Galena Biopharma Provides 2015 Outlook
January 08 2015 - 07:05AM
Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company
developing and commercializing innovative, targeted oncology
treatments that address major medical needs across the full
spectrum of cancer care, today provided the Company's outlook for
2015.
Mark W. Schwartz, Ph.D., President and Chief Executive Officer,
commented, "We are providing this update today to set the stage for
what we believe will be a strong 2015 for Galena Biopharma. On the
commercial side, I reiterate our 2014 guidance as we had our best
sales quarter to date, and expect net revenues to fall in the
middle of our $8-$10 million range. Further, we expect Abstral® to
become accretive in 2015 and, with the launch of Zuplenz®, we
expect over 50% revenue growth this year."
Schwartz continued, "NeuVax™, our lead cancer immunotherapy
agent, has a portfolio of trials providing diversification and
increased potential of program success. Our Phase 3 PRESENT
trial is expected to enroll the 700th patient near the end of
January and complete over enrollment near the end of the first
quarter. We also expect top-line data and the determination of
next steps for the GALE-301 and GALE-401 Phase 2
programs. While 2014 was a challenging year for Galena, this
did not impede the advancement of our two commercial programs and
three clinical assets, all of which are poised for significant
progress in 2015."
2015 Outlook:
Galena expects to reach a number of key milestones this year
across its multiple programs.
Commercially, the Company anticipates a strong year for sales
growth along with the launch of a second asset:
- 2014 Net revenue expected in the middle of the established
range of $8-$10 million with year-end and fourth quarter earnings
to be announced in March.
- Upcoming launch of Zuplenz® (ondansetron) oral soluble film in
the United States to treat nausea and vomiting caused by
chemotherapy, radiation therapy, and following surgery.
- Achieve $15-18 million net revenue in 2015. As penetration
of Abstral® (fentanyl) sublingual tablets continues to grow to
treat patients with breakthrough cancer pain, the Company expects
the product to become accretive this year.
Galena's targeted cancer immunotherapy programs are designed to
prevent recurrence in breast, gastric, ovarian and endometrial
cancers. As the number of cancer survivors continues to grow,
preventing recurrence of the disease becomes more important as
metastatic tumors are most often fatal. Galena's programs
harness the power of the immune system and primarily target
patients in the adjuvant (after-surgery) setting who have
relatively healthy immune systems. Employing this approach,
the company is currently engaged in multiple clinical trials with
NeuVax™ (nelipepimut-S) and GALE-301, or Folate Binding Protein,
combined with the immune adjuvant, granulocyte macrophage-colony
stimulating factor (GM-CSF).
Galena's lead development asset is NeuVax, which is designed to
prevent recurrence in breast and gastric cancers targeting the HER2
protein, one of the more common proteins expressed with these
diseases. The company has developed a portfolio of trials with
a number of key collaborators and in multiple indications where
there are currently no approved treatments:
- The pivotal, Phase 3 PRESENT (Prevention of
Recurrence in
Early-Stage, Node-Positive Breast
Cancer with Low to Intermediate HER2 Expression
with NeuVax Treatment) study is
expected to reach its protocol established enrollment of 700
patients near the end of this month. Galena expects to over
enroll and complete enrollment of the trial near the end of the
first quarter of this year. This trial is being run under a
Special Protocol Assessment (SPA) granted by the U.S. Food and Drug
Administration (FDA) and, if successful, expected to be the basis
for approval of the compound. The interim analysis for safety
and futility for the PRESENT trial is expected by the end of
2015/beginning of 2016.
- Two Phase 2 trials are also being run with NeuVax in
combination with Herceptin® (trastuzumab; Genentech/Roche). A
Phase 2b trial in node positive and triple negative HER2 IHC 1+/2+
patients is ongoing under a clinical collaboration with
Genentech/Roche and the Henry M. Jackson Foundation. Late last
year, the initiation of a Phase 2 trial was announced in
neoadjuvant, node positive and negative HER2 IHC 3+
patients. The trial is partially funded via a grant from the
Department of Defense under the Congressionally Directed Medical
Research Program.
- Through collaboration with Dr. Reddy's Laboratories, Inc., a
fourth trial of NeuVax is expected to initiate this year in gastric
(stomach) cancer in India. Gastric cancer is one of the leading
causes of death in the Asian population, and this trial could
significantly expand the potential patient population for
NeuVax.
Galena's second immuno-oncology compound, GALE-301 targets
folate binding protein receptor-alpha, a well-validated therapeutic
target, which is highly over-expressed in ovarian, endometrial and
breast cancers. GALE-301 is in a Phase 2a clinical trial for
the prevention of recurrence in ovarian and endometrial
cancers. Current treatments for these diseases are principally
with chemotherapeutic agents and patients suffer a high recurrence
rate; and, most patients relapse with an extremely poor
prognosis.
- Recent preliminary Phase 2a data of GALE-301 plus GM-CSF showed
promising results with a 38% reduction in relative risk of
recurrence, is well tolerated with primarily Grade 1 and 2
toxicities, and elicits a strong in vivo immune response.
- Top-line safety and efficacy data will be presented this
year.
Galena's final clinical program is a hematology compound known
as GALE-401, or Anagrelide Controlled Release. GALE 401 is
currently in a Phase 2 proof-of-concept clinical trial for the
reduction of elevated platelet counts in patients with
thrombocythemia, secondary to myeloproliferative neoplasms (MPNs).
Phase 2 top-line safety and efficacy data will be presented this
year.
Herceptin is a registered trademark of
Genentech/Roche. NeuVax and Abstral are trademarks of Galena
Biopharma. All other trademarks are the property of their
respective owners.
About Galena Biopharma
Galena Biopharma, Inc. (Nasdaq:GALE) is a biopharmaceutical
company developing and commercializing innovative, targeted
oncology therapeutics that address major medical needs across the
full spectrum of cancer care. Galena's development portfolio
ranges from mid- to late-stage clinical assets, including a robust
immunotherapy program led by NeuVax™ (nelipepimut-S) currently in
an international, Phase 3 clinical trial. The Company's
commercial drugs include Abstral® (fentanyl) Sublingual Tablets and
Zuplenz® (ondansetron) Oral Soluble Film. Collectively, Galena's
clinical and commercial strategy focuses on identifying and
advancing therapeutic opportunities to improve cancer
care, from direct treatment of the disease to the reduction of
its debilitating side-effects. For more information, visit
www.galenabiopharma.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 progress of the commercialization of Abstral®
and development of Galena's product candidates, including patient
enrollment in our clinical trials, as well as statements about our
expectations, plans and prospects. 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, 2013 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: Remy Bernarda
VP, Marketing & Communications
(503) 405-8258
rbernarda@galenabiopharma.com
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