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Saturday, December 3, 2022

Record Sales Spark Elite Pharmaceuticals Inc (OTCBB:ELTP)

Elite Pharmaceuticals Inc (OTCBB:ELTP) continues to trade higher since a brief dip below $0.30 in recent trading. The stock has been bolstered by the Company’s recent report that revenues for fiscal 2016 were $12.5 million, an increase of approximately 150% over revenues of the prior year.

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 used to trade as high as $22 a share on the AMEX but 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 OTC tend to make highly explosive moves which is exactly what ELTP did last year running from $0.10 to highs near $1 a share.

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 June 15 ELTP reported Financial Results for the Fiscal Year Ended March 31, 2016: Consolidated revenues for Fiscal 2016 were a record $12.5 million, an increase of approximately 150% over revenues of 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 in Fiscal 2016.  The growth was 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 in Fiscal 2016.  This increase was from growth in of Elite’s generic product fees and from development milestones for SequestOx(TM), the first of Elite’s abuse-deterrent opioid products.

“During this fiscal year Elite achieved a third straight year of record revenues and we filed our first-ever NDA, abuse-deterrent SequestOx(TM),” commented Nasrat Hakim, Elite’s President and CEO. “We look forward to continued growth of our generic business and the approval and launch of SequestOx(TM).”

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Currently trading at a $246 million market valuation ELTP does have $11 million in the treasury, manageable debt and fast growing revenues reporting $12.5 million in sales for fiscal 2016 up 150% from last year. ELTP has fast become an Investors favorite; the Company is fully-funded moving forward, 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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