Fate of Rule 21 in balance as med devices talks begin
Transcription
Fate of Rule 21 in balance as med devices talks begin
23 October 2015 COMPANY NEWS 3 Mid Europa Partners set to take control of Walmark Perrigo strikes deal with Flamel J&J ready to pursue OTC opportunities Shionogi forms OTC subsidiary 23andMe gets investment to grow global operations Nestlé to open research facility Genomma on the look out for brands to grow portfolio IPO on the cards for AFT Pharma Boiron hit by lower sales in key European markets 3 GENERAL NEWS 9 ASMI wants better codeine measures PAGB lends its support to NHS winter campaign Foreign traditions challenge HMPC US slow to adopt digital health tech 9 3 4 5 6 6 7 7 8 10 10 11 MARKETING NEWS 14 Vicks makes its debut in “connected health space” GSK teams with X Factor in Australia Sanofi promotes Doliprane for French self-medication Infirst Healthcare prepares to launch UniCough in UK Covonia grows with hot dose variant Dolormin capsules aim to relieve pains in the neck Pregnacare Liquid is said to be UK’s first 14 FEATURES 20 Pharmacy needs to adapt to flourish 20 14 15 16 17 18 18 REGULARS Events – Our regular listing People – Oschmann to replace Kley as head of Merck in 2016 19 23 Fate of Rule 21 in balance as med devices talks begin R ule 21 was on the table when talks began last week on the fate of the European Union’s (EU’s) proposed medical device legislation. The rule – proposed by the Commission, rejected by the Parliament, and expanded by the Council – will determine whether self-care medical devices have a future, according to speakers at a meeting organised by the Association of the European Self-Medication Industry, the AESGP, last week. Mairead McGuinness, vice-president of the European Parliament, said that while the first round of trialogue discussions had been positive – with a decision made to try and complete the work by the end of the year – there had been no movement on the future of the legislation’s controversial Rule 21. If implemented, Rule 21 could see a raft of self-care medical devices, such as nasal sprays, removed from the market. In June, the Council expanded the scope of Rule 21 in Annex VII of the proposed legislation to cover “all devices that are introduced into the human body via body orifice or applied on skin”. The AESGP said at the time that this new language would mean numerous self-care devices would unnecessarily be classified in the highest risk category – class III (OTC bulletin, 24 July 2015, page 1). Commenting on the first trialogue discussions on the proposed legislation between the Council of Health Ministers, the European Commission and the European Parliament – which were held on 13 October – McGuinness said that “it was not clear if there is an acceptable compromise”. “That is not to say that things might not evolve and move on before our next meeting,” McGuinness added. “This is not a race to the end. Let’s not rush; let’s do the right thing.” The AESGP meeting clearly showed the scale of the task facing the self-care industry in convincing member states to delete Rule 21. Vincent Houdry, health advisor for the permanent representation of France to the EU, simply stated that if a product fell under the def- inition of Rule 21, France was “quite happy to have these products in class III”. However, Houdry did leave some room for compromise noting that France was not happy with the current language of Rule 21 and conceded that the legislation might be “excessive for some products”, and that France was “happy to work on this topic”. Adopting a similar view, Matthias Neumann, of Germany’s Ministry of Health, said that his country felt the rule was needed, but that the Council’s current text was ill-defined. To find a compromise, the language needed to be revisited, he argued. Meanwhile, John Wilkinson, from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), said the agency’s position had been laid out in 2012 and had not changed – orally ingested, inhaled, rectal and vaginal products were all medicines if absorbed or dispersed. “Caution is needed here,” he warned. “There is potential for a wide open door that a load of stuff goes through which was not intended, and nobody wants that.” “No rationale” for Rule 21 Facing such entrenched positions, GlaxoSmithKline’s (GSK’s) Andrew Wilson, speaking in his capacity as a member of the AESGP’s Committee on Medical Devices, argued that there was “no rationale” for Rule 21. “We have heard it said that member states are concerned about ingested medical devices. Yet we’ve not seen any data to support this concern,” he claimed. “But if there is, let’s reach a conclusion on it.” “Then if action is needed, let’s make provision in a delegated act,” Wilson urged. “Let’s write a technical specification for ingested medical devices and the standards they should meet.” “It will be clear, understandable, actionable and easier to reach alignment on than a general rule,” Wilson added. “The regulation has the tools to do this already and because of this we would urge the trialogue discussions to come out in line with the Parliament position and delete Rule 21.” OTC bulletin print OTC bulletin-i digital news@OTCbulletin electronic newsflash The best decision-makers in the OTC industry don’t have the time to go looking for good information. They let it come to them. They subscribe to OTC bulletin. 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(Tel: +44 (0)1564 777550; Fax: +44 (0)1564 777524). Registered in England No: 2765878. VAT No: GB 608 0432 69 COMPANY NEWS OTC Mergers & Acquisitions Mergers & Acquisitions Perrigo strikes Mid Europa Partners set deal with Flamel to take control of Walmark P P errigo has struck an exclusive deal to license Flamel Technologies’ LiquiTime drug-delivery technology to develop a range of products for the US OTC market. Noting that LiquiTime permitted extendedrelease of liquid medicines – such as ibuprofen or guaifenesin – the US store-brand specialist said the technology would be “utilised in the development of a portfolio of extended-release suspension products”. Commenting on the agreement, Perrigo’s chairman, president and chief executive officer, Joseph Papa, said the partnership with Flamel for its “innovative” LiquiTime technology demonstrated the firm’s “continued focus on its growth strategy”. “This is yet another excellent example of Perrigo’s commitment to providing quality affordable healthcare products for our customers across the globe,” Papa insisted. Michael Anderson, Flamel’s chief executive officer, said the company “looked forward to continued successful development programmes and commercial launches with Perrigo”. Perrigo is currently the target of a hostile takeover bid from Mylan, which the generics giant made directly to the firm’s shareholders on 14 September (OTC bulletin, 25 September 2015, page 3). OTC 23 October 2015 Number 451 Editor: Matt Stewart Editor-in-Chief: Aidan Fry Production Editor: Jenna Meredith Assistant Editors: Tom Gallen, Marie McEvoy Contributing Editor: David Wallace Advertising Controller: Debi Minal Director of Subscriptions: Val Davis Group Sales Manager: Rob Coulson Awards Manager: Natalie Cornwell Managing Director: Mike Rice Editorial enquiries: OTC bulletin, 4 Poplar Road, Dorridge, Solihull, West Midlands B93 8DB, UK. Website: www.OTC-bulletin.com Tel: +44 (0)1564 777550 Fax: +44 (0)1564 777524 Email: [email protected] Advertising enquiries: As above, or [email protected] SUBSCRIPTIONS Subscription rates are published at www.OTC-bulletin.com/subscribe. 23 October 2015 OTC bulletin rivate-equity firm Mid Europa Partners is set to take full control of family-owned Czech dietary supplements and natural products company Walmark. Under the terms of the deal, Mid Europa will acquire the 50% of Walmark that it does not already own from the founding Walach family. Mid Europa first snapped up a 50% stake in Walmark in December 2012. Commenting on the agreement, Adam Walach, member of Walmark’s board, said that the Walach family had concluded that the time was right to sell the business. “After 25 years of building Walmark, we have decided to pursue other interests and new investment opportunities, capitalising on our experience,” Walach explained. Enjoyed an excellent partnership Michelle Capiod, a partner at Mid Europa, said the private-equity company had enjoyed an “excellent partnership” with the Walach family for the past three years. “We have jointly transformed Walmark from the leading dietary supplements business in Central and Eastern Europe (CEE) into a focused consumer healthcare platform with an exciting pipeline of new products,” Capiod insisted. “We are delighted to continue our active supIndividual subscriptions An annual subscription comprises: ■ 20 OTC bulletin newsletters; ■ AND at least 45 weekly news@OTCbulletin electronic newsflashes containing the week’s top news stories (currently delivered by email). Choice of formats The 20 OTC bulletin newsletters are available: ■ EITHER as the digital OTC bulletin-i for online access by desktop, and tablet and smartphone. Mobile devices can have Apple or Android operating systems. ■ OR in traditional hard-copy print format, delivered by airmail. Corporate and multiple subscriptions Global Site Licences are available to companies. These provide in-house electronic access for staff to OTC bulletin and news@OTCbulletin. Please ask for a quotation. Discounted multiple subscriptions are available to OTC bulletin-i at the same location. Subscription enquiries: Contact [email protected] port of the management in their execution of this successful strategy,” she added. Echoing Capiod’s comments, Jorge Manuel, Walmark’s chief executive officer, insisted that this “evolution in Walmark’s ownership” would not alter the firm’s “strategy and priorities”. “I and the whole Walmark team remain highly motivated to materialise the value-creation opportunities ahead of us,” Manuel stressed, “through our commitment to consumer insightled innovation and brand-equity building in partnership with pharmacists and other healthcare professionals across the CEE region.” Established in 1990, Walmark claims to be the “fastest growing healthcare company” across the CEE region. The firm’s portfolio includes the Benosen sleep-aid, Pneumolan respiratory health products, Septofort sore-throat line and Spektrum multivitamins. Walmark expanded its product portfolio earlier this month by acquiring Czech dietary supplements and natural products firm Valosun for an undisclosed sum (OTC bulletin, 9 October 2015, page 3). Describing Valosun as the “leading probiotic player in the Czech Republic and Slovakia”, Walmark said the deal would “further strengthen” its position in both “key” markets. OTC Terms & Conditions: These can be viewed in full at www.OTC-bulletin.com/subscribe. No part of this publication may be copied, reproduced, stored in a retrieval system, distributed or transmitted by any means, including electronic, mechanical, photocopying or recording, without the prior written permission of the publisher, or under the terms and conditions of a Global Site Licence or of a licence issued by the Copyright Licensing Agency (CLA) in London, UK, or rights bodies in other countries that have reciprocal agreements with the CLA. Neither may this publication be exported, distributed or circulated by any means without the prior written permission of the publisher. While due care has been taken to ensure the accuracy of information contained in this publication, the publisher makes no claim that it is free of error and disclaims any liability whatsoever for any decisions or actions taken as a result of its contents. © OTC Publications Ltd. All rights reserved. OTC bulletin® is registered as a trademark in the European Community. ISSN 1350-1097. Company registered in England No 2765878. Printed by Warwick Printing Company Limited, Leamington Spa CV31 1QD, UK. 3 OTC COMPANY NEWS Third-Quarter Results J&J ready to pursue OTC opportunities J ohnson & Johnson is on the look out for acquisitions to grow its OTC and certain other Consumer businesses, according to the firm’s chief financial officer Dominic Caruso. Speaking as the US pharmaceutical giant announced its third-quarter results, Caruso said Johnson & Johnson would pursue acquisitions to expand its OTC, Oral Care and Skin Care businesses if the right opportunities came along. The company would look to add scale to these three businesses in particular, Caruso said, as they constituted Johnson & Johnson’s “core platforms” within its Consumer unit. Not averse to big deals Commenting on the size of any potential deal, Caruso insisted that the company was not “averse to large mergers and acquisitions”. However, such a transaction had to drive “long-term, value-creating growth”, he stressed. Turning to the manufacturing issues