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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

e Francophone du Myelome. "This recommendation recognizes the importance of the study results, opens drug access to all physicians and patients in Europe and provides great hope for patients with this devastating disease."

Multiple myeloma, the second most common cancer of the blood, affects approximately 82,000 people in the EU, and approximately 25,000 people in the EU are diagnosed with multiple myeloma each year.

Thalidomide Pharmion has been designated as an Orphan Medicinal Product in the EU for the treatment of multiple myeloma, which, if approved, entitles the drug to ten years of market exclusivity for the approved indications.

Thalidomide Pharmion must be prescribed and dispensed through the Thalidomide Pharmion Pregnancy Prevention Programme, a risk management plan that includes a number of actions intended to prevent pregnancies in women being treated with thalidomide and exposure of unborn children to the medicine. Treatment with Thalidomide Pharmion, only available by prescription, will be initiated and monitored by a doctor who has experience in the treatment of multiple myeloma. A clear warning will be printed on the boxes containing the medicine, indicating that Thalidomide Pharmion causes birth defects and fetal death. Prior to the launch of Thalidomide Pharmion, Pharmion will provide healthcare professionals and patients with educational materials about the treatment-related risks and the precautions required to ensure the safe use of the product.

Thalidomide Pharmion is approved in Australia, New Zealand, Turkey, Israel, South Korea, Thailand and South Africa for the treatment of multiple myeloma after the failure of standard therapies.

Thalidomide is currently provided by Pharmion on a named patient/compassionate use basis in most of the EU and under an Autorisation Temporaire d'Utilisation (ATU) in France while the Company seeks an approval. Pharmion is the only provider of Thalidomide outside of the US with a
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SOURCE Pharmion Corporation
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