Pharmion Corporation Withdraws Vidaza(R) European Drug Application
BOULDER, Colo., Nov. 17 /PRNewswire-FirstCall/ -- Pharmion Corporation , as previously announced, confirmed that the European regulatory authorities will require additional data in order to gain marketing approval for Vidaza(R) (azacitidine for injectable suspension) in Europe and today announced the withdrawal of its Marketing Authorization Application (MAA). Pharmion intends to incorporate data from the Company's ongoing survival trial into the MAA.
Pharmion is currently sponsoring a study of 354 high-risk myelodysplastic syndromes (MDS) patients comparing Vidaza to best supportive care (BSC) with or without low-dose chemotherapy, with overall survival as the primary endpoint of the study. Secondary endpoints in the trial include time to relapse after a partial or complete response, time to acute myeloid leukemia (AML) progression as well as hematologic response and improvement. This is the largest study ever conducted in MDS, and if successful, would be the first prospectively designed trial to demonstrate a survival advantage in patients with high-risk MDS. Based on current enrollment trends, the Company anticipates that enrollment will be complete in early 2006. The Company is assessing the possibility of submitting data from an interim analysis of the survival study, which Pharmion anticipates could occur as early as mid-2006.
Pharmion intends to initiate named patient and compassionate use sales of Vidaza in the E.U. until the time its marketing authorization is approved.
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.
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 Thalidomide Pharmion 50mg and, outside the U.S. for Vidaza; 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.Pharmion Corporation
CONTACT: Breanna Burkart or Anna Sussman, Directors, Investor Relationsand Corporate Communications of Pharmion Corporation, +1-720-564-9150
Web site: http://www.pharmion.com/