Onyx Pharmaceuticals Receives $15 Million Milestone Payment From Bayer
December 18 2003 - 6:00AM
PR Newswire (US)
Onyx Pharmaceuticals Receives $15 Million Milestone Payment From
Bayer Milestone Achieved with Initiation of Phase III Clinical
Trial RICHMOND, Calif., Dec. 18 /PRNewswire-FirstCall/ -- Onyx
Pharmaceuticals, Inc. today announced that it has received a $15
million creditable milestone-based payment from Bayer
Pharmaceuticals Corporation related to the development of BAY
43-9006, a novel anti-cancer compound, which the two companies are
co-developing. The milestone was achieved upon the previously
announced initiation of the first Phase III clinical trial for BAY
43-9006. This is the second milestone payment Onyx has received
from Bayer. The first payment of $5 million was paid when the two
companies began the first Phase II trial of BAY 43-9006 in 2002. In
addition, Onyx can achieve two more milestones, each triggering a
creditable milestone-based payment from Bayer of $10 million. The
first of these milestones is the filing of a New Drug Application
(NDA), and the second is the approval of BAY 43-9006 in any one of
the United States, Germany, Italy, Spain or the United Kingdom. All
milestone payments are repayable to Bayer from a portion of Onyx's
future profits and royalties. BAY 43-9006 is an orally active small
molecule in Phase III clinical testing for patients with advanced
renal cancer. The compound is also being studied in two ongoing
Phase II trials, as well as eight Phase Ib studies evaluating its
use in combination with standard chemotherapeutics. This novel
signal transduction inhibitor has a dual mechanism of action,
targeting both cell proliferation and angiogenesis (formation of
blood vessels). By inhibiting RAF kinase, BAY 43-9006 blocks the
RAS/MEK/ERK signaling pathway in cells, an important mediator of
tumor cell proliferation. BAY 43-9006 also exerts an
anti-angiogenic effect, which could come from both direct effects
on the VEGFR-2 and PDGFR-beta receptors, as well as from downstream
effects on RAF kinase. Under the co-development agreement between
Bayer and Onyx, Onyx funds 50 percent of the development costs for
BAY 43-9006. In return, Onyx will have a 50/50 profit share in the
United States, if it elects to co-promote the product and continues
to fund development costs. Everywhere else in the world, except
Japan, Bayer has exclusive marketing rights, and Onyx's share of
any profits will be less than 50 percent. In Japan, Bayer will fund
all product development, and Onyx will receive a royalty on any
product sales. Onyx Pharmaceuticals is engaged in the development
of novel cancer therapies that target the molecular basis of
cancer. With its partners, the company is developing small molecule
drugs, including BAY 43-9006 with Bayer Pharmaceuticals
Corporation. For more information about Onyx's pipeline and
activities, visit the company's web site at
http://www.onyx-pharm.com/. This news release contains
forward-looking statements regarding expectations as to the
company's plans as to the development of BAY 43-9006, including
further clinical testing and the timing of clinical trials; the
receipt of creditable milestone-based payments; the company's
expectations or beliefs of the commercial potential of BAY 43-9006;
and the mechanisms of action for BAY 43-9006. These forward-looking
statements involve a number of risks and uncertainties that could
cause actual events to differ from the company's expectations.
These risks are addressed in the company's periodic reports filed
with the Securities and Exchange Commission, including but not
limited to its Annual Report on Form 10-K filed on March 25, 2003
and its Quarterly Reports on Form 10-Q. DATASOURCE: Onyx
Pharmaceuticals, Inc. CONTACT: Julianna Wood, +1-510-262-8757, for
Onyx Pharmaceuticals, Inc. Web site: http://www.onyx-pharm.com/
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