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
exclusive partnership. 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
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. 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.
CONTACT: |
Corporate Communications |
Investor Relations |
|
Joe
McGrath |
Jackie Marcus or Chris Hodges |
|
INSYS
Therapeutics |
Alpha
IR Group |
|
480-500-3101 |
312-445-2870 |
|
jmcgrath@insysrx.com |
INSY@alpha-ir.com |
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.
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