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Thalidomide Pharmion(R) Receives Positive Opinion for Treatment of First-line Multiple Myeloma from European Medicines Agency
Date:1/24/2008

-- Recommendation based on study results demonstrating survival advantage

of 18.4 months when added to standard therapy -- First study to show survival advantage over European standard of care

BOULDER, Colo., Jan. 24 /PRNewswire-FirstCall/ -- Pharmion Corporation (Nasdaq: PHRM) today announced that the European Medicines Agency (EMEA) has issued a positive opinion to recommend approval of Thalidomide Pharmion(R) for use in combination with melphalan and prednisone as first line treatment for patients with untreated multiple myeloma (MM), aged 65 years or older or ineligible for high dose chemotherapy. The marketing authorization application (MAA) for Thalidomide Pharmion was submitted to the EMEA in January 2007.

The EMEA's Committee for Medicinal Products for Human Use (CHMP) reviewed the application, and its positive opinion will be forwarded to the European Commission (EC), which generally follows, but is not obligated to follow, the recommendation of the CHMP, and issues final marketing approval within two to three months. Once ratified by the EC, a single marketing authorization would be granted to Pharmion to market Thalidomide Pharmion for first line multiple myeloma in the 27 member states of the European Union (EU) as well as Norway and Iceland.

"We are very pleased with this recommendation by the EMEA for the approval of Thalidomide in the treatment of first line multiple myeloma, and clearly appreciate that the return of Thalidomide to Europe as an approved therapy represents a significant step toward the safe distribution of this important and widely used drug for patients with multiple myeloma," said Patrick J. Mahaffy, Pharmion's president and chief executive officer. "This has been a lon
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SOURCE Pharmion Corporation
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