Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company
committed to the development and commercialization of targeted
oncology therapeutics that address major unmet medical needs, today
announced the sale of its Abstral® (fentanyl) Sublingual Tablet
product to a private company in a deal valued at up to $12 million,
with $8 million cash upfront and up to $4 million in additional
cash upon the achievement of certain sales milestones, effective as
of November 19, 2015. For additional information about the
transaction, please refer to the Form 8-K filed with the SEC and
available on our website.
"We are pleased to complete this divestiture in a timely manner
to allow us to focus our energy and resources solely on our
clinical development programs as we believe this strategic shift is
in the best interest of our patients, our shareholders, and the
long-term success of our company," said Mark W. Schwartz, Ph.D.,
President and Chief Executive Officer of Galena Biopharma.
Mizuho Securities acted as exclusive advisor to Galena Biopharma
on this transaction.
About Abstral® (fentanyl) Sublingual
Tablets
Abstral® (fentanyl) Sublingual Tablets, is a treatment option
for inadequately controlled breakthrough cancer pain (BTcP), which
is estimated to affect more than 50% of all cancer patients.
Abstral is approved by the FDA, and is a sublingual (under the
tongue) tablet for the management of breakthrough pain in patients
with cancer, 18 years of age and older, who are already receiving,
and who are tolerant to, opioid therapy for their persistent
baseline cancer pain. The Abstral formulation delivers the
analgesic power and increased bioavailability of micronized
fentanyl in a sublingual tablet that is designed to dissolve under
the tongue in seconds and provide relief of breakthrough pain
within minutes. Abstral is a transmucosal immediate release
fentanyl (TIRF) product with product class oversight by the TIRF
Risk Evaluation and Mitigation Strategy (REMS) access program. See
full prescribing information at www.abstral.com.
Important Safety Information
ABSTRAL is an opioid agonist indicated for the management of
breakthrough pain in cancer patients 18 years of age and older who
are already receiving and who are tolerant to opioid therapy for
their underlying persistent cancer pain.
WARNING: RISK OF RESPIRATORY DEPRESSION, MEDICATION
ERRORS, ABUSE POTENTIAL
RESPIRATORY DEPRESSION
Fatal respiratory depression has occurred in patients
treated with immediate-release transmucosal fentanyl, including
following use in opioid non-tolerant patients and improper dosing.
The substitution of ABSTRAL for any other fentanyl product may
result in fatal overdose. Due to the risk of respiratory
depression, ABSTRAL is contraindicated in the management of acute
or postoperative pain including headache/migraine and in opioid
non-tolerant patients
ABSTRAL must be kept out of reach of
children.
The concomitant use of ABSTRAL with CYP3A4 inhibitors may result
in an increase in fentanyl plasma concentrations, and may cause
potentially fatal respiratory depression.
MEDICATION ERRORS
Substantial differences exist in the pharmacokinetic
profile of ABSTRAL compared to other fentanyl products that result
in clinically important differences in the extent of absorption of
fentanyl that could result in fatal overdose.
- When prescribing, do not convert patients on a mcg per
mcg basis from any other fentanyl products to
ABSTRAL.
- When dispensing, do not substitute an ABSTRAL
prescription for other fentanyl products.
ABUSE POTENTIAL
ABSTRAL contains fentanyl, an opioid agonist and a
Schedule II controlled substance, with an abuse liability similar
to other opioid analgesics. ABSTRAL can be abused in a manner
similar to other opioid agonists, legal or illicit. This should be
considered when prescribing or dispensing ABSTRAL in situations
where the physician or pharmacist is concerned about an increased
risk of misuse, abuse or diversion.
Because of the risk for misuse, abuse, addiction, and
overdose, ABSTRAL is available only through a restricted program,
required by the Food and Drug Administration, called a
Risk Evaluation and
Mitigation Strategy (REMS). Under
the TIRF (Transmucosal Immediate Release Fentanyl) REMS Access
program, outpatients, healthcare professionals who prescribe to
outpatients, pharmacies, and distributors must enroll in the
program. Further information is available at www.TIRFREMSAccess.com
or by calling 1-866-822-1483.
For additional important safety information, see the full
Prescribing Information for ABSTRAL available at
www.abstral.com.
About Galena Biopharma, Inc.
Galena Biopharma, Inc. is a biopharmaceutical company committed
to the development and commercialization of targeted oncology
therapeutics that address major unmet medical needs. Galena's
development portfolio is focused primarily on addressing the
rapidly growing patient populations of cancer survivors by
harnessing the power of the immune system to prevent cancer
recurrence. The Company's pipeline consists of multiple mid- to
late-stage clinical assets, including novel cancer immunotherapy
programs led by NeuVax™ (nelipepimut-S) and GALE-301. NeuVax is
currently in a pivotal, Phase 3 clinical trial with several
concurrent Phase 2 trials ongoing both as a single agent and in
combination with other therapies. GALE-301 is in a Phase 2a
clinical trial in ovarian and endometrial cancer and in a Phase 1b
given sequentially with GALE-302. 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 expected and realized revenue from the sale of Abstral®, the
divestiture of the commercial operations including our commercial
products, the issuance and exclusivity of patents, the progress of
development of Galena's product candidates, including patient
enrollment in our clinical trials., as well as other statements
related to the progress and timing of our development activities,
present or future licensing, collaborative or financing
arrangements or that otherwise relate to future periods. 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, 2014 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.
NeuVax is a trademark of Galena Biopharma, Inc. All other
trademarks are the property of their respective owners.
CONTACT: Remy Bernarda
SVP, Investor Relations & Corporate Communications
(503) 405-8258
rbernarda@galenabiopharma.com
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