Biovest International, Inc. (BVTI.PK), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (ABPI.PK), said the FDA has granted Orphan Drug Designation to BiovaxID for the treatment of Waldenstrom's macroglobulinemia.
Waldenstrom's macroglobulinemia is a rare subtype of B-cell non-Hodgkin's lymphoma.
This milestone advances Biovest's plans to develop and commercialize BiovaxID as an autologous active immunotherapy (personalized cancer vaccine) for the treatment of multiple subtypes of B-cell non-Hodgkin's lymphoma including follicular lymphoma and mantle cell lymphoma.
With FDA Orphan Drug Status, Biovest gains seven years of market exclusivity for BiovaxID for the treatment of Waldenstrom's macroglobulinemia upon its approval by the FDA, thereby offering competitive protection from similar drugs of the same class. Orphan Drug Status also provides Biovest with eligibility to receive potential tax credit benefits, potential grant funding for research and development and significantly reduces the requisite filing fees for marketing applications.
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