Rentschler enters into second manufacturing agreement with Maxygen
German company Rentschler Biotechnologie has signed a contract with Maxygen Holdings Ltd, a wholly owned subsidiary of California-based Maxygen Inc for the manufacture of a novel factor VIIa protein therapeutic.
German company Rentschler Biotechnologie has signed a contract with Maxygen Holdings Ltd, a wholly owned subsidiary of California-based Maxygen Inc for the manufacture of a novel factor VIIa protein therapeutic.
The announcement follows a recent agreement between Maxygen and Roche, of Basel, Switzerland, to co-develop and commercialise the protein for multiple clinical indications.
In the first phase Rentschler will set up the GMP process and manufacture the drug to supply the clinical studies. Additionally, Maxygen and Roche have an option to retain Rentschler as contract manufacturer for late stage clinical and commercial supplies.
Factor VIIa is a natural protein with a pivotal role in blood coagulation and clotting. Today a recombinant factor VIIa product is approved in the US and Europe for the treatment of hemophilia. Maxygen's novel protein will be evaluated for its therapeutic potential in new indications such as severe bleeding in trauma and intracerebral haemorrhage (ICH). Analysts estimate that world wide sales of all factor VII products could exceed US$2bn by 2012.
"We are very pleased about Maxygen's decision to expand the cooperation of our companies," said Dr Nikolaus F. Rentschler, ceo. "We will be fully committed to contributing to the success of this novel drug project."
Rentschler Biotechnologie recently announced an investment of Euro 50m in the expansion of its production capacities, including 2 x 2500-litre mammalian cell fermentation lines. The new facilities will be in operation early in 2008.