Proteolix, Inc. to be Acquired By Onyx Pharmaceuticals

Acquisition Provides Onyx with a Late-Stage Next-Generation Therapy for Multiple Myeloma and a Leading Proteasome Inhibition Platform

SOUTH SAN FRANCISCO, Calif., Oct. 12 /PRNewswire/ -- Proteolix, Inc. today announced that it has signed a definitive agreement to be acquired by Onyx Pharmaceuticals, Inc. (NASDAQ:ONXX) . Proteolix is a privately-held biopharmaceutical company focused on discovering and developing novel therapies that target the proteasome for the treatment of hematological malignancies and solid tumors. Proteolix's lead compound, carfilzomib, is a proteasome inhibitor currently in multiple clinical trials, including an advanced Phase 2b clinical trial for patients with relapsed and refractory multiple myeloma.
 

"Proteolix has succeeded in pioneering a new class of potent proteasome inhibitors, as demonstrated by the promising data achieved in multiple studies of our lead candidate, carfilzomib. We believe Onyx truly shares our vision for carfilzomib as an important new therapy in oncology and recognizes Proteolix's scientific leadership in proteasome inhibition," said John A. Scarlett, M.D., President and Chief Executive Officer of Proteolix. "Onyx's proven track record and commercial resources in oncology are impressive. We are excited to join forces and together we are poised to advance carfilzomib through regulatory approval and achieve our ultimate objective of helping patients."
 

Under the terms of the transaction, Onyx will make a $276 million cash payment upon closing of the transaction. Additional payments include $40 million payable in 2010 based on the achievement of a development milestone and up to $535 million contingent upon the achievement of anticipated approvals for carfilzomib in the U.S. and Europe. Of the potential $535 million, a payment of $170 million is based upon the achievement of accelerated U.S. Food and Drug Administration approval. The transaction is expected to close in the fourth quarter of 2009, subject to the receipt of clearance under the Hart-Scott-Rodino Act and customary closing conditions.
 

Proteolix is a leader in developing therapeutics that inhibit the cellular proteasome, a validated and well-characterized approach to treating certain hematologic cancers. Carfilzomib is the first in a new class of selective and irreversible proteasome inhibitors. To date, carfilzomib has demonstrated strong response rates in multiple studies and a potentially more tolerable safety profile than currently approved agents. An ongoing accelerated approval Phase 2b trial in patients with relapsed and refractory multiple myeloma is expected to complete enrollment in 2009 with data anticipated in the second half of 2010. Carfilzomib is also being evaluated in a companion Phase 2 trial in relapsed multiple myeloma. A Phase 3 trial evaluating carfilzomib in combination with lenalidomide and dexamethasone as a potential treatment option for patients with multiple myeloma is expected to begin in 2010. Carfilzomib is also being evaluated in a Phase 1b/2 study for solid tumor cancers. In addition, Proteolix has discovered additional next-generation proteasome inhibitors to which it holds worldwide development and commercialization rights, including an oral proteasome inhibitor and a selective immunoproteasome inhibitor.
 

"Treatment options in multiple myeloma have historically been limited, and there is a tremendous need to expand the treatment paradigm with agents offering an improved efficacy and safety profile," said Michael Kauffman, M.D., Ph.D., Chief Medical Officer at Proteolix. "Carfilzomib is in multiple ongoing clinical studies and has revealed clear single-agent activity in a heavily pre-treated multiple myeloma patient population, as well as being well tolerated alone, or in combination with Revlimid. Upcoming data for carfilzomib could support the potential near-term introduction of a novel therapy for this debilitating disease."
 

Cooley Godward Kronish LLP acted as legal advisor to Proteolix on this transaction.
 

About Multiple Myeloma
 

Multiple myeloma (MM) 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 MM and approximately 20,000 new cases are diagnosed annually(i). Worldwide, more than 180,000 people are living with MM and approximately 86,000 new cases are diagnosed annually(ii).
 

About Carfilzomib
 

Carfilzomib is the first in a new class of highly specific proteasome inhibitors. Carfilzomib produces specific and sustained inhibition of the proteasome, leading to apoptosis in cancer cells with minimal off-target effects. In Phase 1 and Phase 2 clinical trials, carfilzomib has demonstrated single-agent activity in hematologic and solid tumors, including multiple myeloma and renal cancer. Proteolix is currently conducting a comprehensive clinical development program evaluating carfilzomib for the treatment of multiple myeloma, including two ongoing Phase 2 clinical trials of single-agent carfilzomib, one in heavily pre-treated relapsed and refractory patients with progressive disease who have failed to respond to prior treatment, and a second in relapsed patients stratified by prior treatment with bortezomib. A Phase 1b clinical trial of carfilzomib in combination with lenalidomide and dexamethasone in patients with relapsed multiple myeloma is also ongoing. In addition, based on promising Phase 1 results, Proteolix is conducting a single-agent Phase 1b/2 clinical trial of carfilzomib in patients with recurrent or advanced solid tumors. For the latest information regarding ongoing carfilzomib clinical trials, please visit www.clinicaltrials.gov.
 

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®, a small molecule drug. Nexavar 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. For more information about Onyx, visit the company's website at www.onyx-pharm.com.
 

About Proteolix, Inc.
 

Founded in December 2003, Proteolix, Inc. is a privately-held biopharmaceutical company, headquartered in South San Francisco, dedicated to discovering, developing and commercializing novel therapeutics that target protein degradation pathways for cancer and autoimmune diseases. Proteolix's lead product, carfilzomib, is the first in a new class of highly specific proteasome inhibitors, and is currently in multiple Phase 2 clinical studies to evaluate its safety and efficacy in multiple myeloma and other malignancies. Proteolix is also developing a pipeline of novel proteasome inhibitors, including an oral proteasome inhibitor and a selective immunoproteasome inhibitor.
 

Venture capital investors in Proteolix include U.S. Venture Partners, Advanced Technology Ventures, Latterell Venture Partners, Delphi Ventures, The Vertical Group, Nomura Phase4 Ventures and Westfield Capital Management.
 

  CONTACT:

  Investors:
  Craig C. Parker
  Senior VP, Finance and Corporate Development
  & Chief Financial Officer
  650-266-2610
  investors@proteolix.com

  Media Inquiries:
  BCC Partners
  Karen L. Bergman or Michelle Corral
  650-575-1509 or 415-794-8662

(i) National Cancer Institute, Surveillance Epidemiology and End Results, 2007 Facts and Figures
 

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

Source: Proteolix, Inc.

CONTACT: Investors, Craig C. Parker, Senior VP, Finance and Corporate
Development & Chief Financial Officer, +1-650-266-2610,
investors@proteolix.com; Media Inquiries, Karen L. Bergman, +1-650-575-1509,
or Michelle Corral, +1-415-794-8662, both of BCC Partners
 

Web Site: http://www.proteolix.com/
http://www.onyx-pharm.com/
 

Posted: October 2009


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