ELITE PHARMACEUTICALS INC /DE/ (Form: 8-K, Received: 09/01/2010 15:36:23)

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

PURSUANT TO SECTION 13 OR 15(D)

OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported)

ELITE PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

Delaware	001-15697	22-3542636
(State or other jurisdiction	(Commission	(IRS Employer
of incorporation)	File Number)	Identification No.)

165 Ludlow Avenue, Northvale, New Jersey 07647

(Address of principal executive offices)

(Registrant’s telephone number, including area code)

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 1.01 Entry Into A Material Definitive Agreement.

On August 27, 2010, Elite Pharmaceuticals Inc. (“Elite”) executed an agreement with Mikah Pharma, LLC (“Mikah”) to undertake and perform development work to facilitate the preparation of a regulatory filing for a product under development (the “Product Development Agreement”). The product will be formulated with a previously approved drug substance and will be designed to be delivered in a unique delivery profile. Among other responsibilities, Elite will provide formulation, analytical development, clinical batch manufacture and validation work for the product. The parties agreed that, in lieu of cash, the transfer to Elite of the Naltrexone product in accordance with the terms of the Naltrexone Asset Purchase Agreement (see discussion at Item 2.01 below), which they valued at $200,000, constituted the consideration for the development services being performed by Elite under the Product Development Agreement. Mikah will also pay to Elite, on a quarterly basis, a royalty in the amount of 5% of net sales of the product. The royalty will be due and payable for the duration of the period beginning on the date that the product is approved by the United States Food and Drug Administration (the “FDA”) and ending on the date of the introduction into the market of an equivalent generic product. Upon approval of the new drug application by the FDA, Elite will manufacture the product and the parties will negotiate in good faith a manufacturing and supply agreement for the product. The Product Development Agreement has a term of 10 years. One year prior to the termination date, the parties will meet to discuss the commercial options relating to the supply and distribution of the product after the termination date. There is no guarantee that the product will receive approval from the FDA.

Item 2.01 Completion of Acquisition or Disposition of Assets.

On August 27, 2010, Elite executed the Naltrexone Asset Purchase Agreement with Mikah pursuant to which Elite acquired from Mikah the Abbreviated New Drug Application number 75-274 (Naltrexone Hydrochloride Tablets USP, 50 mg), and all amendments thereto (the “ANDA”), that have to date been filed with the FDA seeking authorization and approval to manufacture, package, ship and sell the products described in the ANDA within the United States and its territories (including Puerto Rico) for aggregate consideration of $200,000. In lieu of cash, Mikah agreed to accept from Elite product development services to be performed by Elite, as described in Item 1.02 above. Elite has assumed and agreed to discharge certain liabilities related to the purchased assets, including but not limited to liabilities arising from any infringement claim, product liability claim or liabilities arising from an action by the FDA or any other governmental entity, so long as any such liability occurs after the date of acquisition. Elite granted to Mikah and its affiliates a fully-paid, perpetual, royalty-free non-exclusive license to use the ANDA in connection with the manufacture, registration or sale of the products outside of the United States and its territories.

Item 9.01. Financial Statements and Exhibits.

99.1 Press Release dated September 1, 2010.

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Dated: September 1, 2010

	ELITE PHARMACEUTICALS, INC.

	By:	/s/ Chris Dick
		Name: Chris Dick
	Title:	President & Chief Operating Officer

ELITE PHARMACEUTICALS ANNOUNCES ACQUISITION OF GENERIC NALTREXONE PRODUCT

NORTHVALE, N.J. – September 1, 2010 – Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (OTCBB: ELTP) announced today the acquisition of a currently approved Abbreviated New Drug Application (ANDA) for naltrexone hydrochloride 50 mg tablets from Mikah Pharma LLC (“Mikah”). The brand product and its generic equivalents had annual sales of approximately $14 million in 2009 and there are currently three other approved generic manufacturers plus the innovator. The transfer of the ANDA will begin immediately and Elite expects to begin manufacture of the product early next year. Pursuant to the agreement, Elite will be entitled to sell the drug in the United States and its territories, including Puerto Rico, and has licensed to Mikah the right to sell the drug in the remainder of the world.

Elite also has entered into an agreement with Mikah for a product to be developed. Elite will be responsible for the formulation, analytical development, clinical batch manufacture and validation work for the product and will seek approval of the product from the FDA pursuant to 505(b)2 of the Drug Price Competition Act. Upon approval, Elite will manufacture the product and the parties will negotiate in good faith a manufacturing and supply agreement for the product. Elite will also receive a royalty of five percent of net sales after product launch and prior to the introduction of the first generic of the product.

“These acquisition and development agreements continue our strategy of leveraging the manufacturing and development expertise of the company into products that we believe may generate positive cash flow to support our research activities,” stated Jerry Treppel, Chairman and CEO .

About Elite Pharmaceuticals, Inc.

Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company that develops and manufactures oral, controlled-release products using proprietary technology. Elite's strategy includes 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. Elite developed and manufactures for its partner, Lodrane 24® and Lodrane 24D®, for allergy treatment and expects to launch soon three approved generic products. Elite also has a pipeline of additional generic drug candidates under active development and the Company is developing ELI-216, an abuse resistant oxycodone product, and ELI-154, a once-a-day oxycodone product. Elite conducts research, development and manufacturing in its facility in Northvale, New Jersey.

This news release contains forward-looking statements, including the statement that the acquisition and development of the naltrexone hydrochloride product may generate positive cash flow to support the Company’s research activities. These statements 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.

For Elite Pharmaceuticals, Inc.

Dianne Will, Investor Relations, 518-398-6222

Dianne@elitepharma.com