SEATTLE, Dec. 14 /PRNewswire-FirstCall/ -- ZymoGenetics, Inc. today provided research and development program updates at an annual Analyst & Investor Briefing in New York City. Highlights of the meeting follow. An archived webcast of the ZymoGenetics Analyst and Investor Briefing may be accessed at www.zymogenetics.com.
"ZymoGenetics is making significant progress toward our goal of introducing novel therapies for patients in need," said Bruce L.A. Carter, President and Chief Executive Officer. "Early on, we adopted a diversified strategy involving the development of multiple products in multiple disease indications. We continue to pursue this strategy and, with the potential approval and launch of rhThrombin, hope to see it begin to bear fruit in the coming year."
Highlights Company highlights discussed at the meeting include the following: Recombinant human Thrombin (rhThrombin) -- ZymoGenetics is on track to file a biologics license application for rhThrombin with the U.S. Food and Drug Administration (FDA) by year end. In a recently completed Phase 3 pivotal study, rhThrombin had comparable efficacy to the approved bovine thrombin product and showed a far lower rate of immune response. Phase 3 clinical trial results were presented at the Society for the Advancement of Blood Management Annual Meeting in September 2006. -- The company continues to enroll patients in a Phase 2 clinical trial with rhThrombin delivered from a spray applicator. A spray registration trial is expected to begin in mid-2007. -- Senior management reported its strategy and plans for launch of rhThrombin in the U.S. The strategy reflects the relative concentration of the U.S. thrombin market, where approximately 80% of bovine thrombin sales revenues come from about 900 hospitals. The company reviewed its plans for building a sales force and related infrastructure to address this market. Atacicept (formerly TACI-Ig) -- ZymoGenetics and partner Serono will pursue a clinical trial program with atacicept in multiple sclerosis (MS), and plan to initiate a clinical trial in MS in 2007. -- A Phase 2 clinical trial with atacicept in patients with rheumatoid arthritis (RA) will be initiated shortly. The randomized, double-blind, placebo-controlled, multi-center dose finding study will test three dose levels in approximately 300 patients whose disease has failed to respond to TNF inhibitors. -- ZymoGenetics and Serono are in discussions with regulatory authorities, and are planning follow-on clinical trials with atacicept in patients with Systemic Lupus Erythematosus (SLE). A registration study is expected to start in 2007. -- Results from Phase 1b clinical trials with atacicept in patients with multiple myeloma and non-Hodgkin's Lymphoma were recently reported at the American Society of Hematology Annual Meeting. In the two trials, atacicept was found to be well tolerated, and biological activity was observed. The companies will evaluate the atacicept B-cell cancer program after completing an ongoing Phase 1b trial in patients with chronic lymphocytic leukemia (B-CLL). -- Results from a Phase 1b clinical trial in patients with SLE were presented at the American College of Rheumatology Annual Meeting in November 2006. Atacicept was well tolerated and showed signs of biological activity, such as dose-dependent reductions in immunoglobulin and B-cell levels. Interleukin 21 (IL-21) -- ZymoGenetics is developing IL-21 as a potential treatment for renal cell cancer (RCC), metastatic melanoma and lymphoma in collaboration with Novo Nordisk A/S, which has commercial rights to IL-21 outside North America. Results were reviewed from recent presentations of two Phase 1 studies conducted by ZymoGenetics and Novo Nordisk. The Phase 1 studies indicated that IL-21 showed evidence of anti-tumor activity and the tolerability allows for it to be administered in an outpatient regimen. -- ZymoGenetics initiated a Phase 1/2 clinical trial with IL-21 in combination with Nexavar(R) in patients with RCC. Treatment with both a tyrosine kinase inhibitor such as Nexavar and IL-21 may result in greater efficacy than treatment with either agent alone. Preclinical research using concurrent dosing of IL-21 with Nexavar showed in vivo additive effects in a preclinical model of RCC. ZymoGenetics plans to complete Phase 1 and start the Phase 2 part of this combination trial in 2007. -- Preclinical studies have shown that IL-21 enhances Rituxan-mediated ADCC both in vitro and in vivo. ZymoGenetics has started a Phase 1 open label dose escalation study with IL-21 and Rituxan in patients with NHL who have failed prior therapies, and plans to complete that study in 2007. PEG-Interferon lambda (IL-29) -- ZymoGenetics is investigating PEG-Interferon lambda as a treatment for viral infection with the potential for fewer side effects than current therapies. The company plans to evaluate this agent in patients with chronic hepatitis C infection. ZymoGenetics recently submitted an Investigational New Drug application for a Phase 1 study in healthy volunteers, and expects to begin the trial in Q1 2007. Preclinical Research -- ZymoGenetics is developing preclinical candidates Interleukin 31 with partner Serono and Interleukin 17-RC with partners Serono and Novo Nordisk. Preclinical studies for both molecules have shown promising results in inflammatory diseases with unmet medical needs. Preclinical research activities are continuing for these potential product candidates. 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 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.
Contact 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: investor relations, John Calhoun, MD, MBA, Director, CorporateCommunications & Investor Relations, +1-206-442-6744, or media relations,Susan W. Specht, MBA, Associate Director, Corporate Communications,+1-206-442-6592, both of ZymoGenetics, Inc.
Web site: http://www.zymogenetics.com/
