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® (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 support
"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 possible."
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) privacy standards.
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 R isk E valuation and M itigation S trategy (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 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, 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.
Remy Bernarda VP, Marketing & Communications (503) 405-8258
