Intellipharmaceutics International Inc. (IPCI)

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Link: https://globenewswire.com/news-release/2018/01/24/1304271/0/en/Intellipharmaceutics-Provides-Operational-Update.html

Here are the important ones:

Intellectual Property Portfolio

PODRAS™ Technology

Intellipharmaceutics continues to make progress regarding its PODRAS™ delivery technology, recently obtaining three additional patents from the U.S. Patent and Trademark Office (U.S. Patent Nos. 9700515 and 9700516 in July 2017 and No. 9,801,939 in October 2017) also entitled "Compositions and Methods for Reducing Overdose" and covering aspects of the Company's PODRAS™ delivery technology. The Company is optimistic about the prospects of this technology, which deliberately regulates the bioavailability of active ingredients in both generic and non-generic medications in a way that reduces the opportunity for overdose and/or abuse. The Company is finalizing plans to initiate proof of concept trials in humans. The Company believes that the preclinical work on the technology to date has shown encouraging results, but human trials are required to show that the technology works as expected. The human studies for PODRAS™ are expected to take place in the first half of 2018. Based on the results of these studies, the Company will evaluate commercial opportunities for the technology including potential out-licensing as well as incorporation into products within our pipeline.

Drug Development and Commercialization Progress

Generic Seroquel XR® and Generic Focalin XR®

Intellipharmaceutics’ marketing and distribution partner, Mallinckrodt launched all strengths of generic Seroquel XR® (quetiapine fumarate extended-release tablets) in the U.S. in June 2017. With the launch of two additional strengths of generic Focalin XR® (dexmethylphenidate hydrochloride extended-release capsules) in November 2017, the Company’s marketing and distribution partner, Par has now launched all strengths of generic Focalin XR in the U.S. Intellipharmaceutics continues to work with Mallinckrodt and Par to gain traction in the competitive U.S. market, and is actively pursuing opportunities it has identified outside of the U.S. to expand global market reach.

Regabatin™ XR

The Company has had in development a once-a-day non-generic controlled release version of pregabalin (marketed in the U.S. by Pfizer under the Lyrica® brand) under the NDA 505(b)(2) regulatory pathway, with a view to possible commercialization in the U.S. at some time following the December 30, 2018 expiry of the patent covering the pregabalin molecule. Regabatin™ XR is based on our controlled release drug delivery technology platform which utilizes the symptomatology and chronobiology of fibromyalgia in a formulation intended to provide a higher exposure of pregabalin during the first 12 hours of dosing. The FDA has recently approved Lyrica® CR, a branded controlled release formulation of pregabalin. The Company believes its product has significant additional benefits to anything currently on the market and is very excited to continue development of its formulation. We are currently evaluating partners for required Phase III studies and expect to begin these studies in the second half of 2018.