Onyx Pharmaceuticals Announces Carfilzomib Data Presentations at 13th International Myeloma Workshop

SOUTH SAN FRANCISCO, Calif., April 28, 2011 /PRNewswire/ -- Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced the presentation of several studies evaluating carfilzomib, a selective, next-generation proteasome inhibitor, at the 13th International Myeloma Workshop (IMW), May 3-6, 2011, in Paris, France.

"The data we are accumulating for carfilzomib continues to support its potential as an important new treatment option for patients with multiple myeloma.  Data from several studies will be presented at the upcoming IMW meeting, including interim data in newly diagnosed patients from a Multiple Myeloma Research Consortium study being led by Dr. Andrzej Jakubowiak at the University of Michigan Comprehensive Cancer Center that is evaluating carfilzomib in combination with a standard therapy," said Ted W. Love, M.D., Executive Vice President and Head of Research and Development and Technical Operations at Onyx Pharmaceuticals. "Onyx is committed to bringing this promising therapy to patients as quickly as possible and remains on track for filing a new drug application with the U.S. Food and Drug Administration as early as mid-year under the accelerated approval process.  We are also actively enrolling patients in the Phase 3 FOCUS trial for the treatment of patients with relapsed and refractory myeloma to support a filing with the European Medicines Agency, as well as, in the Phase 3 ASPIRE trial in relapsed multiple myeloma."

Carfilzomib data highlights include:

Carfilzomib and other new proteasome inhibitors: Clinical data

• Andrzej Jakubowiak, M.D., Ph.D., University of Michigan Comprehensive Cancer Center, USA
• Thursday, May 5, 2011, 14:19 – 14:31
• Oral Session Name: Plenary Session I: New Drugs and Therapeutic Approaches

Results of PX-171-003-A1, an open-label, single-arm, phase (PH) 2 study of carfilzomib (CFZ) in patients (pts) with relapsed/refractory multiple myeloma (R/R MM)

• David Siegel, M.D., Ph.D., John Theurer Cancer Center at Hackensack University Medical Center, USA
• Friday, May 6, 2011, 12:15 – 12:30
• Oral Session Name: Plenary Abstract Session II – O-13
• Abstract 305

CRD combination treatment with carfilzomib, lenalidomide (Revlimid®), and low dose dexamethasone is highly active in newly diagnosed multiple myeloma (MM): phase I/II MMRC study

• Andrzej Jakubowiak, M.D., Ph.D., University of Michigan Comprehensive Cancer Center, USA
• Thursday-Friday, May 5-6, 2011, all breaks
• Poster Session Section C: Clinical Studies (including Transplantation) – P-253
• Multiple Myeloma Research Consortium, Onyx Pharmaceuticals, Celgene Corporation and the University of Michigan Comprehensive Cancer Center are co-sponsors of the study

Phase (Ph) 1b evaluation of the safety and efficacy of a 30-minute IV infusion of carfilzomib (CFZ) in patients (pts) with relapsed and/or refractory (R/R) multiple myeloma (MM)

• David Siegel, M.D., Ph.D., John Theurer Cancer Center at Hackensack University Medical Center, USA
• Tuesday-Wednesday, May 3-4, 2011, all breaks
• Poster Session Section C: Clinical Studies (including Transplantation) – P-207
• Abstract 309

Phase (Ph) 1b/2 dose-ranging study of carfilzomib (CFZ) in combination with lenalidomide (LEN) and dexamethasone (LODEX) in relapsed/refractory multiple myeloma (R/R MM)

• Ruben Niesvizky, M.D., Weill Medical College of Cornell University, USA
• Tuesday-Wednesday, May 3-4, 2011, all breaks
• Poster Session Section C: Clinical Studies (including Transplantation) – P-209
• Abstract 318

Carfilzomib (CFZ) in patients with relapsed and/or refractory multiple myeloma (R/R MM): summary of safety and efficacy data upon long-term treatment

• David Siegel, M.D., Ph.D., John Theurer Cancer Center at Hackensack University Medical Center
• Tuesday-Wednesday, May 3-4, 2011, all breaks
• Poster Session Section C: Clinical Studies (including Transplantation) – P-210
• Abstract 321

Carfilzomib (CFZ) produces a high single-agent response rate with minimal neuropathy even in relapsed multiple myeloma (MM) patients (pts) with high-risk disease

• Michael Wang, M.D., The University of Texas MD Anderson Cancer Center, USA
• Tuesday-Wednesday, May 3-4, 2011, all breaks
• Poster Session Section C: Clinical Studies (including Transplantation) – P-211
• Abstract 322

