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Xechem’s (OTCBB: XKEM) Orphan Drug Status Approved for New Sickle Cell Drug |
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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. |
