Xechem's Orphan Drug Status Approved for Its Sickle Cell Medicine in the European Union
Tuesday October 4, 8:30 am ET
NEW BRUNSWICK, N.J.--(BUSINESS WIRE)--Oct. 4, 2005--Xechem International, Inc. (OTC BB: XKEM - News) Xechem International announced today that its wholly owned subsidiary, Xechem UK Ltd., has received Orphan Drug designation from the European Medicine Evaluation Agency (EMEA) for NIPRISAN (now known as NICOSAN(TM)/HEMOXIN(TM)), a phytopharmaceutical product that has shown efficacy in the treatment of Sickle Cell Disease. The designation covers all 25 countries that comprise the European Union. Similar Orphan Drug status was previously granted to Xechem by the U.S. Food and Drug Administration.
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Dr. Ramesh Pandey, Xechem's Chairman & CEO said, "Obtaining Orphan Drug status for our Sickle Cell Disease product in both the European Union and the United States brings to Xechem substantial advantages and incentives which will help facilitate approval of the drug and make it easier for us to bring this important medicine to market. To have received these coveted designations from both the FDA and EMEA for a natural, herb-based product such as ours is particularly gratifying."
Significance of Orphan Drug Designation
The EMEA regulation on orphan medicinal products is designed to encourage companies to develop and market treatments for rare, life threatening medical conditions that affect less than five people in every 10,000 in the EU. In addition to granting the license holder protection from direct or generic competition for a period of ten years within the EU following drug approval, orphan drug status allows for regulatory assistance, reduced regulatory fees associated with applying for marketing approval, protocol assistance and scientific advice. Similar incentives, including seven years of marketing exclusivity, tax credits, and access to potential grant funding for non-clinical and clinical research, accompany orphan drug status in the U.S.
According to Dr. Pandey, "Given the virtual lack of commercially viable treatments for SCD in the United States and the EU, the multi-year exclusivity for NICOSAN(TM)/HEMOXIN(TM) could create a significant revenue producing opportunity for Xechem."
About Sickle Cell Disease
Sickle Cell Disease (SCD) is a devastating hereditary blood disorder, caused by an abnormal Hemoglobin called Sickle Hemoglobin, and is characterized by acute painful crises, organ damage, anemia and early death. SCD is particularly prevalent among people from sub-Saharan Africa. In Nigeria alone over 4 million people are afflicted with the disease and another 26 million are believed to be carriers of the sickle cell trait. It is estimated that more than one out of seven persons living on the African continent carry the sickle cell trait and over 18 million actually suffer with the disease worldwide. |
