The FDA has granted Orphan Drug Designation to Biovest International (Biovest) for its personalised lymphoma vaccine, BiovaxID. The company claims that BiovaxID represents a new class of active immunotherapy and is one of the few select late-stage patient-specific cancer vaccines vying to be among the first to reach market.
Biovest said that with the Orphan Drug status, it has a seven-year period of market exclusivity for BiovaxID upon approval, thereby offering competitive protection from similar drugs of the same class.
Moreover, the Orphan Drug status also provides Biovest with eligibility to receive potential tax credit benefits, potential grant funding for research and development and reduced filing fees for marketing applications.
Reportedly, based on results from phase III study data demonstrating an extended disease-free survival benefit, Biovest expects to file a Biologic License Application (BLA) with the FDA, by approximately mid-year, in order to seek US approval of BiovaxID. The company also expects to file regulatory applications seeking approvals in Europe and Canada.