TAMPA, Fla. — Biovest International Inc. announced Jan. 7 that the U.S. Food and Drug Administration has granted orphan drug designation to BiovaxID, Biovest’s personalized lymphoma vaccine.

BiovaxID represents a new class of active immunotherapy and is one of the few late-stage, patient-specific cancer vaccines vying to be among the first to reach market, Biovest stated in a press release.

With FDA orphan drug status, Biovest has seven years of market exclusivity for BiovaxID upon approval, thereby offering competitive protection from similar drugs of the same class. Orphan drug status also gives Biovest eligibility to receive potential tax credit benefits, potential grant funding for research and development and significantly reduced filing fees for marketing applications.

Based on statistically significant Phase III study data demonstrating an extended disease-free survival benefit, Biovest expects to file a biologic license application with the FDA by approximately midyear in order to seek U.S. approval of BiovaxID.

The company also expects to file regulatory applications seeking approvals in Europe and Canada.