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[ biotech news ] Pharmion Corporation and GPC Biotech Announce Partnering Agreement for Satraplat
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Pharmion Corporation and GPC Biotech Announce Partnering Agreement
for Satraplatin
* Pharmion Obtains Commercial Rights for Satraplatin in Europe,
Turkey, the Middle East, Australia and New Zealand; GPC Biotech
Retains Rights in North America and all other Territories
* Pharmion to make an upfront payment of $37.1 million to GPC
Biotech; GPC Biotech may receive up to $270 million in total based
upon the achievement of regulatory and sales milestones
* Target Enrollment Achieved in Pivotal Phase 3 Study for Second-
Line Chemotherapy in Hormone-Refractory Prostate Cancer; Pharmion
Expects to Submit for European Marketing Authorization in 2007
pending concurrence with the EMEA
BOULDER, Colo., MARTINSRIED/MUNICH, Germany, WALTHAM, Mass. and
PRINCETON, N.J., Dec. 20 -- Pharmion Corporation (Nasdaq: PHRM -
News) and GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX
index; Nasdaq: GPCB) today announced that the companies have entered
into a co-development and license agreement for satraplatin, the
only oral platinum-based compound in advanced clinical development.
Satraplatin has shown promising safety and efficacy as demonstrated
by significant improvement in progression-free survival (PFS) in a
randomized study of first-line treatment of patients with hormone-
refractory prostate cancer (HRPC) and is currently the subject of a
Phase 3 registrational trial as second-line chemotherapy treatment
for patients with HRPC. Data from the pivotal Phase 3 trial are
expected to form the basis of a Marketing Authorization Application
(MAA) in Europe and a New Drug Application (NDA) in the U.S. for
this indication. Based on data from this trial, Pharmion expects to
file the MAA in Europe in 2007, pending concurrence with the EMEA.
ADVERTISEMENT
Under the terms of the agreement, Pharmion gains exclusive
commercialization rights for Europe, Turkey, the Middle East,
Australia and New Zealand, while GPC Biotech retains rights to the
North American market and all other territories. Pharmion is to
provide an upfront payment of $37.1 million to GPC Biotech,
including an $18 million reimbursement for past satraplatin clinical
development costs and $19.1 million for funding of ongoing and
certain future clinical development to be conducted jointly by
Pharmion and GPC Biotech. The companies will pursue a joint
development plan to evaluate development activities for satraplatin
in a variety of tumor types and will share global development costs,
for which Pharmion has made an additional commitment of $22.2
million, in addition to the $37.1 million in initial payments.
Pharmion will also pay GPC Biotech $30.5 million based on the
achievement of certain regulatory filing and approval milestones,
and up to an additional $75 million for up to five subsequent EMEA
approvals for additional indications. GPC Biotech will also receive
royalties on sales of satraplatin in Pharmion's territories at rates
of 26 to 30 percent on annual sales up to $500 million, and 34
percent on annual sales over $500 million. Finally, Pharmion will
pay GPC Biotech sales milestones totaling up to $105 million, based
on the achievement of significant annual sales levels in the
Pharmion territories. Pharmion and GPC Biotech will lead regulatory
and commercial activities in their respective territories.
"We believe that satraplatin has the potential to provide
significant additional benefits in the well-characterized platinum
treatment class, and we will work closely with GPC Biotech to get
this vital therapy to physicians and patients as quickly as
possible," said Patrick J. Mahaffy, Pharmion's president and chief
executive officer. "Satraplatin represents an important addition to
our product portfolio, complementing our existing products as well
as the global regulatory, clinical development and commercial
organizations that support them."
Bernd R. Seizinger, M.D., Ph.D., chief executive officer of GPC
Biotech, said: "We were very pleased with the significant interest
in satraplatin shown by a large number of pharmaceutical and biotech
firms in the U.S. and Europe. We have selected Pharmion as a partner
because we believe they are ideally suited to help us fully exploit
the potential of satraplatin in Europe and are strongly committed to
continued development of this important compound for a variety of
cancers. The deal structure provides us with significant funding but
still allows GPC Biotech to retain the full commercialization rights
to the U.S. market and other key pharmaceutical markets." Dr.
Seizinger continued: "Pharmion's expertise and its strong oncology
focused commercial infrastructure in Europe and other licensed
territories will be critical in bringing satraplatin to patients in
those countries. With the complementary expertise and the great
respect that our teams have developed for one another, we look
forward to a very productive relationship."
