Laupheim, Germany, May 30, 2006 -- Today Rentschler Biotechnologie GmbH announced the signing of a contract with Maxygen Holdings Ltd., a wholly owned subsidiary of Maxygen Inc. (Redwood City, California) for the manufacture of a novel factor VIIa protein therapeutic. The announcement follows a recent agreement between Maxygen and Roche (Basel, Switzerland) to co-develop and commercialize 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.
Dr. Nikolaus F. Rentschler, CEO, commented on the agreement:
“We are very pleased about Maxygen’s decision to expand the cooperation of our companies. In the light of the successful ongoing collaboration on Maxygen’s next-generation G-CSF project we take this as a sign of confidence in our professional skills. We will be fully committed to contributing to the success of this novel drug project.”
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 United States 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 $2 billion by 2012.
About Rentschler Biotechnologie – www.rentschler.de
Headquartered in Laupheim, Germany, Rentschler Biotechnologie GmbH is part of the privately held Rentschler Group of pharmaceutical companies. As a full-service contract manufacturer, Rentschler Biotechnologie has 30 years of experience in development, production and approval of biopharmaceutical drugs, compliant with international GxP-standards. The company’s area of expertise includes regulatory affairs and fill and finish. Rentschler is a pioneer for the development and production of biopharmaceuticals and was the first company to receive market authorization for an interferon-containing drug.
Rentschler Biotechnologie has recently announced an investment of 50 million euros into the expansion of their production capacities, including 2 x 2.500 L mammalian cell fermentation lines. The new facilities will be in operation early 2008.