Message #7 From:
NewsBot Date: July 31, 2006 06:07:00 AM
BVTI News Biovest International Receives Positive Opinion on Application for Orphan Medicinal Product Designation by European Agency; Opinion expected to aid approval of BiovaxID(TM) in the EU
WORCESTER, Mass.--(BUSINESS WIRE)--July 31, 2006--Biovest International, Inc. (OTCBB: BVTI) has received official notification from the Committee on Orphan Medical Products (COMP) of the European Medicines Agency (EMEA;www.emea.eu.int/) that a positive opinion was made regarding the application for orphan medicinal product designation for BiovaxID(TM) the Company's autologous immunotherapy for the treatment of follicular lymphoma in the European Union (EU).
In the EU products targeted to treat disorders that affect fewer than 5 in 10,000 people are eligible for Orphan designation. Such status provides significant advantages and assistance to Biovest in getting final approval to market BiovaxID(TM) in the EU. These include: Ten year market exclusivity in the EU once the product is approved; direct assistance from the EMEA in preparing the final protocol for drug approval, and access to EMEA centralized filing procedures for approval in the EU; and, reduced fees for EMEA filings.
In its letter to Biovest, the COMP noted that while treatments for follicular lymphoma are currently available, "..justifications have been provided that autologous tumor-derived immunoglobulin idiotype coupled to keyhole limpet hemocyanin may be of significant benefit to those affected by the condition."
The positive opinion of the COMP has now been forwarded to the EU commission for final approval and publication in the community register.
Dr. Steve Arikian, Biovest CEO and Chairman commented: "We are extremely gratified by this rapid action by the COMP on our application for Orphan Medicinal Product Designation for BiovaxID(TM). This positive opinion follows our recent very productive meeting with EMEA representatives whereby we are seeking their guidance and advice regarding our plans to obtain approval for BiovaxID(TM) in the EU. The granting of Orphan Medicinal Product Designation in the EU will provide Biovest with access to invaluable resources and input from the agency when we prepare to file an application for marketing."
About Biovest International, Inc.
Biovest International, Inc. is a pioneer in the development of advanced individualized immunotherapies for life-threatening cancers of the blood system. Biovest is a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (NASDAQ: ABPI), with its remaining shares publicly traded. Biovest has a foundation in the manufacture of biologics for research and clinical trials. In addition, Biovest develops, manufactures and markets patented cell culture systems, including the innovative AutovaxID(TM), which is being developed as an automated vaccine manufacturing instrument and for production of cell-based materials and therapeutics. Biovest's therapy for follicular non-Hodgkin's lymphoma is currently in a Phase 3 pivotal clinical trial at more than 20 major medical centers throughout the U.S. For further information, visit the Company Web site at www.biovest.com.
Forward-Looking Statements
Statements in this release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, statements about BiovaxID(TM) and any other statements relating to products, product candidates, and product development programs. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, expectations and intentions and other statements identified by words such as "may," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans" or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause the actual results of Accentia and/or Biovest to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval for product candidates; competition from other pharmaceutical or biotechnology companies; and the additional risks discussed in filings with the Securities and Exchange Commission. All forward looking statements are qualified in their entirety by this cautionary statement, and neither Accentia nor Biovest undertakes any obligation to revise or update this news release to reflect events or circumstances after the date hereof.
