TAMPA, Fla. & MINNEAPOLIS, Oct 06, 2011 (BUSINESS WIRE) -- Biovest International, Inc. (otcqb:BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (otcqb:ABPI), today announced that it has started the process to conduct clinical pre-filing discussions with various regulatory agencies including Health Canada, the U.S. Food & Drug Administration (FDA) and the European Medicines Agency (EMA). The first agency meeting is confirmed and on the calendar with other meetings expected to follow. The meetings will focus on the Company's plans to seek regulatory approval for BiovaxID(R), Biovest's personalized cancer vaccine initially targeting follicular lymphoma, and will help determine the next steps and requirements in the process. The Company expects to discuss various regulatory approaches to facilitate the submission of marketing applications at the earliest possible date.
Anticipated Regulatory Milestones:
-- Request Pre-filing Meetings with Health Canada, FDA and EMA (4Q 2011) -- First regulatory meeting request has been submitted and is scheduled to occur prior to year-end.
-- The regulatory meetings will be based on formal briefing packets submitted pre-meeting, setting forth the comprehensive body of clinical data available from the Company's controlled, randomized Phase III study for the treatment of follicular lymphoma; the Phase II study for the treatment of follicular lymphoma; and the Phase II study for the treatment of mantle cell lymphoma.
-- Conduct Pre-filing Clinical Meetings with Health Canada, FDA and EMA (Q4 2011 & 1H 2012) -- These clinical meetings represent each agency's first full regulatory review of the body of BiovaxID clinical data from the three clinical trials which collectively were conducted over approximately fifteen years. It is anticipated that the meetings will: cover the clinical data review; discuss the Company's desire to seek regulatory approvals based on the available data; and secure each agency's respective feedback and guidance regarding the potential next steps or requirements to filing applications seeking approval.
To further discuss this strategy, Biovest is scheduled to present this morning at the MD Becker Partners Cancer Immunotherapy Conference at the New York Academy of Medicine at 9:00 a.m. EDT, and the presentation will be webcast with the live and archived versions of the broadcast available at the Media Center on Biovest's corporate website at http://www.Biovest.com .
Biovest's President, Mr. Samuel S. Duffey, stated, "As a highly-personalized active immunotherapeutic, BiovaxID does not induce immunosuppression, and spares patients from the serious potential side effects related to extended immunosuppression or radiation exposure. BiovaxID represents a potentially novel option for consolidation therapy that in our Phase 3 clinical trial was demonstrated to be safe and effective in treated patients. Utilizing a protein present only on cancerous B-cells, the effectiveness of BiovaxID is unlikely to be compromised when tumor cells become resistant to, or escape from, existing therapies. Because of its mode of action, safety, efficacy and targeted nature, BiovaxID may indeed be a nearly ideal consolidation agent for follicular lymphoma. We anticipate that these upcoming pre-filing clinical meetings will prelude additional manufacturing (CMC) meetings with the respective agencies. We look forward to each agency's collective feedback, as their input and guidance will be critical to our regulatory strategy."
About Biovest International, Inc.
Biovest International, Inc. is an emerging leader in the field of active personalized immunotherapies. In collaboration with the National Cancer Institute, Biovest has developed a patient-specific, cancer vaccine, BiovaxID(R), with three clinical trials completed, including a Phase III study, demonstrating evidence of safety and efficacy for the treatment of indolent follicular non-Hodgkin's lymphoma.
Headquartered in Tampa, Florida with its bio-manufacturing facility based in Minneapolis, Minnesota, Biovest is publicly-traded on the OTCQB(TM) Market with the stock-ticker symbol "BVTI," and is a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (otcqb:"ABPI").