Pharmion Corporation (Nasdaq: PHRM) and GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX index; Nasdaq: GPCB) today announced positive topline results for the
double-blinded, randomized satraplatin Phase 3 registrational trial, the
SPARC trial (Satraplatin and Prednisone Against Refractory Cancer). The
trial is evaluating satraplatin plus prednisone versus placebo plus
prednisone as a second-line treatment in 950 patients with
hormone-refractory prostate cancer (HRPC). The study data show that the
results for progression-free survival (PFS) are highly statistically
significant (p
As anticipated, the most common adverse reactions consisted of
myelosuppression (bone marrow functions, such as lowered platelet count or
lowered white blood cell count) and gastrointestinal events, such as
nausea, vomiting and diarrhea. These adverse reactions were mostly mild to
moderate in severity.
"Patients with advanced hormone-refractory prostate cancer are in
urgent need of new treatment options. We are excited about the highly
statistically significant improvement in progression-free survival
demonstrated by satraplatin in our Phase 3 registrational trial.
Importantly, the difference in progression-free survival increases over
time in favor of the satraplatin group," said Bernd R. Seizinger, M.D.,
Ph.D., Chief Executive Officer of GPC Biotech. "Based on the positive data
announced today, we will move forward as rapidly as possible with the FDA
with the goal of completing the filing for marketing approval of
satraplatin in the U.S. before the end of this year."
Dr. Seizinger continued: "Today's results are indeed great news for GPC
Biotech and our partners. We look forward to an ongoing productive
relationship with Pharmion as they advance satraplatin in Europe. We are
delighted that the vision we shared with Spectrum Pharmaceuticals for
satraplatin at the time we licensed the compound is now becoming tangible."
"We believe that these results demonstrate the benefits that
satraplatin can provide men with advanced prostate cancer. In addition, the
oral administration of satraplatin offers the patient the convenience of
outpatient therapy and the potential for greater dosing coordination with
other cancer therapies," said Patrick J. Mahaffy, President and Chief
Executive Officer of Pharmion Corporation. "Pharmion remains focused on
preparing its marketing authorization application, which we plan to file
with the European regulatory authorities in the first half of 2007. We have
worked closely with GPC Biotech since licensing the European and other
international rights to satraplatin last December and look forward to
continuing our partnership as we move through the regulatory process
towards commercialization."
The SPARC trial is a double-blinded, randomized, placebo-controlled
multinational Phase 3 trial assessing satraplatin plus prednisone as a
second- line chemotherapy treatment for patients with HRPC. A total of 950
patients were accrued to the trial at more than 200 clinical sites in
fifteen countries on four continents. The companies plan to submit data
from the SPARC trial for presentation at an upcoming major medical
conference.
GPC Biotech intends to move forward with the U.S. Food and Drug
Administration (FDA) with the goal of completing the submission of the
rolling New Drug Application (NDA) by the end of 2006 for approval to
market satraplatin. Pharmion Corporation intends to file an MAA to the
European Medicines Agency (EMEA) in the first half of 2007.
About Prostate Cancer
Prostate cancer is the most common cancer among men in the U.S. and
Europe. Approximately 234,000 men in the U.S. are expected to be diagnosed
with the disease in 2006 and over 27,000 men are expected to die from the
disease. In the European Union, over 200,000 new cases are expected to be
diagnosed, and over 60,000 patients are expected to die each year. Since
the incidence of prostate cancer increases with age, the aging of the
overall population is expected to further increase the number of prostate
cancer patients.
Most patients diagnosed with prostate cancer initially receive surgery
or radiation therapy, and some of these patients are cured. For many
others, though, the disease recurs. At this point, the recurrent disease is
treated with hormone therapy, and most patients initially respond well to
this treatment. Eventually, however, the tumor cells become resistant to
the hormones -- or "hormone-refractory" -- and the tumor again progresses.
Increasingly, chemotherapy is being used as an effective first-line
treatment for HRPC. However, it is not a cure, and so this is creating a
need for effective therapeutic options for these patients once they have
progressed.
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 signed a co-development and license
agreement with Pharmion GmbH, a wholly owned subsidiary of Pharmion
Corporation, under which Pharmion was granted exclusive commercialization
rights to satraplatin for Europe and certain other territories. GPC Biotech
licensed satraplatin from Spectrum Pharmaceuticals, Inc. in 2002.
GPC Biotech has submitted two of three sections of a rolling submission
of an NDA with the U.S. FDA for satraplatin as a second-line chemotherapy
treatment for HRPC and expects to complete this filing by the end of 2006.
Pharmion plans to file an MAA for Europe in the first half of 2007. In
addition, the companies have ongoing a broad oncology development program
for satraplatin that includes a number of trials evaluating this compound
in combination with radiation therapy, in combination with other cancer
therapies and in various other cancers.
Conference Calls Scheduled
Separate conference calls are planned for GPC Biotech at 8:00 a.m. and
for Pharmion Corporation at 8:30 a.m. (both times Eastern), to which
participants may listen via live webcast, accessible through each company's
Web site at pharmion, gpc-biotech, or via telephone.
About Pharmion
Pharmion is a biopharmaceutical company focused on acquiring,
developing and commercializing innovative products for the treatment of
hematology and oncology patients in the U.S., Europe and additional
international markets. Pharmion has a number of products on the market
including the world's first approved epigenetic cancer drug, Vidaza(R), a
DNA demethylating agent. For additional information about Pharmion, please
visit Pharmion's website at pharmion.
About GPC Biotech
GPC Biotech AG is a biopharmaceutical company discovering and
developing new anticancer drugs. GPC Biotech'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), and its wholly owned U.S. subsidiary has sites in Waltham,
Massachusetts and Princeton, New Jersey. For additional information, please
visit GPC Biotech's Web site at gpc-biotech.
This press release contains forward-looking statements, which express
the current beliefs and expectations of the management of GPC Biotech AG
and Pharmion Corporation, including summary statements relating to top line
results of the SPARC trial and summary statements relating to the potential
efficacy and safety profile 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. In particular, there can be no
guarantee that topline results from the clinical trial discussed in this
press release will be confirmed upon full analysis of the results of the
trial and 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, even if these topline results
are confirmed upon full analysis of the trial, 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, 2005, Pharmion's Annual
Report on Form 10-K for the fiscal year ended December 31, 2005, its most
recent filings on Form 10-Q 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
either Pharmion or GPC Biotech. Forward-looking statements speak only as of
the date on which they are made and neither Pharmion nor GPC Biotech
undertakes any obligation to update these forward-looking statements, even
if new information becomes available in the future.
The scientific information discussed in this press release related to
satraplatin is preliminary and investigative. 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.
Taxotere(R) (docetaxel) is a registered trademark of Aventis Pharma
S.A.
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