that have blighted the company’s US OTC business over the past few years, Caruso noted that the majority of the brands that had been withdrawn were now back on the market. “We are back to a consistent cadence of new products as we Business continue to reintroduce products to shelves,” he pointed out. All three of the firm’s US OTC manufacturing plants operating under a consent decree (OTC bulletin, 17 March 2011, page 1) have now passed US Food and Drug Administration (FDA) inspections (OTC bulletin, 11 September 2015, page 11). Despite receiving FDA certification for all three plants, Johnson & Johnson will continue to operate under the consent decree for a further five-year period. The firm was issued with the consent decree for failing to comply with good manufacturing practice (GMP) requirements at its Fort Washington facility in Pennsylvania, US and its Las Piedras site in Puerto Rico. A string of product recalls by Johnson & Johnson’s OTC business during 2010 and 2011 prompted a government investigation and the closure of the Fort Washington facility. Manufacturing problems at Fort Washington led to the withdrawal of the bulk of Johnson & Johnson’s OTC portfolio in the US. Johnson & Johnson’s OTC brands returning to shelves in the third quarter of 2015 helped to lift its US OTC sales by 22.4% to US$383 million (C338 million). Growth had been recorded by the firm’s US analgesics brands, Johnson & Johnson noted, with the company singling out the “positive contributions” of Motrin and Tylenol. Johnson & Johnson’s share of the US adult analgesics market in the quarter had reached 12.5%, the company pointed out, up from 11% in the prior-year period. In addition, the firm noted that it had taken a 44.5% share of the paediatric analgesics market, up from 41% in the third quarter of 2014. US OTC sales had also benefitted from seasonal inventory build-up for Zyrtec and initial stocking for a number of relaunched d igestive-health products, the company added. Outside the US market, international OTC sales slumped by 17.8% to US$580 million, as an operational fall of 0.7% was compounded by a 17.1% negative currency effect. Johnson & Johnson blamed the operational fall on the “timing of the seasonal inventory build-up for upper respiratory products”, noting that the build-up had occurred earlier than in the prior year. Third-quarter sales (US$ millions) Change 2014/2015 (%) Operational change (%) Currency effect (%) OTC – US OTC – International Total OTC 383 580 963 +22.4 -17.8 -5.5 +22.4 -0.7 +6.3 – -17.1 -11.8 Skin Care – US Skin Care – International Total Skin Care 435 428 863 +8.8 -17.7 -6.2 +8.8 -2.3 +2.5 – -15.4 -8.7 Baby Care – US Baby Care – International Total Baby Care 103 403 506 +1.0 -12.6 -10.1 +1.0 +2.1 +2.0 – -14.7 -12.1 Oral Care – US Oral Care – International Total Oral Care 154 224 378 +4.1 -14.2 -7.6 +4.1 +3.2 +3.5 – -17.4 -11.1 Women’s Health – US Women’s Health – International Total Women’s Health 6 304 310 -25.0 -4.1 -4.6 -25.0 +14.2 +13.3 – -18.3 -17.9 Wound Care/Other – US Wound Care/Other – International Total Wound Care/Other* 196 98 294 -3.0 -35.1 -16.7 -3.0 -23.9 -11.9 – -11.2 -4.8 Total Consumer 3,314 -7.7 +3.1 -10.8 Consumer – US Consumer – International 1,277 2,037 +8.9 -15.7 +8.9 +0.4 – -16.1 * Now includes Nutritionals, which was previously grouped with OTC Figure 2: Breakdown of sales by Johnson & Johnson’s Consumer division in the third quarter of 2015 (Source – Johnson & Johnson) 4 OTC bulletin 23 October 2015 COMPANY NEWS OTC Business Third-quarter Change sales (US$ millions) (%) Operational change (%) Currency effect (%) Pharmaceutical 7,694 -7.4 -0.3 -7.1 Medical Devices 6,094 -7.3 +0.9 -8.2 Consumer 3,314 -7.7 +3.1 -10.8 Total Johnson & Johnson 17,102 -7.4 +0.8 -8.2 Consumer 19% US$3.3 billion Pharmaceutical 45% US$7.7 billion Medical Devices 36% US$6.1 billion Figure 3: Johnson & Johnson’s sales in the third quarter of 2015 – US$17.1 billion – broken down by business segment (Source – Johnson & Johnson) declined by 7.6% to US$378 million, as a 4.1% rise in US sales was held back by a 14.2% drop in international turnover. Operationally, international Oral Care sales had advanced by 3.2%, the company said, thanks to better sales of the Listerine mouthwash brand following new product launches. The Women’s Health unit posted worldwide sales down by 4.6% to US$310 million, following the sale of its North American sanitary protection product unit. The sell-off contributed to a 25.0% slump in Women’s Health turnover in the US during the three months, while international sales declined by 4.1% due to negative currency effects. Turning to Consumer’s Wound Care/Other unit, Johnson & Johnson reported worldwide sales at the business down by 16.7% to US$294 million, as the divestment of Benecol in November 2014 had caused international turnover to slump by 35.1% to US$98 million. US sales fell back at a slower rate, sliding by 3.0% to US$196 million. The Consumer division accounted for 19.4% of Johnson & Johnson’s worldwide sales in the third-quarter (see Figure 3), which dropped by 7.4% to US$17.1 billion. OTC Mergers & Acquisitions Help Net to acquire Centrofarm stores R said the deal would enhance Hi-Tech’s “industry-leading sports-nutrition position” by expanding “market opportunities”. “We will have an even larger product portfolio, broader geographic reach and enhanced scale,” Wheat claimed. OTC OTC IN BRIEF 23 October 2015 OTC bulletin apan’s Shionogi is set to spin off its consumer healthcare business into a wholly-owned subsidiary in response to rising demand for its OTC products. Scheduled to begin operations in April 2016, the new subsidiary would be named Shionogi Healthcare, the company noted, and be led by Itaru Hirano, currently vice-president of the firm’s existing Consumer Health Care division. Explaining the rationale behind the move, Shionogi said that in Japan, self-medication was “becoming more and more important”. The new subsidiary would help the firm to increase its “focus” on consumer healthcare, Shionogi claimed, while also facilitating “quick decision making”. Shionogi Healthcare would concentrate its efforts on providing consumers with “highquality healthcare products” to help “extend healthy life expectancy”, the firm noted. Shionogi’s OTC product portfolio – which includes the Popon multivitamin range, Pylon cold remedies and the Sedes analgesic – generated sales of ¥4.6 billion (C34 million) in 2014. The firm’s total 2014 turnover amounted to ¥274 billion from sales of prescription medicines and medical devices, as well as OTC lines. omania’s competition authority has given the go-ahead to pharmacy chain Help Net Farma’s acquisition of 19 stores from local rival Centrofarm. The country’s Consiliul Concurentei said its investigations had concluded that the deal “does not raise significant obstacles to competition” in the Romanian pharmacy market. By adding 19 Centrofarm outlets to its network, Help Net would not “create a dominant position” in the market, the authority judged. Under the terms of the agreement – announced in June – Help Net has acquired for an undisclosed sum 19 Centrofarm pharmacies located in 10 cities across Romania, including the country’s capital city, Bucharest. Help Net currently operates more than 190 pharmacies in its domestic market. OTC ■ HI-TECH PHARMACEUTICALS – the US-based sports-nutrition firm – has grown its brand portfolio by buying iForce Nutrition and its range of sports-nutrition and bodybuilding products for an undisclosed sum. Jared Wheat, Hi-Tech’s president and chief executive officer, Shionogi forms OTC subsidiary J Figure 1: Johnson & Johnson’s sales in the third quarter of 2015 (Source – Johnson & Johnson) Worldwide OTC sales fell back by 5.5% to US$963 million, as an operational gain of 6.3% was held back by an 11.8% negative currency effect. The decline at the OTC business contributed to an overall slump in sales at Johnson & Johnson’s Consumer division, which reported worldwide turnover down by 7.7% to US$3.31 billion (see Figure 1). A rise in US Consumer sales of 8.9% to US$1.28 billion failed to offset a 15.7% drop in international turnover to US$2.04 billion. Operationally, international sales edged up by 0.4%, but this gain was wiped out by a 16.1% negative currency effect (see Figure 2). Excluding divestments, Johnson & Johnson said worldwide Consumer sales had improved operationally by 4.0%, with US sales increasing by 8.9% and international turnover advancing by 1.5%. Along with the OTC unit, all of Johnson & Johnson’s other Consumer businesses reported a drop in sales in the three months. Skin Care posted worldwide turnover down by 6.2% to US$863 million, as a 17.7% fall in international sales held back an 8.8% rise in the US. The international decline had been due to a combination of negative currency effects and “soft sales” in China, the firm noted. Johnson & Johnson attributed the increase in US Skin Care turnover to market share gains for Aveeno and Neutrogena in the country. Consumer’s Baby Care business reported a 10.1% drop in worldwide sales to US$506 million, due to a 12.6% fall in international turnover. US Baby Care sales had edged up by 1.0% to US$103 million, the firm pointed out, with gains from new product launches. However, this progress has been “partially offset” internationally by a poor performance in China. Meanwhile, worldwide Oral Care turnover Business Strategy 5 OTC COMPANY NEWS Business Strategy Business Strategy estlé Health Science is investing US$70 million (C62 million) to open a research and development facility in New Jersey, US, in a move the firm claims will help it to develop “innovative nutritional solutions”. Scheduled to open in 2016, the Nestlé Product Technology Center (NPTC) would focus on “applied research and innovative product development” and provide “technological knowhow in packaging”, the Swiss firm explained. Greg Behar, chief executive officer of Nestlé Health Science, said the investment reflected the firm’s “commitment to leading the development of innovative nutritional therapies”. The NPTC would use the “latest technologies” to “accelerate the quality and speed to market of Nestlé Health Science’s innovations”, Behar added. Nestlé Health Science focuses on “deepening the role of nutrition in healthcare” and sits alongside Nestlé Skin Health in the company’s Nutrition and Health Science business unit. S OTC genetic testing firm 23andMe has secured US$115 million (C102 million) of capital to help grow its presence in its domestic market and abroad. Noting that the funds had been generated during a recent round of financing, 23andMe said the investment would enable the company to “expand its operations and maximize the potential of its direct-to-consumer product in the US and abroad”. 23andMe currently markets an ‘at home’ genetic testing kit in Canada, the US, UK and a number of other European countries. The kit offers consumers access to health, ancestry and genetic data. However, the kit is sold in the US without the health test component after the Food and Drug Administration (FDA) in 2013 banned this part of the product for violating the Food, Drug and Cosmetic Act. The firm revealed in May that it was “act- Nestlé to open 23andMe gets investment research facility to grow global operations N U ively working” with the FDA to return the health element of the kit to the market. Expanding on its plans for the investment, 23andMe said the funding would help the company to launch a “new user experience” for the kit, plus “enhanced tools and functionality by the end of the year”. “The financing will also provide capital for strategic infrastructure,” 23andMe explained, “including new laboratory space for therapeutic research and a next-generation sequencing laboratory, as well as other investments in longterm growth.” Andy Page, 23andMe’s president, said the firm would use the investment to further its “vision for long-term growth” in its consumer and therapeutic businesses. Page noted that earlier this year 23andMe had achieved its initial goal to “reach and serve one million individuals” and was now “focused” on expanding further its customer base. OTC OTC Register online: www.europlx.com Each euroPLX Conference’s actual collaboration interests are summarised and displayed on www.europlx.com as an hourly updated Dynamic Partnering Focus, as soon as sufficient data are submitted by registrants. www.europlx.com [email protected] ph. ++49 (6221) 426296-0 6 The Original since 1995. Often copied. Never equaled. ain) a (Sp, 2016 8 celon 0 Bar March 7 + Seeking and offering business opportunities in patented and generic (incl. biosimilars), prescription and OTC drugs, medical devices, and nutraceuticals development, licensing, marketing, promotion, and distribution… PLX 6 euro March 7 + 8, 2016 Hotel Fairmont Rey Juan Carlos I, Barcelona 