JANUARY 12, 2016 BY ALEX CARLSON
Elite Pharmaceuticals (OTCMKTS:ELTP) is one of the most exciting names on the OTC markets. The company is on the verge of same major developments that we think will propel shares higher in 2016. Matter of fact, ELTP could be one of the best performers on the bulletin boards if all goes according to plan.
Elite Pharmaceuticals is a specialty pharmaceutical company which is developing a pipeline of proprietary pharmacological abuse-deterrent opioid products as well as niche generic products. Elite specializes in oral sustained and controlled release drug products which have high barriers to entry. Elite owns generic and OTC products which have been licensed to TAGI Pharma, Epic Pharma and Valeant Pharmaceuticals International. Elite currently has eight commercial products being sold, additional approved products pending manufacturing site transfer and a product under review pending approval by the FDA.
Elite’s lead pipeline products include abuse-deterrent opioids which utilize the company’s patented proprietary technology and a once-daily opioid. These products include sustained release oral formulations of opioids for the treatment of chronic pain. These formulations are intended to address two major limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential opioid abuse. Elite also provides contract manufacturing for Ascend Laboratories (a subsidiary of Alkem Laboratories Ltd.), and a Hong Kong based company for development of a branded product for the United States market and its territories. Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.
Elite’s proprietary abuse deterrent technology, ART™, is a multi-particulate capsule which contains an opioid agonist in addition to naltrexone, an opioid antagonist used primarily in the management of alcohol dependence and opioid dependence. When this product is taken as intended, the naltrexone is designed to pass through the body unreleased while the opioid agonist releases as intended providing therapeutic pain relief for which it is prescribed. If the multi-particulate beads are crushed or dissolved, the opioid antagonist is designed to release and so block the effects of active opioid agonist. The absorption of the naltrexone is intended to block the euphoria by preferentially binding to the same receptors in the brain as the opioid agonist and thereby reducing the incentive for abuse or misuse by recreational drug abusers.
Elite’s pharmacological approach to abuse-deterrence can be applied to a wide range of opioids used today in pain management. The key here is that most physicians think opioid antagonists is the abuse-deterrent formulation that is most needed to combat the opioid abuse epidemic–an issue that’s been implicated in the startling rise of the death rate of middle-aged white Americans without a college degree. This painkiller addiction has a big impact on America as there are an estimated 44 deaths per day from prescription painkiller abuse. This has become a major problem and why advances by ELTP are so important to solving this opioid epidemic.
The next step for ELTP is with ELI-200. In October, ELTP announced positive top-line results from the Phase 3 pivotal trial of its lead opioid abuse-deterrent candidate, ELI-200, for the treatment of moderate to severe pain. The pivotal trial met its primary endpoint (p = 0.001), demonstrating statistical significance that the product provided pain relief following surgery in the treatment group using ELI-200 compared to the placebo group. Secondary endpoint results were consistent with primary findings and included safety measures. There were no serious adverse events or deaths related to ELI-200 reported during the conduct of the trial.
We are now just waiting on the NDA for ELI-200. Once that happens we at Insider Financial expect to see 2 to 3 more NDAs this year. We’ll at least see NDAs for ELI-201, ELI-202, and possibly ELI-216. Why we think this will happen is because of acceptance by not only physicians, but also from insurance companies to cover ADT opioids. Both will benefit from wrongful death lawsuits and we see Federal and State agencies getting behind the push towards ADT opioids. It’s a major problem in America and ELTP is at the forefront of this problem. Matter of fact, ELTP is the solution to the problem!
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