- RELIEF: Rapid Evaluation of Lifestyle, Independence, and Elimination of breakthrough cancer pain with Freedom from oral discomfort through the use of Abstral® (fentanyl) Sublingual Tablets
- Galena debuts Abstral campaign at PAINWeek September 4-7, 2013 in Las Vegas
- Galena to generate sales revenue in 2013 with significant progress towards Abstral® commercial launch in the fourth quarter.
PORTLAND, Ore., Sept. 3, 2013 (GLOBE NEWSWIRE) -- Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company commercializing and developing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced the initiation of the Company's Institutional Review Board (IRB)-approved cancer patient registry study entitled RELIEF: Rapid Evaluation of Lifestyle, Independence, and Elimination of breakthrough cancer pain with Freedom from oral discomfort through the use of Abstral® (fentanyl) Sublingual Tablets. RELIEF is a post-marketing multicenter trial to assess Abstral for breakthrough cancer pain (BTcP) in opioid-tolerant cancer patients. Abstral is available to patients and health care professionals at pharmacies nationwide, and recruitment and enrollment for the registry trial is underway.
RELIEF is a registry study to be completed by enrolled patients over a thirty day period while using Abstral for treatment of their breakthrough cancer pain. Approximately 2,500 patients are expected to enroll in the program.
Galena also announced the debut of Abstral's sales and marketing campaign at the PAINWeek conference taking place September 4-7, 2013 in Las Vegas, NV. With over 1,800 attendees, PAINWeek is one of the nation's largest pain conferences for healthcare professionals with an interest in pain management. Galena's commercial team is now fully staffed and on schedule for a fourth quarter launch with senior level executives and a highly experienced sales force. The Company's patient assistance and reimbursement program has been implemented and is being accessed by patients across the country.
"With collaboration and support from the physician community, we are excited to initiate our RELIEF trial and debut Abstral this week, which we believe is the the best product in this class of drugs for patients suffering from breakthrough cancer pain," said Mark J. Ahn, President and CEO. "Abstral's product features, including its ease of use, and lack of product disposal issues, make it an important treatment option for these patients. The RELIEF registry is a critical initiative that will help assess the attributes of the drug and provide a sizeable data set to support physicians who prescribe Abstral. The initiation of our registry program ahead of our official launch is an important first step in our overall commercial plan as the second half of the year will be transformational for Galena, as we generate sales and become a revenue producing organization."
RELIEF was developed with input from leading pain treatment specialists and is intended to provide Galena with valuable insight from patients taking Abstral by assessing a variety of characteristics including pain severity, ease of use, patient satisfaction, and overall quality of life. Galena expects to share the RELIEF results with physicians to provide relevant feedback as they address the challenges in treating patients suffering from BTcP.
About Abstral® (fentanyl) Sublingual Tablets
Abstral® (fentanyl) Sublingual Tablets are an important treatment option for inadequately controlled breakthrough cancer pain (BTcP) which impact 40%-80% of cancer patients. Abstral is approved by the FDA, and is a sublingual (under the tongue) fentanyl tablet indicated 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. Abstral is available through the transmucosal immediate-release fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) program. 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 commercializing and developing 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 relating to Galena's expectations for commercialization of Abstral® and the development of Galena's NeuVax™ product candidate. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including the possibility that Galena's commercialization of Abstral may be delayed or prove unsuccessful. Galena's business and operations and the development of its product candidates also are subject to the risks and uncertainties 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 June 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.