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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. -- Biovest International, Inc. (OTCBB OTCBB

See OTC Bulletin Board (OTCBB).
: BVTI) has received official notification from the Committee on Orphan Medical Products (COMP) of the European Medicines Agency The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. Until 2004, the European Medicines Agency was known as The European Agency for the Evaluation of Medicinal Products.

Roughly parallel to the U.S.
 (EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. ;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 autologous /au·tol·o·gous/ (aw-tol´ah-gus) related to self; belonging to the same organism.

au·tol·o·gous
adj.
1.
 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 id·i·o·type
n.
A determinant that confers on an immunoglobulin molecule an antigenic individuality that is analogous to the individuality of the molecule's antibody activity.
 coupled to keyhole limpet limpet, marine gastropod mollusk with a simple, flattened, conical shell, found in cooler waters of the Atlantic and the Pacific oceans. Certain species creep over rocks, feeding on algae during high tides, but when the tide recedes they return instinctively to the  hemocyanin hemocyanin /he·mo·cy·a·nin/ (-si´ah-nin) a blue copper-containing respiratory pigment occurring in the blood of mollusks and arthropods.  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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  and Chairman commented: "We are extremely gratified grat·i·fy  
tr.v. grat·i·fied, grat·i·fy·ing, grat·i·fies
1. To please or satisfy: His achievement gratified his father. See Synonyms at please.

2.
 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 NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: ABPI ABPI Association of the British Pharmaceutical Industry
ABPI Associação Brasileira da Propriedade Intelectual (Brazilian Intellectual Property Association; Brazil)
ABPI Ankle Brachial Pressure Index
), 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 fol·lic·u·lar
adj.
1. Relating to, having, or resembling a follicle or follicles.

2. Affecting or growing out of a follicle or follicles.
 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.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Jul 31, 2006
Words:647
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