| Northvale, New Jersey, Thursday, June 28, 2007: Elite Pharmaceuticals, Inc. (AMEX: ELI) provided an update on the progress of the Company at the annual shareholders meeting on June 26, 2007. A review of recent key accomplishments and a product pipeline status are provided below.
Abuse Resistant Oxycodone - ELI-216
The Company continues to advance ELI-216 forward in its developmental program. This product is a patent-pending opioid abuse deterrent technology that is based on a pharmacological intervention approach. ELI-216 is a combination of a narcotic agonist, oxycodone hydrochloride, and an antagonist, naltrexone hydrochloride, formulated to deter abuse of the drug. This sustained release product is intended for use in patients with moderate to severe chronic pain.
Elite met with the FDA in October 2006 for a Type C clinical guidance meeting regarding the NDA development program for ELI-216 and has incorporated the FDA’s guidance into its developmental plan. As a result, Elite submitted a Phase III protocol for ELI-216 for a special protocol assessment (SPA) review to the FDA and is waiting for comments. Elite intends to enter a Phase III study shortly after receiving comments/agreement with the FDA on the protocol.
Elite also plans to conduct pivotal Phase I studies including, but not limited to, food effect, ascending dose and multi-dose studies. Such Phase I studies will not affect the timetable of the Phase III study described above. In a Phase II study using recreational drug users, ELI-216 demonstrated the euphoria-blocking effect of ELI-216 when the product was administered in its crushed form. This study was designed to determine the optimal ratio of oxycodone hydrochloride and the opioid antagonist, naltrexone hydrochloride, to significantly block the euphoric effect of the opioid if the product is abused by physically altering it by crushing. Elite intends to complete a second stage of this study that will be a double blinded, cross-over pivotal study for submission to the FDA.
Elite has previously filed an IND for the product and has tested the product in a series of pharmacokinetic studies. It was demonstrated in single dose studies for ELI-216 that no quantifiable blood levels of naltrexone hydrochloride were released at a limit of quantification (“LOQ”) of 7.5 pg/ml. This data is consistent with the premise of Elite’s abuse deterrence technology, that essentially no naltrexone is released and absorbed when administered as intended without a physical alteration of the product. Elite retains all rights to ELI-216 and has chosen to develop the product on its own to this point. It intends to license the product at a later date to a third party for sales and distribution.
Elite has begun scale up of ELI-216 to commercial size batches and expects to begin Phase III studies for ELI–216 by late 2007 and file the new drug application (NDA) by the end of 2008. Based upon this timetable, the current expectation is to commercialize ELI-216 by 2009. Independent market research, commissioned by the Company, indicated a potential market of $800M for ELI-216. Once-daily Oxycodone - ELI-154
The Company has also continued to advance ELI-154, a once-daily oxycodone hydrochloride product that uses Elite’s proprietary controlled release technology.
Elite has submitted a proposed clinical plan to the FDA for comments and it expects to receive comments from the FDA in the third quarter of 2007. Upon receipt of such comments, Elite intends to submit a Phase III study protocol for FDA review. Elite intends to begin the Phase III trial shortly after receiving comments back from the FDA on the protocol.
Elite also plans to conduct pivotal Phase I studies including, but not limited to, food effect, ascending dose, and multi-dose studies. Such Phase I studies will not affect the timetable of the Phase III study described above.
Elite has previously filed an IND on ELI-154 and has completed two pharmacokinetic studies in healthy subjects that compared blood levels of oxycodone from dosing ELI-154 and the twice-a-day product that is on the market currently. These results support the conclusion that Elite’s formulation of a once-daily oxycodone provided sustained blood levels of the active ingredient over a 24-hour period while achieving similar levels of the drug in the early and latter parts of the 24-hour period as did commercially available twice-a-day oxycodone product, thereby demonstrating the potential of ELI-154 as a once-daily product.
Elite retains all rights to ELI-154 and has chosen to develop the product on its own to this point. It intends to license the product at a later date to a third party for sales and distribution.
Elite has begun scale up of ELI-154 to commercial size batches and expects to begin Phase III studies for ELI–154 in late 2007 and file the NDA by 2008. Based upon such timetable, the expectation is to commercialize ELI-154 by 2009. Independent market research, commissioned by the Company, indicates a potential market of $400M for ELI-154.Novel Laboratories Joint Venture
In December 2006, Elite entered into a joint venture with VGS Pharma, LLC and created Novel Laboratories, Inc., a privately-held company specializing in pharmaceutical research, development, manufacturing, licensing, acquisition and marketing of specialty generic pharmaceuticals. Novel’s business strategy is to focus on its core strength in identifying and timely executing niche business opportunities in the generic pharmaceutical area. Elite currently holds 49% and VGS holds 51% of Novel’s capital stock. Elite initially contributed $2,000,000 to Novel in December 2006 and on May 15 and June 15, 2007, Elite contributed $2,000,000 and $3,000,000, respectively. The remaining contributions to be made by Elite in order to maintain its full equity interest in Novel equal $20,000,000.
