Elite Pharmaceuticals, Inc. Reports Record Revenues for First Quarter of Fiscal Year 2016

NORTHVALE, N.J., Aug. 10, 2015 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP), announced results for the quarter ended June 30, 2015, the first quarter of its 2016 fiscal year.

Consolidated revenues for the first quarter of Fiscal 2016 were $7.1 million, with operating profits totaling $2.5 million. Revenues consisted of $5 million in milestone payments from the ELI-200 license to Epic Pharma and a record $2.1 million generated from product revenue. The milestone payments are the first of a total $15 million in milestones from the ELI-200 licensing agreement. The license agreement also includes, upon commercialization, royalty payments based on net sales. Elite invested $2.4 million this quarter in clinical trials for ELI-200 and on other product development activities, and net income was $16.1 million. Elite will provide an update on development activities during the conference call.

"I am extremely pleased with the record revenues and operating profit this quarter," commented Nasrat Hakim President and CEO of Elite. "I am also excited that Elite has completed dosing of the efficacy study required for the ELI-200 submission. We will have final results for this trial later this year and we expect to complete our NDA submission for ELI-200 thereafter."

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 First 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.

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.