|Mar 31, 2006
|Elite Pharmaceuticals Reviews Key Highlights from Conference Call
|Northvale, New Jersey, Friday, March 31, 2006: Elite Pharmaceuticals, Inc (“Elite” or the “Company”) (AMEX: ELI) hosted a conference call on Wednesday, March 29, 2006 in which management highlighted their accomplishments and outlined future goals.
The Company’s completion of a private placement to a group of institutional and other private investors through the issuance of 10,000 shares of its Series B Preferred Stock and warrants to purchase its Common Stock resulted in gross proceeds of $10 million. This financing will allow the Company to advance its two lead pain products, OxyNal™, an abuse-resistant formulation of oxycodone, and OxyQD™, a once-daily formulation of oxycodone, through clinical studies and to move forward with the Company’s other ANDA products.
The positive results from the Company’s completed pilot Phase I study for OxyNal™ were a significant milestone in the development of OxyNal™. The Company’s current timeline for OxyNal™ is to complete all pilot studies on OxyNal™ by the first quarter of 2007, commence Phase III studies in 2007 and file an NDA in 2008. The Company anticipates, but cannot give any assurance, that OxyNal™ will go to the market in 2009.
The FDA acceptance of the Company’s investigational new drug ("IND") application for OxyQD™ has allowed the Company to initiate its developmental program for OxyQD™. The Company may begin a second pilot Phase I clinical trial for OxyQD™ as early as May 2006. The Company expects to complete the pilot Phase I study and begin Phase II studies during calendar year 2006.
A market consulting group, commissioned by the Company to do market research prepared a report which indicated that the market size for OxyNal™ may be greater than $800 million and the market size for OxyQD™ may be greater than $400 million.
The Company continues to make progress with its ANDA projects. It intends to file two ANDA’s in 2006, as well as enter into one or more agreements with marketing partners in the next 12 months for those ANDA projects for which marketing rights have not yet been assigned. The Company also intends to launch a second allergy drug product by the end of 2006.
A replay of the conference call is available through April 5, 2006. Elite invites all those interested in hearing management's discussion to access the replay by dialing 1-877-660-6853 for domestic participants and 201-612-7415 for international participants. When prompted participants should enter passcode 286 and conference ID number 197263. A webcast is also available on the Company's website at www.elitepharma.com which will be available for ninety days.
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:
For Elite Pharmaceuticals, Inc.
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 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.