Healthcare Industry News: protein therapeutics
News Release - May 9, 2006
Maxygen Achieves Milestone in Alliance with Roche for Factor VIIa TherapeuticsREDWOOD CITY, Calif., May 9 (HSMN NewsFeed) -- Maxygen, Inc. (Nasdaq: MAXY ) today announced that it has achieved a $5 million preclinical milestone in its alliance with Roche to co-develop next-generation factor VIIa therapeutics. Maxygen has achieved the milestone for development of a manufacturing process for its factor VIIa product candidates.
In December 2005, Maxygen and Roche established an agreement to co-develop and commercialize next-generation factor VIIa products for multiple indications of severe bleeding, including trauma and intracerebral hemorrhage (ICH). Under the terms of the agreement, Roche and Maxygen agreed to share worldwide research and development costs for the creation of next-generation factor VIIa product candidates. Maxygen is leading early stage clinical development, and Roche will lead late stage clinical development. Roche will have exclusive worldwide rights to commercialize the next-generation recombinant factor VIIa products for acute indications. Including an upfront fee, total event payments to Maxygen could total $95 million. In addition, Maxygen is also eligible to receive royalties on product sales. Maxygen has retained all rights for development and commercialization of its next-generation recombinant factor VIIa product candidates for hemophilia.
"This milestone represents significant progress in our next-generation factor VIIa program," said Russell Howard, CEO of Maxygen. "We view Roche as a leader in the development, manufacture and commercialization of biologics and we are pleased that they have accepted the manufacturing process developed by our project team. We are very excited about this program and the potential to develop improved factor VIIa products specifically tailored for acute bleeding indications."
Maxygen also announced that it has entered into an agreement with Rentschler Biotechnologie GmbH for the manufacture of the clinical supply of its next-generation factor VIIa protein therapeutics and has initiated technology transfer to Rentschler.
About Recombinant Factor VII
Factor VII is a natural protein with a pivotal role in blood coagulation and clotting. Currently, recombinant factor VIIa is approved in the United States and Europe only for the treatment of hemophilia. The market for the use of all factor VIIa products for the treatment of new indications, such as severe bleeding in trauma and intracerebral hemorrhage is estimated to exceed $2 billion by 2012.
It is estimated that there are over 160,000 deaths in the United States each year that are a direct result of trauma injuries. The direct and indirect healthcare costs associated with trauma injuries are estimated to be approximately $260 billion per year. Uncontrolled bleeding is believed to account for approximately half of all trauma related deaths that occur within the first 48 hours after injury. There is currently no effective medical therapy for uncontrolled bleeding other than physical interventions, such as surgery or blood transfusions.
Intracerebral hemorrhage (ICH), also known as hemorrhagic stroke, occurs when a blood vessel within the brain bursts, allowing blood to leak inside the brain. The sudden increase in pressure within the brain can cause damage to the brain cells. If the amount of blood increases rapidly, the sudden buildup in pressure can lead to severe neurological impairment, coma or death. The most common cause of intracerebral hemorrhage is high blood pressure (hypertension). Hemorrhagic strokes make up about 12% of all strokes.
Maxygen, Inc., headquartered in Redwood City, California, is committed to the discovery, development and commercialization of improved next-generation protein pharmaceuticals for the treatment of disease and serious medical conditions. For additional information on Maxygen, including access to Maxygen's SEC filings, please visit Maxygen's website at www.maxygen.com.
This news release contains forward-looking statements about our research and business prospects, including those relating to: Maxygen's ability to develop its factor VIIa product candidates and other pharmaceutical products; the potential utility of Maxygen's factor VIIa product candidates for the treatment of severe bleeding in trauma, ICH or other indications and the market potential of such products; whether Maxygen will achieve further milestones relating to its factor VIIa product candidates or receive any future event-based payments or royalties for its factor VIIa product candidates; and the success or continuation of any existing or future alliance, collaboration or manufacturing arrangement. Such statements involve risks and uncertainties that may cause results to differ materially from those set forth in these statements. Among other things, these risks and uncertainties include, but are not limited to: changing research and business priorities of Maxygen and/or Roche; the inherent uncertainties of clinical research and development; the ability to develop human therapeutic drugs in an increasingly competitive biotechnology industry; the uncertain timing of such development, and the ability of competitors to produce superior products. These and other risk factors are more fully discussed in our Form 10-K for the year ended December 31, 2005, including under the caption "Risk Factors," and in our other periodic SEC reports, all of which are available from Maxygen at 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 registered trademark of Maxygen, Inc. The Maxygen logo is a trademark of Maxygen, Inc.
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