GPC Biotech Reports That Marketing Authorization Application for Satraplatin is to Be Withdrawn
July 25 2008 - 3:15PM
Business Wire
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. Bernd R. Seizinger, M.D., Ph.D.,
Chief Executive Officer of GPC Biotech said: �Although we
previously communicated that the approval of the MAA for
satraplatin would be challenging, today�s outcome is nevertheless
disappointing. We are working closely with our partners to
determine the next steps regarding the development of satraplatin
and continue to focus our other efforts on advancing our RGB-286638
kinase inhibitor into the clinic and exploring various merger and
acquisition opportunities.� About GPC Biotech GPC Biotech AG is a
publicly traded biopharmaceutical company focused on anticancer
drugs. GPC Biotech's lead product candidate is satraplatin, an oral
platinum compound. The Company has various anti-cancer programs in
research and development that leverage its expertise in kinase
inhibitors. GPC Biotech AG is headquartered in Martinsried/Munich
(Germany) and has a wholly owned U.S. subsidiary in Princeton, New
Jersey. For additional information, please visit GPC Biotech's Web
site at www.gpc-biotech.com. This press release 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 press release.
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.
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