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Elite Pharmaceuticals, Inc. (ELTP)

Elite Pharmaceuticals, Inc. develops oral sustained and controlled release products. The company is developing a pipeline of proprietary pharmacological abuse-deterrent opioid products and niche generic products. Elite specializes in oral sustained and controlled release drug products that have high barriers to entry. A specialty pharmaceutical company, Elite Pharmaceuticals is headquartered in Northvale, New Jersey, where it operates a GMP and DEA registered facility for research, development, and manufacturing.

Elite also provides contract manufacturing for Ascend Laboratories (a subsidiary of Alkem Laboratories Ltd.). Elite owns generic and Over-the Counter (OTC) products that have been licensed to TAGI Pharma, Epic Pharma, and Valeant Pharmaceuticals International. At present, Elite Pharmaceuticals has eight commercial products selling, additional approved products pending manufacturing site transfer, and the NDA for SequestOx™, for which it has received the CRL from the Food and Drug Administration (FDA).

Elite's lead pipeline products include abuse-deterrent opioids, which use its patented proprietary technology and a once-daily opioid. These products include sustained release oral formulations of opioids for the treatment of chronic pain.

Concerning the company's proprietary abuse-deterrent technology, ART™, it is a multi-particulate capsule that contains an opioid agonist in addition to naltrexone, an opioid antagonist used primarily in the management of alcohol dependence and opioid dependence. When the product is taken as intended, the design of naltrexone is to pass through the body unreleased while the opioid agonist releases over time providing therapeutic pain relief for which it is prescribed.

Recently, Elite Pharmaceuticals announced that it initiated pharmacokinetic testing of its reformulated SequestOx™. The expectation is that the reformulated product will have a shorter Tmax under fed conditions. The company is conducting a bioequivalence study that is a pivotal, open-label, randomized, single-dose, three-way, crossover study to evaluate the relative comparative bioavailability and bioequivalence of the modified formulation of SequestOx™ to the original formulation of SequestOx™ and to a comparator product under fed conditions. The study has enrolled 45 healthy volunteers - the first subjects have been dosed.

Elite Pharmaceuticals also recently announced that it filed an Abbreviated New Drug Application (ANDA) with the FDA for a generic version of a synthetic narcotic analgesic indicated for the management of pain. The branded product and its equivalents had yearly sales of more than $40 million in 2016 according to IMS Health data.

Nasrat Hakim, Elite Pharmaceuticals' President and Chief Executive Officer, said, "With the filing of this ANDA, Elite has three pain product ANDAs under review by the FDA. The market for these products has combined annual sales of over $1 billion. Elite continues developing new generics to grow its business."




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