As of June 15, 2007, Novel has 30 employees, has identified 22 generic product opportunities and is actively developing 11 generic products. It is Novel’s general policy not to disclose products in its development pipeline or the status of such products until a product reaches a stage that we determine, for competitive reasons, in our discretion, to be appropriate for disclosure.
Other Elite Products and Progress
Dr. Veerappan Subramanian, a Director on Elite’s Board of Directors, became Elite’s acting Chief Scientific Officer in February, 2007. Dr. Subramanian also serves as the Chairman and Chief Executive Officer of Novel.
Elite’s marketing partner, ECR Pharmaceuticals, launched in December 2006 Elite’s second once-a-day allergy product under ECR’s brand name Lodrane 24D®. This product is a once-daily antihistamine with a decongestant. Lodrane 24D® utilizes Elite’s proprietary extended release technology to provide once-daily dosing of an effective, low-sedating antihistamine combined with a decongestant. The once-a-day formulation enhances patient convenience and compliance for those who require chronic allergy therapy. This product and ECR’s previously marketed Lodrane 24®, a once-daily antihistamine-only formulation, were both developed by Elite. The product is available by prescription through pharmacies. Elite Pharmaceuticals will manufacture the product and will receive a royalty on product revenues. The current annual U.S. allergy market exceeds $3 billion.
Elite entered into a product collaboration agreement in November 2006 with The PharmaNetwork, LLC for the development of the generic equivalent of a synthetic narcotic analgesic drug product. The 2006 revenues for the branded product and its equivalents were approximately $30 million. Formulation development work for this product is currently underway. Elite has reacquired the rights to its controlled release generic drug product which had been under development with PLIVA d.d., now a subsidiary of Barr Pharmaceuticals, Inc. Elite and PLIVA have mutually agreed to terminate the product development and license agreement entered into by the parties in June 2005 for the controlled release generic drug product, prior to Barr acquiring PLIVA. As a result of the termination of the agreement, Elite will have the right to market and sell the controlled release generic drug product, and will retain 100% of any profits generated from such sales. Additionally PLIVA will pay Elite $100,000 owed under the Agreement. The controlled release generic drug product to which Elite has reacquired such rights is an anti-infective with a total U.S market size of approximately $40 million in 2006.
Elite has grown its employee base and has hired additional key experienced personnel in the areas of analytics and quality control, formulation development and quality assurance. These additional employees complement Elite’s existing team of scientists and researchers. Currently Elite has 41 employees. American Stock Exchange
On June 22, 2007, Elite received notice from the American Stock Exchange (“Amex”) that it was not in compliance with Section 301 of the Amex Company Guide pertaining to the issuance of certain securities prior to filing an application for the listing of such additional securities and receiving notification from the Amex that the securities have been approved for listing. Specifically, on December 6, 2006, the Company issued 957,396 shares of its common stock to VGS Pharma, LLC prior to submitting an Additional Listing Application and receiving Amex approval of such application.
The Company submitted an Additional Listing Application covering, among other things, the VGS Shares, as well as the shares underlying the securities issued in Elite’s April 24, 2007 Series C financing, to the Amex on June 6, 2007, which application was subsequently amended and restated on June 21, 2007. Upon approval of such application, the Company will regain compliance with all applicable continued listing standards of the Amex. Future Milestones
For ELI-216, the Company expects to receive FDA comments on the SPA, complete scale up in the third quarter, and enter Phase III by year end 2007.
For ELI-154, Elite expects to receive comments shortly from the FDA on the clinical program that was submitted earlier this year. Upon receiving their comments, the Company intends to submit a Phase III Study Protocol. The Company intends to begin the Phase III trial shortly after receiving agreement with the FDA on the protocol. In addition to its pain portfolio, the Company continues to advance its partnered generic product candidates.
Novel intends to file at least three ANDAs in 2007 and at least six ANDAs in 2008.
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 and infection. The addressable market for Elite's current pipeline of products exceeds $6 billion. Elite formed, together with VGS Pharma, LLC, Novel Laboratories, Inc., as a separate specialty pharmaceutical company for the research, development, manufacturing, licensing and acquisition of specialty generic pharmaceuticals. Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.
For Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations, 518-398-6222
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 the Company, 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.