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Lauren Fischer, Director of IR

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Keryx Biopharma (NASDAQ: KERX)

Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease. Keryx is developing ZerenexTM (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of ZerenexTM for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA. Keryx is headquartered in New York City. Keryx is headquartered in New York City.

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KERX Announces Positive P2 Perifosine Results

  
  
  
  

On 1/29/10, KERX announced that an article entitled "Clinical and Translational Studies of a Phase II Trial of the Novel Oral Akt Inhibitor Perifosine in Relapsed or Relapsed/Refractory Waldenstrom's Macroglobulinemia," reporting Phase 2 data demonstrating the single agent activity of KRX-0401 (Perifosine) for the treatment of advanced Waldenstrom's Macroglobulinemia will appear in the 2/1/10 issue of Clinical Cancer Research. 

 Perifosine, the Company's oral PI3K/Akt pathway inhibitor is currently being investigated in a Phase 3 trial, under Special Protocol Assessment (SPA), for the treatment of Advanced Multiple Myeloma.  Similar to Multiple Myeloma and Non-Hodgkin's Lymphoma, Waldenstrom's is a hematologic disease in which the cancer cells target the bone marrow.  There are currently no drugs FDA approved for the treatment of Waldenstrom's.

The progression-free survival (PFS) of 12.6 months is considered long compared to other targeted agents used in a similar population such as bortezomib (Velcade), where the median time to progression was reported at 7.9 months.  KERX provided guidance for further clinical studies to evaluate perifosine for this disease, either as a single agent or in combination with agents such as Rituxan or Velcade.

Disclosure: Long KERX

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