Ad hoc: GPC Biotech AG: GPC Biotech Reports that Marketing Authorization Application forSatraplatin is to be Withdrawn

Freitag, 25.07.2008 22:10 von Hugin - Aufrufe: 958

GPC Biotech AG / Misc. matters / GPC Biotech Reports that Marketing 
Authorization Application for
Satraplatin is to be Withdrawn

Ad hoc announcement according to §15 WpHG processed and transmitted
by Hugin ASA. The issuer is solely responsible for the content of
this announcement.

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Martinsried/Munich (Germany) and Princeton, N.J., July 25, 2008 -
GPC Biotech AG (Frankfurt Stock Exchange: GPC, NASDAQ: GPCB) reported
that the Company has been informed by its partner for satraplatin in
Europe that they plan to withdraw the Marketing Authorization
Application (MAA) for satraplatin plus prednisone for the treatment
of hormone-refractory prostate cancer patients whose prior
chemotherapy has failed. This decision was based on a list of
outstanding issues received following review by the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMEA) of the filing, which indicates that the opinion of the
Committee is that the application is currently not approvable based
on the information provided. GPC Biotech is working closely with its
partners to determine the next steps regarding the development of
satraplatin.
 
End of Ad Hoc Announcement
 
This ad hoc announcement contains forward-looking statements, which
express the current beliefs and expectations of the management of GPC
Biotech, including statements about the efficacy and safety of
satraplatin. 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 ad hoc announcement.
Satraplatin may not be approved for marketing in a timely manner, if
at all. We direct you to GPC Biotech's Annual Report on Form 20-F
for the fiscal year ended December 31, 2007 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 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.
 
For further information, please contact:
 
GPC Biotech AG
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: +1 609-524-5884
usinvestors@gpc-biotech.com
 
Additional media contacts for Europe:
MC Services AG
Phone: +49 (0) 89 210 228 0
 
Raimund Gabriel
raimund.gabriel@mc-services.eu
 
Hilda Juhasz
hilda.juhasz@mc-services.eu
 
Additional investor contact for Europe:
Trout International LLC
Mike Booth, Senior Vice President
Phone: +44 207 936 9326
mbooth@troutgroup.com
 
--- End of Message ---
 
GPC Biotech AG
Fraunhoferstr. 20 Martinsried
 
WKN: 585150; ISIN:
DE0005851505; Index: CDAX, MIDCAP, Prime All Share, TecDAX, HDAX,
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