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Sunday, November 27, 2022

The Inside Scoop on Elite Pharmaceuticals Inc (OTCBB:ELTP)

Elite Pharmaceuticals Inc (OTCBB:ELTP) has long been one of the top most traded stocks on the entire OTC boasting a massive following and legions of shareholders. The stock recently made an explosive move up to highs of $0.443 and has been consolidating over $0.30 since.

ELTP is an ex AMEX stock that was trading as high as $22 a share. The Company was de-listed to the OTCBB in 2009 where it sat dormant for several years before the recent explosion in price and volume. as everyone knows; ex big board stocks that hit the bb’s tend to make highly explosive moves which is exactly what ELTP did last year running from $0.10 to highs near $1.

Elite Pharmaceuticals Inc (OTCBB:ELTP) is a specialty pharmaceutical company developing a pipeline of proprietary pharmacological abuse-deterrent opioid products and niche generic products. Elite specializes in oral sustained and controlled release drug products with high barriers to entry. Elite has seven commercial products currently being sold, twelve additional approved products pending manufacturing site transfer and two additional products 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(TM), 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.

The Phase 3 study evaluated safety and efficacy following dosing of ELI-200 for the treatment of moderate to severe pain following surgery.  It was a multicenter, randomized, multiple-dose, double blind, placebo-controlled, and parallel group study.  The clinical trial was conducted at five study sites in the United States which randomized 163 patients into the clinical study.

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ELTP is a company with a 10 million dollar financing deal in place, nineteen FDA approved drugs to be manufactured, approximately eighteen more in the pipeline in various stages with numerous partners, and are about to enter studies to submit for a 505b2 NDA, twice daily abuse-deterrent Oxycontin/Oxycodone product. Additional abuse-deterrent products are also scaled up or in development such as a once daily Oxycontin/Oxycodone and a Morphine product. New senior leadership with extensive experience to take these products from the development phase to the approved phase was announced several weeks ago. And this is where we will begin to look at these relationships I note above and what I believe is the New Elite Pharmaceuticals.”

On October 21 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.

In November ELTP announced results for Q2 ended September 30, 2015, reporting record revenues of $2.7 million, a 115% increase on a year-on-year basis. The increase in revenues is due to the continued growth of Elite’s niche generic product lines. During the quarter, Elite invested an additional $4.2 million in the development of ELI-200, the first product in Elite’s line of abuse-deterrent opioids.

On February 9 ELTP announced results for the quarter ended December 31, 2015, the third quarter of its 2016 fiscal year. Consolidated revenues for the third quarter of Fiscal 2016 were $2.2 million, a 61% increase on a year-on-year basis. The increase in revenues is due to the continued growth of Elite’s niche generic product lines.

During the quarter, Elite invested an additional $3.2 million in the development of SequestOx(TM) (ELI-200), immediate release Oxycodone with sequestered Naltrexone, the first product in Elite’s line of abuse-deterrent opioids. The successful development of SequestOx(TM) has culminated in the January 2016 FDA submission of a 505(b)(2) New Drug Application (“NDA”) for 5mg, 10mg, 15mg, 20mg and 30mg abuse deterrent dosage strengths for the treatment of moderate to severe pain.

ELTP CEO Nasrat Hakim said “It was a special quarter for Elite. We successfully completed the studies for Elite’s first abuse deterrent opioid SequestOx(TM) and in January we submitted our first NDA. We now await confirmation from the FDA of acceptance for review of our SequestOx(TM) submission.”

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Currently trading at a $225 million market valuation ELTP does have $11 million in the treasury, manageable debt and fast growing revenues reporting $7,079,772 in sales for the 3 months ended June, 30, 2015. The stock has fast become an Investors favorite; ELTP is fully-funded moving forward, the Company has nineteen FDA approved drugs to be manufactured, approximately eighteen more in the pipeline in various stages with numerous partners, and just announced they successfully completed the studies for opioid SequestOx(TM) and in January submitted their first NDA. We will be updating on ELTP when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with ELTP.

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Disclosure: we hold no position in ELTP either long or short and we have not been compensated for this article.

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