Biotech Values

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SNY TEVA MNTA
Lovenox Trial Resumes Oct.10

http://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn:newsml:reuters.com:20060810:MTFH68858_2...

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PARIS, Aug 10 (Reuters) - Sanofi-Aventis <SNY> said on Thursday a U.S. court had fixed Oct. 10 as trial date for its blood-thinner Lovenox, which is being challenged by generic rivals Teva Pharmaceutical Industries and Amphastar Pharmaceuticals.

The French drugmaker, faced with a slew of generic threats, said the Oct. 10 trial would address the issue of intent which was unresolved in April when a U.S. Court of Appeals reversed a lower court decision that had invalidated the Lovenox patent.

The court said it was not convinced the company intended to deceive the U.S. Patent and Trademark Office as Teva and privately held Amphastar had claimed.

Following Sanofi's appeal victory, the case returned to the U.S. district court of California where the trial on Sanofi's best-selling drug, with sales of 2.14 billion euros ($2.75 billion) last year, will continue.

The generic drugmakers are trying to sell cheaper Lovenox copies in the United States even though the patent expires in 2012. Lovenox is also under attack from Momenta Pharmaceuticals <MNTA> and Sandoz, owned by Switzerland's Novartis <NVS>.

Lovenox is a complex mixture of ingredients based on live organisms and Sanofi has said that part of the drug cannot be characterised and therefore not be copied.

The U.S. Food and Drug Administration requires a generic drug to show it has the same active ingredients as the innovator product upon which the cheaper copy is based.

"It's one small part of a fairly long process," one London-based analyst said. "Chances are very high Sanofi could keep its Lovenox patent and the FDA would first need to approve an abbreviated new drug application (submitted by the generic drugmakers)."

A date for the trial on issues of validity, infringement and enforceability should be set at a later time, Sanofi said in a statement, adding it would vigorously pursue its legal options.
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