Untitled Document

Xechem’s (OTCBB: XKEM) Orphan Drug Status Approved for New Sickle Cell Drug PDF Print E-mail
Recently, the EU approved "Orphan Drug Status" for Xechem International's sickle cell drug dubbed Niprisan, a phytopharmaceutical product that has shown efficacy in the treatment of Sickle Cell Disease. The designation covers all 25 member countries that comprise the European Union. A similar Orphan Drug Status was granted to Xechem by the U.S. Food and Drug Administration. 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."

In addition to granting the maker protection from direct and generic competition for ten years after approval, Orphan Drug Status also gives Xechem 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.

Xechem International, Inc., is a development stage biopharmaceutical company focusing on anticancer, antiviral (including AIDS), antifungal, Sickle Cell Disease (SCD), antimalarial and antibacterial products from natural sources including microbial and marine organisms. Currently the majority of Xechem's efforts revolve around the push to get Niprisan to market, due to its shown efficacy in treating Sickle Cell Disease.
< Prev   Next >