Clarke To Oversee Glaxo Consumer Division During Xenical Switch Bid
This article was originally published in The Tan Sheet
Executive Summary
Glaxo's plan to switch Xenical (orlistat 60 mg) to over-the-counter status for adults only "provides difficulties in the ultimate marketing," incoming Consumer Healthcare president John Clarke allowed
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Glaxo's plan to switch Xenical (orlistat 60 mg) to over-the-counter status for adults only "provides difficulties in the ultimate marketing," incoming Consumer Healthcare president John Clarke allowed. As Xenical is "intended for adults, not for those under the age of 18," GSK is "still working" on how to make the drug OTC for individuals over 18 and Rx for those 17 and under, according to a GSK spokesperson. The firm filed an Rx-to-OTC switch application in June (1 (Also see "GSK Sees Big Opportunity In OTC Diet Aids: Xenical Switch NDA Filed" - Pink Sheet, 1 Aug, 2005.) p. 5). The switch will be one of the major initiatives Clarke will oversee in his new position. Currently head of GSK Consumer Healthcare's global marketing team, Clarke will replace Jack Ziegler, who will retire as president effective Jan. 31, 2006, Glaxo announced Sept. 15. The incoming president is optimistic about the proposed switch; he expects Xenical to be available over-the-counter in 2006. "GSK is uniquely positioned for that with our ownership of the license for orlistat and we expect that product to be launched in the middle of next year," Clarke said. As a result, the firm "expects to have the only FDA-approved molecule in [the] weight control category." The age-based availability could prove a significant challenge for the company, as FDA has named age-based concerns responsible for its deferment of a final decision on Barr Labs' switch NDA for Plan B ("The Tan Sheet" Aug. 29, 2005, p. 4). The agency also issued an advance notice of proposed rulemaking for comment on the appropriateness of using age in delineating between Rx and OTC versions of the same drug, among other criteria. Overall, the firm would maintain its focus on the switch as it is "one of the significant drivers of the business," Clarke stated. In particular, GSK plans to concentrate on continued expansion of its global OTC market for smoking cessation products. GSK makes Nicorette anti-smoking gum, the NiQuitin CQ patch and Commit Lozenge. "The opportunities for the brand are large in overseas markets as the public health pressure is brought to bear and legislation changes," Clarke noted. "That gives us great global opportunities to drive our smoking control business." Clarke, a 29-year GSK veteran, has held a number of marketing and General Manager roles in the international sector. These include positions in Australasia, South Africa, the Far East, Japan, Canada and the UK, according to the firm. Acting as president of Consumer Healthcare Europe from 1998 to 2003, Clarke "delivered strong growth and developed a high-performing leadership team," GSK noted. Clarke went on to head the Futures Group, a team "charged with reinvigorating GSK's global brands pipeline in partnership with R&D," the company said. As president of the group, Clarke's duties included managing the formation of the group while overseeing the creation of a global brands pipeline. Ziegler, who joined SmithKline Beecham in 1991 as the head of the North American Consumer Healthcare division, has served as president of Consumer Healthcare since 2001. "Jack is recognized as an outstanding leader within both GSK and our industry," Glaxo CEO JP Garnier said. "He has expanded our Consumer Healthcare business and developed innovative new products that have made our consumer division highly competitive and fit for the future." Two major acquisitions came about under Ziegler's leadership, including the 1994 integration of Sterling Health and its analgesic Panadol and the 2001 acquisition of Block Drug and Sensodyne toothpaste (2 (Also see "Block Acquisition Could Boost SmithKline International Sales By $560 Mil." - Pink Sheet, 16 Oct, 2000.), p. 6). The firm also began actively filing switch applications during Ziegler's reign; these include the successful 1996 Rx-to-OTC switch of Nicorette and the 2005 switch NDA filed in June for Xenical (orlistat). GSK attributes the internal transfer of leadership from Ziegler to Clarke as reflective of "the strength of Consumer Healthcare's management team." Clarke will reside in Philadelphia, Pa. and report to CEO JP Garnier. |