Attached files
file | filename |
---|---|
8-K - FORM 8-K - Ardea Biosciences, Inc./DE | a58321e8vk.htm |
Exhibit 99.1
Contact: | John Beck Ardea Biosciences, Inc. (858) 652-6523 jbeck@ardeabio.com |
Ardea Biosciences Earns $15 Million Payment from Bayer HealthCare AG for
Achievement of Important Clinical Milestone in Ongoing Collaboration
Achievement of Important Clinical Milestone in Ongoing Collaboration
Bayer Advances BAY 86-9766 into Phase 2 Clinical Trial for Liver Cancer
SAN DIEGO,
January 10, 2011 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 Ardeas 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, Ardeas 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.
###