Biotie Therapeutics has decided not to exercise its option to purchase Neurelis and is returning the rights to Neurelis’s lead product, NRL-1 intranasal diazepam for the treatment of epileptic seizures. Biotie paid $1 million for the option to purchase Neurelis in June 2013. Under the deal, Biotie will still participate in any future revenues from the product to recover its development costs.
Biotie President and CEO Timo Veromaa commented, “Following the return of full global rights of tozadenant to Biotie in March 2014 we have now decided not to pursue further development of NRL-1 and wish Neurelis success with this important product.”
Neurelis President and CEO Craig C. Chambliss said, “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. 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.”
Neurelis submitted an Investigational New Drug Application for NRL-1 in 2012. Acorda Therapeutics is also developing an intranasal diazepam and submitted a 505(b)(2) application for the product, to be called Plumiaz, in November 2013. The FDA issued a Complete Response Letter to that application in May 2014.
Read the Biotie press release.
Read the Neurelis press release.
