Biovest Interviewed by OneMedRadio; Discusses Key Milestones Expected to Establish BiovaxID® as the World’s First Personal...
May 31 2012 - 3:13PM
Business Wire
Biovest International, Inc. (OTCQB: “BVTI”), a majority-owned
subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB: “ABPI”),
today announced that Brett Johnson, President and Executive Editor
of OneMedPlace interviewed Biovest’s President and CEO, Samuel S.
Duffey, and its Senior Vice President, Product Development &
Regulatory Affairs, Carlos F. Santos, Ph.D. In the webcast audio
interview on OneMedRadio, Biovest discussed its global regulatory
strategy for BiovaxID®, Biovest’s personalized cancer vaccine for
the treatment of follicular non-Hodgkin’s lymphoma, including plans
to file applications in the EU and Canada seeking approvals. The
Company also discussed its upcoming planned pre-filing meeting with
the U.S. FDA and corporate partnering initiatives.
The OneMedRadio interview can be accessed at the Biovest
corporate website home page at: http://www.biovest.com
In the interview, Biovest executives cover the following key
topics:
- Based on guidance provided in
regulatory meetings with European Union (EU) member national
regulatory agencies, Biovest is proceeding with plans to file a
Marketing Authorization Application (MAA) with the European
Medicines Agency (EMA) via the centralized procedure seeking
marketing approval for BiovaxID in the EU.
- Based on guidance provided in a
regulatory meeting with Health Canada, Biovest is proceeding with
plans to file a New Drug Submission (NDS) seeking marketing
approval for BiovaxID in Canada.
- Biovest is currently preparing for an
upcoming pre-filing meeting with the FDA in order to seek U.S.
regulatory guidance and define the pathway for registration.
- The U.S. National Cancer Institute
(NCI) will present updated, long-term data from its BiovaxID Phase
II mantle cell lymphoma trial on June 2nd at the American Society
of Clinical Oncology (ASCO) Annual Meeting with that study
demonstrating significant Overall Survival and
Time-to-Next-Treatment benefits correlating with a specific
vaccine-induced immune response.
- Biovest recently retained investment
banker Ferghana Partners as its strategic transaction advisor to
evaluate partnering opportunities.
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”).
For further information, please visit:
http://www.biovest.com
Forward-Looking
Statements:
Statements in this presentation/interview 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.