-- Partnership includes future commercialization of NeuVax(TM) in Israel
and financial support
-- Key clinical sites approved and established in Israel for PRESENT Phase
3 trial
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(TM) (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) study.
"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(TM) (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(TM) 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 at www.neuvax.com.
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
http://www.globenewswire.com/newsroom/prs/?pkgid=10647
Forward-Looking Statements
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(TM) 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 this presentation.
CONTACT: Madeline Hatton
Toll free: +1 (855) 855-GALE (4253), ext. 109
[email protected]
or
Remy Bernarda
IR Sense, LLC
+1 (503) 400-6995
[email protected]