IntelliPharmaCeutics Intl Inc (USA) (NASDAQ: IPCI) announced that U.S. Patent No. 9,522,119 and Canadian Patent No. 2,910,865 were issued by the U.S. Patent and Trademark Office and the Canadian Intellectual Property Office in respect of “Compositions and Methods for Reducing Overdose.”
The issued patents cover aspects of the Company’s Paradoxical OverDose Resistance Activating System (“PODRAS”) delivery technology, which is designed to prevent overdose when more pills than prescribed are swallowed intact. Preclinical studies of prototypes of oxycodone with PODRAS technology suggest that, unlike other third-party abuse-deterrent oxycodone products in the marketplace, if more tablets than prescribed are deliberately or inadvertently swallowed, the amount of drug active released over 24 hours may be substantially less than expected. However, if the prescribed number of pills is swallowed, the drug release should be as expected.
In April 2015, the United States Food and Drug Administration (“FDA”) published Guidance for Industry: Abuse-Deterrent Opioids — Evaluation and Labeling, which cited the need for more efficacious abuse-deterrence technology. In this Guidance, the FDA stated, “opioid products are often manipulated for purposes of abuse by different routes of administration or to defeat extended-release properties, most abuse-deterrent technologies developed to date are intended to make manipulation more difficult or to make abuse of the manipulated product less attractive or less rewarding. It should be noted that these technologies have not yet proven successful at deterring the most common form of abuse—swallowing a number of intact capsules or tablets to achieve a feeling of euphoria.”
“The issuance of these patents represents a significant advance in our abuse deterrence technology platform. We believe that the platform has the potential to positively differentiate the Company’s technology from others of which we are aware, and may represent an important step toward addressing the FDA’s concern over the ingestion of a number of intact pills or tablets,” said Dr. Isa Odidi, Chief Executive Officer of Intellipharmaceutics. “In addition to its use with opioids, the PODRAS platform is potentially applicable to a wide range of drug products that are intentionally or inadvertently abused and cause harm by overdose to those who ingest them.”
On November 25, 2016, the Company announced that it filed a New Drug Application (“NDA”) with the FDA 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 issuance of these patents provides the Company the opportunity to accelerate its PODRAS development plan by pursuing proof of concept studies in humans. The Company intends to incorporate this technology in an alternate Rexista product candidate. There can be no assurance that any Rexista product candidate will receive FDA approval or that, if approved, it will be successfully commercialized. (Original Source)
Shares of Intellipharmaceutics International are currently falling 2.51% to $2.72, or down $0.0 7in pre-market trading Wednesday. IPCI has a 1-year high of $3.35 and a 1-year low of $1.41. The stock’s 50-day moving average is $2.81 and its 200-day moving average is $2.16.
On the ratings front, Intellipharmaceutics International has been the subject of a number of recent research reports. In a report issued on November 25, Maxim Group analyst Jason Kolbert reiterated a Buy rating on IPCI, with a price target of $6, which represents a potential upside of 116% from where the stock is currently trading. Separately, on October 17, Aegis Capital Corp.’s Difei Yang reiterated a Buy rating on the stock and has a price target of $8.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason Kolbert and Difei Yang have a yearly average loss of -15.2% and a return of 1.6% respectively. Kolbert has a success rate of 30% and is ranked #4217 out of 4291 analysts, while Yang has a success rate of 42% and is ranked #1541.
Intellipharmaceutics International, Inc. is a pharmaceutical company, which engages 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 development of existing and new pharmaceuticals in the areas of neurology, cardiovascular, gastrointestinal tract, diabetes and pain.