Biovest Initiates Formal Regulatory Approval Process for BiovaxID® Cancer Vaccine in Europe
June 20 2012 - 7:45AM
Business Wire
Biovest International, Inc. (OTCQB: BVTI), a majority-owned
subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB: ABPI),
today announced that formal notification was submitted to the
European Medicines Agency (EMA) informing of Biovest’s intent to
file a Marketing Authorization Application (MAA) seeking approval
in the European Union (EU) for BiovaxID®, its personalized cancer
vaccine for the treatment of follicular non-Hodgkin’s lymphoma, an
incurable cancer of the immune system. Upon approval, BiovaxID
would be the first cancer vaccine available in Europe for lymphoma
patients.
According to Carlos F. Santos, Ph.D., Biovest’s Senior Vice
President, Product Development and Regulatory Affairs, “This formal
notice submitted to the EMA marks a significant milestone in our
BiovaxID global regulatory strategy, as this is the initial step
required by the EMA in the process leading up to our planned MAA
submission.”
Biovest based its decision to pursue EU marketing approval for
BiovaxID on guidance received at a series of pre-filing clinical
advisory meetings conducted with EU-member national regulatory
agencies. The Company will soon conduct a meeting with the FDA to
define the path for U.S. registration as well.
Under the EMA centralized procedure, Biovest’s application will
be assessed by the EMA’s Committee for Medicinal Products for Human
Use (CHMP). An approval under the centralized procedure is valid in
all EU-member countries. Subsequent to completion of the
pre-submission process, Biovest could receive a decision regarding
EU marketing approval for BiovaxID within 12 months after the MAA
submission, assuming its pre-submission, formal marketing
application and the rigorous review process advance forward in a
timely and positive manner.
In other news, Biovest has named Prof. J.H. Veelken, M.D.,
Ph.D., to its Scientific Advisory Board (SAB). The Biovest SAB
represents a group of preeminent physicians and doctors from the
fields of cancer immunotherapy, immunology, bioinformatics,
regulatory affairs and cell culture bio-manufacturing.
Prof. Veelken serves as Professor of Internal Medicine
(Hematology) and Head of the Department of Hematology at Leiden
University Medical Center, (Leiden, Netherlands). An
internationally-recognized authority in cancer immunotherapy, Prof.
Veelken’s research focuses on the immunopathogenesis of malignant
lymphoma, including the role of antigen receptor signaling in the
etiology of indolent non-Hodgkin’s lymphomas and chronic
lymphocytic leukemia. His research also covers natural
immunosurveillance and the mechanisms of stroma interaction as
survival signals for these tumors, and high-resolution genomic and
transcriptomic profiling to identify pathogenetically relevant
genetic pathways and novel therapeutic targets. His projects form
the basis for translational research and clinical trials for
therapeutic anti-tumor vaccination in lymphomas and other
malignancies.
According to Prof. Veelken, “BiovaxID will meet an important
need in the management of lymphoma in the European clinic as an
active immunotherapy that can extend duration of tumor remission
and offer patients a non-immunosuppressive post-induction
therapy.”
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
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without limitation), statements regarding the timing of anticipated
filing of a Marketing Authorization Application for BiovaxID with
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