Neurelis, Inc. today announced an agreement with Biotie Therapies Corp. to end the option held by Biotie to purchase Neurelis, clearing the way for Neurelis to commence further development of NRL-1 (intranasal diazepam) for pediatric and adult epilepsy patients who experience acute repetitive seizures.
Over the past year, Biotie has advanced the development program for NRL-1 and worked with Neurelis in preparation for the pivotal clinical work required for NDA submission to the FDA. Given the need to address other development priorities, Biotie has now decided not to pursue continued development of NRL-1. Under the terms of the agreement between Biotie and Neurelis, Biotie will have the opportunity to participate in the future success of NRL-1 and recoup the significant investment in the development of the program.
"We are excited at the prospect of advancing the development of NRL-1 to NDA filing, with the goal of bringing this promising and unique therapy to pediatric and adult patients with epilepsy," stated Craig C. Chambliss, President and Chief Executive Officer of Neurelis. "The NRL-1 program has progressed significantly over the past year, benefiting from Biotie's development expertise. Neurelis is now prepared to complete the development program and the clinical trials requested for submission to the FDA. Most importantly, we are committed to bringing NRL-1 to the epilepsy community and the patients who may benefit from this novel therapy."