ELI -216 Demonstrates Successful Euphoria Blocking Effect During Initial Stage of Phase II Study Northvale, New Jersey, Thursday, February 15, 2007:Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (AMEX: ELI - News), has completed the first stage of its Phase II study for ELI-216 and is preparing to initiate the final stage. The initial study successfully demonstrated the euphoria-blocking effect of ELI-216. This study was designed to determine the optimal ratio of oxycodone hydrochloride and opioid antagonist, naltrexone hydrochloride, to significantly block the euphoric effect of the opioid if the product is abused.
The study successfully demonstrated the euphoria-blocking effects of ELI-216. Without abuse deterrent technology, the subjects (n=17) dosed with crushed oxycodone hydrochloride 40 mg extended release capsules reported a high level of euphoria during the first three hours (average peak of 71 on the euphoria scale) and ELI-216 crushed (n=11) showed very low levels of euphoria (less than 10 on the scale). The study showed similar results with other levels of oxycodone hydrochloride. The study also helped determine the appropriate levels of naltrexone hydrochloride required to reduce or eliminate the euphoria experienced by subjects who might take crushed product to achieve a “high”.
The next and final stage of this study will be a double blinded, cross-over pivotal study for submission to the FDA. The Company expects the final stage to begin by the end of this quarter.
As previously announced, Elite met with the FDA in October 2006 for a Type C clinical guidance meeting regarding ELI-216. Elite has incorporated the guidance into its developmental plan. Phase II studies, as well as the food effect, multi-dose and dose escalation studies, are expected to be completed by the third quarter of this year, and the Phase III study shall begin shortly thereafter. Elite has also begun scale up of ELI-216 to commercial size batches.
“These findings underscore our belief that ELI-216 will minimize the abuse potential of a widely proscribed analgesic, sustained release oxycodone,” said Bernard Berk, President and CEO of Elite. “These initial Phase II findings give us strong reason to believe that our technology is effective and can address a large unmet medical need for abuse deterrent opioid analgesics.”
ELI-216 uses the Company’s patent-pending abuse resistant technology, based on a pharmacological intervention approach. The product utilizes an agonist-antagonist combination approach to deter opioid abuse. ELI-216 is a combination of a narcotic agonist, oxycodone hydrochloride, in a sustained release formulation intended for use in patients with moderate to severe chronic pain, and an antagonist, naltrexone hydrochloride, formulated to deter abuse of the drug. Both of these compounds, oxycodone hydrochloride and naltrexone hydrochloride, have been on the market for a number of years and are widely accepted by the medical community. Independent market research, commissioned by the Company, indicated a potential market of $800M for ELI-216.
About Elite Pharmaceuticals Elite Pharmaceuticals is a specialty pharmaceutical company principally engaged in the development and manufacturing of oral controlled-release products. The Company's strategy includes developing generic versions of controlled release drug products with high barriers to entry and assisting partner companies in the life cycle management of products to improve off-patent drug products. Elite's technology is applicable to develop delayed, sustained or targeted release capsules or tablets. Elite has two products currently being sold commercially and a pipeline of seven drug products under development in the therapeutic areas that include pain management, allergy, cardiovascular and infection. The addressable market for Elite's current pipeline of generic and branded drug products exceeds $6 billion. Elite also has a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.
For Elite Pharmaceuticals, Inc. Dianne Will, Investor Relations Phone: 518-398-6222 E-Mail: dwill@willstar.net Website: www.elitepharma.com
This news release contains forward-looking statements, including those related to the preliminary nature of the clinical program results and the potential for further product development, that involve known and unknown risks, delays, uncertainties and other factors not under the control of Elite, which may cause actual results, performance or achievements of the companies to be materially different from the results, performance or other expectations implied by these forward-looking statements. In particular, because substantial future testing will be required prior to approval, the results described above may not be supported by additional data or by the results of subsequent trials. These risks and other factors, including the timing or results of pending and future clinical trials, regulatory reviews and approvals by the Food and Drug Administration and other regulatory authorities, and intellectual property protections and defenses, are discussed in the Elite’s filings with the Securities and Exchange Commission such as the 10K, 10Q and 8K reports. The Company undertakes no obligation to update any forward-looking statements. |