59 ment velop ss De euroPLX 60 Barcelona (Spain) usine euroPLX 59 Athens (Greece) November 23 + 24, 2015 Hotel Grande Bretagne, Athens und B Second to none. Don’t miss the next two. ce) Gree2015 ens ( , 9 Ath 23 + 24 PLX 5 November Because of results delivered. euro euroPLX is the world’s most often held partnering conference for the pharma and biotech industries. Ro Year- Since 20 Years 60 OTC bulletin 23 October 2015 COMPANY NEWS OTC Business Strategy Business Strategy IPO on the cards Genomma on the look out for AFT Pharma for brands to grow portfolio N G ew Zealand’s AFT Pharmaceuticals has revealed it is “considering” an initial public offering (IPO) to help the firm accelerate its international growth. Hartley Atkinson, AFT’s chief executive officer, said the “time was right” for the company to consider an IPO and listing on the NZX Main Board and the Australian Securities Exchange (ASX) in order to raise capital and “embark on the next phase of global growth”. AFT exports prescription and OTC medicines – including the Histaclear allergy relief product, Hylo-Forte eye drops, Maxiclear cold and flu brand, and the Maxigesic analgesic – to more than 40 countries worldwide and generated sales of NZ$76 million (C45 million) in 2014. “Raising new capital is really about taking this business to the next level,” Atkinson explained, “and advancing our portfolio of innovative development products.” Claiming that AFT was “set up to perform well on the world stage,” Atkinson noted that the firm had developed a “good track record” in terms of product development, regulatory approvals, licensing and distribution. “Our first patented development product, Maxigesic, is already approved and licensed in multiple European countries,” Atkinson said. AFT pointed out that a final decision on launching the IPO had not yet been made, but potential investors were able to register “preliminary indications of interest” with investment company First NZ Capital. OTC IN BRIEF ■ GLAXOSMITHKLINE (GSK) Consumer Healthcare is investing US$11 million (C9.7 million) in expanding its manufacturing plant in Buenos Aires, Argentina to increase production of its Corega denture care brand. Corega – also known as Poligrip in some markets – was GSK Consumer Healthcare’s biggest-selling brand in Argentina, the firm noted, and was one of the company’s seven global ‘power brands’. Expanding the Buenos Aires site would allow GSK Consumer Healthcare to produce 16 million tubes of Corega denture-adhesive cream annually by 2017, the firm explained, to supply 10 markets across South America, including Argentina, Brazil, Colombia and Venezuela. OTC 23 October 2015 OTC bulletin enomma Lab is “always” seeking opportunities to acquire OTC and personal-care brands to grow its presence in the US and Latin America, according to the firm’s chief executive officer Maximo Juda. Speaking at a recent analysts’ day, Juda – who was recently promoted from the position of chief operating officer to lead Genomma (OTC bulletin, 14 August 2015, page 27) – revealed that the Mexican firm was “always willing to take opportunities” to buy both OTC and personal-care products to expand its portfolio. Open to potential deals While Genomma had no specific targets in mind, Juda said the company was open to deals that fitted with the firm’s strategy. “When buying a brand, we will take into consideration how that brand aligns with the long-term strategy of the company and our existing portfolio,” Juda explained. If an opportunity came along to acquire an OTC or personal-care brand that had a “potential upside in terms of sales and margin”, Genomma would definitely consider it, Juda insisted. “If a brand appears for two-times sales, is a crown jewel, and makes a lot of sense for us and our investors, we will consider it, analyse it and then buy it,” he said. As well as brand acquisitions, Genomma would be interested in licensing products from other companies if attractive opportunities came along, Juda noted, adding that such deals would be carefully “analysed” by the firm’s board. While Genomma was looking to add brands to its portfolio, the firm was not averse to offloading products that did not fit with the company’s plans, Juda noted. “If a brand doesn’t make sense for us in the long run we will engage in discussions to sell that brand,” he explained. Genomma’s OTC range includes the Alliviax analgesic, Gargax sore-throat treatment, Nasalub nasal-spray and Oxigricol allergy brand. The firm reported 2014 sales up by 1.6% to MXN11.5 billion (C703 million) thanks to better sales of both OTC and personal-care products. Genomma is currently plotting its expansion into Europe, and has plans to launch its OTC and personal-care products into a small number of markets in the region next year (OTC bulletin, 20 March 2015, page 1). OTC Mergers & Acquisitions Oriola-KD hit by fine over Russian sale O riola-KD has been fined by the Helsinki stock exchange for breaching the rules of the exchange in connection with the sale of its Russian businesses in December last year. Issuing the Finnish firm with a C50,000 fine, the Nasdaq Helsinki disciplinary committee said Oriola had breached the rules “regarding the obligation to maintain adequate administrative procedures and to disclose corrected information in connection with the sale of its Russian businesses without undue delay”. Oriola had announced on 8 December 2014 it had completed the sale of the businesses to Russia’s Pharmacy Chain 36.6 (OTC bulletin, 12 December 2014, page 9), the committee pointed out, and had stated that it expected to record a loss of C26 million related to the deal. The committee noted that in a stock exchange release almost two months later, on 2 February 2015, Oriola had revised the amount of the loss to C147.7 million. As a result, the amount of the estimated loss disclosed by Oriola on 8 December had “proven to be erroneous to a substantial degree”, the committee insisted. From the “market’s perspective” the amount of the loss was “not insignificant”, it added. “Detecting the final losses only in connection with the financial statement process, and the materiality of the errors, prove that the financial administration of the company has not acted in a sufficiently compliant manner,” the committee ruled. Noting that the firm always aimed to “follow all the rules of the exchange”, Oriola claimed that the revised loss had been published “as soon as the loss was verified in connection with the annual closing process”. The firm said it had already “implemented corrective actions to avoid similar situations in the future”. OTC 7 OTC COMPANY NEWS Third-Quarter Results Third-Quarter Results Valeant reports Boiron hit by lower sales double-digit rise in key European markets V F aleant Pharmaceuticals posted third-quarter sales up by 36% to US$2.79 billion (C2.45 billion), driven by a double-digit gain in its Developed Markets region. In the Canadian firm’s Developed Markets, turnover increased by 54% to US$2.32 billion. Valeant said the rise was thanks to “strong volume organic growth” across its OTC, dermatology and ophthalmology portfolios. Noting that 85% of Developed Markets sales had been generated in the US, Valeant commented that it had enjoyed “exceptional growth” in the country during the three months. Sales in the US had jumped by 81% to US$1.97 billion, the company noted, driven by the performance of its dermatology products and the Bausch & Lomb eye-care business. Valeant snapped up global eye-health specialist Bausch & Lomb from private-equity firm Warburg Pincus in 2013 in a deal that gave the Canadian firm a number of prescription and non-prescription pharmaceuticals and a wide-ranging vision-care portfolio (OTC bulletin, 31 May 2013, page 1). Meanwhile, Valeant’s growth in the thirdquarter was held back by the performance of its Emerging Markets region. Turnover had slipped back by 15% to US$466 million in Emerging Markets, Valeant noted, due to a “difficult” quarter in Russia. The Russian business had been hit by the “economic slowdown” of the country’s pharmaceutical market, Valeant explained, as well as the “sharp drop” in the value of the rouble versus the US dollar. On a more positive note for its Emerging Markets business, Valeant said its operations in China had continued to perform well, with the company seeing “very strong growth” in the three months. OTC IN BRIEF ■ MYLAN has made a fresh appeal to Perrigo’s, shareholders restating its intention to run the company as a subsidiary if it takes control of 50% or more of the firm’s shares but is unable to gain over 80%. Mylan launched its formal offer to the Perrigo shareholders on 14 September (OTC bulletin, 11 September 2015, page 3) and has since attempted to convince them of the merits of the deal. OTC 8 rench homoeopathy specialist Boiron reported turnover down by 2.4% to C168 million in the third quarter of 2015, as sales fell in a number of its key European markets. Sales in Europe, excluding France, had dropped in the three months by 19.4% to C50.6 million, Boiron pointed out, due “mainly” to the firm’s performance in Russia. Turnover in the region had also been held back by lower sales in both Italy and Poland, the company added. Sales in Other countries also declined in the period, slipping back by 4.9% to C3.59 million (see Figure 1). On a more positive note, Boiron said that Business sales in France had increased by 5.7% to C97.8 million, while turnover in North America had jumped by 22.5% to C16.1 million. Turning to the firm’s performance by product category, Boiron said sales by its OTC Specialities had fallen by 4.7% to C94.3 million. The majority of the company’s turnover came from its non-proprietary homoeopathic medicines, with sales of these products moving forward by 1.0% to C73.7 million. Commenting on the firm’s strategy for its homoeopathic products, Boiron said it was committed to continuing its “involvement in the development of homoeopathy around the world”. Third-quarter sales (C millions) Change 2014/2015 (%) Proportion of total (%) France Europe* North America Other countries 97.8 50.6 16.1 3.6 +5.7 -19.4 +22.5 -4.9 58 30 10 2 Total Boiron 168.0 -2.4 100 OTC Specialties Non-proprietary Other 94.3 73.7 0.03 -4.7 +1.0 -80.8 56 44 >1 * Excluding France Figure 1: Breakdown of Boiron’s sales in the third quarter of 2015 (Source – Boiron) OTC Licensing Agreements Probi set to expand reach in Asia-Pacific P robi is set to grow the reach of its probiotics in South Korea, after signing a licensing deal with Seoul Milk. Under the terms of the agreement, Probi said its Lactobacillus plantarum 299v probiotic strain would be included in Seoul Milk’s product range by the end of the year. Noting that Seoul Milk was the largest supplier of milk products in Korea, Probi pointed out that the firm’s portfolio also included fruit juices and “other types of beverages”. Peter Nählstedt, Probi’s chief executive officer, said the company was “looking forward to the first launch of a food product containing Probi’s probiotics in the important and growing Asia region”. “We are increasing our business development activities in functional food,” Nählstedt explained, “and Asia-Pacific, with its high con- sumer acceptance for probiotics, is a very interesting area for expansion.” Nählstedt pointed out that Probi had already established, through its partners, a presence in the Korean dietary supplements market. In April last year, Probi signed up Korea’s Dongkook Pharmaceutical to launch its guthealth probiotic Probi Mage in the country (OTC bulletin, 11 April 2014, page 9). Later that month, Probi secured a deal with Sanofi to add its Probi Digestis probiotic to the French firm’s Cenovis vitamins minerals and supplements brand in Korea (OTC bulletin, 25 April 2014, page 3). Speaking at the time of the deal, Nählstedt noted that with a market value of around US$54 million (C47 million), Korea was now the thirdlargest probiotic supplements market in Asia. OTC OTC bulletin 23 October 2015 GENERAL NEWS OTC Regulatory Affairs ASMI wants better codeine measures R eclassifying all OTC medicines containing codeine to prescription-only status in Australia will not adequately address issues of misuse and addiction, according to the Australian Self-Medication Industry (ASMI). Responding to a proposal to reverse-switch all OTC codeine medicines by the country’s Therapeutic Goods Administration (TGA) earlier this month (OTC bulletin, 9 October 2015, page 1), the ASMI said that only a package of “targeted measures” would find the “correct balance” between the risks and benefits of access for the vast majority of consumers who used the medicines “safely and effectively”. In its supplementary submission to the Federal government, the ASMI also argued for the decision on rescheduling OTC codeine to be deferred for 12 months to “allow