Biovest gets positive opinion on orphan-drug mark for lymphoma drug

By Elaine Rigoli

Tampa, Fla., July 31 - Biovest International, Inc. said the Committee on Orphan Medical Products of the European Medicines Agency (EMEA) gave a positive opinion regarding the application for orphan medicinal product designation for BiovaxID, the company's autologous immunotherapy for the treatment of follicular lymphoma.

In the European Union, products targeted to treat disorders that affect fewer than five in 10,000 people are eligible for orphan designation.

The company said this status would provide significant advantages and assistance to Biovest in getting final approval to market BiovaxID in the European Union, including 10-year market exclusivity in the European Union once the product is approved; direct assistance from the EMEA in preparing the final protocol for drug approval; access to EMEA centralized filing procedures for E.U. approval; and reduced fees for EMEA filings.

Based in Worcester, Mass., Biovest develops immunotherapies for life-threatening cancers of the blood system.

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