Elite Pharmaceuticals Inc (OTCMKTS:ELTP) Is Today's Pharma Focus

Shares of Elite Pharmaceuticals Inc (OTCMKTS:ELTP) have been pretty much range bound all year. However, we think this is about to change after the company posted solid financial results for the 2016 fiscal year. As a result, more investors are start going to be paying attention to a company that is at the forefront of the ADT opioid boom.Elite Pharmaceuticals Inc 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 and operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.Fiscal 2016 revenues were a record $12.5 million, an increase of approximately 150% over the prior year. This increase is due to across-the-board increases in both manufacturing revenues and license fees. Manufacturing revenues more than doubled from $3.8 million last year to $8.0 million. The growth came from a strong, sustained and broad expansion in the sales of Elite’s product revenues. License fees more than tripled from $1.1 million last year to $4.5 million. This increase was from Elite’s generic product fees and from development milestones for SequestOx, the first of Elite’s abuse-deterrent opioid products. CEO Nasrat Hakim said:

“During this fiscal year Elite achieved a third straight year of record revenues and we filed our first-ever NDA, abuse-deterrent SequestOx. We look forward to continued growth of our generic business and the approval and launch of SequestOx.”

In March, Elite announced that the New Drug Application (NDA) for SequestOX (ELI-200), Elite’s lead opioid abuse-deterrent candidate for the management of moderate to severe pain where the use of an opioid analgesic is appropriate, has been accepted and granted priority review by the FDA. The FDA set a target action date under the Prescription Drug User Fee Act of July 14, 2016.The key for investors to understand is that 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 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 caught the attention of both President Obama and Congress. Bowing to political pressure, 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 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.Currently trading with a market cap of $229 million, ELTP is one of the most exciting pharma plays for investors today. We expect to hear some big news next month from the FDA. We think this will be just the start for Elite and expect to see 2 to 3 more NDAs this year; 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, sign up for our free newsletter today and get our next hot stock pick!Disclosure: We have no position in ELTP and have not been compensated for this article.