SEATTLE, March 7 /PRNewswire-FirstCall/ -- ZymoGenetics, Inc. today reported that the U.S. Food and Drug Administration (FDA) will not require additional clinical trials with recombinant human Thrombin (rhThrombin) administered by a spray device. ZymoGenetics is developing rhThrombin as an aid to controlling bleeding during surgery.
"The FDA has said it will not require any more clinical trials for spray rhThrombin," said Bruce L.A. Carter, President and Chief Executive Officer. "This is tremendous news for ZymoGenetics. It should shorten our timeline for offering spray rhThrombin by about 18 months and save substantial amounts of money for the company."
Approval of a spray device combination will be subject to acceptance of a Prior Approval Supplement to be submitted after the approval of the company's Biologics License Application for rhThrombin. ZymoGenetics now plans to file Prior Approval Supplements for the 20,000 Unit vial and a 20,000 Unit spray kit immediately after receiving approval of the 5,000 Unit vial. Prior Approval Supplements cannot be filed until the original product configuration is approved and require FDA action within four months of filing. Spray configurations account for approximately one-third of the sales of the existing bovine thrombin product.
The company's current Phase 2 rhThrombin spray trial has been enrolling patients requiring skin grafts for burns and traumatic injuries since August 2006. The trial is expected to be completed in the second quarter.
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.
About rhThrombin
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.
About ZymoGenetics
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, 2006. 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.
Investor Relations John Calhoun, MD, MBA Director, Corporate Communications & Investor Relations 206-442-6744 Media Relations Susan W. Specht, MBA Associate Director, Corporate Communications 206-442-6592
ZymoGenetics, Inc.CONTACT: investors, John Calhoun, MD, MBA, Director, CorporateCommunications & Investor Relations, +1-206-442-6744, or media, Susan W.Specht, MBA, Associate Director, Corporate Communications, +1-206-442-6592,both of ZymoGenetics
Web site: http://www.zymogenetics.com/
