REDWOOD CITY, Calif. and LAUPHEIM, Germany, Sept. 9 /PRNewswire-FirstCall/ -- Maxygen, Inc. and Rentschler Biotechnologie GmbH today announced the signing of an agreement for the scale-up and manufacture of Phase I and Phase II clinical supplies of Maxygen's next-generation granulocyte cell stimulating factor (G-CSF) molecule.
Maxygen has developed a next-generation G-CSF that preclinical studies suggest reduces the duration of neutropenia in comparison to currently marketed products while maintaining the convenience of once-weekly dosing. Preclinical data obtained in established neutropenia models in primate, rat, and mouse suggest that Maxygen's product candidate reduces the duration of neutropenia by clinically relevant shorter periods (approximately 25 percent shorter duration of neutropenia) when compared to currently marketed products for the treatment of neutropenia.
Rentschler Biotechnologie has over 25 years of expertise in mammalian cell culture technology and proven capabilities in manufacturing recombinant biopharmaceutical products. It was amongst the pioneers for the development and production of interferon beta-1a and was also the first company to receive market authorization for an interferon biologic. The company has recently substantially expanded its state-of-the-art facilities to meet capacity demand.
"Rentschler is a preferred partner to manufacture our clinical material for our novel G-CSF program because of its long history and expertise in biologics manufacturing," said Grant Yonehiro, Vice President Business Development of Maxygen. "Our G-CSF is one of the product candidates that we expect will advance to clinical development in the next 18 to 24 months. This agreement with Rentschler is important for the advancement of this program."
"We are pleased to be working with Maxygen on the production of their novel G-CSF product candidate," said Wieland Wolf, member of the board at Rentschler Biotechnologie. "We have key competences in the cGMP manufacturing of recombinant proteins for clinical development and commercial sale and we look forward to working with Maxygen as an emerging leader in the field of improved protein therapeutics."
Maxygen, Inc., headquartered in Redwood City, California, is focused on creating novel products using its integrated proprietary technologies for human therapeutics. Maxygen's technologies bring together advances in molecular biology and protein modification to create novel biotechnology products. Maxygen has strategic collaborations with leading companies including Roche and Aventis.
Headquartered in Laupheim, Germany, Rentschler Biotechnologie GmbH (http://www.rentschler.de/) is part of the Rentschler group. With more than two decades of experience in drug development, Rentschler Biotechnologie is a full service contract manufacturer primarily engaged in contract development, production, and clinical testing of novel drugs produced with recombinant DNA- technology.
This news release contains forward-looking statements about the research and business prospects of Maxygen, including those relating to: Maxygen's human therapeutics focus; the properties of Maxygen's G-CSF variant, and its therapeutic benefit for neutropenia; and Maxygen's plans to advance products into clinical trials and the timing of such development. Such statements involve risks and uncertainties that may cause results to materially differ from those set forth in these statements. Among other things these risks and uncertainties include, but are not limited to: competitors creating and marketing superior products; the inherent risks of manufacturing novel biopharmaceutical products; inherent uncertainties whether Maxygen's product candidates will have properties making them unsuitable for clinical testing or development; Maxygen's ability to successfully develop its products including its G-CSF variant within the projected time frames; and risks relating to Maxygen's ability to adequately avoid, and defend against third party intellectual property claims. These and other risk factors are more fully discussed in Maxygen's Form 10-K for the year ended December 31, 2003, including under the caption "Risk Factors," and in Maxygen's other periodic SEC reports, all of which are available from Maxygen at http://www.maxygen.com/. Maxygen disclaims any obligation to update or revise any forward-looking statement contained in this release as a result of new information or future events or developments. Maxygen is a trademark of Maxygen.
CONTACT: Dr. Wieland W. Wolf of Rentschler Biotechnologie,+49-0-7392-701-570, or fax, +49-0-7392-701-521, or firstname.lastname@example.org; orJeannine Medeiros of Maxygen, Inc., +1-650-298-5859, or fax, +1-650-298-5877,or jeannine.Medeiros@maxygen.com