Elite Pharmaceuticals Inc (OTCBB:ELTP) continues to trend up in recent trading after the stock hit a recent low of $0.29 a share. ELTP has a history of big moves running from a dime to over $0.90 per share earlier this year.
ELTP has been around for many years and used to trade on the Amex stock exchange where it once saw highs of $22 per share. The Company was delisted to the OTCBB in 2009 where it sat dormant for several years before the recent explosion in price and volume.
Elite Pharmaceuticals, Inc. 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 utilizing the Company’s patented proprietary technology, and a once-daily opioid. They are sustained release oral formulations of opioids for the treatment of chronic pain, which address two of the limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential abuse.
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Elite also provides contract manufacturing for Ascend Laboratories (a subsidiary of Alkem Laboratories Ltd.) and has partnered with Epic Pharma for the manufacturing and distribution of eleven approved products pending manufacturing site transfer, with Hi-Tech Pharmacal to develop an intermediate for a generic product, and a Hong Kong based company to develop 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.
The biggest catalyst in recent ELTP history is the Company finally starting the trials that have been anticipated for several years. A twice daily Oxycodone (Oxycontin) product identified as ELI-201 has entered a short pilot bio-equivalence study on December 5th. Oxycontin represents a $2.7 billion dollar market within an eight billion dollar opioid market. This is likely the biggest news in company history.
As Mathew David said on Seeking Alpha ”This is now 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 September 9 ELTP announced top line results from a Human Abuse Liability (HAL) study for the ELI-200 product. ELI-200 is an undisclosed abuse deterrent opioid product for pain. The study results demonstrated statistically significant (p <.0001) lower measures of drug liking, drug high and good drug effects for Elite’s manipulated (crushed) ELI-200 when compared to the manipulated (crushed) drug listed comparator product and found 91.9% of the subjects experienced increased drug liking with the comparator product compared to ELI-200 in non-dependent recreational drug users when administered intranasally. The study also found 80.6% of the subjects experienced a decrease in drug liking with the intranasal crushed ELI-200 in comparison to the administration of oral intact ELI-200.
Conclusion: ELTP continues to be one of the top traded stock on the OTCBB as it reverses off the $0.28 mark. This is a stock with a history of explosive moves that used to trade for $22 on the big boards.The science behind this Company remains compelling and with ELI-201 in clinical trials investors have alot to be excited about there. Currently trading at a $160 million market valuation ELTP has a bit over $8 million in the treasury and is fully funded going forward.
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Investors at current levels site the Company’s rapidly growing base of products that are starting to bring significant revenue streams to the Company with ELTP reporting $1,161,682 in sales for the 3 months ended June 30, 2014 up from $721,689 for the same period the year before. All this makes ELTP a stock to watch and might just provide a spectacular trade opportunity in the coming weeks and months ahead.
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Disclosure: we hold no position in ELTP either long or short and we have not been compensated for this article.