Cougar Biotechnology Announces Initiation of Phase III Trial of CB7630 (Abiraterone...

Cougar Biotechnology Announces Initiation of Phase III Trial of CB7630 (Abiraterone Acetate)

LOS ANGELES--(Business Wire)--
Cougar Biotechnology, Inc. (NASDAQ: CGRB) today announced that it
has started enrolling patients in its Phase III clinical trial
(COU-AA-301) of the Company's lead drug candidate CB7630 (abiraterone
acetate). The Phase III trial is a randomized, double-blind,
placebo-controlled trial of CB7630 plus prednisone in patients with
metastatic castration-resistant prostate cancer who have failed
docetaxel-based chemotherapy. Similar to the patient populations in
Cougar's Phase II trials COU-AA-003 and COU-AA-004, patients are
allowed to have received up to two prior chemotherapy regimens before
entering the trial. The trial will enroll approximately 1,160 patients
who will be randomized (2:1) to receive either CB7630 plus prednisone
or placebo plus prednisone. The trial will be conducted at
approximately 150 sites in North America, Europe and Australia. The
primary endpoint of the trial will be overall survival.

Alan H. Auerbach, Chief Executive Officer and President of Cougar
Biotechnology, said, "Commencing the Phase III trial of abiraterone
acetate represents an important milestone in the global development of
CB7630. The COU-AA-301 trial represents one of several options for
registration of CB7630 in prostate cancer that Cougar intends to
pursue. We also look forward to pursuing additional registration
opportunities for CB7630, including a potential Phase III trial of the
drug in patients with castration-resistant, chemotherapy-naive
prostate cancer, which we anticipate initiating in the second half of
2008."

Arturo Molina, M.D., M.S., FACP, Cougar's Senior Vice President of
Clinical Research and Development, added, "The results of our Phase II
trials of CB7630 have shown strong evidence of antitumor activity in
patients with metastatic, castration-resistant prostate cancer who
have failed docetaxel-based chemotherapy; therefore, we are pleased to
be able to initiate the COU-AA-301 trial in this patient population."

About Cougar Biotechnology

Cougar Biotechnology, Inc. is a Los Angeles-based biotechnology
company established to in-license and develop clinical stage drugs,
with a specific focus on the field of oncology. Cougar's oncology
portfolio includes CB7630, a targeted inhibitor of the 17-alpha
hydroxylase/c17,20 lyase enzyme, which is currently being tested in
Phase III clinical trials in prostate cancer; CB3304, an inhibitor of
microtubule dynamics, which is currently in a Phase I trial in
multiple myeloma; and CB1089, an analog of vitamin D, which has been
clinically tested in a number of solid tumor types.

Further information about Cougar Biotechnology can be found at
www.cougarbiotechnology.com.

This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. These
statements are often, but not always, made through the use of words or
phrases such as "anticipates," "expects," "plans," "believes,"
"intends," and similar words or phrases. These forward-looking
statements include, without limitation, statements related to the
number of subjects to be enrolled in the COU-AA-301 study and the pace
of such enrollment, the number of sites at which COU-AA-301 will be
conducted, the initiation of other clinical trials of CB7630,
additional FDA registration strategies for CB7630, the benefits to be
derived from Cougar's drug development programs, including the
potential advantages of CB7630 and its potential for use in the
treatment of CRPC and in second line hormone and chemotherapy
treatment settings. Such statements involve risks and uncertainties
that could cause Cougar's actual results to differ materially from the
anticipated results and expectations expressed in these
forward-looking statements. These statements are only predictions
based on current information and expectations and involve a number of
risks and uncertainties. Actual events or results may differ
materially from those projected in any of such statements due to
various factors, including the risks and uncertainties inherent in
clinical trials, and drug development and commercialization, including
the uncertainty of whether results of prior clinical trials of CB7630
will be predictive of results of later stage clinical trials,
including COU-AA-301. For a discussion of these and other factors,
please refer to Cougar's annual report on Form 10-KSB for the year
ended December 31, 2007 as well as other subsequent filings with the
Securities and Exchange Commission. You are cautioned not to place
undue reliance on these forward-looking statements, which speak only
as of the date hereof. This caution is made under the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
All forward-looking statements are qualified in their entirety by this
cautionary statement and Cougar undertakes no obligation to revise or
update this press release to reflect events or circumstances after the
date hereof.

Cougar Biotechnology, Inc.
+1-310-943-8040
Alan H. Auerbach, Chief Executive Officer and President
ahauerbach@cougarbiotechnology.com
Mariann Ohanesian, Director of Investor Relations
mohanesian@cougarbiotechnology.com
or
Russo Partners, LLC
David Schull, +1-212-845-4271
David.schull@russopartnersllc.com
Andreas Marathovouniotis, +1-212-845-4235
Andreas.marathis@russopartnersllc.com

Copyright Business Wire 2008