NORTHVALE, N.J., Feb. 09, 2016 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (OTCBB: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.
The financial statements can be viewed in Elite’s Third Quarter Report on Form 10-Q here.
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. 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 a product under review pending approval by 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.), and a Hong Kong based company for development of 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. For more information about Elite Pharmaceuticals, please visit www.elitepharma.com.
This news release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Including those related to the effects, if any, on future results, performance or other expectations that may have some correlation to the subject matter of this press release, readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, its ability to obtain FDA approval of the transfers of the ANDAs or the timing of such approval process, delays, uncertainties, inability to obtain necessary ingredients and other factors not under the control of Elite, which may cause actual results, performance or achievements of Elite to be materially different from the results, performance or other expectations that may be implied by these forward-looking statements. These risks and other factors, including, without limitation, the Company’s ability to obtain sufficient funding under the LPC Agreement or from other sources, the timing or results of pending and future clinical trials, regulatory reviews and approvals by the Food and Drug Administration and other regulatory authorities, intellectual property protections and defenses, and the Company’s ability to operate as a going concern, are discussed in Elite's filings with the Securities and Exchange Commission, including its reports on forms 10-K, 10-Q and 8-K. Elite undertakes no obligation to update any forward-looking statements.
Contact:
For Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations, 518-398-6222
Dianne@elitepharma.com
www.elitepharma.com
