Sanofi Seeks to Halt Lovenox Generic

Quote: By ALICIA MUNDYWASHINGTON—Sanofi-Aventis SA filed papers in federal court Monday seeking a temporary restraining order that would prevent a rival company from selling a copycat version of Sanofi's top-selling blood thinner Lovenox.Sandoz, a unit of the European pharmaceutical giant Novartis AG, and partner Momenta Pharmaceuticals Inc. of Boston won Food and Drug Administration approval last Friday for a generic version of Lovenox. In court papers in Washington, D.C., Sanofi said it wants a temporary order "requiring the FDA to withdraw its approval" of the Sandoz application.Sanofi said the FDA acted arbitrarily and capriciously in granting the approval. Lovenox, a rapid-acting blood thinner, brought roughly $4 billion in sales to Sanofi in 2009. "The company 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 said in a statement. The company has said Lovenox is too complex to be matched fully by a generic maker. Representatives of Sandoz and Momenta could not be immediately reached for comment. Momenta said last week that the FDA's decision "demonstrates our ability to characterize and develop a complex mixture drug like Lovenox."Momenta has been in a battle with a California biotech company, Amphastar Pharmaceuticals Inc., for several years to win FDA approval to make the drug. Heparin is crucial to millions of cardiac and diabetes patients. The rapid-acting heparin, which carries the generic name enoxaparin, serves an expanding market of consumers with heart disease and obesity-related diabetes. Sanofi has attempted to keep the FDA from approving a generic Lovenox, and in June outside researchers with ties to the company filed citizens' petitions to the FDA to stop any approval. The FDA told Amphastar and Sandoz-Momenta in 2007 that it wanted further safety testing con...
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