Accentia Biopharmaceuticals Inc : Biovest Prepares for EU Regulatory Meetings; SME Status Granted Providing European Regulatory Benefits for BiovaxID Personalized Lymphoma Vaccine
01/19/2012 | 10:43pm
Biovest International, Inc. (OTCQB:BVTI), a majority-owned
subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB:ABPI),
today announced that the European Medicines Agency (EMA) has
granted Small and Medium Sized Enterprise (SME) status to
Biovest. With EMA SME status confirmed, Biovest will be
provided with certain administrative and economic benefits
related to the EU regulatory process for the Company's
BiovaxID® personalized lymphoma vaccine targeting the
treatment of certain B-cell subtypes of non-Hodgkin's
lymphoma.
According to Biovest's Senior Vice President, Product
Development & Regulatory Affairs, Dr. Carlos F. Santos,
Ph.D., "Securing EMA SME status is an important regulatory
milestone for Biovest, as we will receive procedural
assistance in coordinating upcoming BiovaxID meetings with
the EMA, and we also expect significant cost-savings based on
potential application fee exemptions and fee reductions."
Samuel S. Duffey, the Company's President & CEO, added,
"After receiving SME status, the next step in our regulatory
strategy is to conduct scientific advice meetings with
several national regulatory authorities in the EU."
In other news, Biovest announced that the Company is
scheduled to present at the Phacilitate Vaccine Forum
Washington 2012 at the Grand Hyatt Hotel in Washington D.C.
On Tuesday, January 31stat 11:55 a.m. EST, Dr.
Santos will present on BiovaxID, including a regulatory
update, in a session titled, "Effectively Delivering
Therapeutic Vaccines to Blockbuster Markets."
To meet with Biovest at the Vaccine Forum Washington 2012,
please contact Douglas Calder at 813-507-2633 or dwcalder@biovest.com.
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®, 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™ Market with the stock-ticker
symbol "BVTI", and is a majority-owned subsidiary of Accentia
Biopharmaceuticals, Inc. (OTCQB: "ABPI").
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®, AutovaxID®, events occurring
after dates hereof, and any other statements relating to
products, product candidates, product development programs,
the FDA or clinical study process including the commencement,
process, or completion of clinical trials or the regulatory
process.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 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 Biovest undertakes no
obligation to revise or update this news release to reflect
events or circumstances after the date hereof. The product
names used in this statement are for identification purposes
only. All trademarks and registered trademarks are the
property of their respective owners.