Biovest Conducts Meeting with EMA Advancing Process to Seek EU Approval for Cancer Vaccine
September 20 2012 - 08:15AM
Business Wire
Biovest International, Inc. (OTCQB: BVTI), a majority-owned
subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB: ABPI),
today reported milestone achievements advancing BiovaxID™,
Biovest’s personalized cancer vaccine for the treatment of
non-Hodgkin’s lymphoma, including a recently conducted regulatory
meeting with the European Medicines Agency (EMA) and the
appointment of a key contributor to the Human Genome Project to its
Scientific Advisory Board.
Biovest reported that it recently conducted a regulatory meeting
with the EMA in London, at which the EMA provided Biovest with
information to help finalize Biovest’s pending Marketing
Authorization Application (MAA) seeking EU marketing approval for
BiovaxID. The meeting addressed legal, regulatory, and scientific
matters for the planned MAA in order to facilitate subsequent
validation and assessment of the application. The Company believes
that the meeting with the EMA was favorable and will support final
preparation and filing of the MAA anticipated for early next
year. Based on the meeting, Biovest anticipates that the filing and
review of the application will proceed in a timely and customary
manner. Next steps in the pre-submission process will include
upcoming meetings planned with the Rapporteur and
Co-Rapporteur.
The Rapporteur and Co-Rapporteur are members of the EMA’s
Committee for Medicinal Products for Human Use (CHMP). They are
supported by a team of assessors from their National Authority. The
Rapporteur and Co-Rapporteur have been assigned with the primary
responsibility of preparing and delivering an approvability
evaluation report under the EMA’s Centralized Procedure. Under this
procedure, a registration of BiovaxID throughout all EU-member
countries can be obtained simultaneously via a single application.
Upon approval, BiovaxID would be the first cancer vaccine available
in Europe for lymphoma patients.
In other news, Biovest announced that it appointed David J.
States, M.D., Ph.D., to the Company’s Scientific Advisory Board.
Dr. States is a systems biologist and leader who helped to
established the discipline of bioinformatics. He received his M.D.
and Ph.D. from Harvard University and clinical training in internal
medicine at the University of California, San Diego and the
National Institutes of Health in Bethesda, Maryland. He is board
certified in internal medicine and is a Fellow of the American
College of Medical Informatics. Dr. States has been a leader in
establishing bioinformatics as a field including work on molecular
modeling, genome mapping and sequencing and proteomics. Notably,
Dr. States has been involved in the Human Genome Project from its
inception and helped to establish the NIH National Center for
Biotechnology Information (NCBI).
About Biovest International,
Inc.
Biovest International, Inc. develops active immunotherapies
(cancer vaccines) which treat and diminish the aggressiveness of
B-cell non-Hodgkin’s lymphoma, a cancer of the immune system. The
Company’s lead personalized cancer vaccine product candidate,
BiovaxID™, has been evaluated in three clinical trials conducted in
collaboration with the U.S. National Cancer Institute (NCI)
demonstrating that BiovaxID increases the duration of cancer
remission following chemotherapy and induces immune responses which
correlate highly with long-term survival. Biovest is currently in
the process of pursuing European and Canadian marketing approvals
for BiovaxID.
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”).
For further information, please visit:
http://www.biovest.com
Forward-Looking
Statements:
Statements in this press release that are not strictly
historical in nature constitute "forward-looking statements.”
Such statements include, but are not limited to, statements
about Biovest and its product candidate, BiovaxID™ and any other
statements relating to products, product candidates, product
development programs, the FDA, the EMA, Health Canada 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. In particular (and
without limitation), statements regarding the timing of anticipated
filing of a Marketing Authorization Application for BiovaxID with
the EMA or a New Drug Submission for BiovaxID with Health Canada,
pre-filing meetings with the FDA or other jurisdictions and/or
commercial plans reflect current expectations but are subject to
inherent risks of delay in compilation and finalization of all
components of the licensing application. 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.