GPC Biotech Withdraws Satraplatin NDA Filed for Accelerated Approval
July 30 2007 - 9:57AM
PR Newswire (US)
* Company Plans to Resubmit Application Pending Final Survival
Analysis MARTINSRIED/MUNICH, Germany, July 30
/PRNewswire-FirstCall/ -- PRINCETON, N.J. -- GPC Biotech AG
(Frankfurt Stock Exchange: GPC; TecDAX index; Nasdaq: GPCB) today
announced that it has withdrawn the satraplatin capsules New Drug
Application (NDA) filed for accelerated approval for the treatment
of hormone- refractory prostate cancer patients whose prior
chemotherapy has failed. The Company based its decision on the vote
by the Oncologic Drugs Advisory Committee (ODAC) to the U.S. Food
and Drug Administration (FDA) on July 24, 2007 that the FDA should
wait for the final survival analysis of the SPARC trial before
deciding whether satraplatin is approvable. The Company anticipates
overall survival results from the SPARC trial to be available
within six months. However, this timing is based on an
extrapolation of death rates in the trial and may change. "While we
were very surprised and disappointed by last week's ODAC outcome,
we need to move forward," said Bernd R. Seizinger, M.D., Ph.D.,
Chief Executive Officer of GPC Biotech. "Thus, we are focusing our
efforts on the overall survival results from the satraplatin SPARC
trial and integrating these data into the strongest possible NDA
submission. If these data are positive, we plan to submit an NDA to
the FDA as quickly as possible." About Satraplatin Satraplatin, an
investigational drug, is a member of the platinum family of
compounds. Platinum-based drugs are a critical part of modern
chemotherapy treatments and are used to treat a wide variety of
cancers. All platinum drugs currently on the market require
intravenous administration. Satraplatin is an oral compound that
clinical trial patients are able to take at home. Satraplatin is
not currently approved by the FDA in the United States, by the EMEA
in the European Union or any other regulatory authority, and no
conclusions can or should be drawn regarding its safety and
efficacy. A Phase 3 registrational trial, called SPARC, is
evaluating satraplatin plus prednisone versus placebo plus
prednisone in 950 patients with hormone- refractory prostate cancer
whose prior chemotherapy has failed. Patients who have not
progressed continue to be treated and all patients are being
followed for overall survival. In July 2007, ODAC recommended that
the FDA should wait for the final survival analysis of the SPARC
trial before deciding whether satraplatin is approvable. GPC
Biotech has a co-development and license agreement with Pharmion
GmbH, a wholly owned subsidiary of Pharmion Corporation, under
which Pharmion has been granted exclusive commercialization rights
to satraplatin for Europe and certain other territories. GPC
Biotech has also entered into an agreement with Yakult Honsha Co.
Ltd. under which Yakult has been granted exclusive
commercialization rights to satraplatin for Japan. GPC Biotech
in-licensed satraplatin from Spectrum Pharmaceuticals, Inc. in
2002. Satraplatin has been studied in clinical trials involving a
range of tumors. Trials evaluating the effects of satraplatin in
combination with radiation therapy, in combination with other
cancer therapies and in a number of cancer types are underway or
planned. About GPC Biotech GPC Biotech AG is a publicly traded
biopharmaceutical company focused on discovering, developing and
commercializing new anticancer drugs. GPC Biotech's lead product
candidate satraplatin is currently in a Phase 3 registrational
trial in second-line hormone-refractory prostate cancer. GPC
Biotech 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 AG is headquartered in
Martinsried/Munich (Germany) and has a wholly owned U.S. subsidiary
headquartered in Princeton, New Jersey. For additional information,
please visit GPC Biotech's Web site at http://www.gpc-biotech.com/.
This press release contains forward-looking statements, which
express the current beliefs and expectations of the management of
GPC Biotech AG, including statements about the status of the FDA
review process. Such statements are based on current expectations
and are subject to risks and uncertainties, many of which are
beyond our control, that could cause future results, performance or
achievements to differ significantly from the results, performance
or achievements expressed or implied by such forward-looking
statements. Actual results could differ materially depending on a
number of factors, and we caution investors not to place undue
reliance on the forward- looking statements contained in this press
release. In particular, there can be no guarantee that additional
information relating to the safety, efficacy or tolerability of
satraplatin may be discovered upon further analysis of data from
the SPARC trial or analysis of additional data from other ongoing
clinical trials for satraplatin. Furthermore, we cannot guarantee
that satraplatin will be approved for marketing in a timely manner,
if at all, by regulatory authorities nor that, if marketed,
satraplatin will be a successful commercial product. We direct you
to GPC Biotech's Annual Report on Form 20-F for the fiscal year
ended December 31, 2006 and other reports filed with the U.S.
Securities and Exchange Commission for additional details on the
important factors that may affect the future results, performance
and achievements of GPC Biotech. Forward-looking statements speak
only as of the date on which they are made and GPC Biotech
undertakes no obligation to update these forward-looking
statements, even if new information becomes available in the
future. Satraplatin has not yet been approved by the FDA in the
U.S., the EMEA in Europe or any other regulatory authority and no
conclusions can or should be drawn regarding its safety or
effectiveness. Only the relevant regulatory authorities can
determine whether satraplatin is safe and effective for the use(s)
being investigated. DATASOURCE: GPC Biotech AG CONTACT: GPC Biotech
AG - Martin Braendle, Director, Investor Relations & Corporate
Communications, +49 (0)89 8565-2693, ; In the U.S. - Laurie Doyle,
Director, Investor Relations & Corporate Communications,
+1-609-524-5884, ; Additional Media Contacts - In Europe - Brian
Hudspith of Maitland, +44 (0)20 7379 5151, ; In the U.S. - David
Schull of Russo Partners, LLC, +1-212-845-4271, Web site:
http://www.gpc-biotech.com/
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