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 announced that its partner, Orexo
AB, has filed a patent infringement lawsuit in United States
District Court for the District of New Jersey, against Actavis
Laboratories FL, Inc., Andrx Corporation, Actavis, Inc. and Actavis
Pharma, Inc. (collectively "Actavis").
The lawsuit was filed in response to the Abbreviated New Drug
Application ("ANDA") filed by Actavis. In its application, Actavis
seeks to market and sell generic versions of Abstral® (fentanyl)
sublingual tablets in the U.S. prior to the expiration of Orexo's
U.S. patents for Abstral listed in the FDA's Orange Book. The
listed patents are U.S. patents 6,759,059, 6,761,910 and 7,910,132
with expiration dates in September 2019. Galena currently markets
Abstral and is the owner of the New Drug Application in the United
States.
Because Orexo initiated a lawsuit against Actavis in a timely
manner, the FDA is statutorily precluded from approving Actavis'
ANDA for 30 months, or until a district court decision finding the
patents invalid or not infringed, whichever occurs earlier. The
30-month stay period began as of the date Orexo received the Notice
Letter from Actavis that notified Orexo of the ANDA filing.
Mark W. Schwartz, Ph.D., President and Chief Executive Officer
of Galena Biopharma, commented, "We are confident in the patents
listed in the FDA's Orange Book and fully support our partner,
Orexo, as they vigorously enforce the intellectual property rights
around Abstral. Given the significant sales growth and future
market potential for Abstral, ANDA filings of generic versions are
not entirely unexpected. Our overall strategy and revenue
projections for Abstral are unchanged, and we look forward to
continued growth and increased market penetration during 2015."
About Abstral® (fentanyl) Sublingual
Tablets
Abstral® (fentanyl) Sublingual Tablets are an important
treatment option for inadequately controlled breakthrough cancer
pain which impacts 40%-80% of cancer patients. Abstral is approved
by the U.S. Food and Drug Administration, and is a sublingual
(under the tongue) fentanyl tablet indicated only 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
innovative Abstral formulation delivers the analgesic power and
increased bioavailability of micronized fentanyl in a more
convenient sublingual tablet which rapidly dissolves under the
tongue in seconds, provides rapid relief of breakthrough pain in
minutes, and matches the duration of the entire pain episode. 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
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®,
beliefs and intentions related to litigation with Actavis, 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.
Abstral and NeuVax are trademarks of Galena Biopharma,
Inc. All other trademarks are the property of their respective
owners.
CONTACT: Remy Bernarda
Senior VP, Investor Relations & Corporate Communications
(503) 405-8258
rbernarda@galenabiopharma.com
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