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
