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| 8-K - FORM 8-K - BIOVEST INTERNATIONAL INC | d336604d8k.htm |
| EX-99.1 - PRESS RELEASE - BIOVEST INTERNATIONAL INC | d336604dex991.htm |
 Fighting Lymphoma…
and Making it Personal
www.Biovest.com
Biovest (OTCQB: BVTI)
Interview with
OneMedPlace Research:
Brett Johnson
President & Executive Editor
OneMedPlace
Samuel S. Duffey, Esq.
President & CEO
Biovest International, Inc.
Carlos F. Santos, Ph.D.
SVP, Product Development
& Regulatory Affairs
Biovest International, Inc.
April 18, 2012
EXHIBIT 99.2 |
 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 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 New Drug Submission for BiovaxID with
Health Canada, pre-filing meetings with the FDA, Europe or other
jurisdictions an/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.
Safe Harbor Statement |
 A
Late-Stage Personalized Cancer Vaccine Poised to Seek Approval(s) for
Follicular non- Hodgkin’s Lymphoma in 2012/2013
|
 Regulatory Strategy
If Approved, BiovaxID Represents the World’s First
Cancer Vaccine Available for Lymphoma Patients
Canada: Based on positive guidance from pre-filing clinical
meeting conducted with Health Canada, Biovest plans to file a
New Drug Submission (NDS) later this year seeking marketing
approval in Canada. European
Union:
Biovest
is
preparing
to
report
on
pre-filing
clinical
meetings conducted with European authorities and expects to announce
the outcome and expected EU regulatory pathway in Spring/Summer
2012 U.S.A.: Biovest is preparing to conduct and report on a
pre-filing clinical meeting with the FDA and expects to
announce the outcome and expected U.S. regulatory pathway in
Summer 2012 |
 BiovaxID Body of Clinical Evidence
Follicular
Lymphoma
Phase
2
demonstrates
nearly
universal
immune
response to BiovaxID, durable molecular remission in FL with highly
encouraging Overall Survival signal (15-year follow-up)
Follicular
Lymphoma
Phase
3:
randomized,
multicenter,
controlled
clinical trial improved DFS by 13.6 months in patients in first remission
who received at least one dose of BiovaxID
This study was conducted in 12 major cancer centers across the US with a
median follow-up of 4.7 years
Mantle
Cell
Lymphoma
Phase
2
demonstrates
strong
association
between vaccine-induced GM-CSF cytokine response and Overall
Survival (10-year follow-up) following a rituximab containing induction
therapy
No significant safety risks have been identified for BiovaxID
|
 BiovaxID
Personalized
Manufacturing
Process |
 Proprietary Manufacturing Technology Ensures Reliable Production
Hollow-Fiber Bioreactor
Cultures Tumor Derived Cells
(Heterohybridoma)
for Id Protein Production
Isotype-Matched Id Protein
Secreted and
Purified |
 Why
Do We Need BiovaxID? BiovaxID acts as a novel,
non-cross-resistant, consolidation therapy for patients
with Follicular Lymphoma (FL) that achieve a Complete Response
following induction treatment. Why do we need another
consolidation therapy in FL? Maintenance rituximab appears
equivalent to rituximab retreatment and is being challenged as a
consolidation option (RESORT, Hainsworth et al) Practicing
oncologists reconsidering the role of maintenance rituximab based
on the RESORT trial
Safety profile of vaccine compares favorably to maintenance
rituximab Vaccination,
unlike
all
other
consolidation
therapies,
generates
long-term
anti-lymphoma immunity
Vaccination does not preclude future retreatment with rituximab and may
even enhance the benefit of subsequent therapies
Vaccine mechanism of action complements rituximab’s mechanism of
action Not all patients are eligible or can tolerate prolonged
immunosuppression associated with currently available
consolidation therapies. |
 Redefining Immunity for Life
OTCQB: BVTI
www.Biovest.com
Corporate Contact:
Douglas W.
Calder
Vice President, Strategic
Planning & Capital Markets
324 South Hyde Park Ave. #350
Tampa, FL 33606
Phone: 813-864-2558
Email: dwcalder@Biovest.com
|