Reuters: Regulatory News: UPDATE 1-EU regulator backs Novo's new long-acting insulin

Reuters: Regulatory News Reuters.com is your source for breaking news, business, financial and investing news, including personal finance and stocks. Reuters is the leading global provider of news, financial information and technology solutions to the world's media, financial institutions, businesses and individuals. // via fulltextrssfeed.com

UPDATE 1-EU regulator backs Novo's new long-acting insulin Oct 19th 2012, 12:33 Fri Oct 19, 2012 8:33am EDT By Ben Hirschler LONDON Oct 19 (Reuters) - Novo Nordisk's ultra long-acting insulin Tresiba has been recommended for approval by the European Medicines Agency in an important boost for the Danish drugmaker's key new product. The European endorsement, announced by the London-based agency on Friday, comes after the diabetes treatment hit regulatory delays in the United States. Tresiba, or degludec, is central to Novo's aim of ending Sanofi's dominance of the long-acting insulin market and the group said it expected to launch it in several European markets early next year, subject to final approval. Recommendations for marketing approval by the European agency's Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within around two months. Novo also won a green light for Ryzodeg, which combines degludec with insulin aspart, and this product is expected to go on sale around a year after Tresiba. "This is extremely important for Novo Nordisk," said Sydbank analyst Soren Lontoft. "(Tresiba) is a good product, a flexible product which will be capable of taking on rival Lantus from Sanofi." He estimated the peak annual sales of Tresiba at around 22 billion Danish crowns ($3.86 billion) worldwide and around 6 billion crowns in Europe. Shares in Novo rose 1.5 percent by 1205 GMT following the news, although analysts cautioned the positive decision in Europe did not provide an automatic read-through in the all-important U.S. market. "The FDA (Food and Drug Administration) is known to be more sensitive than the EMA (European Medicines Agency) in this field as can be seen with past delays to Novo's own Victoza and Levemir in the U.S.," said Deutsche Bank analyst Tim Race. "That said, we do expect a positive FDA panel vote and approval." The FDA said three months ago it was convening an advisory committee meeting on Nov. 8 to assess Tresiba. It convenes such panels when it wants independent expert advice on scientific, technical and policy matters relating to new drugs. Competition is heating up in the multibillion-dollar market for long-lasting insulins. Novo hopes degludec can trump Lantus, while Eli Lilly is also developing a rival drug 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 coup for Novo, whose long-acting insulin Levemir has failed to dent seriously the French drugmaker's grip on the market. Link this Share this Digg this Email Reprints

You are receiving this email because you subscribed to this feed at blogtrottr.com. If you no longer wish to receive these emails, you can unsubscribe from this feed, or manage all your subscriptions