Effects of cytogenetics on responses and survival in patients with relapsed and refractory multiple myeloma (R/R MM) treated with single-agent carfilzomib (CFZ)

• Andrzej Jakubowiak, M.D., Ph.D., University of Michigan Comprehensive Cancer Center
• Tuesday-Wednesday, May 3-4, 2011, all breaks
• Poster Session Section C: Clinical Studies (including Transplantation) – P-205
• Abstract 297

About the Carfilzomib Development Program

The carfilzomib development program includes a 700-patient, 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 received Scientific Advice from the European Medicines Agency (EMA) and has an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) on the design and planned analysis of the ASPIRE trial. Carfilzomib is also being evaluated in the Phase 3 European FOCUS trial, which is designed to support a European registrational filing.  Carfilzomib is also being evaluated in a broad investigator sponsored trial program including first-line multiple myeloma, combination studies, lymphoma and other malignancies.

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 Europe, it is estimated that more than 60,000 people are living with multiple myeloma and approximately 21,000 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.

Important Safety Considerations For Patients Taking Nexavar

NEXAVAR in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer. Nexavar may cause fetal harm when administered to a pregnant woman. Women of childbearing potential are advised to avoid becoming pregnant and female patients should also be advised against breast-feeding while receiving Nexavar.

Cardiac ischemia and/or myocardial infarction may occur. Temporary or permanent discontinuation of Nexavar should be considered in patients who develop cardiac ischemia and/or myocardial infarction.  Gastrointestinal perforation was an uncommon adverse reaction and has been reported in less than 1% of patients taking Nexavar.

Uncommon but serious adverse reactions including keratoacanthomas/squamous cell cancer of the skin and Stevens - Johnson Syndrome have been reported in clinical trials.

An increased risk of bleeding may occur following Nexavar administration. If bleeding necessitates medical intervention, consider discontinuation of Nexavar.  Hypertension may occur early in the course of treatment. Monitor blood pressure weekly during the first 6 weeks and periodically thereafter and treat, as required.

Hand-foot skin reaction and rash are common and management may include topical therapies for symptomatic relief.  In cases of any severe or persistent adverse reactions, temporary treatment interruption, dose modification, or permanent discontinuation of Nexavar should be considered. Temporary interruption of Nexavar therapy is recommended in patients undergoing major surgical procedures.

Elevations in serum lipase and reductions in serum phosphate of unknown etiology have been associated with Nexavar.  Caution is recommended when administering Nexavar with compounds that are metabolized/eliminated predominantly by the UGT1A9 pathway, UGT1A1 pathway (eg, irinotecan), doxorubicin, docetaxel, fluorouracil, and substrates of CYP2B6 and CYP2C8, and CYP3A4 inducers.  Concomitant use of carboplatin and paclitaxel with sorafenib resulted in an increase in paclitaxel exposure and an increase in Nexavar exposure.  Patients taking concomitant warfarin should be monitored regularly for changes in prothrombin time, INR, or clinical bleeding episodes. Nexavar exposure decreases when co-administered with oral neomycin. Effects of other antibiotics on Nexavar pharmacokinetics have not been studied.

Most common adverse reactions reported for Nexavar-treated patients vs placebo-treated patients in unresectable HCC, respectively, were: diarrhea (55% vs 25%), fatigue (46% vs 45%), abdominal pain (31% vs 26%), weight loss (30% vs 10%), anorexia (29% vs 18%), nausea (24% vs 20%), and hand-foot skin reaction (21% vs 3%). Grade 3/4 adverse reactions were 45% vs 32%.

Most common adverse reactions reported for Nexavar-treated patients vs placebo-treated patients in advanced RCC, respectively, were: diarrhea (43% vs 13%), rash/desquamation (40% vs 16%), fatigue (37% vs 28%), hand-foot skin reaction (30% vs 7%), alopecia (27% vs 3%),and nausea (23% vs 19%). Grade 3/4 adverse reactions were 38% vs 28%.

For information about Nexavar including U.S. Nexavar prescribing information, visit www.nexavar.com or call 1.866.NEXAVAR (1.866.639.2827).

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, 2010, 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.  

(i) Myeloma Euronet. Frequently asked questions. Available at: http://www.myeloma-euronet.org/en/multiple-myeloma/faq.php

(ii) International Agency for Research on Cancer, GLOBOCAN 2002 database

SOURCE Onyx Pharmaceuticals, Inc.

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