Elite, Epic Pharma enter into licensing deal for abuse-deterrent ELI-200

Epic will be responsible for sales and marketing of ELI-200, and Elite will be responsible for the manufacture of the product. Epic will pay Elite non-refundable milestone payments totaling $15 million and a royalty based on net product sales.

The term of the License is five years and the License is renewable upon mutual agreement at the end of the initial term.

Elite also announced today the dosing of the first subjects for an ELI-200 Phase III clinical study. This Phase III study is a multi-center, randomized, multiple-dose, blinded, placebo-controlled, parallel group, study to evaluate the efficacy and safety of abuse deterrent ELI-200 for the treatment of adults with moderate to severe pain following surgery. The study will enroll approximately 165 patients at five clinical sites.

"Epic is pleased to have an opportunity to market this important new product and to add to our current pipeline of opioid products that includes a pending application for an abuse-deterrent oxycodone HCl extended release product," said Dr. Ashok Nigalaye, Chief Executive Officer of Epic.

"ELI-200 will allow Epic to extend its reach in the anti-abuse pain space, and to position both companies for long-term growth."

"I am delighted to have a partner like Epic for Elite’s first abuse-deterrent product," said Nasrat Hakim, President and Chief Executive Officer of Elite Pharmaceuticals.

"We will work closely with Epic to prepare for and ensure a successful launch. The ELI-200 Phase III study is expected to be wrapped up later this year and we expect an NDA filing for ELI-200 by year’s end."

Additional information about the licensing agreement and Phase III clinical trial will be provided at our yearend conference call following the filing of our annual report on form 10-K for the fiscal year ended March 31, 2015.

We anticipate that the conference call will be held on June 16th, 2015. Additional information about the conference call will be provided.