time for the implementation and impact assessment of a real-time monitoring system in pharmacy”. Steve Scarff, the ASMI’s director of regulatory and scientific affairs, said such a system would help pharmacists to determine if supply of a codeine-containing medicine was appropriate. Furthermore, real-time monitoring would help pharmacists to “identify at-risk consumers, facilitate access to educational material, and support referral to a pain specialist when necessary”, he claimed. “The industry and consumer groups have jointly developed a prototype,” Scarff revealed, “which could be quickly implemented in community pharmacies nationally.” Ideally, this system would form part of a package of measures, he continued, including front-of-pack warnings about the risk of codeine addiction, training for pharmacists and information for consumers. “This conclusion applies equally well to the products intended for treating coughs and colds, and those intended for the treatment of pain,” the agency explained. A final decision on the scheduling of OTC codeine products is set to delivered in “late November 2015”. “The earliest possible implementation for any final decision is from 1 June 2016,” the agency pointed out. “The availability of any OTC products containing codeine will not change before then,” it added. Move codeine to schedule 4 Announcing its review of codeine in April, the TGA said it was inviting comments on its proposal to delete the current schedule 3 – or pharmacist-only – entry for codeine and reschedule the medicine as a schedule 4, or prescription-only, product. The agency noted that it had been prompted to act by “potential issues of morbidity, toxicity and dependence”. Concerns over the safety of codeine have not been limited to Australia, with regulators in Europe and the US recently conducting reviews of the medicine. Cough and cold medicines containing codeine are currently under investigation by the US Food and Drug Administration (FDA) due to the potential for serious side effects – including slowed or difficult breathing – in children aged under 18 years (OTC bulletin, 24 July 2015, page 11). The FDA announced the safety assessment shortly after the European Medicines Agency’s (EMA’s) Coordination Group for Mutual Recognition and Decentralised Procedures – CMDh – supported recommendations by the agency’s Pharmacovigilance Risk Assessment Committee (PRAC) that children and adolescents between 12 and 18 years who had breathing problems should not use codeine as a cough or cold treatment (OTC bulletin, 1 May 2015, page 10). The CMDh also backed the PRAC’s recommendation that codeine should not be used to treat coughs and colds in those aged under 12 years. OTC Call for impact assessment In its submission, the ASMI also called for a “comprehensive examination of the impacts of the scheduling decision in the form of a Regulation Impact Statement”, along with a “reform of the current Scheduling Policy Framework to address its well-documented limitations”. The TGA made its proposal after conducting a review of the scheduling of codeine in Australia – announced in April (OTC bulletin, 17 April 2015, page 12) – and claiming that codeine appeared to be “an unsuitable candidate for OTC availability”. The recommendation was based on an “assessment of many issues”, the regulator said, “including risk of dependence and adverse events, compared to safer products also available OTC”. 23 October 2015 OTC bulletin 9 OTC GENERAL NEWS Regulatory Affairs Foreign traditions challenge HMPC H armonised standards for all traditional medicines sold in the European Union (EU), regardless of origin, are needed “to protect public health”, according to Werner Knöss, chair of the Herbal Medicinal Products Committee (HMPC) of the European Medicines Agency (EMA). Knöss told a recent meeting of the EMA’s management board that traditional medicines of non-European origin were presenting challenges for the HMPC. “Chinese and Indian herbal substances are already a reality in the EU market,” Knöss pointed out. “We need harmonised standards to protect public health and the Committee is working towards this aim.” Commenting on the HMPC’s recent work in this area, Knöss noted that working party discussions had been held during the first half of 2015 on setting European standards for herbal combination products originating from nonEuropean traditional systems – including standards for tea combinations – with these talks expected to continue in the second half of the year. In addition, a meeting of the EU-India joint working group had been held in May, Knöss explained, which had led to an agreement to invite an expert in the field from India to attend an HMPC meeting at the end of 2015 or the beginning of 2016. Earlier this year, Knöss admitted that the rise in popularity of traditional medicines could pose problems, especially around definitions of traditional use and how these products were distributed (OTC bulletin, 12 June 2015, page 11). Addressing delegates at the 51st Annual Meeting of the Association of the European Self-Medication Industry, the AESGP, in Barcelona, Spain, Knöss said that there were many areas to discuss, including the transfer of product indications and access to supporting data. Furthermore, the HMPC had to consider how much these treatments were designed to support self-medication, Knöss explained. “The starting point for using a traditional Chinese medicine (TCM) or an Indian Ayurvedic product is normally a very careful diagnosis by a specialist,” he noted. This was followed by a “very individual prescription”. Despite these questions, the HMPC’s basic position was clear, Knöss pointed out, and that was that these products had to meet the same standards as any herbal medicinal product valid in the EU. OTC 10 Trade Associations PAGB lends its support to NHS winter campaign T he Proprietary Association of Great Britain (PAGB) – the UK OTC industry association – has partnered with National Health Service (NHS) England and Public Health England on a national campaign to educate people on staying healthy this winter. ‘Stay Well This Winter’ was the theme of the campaign, PAGB explained, which would communicate messages on using NHS services appropriately. It would encourage people to visit a pharmacist for winter ailments, and promote the flu vaccination service pharmacies offer. John Smith, PAGB chief executive, said the association was “delighted” to be a partner in the campaign, which would “deliver a clear message to people about self-care and managing winter ailments”. Speaking to OTC bulletin earlier this year, Smith – along with Helen Darracott, his deputy chief executive – revealed that the association’s focus in the three years ahead of its centenary in 2019 would be on ensuring that the British public were receiving a “consistent, single message on self-care” from the UK government down (OTC bulletin, 14 August 2015, page 15). Pointing out that one message “consistently delivered at the national and local level” was more effective than “numerous different” campaigns trying to communicate the same point, Smith said PAGB was not running the ‘Treat Yourself Better’ campaign this year. Launched in 2013 with community pharmacy association Pharmacy Voice, the Treat Yourself Better campaign initially urged people to self-treat winter ailments, rather than using antibiotics prescribed by a doctor (OTC bulletin, 29 November 2013, page 17). This was adapted last year to encourage consumers suffering with colds and flu to “treat yourself better with pharmacist advice” (OTC bulletin, 10 October 2014, page 13). Instead, Smith explained, PAGB had been working with Public Health England to ensure the experience and lessons from Treat Yourself Better had “informed the development” PAGB has partnered with NHS England and Public Health England for the ‘Stay Well This Winter’ campaign PAGB has developed a leaflet that offers advice on common winter ailments as part of the ‘Stay Well This Winter’ campaign in association with NHS England and Public Health England of the Stay Well This Winter campaign. The association had also created a leaflet – entitled ‘When will I feel better?’ – Smith pointed out, to explain how long people could expect cough and cold symptoms, including sore throats and nasal congestion, to last. In addition, the leaflet outlined what consumers could do to feel better, Smith said, as well as highlighting the warning signs that meant they might need to seek professional advice. PAGB member companies would be encouraged to “get behind the campaign and increase its reach”, Smith added, by using the supporting Stay Well This Winter logo in advertising and marketing materials for relevant products. OTC IN BRIEF ■ CASH-BACK COUPONS and on-pack promotions for OTC medicines should be banned by German legislators, according to the country’s pharmacists. Noting the increasing prevalence of such offers, German pharmacists during their Expopharm convention passed a resolution that alleged such promotions trivialised medicines and triggered purchase impulses that “undermine the professional health duties of pharmacists”. OTC OTC bulletin 23 October 2015 GENERAL NEWS OTC Market Research US slow to adopt digital health tech D espite the need for consumer engagement in healthcare having never been higher, nearly half of all Americans have used only one, or have never used any, of the services available across the major consumer digitalhealth categories, according to a new survey from Rock Health. Questioning 4,017 internet-connected adults, the survey covered six main categories of consumer digital health: online health information; online health reviews; mobile health tracking; wearables; genetic services; and telemedicine. Most Americans – 80% – had used at least one of the digital-health categories studied for the survey, the US-based venture capital company pointed out, but 48% of people – dubbed ‘non-adopters’ – had used zero or just one of the technologies listed. At the other end of the spectrum, only 2% of people had used five or six of the technologies and could be referred to as ‘super-adopters’, Rock pointed out. While these figures might initially seem to be low, Rock claimed that the slow rate of adoption and lack of an “iconic company” in the consumer digital-health space represented “one of the largest opportunities” in the digitalhealth arena. Searching online for health information was the most well-adopted digital-health category, the firm noted, with 71% of people using the internet to search for information on prescription drugs, diagnosis, dietary supplement products or treatment options (see Figure 1). Six out of 10 people had searched for information on prescription drugs, the survey found, making it the highest-ranked search category, while just under half had searched for treatment options (see Figure 2). SEARCHED FOR INFORMATION (%) Prescription drugs Information about prescription drugs or side effects Diagnosis 57% A diagnosis based on your symptoms 52% Information about dietary supplements Treatment options Online health reviews Historical use of online or mobile resources to find reviews of healthcare services Mobile health tracking Current use of a mobile health application to track one or more health-related factors Wearables Ownership of wearable devices that help track key health-related factors Genetic services Consumer-driven historical use of genetic-based services including family planning and personal DNA Telemedicine Historical use of video-based technologies to receive medical care or advice from a healthcare professional Figure 1: The top-six categories in the US consumer digital-health space in terms of popularity (Source – Rock Health) The survey also asked whether those that had searched for health information online had presented their findings to their physician, or in the case of supplements had purchased, or discontinued use of, a product. About 40% of people who had searched had taken action, the company noted, with 45% of those who had sought an online diagnosis presenting it to their doctor. Those taking action, represented approximately 15%-20% of the US adult population and could be described as “highly-activated consumers, hungry for information and confident enough to discuss it with their doctors”. However, there was still “significant work to be done by health information websites” to fully convince consumers to trust them, Rock pointed out, as people still ranked health websites, mobile health apps and social-media/online communities behind physicians and family/friends when it came to trustworthiness. 