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November 29, 2006
By: Tim Wright
Editor-in-Chief, Contract Pharma
Auxilium Pharmaceuticals, Inc. has amended its manufacturing agreement with UK-based Cobra Biologics, Ltd. Under the amended agreement, Cobra will complete one BLA batch of the active ingredient for AA4500, the company’s injectable enzyme. The revised agreement is a result of Auxilium’s decision to move forward with its facility in Horsham, PA to support the BLA submission and to serve as a primary source of the commercial supply of AA4500. Auxilium will use the materials in ongoing and future clinical trials for AA4500 for the treatment of Dupuytren’s contracture and other indications. The companies agreed to continue their collaboration related to the technology transfer, ongoing stability programs and other services provided by Cobra. “This amendment allows our manufacturing, quality assurance and development teams to focus on getting the Horsham facility ready for the BLA submission expected at the end of 2007,” said Mr. Armando Anido, Auxilium’s chief executive officer and president. “The amendment also ensures that Cobra will continue to provide technology support and be involved as a development partner for this critical asset. We look forward to continuing our collaboration with the Cobra team.”
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