Adamis Pharmaceuticals provides update on its higher dose Naloxone Injection Product

Adamis Pharmaceuticals Corporation announced that the FDA has acknowledged the receipt of Adamis’ amendment to its previously submitted New Drug Application (NDA) for its higher dose naloxone injection product. This revision removed Evzio as a Reference Listed Drug (RLD) and withdrew the associated Paragraph IV certification. Narcan injectable (NDA 016636) now remains as the sole RLD and, because there are no Orange Book listed patents for NDA 016636, no patent certification is required.

With this change, it is Adamis’ opinion that the amended NDA will not be subject to a 30-month stay and that the FDA will be free to issue an approval as soon as the agency completes a satisfactory review of the Adamis naloxone NDA.

Adamis decided to amend its original NDA after consulting with the FDA regarding the proposed change. The removal of the Paragraph IV certification does not terminate the previously announced lawsuit filed by kaléo Inc. in the United States District Court for the District of Delaware, which alleges, among other things, that Adamis’ product infringes patents purportedly held by kaléo. As previously stated, Adamis believes that its higher dose naloxone injection product does not infringe any valid and enforceable patent held by kaléo and that kaléo’s patent infringement allegation is without merit. Adamis has separately demanded that Cooley LLP withdraw as counsel for kaléo. Cooley has served as counsel to Adamis since Adamis’ formation in 2006, has counseled Adamis on all areas of its business and has a clear conflict of interest. Adamis will continue to vigorously defend its naloxone injection product against any and all patent infringement allegations..