TORONTO, ON / ACCESSWIRE / November 21, 2018 / Intellipharmaceutics International Inc. (NASDAQ: IPCI; 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.
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
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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.
Intellipharmaceutics International Inc.
Chief Financial Officer
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SOURCE: Intellipharmaceutics International Inc.