Biotech company Auxilium has decided to amend its manufacturing agreement with UK-based Cobra biologics in order to favour the in-house production of its new injectable enzyme.
Under the new deal, Cobra will complete only one biologics license application (BLA) batch of the active ingredient for AA4500, Auxilium's new product. "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," said Auxilium.
The company will use the materials produced by Cobra in its ongoing and potential future clinical trials for the enzyme which could be used in the treatment of Dupuytren's contracture.
The two firms agreed to continue their collaboration as far as the technology transfer is concerned.
"This amendment allows our manufacturing, quality assurance (QA) and development teams to focus on getting the Horsham facility ready for the BLA submission expected at the end of 2007," said Armando Anido, Auxilium's CEO and president.
"It also ensures that Cobra will continue to provide technology support and be involved as a development partner for this critical asset."
Efforts to increase R&D pipeline productivity have never been more aggressive, and clinical outsourcing is one strategy employed by pharma companies to save on costs and stay in the competition.
However it seems that the reality is different for small companies as a number of small drug makers are now bailing out of contract manufacturing deals in favour of self-production.
Last week, Brisbane-based Progen said that manufacturing the first step of its drug in-house would save it approximately AUD7.8m (€4.6m) in outsourcing fees to a contract manufacturing organisation.
Auxilium currently has four projects in clinical development and AA4500 is in Phase III of development for the treatment of Dupuytren's contracture and in Phase II trial for the treatment of Peyronie's disease and Frozen Shoulder Syndrome.