Gpc Biotech AG ADS (MM) (NASDAQ:GPCB)
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GPC Biotech AG (Frankfurt Stock Exchange: GPC; NASDAQ: GPCB) today
announced the granting of a European Patent (EP 1 720 540 B1) related to
satraplatin, a novel, oral platinum compound. The patent is entitled, “Satraplatin
for treating resistant or refractory tumors”
and covers certain uses of satraplatin related to the treatment of a
cancer or tumor resistant or refractory to a taxane, including docetaxel
(Taxotere®) and
paclitaxel (Taxol®).
The term of the patent extends up to 2025.
“Docetaxel is the standard of care for the
first-line treatment of patients with hormone-refractory prostate
cancer, or HRPC, and approximately half of the patients in the
satraplatin Phase 3 SPARC trial in second-line HRPC were previously
treated with docetaxel,” said Bernd R.
Seizinger, M.D., Ph.D., Chief Executive Officer. “With
an active filing for satraplatin under review in Europe, we believe this
patent will be of particular commercial importance, should satraplatin
be approved for HRPC patients whose prior chemotherapy has failed.”
The Company conducted the SPARC Phase 3 trial evaluating satraplatin in
combination with prednisone in the second-line treatment of patients
with HRPC. Approximately 50% of patients recruited into the study had
progressive disease following prior treatment with docetaxel. The SPARC
trial results showed a statistically significant improvement in
progression-free survival in the overall intent-to-treat (ITT)
population, as well as in the group of patients who had progressed after
receiving docetaxel. While the overall survival results in the overall
ITT population did not show a difference between the two treatment arms,
there was a positive trend toward improved survival observed in those
patients whose disease had progressed after receiving docetaxel, when
adjusting for the three significant prognostic factors in the SPARC trial*.
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.
All platinum drugs currently on the market require intravenous
administration. Satraplatin is an oral compound that clinical trial
patients are able to take at home. A Marketing Authorization Application
for satraplatin in combination with prednisone is currently under review
in Europe for the treatment of hormone-refractory prostate cancer
patients whose prior chemotherapy has failed. A decision on the filing
by the European regulators is expected in the second half of 2008.
Celgene Corporation is responsible for the regulatory filings for
satraplatin and its development and commercialization for Europe and
certain other territories. GPC Biotech also has a license agreement with
Yakult Honsha Co. Ltd. under which Yakult has exclusive
commercialization rights to satraplatin for Japan and is taking the lead
in developing the drug in that territory. GPC Biotech in-licensed
satraplatin from Spectrum Pharmaceuticals, Inc. in 2002.
About GPC Biotech
GPC Biotech AG is a publicly traded biopharmaceutical company focused on
new 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, 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 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.
Taxotere® is a
registered trademark of Aventis Pharma S.A.
Taxol® is a
registered trademark of Bristol-Myers Squibb Company.
* The three pre-specified prognostic factors in
the SPARC trial which showed statistically significant imbalances
between the two treatment arms were lactate dehydrogenase, hemoglobin
and alkaline phosphatase.