Onyx Pharmaceuticals Announces Data Presentations Highlighting Carfilzomib Development Program at 52nd American Society of Hematology Annual Meeting

Full Data from Carfilzomib Phase 2b 003-A1 Study to be Presented

Emeryville, CA. — Nov. 09, 2010

Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced the presentation of several studies evaluating carfilzomib, a selective, next-generation proteasome inhibitor, at the American Society of Hematology (ASH) Annual Meeting, December 4-7, 2010, at the Orange County Convention Center in Orlando, FL.

“The accumulating carfilzomib data support the compound’s potential as a new treatment option for patients with multiple myeloma, and we are committed to bringing this promising compound to patients as quickly as possible,” said Ted W. Love, M.D., Executive Vice President and Head of Research and Development of Onyx Pharmaceuticals. “Based on the full results of the Phase 2b 003-A1 carfilzomib study, which will be presented at ASH, we plan to submit a New Drug Application (NDA) filing for accelerated approval as early as mid-2011.”

Carfilzomib data highlights include:

Results of PX-171-003-A1, An Open-Label, Single-Arm, Phase 2 Study of Carfilzomib In Patients with Relapsed and Refractory Multiple Myeloma
• Dr. David Siegel, Hackensack University Medical Center
• Tuesday, December 7, 2010, 7:30 - 7:45 a.m., Auditorium 320
• Oral Session Name: Myeloma - Therapy, excluding Transplantation: Myeloma and Amyloidosis - Novel Drugs
• Abstract #985

Carfilzomib, Lenalidomide, and Dexamethasone In Newly Diagnosed Multiple Myeloma: Initial Results of Phase 1/2 MMRC Trial
• Dr. Andrzej Jakubowiak, University of Michigan
• Monday, December 6, 2010, 7:00 - 7:15 p.m., Auditorium 230
• Oral Session: Myeloma - Therapy, excluding Transplantation: Myeloma Phase I/II Trials and Correlative Studies
• Abstract #862

Carfilzomib: High Single-Agent Response Rate with Minimal Neuropathy Even In High-Risk Patients (PX-171-004)
• Dr. Ravi Vij, Washington University School of Medicine
• Saturday, December 4, 2010, 5:30 - 7:30 p.m., Hall A3/A4
• Poster Session: Myeloma - Therapy, excluding Transplantation: Poster I
• Abstract #1938, Poster # I-918

Baseline Peripheral Neuropathy Does Not Impact the Efficacy and Tolerability of the Novel Proteasome Inhibitor Carfilzomib: Results of a Subset Analysis of a Phase 2 Trial In Patients with Relapsed and Refractory Multiple Myeloma (PX-171-003-A1)
• Dr. Thomas Martin, University of California, San Francisco
• Sunday, December 5, 2010, 6:00 - 8:00 p.m., Hall A3/A4
• Poster Session: Myeloma - Therapy, excluding Transplantation: Poster II
• Abstract #3031, Poster # II-911

Responses and Survival Are Not Affected by Cytogenetics In Patients with Relapsed and Refractory Multiple Myeloma Treated with Single-Agent Carfilzomib (PX-171-003-A1)
• Dr. Andrzej Jakubowiak, University of Michigan
• Saturday, December 4, 2010, 5:30 - 7:30 p.m., Hall A3/A4
• Poster Session: Myeloma - Therapy, excluding Transplantation: Poster I
• Abstract #1942, Poster # I-922

Long-Term Treatment and Tolerability of the Novel Proteasome Inhibitor Carfilzomib In Patients with Relapsed and/or Refractory Multiple Myeloma
• Dr. Sundar Jagannath, Mount Sinai School of Medicine
• Saturday, December 4, 2010, 5:30 - 7:30 p.m., Hall A3/A4
• Poster Session: Myeloma - Therapy, excluding Transplantation: Poster I
• Abstract #1953, Poster # I-933

Pooled Safety Analysis From Phase 1 and 2 Studies of Carfilzomib In Patients with Relapsed and/or Refractory Multiple Myeloma
• Dr. Seema Singhal, Northwestern University Medical School
• Saturday, December 4, 2010, 5:30 - 7:30 p.m., Hall A3/A4
• Poster Session: Myeloma - Therapy, excluding Transplantation: Poster I
• Abstract #1954, Poster # I-934

About the Carfilzomib Development Program
Carfilzomib is a selective, next generation proteasome inhibitor that has shown encouraging results in a broad clinical trial program in multiple myeloma.

Two recent additions to the carfilzomib development program include a large, randomized international Phase 3 clinical trial, known as the ASPIRE trial, studying the combination of lenalidomide and low dose dexamethasone with or without carfilzomib in patients with relapsed multiple myeloma. The company has an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) and received Scientific Advice from the European Medicines Agency (EMA) on the design and planned analysis of the ASPIRE trial. A second Phase 3 clinical trial, called the FOCUS trial, in evaluating carfilzomib in patients with relapsed and refractory myeloma in Europe. Carfilzomib is also being evaluated in advanced solid tumors.

About Multiple Myeloma
Multiple myeloma is the second most common hematologic cancer and results from an abnormality of plasma cells, usually in the bone marrow. In the United States, more than 50,000 people are living with multiple myeloma and approximately 20,000 new cases are diagnosed annually.i Worldwide, more than 180,000 people are living with multiple myeloma and approximately 86,000 new cases are diagnosed annually.ii

About Onyx Pharmaceuticals, Inc.
Onyx Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving the lives of people with cancer. The company, in collaboration with Bayer HealthCare Pharmaceuticals Inc., is developing and marketing Nexavar® (sorafenib) tablets, a small molecule drug that is currently approved for the treatment of liver cancer and advanced kidney cancer. Additionally, Nexavar is being investigated in several ongoing trials in a variety of tumor types. Beyond Nexavar, Onyx has established a development pipeline of anticancer compounds at various stages of clinical testing, including carfilzomib, a selective proteasome inhibitor, that is currently being evaluated in multiple clinical trials for the treatment of patients with relapsed or relapsed/refractory multiple myeloma and solid tumors. ONX 0801, an alpha-folate receptor targeted inhibitor of thymidylate synthase, and ONX 0912, an oral proteasome inhibitor, are currently in Phase 1 testing. For more information about Onyx, visit the company’s website at www.onyx-pharm.com.

Forward Looking Statements
This news release contains “forward-looking statements” of Onyx within the meaning of the federal securities laws. These forward-looking statements include without limitation, statements regarding the progress and results of the clinical development, safety, regulatory processes, commercialization efforts or commercial potential of carfilzomib. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including risks related to the development and commercialization of pharmaceutical products. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Reference should be made to Onyx’s Annual Report on Form 10-K for the year ended December 31, 2009, filed with the Securities and Exchange Commission under the heading “Risk Factors” and Onyx’s Quarterly Reports on Form 10-Q for a more detailed description of such factors. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. Onyx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release except as required by law.

 

iNational Cancer Institute, Surveillance Epidemiology and End Results, 2007 Facts and Figures
iiInternational Agency for Research on Cancer, GLOBOCAN 2002 database

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