Under the amended agreement, Cobra will complete only one biologics license application batch of the active ingredient for AA4500, the company's injectable enzyme for the treatment of Dupuytren's contracture, an abnormal thickening of tissue on the hand.
The companies agreed to continue their collaboration related to the technology transfer, ongoing stability program and other services provided by Cobra. As part of the joint venture, Cobra will provide scale up and manufacturing services and supply of drug for phase II/III clinical trials.
Auxilium's new facility in Horsham, Pennsylvania will manufacture AA4500.
“This amendment allows our manufacturing, quality assurance and development teams to focus on getting the Horsham facility ready for the biologics license application submission expected at the end of 2007,” said Mr Armando Anido, Auxilium's CEO and president.