- Second oxycodone HCl product in clinical trials -
Northvale, New Jersey, Thursday, May 25, 2006: Elite Pharmaceuticals, Inc. (“Elite” or the Company”) (AMEX: ELI) has initiated a pilot Phase I pharmacokinetic study evaluating the Company’s ELI-154, a once-daily oxycodone HCl. This patent pending product is intended to deliver more consistent levels of the drug to patients who take the drug for chronic pain. Currently, there is no once-daily oxycodone on the market.
This is the second study for ELI-154 and the Company’s second oxycodone HCl product in clinical trials. The first pilot Phase I study for this product demonstrated proof of concept. This second study will evaluate variables to optimize the formulation. Upon completion of this study, Elite intends to enter into a Phase II study, which it anticipates commencing by the end of 2006.
“We are pleased to commence this important next step in the development of ELI-154,” said Bernard Berk, Chairman and CEO of Elite Pharmaceuticals. “We believe that ELI-154 and ELI-216, our abuse resistant oxycodone HCl, will offer medical practitioners a better alternative to opioids currently being used to treat moderate to severe chronic pain. We are committed to advancing the development activities of both of these products.”
A market consulting group, commissioned by the Company to do market research, prepared a report which indicated that the market size for ELI-216 may be greater than $800 million and the market size for ELI-154 may be greater than $400 million. ELI-154 has previously been referred to as OxyQD and ELI-216 has previously been referred to as OxyNal.
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 one product currently being sold commercially and a pipeline of eight 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 products exceeds $6 billion. Elite also has a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.
FOR FURTHER INFORMATION, CONTACT:
Dianne Will, Investor Relations
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 Company’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.