Healthcare Industry News: Vidaza
News Release - June 26, 2007
Pharmion Submits European Marketing Authorization Application for Satraplatin in Combination With Prednisone for the Treatment of Patients With Metastatic Hormone-Refractory Prostate Cancer Who Have Failed Prior ChemotherapyBOULDER, Colo., June 26 (HSMN NewsFeed) -- Pharmion Corporation (Nasdaq: PHRM ) today announced the submission of a marketing authorization application (MAA) with the European Medicines Agency (EMEA) for Satraplatin in combination with prednisone for the treatment of patients with metastatic hormone-refractory prostate cancer (HRPC) who have failed prior chemotherapy. The submission is based upon data from the double-blind, randomized Phase 3 registrational trial, Satraplatin and Prednisone Against Refractory Cancer (SPARC) comparing Satraplatin plus prednisone to placebo plus prednisone in 950 patients with HRPC whose prior chemotherapy has failed. Hormone-refractory prostate cancer affects approximately 80,000 men in the EU.
"Data from the SPARC trial demonstrate that Satraplatin lowers the risk of disease progression or death by 33 percent compared to control, including for patients previously treated with docetaxel chemotherapy," said Cora Sternberg, M.D., FACP, Chief, Department of Medical Oncology, San Camillo Forlanini Hospital, Rome, Italy and one of the principal investigators of the SPARC registrational trial. "These encouraging results, together with Satraplatin's manageable side effect profile, suggest that Satraplatin represents an important new therapy option for patients with advanced prostate cancer whose prior chemotherapy has failed."
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 orally bioavailable compound and is given as capsules that patients can take at home.
Primary and secondary endpoint data from the SPARC trial have been presented at recent medical conferences. In accordance with the recommendation of the independent Data Monitoring Board for the SPARC trial, patients who have not progressed continue to be treated and all patients will be followed for overall survival. Overall survival data from the SPARC trial are expected in the Fall.
"This submission -- our second to the European regulatory authority this year -- represents a significant milestone for Pharmion," said Patrick J. Mahaffy, Pharmion's president and chief executive officer. "The data for Satraplatin in the treatment of second-line HRPC are extremely encouraging, demonstrating significant improvement in progression-free survival, as well as time to pain progression and pain response when Satraplatin is added to prednisone therapy. With no therapies currently approved for these patients, we believe Satraplatin represents an important step forward in the management of advanced prostate cancer."
Pharmion has a co-development and license agreement with GPC Biotech, under which Pharmion has been granted exclusive commercialization rights to Satraplatin for Europe and certain other territories. GPC Biotech submitted a New Drug Application (NDA) for satraplatin to the U.S. Food and Drug Administration (FDA) earlier this year, which has been accepted for priority review. The NDA will be reviewed by the Oncologic Drugs Advisory Committee (ODAC) on July 24, 2007, and an action from the FDA on the application is expected in August of this year.
Satraplatin has been studied in clinical trials involving a range of tumors. Trials evaluating the effects of Satraplatin in combination with radiation therapy, in combination with other cancer therapies and in a number of cancer types are underway or planned.
Pharmion is a leading global oncology company uniquely 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 drug, Vidaza®, a DNA demethylating agent. For additional information about Pharmion, please visit the company's website at http://www.pharmion.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 regulatory status and timing of regulatory approvals for Satraplatin; the impact of competition from other products sold by Pharmion's competitors in the E.U.; 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 Pharmion's ability to enforce market exclusivities in member states of the E.U.; 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.
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