Galena Biopharma Launches Galena Patient Services (GPS)
Galena Patient Services (GPS) is a Full-Service Program to Help Manage Access and Reimbursement for Patients Taking Abstral(R) (fentanyl) Sublingual Tablets
PORTLAND, Ore., March 3, 2014 (GLOBE NEWSWIRE) -- Galena Biopharma
(Nasdaq:GALE), a biopharmaceutical company developing and
commercializing innovative, targeted oncology treatments that address
major unmet medical needs to advance cancer care, today announced the
launch of Galena Patient Services (GPS), a full-service support program
designed to enhance patient access to commercial products offered by
the Company. Currently, Galena markets Abstral(R) (fentanyl) Sublingual
Tablets for the treatment of breakthrough cancer pain.
A dedicated GPS team works with the healthcare professionals, patients,
and insurance providers to guide the benefits approval process and make
prescribing and receiving Galena Biopharma commercial products as
simple as possible. Enrollment in the GPS program is done quickly and
easily through a patient's certified prescriber. An overview of the
program can be found at www.galenapatientservices.com.
Galena Patient Services will:
-- Guide the benefits investigation and prior authorization process
-- Help manage the appeals and denials process
-- Locate the preferred pharmacy
-- Execute the Patient Assistance Program (PAP) for patient reimbursement
"Patients suffering from breakthrough cancer pain are confronted with
extraordinary issues on a daily basis, including insurance
reimbursement and access," said Mark J. Ahn, Ph.D., President and Chief
Executive Officer. "Galena Patient Services will offer support to these
patients and their healthcare providers by managing the benefits
approval process to make prescribing and receiving Abstral as simple as
All GPS services will be coordinated by a contracted third party
vendor. All personal data in the GPS program are kept confidential to
maintain HIPAA (Health Insurance Portability and Accountability Act)
About Abstral(R) (fentanyl) Sublingual Tablets
Abstral(R) (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
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.
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
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 Breakthrough Cancer Pain
Breakthrough cancer pain is defined as a transient exacerbation of pain
that occurs either spontaneously, or in relation to a specific
predictable or unpredictable trigger, despite relatively stable and
adequately controlled background pain. Breakthrough cancer pain occurs
in 40-80 percent of patients who are already receiving chronic,
long-acting opioid pain management and yet have episodes of severe
tumor- and treatment-related cancer pain. Breakthrough pain occurs
frequently in these patients, particularly as they try to conduct
normal daily activities, with a mean number of episodes of 4 per day
(average range 1-14 per day) and a median duration of 30 minutes (range
1-240 minutes). The wide range of time to relief of these severe pain
episodes leads to high levels of distress and impaired quality of life
experienced by patients.
About Galena Biopharma
Galena Biopharma, Inc. (Nasdaq:GALE) is a Portland, Oregon-based
biopharmaceutical company developing and commercializing innovative,
targeted oncology treatments that address major unmet medical needs to
advance cancer care. For more information visit
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(R) 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, 2012 and Quarterly Report on Form 10-Q for the
quarter ended September 30, 2013 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