Northvale, New Jersey, Wednesday, December 03, 2014: Elite Pharmaceuticals, Inc. (“Elite” or the “Company”) (OTCBB: ELTP) announced today successful results from a pivotal bioequivalence (BE) study for ELI-201, Elite’s twice daily abuse-deterrent oxycodone product which utilizes Elite’s proprietary pharmacological abuse-deterrent technology.
The study, initiated in July of 2014, demonstrated Elite’s product is bioequivalent to the branded drug based on pharmacokinetic measures including peak concentration (Cmax) and area under the curve (AUC) as measured for opioid blood plasma levels. The study was a single dose, open label, randomized, cross-over study in healthy volunteers with 34 subjects conducted under fasted conditions Final findings of bioequivalence are dependent upon FDA review.
ELI-201 is another product in Elite’s line of abuse deterrent opioids to pass pivotal bioequivalence studies. The first Elite product to pass pivotal bioequivalence was ELI-200. A third product in this line, ELI-202 is currently undergoing a pivotal BE study, after having successfully completed a pilot study.
“This successful bioequivalence study marks an important milestone in our development of a full line of abuse resistant opioid products. Our proprietary technology, which has been proven in multiple clinical trials, is the key to Elite’s goal of creating a diverse range of abuse-deterrent products and establishing Elite as a leader in the opioid market”, commented Nasrat Hakim, Elite’s President and CEO. “Our top priority remains the filing of a New Drug Application with the FDA and preparing for the commercial product launch of ELI-200 scheduled for the fourth quarter of 2015.”
The bioequivalence studies for these opioid abuse-deterrent products are being conducted under the direction of Camargo Pharmaceutical Services.
About Elite’s Abuse-Deterrent Technology
Elite’s abuse-deterrent products utilize the Company’s proprietary pharmacological abuse-deterrent technology. Elite’s abuse-deterrent technology is a multi-particulate capsule which contains an opioid agonist in addition to naltrexone, an opioid antagonist. Naltrexone is an opioid receptor 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 over time providing therapeutic pain relief for which it is prescribed. If the multi-particulate beads are crushed or dissolved, the opioid antagonist, naltrexone, is designed to release. The absorption of the naltrexone is intended to block the euphoria by preferentially binding to same receptors in the brain as the opioid agonist and thereby reducing the incentive for abuse or misuse by recreational drug abusers.
About Section 505(b)(2)
The Company plans to file an NDA for this product based on the provisions of section 505(b)(2) of the U.S. Food, Drug & Cosmetic Act. Section 505(b)(2) allows the FDA to approve a drug on the basis of data in the scientific literature or data previously cited by the FDA as the basis for the approval of related drugs. This procedure makes it easier and potentially faster for drug developers to obtain approval of new formulations of drugs based, in part, on proprietary data of the developer of the original drug.
About Camargo Pharmaceutical Services
Camargo is a full-service drug development partner specializing in the 505(b)(2) process — an approach for developing products that offer differentiated benefits. Camargo is capable of managing every facet of the plan throughout the development continuum, from feasibility assessments, formulation and testing the drug product, to conducting preclinical and clinical studies, to final submission.
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company developing a pipeline of proprietary pharmacological abuse-deterrent opioid products and niche generic products. Elite specializes in oral sustained and controlled release drug products with high barriers to entry. Elite has seven commercial products currently being sold, twelve additional approved products pending manufacturing site transfer and two additional products under review pending approval by the FDA. Elite’s lead pipeline products include abuse-deterrent opioids utilizing the Company’s patented proprietary technology, and a once-daily opioid. They are sustained release oral formulations of opioids for the treatment of chronic pain, which address two of the limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential abuse. Elite also provides contract manufacturing for Ascend Laboratories (a subsidiary of Alkem Laboratories Ltd.) and has partnered with Epic Pharma for the manufacturing and distribution of eleven approved products pending manufacturing site transfer, with Hi-Tech Pharmacal to develop an intermediate for a generic product, and a Hong Kong based company to develop 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.
Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations, 518-398-6222
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.