Healthcare Industry News: GPC Biotech
News Release - February 28, 2006
Scientific Advice From European Regulatory Authorities Confirms Progression-Free Survival Data Acceptable for Satraplatin SubmissionPharmion Expects to File MAA in Europe by Q1 2007
BOULDER, Colo., Feb. 28 (HSMN NewsFeed) -- Pharmion Corporation (Nasdaq: PHRM ), confirmed today that its marketing authorization application (MAA) for satraplatin for the treatment of second-line hormone refractory prostate cancer (HRPC) is expected to be filed in the first quarter of 2007, based on the completion of a follow-up scientific advice procedure with the European Medicines Authority (EMEA). In its final correspondence of this advice process, the regulatory agency confirmed that it would accept the final analysis for progression-free survival (PFS) from the SPARC trial and the available overall survival data as the basis for the submission.
Pharmion Corporation licensed the European and certain other international marketing rights to satraplatin, the only oral platinum-based compound in advanced clinical development, from GPC Biotech in December 2005. The companies are seeking an initial application in second line chemotherapy of HRPC and are exploring the potential for satraplatin in a wide range of additional indications.
"We are pleased to have agreement with the EMEA on our filing strategy for satraplatin," said Patrick J. Mahaffy, Pharmion's president and CEO. "We are committed to providing the submission to the EMEA in as timely a fashion as possible, pending the results from a final analysis of PFS in the SPARC study which we anticipate in the second half of 2006."
Patient enrollment is completed for the Phase 3 Satraplatin and Prednisone Against Refractory Cancer (SPARC) registrational trial, which is assessing the safety and efficacy of satraplatin in combination with prednisone as a second-line chemotherapy in patients with HRPC. 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 in December 2005. 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, having received concurrence from the EMEA, Pharmion expects to submit that application based on the progression-free survival endpoint in the first quarter of 2007.
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 evaluated the effects of adding satraplatin to 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.
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. To date, satraplatin is the only platinum compound that has demonstrated activity in a randomized trial in HRPC.
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. Pharmion has a number of products on the market including the world's first approved epigenetic cancer drug, VidazaŽ, a DNA demethylating agent. For additional information about Pharmion, please visit the company's website at 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 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.
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