Galena Biopharma and Dr. Reddy's Announce Strategic Partnership for NeuVax(TM) in India
-- 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
PORTLAND, Ore. and HYDERABAD, India, Jan. 14, 2014 (GLOBE NEWSWIRE) --
Galena Biopharma (Nasdaq:GALE) and Dr. Reddy's Laboratories Ltd.
(NYSE:RDY) 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. (Nasdaq:GALE) 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 visit
www.galenabiopharma.com.
About Dr. Reddy's
Dr. Reddy's Laboratories Ltd. (NYSE:RDY) 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.
CONTACT: Galena Biopharma Contact:
Remy Bernarda
Vice President, Marketing & Communications
+1 (503) 405-8258
[email protected]
Dr. Reddy's Investors and Financial Analysts Contacts:
Kedar Upadhye at [email protected] /+91-40-66834297
Saunak Savla at [email protected] / +91-40-49002135
Milan Kalawadia (USA) at [email protected] /
+1 908-203-4931
Dr. Reddy's Media Contact:
SVS Chowdary Lakamsani at [email protected]