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Saturday, July 2, 2022

Consolidation is Good for Elite Pharmaceuticals Inc (OTCBB:ELTP)

Elite Pharmaceuticals Inc (OTCBB:ELTP) has been consolidating over $0.30 since the recent run up the stock made to $0.443 highs. The stock has once again established itself as a volume leader on the OTC.

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.

CEO Nasrat Hakim said “Another outstanding quarter. Our generic products set another revenue record, and we successfully completed Phase 3 trials for ELI-200. Elite has never been stronger as we steadily move towards the filing of ELI-200 this year, the expected launch next year and the continued development of a range of abuse deterrent opioids.”

On January 13 ELTP announced the FDA granted them a waiver of the application fee required for the filing of a New Drug Application (NDA). Under section 736(d)(1)(E) of the Federal Food, Drug and Cosmetic Act the FDA may grant a waiver of the $2,335,200 NDA application fee for the first human drug application that a small business submits for review.

Elite will immediately submit a 505(b)(2) New Drug Application for its lead opioid abuse-deterrent candidate ELI-200, immediate-release Oxycodone Hydrochloride 5mg, 10mg, 15 mg, 20 mg and 30mg capsules with sequestered Naltrexone Hydrochloride, for the treatment of moderate to severe pain with the United States Food and Drug Administration. FDA notification regarding acceptance of the submission for review is expected to take 6 to 12 weeks.

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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 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. 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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