Intellipharmaceutics Reports
Exclusive Supply Agreement for its Abuse-Deterrent Oxycodone ER
Product Candidate and Four Generic Drug Products in the
Philippines
Toronto, Ontario, November 21, 2018 Intellipharmaceutics
International Inc. (Nasdaq and TSX:IPCI)
("Intellipharmaceutics" or the "Company"), a pharmaceutical company
specializing in the research, development and manufacture of novel
and generic controlled-release and targeted-release oral solid
dosage drugs, today announced it has entered into an exclusive
licensing and distribution agreement for its abuse resistant
Oxycodone ER product candidate and four generic drug products with
a pharmaceutical distributor in the Philippines.
“Our
supply agreement in the Philippines is another step forward in
Intellipharmaceutics’ goal to impact the global opioid
market,” commented Dr. Isa Odidi, CEO of
Intellipharmaceutics. “We are doubly excited to combine this
milestone with the opportunity to further monetize our pipeline of
U.S. FDA approved generics in a region with a population of over
100 million people.”
A
Philippines based pharmaceutical distributor has been granted the
exclusive right, subject to regulatory approval, to import and
market Intellipharmaceutics’ first novel drug formulation,
abuse-deterrent Oxycodone ER, in the Philippines. Additionally,
this distributor has been granted, subject to regulatory approval,
the exclusive right to import and market the Company’s
generic Seroquel XR®, Focalin XR®, Glucophage® XR,
and Keppra XR® in the Philippines.
Under
the terms of the agreement, the distributor will be required to
purchase a minimum yearly quantity of all products included in the
agreement and Intellipharmaceutics will be the exclusive supplier
of said products.
The
Philippines has a population of approximately 104.9 million
people.
The
Company's new drug application ("NDA") for an abuse-deterrent
version of Oxycodone ER was accepted for filing by the U.S. Food
and Drug Administration ("FDA") in February 2017. As previously
reported in October 2018, the Company announced it had completed
the clinical portion of its Category 2 and 3 human abuse liability
studies for its Oxycodone ER product candidate to support its
abuse-deterrent label claims for both the oral and intranasal route
of administration. Bioanalytical samples and statistical analysis
for such studies are pending. An update on the results will be
provided once the analysis is complete.
The
multi-year agreement with the distributor is subject to early
termination. Financial terms of the agreement have not been
disclosed.
There
can be no assurance as to when or if any of our products or product
candidates will receive regulatory approval for sale in the
Philippines or that, if so approved, any such products will be
successfully commercialized there and produce significant revenues
for the Company. Moreover, there can be no assurance that
Intellipharmaceutics will not be required to conduct further
studies for Oxycodone ER, that the FDA will approve any of the
Company's requested abuse-deterrent label claims or that the FDA
will ultimately approve the NDA for the sale of Oxycodone ER in the
U.S. market, or that it will ever be successfully
commercialized.
About Intellipharmaceutics
Intellipharmaceutics International Inc. is a
pharmaceutical company specializing in the research, development
and manufacture of novel and generic controlled-release and
targeted-release oral solid dosage drugs. The Company's patented
Hypermatrix™ technology
is a multidimensional controlled-release drug delivery platform
that can be applied to a wide range of existing and new
pharmaceuticals. Intellipharmaceutics has developed several drug
delivery systems based on this technology platform, with a pipeline
of products (some of which have received FDA approval) in various
stages of development. The Company has abbreviated new drug
application (“ANDA”) and NDA 505(b)(2) drug product
candidates in its development pipeline. These include the
Company’s Oxycodone ER
based on its proprietary nPODDDS™ novel Point Of Divergence Drug
Delivery System (for which an NDA has been filed with the FDA), and
Regabatin™ XR (pregabalin
extended-release capsules).
Cautionary Statement Regarding Forward-Looking
Information
Certain statements in this document constitute
“forward-looking statements” within the meaning of the
United States Private Securities Litigation Reform Act of 1995
and/or “forward-looking information” under the
Securities Act (Ontario). These statements include, without
limitation, statements expressed or implied regarding our
expectations regarding our plans, goals and milestones, status of
developments or expenditures relating to our business, plans to
fund our current activities, and statements concerning our
partnering activities, health regulatory submissions, strategy,
future operations, future financial position, future sales,
revenues and profitability, projected costs and market penetration
and risks or uncertainties related to our ability to realize any
benefits from our recent reverse stock split and our ability to
comply with the Nasdaq and TSX continued listing standards. In some
cases, you can identify forward-looking statements by terminology
such as “appear”, “unlikely”,
“target”, "may", "will", "should", "expects", "plans",
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"confident", "prospects", "potential", "continue", "intends", "look
forward", "could", “would”, “projected”,
“goals”, “set to”, “seeking” or
the negative of such terms or other comparable terminology. We made
a number of assumptions in the preparation of our forward-looking
statements. You should not place undue reliance on our
forward-looking statements, which are subject to a multitude of
known and unknown risks and uncertainties that could cause actual
results, future circumstances or events to differ materially from
those stated in or implied by the forward-looking statements. Risks
and uncertainties relating to us and our business can be found in
the "Risk Factors" section of our latest annual information form,
our latest Form 20-F, and our latest Form F-1 and Form F-3
(including any documents forming a part thereof or incorporated by
reference therein), as amended, as well as in our reports, public
disclosure documents and other filings with the securities
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which are available on www.sedar.com and www.sec.gov. The
forward-looking statements reflect our current views with respect
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required by law, to update or revise any forward-looking
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Trademarks used herein are the property of their respective
holders.
Unless the context otherwise requires, all references to "we,"
"us," "our," "Intellipharmaceutics," and the "Company" refer to
Intellipharmaceutics International Inc. and its
subsidiaries.
CONTACT INFORMATION
Company
Contact:
Intellipharmaceutics
International Inc.
Andrew
Patient
Chief
Financial Officer
416.798.3001
ext. 106
investors@intellipharmaceutics.com
Investor
Contact:
ProActive
Capital
Kirin
Smith
646.863.6519
ksmith@pcgadvisors.com