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US Approves OTC Differin in First Retinoid Drug Switch

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US Approves OTC Differin in First Retinoid Drug Switch OTC22-07-2016p1_OTC15/11/2005 p1&24 19/07/2016 12:57 Page 1 22 July 2016 COMPANY NEWS 2 US approves OTC Differin Moberg buys three brands 2 from Prestige J&J takes 19.9% stake 3 in Japan’s Ci:z Holdings in first retinoiddrugswitch WBA to enter South Korea 4 with Emart cne sufferers in the US will soon be able Taisho takes DHG stake 5 Ato buyGalderma’sadapalene-based to aid its expansion plans Differin Gel 0.1% without aprescription, Alibaba grabs Chinese pharmacy chain 6 after the Food and Drug Administration Japan’s Suntorypicks up 7 (FDA)approvedthe product for OTC sale. GSK’s drinks in Nigeria Differin is the first retinoid-based product Alphrema purchase grows 8 to be made available OTCfor the treatment of Urgo’s presence in Italy acne in the US, with adapalene the first new Pharmacy2U agrees merger 8 ingredient for treating acne to be switched in the country since the 1980s. The product has Differin Gel 0.1% is the first retinoid-based product to GENERAL NEWS 9 been approvedfor the OTCtreatment of acne be available OTC in the US vulgaris in people aged 12 years or older. vations to enhance skin health,”hesaid. German experts against 9 Miles Harrison, president and general man- Commenting on the switch, LesleyFurlong, switching metronidazole ager of Galderma, claimed that the switch would deputy director of the FDA’sOffice of New PRACopens safetyreview 10 be a“game-changer for consumers and the acne Drugs IV,said that millions of consumers, of modified paracetamol category”, butdid not give alaunch date for from adolescents to adults, would nowhave BAH wants EMA to move to Bonn 10 the OTCproduct. access to a“newsafe and effective OTCoption” German manufacturers 11 “Weare excited to deliverthis levelofeffi- for tackling their acne. anticipateconsolidation cacy without aprescription to consumers,”he Differin’ssafety and efficacyhad initially ICH welcomes WSMI as amember 11 added, “and to bring the first newactive in- been establishedthrough five clinical trials in CHPAand FDAdebate 12 gredient to the category for over30years.” people with mild to moderate acne, the FDA user-fee system Acne wasthe most common skin condition pointed out. To support its OTCswitch appli- in the US, Galderma pointed out, affecting up cation, Galderma had submitted post-market- MARKETING NEWS 13 to 60 million teens and adults annually. ing safety data accrued between 1996 –when Bayeradds TENS device 13 However, only athird of those affected the product wasapprovedasaprescription to Aleve range in the US sought the help of ahealthcare provider to product –and 2016, the agencyadded. Con- ASA bans Nurofen 14 tackle the problem, the companynoted, add- sumer studies, including alabel comprehension Joint &Back spot ing that 45% of adults were not satisfied with study,aself-selection study and an actual-use Remisens peps up Germans’ sexlives 14 theproducts theyused, with nearly half of them trial, as well as data from amaximum-use trial, Social data can 15 using three or more acne products. had also been submitted. back product claims There wasagrowing trend amongst con- Overall, results from the consumer studies Startengaging with consumersdigitally 16 sumers to self-treat, with manyturning to the had shown that consumers understood the in- Digital media promoteshealth literacy 17 skin-care aisle at their local drugstore, Gal- formation on the OTClabelling of the prod- derma said. Until now, however, there had only uct, the FDAsaid, could appropriately select Pharma FGP spends C5mn 18 on Neodolor television push been five active ingredients available OTCin whether the product wasright for them and the US, with twoofthose ingredients–ben- use the product correctly. Stada renames Hoggar Balance 18 zoyl peroxide and salicylic acid –accounting Furthermore, the maximum use trial –a FEATURES 20 for 99% of the market. study of absorption of the drug through acne- Philip Brown, Galderma’ssenior vice-pres- affected skin when applied daily overalarge Perrigo offers ‘total healthcare’ 20 ident for medical and regulatory affairs, said surface area –had demonstrated that absorp- in the UK the switch had been “years in the making”. tion waslimited, thus supporting safe OTCuse, “This landmark approvaldemonstrates our the FDApointed out. REGULARS ongoing commitment to individuals with der- The switch receivedfinal approvalafter Events – Our regular listing 19 matologic concerns such as acne,”headded. the FDA’sNonprescription Drugs Advisory People – Stada makes board 23 “Galderma will continue to partner with health- Committee (NDAC)voted unanimously in picks to counter activist investor care professionals and invest in prescription, April to recommend switching adapalene gel