INSYS Therapeutics Signs Definitive License Agreement with Lunatus to Commercialize SUBSYS® (fentanyl sublingual spray) in the Middle East

PHOENIX, Oct. 01, 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 signed a definitive license agreement with Lunatus for commercialization of SUBSYS^® (fentanyl sublingual spray) in eight countries in the Middle East.

In May, the two companies announced their intent to form an . Today’s announcement confirms that the definitive agreement has been executed, making Dubai-based Lunatus the exclusive licensee and authorized agent for SUBSYS in the territory, which comprises Bahrain, Jordan, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia and the United Arab Emirates.

Under the terms of this 10-year agreement, INSYS will supply SUBSYS to Lunatus, and Lunatus will obtain the regulatory approvals and commercialize SUBSYS in the territory.

“We are excited to bring SUBSYS, an FDA approved and leading branded TIRF product in the United States, to cancer patients in the Middle East,” said Dr. Lina Kouatly, president and chief executive officer of Lunatus. “SUBSYS will fulfill an unmet need in supportive cancer care and will be a welcome option for treating breakthrough cancer pain in adult opioid-tolerant patients. The Middle East is a fast-growing market for this class of drugs. Notably in Saudi Arabia, the largest market in this territory, the TIRF market grew by over 100 percent year on year for the past three years. Assuming regulatory approval and subsequent commercialization starting in 2020, we believe our partnership can achieve a significant share and expand the TIRF market, given the differentiated profile of SUBSYS.”

Saeed Motahari, president and chief executive officer of INSYS Therapeutics, added: “This partnership with Lunatus represents an important milestone for our organization as we continue to make progress against our strategic plan to transform INSYS. We see meaningful opportunities to expand into other international markets and continue to advance conversations with potential strategic partners. We believe that these potential partners understand the important role that SUBSYS can play in the lives of patients with breakthrough cancer pain and look forward to expanding our network of international partnerships in the future.”

About INSYS

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. The company 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 anaphylaxis, epilepsy, Prader-Willi syndrome, opioid addiction and overdose, 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.

About Lunatus

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, SoftFil, Opko Lab, Cheplapharm, Alfa Sigma, VSL#3, Filorga and IPRAD Laboratories.

Forward-Looking Statements 

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.

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 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.