Elite Pharmaceuticals Inc (OTCMKTS:ELTP) To Benefit From Political Tailwinds

Source: pbs.org

The opioid abuse epidemic is one of the biggest problems America faces. Millions have become hooked on painkillers. U.S. deaths from drug overdoses hit a record in 2014, increasing 6.5 percent to 47,055, propelled by prescription painkiller and heroin abuse, according to the U.S. Centers for Disease Control and Prevention.

The problem has now caught the attention of President Obama and Congress. Bowing to pressure from lawmakers, Dr. Robert Califf, President Barack Obama's nominee to lead the Food and Drug Administration, said earlier this month that the agency would reform its process for approving opioid painkillers. This will benefit companies like Elite Pharmaceuticals Inc (OTCMKTS:ELTP). CEO Nasrat Hakim said on the company's latest earnings call:

"Our stockholders are looking to the political environment and the increased support for ADF in that environment. This is very true, the recent political environment has been very positive for Elite and its ADF pipeline. ADF discussions have been very prominent in the presidential campaign and national news. The FDA put out a factsheet on opiod abuse that they committed to expanding access to ADF. Robert Califf, the nominee for FDA commissioner, he co-authored a paper in the New England Journal of Medicine reiterating the importance of FDA to encourage the use of ADF. It’s a very good paper, if you get a chance, read it. A lot of our states like Utah, Colorado, and Maryland have passed legislation to ensure that managed care provides equal access to physicians and patients desiring ADF. Many more states have similar litigation under review and hopefully one of these days the federal government will act on that. There is more pressure now to overcome the short term budget concerns for the higher priced ADF so that the government can achieve the long term reduction in costs for addressing opiod abuse issue that we face in this nation."

The FDA has agreed to convene a committee before approving any new opioid that does not have abuse-deterrent properties. And it said the agency's pediatric advisory committee will make recommendations before any new labeling relating to children is approved. The FDA also said in its announcement it would develop additional safety information for immediate-release opioid painkillers; strengthen the requirement for drugmakers to produce information after a drug reaches the market; and expand access to abuse-deterrent opioid drug formulations.

ELTP is at the forefront of of the ADT opioid boom. Elite Pharmaceuticals 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 biggest accomplishment to date at Elite is the 505(b)(2) NDA filing for SequestOx, what used to be called ELI-200. It’s Elite's first abuse-deterrent opioid. We expect Elite to get a priority review because the technology uses the pharmacological approach and it is abuse deterrent. We think this is just the start for Elite. We 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. We will be updating Insider Financial as soon as we know more. For continuing coverage on ELTP and our other hot stock picks, sign up to Insider Financial today and get our next hot stock pick!Disclosure: We have no position in ELTP and have not been compensated for this article.