Healthcare Industry News: rhThrombin
News Release - December 18, 2006
ZymoGenetics Submits Biologics License Application to the FDA for rhThrombin as an Aid to Controlling Bleeding During SurgerySEATTLE, Dec. 18 (HSMN NewsFeed) -- ZymoGenetics, Inc. (Nasdaq: ZGEN ) today announced that the company has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for licensure to market recombinant human thrombin (rhThrombin) as a general aid to achieving hemostasis during surgery.
"Submitting the biologics license application for rhThrombin is an important milestone for ZymoGenetics," said Bruce L.A. Carter, President and Chief Executive Officer. "We believe that a recombinant version of thrombin will provide important benefits to patients and healthcare providers. We're very excited about the potential of rhThrombin to significantly impact the market for hemostasis products."
As previously disclosed, the Phase 3 pivotal study showed that rhThrombin had comparable efficacy and a superior immunogenicity profile compared to the approved bovine thrombin product.
ZymoGenetics is developing rhThrombin, a recombinant form of human thrombin that is not derived from animal or human blood, as an aid to controlling bleeding during surgery. Thrombin is used in more than 1 million surgeries each year in the United States. Currently, only thrombin derived from bovine blood is available in the U.S. as a stand-alone thrombin product. Bovine-derived thrombin has been associated with the development of antibodies that may cross-react with human blood proteins and in some cases these antibodies appear to be related to serious bleeding complications. The production of recombinant proteins is not dependent on the availability of blood from animals or human donors and can be scaled-up to meet market demand.
ZymoGenetics creates novel protein drugs with the potential to significantly help patients fight their diseases. The Company is developing a diverse pipeline of potential proprietary product candidates that are moving into and through clinical development. These candidates span a wide array of clinical opportunities that include bleeding, autoimmune diseases and cancer. ZymoGenetics intends to commercialize these product candidates through internal development, collaborations with partners, and out-licensing of patents from its extensive patent portfolio. For further information, visit www.zymogenetics.com .
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on the current intent and expectations of the management of ZymoGenetics. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. ZymoGenetics' actual results and the timing and outcome of events may differ materially from those expressed in or implied by the forward-looking statements because of risks associated with our unproven discovery strategy, preclinical and clinical development, regulatory oversight, intellectual property claims and litigation and other risks detailed in the company's public filings with the Securities and Exchange Commission, including the company's Annual Report on Form 10-K for the year ended December 31, 2005. Except as required by law, ZymoGenetics undertakes no obligation to update any forward-looking or other statements in this press release, whether as a result of new information, future events or otherwise.
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