U.S. Judge Denies Sanofi's Request to Get Lovenox Generic Rival Blocked
Sanofi-Aventis SA's Lovenox
JB Reed/Bloomberg
Syringes containing the anti-clot drug Lovenox are made by Sanofi-Aventis SA.
Syringes containing the anti-clot drug Lovenox are made by Sanofi-Aventis SA. Photographer: JB Reed/Bloomberg
Sanofi-Aventis SA’s request to bar the U.S. Food and Drug Administration from allowing sales of a generic rival to its Lovenox blood thinner was rejected by a federal judge yesterday.
U.S. District Judge Emmet Sullivan in Washington denied the request, which would have forced the regulator to suspend its approval of the lower-cost copy produced by Novartis AG’s Sandoz unit with Momenta Pharmaceuticals Inc.’s technology. The court didn’t rule on the merits of Sanofi’s case, the Paris-based drugmaker said today in a statement.
Lovenox, an injection that helps prevent blood clots, was Sanofi’s second-biggest product last year, accounting for about 10 percent of revenue. Sanofi said on July 26 that profit may fall this year after the FDA approved the generic version of Lovenox, which is given by injection to prevent clots in the legs or in vessels deep in the body.
“The company’s case against the FDA will continue to move forward,” Sanofi said in the statement. “Sanofi-Aventis believes that this case poses a number of significant questions regarding the FDA review process for complex pharmaceutical products which are important to pursue.”
Sanofi fell 14 cents, or 0.3 percent, to 44.46 euros as of 9:55 a.m. in Paris trading. Novartis rose 20 centimes, or 0.4 percent, to 52.25 Swiss francs in Zurich trading.
Novartis, based in Basel, Switzerland, and Momenta, a biotechnology company in Cambridge, Massachusetts, won U.S. approval in July for a copy of Lovenox, ending a five-year wait to challenge the $3.9 billion-a-year product.
Sullivan said in the 33-page ruling that the public would be harmed by a court-ordered delay in the distribution of the generic.
The case is Sanofi-Aventis U.S. LLC v. Food and Drug Administration, 10cv1255, U.S. District Court for the District of Columbia (Washington).
To contact the reporter on this story: Douglas Wong at dwong19@bloomberg.net
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