The ‘2017 Disruptive Growth & Healthcare Conference’, which ran February 15-16 at the Convene at 730 Third Avenue Conference Center in midtown Manhattan, New York, featured some stellar participants, either as presenters or as sponsors. Along with over 60 other firms in a variety of fields related to biotech, IntelliPharmaCeutics International, Inc. (NASDAQ: IPCI) (TSX: I) was on the bill. The Toronto, Ontario-based company was scheduled to introduce its drug delivery technologies and exhibit its leading pipeline candidates.
The ‘2017 Disruptive Growth & Healthcare Conference’ hosted by RHK Capital, which formerly operated as Source Capital Group, was sponsored by leading investor relations and financial services firms, including NetworkNewsWire, a Platinum Sponsor.
With its drug delivery technologies built on the Hypermatrix™ platform, IPCI is targeting billion dollar markets. The company’s extended release (ER) (XR) formulations provide mechanisms to slowly dissolve and release constant amounts of a medication over time. Instead, of a patient having to take a pill three times a day, with the risk of losing count or forgetting, one daily dose will improve efficacy. Closer compliance with prescription rules results in better therapy.
ER formulations, widespread for leading indications, are expanding to new drugs. Medications that benefit from the IPCI technology include Oxycodone XR, Dexmethylphenidate ER, Venlafaxine ER, Desvenlafaxine ER, Levetiracetam ER, Lamotrigine ER and Pregabalin. Together, these pharmaceuticals present a market opportunity that exceeds $9 billion.
But a bigger prize is the market for abuse deterrent formulations (ADF), which attempt to fight prescription drug abuse by increasing the difficulty of inappropriate use of opioid medications. In the U.S., opioid abuse is on the rise. Data published by the American Society of Addiction Medicine reveals that in 2015 there were 21,101 deaths caused by opioid overdose. Opioids include licit substances such as codeine, fentanyl, hydrocodone and oxycodone, and illicit ones such as heroin and opium. This is a market estimated to be about $60 billion.
Apart from having its eye on these two lucrative opportunities, IPCI has a growing pipeline of new candidates that may lead to New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) filings. An NDA is filed when a sponsor believes there is enough evidence on a new drug’s safety and effectiveness to support FDA approval to bring it to market. An ANDA is required for generic drugs that are bioequivalent to a drug already being marketed.
IPCI has two novel NDA candidates, Rexista® and Regabatin XR™. Earlier this month, the company announced it had filed a New Drug Application (NDA) seeking authorization to market its Rexista™ abuse-deterrent oxycodone hydrochloride extended release tablets in the 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg strengths.
The FDA has determined that the company’s application is sufficiently complete to permit a substantive review, and has set a target action date under the Prescription Drug User Fee Act (PDUFA) of September 25, 2017. IPCI was able to demonstrate that Rexista™ is bioequivalent to OxyContin® (oxycodone hydrochloride extended release). With this upcoming milestone, IPCI will be setting another marker on its journey to success.
Founded in 1998 by the husband and wife team of Dr. Isa Odidi and Dr. Amina Odidi, IPCI has come a long way. The company now specializes in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. Its 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 in therapeutic areas that include neurology, cardiovascular, gastrointestinal tract, diabetes and pain.
For more information, visit www.Intellipharmaceutics.com