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|INSYS Therapeutics Announces Exclusive License Partnership with Lunatus to Commercialize SUBSYS® (fentanyl sublingual spray) in the Middle East|
“Partnering with Lunatus will make SUBSYS® available to adult cancer patients in the licensed territory who are suffering episodes of breakthrough cancer pain despite receiving around-the-clock opioid therapy,” said
Under the terms of the partnership, INSYS Therapeutics’ responsibilities will include supplying SUBSYS® to Lunatus, whose responsibilities will include obtaining the required regulatory approvals to commercialize SUBSYS® in the licensed territory.
“We are proud of this partnership, which will bring a unique breakthrough cancer pain management solution to the Middle East,” said Dr.
Manufactured and distributed in
The proposed transaction remains subject to each party conducting confirmatory due diligence and execution of a definitive agreement (and other documentation). Conditions precedent to the closing of the proposed transaction will include, among other things, receipt of requisite regulatory approvals and other customary conditions for a transaction of this nature. The parties are working towards completing their confirmatory due diligence, negotiating and entering into definitive agreement and obtaining regulatory approval by early 2019.
SUBSYS® is a strong prescription pain medicine that contains an opioid (narcotic). It is used to manage breakthrough pain in cancer patients 18 years of age and older who are already routinely taking other opioid pain medicines around-the-clock for cancer pain. SUBSYS is started only after you have been taking other opioid pain medicines and your body has become used to them (you are opioid tolerant). Do not use SUBSYS if you are not opioid tolerant.
SUBSYS is prescribed when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them. SUBSYS is an opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
IMPORTANT SAFETY INFORMATION
Get emergency help right away if you take too much SUBSYS (overdose). When you first start taking SUBSYS, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
Taking SUBSYS with other opioid medicines, that may make you sleepy, such as other pain medicines, antidepressants, sleeping pills, antianxiety medicines, antihistamines, or tranquilizers, or with alcohol or street drugs can cause severe drowsiness, confusion, breathing problems, coma, and death.
Selling or giving away SUBSYS is against the law.
Because of the risk for misuse, abuse, addiction, and overdose, SUBSYS is available only through a program called the Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access program. To receive SUBSYS, you must:
o Talk to your healthcare provider
o Understand the benefits and risks of SUBSYS.
o Agree to all of the instructions.
o Sign the Patient-Prescriber Agreement form.
For more information about the TIRF REMS ACCESS program, go to www.TIRFREMSaccess.com or call 1-866-822-1483.
SUBSYS is only available at pharmacies that are part of the TIRF REMS Access program. Your healthcare provider will let you know the pharmacy closest to your home where you can have your SUBSYS prescription filled.
Be very careful about taking other medicines that may make you sleepy, such as other pain medicines, antidepressants, sleeping pills, antianxiety medicines, antihistamines, or tranquilizers.
SUBSYS can cause life-threatening breathing problems which can lead to death.
SUBSYS® and SYNDROS® are trademarks of Insys Development Company, Inc., a subsidiary of INSYS Therapeutics, Inc.
NOTE: All trademarks and registered trademarks are the property of their respective owners.