marketing com- tions and responsibilities of the agency”. orah Autor as deputy commissioner for glo- munications team. Hamburg said the overhaul had been driven bal regulatory operations, with a mandate to pri- The UK-based retailer pointed out that Wilt- by “the changing nature of both the agency and oritise responding to the “challenges of glo- on had carried out the role in an interim capac- the job of commissioner”, including the “dra- balisation and import safety”. Autor recently ity since joining Lloydspharmacy in 2010. He matic transformation of globalisation”. led a reorganisation of the FDA’s Office of is responsible for a team of 21 at the 1,650- Compliance into a “super office” comprising strong pharmacy chain. Spielberg takes up new position four subordinate divisions (OTC bulletin,30 Wilton had over 23 years of experience in Dr Steven Spielberg has been appointed June 2011, page 23). marketing and advertising,noted Lloydsphar- to the newly-created position of deputy com- Dr Murray Lumpkin has been appointed macy, and had previously served as head of missioner for medical products and tobacco. senior advisor and representative for global is- business development and interim managing Hamburg said that Spielberg would provide sues, whilst Mike Taylor remains in charge of director at TDA. Prior to that, he worked at “high-level coordination and leadership across the Office of Foods. The Haystack Group for four years. the centres for drugs, biologics, medical devices Hamburg also plans to establish a new Of- Noting that the pharmacy chain had already and tobacco products”. However, she noted that fice of Operations to be led by a chief operat- “pioneered services such as the Lloydsphar- the centres would remain “discrete management ingofficer. macy Online Doctor”,Wilton said it would con- entities” under their current leaderships. The office will include a chief financial offi- tinue to “revolutionise consumers’ access to Spielberg is director of the Center for Per- cer, who will be responsible for budget formu- health products and services”. sonalized Medicine and Therapeutic Innova- lation and execution. OTC OTC We also publish Generics bulletin – www.generics-bulletin.com

26 OTC bulletin 29 July 2011 OTC29-07-11p26-27FIN.qxd 29/7/11 09:19 Page 3

PEOPLE OTC

Manufacturers Industry Associations Reckitt promotes Pane to ASMI recruits global healthcare position Maiese to team he Australian Self-Medication Industry eckitt Benckiser has promoted Camillo tor for and fabric softeners in 2006. He T(ASMI) has recruited Filomena Maiese RPane,general manager of its UK business, was made general manager of the Canadian as marketing and business development direc- to senior vice-president and global category of- business in 2009. tor with effect from 1 August 2011. ficer healthcare. Reckitt Benckiser noted that Pane would Maiese had previously worked alongside The UK-based company said Pane would continue to work closely with the UK business the ASMI as chair of its marketing and ethics be located at its headquarters in Slough, and until the handover had been completed. committee, the association pointed out, and would report to its executive vice-president of Pane was made general manager of Reckitt had also been involved with its Self-Care Com- category development, Heather Allen. Benckiser’s UK healthcare business in April mittee, Pseudoephedrine Taskforce and Co- Pane’s replacement at the UK business is 2007. Following the merger of the UK house- deine Committee. Alan Thompson,general manager of Reckitt hold, personal care and healthcare businesses in The ASMI said Maiese had more than 15 Benckiser’s Canadian business. Thompson join- 2010, he was promoted to head of the combin- years of experience in the consumer health- ed the company as sales director for Russia in ed businesses (OTC bulletin,18 December care industry with companies including Warn- 2003, and was appointed global category direc- 2009, page 5). er Lambert Consumer Healthcare, Pfizer Con- In his new post, Pane would be responsible sumer Healthcare, and the OTC division of for “driving innovation, equity and growth” for Johnson & Johnson Pacific. the global healthcare category,which included The ASMI’s executive director,Dr Deon brands such as Nurofen,Strepsils and Gaviscon, Schoombie, said Maiese had a “very strong said Reckitt Benckiser. commercial and marketing perspective”. Her Meanwhile, Reckitt Benckiser has announc- understanding of the industry would add “sig- ed that Richard Joyce will become investor nificant value to the association and its mem- relations director with effect from 1 Septem- bers”, he added. ber 2011, reporting to the chief financial of- ficer Liz Doherty. Filomena Maiese Joyce has been the company’s director of Camillo Pane financial reporting for three years, and prior (above) and Alan to that he was finance director for the Nordic Thompson (left) region. He joined the company in 2002 from PricewaterhouseCoopers. To ease Joyce into his new position, Reckitt Benckiser’s former head of investor relations, Tom Corran,will return in August as a part- time consultant for a year. Joyce will replace Joanna Speed who an- nounced earlier this year that she would be leav- ing in October (OTC bulletin,30 May 2011, OTC page 27). OTC IN BRIEF IN BRIEF ■ MHRA – the UK’s Medicines and Health- care products Regulatory Agency – has taken ■ MEDCO CELESIO has appointed Marc in providing integrated pharmacy solutions to on Rachel Bosworth to replace Simon Gre- van Kempen as managing director of the Neth- patients with chronic and complex conditions. gor as director of communications. Bosworth, erlands with a remit to develop and implement Starting in Germany, Medco Celesio intends who is a member of the Chartered Institute of the joint venture’s strategic plan for the Dutch to expand across Europe. Public Relations, moves to the MHRA from the market. He joins Medco Celesio from Merck East of England Development Agency, where Sharp & Dohme,where he was commercial ■ DIAPHARM said Anja Kapelski had join- she was executive director of communications director for the Dutch market and board mem- ed its Good Manufacturing Practice (GMP) and and deputy chief executive. The MHRA pointed ber of the Dutch management team. Formed a quality management consultancy team in Ger- out that Bosworth had a wealth of experience year ago, Medco Celesio is a 50:50 joint ven- many. The pharmaceutical services provider in communications, marketing and external re- ture between the US-based pharmacy benefit noted Kapelski had joined from RP Scherer, lations in the private and public sectors, and manager Medco Health Solutions and the pan- where she was GMP auditor and manager of had managed public affairs and media rela- European wholesaler and retailer Celesio (OTC change control in quality assurance. tions in the rail industry. bulletin,30 June 2010, page 5). It specialises OTC OTC

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