NORTHVALE, N.J., March 17, 2011 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite") (OTCBB:ELTP) announces the settlement of a lawsuit filed in the Superior Court of New Jersey, Chancery Division: Bergen County entitled ThePharmaNetwork, LLC v. Elite Pharmaceuticals, Inc. (Index No. C-272-10) (the "Action"). The Action was commenced on or about August 27, 2010 by ThePharmaNetwork, LLC ("TPN"). TPN alleged that Elite breached certain obligations in connection with a Product Collaboration Agreement (the "Collaboration Agreement"), made as of November 10, 2006, pursuant to which Elite and TPN agreed to collaborate in the development, commercialization, manufacturing and distribution of a generic pharmaceutical product, which the parties subsequently agreed would be methadone hydrochloride in a 10 mg. tablet (the "Product"). In the lawsuit, Elite asserted counterclaims against TPN arising out of the Collaboration Agreement, and sought damages of no less than $1,125,000 from TPN. Both parties denied the other side's allegations.
In order to fully and finally resolve the disputed claims arising in the Action, Elite and TPN have entered into a settlement agreement, dated March 11, 2011 (the "Settlement Agreement"), pursuant to which the Action, including all of TPN's claims and Elite's counterclaims, will be dismissed with prejudice. Pursuant to the Settlement Agreement, the parties have agreed to terminate the Collaboration Agreement. In addition, in consideration of Elite's agreement to terminate the Collaboration Agreement and to relinquish to TPN all rights and interest in the Abbreviated New Drug Application ("ANDA") for the Product approved by the U.S. Food and Drug Administration (FDA), TPN made a cash payment to Elite. As part of the Settlement Agreement, TPN also acknowledges that Elite may develop a generic product containing methadone of any strength (including the filing of an abbreviated new drug application relating to such product) and that nothing in the Settlement Agreement restricts Elite from developing, commercializing, manufacturing and distributing any pharmaceutical product similar to, or which may compete with, the Product or the ANDA filed in connection with the Product.
The Settlement Agreement also contained a mutual release pursuant to which Elite and TPN agreed to release and discharge each other and their respective affiliates from all claims arising before the date of the Settlement Agreement.
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. develops oral sustained and controlled release products. Elite's strategy includes assisting partner companies in the life cycle management of products to improve off-patent drug products and developing generic versions of controlled release drug products with high barriers to entry. Two of Elite's products, Lodrane 24® and Lodrane 24D®, are marketed by a partner, ECR Pharmaceuticals, for allergy treatment. Elite's lead pipeline products are novel sustained release oral formulations of oxycodone 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. Both products, ELI-216, a once-daily abuse resistant oxycodone, and ELI-154, a once-daily oxycodone, are in late-stage development. Elite, with partners, also has an ANDA filed with the FDA for a generic equivalent of a pain product and has a generic gastrointestinal drug product in clinical development. Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.
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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. Elite undertakes no obligation to update any forward-looking statements.
CONTACT: For Elite Pharmaceuticals, Inc. Dianne Will, Investor Relations, 518-398-6222 Dianne@elitepharma.com www.elitepharma.com