SAN DIEGO, Jan. 10, 2011 /PRNewswire/ -- Ardea Biosciences,
Inc. (Nasdaq: RDEA) today announced that it has earned a
$15 million milestone payment from
Bayer HealthCare AG (Bayer) under the terms of their April 2009 global license agreement to develop
and commercialize Ardea's mitogen-activated ERK kinase (MEK)
inhibitor compounds for cancer and other indications. This
milestone was triggered by the initiation of a Phase 2 clinical
study evaluating BAY 86-9766 in combination with sorafenib
(Nexavar®; Bayer, Onyx Pharmaceuticals) for the treatment of
hepatocellular carcinoma, or primary liver cancer.
Upon receipt of this milestone payment, which is expected
shortly, Ardea will have received license fee and milestone
payments under the agreement totaling $50
million. Ardea is eligible to receive up to an
additional $357 million for
achievement of future development and commercialization milestones,
including $7.5 million for the
initiation of a second Phase 2 clinical study of BAY 86-9766 for a
different indication. Ardea will also be eligible to receive
low double-digit royalties on worldwide sales of products under the
license agreement.
"We are extremely pleased to have reached this important
clinical milestone in the development of BAY 86-9766," commented
Barry D. Quart, PharmD, Ardea's president and chief executive
officer. "Based on the good tolerability and impressive
number of patients who achieved stable disease or partial response
to treatment in Phase 1 trials in refractory patients with advanced
solid tumors, we believe BAY 86-9766 has the potential to be a
clinically important drug in the treatment of patients across
multiple tumor types. Including this milestone payment, we
ended 2010 with unaudited, pro-forma cash and short-term
investments of approximately $95
million, which will primarily be used to fund the further
development of RDEA594, our lead product candidate for the chronic
management of hyperuricemia and gout."
About Ardea Biosciences, Inc.
Ardea Biosciences, Inc., of San Diego,
California, is a biotechnology company focused on the
development of small-molecule therapeutics for the treatment of
serious diseases. RDEA594, our lead product candidate for the
chronic management of hyperuricemia and gout, is a once-daily, oral
inhibitor of the URAT1 transporter in Phase 2 clinical development.
Our next-generation URAT1 inhibitor program is currently in
preclinical development. BAY 86-9766, formerly known as
RDEA119, is a potent and specific inhibitor of mitogen-activated
ERK kinase (MEK) for the treatment of cancer being developed under
a global license agreement with Bayer HealthCare AG. BAY
86-9766 is currently in Phase 2 development in patients with
hepatocellular carcinoma in a combination study with sorafenib
(Nexavar®; Bayer, Onyx Pharmaceuticals). Bayer is also
investigating the activity of BAY 86-9766 in other tumor types in
combination with additional agents.
Statements contained in this press release regarding matters
that are not historical facts are "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995. Because such statements are subject to risks and
uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. Such
statements include, but are not limited to, statements regarding
our plans and goals, the expected properties and benefits of
RDEA594, BAY 86-9766 and our other compounds and the timing and
results of our preclinical, clinical and other studies. Risks
that contribute to the uncertain nature of the forward-looking
statements include risks related to the outcome of preclinical and
clinical studies, risks related to regulatory approvals, delays in
commencement of preclinical and clinical studies, costs associated
with our drug discovery and development programs, and risks related
to the outcome of our business development activities, including
collaboration or license agreements. These and other risks
and uncertainties are described more fully in our most recently
filed SEC documents, including our Annual Report on Form 10-K and
our Quarterly Reports on Form 10-Q, under the headings "Risk
Factors." All forward-looking statements contained in this
press release speak only as of the date on which they were made.
We undertake no obligation to update such statements to
reflect events that occur or circumstances that exist after the
date on which they were made.
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SOURCE Ardea Biosciences, Inc.