49% Treatment options based on your diagnosis Asked his or her physician to prescribe a specific drug or asked to discontinue taking a specific drug OTC Be active 65% Lose weight Proposed own diagnosis of his or her physician Purchased or discontinued use of a dietary supplement Proposed a treatment to your physician Figure 2: Breakdown of health-related internet searches carried out by US consumers along with a breakdown of the most popular uses of this information for each search (Source – Rock Health) 23 October 2015 OTC bulletin Looking at some of the less well-adopted areas of consumer digital health, Rock’s survey found that of the 12% of respondents who said they had a wearable health device, threequarters had only begun using the product in the past 12 months. Nearly two-thirds of individuals with wearables had purchased them for themselves, the company pointed out, with most citing becoming more active or losing weight as the primary reasons for purchasing wearable digital-health devices (see Figure 3). There was also a shift in who was buying these products, Rock noted. Those that had purchased a wearable in the past three months were more likely to be less healthy than early adopters and were more likely to have been hospitalised in the previous 12 months, the firm said, countering the “popular narrative of only healthy individuals purchasing wearables”. ACTED UPON INFORMATION (%) As a percentage of those who had sought information 60% Supplements Online health information Historical use of online or mobile resources to search for specific health topics 42% As an experiment Improve sleep Social reasons 25% 21% 14% Figure 3: Reasons for consumers purchasing wearable digital-health devices (Source – Rock Health) 11 The Presented by s… Make sure you enter the Awards that Really Matter The OTC Marketing Awards 2016: ◆ OTC Company of the Year Sponsored by IRI ◆ OTC Brand of the Year ◆ OTC Launch of the Year ◆ OTC Brand Revitalisation of the Year Supported by PAGB ◆ Most Innovative New OTC Product ◆ Best OTC Marketing Campaign on a Big Budget Sponsored by Skills in Healthcare ◆ Best OTC Marketing Campaign on a Small Budget ◆ Best OTC Consumer Advertising on Television ◆ Best OTC Consumer Advertising in the Press or Out-of-Home Sponsored by NetDoctor ◆ Best OTC Campaign in Digital & Social Media Sponsored by CIG Healthcare Partnership ◆ Best OTC Public Relations Campaign for a Medicine ◆ Best OTC Public Relations Campaign for a Non-Medicine ◆ Best New OTC Packaging Design ◆ Best OTC Trade Advertising & Support Package Sponsored by Pharmacy Magazine ◆ Best OTC Pharmacy Training Sponsored by Powermed Plus ◆ Best OTC Pharmacy Salesforce ◆ Best OTC Performer Outside Pharmacy Sponsored by IRI ◆ Best OTC Multiple Retailer of the Year Sponsored by Bristol Laboratories Sponsor ed by Gala Dinner & Aw Park Lane Hotel, Piccadilly, Lond In association with ENTRY DEADLINE The deadline for Awards entries is 11th December 2015 Get all of your great ideas, hard work and commercial success recognised by entering the wards Presentation don, Thursday, 10th March 2016 OTC Marketing Awards 2016. Companies of all sizes – from the smallest to the very largest – have the opportunity to win one of OTC bulletin’s prestigious OTC Marketing Awards 2016, recognising the best of the British OTC industry. It’s now time to start preparing your entries. The entry deadline of 11th December 2015 may seem a long way ahead, but you need to start turning your latest campaign into a prestigious Award winner. The winners will be announced at a Gala Dinner & Awards Presentation on Thursday, 10th March 2016 at London’s Park Lane Hotel. Sponsorship packages are available that offer companies a unique opportunity to highlight their commitment to OTC excellence. Suppor ted by Visit OTC-bulletin.com/Awards Or call Natalie Cornwell on 01564 777550 OTC MARKETING NEWS Product Launches Vicks makes its debut in “connected health space” T Italian pharmaceutical firm Angelini has bolstered its Juanola Jalea Real (Royal Jelly) range in Spain with two food-supplement syrups for children. Both royal jelly-based syrups – an option for immune-system support and a variant to stimulate appetites – are suitable for those aged from two years. Juanola Jalea Real Vitalidad Y Defensas combined royal jelly, echinacea, propolis and prebiotics to “reinforce” the body’s natural defences, the firm pointed out, while Juanola Jalea Real Apetito was formulated with royal jelly, propolis, B vitamins and vitamin D, as well as quinine, to stimulate the desire to eat in those with reduced appetites. Angelini noted that the recommended dosage for both syrups was 5ml a day for children aged between two and five years, while this was doubled in those aged over five. The Juanola Jalea Real range also includes Plus, Energy Plus and Defences options. Other products available under the wider Juanola brand umbrella include herbal candies and liquorice-based pastilles, as well as the Propolis range of lozenges, mouth sprays and syrups. OTC he Vicks decongestant brand has entered into the “connected health space” for the first time through the US launch of a SmartTemp wireless smartphone thermometer. Manufactured and distributed under licence from Procter & Gamble (P&G) by Kaz – a subsidiary of US consumer products firm Helen of Troy – the Bluetooth-enabled Vicks SmartTemp thermometer is said to make it easier for parents to “take and track temperature readings for the entire family” when used alongside the Vicks SmartTemp app. The thermometer took “professionally accurate” oral, rectal or under-arm readings in eight seconds, Kaz claimed, which were automatically sent via Bluetooth to the user’s Apple or Android device to help parents “monitor the progress” of their child’s fever. Individualised profiles could be created for each family member to “store their detailed temperature history”, the company noted. Other features of the app included ‘Fever InSight’ guidance – which turned the smartphone screen a different colour depending on the thermometer’s reading – and a symptom tracker, Kaz Readings from the Vicks SmartTemp thermometer are sent to mobile devices via Bluetooth explained, while users could also set up reminders to recall the last temperature reading or medicine dosage. Temperature readings and symptoms could also be exported via email for “simple sharing” with medical professionals, the firm noted. Available nationwide in “major pharmacy and baby retailers” – including Toys R Us – Vicks SmartTemp has a recommended retail price of US$24.99 (C21.99). Helen of Troy also holds the rights to manufacture and market in the US the Vicks VapoPads and VapoSteam products. OTC Marketing Campaigns GSK teams with X Factor in Australia A A giant anthropomorphic smiling strawberry is the bold image that Ipsen has chosen to promote its new strawberry flavour of diarrhoea treatment Smecta. Accompanied by a slogan announcing that “the new strawberry flavour has arrived!”, pharmacy-press advertising for Smecta Fraise also sets out the indications of the diosmectite-based remedy, which can also be used to treat painful symptoms associated with oesophageal-gastric and intestinal diseases. Smecta Fraise is available in 3g packs of 12 powder sachets to be diluted in water before use. Infants under one year of age suffering from diarrhoea should use two sachets per day for three days, followed by one sachet per day. For older children, this should be raised to four sachets per day for three days followed by two sachets, and for adults around three sachets per day. OTC 14 ustralians have the opportunity to win A$300,000 (C190,000) through GlaxoSmithKline’s (GSK’s) sponsorship of television show the X Factor to promote its Panadol Rapid analgesic. To enter the “achieve your dreams faster” competition – which ends on 20 November – consumers should watch the show to discover a nightly code word that appears during the programme, the firm explained. This code word can then either be submitted via the Panadol Australia Facebook page; the official X Factor Australia website; through an Singer and X Factor judge Dannii Minogue is promoting the “achieve your dreams faster” competition on television and through social media online smartphone page; or by text message. Eight winners would receive a A$500 ‘Wish’ gift card for the retail group Woolworths, as well as an entry into the grand prize draw. For extra chances to win, GSK noted, potential entrants could purchase from Woolworths a pack of Panadol Rapid, which combines 500mg paracetamol with sodium bicarbonate per caplet, and is claimed to be absorbed twice as fast as regular Panadol tablets. By entering the code on the pack – along with the last two digits of the Woolworths purchase number – via text or online, entrants have the opportunity to win one of 100 ‘Wish’ gift cards worth A$1,000. One winner would also be entered into the grand prize draw. Television advertisements featuring singer and X Factor judge Dannii Minogue were currently running exclusively on Channel 7 – which airs the X Factor show – to promote the competition, GSK pointed out. OTC OTC bulletin 23 October 2015 MARKETING NEWS OTC Product Launches Product Launches Luminarie set to Sanofi promotes Doliprane launch PoxClin for French self-medication L S uminarie is set to enter the A$13 million (C8.2 million) Australian OTC anti-itch market with the PoxClin Sensitive duo product for chicken pox in children. Scheduled for launch on 1 November, PoxClin Sensitive combined the original CoolMousse – which is already available in markets including Spain, Russia and the UK – with a gel for use on more sensitive areas such as the face, the Australian firm explained. A class 1 medical device, PoxClin sensitive is said to provide “rapid relief” from symptoms such as irritation, itching and sensitivity by cooling, soothing and moisturising the skin. The CoolMousse’s ‘2QR complex’ – a “patented bacterial blocker” derived from the aloe barbadensis plant – is also said to prevent secondary infection and scarring on scratched skin. The mousse should be applied three times daily or whenever relief was needed, Luminarie said. One drop of gel should be applied to a sensitive area once the mousse had evaporated, the firm added, to provide further relief. Luminarie said it would spend A$50,000 over the next 12 months to promote PoxClin Sensitive, with marketing activity scheduled to begin in November. “Because itching is not fun” would be the tagline of the campaign, the company pointed out, which would include a collaboration with online parenting community bubhub.com.au. This partnership would encompass blogs and posts on the Bubhub Facebook page and inclusion in newsletters to Bubhub members. PoxClin Sensitive would also be promoted in pharmacy catalogues and through consumer brochures at the point of sale, Luminarie noted, as well as through the brand website, poxclin.com.au, and communications to schools and day-care centres. Luminarie told OTC bulletin it aimed to sell 40,000 units within the first year of PoxClin Sensitive’s launch, equating to turnover of around A$500,000. The firm obtained the marketing and distribution rights to the PoxClin brand in Australia and New Zealand in May this year from Netherlands-based YouMedical, which itself was recently acquired by Swedish OTC firm Trimb (OTC bulletin, 11 September 2015, page 4). PoxClin Sensitive would be available in New Zealand from the first quarter of 2016, Luminarie revealed. OTC 23 October 2015 OTC bulletin anofi’s Doliprane paracetamol-based pain remedies have been launched in France as a non-reimbursable range of self-medication treatments. The non-reimbursable line would “complement the existing reimbursable range”, Sanofi noted, adding that the reimbursable Doliprane range was more geared towards sufferers of chronic pain requiring long-term treatment. Comprising eight presentations of Doliprane, Sanofi’s non-reimbursable self-medication line includes 1g and 500mg tablets and 500mg orodispersible tablets, as well as tablets including 500mg paracetamol with 150mg vitamin C and paracetamol/codeine 400mg/20mg tablets. The range also includes 1g capsules, along with sachets of 200mg and 300mg sugar-free oral suspension under the Doliprane Liquiz name. Retail prices including tax for these presentations are C1.94 for 16-tablet packs of the 500mg tablets and for eight-count packs of the 1g tablets or 1g capsules; C2.45 for 12 orodispersible tablets or 16 tablets with vitamin C; C3.45 for the oral suspensions; and C3.95 for the tablets that include codeine. Five of the eight presentations – all except the oral suspensions and tablets containing codeine – are available for self-selection through France’s ‘free access’ scheme (OTC bulletin, 31 July 2008, page 17). Insisting that the presentations were “adapted to patients’ needs”, Sanofi said the liquid sachets were easily portable while the film- Sanofi’s non-reimbursable Doliprane range includes a liquid suspension and 1g capsules coated tablets helped to “reduce the bitterness” of paracetamol. “Self-medication