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Kyprolis

Treatment for Multiple Myeloma

Update: Kyprolis (carfilzomib) Now FDA Approved - July 20, 2012

Onyx Pharmaceuticals' Kyprolis Receives Positive Vote from Oncologic Drugs Advisory Committee (ODAC)

South San Francisco, CA. — Jun. 20, 2012-Onyx Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) determined by a vote of 11-0 [with 1 abstention] that, in patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent (IMiD), the benefit-risk assessment is favorable for the use of Kyprolis™ (proposed brand name for carfilzomib). Onyx is developing Kyprolis for use in multiple myeloma across a variety of treatment lines.

“Today’s ODAC recommendation is an important regulatory milestone in the review of Kyprolis for relapsed and refractory multiple myeloma,” said Ted W. Love, M.D., Executive Vice President, Research and Development and Technical Operations at Onyx Pharmaceuticals. “Onyx is committed to bringing Kyprolis to patients as quickly as possible and looks forward to working closely with the FDA as the agency completes its review.”

The Prescription Drug User Fee Act (PDUFA) date for completion of FDA review of the Kyprolis NDA for accelerated approval is July 27, 2012. The ODAC provides FDA with independent expert advice and recommendations, however the final decision regarding approval is made by FDA.

The Kyprolis NDA is based on the 003-A1 study, an open-label, single-arm Phase 2b trial as well as supportive data from additional studies. The 003-A1 trial evaluated 266 heavily-pretreated patients with relapsed and refractory multiple myeloma who had received at least two prior therapies, including bortezomib and either thalidomide or lenalidomide.

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 the Kyprolis (proposed brand name for carfilzomib) Development Program

Kyprolis is an investigational agent and is not approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) or other health authorities.

A new drug application (NDA) for Kyprolis for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior therapies is currently being reviewed by the U.S. FDA, and the anticipated date for completion of review is July 27, 2012. The NDA submission is based on the Kyprolis 003-A1 study, an open-label, single-arm Phase 2b trial, as well as safety data from additional studies.

Kyprolis is being studied in several clinical trials either as a single-agent or in combination with other therapies, including:
• A global Phase 3 clinical trial, known as the ASPIRE trial, has completed enrollment and is evaluating the combination of lenalidomide and low-dose dexamethasone with or without Kyprolis in patients with relapsed multiple myeloma who have received one to three prior therapies. The company has an agreement with the FDA on a Special Protocol Assessment (SPA) and has received Scientific Advice from the European Medicines Agency (EMA) on the design and planned analysis of the trial.
• A Phase 3 clinical trial, called the FOCUS trial, is evaluating single-agent Kyprolis in patients with relapsed and refractory myeloma who have received three or more prior therapies. The trial is designed to facilitate regulatory approvals around the world.
• A global Phase 3 clinical trial, called ENDEAVOR, is planned to begin enrolling patients in mid-2012. The head-to-head trial will evaluate the combination of Kyprolis and low-dose dexamethasone vs. the combination of bortezomib and low-dose dexamethasone.
• A Phase 1/2 study being conducted by Onyx’s partner Ono Pharmaceutical Co., Ltd is evaluating Kyprolis in Japanese patients with relapsed/refractory multiple myeloma.

About Onyx Pharmaceuticals, Inc.

Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer. The company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the company's website at www.onyx.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, the expanded access program, safety, regulatory processes, commercialization efforts or commercial potential of Kyprolis (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 submission, review, potential approval of the NDA, 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, 2011, 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

 

Posted: June 2012

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