As previously announced, following the interim efficacy analysis conducted on April 25, 2006, the DMB recommended that the SPARC trial continue as planned. The focus of that analysis was progression-free survival (PFS) and safety data. Progression-free survival remains the endpoint of the SPARC trial for accelerated approval in the U.S., and is also the basis, along with supporting overall survival data, for approval in Europe.
Pharmion and GPC Biotech have not had access to the data that caused the DMB to request this expedited review of overall survival, however in its April 25th meeting, the DMB also had access to preliminary overall survival data. The Companies are now and will continue to remain blinded to the data during this review process.
"While we have not had access to the data that caused the DMB to request this expedited review, we are pleased to comply with the DMB's request as rapidly as we can. We caution against any over interpretation of this expedited review because we do not know the basis of this request," said Dr. Marcel Rozencweig, Chief Medical Officer of GPC Biotech.
The Data Monitoring Board consists of independent oncology and statistical experts whose primary responsibility is to monitor, on a periodic basis, the data from the SPARC trial and to provide recommendations to Pharmion and GPC Biotech on whether the study should proceed as originally planned, be modified or be discontinued for efficacy or safety reasons. Members of the Data Monitoring Board are independent from Pharmion and GPC Biotech and also do not participate as clinical investigators in the SPARC trial.
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 completed accrual to the SPARC trial and initiated the rolling submission of a New Drug Application (NDA) for satraplatin with the U.S. Food and Drug Administration (FDA). Also 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.
Satraplatin has been studied in clinical trials involving a range of tumors, and Phase 2 trials have been completed in HRPC, ovarian cancer and small cell lung cancer. Other trials evaluating the effects of satraplatin in combination with radiation therapy, in combination with other cancer therapies and in various other cancers are underway or planned.
About Pharmion
Pharmion is a biotechnology 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®, a DNA demethylating agent. 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 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). 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.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause Pharmion's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include the status and timing or regulatory approvals for Pharmion's product candidates; the impact of competition from other products under development by Pharmion's competitors; the regulatory environment and changes in the health policies and structure of various countries; acceptance and demand for new pharmaceutical products and new therapies, uncertainties regarding market acceptance of products newly launched, currently being sold or in development; Pharmion's ability to successfully acquire rights to, develop and commercialize additional pharmaceutical products; failure of third-party manufacturers to produce the product volumes required on a timely basis, fluctuations in currency exchange rates, and other factors that are discussed in Pharmion's filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made, and Pharmion undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.
Source: Pharmion Corporation
