Neurelis Regains Rights to Intranasal Diazepam Program

Agreement with Biotie ends option for purchase and allows Neurelis to advance development of NRL-1 in preparation for NDA filing

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Neurelis, Inc.

Jul 11, 2014, 08:00 ET

SAN DIEGO, July 11, 2014 /PRNewswire/ -- Neurelis, Inc. ("Neurelis") today announced an agreement with Biotie Therapies Corp. ("Biotie") 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."

About NRL-1

NRL-1 (intranasal diazepam) is a proprietary formulation of diazepam delivered via an already marketed nasal sprayer, being developed for the management of pediatric and adult patients who require intermittent use of diazepam to control bouts of acute repetitive seizure activity. In clinical trials, NRL-1 has demonstrated high bioavailability, low variability from dose to dose, and was well-tolerated. There are over 2.7 million people with epilepsy in the United States with approximately 200,000 new patients diagnosed each year. It is estimated that between 30% and 40% of these patients are uncontrolled on oral therapy and are at-risk for acute breakthrough seizures. Studies have shown that prolonged or repetitive seizures can cause neurological damage and dramatically increase the risk of changes in neuropsychological function or even death.

Presently, the only product approved in the US for the treatment of acute repetitive seizures outside of the hospital setting, is a rectally administered formulation of diazepam called Diastat®. Because of its rectal mode of administration, Diastat® has been primarily relegated to use in younger pediatric patients. The majority of patients with acute repetitive seizures however, are currently seen in emergency rooms and treated with intravenous benzodiazepines. Most of these patients are admitted to the hospital. Intranasal diazepam has the potential to provide a superior alternative to either rectal administration of Diastat® or the need to visit the emergency room for intravenous administration of drugs.

About Neurelis

Neurelis, Inc. is a privately-held San Diego-based specialty pharmaceutical company organized to license, develop, and commercialize product candidates for epilepsy and the broader central nervous system (CNS) market. Neurelis leverages expertise in the development and commercialization of CNS compounds and strong relationships with leading researchers and clinicians in these markets to advance unique product candidates to address significant unmet medical needs.

About Biotie

Biotie is a specialized drug development company focused on products for neurodegenerative and psychiatric disorders. For the past years, Biotie has successfully operated a strategy built around search, profile and partner. This has delivered Selincro (nalmefene) for alcohol dependence, which received European marketing authorization in February 2013 and is currently being rolled out across Europe by partner H. Lundbeck A/S, and tozadenant, a novel A2a antagonist which is transitioning into Phase 3 development for Parkinson's disease and for which Biotie holds exclusive, global rights. Biotie is actively developing its pipeline assets, including SYN120, a unique potent 5-HT6/5-HT2a dual antagonist for which Biotie initially expects to conduct a Phase 2 study in Parkinson's disease dementia that is largely funded by the Michael J Fox Foundation; nepicastat, a selective inhibitor of dopamine beta hydroxylase which is currently in a Phase 2 study, fully funded by NIDA, for treatment seeking cocaine addicts; and BTT-1023, a monoclonal antibody targeting Vascular Adhesion Protein 1 for which Biotie intends to conduct a Phase 2 study in primary sclerosing cholangitis, a rare fibrotic disease of the liver. Biotie's shares are listed on NASDAQ OMX Helsinki.