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http://www.arizonabiotech.com/

GPC Biotech Begins Rolling NDA Submission for Lead Drug Candidate
Satraplatin

MARTINSRIED/MUNICH, GERMANY -- -- 12/15/2005 -- Waltham, Mass. and
Princeton, N.J. -- GPC Biotech AG (Frankfurt: GPC) (TecDAX index)
(NASDAQ: GPCB) today announced that the Company has begun the
rolling submission of a New Drug Application (NDA) with the U.S.
Food and Drug Administration (FDA) for satraplatin in combination
with prednisone as a second-line chemotherapy treatment for patients
with hormone-refractory prostate cancer (HRPC). To begin the rolling
NDA process, the Company has submitted to the FDA the chemistry,
manufacturing and controls -- or CMC -- section of the NDA filing.

"It is very gratifying for us to begin the rolling NDA submission
process for our lead drug candidate satraplatin," said Bernd R.
Seizinger, M.D., Ph.D., Chief Executive Officer. "Building on our
recent achievement of reaching target enrollment in our Phase 3
registrational trial, it marks another important milestone in the
development process of satraplatin as a potential new treatment
option for patients with hormone-refractory prostate cancer. We are
focused on working with regulatory authorities to efficiently move
our compound through the filing and review process, with the
ultimate goal of making satraplatin available to patients as quickly
as possible."

The rolling submission process enables companies that have been
granted "fast track" designation by the FDA to submit sections of
the NDA to the agency as they become available, allowing the review
process to begin before the complete dossier has been submitted.
Under U.S. regulations, within sixty days after the receipt of such
a submission, the FDA will determine whether that application may be
filed. The filing of an application means that the FDA has
determined that the application is sufficiently complete to permit a
substantive review.

The FDA's fast track programs are intended to expedite the review of
drugs to treat serious or life-threatening conditions and that
demonstrate the potential to address unmet medical needs. The FDA
granted fast track designation to satraplatin as a second-line
chemotherapy treatment for patients with HRPC in September 2003.

About Satraplatin

Satraplatin, an investigational drug, is a member of the platinum
family of compounds. Over the past two decades, platinum-based drugs
have become a critical part of modern chemotherapy treatments and
are used to treat a wide variety of cancers. Worldwide sales of
these drugs exceeded $2.2 billion in 2004. Unlike the platinum drugs
currently on the market, all of which require intravenous
administration, satraplatin is an orally bioavailable compound and
is given as capsules that patients can take at home. An oral
platinum drug could offer key advantages, including ease of
administration and patient convenience, in a variety of
applications. Target enrollment has been achieved in a Phase 3
registrational trial -- the SPARC trial -- as a second-line
chemotherapy treatment for HRPC. GPC Biotech has completed a Special
Protocol Assessment with the U.S. FDA and has received a Scientific
Advice letter from the European regulatory authority, the European
Medicines Agency (EMEA). The FDA has also granted fast track
designation to satraplatin for this indication. Satraplatin was in-
licensed from Spectrum Pharmaceuticals, Inc.

Phase 2 trials have been completed in HRPC, ovarian cancer and small
cell lung cancer. Promising early clinical results have also been
shown when satraplatin is combined with radiation therapy, and a
Phase 1/2 study evaluating this combination in patients with non-
small cell lung cancer has been initiated. Several other studies
evaluating satraplatin in combination with other therapies and in
various cancers, including breast and lung cancers, are underway or
planned. Further information on satraplatin can be found in the
Anticancer Programs section of the Company's Web site at www.gpc-
biotech.com.

GPC Biotech AG is a biopharmaceutical company discovering and
developing new anticancer drugs. The Company's lead product
candidate -- satraplatin -- is currently in a Phase 3 registrational
trial as a second-line chemotherapy treatment in hormone-refractory
prostate cancer following completion of a Special Protocol
Assessment by the U.S. FDA and receipt of a Scientific Advice letter
from the European central regulatory authority, EMEA. The FDA has
also granted fast track designation to satraplatin for this
indication. The Company is also developing a monoclonal antibody
with a novel mechanism-of-action against a variety of lymphoid
tumors, currently in Phase 1 clinical development, and has ongoing
drug development and discovery programs that leverage its expertise
in kinase inhibitors. GPC Biotech has a multi-year alliance with
ALTANA Pharma AG working with the ALTANA Research Institute in the
U.S., which provides GPC Biotech with revenues through mid-2007. GPC
Biotech AG is headquartered in Martinsried/Munich (Germany). The
Company's wholly owned U.S. subsidiary has research and development
sites in Waltham, Massachusetts and Princeton, New Jersey. For
additional information, please visit the Company's Web site at
www.gpc-biotech.com.

This press release may contain projections or estimates about plans
and objectives relating to our future operations, products, or
services; future financial results; or assumptions underlying or
relating to any such statements. These statements are forward-
looking and are subject to risks and uncertainties, many of which
are beyond our control. Actual results could differ materially
depending on a number of factors, including the timing and effects
of regulatory actions, the results of clinical trials, the Company's
relative success developing and gaining market acceptance for any
new products, and the effectiveness of patent protection. There can
be no guarantee regarding the results of the SPARC trial or other
ongoing studies with satraplatin. There can be no guarantee that the
NDA filing for satraplatin will not be completed nor that
satraplatin will be approved for marketing in a timely manner, if at
all. We direct you to the Company's Annual Report on Form 20-F, as
amended, for the fiscal year ended December 31, 2004 and other
reports filed with the U.S. Securities and Exchange Commission for
additional details on the important factors that may affect the
Company's future results, performance and achievements. The Company
disclaims any intent or obligation to update these forward-looking
statements or the factors that may affect the Company's future
results, performance or achievements, even if new information
becomes available in the future.

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For further information, please contact:

GPC Biotech AG
Fraunhoferstr. 20
82152 Martinsried/Munich, Germany

Martin Braendle
Associate Director, Investor Relations & Corporate Communications
Phone: +49 (0)89 8565-2693
ir@gpc-biotech.com

In the U.S.: Laurie Doyle
Associate Director, Investor Relations & Corporate Communications
Phone: +1 781 890 9007 X267
usinvestors@gpc-biotech.com

Additional Media Contacts:

In Europe:
Maitland Noonan Russo
Brian Hudspith
Phone: +44 (0)20 7379 5151
bhudspith@maitland.co.uk

In the U.S.:
Euro RSCG Life NRP
Emily Poe
Phone: +1 212 845 4266
emily.poe@eurorscg.com

SOURCE: GPC Biotech AG

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