MARTINSRIED/MUNICH, Germany and WALTHAM, Mass. and PRINCETON, N.J.,
April 16 /PRNewswire-FirstCall/ -- -- GPC Biotech AG (Frankfurt Stock
Exchange: GPC; TecDAX index; Nasdaq: GPCB) today announced that the U.S.
Food and Drug Administration (FDA) has accepted for filing the Company's
New Drug Application (NDA) for satraplatin in combination with prednisone
for patients with hormone-refractory prostate cancer (HRPC) whose prior
chemotherapy has failed. The Company also announced that the FDA has
granted the NDA priority review status. Priority review designation is
intended for those products that address significant unmet medical needs
and sets the target date for FDA action at six months from the date of
submission. GPC Biotech completed the rolling submission of the NDA for
satraplatin on February 15, 2007. The application will be reviewed under
the provisions of 21 CFR 314 Subpart H, for accelerated approval.
"We are pleased that the FDA has accepted our application for filing
and granted it priority review status. We look forward to working closely
with the agency during the review process," said Bernd R. Seizinger, M.D.,
Ph.D., Chief Executive Officer. "With the designation of priority review,
we expect an action on the application from the FDA in August of this year
and are thus moving forward with commercialization plans for satraplatin.
If approved, we believe that satraplatin has the potential to become an
important therapy for hormone-refractory prostate cancer patients whose
disease has progressed after prior chemotherapy, an area of unmet medical
need."
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.
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.
A Phase 3 registrational trial, called SPARC, is evaluating satraplatin
plus prednisone versus placebo plus prednisone in 950 patients with
hormone- refractory prostate cancer who have failed prior chemotherapy.
Data from the trial on progression-free survival and on safety have been
presented at recent medical conferences. In accordance with the
recommendation of the independent Data Monitoring Board for the SPARC
trial, patients who have not progressed continue to be treated and all
patients will be followed for overall survival.
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. Pharmion has indicated it expects
to complete the Marketing Authorization Application (MAA) for satraplatin
for Europe in the second quarter of 2007. 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.
In addition, GPC Biotech launched in February the Satraplatin Expanded
Rapid Access protocol (SPERA) in the U.S. Expanded access programs are
intended to give patients access to investigational drugs to treat serious
or life-threatening diseases or conditions for which there are no adequate
therapies available. Under the SPERA protocol, satraplatin will be provided
to hormone-refractory prostate cancer patients who have failed prior
chemotherapy free of charge until satraplatin is cleared for marketing in
the U.S. U.S. physicians interested in receiving more information about
SPERA can contact 1- 800-349-8086.
About GPC Biotech
GPC Biotech AG is a biopharmaceutical company discovering and
developing new anticancer drugs. GPC Biotech's lead product candidate
satraplatin is currently under review by the U.S. FDA in combination with
prednisone as a second-line chemotherapy treatment in 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 its
wholly owned U.S. subsidiary has sites in Waltham, Massachusetts and
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, 2005 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.
Investor and Media Contacts:
Martin Braendle
Director, Investor Relations & Corporate Communications
Phone: +49 (0)89 8565-2693
ir@gpc-biotech.com
In the U.S.: Laurie Doyle
Director, Investor Relations & Corporate Communications
Phone: +1 781 890 9007 X267
usinvestors@gpc-biotech.com
Additional Media Contacts:
In Europe:
Maitland
Brian Hudspith
Phone: +44 (0)20 7379 5151
bhudspith@maitland.co.uk
In the U.S.:
Noonan Russo
David Schull
Phone: +1 212 845-4271
david.schull@eurorscg.com
SOURCE GPC Biotech AG
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Related links:
http://www.gpc-biotech.com/
CONTACT:
Martin Braendle, Director, Investor Relations
& Corporate Communications, +49 (0)89 8565-2693,
ir@gpc-biotech.com, or Laurie Doyle, Director, Investor Relations
& Corporate Communications, +1-781-890-9007 ext. 267,
usinvestors@gpc-biotech.com, both of GPC Biotech AG; or In the
U.S.: David Schull of Noonan Russo, +1-212-845-4271,
david.schull@eurorscg.com; or In Europe: Brian Hudspith of
Maitland Noonan Russo, +44 (0)20 7379 5151,
bhudspith@maitland.co.uk
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