Keryx Biopharmaceuticals, Inc., a developer of medically important pharmaceutical products for the treatment of life-threatening diseases, recently announced that the company has received Orphan-Drug designation from the U.S. Food and Drug Administration (FDA) for KRX-0401 (perifosine) for the treatment of multiple myeloma.
Multiple myeloma is a cancer of the plasma cells. Although incurable, this disease, which represents 1 percent of all cancer diagnoses and 2 percent of all cancer deaths, is treatable. According to the American Cancer Society, 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 in 2009. Patients with multiple myeloma typically relapse and become refractory to prior treatments, causing them to eventually die from their disease. Keryx Biopharmaceuticals is committed to developing new therapies to improve patients’ quality of life and extend survival rates.
Ron Bentsur, chief executive officer of Keryx Biopharmaceuticals, stated, “The Orphan-Drug designation for perifosine in multiple myeloma is a very important milestone for Keryx, as the market exclusivity protection provided by this designation significantly enhances the commercial opportunity of perifosine in this indication.” He continued, “Following our exciting announcement last month that we had reached an agreement with the FDA on an SPA for a Phase 3 trial for perifosine in relapsed/refractory multiple myeloma, it is encouraging to further add to the value of the perifosine program with this Orphan-Drug designation. We look forward to commencing the Phase 3 study by year-end.”