Intellipharmaceutics International, Inc. (NASDAQ: IPCI) is engaged in the research, development and commercialization of controlled-release and targeted pharmaceutical products. Leveraging its proprietary Hypermatrix™ technology, the company is focused on addressing two key niche markets, including difficult-to-produce controlled-release generic drugs (ANDA regulatory pathway) and improved current therapies through controlled-release (NDA regulatory pathway). Intellipharmaceutics’ lead product is a generic of Focalin XR®, a mild central nervous system stimulant used to treat attention deficit hyperactivity disorder. This product is currently marketed in a variety of strengths by the company’s U.S. marketing partner, Par Pharmaceutical, Inc. Intellipharmaceutics’ development pipeline also includes its Rexista™ product candidate, an innovative new drug designed to overcome the well-documented abuses associated with oxycodone and other opioid analgesics. In a news release recapping its first quarter 2017 results, the company noted that the FDA has accepted filing of a new drug application for Rexista™, granting a PDUFA date of September 25, 2017.
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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 the efficient development of a wide range of existing and new pharmaceuticals. Based on this technology platform, Intellipharmaceutics has developed several drug delivery systems and a pipeline of products (some of which have received United States Food and Drug Administration (“FDA”) approval) and product candidates in various stages of development, including Abbreviated New Drug Application (“ANDAs”) filed with the FDA (and one Abbreviated New Drug Submission filed with Health Canada) in therapeutic areas that include neurology, cardiovascular, gastrointestinal tract, diabetes and pain.
Intellipharmaceutics also has New Drug Application (“NDA”) 505(b)(2) specialty drug product candidates in its development pipeline. These include Rexista™, an abuse deterrent oxycodone 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). Our current development effort is increasingly directed towards improved difficult-to-develop controlled-release drugs which follow an NDA 505(b)(2) regulatory pathway. The Company has increased its research and development emphasis towards new product development, facilitated by the 505(b)(2) regulatory pathway, by advancing the product development program for both Rexista™ and Regabatin™. The 505(b)(2) pathway (which relies in part upon the approving agency’s findings for a previously approved drug) both accelerates development timelines and reduces costs in comparison to NDAs for new chemical entities. An advantage of our strategy for development of NDA 505(b)(2) drugs is that our product candidates can, if approved for sale by the FDA, potentially enjoy an exclusivity period which may provide for greater commercial opportunity relative to the generic ANDA route.
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