Biovest Advances Process Seeking European Marketing Approval for BiovaxID™ Personalized Lymphoma Vaccine
July 30 2012 - 09:45AM
Business Wire
Biovest International, Inc. (OTCQB: BVTI), a majority-owned
subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB: ABPI),
today announced that the European Medicines Agency (EMA) has
notified Biovest regarding the official designation of the
Rapporteur and Co-Rapporteur for BiovaxID, a personalized cancer
vaccine for the treatment of follicular non-Hodgkin’s lymphoma.
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.
Biovest’s EU regulatory advisor, Adriaan Fruijtier, stated,
“This is another key milestone as part of the formal EMA process
and a precursor to the upcoming filing of our Marketing
Authorization Application (MAA) for BiovaxID. The role of our
Rapporteur and Co-Rapporteur is to perform the scientific
evaluation for BiovaxID and to prepare an assessment report for the
EMA’s CHMP. We look forward to meeting with our selected reviewers,
as we will work closely with them, providing the necessary support
for a comprehensive submission.” Mr. Fruijtier serves on the
Biovest Scientific Advisory Board and as the Managing Director of
CATS Consultants GmbH in Germany. He has extensive EU regulatory
experience, having held positions with the EMA, Bayer, Glaxo,
Micromet and Novartis.
According to Carlos F. Santos, Ph.D., Biovest’s Senior Vice
President, Product Development and Regulatory Affairs, “We are
targeting an urgent unmet need, as approximately 25,000 patients
are newly diagnosed with follicular lymphoma in Europe every year,
and for these patients that achieve a complete remission following
induction therapy, BiovaxID represents the only
non-immunosuppressive, highly-safe consolidation (maintenance)
therapy capable of significantly extending a patient’s remission.
For these patients in first remission, our primary goal is deliver
a treatment option that offers a likelihood of clinical benefit
with quality of life not being adversely affected.”
The EMA has granted Orphan Medicinal Product designation to
BiovaxID for the treatment of follicular lymphoma and mantle cell
lymphoma, which are B-cell subtypes of non-Hodgkin’s lymphoma.
Orphan Drug status gives Biovest a 10-year period of market
exclusivity for BiovaxID upon approval for each indication in the
EU, thereby offering competitive protection from similar drugs of
the same class.
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 seeking US and international 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.