Gale
Galena Biopharma Launches Abstral(R) (fentanyl) Sublingual Tablets for the Treatment of Breakthrough Cancer Pain
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 official product launch of Abstral® (fentanyl) Sublingual Tablets in the United States. Abstral 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. Galena acquired Abstral in March 2013 and since that time has scaled its field commercial team, manufactured the drug for commercial sale, secured broad access and reimbursement support from commercial and federal health insurance entities, implemented a robust patient assistance program, and developed a broad product distribution network. Abstral can be prescribed by healthcare professionals and is available to patients at all retail pharmacies nationwide.
"As an oncology company dedicated to improving patients' lives, we are thrilled to introduce Abstral as our first commercial product and offer cancer patients relief from their breakthrough pain," said Mark J. Ahn, President and Chief Executive Officer. "We believe Abstral delivers best in class performance because it is simple to carry, simple to use, and requires no speacial handling or disposal. We have a commercial team of highly dedicated, patient-focused professionals with experience in both pain and oncology who have helped us reach this tremendous milestone for Galena. I look forward to reporting our continued progress later this year."
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 the majority 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 (range of 1-14 per day) and a median duration of 30 minutes (range of 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 Abstral® (fentanyl) Sublingual Tablets
Abstral® (fentanyl) Sublingual Tablets are an important treatment option for inadequately controlled breakthrough cancer pain which impact 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.
Important Abstral Safety Information
There is a risk of respiratory depression, medication errors, and abuse potential with the use of Abstral. See full prescribing information for important complete black-box warning.
Due to the risk of fatal respiratory depression, ABSTRAL is contraindicated in opioid non-tolerant patients and in management of acute or postoperative pain, including headache/migraines.
Keep out of reach of children.
Use with CYP3A4 inhibitors may cause fatal respiratory depression.
When prescribing, do not convert patients on a mcg per mcg basis from any other oral transmucosal fentanyl product to ABSTRAL.
When dispensing, do not substitute with any other fentanyl products.
Contains fentanyl, a Schedule II controlled substance with abuse liability similar to other opioid analgesics.
ABSTRAL is available only through a restricted program called the TIRF (Transmucosal Immediate Release Fentanyl) REMS (Risk Evaluation and Mitigation Strategy) Access program. Outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors are required to enroll in the program.
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 for our commercial success, 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 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.
CONTACT: Remy Bernarda
Senior Director, Communications
(503) 405-8258
rbernarda@galenabiopharma.com
Galena Biopharma Launches Abstral(R) (fentanyl) Sublingual Tablets for the Treatment of Breakthrough Cancer Pain
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 official product launch of Abstral® (fentanyl) Sublingual Tablets in the United States. Abstral 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. Galena acquired Abstral in March 2013 and since that time has scaled its field commercial team, manufactured the drug for commercial sale, secured broad access and reimbursement support from commercial and federal health insurance entities, implemented a robust patient assistance program, and developed a broad product distribution network. Abstral can be prescribed by healthcare professionals and is available to patients at all retail pharmacies nationwide.
"As an oncology company dedicated to improving patients' lives, we are thrilled to introduce Abstral as our first commercial product and offer cancer patients relief from their breakthrough pain," said Mark J. Ahn, President and Chief Executive Officer. "We believe Abstral delivers best in class performance because it is simple to carry, simple to use, and requires no speacial handling or disposal. We have a commercial team of highly dedicated, patient-focused professionals with experience in both pain and oncology who have helped us reach this tremendous milestone for Galena. I look forward to reporting our continued progress later this year."
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 the majority 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 (range of 1-14 per day) and a median duration of 30 minutes (range of 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 Abstral® (fentanyl) Sublingual Tablets
Abstral® (fentanyl) Sublingual Tablets are an important treatment option for inadequately controlled breakthrough cancer pain which impact 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.
Important Abstral Safety Information
There is a risk of respiratory depression, medication errors, and abuse potential with the use of Abstral. See full prescribing information for important complete black-box warning.
Due to the risk of fatal respiratory depression, ABSTRAL is contraindicated in opioid non-tolerant patients and in management of acute or postoperative pain, including headache/migraines.
Keep out of reach of children.
Use with CYP3A4 inhibitors may cause fatal respiratory depression.
When prescribing, do not convert patients on a mcg per mcg basis from any other oral transmucosal fentanyl product to ABSTRAL.
When dispensing, do not substitute with any other fentanyl products.
Contains fentanyl, a Schedule II controlled substance with abuse liability similar to other opioid analgesics.
ABSTRAL is available only through a restricted program called the TIRF (Transmucosal Immediate Release Fentanyl) REMS (Risk Evaluation and Mitigation Strategy) Access program. Outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors are required to enroll in the program.
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 for our commercial success, 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 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.
CONTACT: Remy Bernarda
Senior Director, Communications
(503) 405-8258
rbernarda@galenabiopharma.com
