ODAC briefing documents now available online on FDA website
MARTINSRIED/MUNICH, Germany, July 20 /PRNewswire-FirstCall/ -- and
PRINCETON, N.J. -- GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX
index; Nasdaq: GPCB) today announced that the Company will hold a
conference call on July 25, 2007 at 7:00 AM CET/1:00 AM ET to discuss the
recommendation of the Oncologic Drugs Advisory Committee (ODAC) relating to
satraplatin for the treatment of patients with hormone-refractory prostate
cancer whose disease has progressed after prior chemotherapy. The ODAC
meeting will be held on Tuesday, July 24, 2007 and its outcome will be
published in advance of the conference call.
The Company also announced that the U.S. Food and Drug Administration
(FDA) has posted on its website briefing documents for the ODAC meeting.
Documents posted on the FDA website include briefs submitted by GPC Biotech
and the FDA. The briefing documents can be accessed at
http://www.fda.gov/ohrms/dockets/ac/cder07.htm#OncologicDrugs
Dial-in information for GPC Biotech conference call on July 25th
Participants may listen to the Company's conference call via live
webcast, accessible through the GPC Biotech Web site at http://www.gpc-biotech.com
or via telephone. A replay will be available on the Web site following the
live event. The call, which will be conducted in English, will be held on
July 25, 2007 at 7:00 AM CET/1:00 AM ET, prior to the opening of the German
markets. The dial-in numbers for the call are as follows:
Participants from Europe: +49 (0)89 9982 99910 or +44 (0)20 7806 1950
Participants from the U.S.: 1-718-354-1385
Please dial in 10 minutes before the beginning of the call.
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 under review by
the U.S. FDA for hormone-refractory prostate cancer patients whose prior
chemotherapy has failed. Satraplatin was in-licensed from Spectrum
Pharmaceuticals, Inc. 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.
The ODAC will report to the FDA and make recommendations and we expect
the report of the ODAC to the FDA on satraplatin to be an important element
in the FDA's review of our NDA. However, views of the ODAC may differ from
those of the FDA and there can be no guarantee that the FDA will follow the
ODAC's recommendations.
SOURCE GPC Biotech AG
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Related links:
http://www.gpc-biotech.com
CONTACT:
GPC Biotech AG, Martin Braendle, Director,
Investor Relations & Corporate Communications, +49 89 8565-2693,
ir@gpc-biotech.com; In the U.S.: Laurie Doyle, Director, Investor
Relations & Corporate Communications, +1-609- 524-5884,
usinvestors@gpc-biotech.com; In Europe: Maitland, Brian Hudspith,
+44 20 7379 5151, bhudspith@maitland.co.uk, In the U.S.: Russo
Partners, LLC, David Schull, +1-212-845-4271,
david.schull@russopartnersllc.com
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