UPDATE: Schweizerhall Says It's Near Generic Plavix Launch
Friday May 9th, 2008 / 16h06
By Sarah Turner LONDON (Dow Jones) -- Swiss generics firm Schweizerhall Holdings said Friday that it's on the verge of launching a generic version of Plavix, a move that, if successful, could ratchet up the pressure on Sanofi-Aventis. Schweizerhall Holdings said it believes it's close to getting approval in Germany for a generic version of Sanofi-Aventis' (SNY) blood-thinning drug Plavix, which Bristol-Myers Squibb Co. (BMY) markets in the U.S. "We expect shortly a positive ruling from the German authorization agency for medicines, and we plan to launch Clopidogrel throughout the European Union in cooperation with marketing partners," Schweizerhall Holdings said in a statement. It expects to record sales from the drug -- which inhibits the formation or growth of blood clots -- in the current quarter. The European market for Clopidogrel is now about 3.2 billion Swiss francs ($3.1 billion), it said. Analysts at Deutsche Bank noted that the European patents covering Plavix don't expire until 2012 and 2019. "We expect that [Schweizerhall unit] Cimex's version of Plavix is a different salt... precedents show that different salts are not substitutable and have in the past made very little inroads into existing franchises," said analyst Michael Leuchten. Still, he added, "clearly the market has gotten tougher and it remains to be seen how much market share a new product could take." In February, Sanofi-Aventis said that fourth-quarter sales for Plavix, its second best-selling drug, rose 14% to 609 million euros ($940 million). Total sales for its top 15 drugs fell 0.3% to 4.2 billion euros, hurt by generic competition on Ambien and Eloxatin. Sanofi-Aventis on Friday said that it's evaluating its legal and regulatory options but pointed out that Plavix still has E.U. regulatory data protection. This isn't the first time the firm has faced a challenge to its Plavix patent. In January, Sanofi-Aventis said it believed it is "highly unlikely" that India's Dr. Reddy's Laboratories Ltd. will launch a generic version of Plavix in the U.S. Dr. Reddy's (RDY) received marketing approval from the U.S. Food & Drug Administration for Clopidogrel Bisulfate. The French company cited a June 19 U.S. district court ruling that Canadian firm Apotex Inc. had infringed Sanofi's Clopidogrel patent and that imposed an injunction preventing Apotex from selling its own generic version of the drug. And analysts at Dresdner Kleinwort said on Friday: "We believe an injunction is possible and that any launch would be at risk -- a large risk for a small company like Cimex. We think the share price reaction is overdone." Sanofi-Aventis shares fell 5.5% in Paris, while Schweizerhall's shares rallied 8.5% in Swiss trading and Bristol-Myers Squibb shares fell 3.7% in early Wall Street action.
Sanofi-Aventis est le 1er groupe pharmaceutique europ éen. Le CA par famille de produits se répartit comme suit :
- produits pharmaceutiques (89,6%)...
