Galena Biopharma Announces Signature of Commercialization Partnership With
Teva for Israel
*Partnership includes future commercialization of NeuVax™ in Israel and
*Key clinical sites approved and established in Israel for PRESENT Phase 3
LAKE OSWEGO, Ore., Dec. 4, 2012 (GLOBE NEWSWIRE) --Galena Biopharma, Inc.
(Nasdaq:GALE), a biotechnology company focused on developing innovative,
targeted oncology treatments, today announced it has signed an agreement with
a subsidiary of Teva Pharmaceutical Industries Limited for the
commercialization of NeuVax™ (nelipepimut-S or E75) in Israel.
"This agreement is the first piece of our global commercialization strategy,"
said Mark Ahn, Ph.D., President and Chief Executive Officer, Galena
Biopharma."Teva is a world-class pharmaceutical company and a major
pharmaceutical company in Israel.We look forward to their valuable financial
support towards our development goals in Israel, as well as market leadership
for NeuVax commercialization in the region."
Under the agreement, Teva Israel will assume responsibility for regulatory
registration in Israel, provide financial support for local development, and
will commercialize the product in the region. Specific financial terms were
not disclosed, but the agreement allows for significant royalty payments to
Galena Biopharma on future sales.
Israel will be the location of at least four clinical trial sites for the
NeuVax Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive
Breast Cancer with Low-to-Intermediate HER2 Expression with NeuVax Treatment)
"We are embarking on a very exciting and innovative venue for the adjuvant
treatment of early breast cancer. In this study we are boosting the body's
natural immune system to deal with possible residual cancer cells still
present.The biological reasoning behind this treatment is sound. We hope that
the results of this large randomized study will confirm the encouraging
results seen in earlier studies using this agent,"commented Dr. Noa Efrat
(Ben-Baruch), M.D., Head Department of Oncology at Kaplan Medical Center, and
an investigator for the trial in Israel.
About NeuVax (nelipepimut-S)
NeuVax™ (nelipepimut-S) is the immmunodominant nonapeptide derived from the
extracellular domain of the HER2 protein, a well-established target for
therapeutic intervention in breast carcinoma.The nelipepimut sequence
stimulates specific CD8+ cytotoxic T lymphocytes (CTL) following binding to
HLA-A2/A3 molecules on antigen presenting cells (APC).These activated
specific CTLs recognize, neutralize and destroy through cell lysis HER2
expressing cancer cells, including occult cancer cells and micrometastatic
foci.The nelipepimut immune response can also generate CTLs to other
immunogenic peptides through inter- and intra-antigenic epitope
spreading.Based on a successful Phase 2 trial, which achieved its primary
endpoint of disease-free survival (DFS), the Food and Drug Administration
(FDA) granted NeuVax™ a Special Protocol Assessment (SPA) for its Phase 3
PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer
with Low to Intermediate HER2 Expression with NeuVax Treatment) study.The
Phase 3 trial is ongoing and additional information on the study can be found
According to the National Cancer Institute, over 230,000 women in the U.S. are
diagnosed with breast cancer annually.Of these women, only about 25% are HER2
positive (IHC 3+). NeuVax targets approximately 50-60% of HER2-negative
patients (IHC 1+/2+ or FISH <2.2) who achieve remission with current standard
of care, but have no available HER2-targeted adjuvant treatment options to
maintain their disease-free status.
About Galena Biopharma
Galena Biopharma, Inc. (Nasdaq:GALE) is a Portland, Oregon-based
biopharmaceutical company that develops innovative, targeted oncology
treatments that address major unmet medical needs to advance cancer care.For
more information please visit us at www.galenabiopharma.com.
The Galena Biopharma, Inc. logo is available at
This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995.Such statements include,
but are not limited to, statements about the possible commercialization of
NeuVax™ and benefits of Galena's new product candidates.These forward-looking
statements are subject to a number of risks and uncertainties, including those
identified under "Risk Factors" in Galena's most recently filed Annual Report
on Form 10-K and Quarterly Report on Form 10-Q and in other filings Galena
periodically makes with the SEC.Actual results may differ materially from
those contemplated by these forward-looking statements.Galena does not
undertake to update any of these forward-looking statements to reflect a
change in its views or events or circumstances that occur after the date of
CONTACT: Madeline Hatton
Toll free: +1 (855) 855-GALE (4253), ext. 109
IR Sense, LLC
+1 (503) 400-6995
Galena Biopharma, Inc.
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