Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, has amended its manufacturing agreement with UK-based Cobra Biologics Ltd. Under the amended agreement, Cobra will complete only one BLA (Biologics License Application) batch of the active ingredient for AA4500, the company's injectable enzyme.
The amendment reflects Auxilium's decision to move forward with its facility in Horsham, Pennsylvania to support the BLA submission and as a primary source of the commercial supply of AA4500. As previously announced, Auxilium will use the materials produced by Cobra in its ongoing and potential 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."
Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical company with a focus on developing and marketing to urologists, endocrinologists, orthopedists and select primary care physicians. Auxilium markets Testim 1 per cent, a topical testosterone gel, for the treatment of hypogonadism through its approximately 180-person sales and marketing team. Auxilium has four projects in clinical development. Auxilium believes that AA4500, an injectable enzyme, is in phase III of development for the treatment of Dupuytren's contracture and is in phase II of development for the treatment of Peyronie's disease and Frozen Shoulder Syndrome (Adhesive Capsulitis). Auxilium's transmucosal film product candidate for the treatment of overactive bladder (AA4010) is in phase I of development. The company is currently seeking a partner to further develop this product candidate. Auxilium has two pain products using its transmucosal film delivery system in pre-clinical development. Auxilium has rights to six additional pain products and products for hormone replacement and urologic disease using its transmucosal film delivery system, and options to all indications using AA4500 for non-topical formulations.