is the first step for patients in taking care of pain,” the French company stated. Isabelle Van Rycke, director of Sanofi Consumer Healthcare in France, said the new range “responds to the desire of patients to become more active in managing their own health”. While the introduction reinforced “Sanofi’s support for responsible self-medication”, she insisted, the company was still committed to helping doctors treat chronic pain through its reimbursable range. Emphasising that patient safety was the “number-one priority for Sanofi”, the company said it was issuing guidance aimed at the general public to inform them of the correct use of paracetamol for pain management, including a brochure to be distributed through pharmacies and a dedicated website. OTC Marketing Campaigns Hypermarcas enlists chef for Vitasay push C elebrity chef Olivier Anquier is the star of Brazilian firm Hypermarcas’ latest domestic television campaign for its Vitasay Stress multivitamin supplement. The 30-second spot showed Anquier travelling the world in search of ingredients for his dishes, Hypermarcas said, to highlight that “even enjoyable activities can lead to physical and emotional exhaustion that needs to be treated”. Targeted at consumers aged over 30 years, the spot signed off with the message: “Vitasay, sua dose diária de vitalidade”, or “vitasay, your daily dose of vitality,” the firm pointed out. The television campaign would run until the end of November 2016, Hypermarcas noted. It would be supported by online content on Facebook and Instagram from next month, the company added. There would also be print advertisements in “major magazines”, the firm said, as well as radio jingles and out-of-home advertising. Meanwhile, Hypermarcas has created a social-media presence for its Doril acetylsalicylic acid-based analgesic brand with the launch of a DorilOficial page on Twitter. The company said it had “identified an opportunity” to “reinforce the brand’s presence” with a more light-hearted and relaxed approach and language. OTC 15 OTC MARKETING NEWS Product Launches Sanofi launches DioraleZe caps S anofi is leveraging the strength of its Dioralyte rehydration brand in the UK with DioraleZe capsules, the local firm’s first antidiarrhoeal medication. Containing 2mg loperamide hydrochloride per capsule, the product is said to stop the symptoms of diarrhoea in one dose. The general-sale list (GSL) capsules will take on established brands in the UK market such as McNeil’s Imodium, Reckitt Benckiser’s (RB’s) Diocalm and Galpharm’s Entrocalm. Suitable for those aged 12 years, DioraleZe joins the existing Dioralyte and Dioralyte Relief rehydration powders, along with the Oralyte hydration drink. The capsules could be taken with the standard Dioralyte sachets to aid a faster recovery time, Sanofi pointed out. A consumer media and digital advertising campaign would begin in 2016 to back the launch of DioraleZe, the firm revealed. In the meantime, the capsules were being Sanofi is promoting DioraleZe alongside its Dioralyte rehydration powders at the point of sale supported through “detailing to healthcare professionals” and “strong” public-relations activity, Sanofi explained, as well as point-of-sale materials that promoted both DioraleZe and Dioralyte together. The main message to consumers was that they could “stop diarrhoea with DioraleZe and rehydrate with Dioralyte”, the company said. In addition, a brand website, dioraleze.co.uk, had been launched, Sanofi noted, which also featured the Dioralyte range. DioraleZe has a recommended retail price of £3.49 (C4.74) for a pack of six capsules. OTC IN BRIEF ■ POHL-BOSKAMP has extended its sponsorship of German football team FC St Pauli to include promotion for its GeloRevoice Halstabletten medical device lozenges. OTC 16 Product Launches Infirst Healthcare prepares to launch UniCough in UK I nfirst Healthcare is set to make its debut in the European consumer healthcare space next month with the UK launch of its UniCough chocolate-flavoured cough liquid. Scheduled for launch in Boots and independent pharmacies, the pharmacy-only (P), “cocoarich” oral solution contains 135mg ammonium chloride, 14mg diphenhydramine hydrochloride and 1.1mg levomenthol per 5ml. Indicated for the symptomatic relief of common coughs associated with upper respiratory tract congestion, UniCough’s “unique” cocoa formulation formed a “soothing film over the mucous membrane” in the buccal cavity and throat, noted Manfred Scheske, the firm’s chief executive officer, adding that it could help prevent sleep disruption. UniCough was a “special product” in the crowded UK cough and cold market, Scheske pointed out, as it had been clinically proven to reduce cough frequency “versus an active comparator product”. Claiming that there was a general lack of evidence regarding consumer cough and cold products, Scheske said the firm – which has recently received £13.2 million (C11.6 million) in funding from Invesco Asset Management – was “spending way more money upfront” on “intense development and regulatory work” than anybody else to create products backed by clinical evidence. Although Scheske would not comment on marketing plans for UniCough, he said Infirst had worked “very hard” on developing a “superior product” and would be “very focused” on making sure that both pharmacists and consumers were aware of the supporting evidence. Also launching ibuprofen capsules Scheske added that the UK would also be the first market to see the launch of the firm’s Flarin 200mg ibuprofen soft-gel capsules, following the results of a clinical trial. Like UniCough, Flarin had been derived from Infirst’s “portfolio of patented technologies”, Scheske noted. Formulated in the company’s patent-protected “lipid excipient matrix”, Flarin – also a P product – was expected to be introduced “in the first half of 2016”, he pointed out, and would be positioned for the relief of rheumatic or muscular pain, as well as pain caused by “nonserious arthritic conditions”. UniCough’s cocoa-rich formulation is said to be clinically proven to reduce cough frequency The firm’s focus on science-backed offerings would set the company apart from its competitors, Scheske maintained, although he said Infirst was “focusing more on execution than from whom we’ll be taking market share”. “We cannot compete with the big players in terms of budgets or shelf space – nor do we intend to,” Scheske insisted. “We need to make sure that we operate in smaller markets and with products that are actually backed by evidence.” Infirst had started “regulatory and geographical expansion into Europe” for Flarin, he noted, pointing out that it already had licences in Scandinavian markets and Holland. The UK was a “prototype” of sorts, Scheske said. “We want to make sure that we get the first market right and then apply the model in other countries.” Turning to the US – where Infirst made its global debut last year with the Dr Cocoa chocolate-flavoured cough-remedy brand for children (OTC bulletin, 15 August 2014, page 19) – Scheske said the company’s reinvigoration of Johnson & Johnson’s digestive-health brands Mylanta and Mylicon was also underway. Infirst agreed a fixed-term licensing deal earlier this year for Mylanta and Mylicon, which had been absent from the market while Johnson & Johnson dealt with a number of manufacturing issues which led to the bulk of its US OTC portfolio being withdrawn (OTC bulletin, 20 March 2015, page 3; OTC bulletin, 17 March 2011, page 1). Mylicon had returned to shelves in July, Scheske noted, while the Mylanta liquid antacid was set to be relaunched in early 2016. Both brands were “extremely well known” and still had “quite strong residual awareness, loyal followers and lots of professional endorsement”, Scheske insisted. OTC OTC bulletin 23 October 2015 MARKETING NEWS OTC Product Launches Covonia grows with hot dose variant A cough and cold syrup positioned to be taken hot at night is the latest addition to Thornton & Ross’ Covonia cough-remedy brand in the UK. Containing 20mg dextromethorphan hydrobromide and 30mg diphenhydramine hydrochloride per 15ml, Covonia Hot Dose Cough & Cold Syrup is said by the company to provide “night-time relief for troublesome dry cough and congestion from colds” in consumers aged over 12 years. Noting that a Night Time formula with the same active ingredients was already available under the Covonia brand umbrella, Thornton & Ross said the new pharmacy-only (P) Hot Dose option was intended to be mixed with 15ml hot water, rather than taken as a syrup alone, to provide the “warm comfort that some consumers desire”. Covonia Hot Dose Cough & Cold’s syrup format meant the product fully dissolved when mixed with hot water, the firm added, rather than leaving “unpleasant granules” at the bottom of the cup, which could “sometimes happen with powder sachets”. The 30ml dose should be consumed “within 10 minutes for the full effect” and could be repeated after six hours if required, pointed out Thornton & Ross, which was acquired by Germany’s Stada in 2013 (OTC bulletin, 23 August 2013, page 1). Covonia Hot Dose Cough & Cold would be supported as part of an overall marketing campaign for the brand worth over £4 million (C5.4 million), the firm said. This would feature “elements of the entire Covonia range”. The range comprises a range of syrups, as well as lozenges and a throat spray. Marketing activity would include a national television commercial that would air from November, Thornton & Ross pointed out, as well as online advertising. This would include the CovoniaUK Facebook page and brand website feelitworking.com. Public-relations activity would place a “big Thornton & Ross says 15ml of Covonia Hot Dose Cough & Cold Syrup should be mixed with 15ml of hot water focus” on the Hot Dose line extension, which would be supported further through “ongoing outreach with health and lifestyle publications”, the company added. Covonia Hot Dose Cough & Cold has a recommended retail price of £5.49 for 150ml. OTC Make sure your colleagues are as well informed as you Make sure your fellow directors and executives get the latest consumer healthcare news and exclusive insights from OTC bulletin. Empower them to make informed decisions and take decisive actions to keep your business ahead of its competitors. Make sure your company has a Corporate Subscription. Business benefits ❖ OTC bulletin is available ❖ A clear nose in less than three minutes is the promise behind GlaxoSmithKline (GSK) Consumer Healthcare’s latest extension to its Otriven nasal-spray range in Germany. Otriven Meerwasser mit Eukalyptus is said to contain “100% pure sea water” from the French Atlantic coast that includes minerals and trace elements as well as eucalyptus for a fresh fragrance. GSK says the spray has a “natural decongestant” effect through its 2.2% salt content and helps to remove excess mucus from the nose. A 20ml bottle of Otriven Meerwasser mit Eukalyptus has a recommended retail price of C6.25. ❖ ❖ ❖ ❖ electronically worldwide to all company executives Keeps your business up-to-date with industry news and exclusive insights A fully-searchable archive offers in-house research facilities Flexible formats – desktop, mobile and print options available Flexible access – online or via company intranet Modest cost – available for a fraction of the price of multiple, individual subscriptions Executives in the world’s leading OTC companies are already benefitting from a corporate subscription to OTC bulletin. ContactVal Davis, Subscriptions Director, at [email protected] or telephone +44 (0) 1564 777 550 OTC 23 October 2015 OTC bulletin 17 OTC MARKETING NEWS Line Extensions Dolormin capsules aim to relieve pains in the neck A “Still got it! Perfect!” is the strapline of Merck KGaA’s UK print campaign for its recently-expanded Perfect 7 anti-ageing supplement range. Featuring two glamorous older women taking a photo of themselves, the advertisement includes the original Perfect 7 product and recently-launched Prime variants. The campaign was running in women’s monthly consumer magazines such as InStyle, Good Housekeeping, and Prima, the firm pointed out, as well as in weekend supplements of newspapers, such as Guardian Weekend, Stella and You. Pointing out that the original Perfect 7 – launched last year (OTC bulletin, 24 October 2014, page 20) – had been created for men and women to tackle the first signs of ageing and catered for their different needs as they got older, the company said Perfect 7 Prime addressed a “key need” of “mature” consumers, which was an improvement in mental cognitive function. The range – which also comprises separate gender-specific formulas – did this, Merck claimed, by combining natural-source marine oil with omega-3 and ginkgo biloba, as well as zinc, in a one-a-day capsule. Both Prime products also