About Satraplatin and its Clinical Development
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. An oral
platinum drug could offer key advantages, including ease of
administration and patient convenience, in a variety of applications.
The results of a clinical study conducted by the European
Organization for Research and Treatment of Cancer (EORTC) evaluating
satraplatin in HRPC were presented at the 2003 Annual Meeting of the
American Society for Clinical Oncology. Fifty patients were
randomized to evaluate the use of satraplatin plus prednisone (n=27)
versus prednisone alone (n=23) for use as a first-line chemotherapy
treatment in HRPC. The study showed that treatment with satraplatin
significantly lengthened progression-free survival (PFS) (p=0.023);
the median PFS was 5.2 months for satraplatin compared to 2.5 months
for the control arm. Additionally, at six months, 41 percent of
patients treated in the satraplatin arm were progression-free
compared to 22 percent of patients in the control arm. A greater
than 50 percent decline in prostate-specific antigen (PSA) was
experienced by 33 percent of patients (9/27) in the satraplatin arm
versus 9 percent of patients (2/23) in the control arm (p=0.046).
The median overall survival time was 15 months for patients treated
in the satraplatin arm versus 12 months for patients in the control
arm (p value not statistically significant). To date, satraplatin is
the only platinum compound that has demonstrated efficacy in a
randomized trial in HRPC.
In the second half of 2003, GPC Biotech launched its phase 3
Satraplatin and Prednisone Against Refractory Cancer (SPARC)
registrational trial. The SPARC trial, which assesses the safety and
efficacy of satraplatin in combination with prednisone as second-
line chemotherapy in patients with HRPC, compares satraplatin plus
prednisone to placebo plus prednisone. This trial is powered to show
improvements in both endpoints of PFS and overall survival. Target
enrollment of 912 patients in this multicenter, multinational,
double-blind, randomized study was achieved earlier this month. GPC
Biotech has initiated the rolling submission of an NDA with the U.S.
Food and Drug Administration (FDA) for satraplatin in combination
with prednisone as a second-line chemotherapy treatment for patients
with HRPC. Assuming continued progress, GPC Biotech expects to
complete the NDA filing in the second half of 2006. Data from the
SPARC trial are also expected to form the basis of an MAA in Europe
for this indication, and, pending concurrence with the EMEA,
Pharmion expects to submit that application in 2007.
In addition, satraplatin has been studied in a range of tumors, and
Phase 2 trials have been completed in HRPC, ovarian cancer and small
cell lung cancer. In other trials, satraplatin appeared to augment
the antitumor effects of radiation therapy, a clinical application
in which satraplatin's oral bioavailability could be particularly
advantageous. A Phase 1/2 study evaluating this combination in
patients with non-small cell lung cancer has been initiated. Several
other Phase 1 and 2 studies evaluating satraplatin in combination
with other therapies and in various cancers are underway or planned.
Conference Call Scheduled
Separate conference calls are planned for Pharmion Corporation at
8:30 a.m. and GPC Biotech at 9:30 a.m. (both times Eastern) to which
participants may listen via live webcast, accessible through each
company's Web site at www.pharmion.com, www.gpc-biotech.com, or via
telephone. Details, including dial-in numbers, will be provided in
separate announcements.
About Pharmion Corporation
Pharmion is a pharmaceutical 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. For additional information about
Pharmion, please visit the company's website at www.pharmion.com.
About GPC Biotech
GPC Biotech AG is a biopharmaceutical company discovering and
developing new anticancer drugs. The Company's lead product
candidate -- satraplatin -- has achieved target enrolment 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. 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). The Company's wholly owned U.S.
subsidiary has sites in Waltham, Massachusetts and Princeton, New
Jersey. For additional information, please visit the Company's Web
site at www.gpc-biotech.com.
This press release contains forward-looking statements, which
express the current beliefs and expectations of management. 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,
including the timing and effects of regulatory actions, the results
of clinical trials, Pharmion's and GPC Biotech's relative success
developing and gaining market acceptance for any new products, and
the effectiveness of patent protection. There can be no guarantee
that GPC Biotech will receive all of the payments and royalties
outlined in this press release. There can be no guarantee that the
SPARC trial will be completed nor that satraplatin will be approved
for marketing in a timely manner, if at all, nor that, if marketed,
satraplatin will be successful. We direct you to GPC Biotech's
Annual Report on Form 20-F, as amended, for the fiscal year ended
December 31, 2004, Pharmion's most recent filings on Form 10-Q and
10-K, 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.
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Source: Pharmion Corporation; GPC Biotech AG
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