AR-News: Generic Premarin

Priscilla Feral feral at
Tue Sep 16 15:41:53 EDT 2003

      Posted on Tue, Sep. 16, 2003   
      Judge: Albert Lea drug company used stolen trade secrets
      Associated Press

      ST. PAUL - An Albert Lea-based drug company has used stolen trade secrets from Wyeth Pharmaceuticals for the manufacture of a generic version of the Premarin estrogen replacement therapy, a federal judge ruled.

      U.S. District Judge Joan Ericksen, in a sweeping decision filed Monday, also barred Natural Biologics from using a proprietary estrogen-extraction process and formula and ordered the company to retrieve and destroy all of the estrogen it has produced to date.

      Natural Biologics also is banned from doing any further research on the therapy, must destroy all documents related to the drug and identify anyone who may have had access to the extraction technology.

      The market for Premarin and Prempro, another drug produced by Wyeth, of Madison, N.J., that combines estrogen with progestin, is significant - nearly $1.5 billion this year. More than 5 1/2 million U.S. women use the two drugs.

      Wyeth said it was pleased with the decision.

      "No therapy should be approved or marketed based on information obtained unlawfully," Wyeth spokeswoman Natalie de Vane said. "Our manufacturing process is a carefully guarded trade secret."

      Estrogen for Premarin and Prempro is extracted from the urine of pregnant mares. Wyeth, formerly known as American Home Products Corp., has been using the technology since 1942.

      Executives with Natural Biologics, which is privately held, did not immediately return a telephone call Tuesday morning seeking comment.

      The original complaint against Natural Biologics suggested a Wyeth insider provided information to Natural Biologics about the hormone extraction process and that Natural Biologics "knew or had reason to know that the means of acquisition were improper."

      The judge's order also threatens a multimillion-dollar agreement between Natural Biologics and New Jersey-based Barr Laboratories Inc. to develop, manufacture and market a generic version of Premarin.

      The order prohibits Natural Biologics from "providing services, information, materials or other assistance" to "any other person or entity" involved in the development of the estrogen product.

      Barr announced its partnership with Natural Biologics in March 2002, offering the Minnesota company up to $35 million in financing over three years. Barr filed a new-drug application with the U.S. Food and Drug Administration in July.

      On Monday, Barr said the court ruling, if allowed to stand, would ban it from using raw material from Natural Biologics to make a generic version of Premarin.

      A statement by Barr said it had been informed that Natural Biologics intends to ask for a rehearing or file an appeal. Barr also said it has $16 million in outstanding loans to Natural Biologics and that the ruling creates uncertainty over the Minnesota company's ability to repay.
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