MARTINSRIED/MUNICH, Germany, July 12 /PRNewswire-FirstCall/ -- WALTHAM,
Mass. and PRINCETON, N.J. -- GPC Biotech AG (Frankfurt Stock Exchange: GPC;
TecDAX index; Nasdaq: GPCB) today announced that the Company has submitted
the non-clinical section of the rolling submission of a New Drug
Application (NDA) to 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). The
Company submitted the chemistry, manufacturing and controls -- or CMC --
section of the NDA in December 2005 and anticipates completing the NDA
submission by the end of 2006.
"The non-clinical section is the second of three parts necessary to
complete the NDA submission. We are very pleased that we continue to make
such good progress in advancing satraplatin toward the market and that we
remain on track with our timelines," said Bernd R. Seizinger, M.D., Ph.D.,
Chief Executive Officer. "The second half of 2006 promises to be of seminal
importance for GPC Biotech as we expect to have the final data on
progression- free survival from our SPARC registrational trial in the fall
and complete the NDA filing by the end of this year."
The FDA granted "fast track" designation to satraplatin as a
second-line chemotherapy treatment for patients with HRPC in September
2003. 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 rolling submission process enables companies that have been granted
fast track designation 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.
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. 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.
In December 2005, GPC Biotech completed accrual to the SPARC trial that
is evaluating satraplatin in combination with prednisone as second-line
chemotherapy in patients with hormone refractory prostate cancer. Also in
December 2005, GPC Biotech initiated the rolling submission of an NDA for
satraplatin with the FDA. The Company 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.
Satraplatin has been studied in clinical trials involving a range of
tumors, and Phase 2 trials have been completed in hormone-refractory
prostate cancer, ovarian cancer and small cell lung cancer. Other trials
evaluating the effects of satraplatin in combination with radiation
therapy, in combination with other cancer therapies and in various other
cancers are underway or planned. GPC Biotech in-licensed satraplatin from
Spectrum Pharmaceuticals, Inc. in 2002. Additional information on
satraplatin can be found in the Anticancer Programs section of the
Company's Web site at http://www.gpc-biotech.com.
About GPC Biotech
GPC Biotech AG is a biopharmaceutical company discovering and
developing new anticancer drugs. The Company's lead product candidate -
satraplatin - has achieved target enrollment in a Phase 3 registrational
trial as a second-line chemotherapy treatment in hormone-refractory
prostate cancer. The U.S. FDA has granted fast track designation to
satraplatin for this indication, and GPC Biotech has begun the rolling NDA
submission process for this compound. 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). The Company's wholly owned U.S. subsidiary has sites in Waltham,
Massachusetts and Princeton, New Jersey. For additional information, please
visit the Company's Web site at http://www.gpc-biotech.com.
This press release may contain forward-looking statements, including,
without limitation, statements about the progress and results of the
outcome of the SPARC trial and other clinical development activities,
regulatory processes and commercialization efforts for satraplatin.
Forward-looking statements are based on the Company's current expectations
and projections about future events and are subject to risks, uncertainties
and assumptions in light of which the forward-looking events discussed in
this press release might not occur. We direct you to the Company's 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 these statements and the Company's
future results, performance and achievements. Readers are cautioned not to
place undue reliance on these forward-looking statements that speak only as
of the date of this release. Except as required by law, the Company does
not undertake any obligation to publicly update or revise any
forward-looking statements, whether as a result of new information, future
events or otherwise.
For further information, please contact:
GPC Biotech AG
Fraunhoferstr. 20
82152 Martinsried/Munich, Germany
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 Noonan Russo
Brian Hudspith
Phone: +44 (0)20 7379 5151
bhudspith@maitland.co.uk
In the U.S.:
Noonan Russo
Matt Haines
Phone: +1 212 845 4235
matthew.haines@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
Europe: Brian Hudspith of Maitland Noonan Russo, +44 (0)20 7379
5151, bhudspith@maitland.co.uk; or In the U.S.: Matt Haines of
Noonan Russo, +1-212-845-4235, matthew.haines@eurorscg.com
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