OTC, aesthetic and correctivemedical inno- ■ Continued on page 11 OTC22-07-2016p2-9_Layout 1 19/07/2016 12:57 Page 2 OTC COMPANY NEWS Mergers&Acquisitions Mobergbuys three brands from Prestige weden’sMobergPharma has expanded fur- Commenting on the rationale behind the Stherits presence in the US consumer health- deal, Peter Wolpert, Moberg’schief executive care market by acquiring three brands from Pres- officer,said the acquisition was“in line with tige Brands for US$40 million (C36 million). ourstrategy to add critical mass to our US op- The three brands –Fiber Choice, New-Skin erations, as well as aleading topical brand to and PediaCare –had generated sales of around our core dermatology franchise”. US$24.4 million in the year ended 31 March “The acquired brands,”continued Wolpert, 2016, Mobergsaid, and were “well-established” “will immediately contribute significantly to in the US OTCmarket. our sales and earnings and also to our long-term The New-Skin liquid bandage wasthe “main financial goal of delivering profitable growth profitabilitycontributor” in the acquired port- andanearnings before interest, tax, depreciation MobergPharma has snapped up three brands –including the New-Skin liquid bandage –fromPrestige Brands folio, the companypointed out, and was“well- and amortisation (EBITDA) margin of 25%.” aligned with Moberg’sstrategic focus on topi- “This transaction is an excellent use of the brands would enable Mobergtofocus further cal dermatology”. proceeds from the bond loan issue earlier this on its “strategic assets, and mergers and ac- “Wesee excellent opportunities to build on year and the funds releasedinthe recent di- quisitions activities”. thebrand equity of New-Skin,”commented Jeff vestment of non-core brands to Strides Phar- Moberg’sstrategic OTCbrands include the Vernimb, general manger of MobergPharma ma,”Wolpert added. Balmexdermatology range, Domeboro skin- North America. In February,Mobergissued abond valued at care line and the Kerasal Nail/Nalox/Emtrix “This is amarket-leading brand with exciting SEK300 million (C32.2 million),with the com- anti-fungal nail-carebrand. prospects for growth,”Vernimb insisted. “We panynoting that the proceeds would allowthe Meanwhile, Prestige said offloading New- will leverage our innovation engine to further firm to “increase its acquisitionactivities going Skin, Fiber Choice and PediaCare to Moberg strengthen the future value proposition of this forward”, expand the international distribution would enable the firm to “move closer to its brand, as well as Fiber Choice and PediaCare, of its products and “strengthen” the “brand plat- stated goal of having aportfolio consisting of to consumers and retailers.” forms” of its strategic brands in the US market 85% of its revenue from ‘invest for growth’ The PediaCare children’spain-relief brand (OTC bulletin,5February 2016, page 8). brands and 15% in ‘manage for cash’ brands”. had “strong equity amongst mums” thanks to its The following month, Mobergoffloaded Achieving this goal, Prestige claimed, would “highly-effective products”, Vernimb insisted, the Fergon, JointFlexand Vanquish brands to “help support long-term organic growth”. while the Fiber Choice range comprised a“com- India’sStrides for US$10 million (OTC bul- Prestige noted that it planned to use the pelling line-up of product options for daily letin,25March 2016, page 2). proceeds from the sale to “pay down debt and fibre supplementation”. Wolpert said at the time that selling the three accelerate de-leveraging”. OTC Distribution contract and IN BRIEF ■ ACHÉ LABORATÓRIOS –the Brazil- product rights on offer ... ian OTCand prescription medicines manu- facturer –has strengthened its position in its domestic market by snapping up Laborat- German companycompany is sellingsellinga food for special ório Químico Farmacêutico Tiaraju for an undisclosed sum. Through the deal, Aché gains medicalmedical purposespurposes for diabetes type IIII.. Tiaraju’srange of herbal medicines, nutra- ceuticals and nutricosmetics. Santo Ângelo- The product fulfils the criteria laid down in the European Union based Tiaraju’sportfolio comprises the Ad- Regulation 609/2013 that comes into effect on 20 July 2016. mire skin-care line, Biofibra herbal supple- On offer is a distribution contract exclusively for the German market ment and the MultiVita multivitamin. Aché reported sales up by 9.3% to BRL2.3 billion which will run until 2021, as well as the product rights. (C634 million) in 2015, thanks to newprod- As the product has been extensively analysed and clinically-proven, uct launches across its non-prescription and claims can be made on its packaging, as determined by a structure- prescription medicines businesses. The com- function or astructure-illness relation for the ingredients. pany’sOTC portfolio includes the Accuvit multivitamin, Dorilax analgesic
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