contain folic acid for energy and vitamin B12. The variant for men contains selenium for immunity, and the version for females is formulated with iodine to “help maintain normal skin”. Pointing out that the Prime variants were available exclusively in Boots until March 2016, Merck said the differences between the two Perfect 7 ranges would be highlighted in store. OTC rock singer who is determined to continue the show despite a sore neck is the star of a launch television campaign for Dolormin 400mg Weichkapseln soft-gel capsules, the latest addition to Johnson & Johnson’s ibuprofenbased analgesic brand in Germany. Launch trade-press advertising depicts the rock star grimacing above a banner that proclaims the liquid-filled capsules, each containing 400mg of ibuprofen, are a new treatment for muscle pain that ensures “the show goes on”. Johnson & Johnson claims the line extension is Germany’s “first ibuprofen soft-gel capsules for muscle pain”. The company says the analgesic offers relief from muscle pain such as stiff necks for up to eight hours. The pharmacy-only medicine’s liquid formulation, Johnson & Johnson states, “allows absorption into the body twice as quickly as classic ibuprofen”. A dolormin.de website includes a video of exercises to alleviate aching necks and shoulders, in addition to advice leaflets to download. Johnson & Johnson is also providing pharmacy staff with online product training. OTC 18 Predominantly green and white, Dolormin 400mg Weichkapseln packs carry a strapline stating that the medicine is for both headaches and muscle pain. The medicine is indicated for adults and children weighing over 40kg or older than 12 years. A pack of 10 Dolormin soft-gel capsules has a recommended retail price of C6.19. Johnson & Johnson – which is using Patheon Softgels in the Netherlands as a contract manufacturer – also holds marketing authorisations for the liquid-filled capsules in Austria, Belgium and the UK. OTC Line Extensions Pregnacare Liquid is said to be UK’s first U Laboratorios Heel – the Spanish arm of German homoeopathic firm Biologische Heilmittel Heel – claims to have bridged “the therapeutic gap between corticosteroids and emollients” with its Dermaveel cream for atopic dermatitis. Comprising a “unique combination” of ingredients – including ectoin, jojoba seed oil, panthenol and butyrospermum parkii butter (shea butter) – the steroidfree medical device was indicated to relieve symptoms of mild-to-moderate forms of the condition, the firm pointed out, such as itching, swelling and dry skin. The cream – which is suitable for use on children – is said by Heel to reduce inflammation and protect skin cells against dehydration, as well as strengthening and maintaining the skin’s “barrier functions”. Dermaveel should be applied twice daily to the affected areas, the firm advises, or as often as needed. Dolormin 400mg Weichkapseln is said to be Germany’s first ibuprofen soft-gel capsule line for muscle pain K supplements firm Vitabiotics claims its Pregnacare Liquid is the first-ever liquid multivitamin supplement for pregnant women in its domestic market. Pointing out that some women experienced greater sensitivity to taste and swallowing when pregnant, the company said the orange-flavoured liquid had been created for those who might have difficulty in swallowing tablets, or simply preferred an alternative format. Containing 18 vitamins and minerals, Pregnacare Liquid provided “a comprehensive formula for during pregnancy”, Vitabiotics noted. The product provided folic acid and vitamin D at the levels recommended by the UK Department of Health (DoH) – 400µg and 10µg respectively – the firm pointed out, as well as vitamin B12, iron and zinc, in a format that was “gentle on the stomach”. Vitabiotics said the liquid variant would feature as part of an ongoing marketing campaign for Pregnacare. Marketing activity included press advertising in publications such as Mother&Baby, OK and Prima, the firm noted, as well as digital promotion on websites such as Babycentre and Bounty. Outdoor advertising would also feature, Vitabiotics pointed out, while a television commercial would air from November. Featuring the Pregnacare Conception, Original and Breastfeeding supplements, the 30-second creative – which aired last year as the first ever television campaign for the brand (OTC bulletin, 9 May 2014, page 17) – showed the path of a couple’s pregnancy journey, from trying for a baby, during pregnancy, to seeing their child take its first steps, the firm explained, highlighting that Pregnacare supported mothers “every step of the way”. A 200ml bottle of Pregnacare Liquid has a recommended retail price of £7.95 (C10.72). The company revealed that it planned to launch the product into overseas markets. OTC OTC bulletin 23 October 2015 EVENTS OTC NOVEMBER 10-12 November ■ ■ An Introduction to the Medical Devices Directives ities of the European Medicines Agency (EMA) and national agencies that work within the European regulatory system is being run by The Organisation for Professionals in Regulatory Affairs (TOPRA). Contact: TOPRA. Tel: +44 20 7510 2560. Email: [email protected]. Website: topra.org. 11 November ASMI Annual Conference Sydney, Australia A one-day conference organised by the Australian Self-Medication Industry (ASMI). Contact: ASMI. Tel: +61 2 9922 5111. Fax: +61 2 9959 3693. Email: [email protected]. Website: asmi.com.au/events/. European Consumer Healthcare Strategy Forum: Pricing Excellence 2.0 Frankfurt, Germany ‘Taking pricing to the next level for consumer healthcare companies’ is the theme of this one-day event, which will highlight key trends and challenges in the consumer healthcare industry, provide an insight into trade spend optimisation and cover the best practices of leading consumer healthcare and fast-moving consumer-goods (FMCG) firms. Contact: Simon Kucher & Partners. Tel: +49 89 544793 10. Fax: +49 89 544793 50. Email: [email protected]. Website: simon-kucher.com/ consumerhealthforum. Regulatory Compliance and GMP Compliance Frankfurt, Germany Regulatory affairs will be discussed at this one-day seminar. Contact: Forum Institut für Management. Tel: +49 6221 500 680. Fax: +49 6221 500 555. Email: [email protected]. Website: forum-institut.com. 19-20 November ■ EMA Review of the Year London, UK This two-day review of the activ- 23 October 2015 OTC bulletin 1 December ■ Advertising Medicinal Products Bonn, Germany A one-day seminar focusing on advertising medicinal products, run by Germany’s medicines manufacturers’ association, the BAH, and conducted in German. Contact: BAH. Tel: +49 228 95745 0. Fax: +49 228 95745 90. Email: [email protected]. Website: bah-bonn.de. Ukrainian Pharmaceutical Forum Kiev, Ukraine Speakers from GlaxoSmithKline, Pfizer, Sanofi Aventis and Takeda will attend this two-day event. Contact: Adam Smith Conferences. Tel: +44 20 3377 3182. Fax: +44 20 7017 7447. Email: nataliapr@adamsmith conferences.com. Website: ukrainianpharma.com. 13 November ■ DECEMBER 24-25 November ■ Pharmaceutical Regulatory Affairs in China 1-2 December ■ Regulatory Affairs in Latin America London, UK A two-day workshop that can be tailored for your company and delivered in-house. Contact: Pharmaceutical Training International (PTI). Tel: +44 20 7017 7481. 15-16 February ■ AESGP Conference Amsterdam, Holland This two-day conference is being organised by the Association of the European Self-Medication Industry, the AESGP with the EU Heads of Medicines Agencies (HMA) during the Dutch Presidency. Contact: AESGP. Tel: +32 2 735 51 30. Fax: +32 2 735 52 22. Email: [email protected]. Website: aesgp.eu/events/Amsterdam2016/. Pharmacovigilance London, UK A three-day course discussing drug safety monitoring in the European Union (EU), Japan and the US. Contact: Management Forum. Tel: +44 1483 730071. Email: [email protected]. Website: management-forum.co.uk. 8-11 December ■ Basel, Switzerland Regulatory requirements in countries such as China, Hong Kong, Macau and Taiwan will be covered at this two-day conference. Contact: Management Forum. Tel: +44 1483 730071. Email: [email protected]. Website: management-forum.co.uk. EuroPLX 59 Athens, Greece This two-day meeting will provide a forum for business development decision makers for discussing and negotiating collaborative agreements in licensing, marketing, and distribution of patented medicines, generics, biosimilars, OTC products, medical devices and food supplements. Contact: RauCon. Tel: +49 6221 426 2960. Fax: +49 6222 9807 77. Email: [email protected]. Website: europlx.com. 7-9 December ■ 26-27 November ■ 23-24 November ■ 12 November ■ 10th Ceuta International Alliance conference Istanbul, Turkey Delivering a solution to your international market management support or expansion plans. This unique event brings together leading health and beauty, OTC and diagnostic manufacturers, key industry opinion leaders, retailers and outsource solution distributors from over 100 global markets, giving delegates an opportunity to meet like-minded people. Contact: Ceuta Healthcare. Tel: +44 1202 449 709. Email: [email protected]. Website: ceutahealthcare.com. London, UK This three-day seminar will discuss the European medical device legislation and give advice on how to apply for a CE mark. Contact: Management Forum. Tel: +44 1483 730071. Email: [email protected]. Website: management-forum.co.uk. ■ Fax: +44 20 7017 7823. Email: [email protected]. Website: pti-global.co.uk/latin. 3-5 November GDP and GMP Symposium London, UK Day one of this two-day meeting – organised by the UK Medicines and Healthcare products Regulatory Agency (MHRA) – will cover good distribution practice (GDP), while day two will look at good manufacturing practice (GMP). The two days will then be repeated. Contact: Glasgows. Tel: +44 1772 767 715. Email: [email protected]. Website: mhragmdp.co.uk. JANUARY 2016 20-21 January ■ Social Media in the Pharmaceutical Industry London, UK Pharmacovigilance, digital marketing and social-media trends will be examined at this two-day seminar. Contact: SMi Group. Tel: +44 20 7827 6000. Fax: +44 20 7827 6001. Email: [email protected]. Website: smi-online.co.uk. MARCH 3-4 March ■ Business Development and Innovation Opportunities in Consumer Healthcare/OTC London, UK This two-day conference and networking event will include sessions on ‘The Future of OTC Medicines – Consumer Healthcare in a Changing Environment’ and ‘Business Development Deal Trends’. Contact: Pharmaceutical Licensing Group (PLG). Tel: +44 1737 356 391. Fax: +44 1737 379 802. Email: [email protected]. Website: plg-group.com/events/ bdconsumerhealthcareotc/. 19 OTC DISTRIBUTION Pharmacy needs to adapt to flourish Driven by consolidation and regulatory shifts, pharmacy across Europe is having to adapt to new supply-chain structures as well as increasing competition from non-pharmacy channels. Matt Stewart reports. T he European pharmacy sector is facing twin challenges: a consumer healthcare industry undergoing a period of consolidation that is globalising supply networks; and greater non-prescription segment deregulation that is opening up the market to non-pharmacy channels, according to a new report published by James Dudley Management. OTC strategist James Dudley told OTC bulletin that these trends had led to a “clear drift” by independent pharmacies across Europe towards virtual pharmacy chains. Meanwhile, major retail pharmacy players were developing multi-channel offerings spanning wholly-owned outlets, affiliates, franchises and the internet. The growth of virtual pharmacy chains was to be expected, he claimed. These collectives gave independent pharmacies access to the procurement and marketing services they needed to stay competitive in a globalised environment, while maintaining their independence. According to the Dudley report, only 10% of the 145,143 pharmacies in the 20 countries studied are part of chains comprising more than 50 pharmacies. The vast majority – 85% – are independent pharmacies that are owner-managed businesses (see Figure 1). There are approximately 14,514 pharmacies in wholly-owned chains across the 20 countries Company/brands studied, notes the report, and around a further 4,354 in chains of between five and 50 stores. Only a limited number of countries in Europe – including Belgium, the Czech Republic, Ireland, the Netherlands, Norway, Poland, Romania, Slovakia, Sweden, Switzerland and the UK – allow companies to own significant chains. In Poland, the law restricts the number of pharmacies that one owner can have to just 1% of the total number of pharmacies in a province, the report points out, but this law has been ignored by a few chains. However, since the start of 2015, the authorities in Poland have started cracking down on the offending firms, it says, with some chains being refused new licences in some