FDA Accepts ZymoGenetics' Recombinant Human Thrombin Application for Review
- Category: Proteins and Peptides
- Published on Monday, 19 February 2007 02:00
- Hits: 2063
SEATTLE, WA, USA | Feb 15, 2007 | ZymoGenetics, Inc. (Nasdaq: ZGEN) today announced that the Biologics License Application for recombinant human thrombin (rhThrombin) has been accepted for review by the U.S. Food and Drug Administration (FDA). ZymoGenetics is developing rhThrombin as a general aid to achieving hemostasis during surgery.
"We're extremely pleased that the FDA accepted our Biologics License Application for rhThrombin for review," said Bruce L.A. Carter, President and Chief Executive Officer. "In the past, recombinant products have quickly replaced animal and human plasma products, so we're excited about the potential opportunity to compete in the thrombin market. We believe based on our market research that we can attain a substantial share of the existing bovine thrombin market and that there is significant potential to grow the use of thrombin in surgical procedures through increased awareness."
The Biologics License Application for rhThrombin was submitted to the FDA on December 15, 2006 and the Prescription Drug User Fee Act (PDUFA) date is October 18, 2007. The Phase 3 pivotal study, which was completed in the fall of 2006, showed that rhThrombin had comparable efficacy and a superior immunogenicity profile compared to the marketed 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 and viral 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.
SOURCE ZymoGenetics, Inc.