European Medicines Agency Accepts Marketing Authorization Application for Biovest’s Cancer Vaccine for Treatment of Non

  European Medicines Agency Accepts Marketing Authorization Application for
  Biovest’s Cancer Vaccine for Treatment of Non-Hodgkin’s Follicular Lymphoma

Business Wire

MINNEAPOLIS & TAMPA, Fla. -- January 13, 2014

Biovest International, Inc. (“Biovest”), a leader and pioneer in the
development of personalized cancer immunotherapies, today reported that the
European Medicines Agency (EMA) accepted the Company’s Marketing Authorization
Application (MAA) for BiovaxID™ (submitted to EMA as “Dasiprotimut-T
Biovest”), a personalized cancer vaccine for the treatment of non-Hodgkin’s
follicular lymphoma. The MAA validation confirms the submission is complete
and begins the formal EMA review process intended to secure approval to market
BiovaxID in the European Union and to allow prescription and sale of BiovaxID
for the treatment of non-Hodgkin’s follicular lymphoma in patients who have
achieved a first complete remission.

“EMA’s acceptance of our Marketing Authorization Application for BiovaxID
marks a major milestone in our efforts to bring BiovaxID to the European
market. If approved, BiovaxID will receive marketing authorization in the 28
EU member states, as well as in Iceland, Liechtenstein and Norway. This
vaccine, if approved, will offer patients diagnosed with non-Hodgkin’s
follicular lymphoma, and who have achieved a first complete remission, a truly
personalized therapy to delay or to prevent tumor recurrence following the
completion of induction therapy. Using currently available treatments, more
than half of the patients diagnosed with non-Hodgkin’s lymphoma achieve
complete remissions, but will almost always suffer from tumor relapse and will
ultimately require re-treatment for ongoing disease. We hope to change that
with BiovaxID,” stated Carlos F. Santos, Ph.D., Biovest’s Chief Executive
Officer. “BiovaxID offers patients a truly personalized immunotherapy to
maintain durable remissions. In our multi-center, randomized, controlled Phase
3 clinical study, BiovaxID demonstrated that it can induce powerful anti-tumor
immune responses while providing a median disease-free survival benefit of
over 15 months, and a reduction of 42% in the risk of relapse, and in our
Phase 2 clinical trial, 28% of patients who received BiovaxID remain in
continuous remission at a median of 12.7 years of follow-up. We look forward
to the day when we can provide all follicular lymphoma patients with this
truly personalized vaccine to fight their disease.”

Biovest submitted its MAA following the successful completion and long-term
follow-up of two Phase 2 clinical trials and of one multi-center, randomized,
Phase 3 clinical trial (all conducted in partnership with the U.S. National
Cancer Institute) in which BiovaxID demonstrated it could induce powerful
anti-tumor immune responses, eradicate residual tumor cells from patients’
blood following chemotherapy, and improve the duration of complete remissions
by a median of 15.4 months relative to control. The Company also embarked upon
an extensive effort to automate nearly all aspects of manufacturing and of
quality control in order to ensure the commercial viability of BiovaxID. Dr.
Santos noted, “In addition to our clinical program, which yielded some of the
most significant and positive personalized cancer vaccine data of which we are
aware, we have successfully designed and deployed proprietary,
highly-automated manufacturing and quality control systems for BiovaxID that
will allow us to make this vaccine a commercial reality.”

Appointment of Chief Financial Officer

Additionally, Biovest announced that it has appointed Robert E. Farrell, J.D.
as Chief Financial Officer. Mr. Farrell joins Biovest from Sanovas, Inc.,
where he served as CFO from 2012 to 2013. Prior to Sanovas, Mr. Farrell served
as CEO (2008-2010) and as EVP and CFO (1996-2008) of Titan Pharmaceuticals,
Inc., a diversified biotechnology company that sought to develop early-stage
therapeutic programs in oncology and in disorders of the central nervous
system.

About Biovest International, Inc.

Biovest International, Inc. develops autologous active immunotherapies
(personalized cancer vaccines) to treat B-cell non-Hodgkin’s lymphomas, which
are cancers of the immune system. The Company’s lead personalized cancer
vaccine candidate, BiovaxID, has undergone three clinical trials conducted in
collaboration with the U.S. National Cancer Institute (NCI) that have
demonstrated BiovaxID’s ability to increase the duration of cancer remission
following chemotherapy and to induce immune responses which correlate highly
with long-term survival. Biovest is currently in the process of pursuing
European marketing approval for BiovaxID.

        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 , its product candidate, BiovaxID™ and
any other statements relating to products, product candidates, product
development programs, the FDA, the EMA, 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 “proposed”, “proposes”,
“seeking”, "may," "could," "would," "should," "believes," "expects,"
"anticipates," "estimates," "intends," "plans," or similar expressions. In
particular (and without limitation), statements regarding potential approval
of a Marketing Authorization Application for BiovaxID by the European
Commission, 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.

Contact:

Biovest International, Inc.
David Moser,813-864-2554
dmoser@biovest.com
 
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