Elite Pharmaceuticals Inc (OTCMKTS:ELTP) Makes a Splash with New FDA Application

Elite Pharmaceuticals Inc (OTCMKTS:ELTP) Makes a Splash with New FDA Application

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There isn’t a whole lot going on in markets on this holiday-shortened trading week, but that didn’t stop shares of Elite Pharmaceuticals Inc (OTCMKTS:ELTP) from skyrocketing on Tuesday to the tune of as much as 33% on 10x average volume. This is a specialty pharma player that just announced that it has received approval of the Company’s abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) for generic Percocet (Oxycodone Hydrochloride and Acetaminophen, USP CII) 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg tablets.

According to the release, “This product is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Based on QuintilesIMS Health data for the twelve months ending May 31, 2018, the retail sales for the brand and generic products were approximately $500 million.”

Elite Pharmaceuticals Inc (OTCMKTS:ELTP) bills itself as a specialty pharmaceutical company, engages in the research, development, manufacture, and licensing of proprietary orally administered controlled-release drug delivery systems and products. The company operates in two segments, ANDA’s for Generic Products and NDA’s for Branded Products.

It owns, licenses, and contract manufactures various generic and oral dose pharmaceuticals products, such as Phentermine HCl 15mg, 30mg, and 37.5mg tablets and capsules for the treatment of bariatrics under Adipex-P brand name; Lodrane D immediate release capsules for OTC allergy treatment; Methadone HCl 10mg tablets for pains under the Dolophine brand name; and Hydromorphone HCl 8mg tablets for pains under the Dilaudid brand name.

Elite Pharmaceuticals, Inc. was founded in 1984 and is headquartered in Northvale, New Jersey.

According to company materials, ELTP 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 the NDA for SequestOx, for which it just received the CRL from 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.). Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.”

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We’ve witnessed 19% tacked on to share pricing for the listing in the past month. Furthermore, the company has seen interest climb, with an increase in recent trading volume of a bit over 160% beyond its prior sustained average level.

“Oxycodone with Acetaminophen is a strategic addition to our expanding product line. It is an immediate release opioid product used extensively by doctors today in pain management. According to the FDA, if the product is crushed and taken intranasally the Acetaminophen creates irritation in the nasal passages and may thereby provide some intranasal abuse-deterrence,” commented Nasrat Hakim, President and CEO of Elite.

“Elite is committed to developing niche generic products and a diverse range of opioid abuse-deterrent products that incorporate our proprietary sequestration technology and other abuse-deterrent products, such as Oxycodone and Acetaminophen tablets that are niche generic drugs. We currently have five products filed with the FDA and we look forward to additional product approvals in 2018.”

Now commanding a market cap of $72.3M, ELTP has a significant war chest ($7.2M) of cash on the books, which stands against about $655K in total current liabilities. One should also note that debt has been growing over recent quarters. ELTP is pulling in trailing 12-month revenues of $7.5M. In addition, the company is seeing major top-line growth, with y/y quarterly revenues growing at 18.3%. You can bet we will update this one again as new information comes into view. Sign-up for continuing coverage on shares of $ELTP stock, as well as other hot stock picks, get our free newsletter today and get our next breakout pick!

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

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