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.