provinces. Some countries restrict ownership of pharmacies to pharmacists, and some allow pharmacists themselves to own chains but restrict the size to two, three or four branches. Norway and the UK have the highest proportion of their pharmacies in wholly-owned chains, the Dudley report points out, at 86.0% and 78.6% respectively (see Figure 2). Commenting on virtual pharmacy chains, the Dudley report points out that there has been a “phenomenal” growth in these voluntary groupings of pharmacies and concludes that virtual chains will expand across the whole con- Number of wholly-owned pharmacies OTC market strategist James Dudley says Europe’s pharmacy sector is facing challenges from consolidation and new channels tinent by the end of the decade. Around 53,900 pharmacies in the 20 countries – over a third of the total – are affiliated in some way, says the study. Although significant pharmacy chains are not permitted in France and Germany, observes the Dudley report, the majority of pharmacies in these countries do participate in virtual chains (see Figure 3). According to the Dudley report, the three largest pharmacy chains in Europe are owned by Walgreens Boots Alliance, Celesio and Phoenix (see Figure 4). Together, these three companies have direct ownership of a large proportion of pharma- Territories and affiliates Country of origin US Walgreens Boots Alliance 2,843 Ireland, Lithuania, the Netherlands, Norway, and the UK Affiliated partner pharmacies in Czech Republic, France, Germany, Italy, the Netherlands, Russia, Spain and the UK Celesio/Lloyds 2,184 Belgium, Germany, Ireland, Italy, Norway, the UK, plus a joint venture in the Netherlands Affiliated partner pharmacies in France, Germany and Norway Phoenix/Rowlands/ Benu/Apteka 1 1,646 Baltic States, Hungary, Italy, Norway, Poland, Serbia, the UK and investments in Austria Affiliated partner pharmacies in France, Hungary, Italy, Norway, the UK and a pharmacy management concept in Germany Germany Penta/Dr Max 850 Czech Republic, Poland and Slovakia Czech Republic/ Slovakia Bestway Group/ Well Pharmacy 779 UK UK Doz/ Dbam o Zdrowie – I Care for My Health 600 Baltic States, Poland and the UK Affiliated partner pharmacies include 320 franchise outlets and 87 partner pharmacies Netherlands Fildes/Catena 500 Romania Romania Figure 4: Europe’s leading retail pharmacy chains as they currently stand (Source – James Dudley Management) 20 OTC bulletin 23 October 2015 DISTRIBUTION OTC StateMinor chains owned (5-50 branches) 2% Co-ops 3% <1% Major chains (>50 branches) 10% 13.3 Total Norway 86.0 UK 78.6 Sweden 56.6 Switzerland 31.6 24.3 Netherlands 23.2 Slovakia Romania 21.7 Czech Republic 19.2 10.9 Poland Affiliated independents 36% Unaffiliated independents 49% Figure 1: Pharmacies in 20 European countries by ownership (Source – James Dudley Management) cies in major chains, the report notes, as well as having a hand in 33% of all pharmacies affiliated to virtual pharmacy chains. This embrace of virtual pharmacy chains by Europe’s three key pharmacy players reflects the “growing determination among more progressive companies to develop large groupings of pharmacies as multi-channel brands”, the Dudley report points out. “A few innovators in this space have gone even further by creating mixed ownership entities,” the report adds, “made up of wholly-owned pharmacies, affiliated independent pharmacies and, increasingly, franchise outlets.” “While these groups can exploit economies of scale to strengthen their competitiveness in terms of procurement, pharmacy management, efficiencies and marketing,” the Dudley report claims, “there are tremendous advantages from building a strong retail brand across all types of outlets.” However, while building strong multi-channel networks allows the major chains to improve margins, this will be achieved against decreasing sales values, the Dudley report says, unless all European pharmacy players pay more attention to non-prescription products. The current average turnover of a pharmacy in Europe is approximately C944,000, the report notes, down by 9% since 2012. At the root of the decline in average turnover is the dependence pharmacies have on social funding, the Dudley report says, noting that 73% of turnover on average across the countries studied is derived from prescription-only medicines and other social health services, funded primarily by statutory healthcare providers. As a consequence, such products and services are generally price-regulated and subject to price and margin controls, the report adds, and there is a “distinct trend” for fund holders to drive down prices and fees across the 20 countries studied. Pharmacies sell a wide range of non-medicinal lines other than prescription and OTC medi23 October 2015 OTC bulletin 9.4 Belgium 8.8 Bulgaria Hungary Finland Italy 7.0 2.1 1.2 0 20 40 60 Share of pharmacies (%) 8 0 100 Figure 2: Proportion of pharmacies in wholly-owned retail chains (Source – James Dudley Management) 35.7 Total 20 countries* 95.0 Denmark 85.0 Germany 78.3 Netherlands 71.0 Slovakia France 68.0 Finland 47.0 Switzerland 40.0 36.0 Bulgaria Czech Republic UK 30.0 Hungary Italy Sweden Belgium Spain 0 35.0 23.0 20.0 Poland Norway 59.4 3.3 12.3 12.0 10.2 20 40 60 Share of pharmacies (%) 8 0 100 * Total includes countries not included in this chart Figure 3: Proportion of pharmacies in virtual retail chains (Source – James Dudley Management) cines, the report points out, including nutritional and baby products, health-related and premium personal-care items, cosmetics, nursing aids, hygiene products and medical devices. Together these represent 16% of the turnover of an average pharmacy in Europe, the report adds, but as attractive as these lines are in terms of prices and margins, pharmacy has no monopoly on them and has to compete with mass-market channels in these categories. However, consumer purchases of OTC medicines represent only 11% of sales turnover of the average pharmacy, the Dudley report reveals, “despite the fact that the pharmacy is the natural channel for consumer healthcare”. “It is in the interests of both pharmacies and suppliers further to develop OTC medicines in pharmacy in most European countries, especially those in Northern Europe,” the report insists. While acknowledging that there is competition in the OTC medicines space in a number of markets from non-pharmacy channels and the internet, the report points out that 85% of the licensed consumer healthcare products in the 20 countries under study are delivered through pharmacies. Furthermore, there are categories within the non-prescription market which will remain exclusively in the pharmacy, due to the regulatory status of the products, it adds. OTC medicines provide pharmacies with a big opportunity to shield themselves against price and margin cuts to prescription products, the report notes, but pharmacy needs to address the category properly, or as deregulation opens up the category to non-pharmacy competitors, it could lose out. OTC 21 All that’s happening in generics and biosimilars Written by generics specialists from a generics industry perspective The best decision-makers in the generics industry don’t have the time to go looking for good information. They let it come to them. They subscribe to Generics bulletin. Join thousands of subscribers from competitor companies in nearly 60 countries who are already benefitting from commercial intelligence about business opportunities in the global generic medicines and biosimilars markets. 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VAT No: GB 608 0432 69 PEOPLE OTC Manufacturers BioGaia appoints managing director S wedish probiotics specialist BioGaia has named Axel Sjöblad as its managing director. He replaces Peter Rothschild, who has been promoted to group president. Sjöblad will join BioGaia on 1 March 2016 from Getinge Sverige, where he currently serves as managing director and vice-president of the sterilisation company’s North and Central Europe region. He has also held a number of roles within medical technology company Gambro, which is now part of Baxter International. BioGaia said Sjöblad had “extensive experience of, and a track record in, the healthcare and life sciences area” and that he was “ideally suited to take over management of the company’s operations, initially with a special focus on marketing and sales”. Meanwhile, Rothschild’s new role would see him retain overall responsibility for BioAxel Sjöblad Gaia’s research and development activities, the firm noted, and remain chairman of the company’s CapAble, IBT and TwoPac subsidiaries. In addition, Rothschild would support the development of BioGaia’s Japanese division, the company pointed out, and remain as the chairman of scientific research company MetaboGen, in which BioGaia invested last year (OTC bulletin, 12 December 2014, page 4). BioGaia said the organisational change would enable the company to “reinforce its sales capabilities and geographic expansion”. The firm would also be able to “increase the focus on its subsidiaries and associated companies”, it noted, as well as to realise its “major development potential”. OTC IN BRIEF ■ GENERINOBEL – the German drug development firm – has recruited Dr Wolfgang Bäurle as its managing director. OTC 23 October 2015 OTC bulletin Manufacturers Oschmann to replace Kley as head of Merck in 2016 S tefan Oschmann will assume the role of Merck KGaA’s chief executive officer and chairman of the executive board on 29 April 2016, the company has announced. Currently deputy chairman of the German firm’s board – and deputy chief executive officer – Oschmann will replace Karl-Ludwig Kley, who will retire after nine years at the helm. A member of Merck’s executive board since 2011, Oschmann is also president of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and vicepresident of the European Federation of Pharmaceutical Industries and Associations (EFPIA). Johannes Baillou, chairman of the board of partners at Merck, said Oschmann’s strategic foresight and strong leadership had turned Merck back into “a respected player in the pharmaceutical industry”. Commenting on Kley’s departure, Baillou pointed out that Merck had gone through the “biggest transformation in its almost 350-year history” under Kley’s leadership. This included “building and expanding no fewer than three strong global businesses” – healthcare, life sciences and performance materials – he noted. Kley has also recently overseen a “complete overhaul” of Merck’s brand identity, including a new company logo. As part of the firm’s “Fit for 2018” efficiency programme, Merck said it had undertaken a Merck KGaA said its new logo reflected its position as a “global science and technology company” Stefan Oschmann “fundamental revision” of its “visual appearance” and introduced a logo which reflected its “transformation” from a “classic supplier of pharmaceuticals and chemicals” into a “global science and technology company”. Furthermore, the previously independent Merck Serono and Merck Millipore brands had been “eliminated” as part of the rebranding exercise, the company noted. Going forward, Merck Serono would operate as the biopharmaceutical division of Merck, the firm noted, while the Millipore division would be incorporated into the life sciences business. Merck holds the rights to the Merck name and brand globally, with the exception of Canada and the US. In these two countries, the company would continue to operate as EMD Serono in the biopharmaceutical business, as EMD Performance Materials in the high-tech materials business, and as EMD Millipore in the life sciences business, up until the planned acquisition of Sigma-Aldrich had been completed. To create a “strong visual link” with its Canadian and US businesses, a “striking, multicoloured” ‘M’ which mirrored the new group identity had been added to the EMD logo, the company noted. OTC Consultants Leyers joins Diapharm’s regulatory unit D iapharm – the Germany-based pharmaceutical services provider – has appointed Dr Stefan Leyers as its senior regulatory affairs manager. A registered pharmacist, Leyers had “many years of experience”, Diapharm noted, having held positions in the regulatory departments of Johnson & Johnson’s German business, as well as at the family-owned pharmaceutical com- pany Medice Arzneimittel Pütter. He had also previously worked as an assessor at BfArM, the German Federal Institute for Drugs and Medical Devices. Meanwhile, Dr Jan Winters has joined the company as senior manager of regulatory affairs for food supplements. He will advise firms about foods with additional health benefits. OTC 23 ˝ 2015 Catalent Pharma Solutions. All rights reserved. consumer health innovative products. better OTC line extensions. faster to market. reliably supplied. 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