Galena licenses commercial rights to Dr. Reddy's for NeuVax(TM)
(nelipepimut-S) in breast and gastric cancers
-- Dr.
Reddy's to lead the development of NeuVax in Gastric Cancer, significantly expanding
the potential addressable patient population
--
Galena to receive development and sales milestones, as well as double-digit
royalties on net sales
--
Licensing and development terms contracted conditioned upon agreement on
ancillary activities
Galena Biopharma GALE +1.72% and Dr.
Reddy's Laboratories Ltd. RDY +0.39% today
announced a strategic development and commercialization partnership on
NeuVax(TM) (nelipepimut-S) in India.
Galena
Biopharma is a biopharmaceutical company commercializing and developing
innovative, targeted oncology treatments that address major unmet medical needs
to advance cancer care. Dr. Reddy's is an integrated global pharmaceutical
company, committed to providing affordable and innovative medicines for
healthier lives.
"This
partnership with Dr. Reddy's is consistent with our strategy to expand the
clinical utility of NeuVax in unmet medical needs while simultaneously
increasing the commercial footprint of this innovative cancer
immunotherapy," said Mark J. Ahn, Ph.D., President and CEO of Galena
Biopharma. "Dr. Reddy's is a leading pharmaceutical company in India with
significant commercialization and development expertise. The gastric cancer
trial will add a significant indication to our pipeline for NeuVax, while
doubling our potential patient population if approved."
G V
Prasad, Chairman and CEO, Dr. Reddy's commented, "The partnership
accelerates our strong commitment to innovation and efforts to bring newer
options for cancer patients. We are delighted with our partnership with Galena
Biopharma and we believe NeuVax can be a good potential treatment option to
prevent the recurrence of breast and gastric cancer."
About
NeuVax(TM) (nelipepimut-S)
NeuVax(TM) (nelipepimut-S) is the immunodominant nonapeptide
derived from the extracellular domain of the HER2 protein, a well-established
target for therapeutic intervention in breast carcinoma. The nelipepimut-S
sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTLs) 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 U.S. 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 PRESENT trial is ongoing and additional
information on the study can be found at www.neuvax.com . A randomized, multicenter
investigator sponsored, 300 patient Phase 2b clinical trial is also enrolling
patients to study NeuVax in combination with Herceptin(R) (trastuzumab;
Genentech/Roche).
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 the approximately 50%-60% of these women who are HER2
low to intermediate (IHC 1+/2+ or FISH < 2.0) and 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. GALE +1.72% is a
Portland, Oregon-based biopharmaceutical company commercializing and developing
innovative, targeted oncology treatments that address major unmet medical needs
to advance cancer care. For more information visitwww.galenabiopharma.com .
About
Dr. Reddy's
Dr. Reddy's Laboratories Ltd. RDY +0.39% is an
integrated global pharmaceutical company, committed to providing affordable and
innovative medicines for healthier lives. Through its three businesses -
Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary
Products - Dr. Reddy's offers a portfolio of products and services including
APIs, custom pharmaceutical services, generics, biosimilars and differentiated
formulations. Major therapeutic focus is on gastro-intestinal, cardiovascular,
diabetology, oncology, pain management and anti-infective. Major markets
include India, USA, Russia-CIS and Europe apart from other select geographies
within Emerging Markets. For more information, log on to: www.drreddys.com
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 planned clinical trial of NeuVax in
gastric cancer in India and the commercialization of NeuVax in India in both
breast and gastric cancers. These forward-looking statements are subject to a
number of risks, uncertainties and assumptions, including those identified
under "Risk Factors" in Galena's Annual Report on Form 10-K for the
year ended December 31, 2012 and most recent Quarterly Reports on Form 10-Q
filed 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 press release
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