Proteolix, Inc. to be Acquired By Onyx Pharmaceuticals
October 12 2009 - 6:00AM
PR Newswire (US)
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 http://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 http://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 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 DATASOURCE: Proteolix, Inc. CONTACT:
Investors, Craig C. Parker, Senior VP, Finance and Corporate
Development & Chief Financial Officer, +1-650-266-2610, ; 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/
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