Message #8 From:
Stock News Bot Date: October 11, 2006 05:30:00 AM
BVTI News Biovest International Therapy for Follicular Non-Hodgkin's Lymphoma Receives Rare Disease Designation from European Drug Agency
WORCESTER, Mass.--(BUSINESS WIRE)--Biovest International, Inc. (OTCBB: BVTI)
has received notification from the Commission of the European Union on
its acceptance of Biovest’s BiovaxID™
therapy for Follicular Lymphoma for entry into the European Community’s
Drug Register for Rare Diseases. This designation significant offers
benefits to Biovest in its development and marketing of BiovaxID™
in the European Union (EU).
This acceptance follows the previously announced recommendation by the
Committee on Orphan Medical Products (COMP) of the European Medicines
Agency (EMEA: www.emea.eu.int/)
that BiovaxID™ be granted designation as a
treatment for a rare disease. The COMP concluded that “…the
condition is chronically debilitating and life threatening due to the
occurrence of relapses and the increasing resistance to treatments
resulting in possible fatal evolution of the disease…justifications
have been provided that (BiovaxID) may be of significant benefit to
those affected by the condition.”
In the EU, products targeted to treat disorders that affect fewer than 5
in 10,000 people are eligible for designation as a Drug to Treat a Rare
Disease. Such status provides significant advantages and assistance to
Biovest toward final approval to market BiovaxID™
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.
Dr. Steve Arikian, Biovest CEO and Chairman commented: "We are extremely
pleased by this acceptance on the part of the Commission of the European
Union, coming as it does shortly after the positive recommendation by
the Committee on Orphan Medical Products (COMP) of the European
Medicines Agency. This acceptance will provide Biovest with access to
valuable resources and input from the Agency while we complete our Phase
3 Clinical Study and prepare to file our Marketing Authorization
Application in the EU."
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™,
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™
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.
