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Keryx Biopharmaceuticals Receives Orphan-Drug Designation for KRX-0401 (Perifosine) for the Treatment of Multiple Myeloma
Date:9/16/2009

ts for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance and waiver of Prescription Drug User Fee Act (PDUFA) filing fees.

About Special Protocol Assessments

The Special Protocol Assessment (SPA) process is a procedure by which the FDA provides official evaluation and written guidance on the design and size of proposed protocols that are intended to form the basis for a new drug application.

Final marketing approval depends on the results of efficacy, the adverse event profile and an evaluation of the benefit/risk of treatment demonstrated in the Phase 3 trial. The SPA agreement may only be changed through a written agreement between the sponsor and the FDA, or if the FDA becomes aware of a substantial scientific issue essential to product efficacy or safety. For more information on Special Protocol Assessment, please visit: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Gui dances/ucm080571.pdf

About Multiple Myeloma

Multiple myeloma, a cancer of the plasma cells, is an incurable but treatable disease. Multiple myeloma is the second most-common hematologic cancer, representing 1% of all cancer diagnoses and 2% of all cancer deaths. According to the American Cancer Society, in 2009 there will be an estimated 20,580 new cases of multiple myeloma and an estimated 10,500 deaths from multiple myeloma in the United States. To date, several FDA approved therapies exist for the treatment of multiple myeloma. Despite this progress, patients continue to relapse, become refractory to prior treatments and eventually die from their disease. Thus, new therapies are needed to treat these patients and extend their survival.

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SOURCE Keryx Biopharmaceuticals
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2. Keryx Biopharmaceuticals, Inc. Announces Poster Presentations Highlighting Observed Clinical Activity of KRX-0401 (Perifosine) to be Presented at the Upcoming American Society of Hematology Meeting in Atlanta, Georgia
3. Keryx Biopharmaceuticals, Inc. Announces Second Quarter 2008 Financial Results
4. Keryx Biopharmaceuticals, Inc. to Hold Conference Call on Third Quarter 2008 Financial Results on Tuesday, November 11, at 8:30 A.M. EST
5. Keryx Biopharmaceuticals KRX-0401 (Perifosine) Data Selected for Oral Presentation at the 50th Annual Meeting of the American Society of Hematology
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