Home Biotech Elite Pharmaceuticals Inc. (OTCMKTS:ELTP) Spikes On NDA Application

Elite Pharmaceuticals Inc. (OTCMKTS:ELTP) Spikes On NDA Application

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Elite Pharmaceuticals Inc. (OTCMKTS:ELTP)

Elite Pharmaceuticals Inc. (OTCMKTS:ELTP)

Elite Pharmaceuticals Inc. (OTCMKTS:ELTP) gained 3.9% after announcing the filling of a New Drug Application (NDA) with the U.S. Food and Drug Administration for a generic version of OxyContin. The company is seeking approval for the use of Oxycodone Hydrochloride to treat severe pain.

OxyContin which comes with Physical deterrent properties generated sales of $2.3 billion last year.

“I am very pleased with this filing of an ANDA for a generic version of OxyContin®. This is our fourth ANDA filing in the past 15 months and is a key addition to our portfolio,” said Nasrat Hakim, President, and CEO of Elite.

Elite Pharmaceuticals Pipeline

In July, the specialty pharmaceutical company announced the signing of an agreement with SunGen for the development of four generic products. The new agreement brought to eight, the total number of drugs under development by the two companies. The two own three of the products jointly as SunGen owns three on its own. Elite Pharmaceuticals Inc. (OTCMKTS:ELTP) owns the remaining two with SunGen entitled to marketing rights upon regulatory approval own the remaining two.

Under the terms of the co-development deal, the two drug makers are to share costs and responsibilities. However, Elite Pharmaceuticals Inc. (OTCMKTS:ELTP) will manufacture and package all the eight products on a cost-plus basis. The products under development include antidepressants, antibiotics as well as antispasmodics.

ELTP Stock Performance

Elite Pharmaceuticals Inc. (OTCMKTS:ELTP)
One month ELTP stock price chart

Elite Pharmaceuticals Inc. (OTCMKTS:ELTP) clinical trial programs have done little to revitalize investor confidence on the stock. A plunge to multi-year lows of $0.10 a share raises concern about the stock’s long-term prospects as the company maintains its focused on developing a diverse product line of generic products.

The stock has underperformed the overall industry in most aspects. The generic drug maker says it generated revenues of $1.7 million in the first quarter, a decrease from the prior year’s comparable period. During the quarter, Elite Pharmaceuticals Inc. (OTCMKTS:ELTP) invested heavily in product development activities awaiting to see if the investments will bore fruits heading into the end of the year

“We expect more product filings before year end including the filing of a generic product of OxyContin which is the largest abuse-deterrent product currently on the market with revenues of $2.3 billion in 2016,” said Mr. Hakim.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

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