Reuters: Regulatory News: REFILE-UPDATE 1-Novo Nordisk faces new hurdle for degludec

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REFILE-UPDATE 1-Novo Nordisk faces new hurdle for degludec Jul 18th 2012, 09:57 Wed Jul 18, 2012 5:57am EDT * FDA sets Nov. 8 advisory panel meeting * FDA has set no new date for approval * Decision had earlier been expected in late October * Novo Nordisk shares down 1.0 pct COPENHAGEN, July 18 (Reuters) - U.S. health regulators have postponed a decision on Danish drugmaker Novo Nordisk's insulin degludec to allow for a review by outside experts, delaying further the potential blockbuster's route to market. The delay, which follows an earlier extension of the review process in June, is a disappointment since degludec is a pivotal new product with which Novo hopes to consolidate its position in the fast-growing diabetes market. The U.S. Food and Drug Administration had said in June it would decide on new drug applications for degludec on its own and in combination with insulin aspart on Oct. 29. But the FDA has now said a further advisory committee meeting will be held on Nov. 8, Novo Nordisk said on Wednesday. The FDA convenes advisory committees when it wants independent expert advice on scientific, technical and policy matters relating to new drugs. The FDA's extension of its review in June to late October had already been a setback for degludec as investors had earlier expected the regulator to render a decision on the experimental drug by July 29. "In its communication about the advisory committee meeting the agency has not informed Novo Nordisk of a new action date," Novo Nordisk said in a statement. Novo, which is the world's biggest insulin producer, submitted the new drug applications to the FDA on Sept. 29. Shares in Novo Nordisk, which have outperformed the market by gaining 34 percent this year, fell 1.0 percent to 884 crowns by 0948 GMT on a flat Copenhagen bourse. Novo Nordisk has said that degludec could become a blockbuster, which is defined by the industry as a drug that generates more than $1 billion in sales within five years of its launch. Competition is heating up in the multibillion-dollar market for long-lasting insulins. Novo Nordisk hopes its new product can trump Sanofi's top-seller Lantus, while Eli Lilly also has a rival drug in development that is a few years behind. Worldwide, Lantus has some 80 percent of the market for long-acting, or basal, insulins and the product had sales of around $5 billion last year. Ending Sanofi's 10-year dominance would be a major coup for Novo, whose existing long-acting insulin Levemir has failed to seriously dent the French drugmaker's grip on the market. Type 2 diabetes, which is linked to obesity, is growing rapidly around the world, making the sector a major target for drug company investment, as highlighted most recently by a deal between Bristol-Myers Squibb and AstraZeneca to share the $7 billion cost of buying U.S. diabetes specialist Amylin Pharmaceuticals. Link this Share this Digg this Email Reprints

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