Biovest’s Eligibility to Seek EU Marketing Approval for its BiovaxID Cancer Vaccine as Orphan Drug Confirmed by EMA
12 July 2012 - 2:45PM
Business Wire
Biovest International, Inc. (OTCQB: BVTI), a majority-owned
subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB: ABPI),
today announced that in response to Biovest’s notice of intent to
file for marketing approval previously submitted to the European
Medicines Agency (EMA), the EMA has provided formal notification
that Biovest is eligible to submit its planned Marketing
Authorization Application (MAA) for BiovaxID under the EMA’s
centralized procedure as an orphan medicinal product for the
treatment of follicular non-Hodgkin’s lymphoma. 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, “With EMA
confirmation in hand, we are continuing to satisfy the EMA’s
requirements. Under the EMA’s centralized procedure, a decision
rendering approval for BiovaxID would result in simultaneous
registration of our cancer vaccine in all EU-member countries. Our
planned submission in Europe is in addition to our plans to file an
application seeking marketing approval in Canada. Additionally,
with EMA Orphan Drug designation, we will have a 10-year period of
market exclusivity for BiovaxID upon approval for follicular
lymphoma in the EU, thereby offering competitive protection from
similar drugs of the same class.” The EMA has also granted BiovaxID
Orphan Drug designation for the treatment of mantle cell lymphoma,
another B-cell subtype of non-Hodgkin’s lymphoma.
In other news, an article was published in Genetic Engineering
& Biotechnology News (GEN) highlighting Biovest’s proprietary
biomanufacturing instruments and processes.
The article, titled, “CMOs Capitalizing on Experience to Develop
Their Own Therapeutics”, includes comments from Biovest’s Vice
President, Strategic Planning, Douglas W. Calder, stating, “With
over three decades of experience in contract manufacturing, Biovest
has managed every aspect of the life cycle (pre-clinical, clinical
and commercial-stage) for protein drug production for thousands of
clients, and this business unit has provided not only a source of
revenues to help support our own proprietary cancer vaccine
development, but more importantly with what we believe are the most
innovative cell culture instruments and production techniques for
the manufacture of vaccines and cell-based products, including
autologous personalized medicines.”
The GEN article can be accessed in the Media Center at Biovest’s
corporate website at: http://www.biovest.com/investor-relations/media-center
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
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Such statements include, but are not limited to, statements
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