PHOENIX, May 08, 2018 (GLOBE NEWSWIRE) — INSYS Therapeutics, Inc. (NASDAQ:INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, announced today that it has agreed to an exclusive license partnership with Lunatus for commercialization of SUBSYS® (fentanyl sublingual spray) in the Middle East.
Based in Dubai with satellite offices across the Gulf Cooperation Council, Lunatus will be the exclusive licensee for SUBSYS® in Bahrain, Jordan, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia and the United Arab Emirates.
“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 Saeed Motahari, president and chief executive officer of INSYS Therapeutics. “Considering the Lunatus footprint in the Middle East, we view this partnership as further validation of the important clinical role that SUBSYS® could play internationally for appropriately selected cancer patients with breakthrough cancer pain.”
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. Lina Kouatly, president and chief executive officer of Lunatus. “Complementing our line of specialty pharmaceuticals for oncology, SUBSYS® will be a welcome addition to the Lunatus portfolio.”
Manufactured and distributed in the United States by INSYS, SUBSYS® received approval from the U.S. Food and Drug Administration (FDA) in 2012 and is indicated for the management of breakthrough cancer pain in opioid-tolerant adult cancer patients. SUBSYS® belongs to a highly regulated class of medication called transmucosal immediate release fentanyl (TIRF) products.
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.
INSYS Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve patients’ quality of life. Using proprietary spray technology and capabilities to develop pharmaceutical cannabinoids, INSYS is developing a pipeline of products intended to address unmet medical needs and the clinical shortcomings of existing commercial products. INSYS currently markets SUBSYS® (fentanyl sublingual spray) and SYNDROS® (dronabinol) oral solution, a proprietary, orally administered liquid formulation of dronabinol. INSYS is committed to developing medications for potentially treating addiction to opioids, opioid overdose, epilepsy, and other disease areas with a significant unmet need.
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.
Since its inception in 2003, Lunatus has established a successful track record in introducing, building and developing profitable brands in the fields of pharmaceutical, RX & OTC, aesthetic medicine & skin care, consumer health and medical equipment for international healthcare companies in the Arabian Gulf and Middle East markets. The Company’s mission is to provide value added marketing and operational services tailored to the versatility of the region. Lunatus partners with wide array of healthcare companies and corresponding brands including Valeant, Mylan, Merz Aesthetics, Omega Pharma, SoftFil, Opko Lab, Lumenis, BSN Medical, Ferris MFG. Corp. and IPRAD Laboratories.
This news release contains forward-looking statements regarding the potential for Lunatus to succeed in commercializing SUBSYS in the Middle East. These forward-looking statements are based on management’s expectations and assumptions as of the date of this news release; actual results may differ materially from those in these forward-looking statements as a result of various factors, many of which are beyond our control. These factors include, but are not limited to, risk factors described in our filings with the United States Securities and Exchange Commission, including those factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended Dec. 31, 2017 and subsequent updates that may occur in our Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date of this news release, and we undertake no obligation to publicly update or revise these statements, except as may be required by law.
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