Elite Pharmaceuticals Inc (ELTP)

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Elite Pharmaceuticals, Inc. Reports Strong Growth for Third Quarter of Fiscal Year 2016

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Conference Call Scheduled for Wednesday, February 10th at 11:30 AM EST
Elite Pharmaceuticals, Inc.
1 minute ago
GlobeNewswire
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NORTHVALE, N.J., Feb. 09, 2016 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (ELTP), announced results for the quarter ended December 31, 2015, the third quarter of its 2016 fiscal year.

Consolidated revenues for the third quarter of Fiscal 2016 were $2.2 million, a 61% 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 $3.2 million in the development of SequestOx™ (ELI-200), immediate release Oxycodone with sequestered Naltrexone, the first product in Elite’s line of abuse-deterrent opioids. The successful development of SequestOx™ has culminated in the January 2016 FDA submission of a 505(b)(2) New Drug Application (“NDA”) for 5mg, 10mg, 15mg, 20mg and 30mg abuse deterrent dosage strengths for the treatment of moderate to severe pain.

“It was a special quarter for Elite. We successfully completed the studies for Elite’s first abuse deterrent opioid SequestOx™ and in January we submitted our first NDA,” commented Nasrat Hakim, President and CEO of Elite. “We now await confirmation from the FDA of acceptance for review of our SequestOx™ submission."

About Elite’s Abuse Deterrent Technology
Elite’s proprietary abuse deterrent technology, ART™, 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. If the multi-particulate beads are crushed or dissolved, the opioid antagonist is designed to release and so block the effects of active opioid agonist. The absorption of the naltrexone is intended to block the euphoria by preferentially binding to the same receptors in the brain as the opioid agonist and thereby reducing the incentive for abuse or misuse by recreational drug abusers. Elite’s pharmacological approach to abuse-deterrence can be applied to a wide range of opioids used today in pain management.

Conference Call Information
Elite's management will host a conference call to discuss the results of operations and provide an update on recent business developments. Company executives will conduct a question and answer session following their remarks.

Date: Wednesday, February 10, 2016
Time: 11:30 AM EST
Dial-in numbers: 1-800-346-7359 (domestic)
1-973-528-0008 (international)
Conference number: 98840
Questions: [e-mail] by 9:00 AM EST on Wednesday, February 10, 2016
Audio Replay: http://ir.elitepharma.com/events_presentations


The financial statements can be viewed in Elite’s Third Quarter Report on Form 10-Q here.