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Thursday, October 02, 2008
Elite Announces Drug Application Filing For Synthetic Narcotic Analgesic Accepted by FDA
Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (AMEX:ELI) in collaboration with ThePharmaNetwork, LLC., announced today the acceptance by the U.S. Food and Drug Administration (FDA) of the Abbreviated New Drug Application (ANDA) for a generic equivalent of a synthetic narcotic analgesic drug product. The product had annual sales of approximately $36 million in 2007. Elite will manufacture the product and will receive a share of the profits from the sale of the product upon commercialization.
"We are pleased to reach this milestone and look forward to working with ThePharmaNetwork in this venture," commented Bernard Berk, Chairman and CEO for Elite. "With the revenue generated from the Lodrane(r) products along with the proceeds of our recent capital raise, Elite continues to move forward with the development of our two lead pain products, ELI-216, our abuse resistant oxycodone, and ELI-154, our once daily oxycodone product and will complete the work necessary for initiating Phase III clinical studies. Prescription drug abuse is a national crisis and abuse resistant drugs, like those being developed by Elite, are aimed at making a significant impact on this problem. ELI-216 is differentiated from other abuse resistant products in development by being the only once daily oxycodone using a pharmacological approach for abuse resistance. The pharmacological approach, we believe, compared to other technologies can provide a higher barrier for those recreational drug users trying to use these prescription drugs inappropriately to achieve a euphoric high and the once daily delivery provides a more consistent blood levels of the drug for these chronic indications as compared to the current sustained release oxycodone products. Elite will continue to prosecute the patents it has filed for this product and is preparing to file additional patents to strengthen our intellectual patent estate. Elite has also improved its financial condition by restructuring its workforce which, together with the growth in Elite's Lodrane revenues (approximately $1.3 million in last 6 months), is expected to significantly reduce Elite's operating losses. Lodrane 24(r) and Lodrane 24D(r) are products manufactured by Elite and sold and distributed by our partner ECR Pharmaceuticals. We will continue to seek out additional partnering prospects and other venture opportunities to leverage our proprietary opioid abuse technology and our unique drug delivery systems."