Neurelis Enters into Option and Merger Agreement with Biotie Therapies Agreement provides option for purchase of Neurelis and advances development of NRL-1 in preparation for NDA filing
SAN DIEGO, June 4, 2013 /PRNewswire/ -- Neurelis, Inc. ("Neurelis") today announced an agreement with Biotie Therapies Corp. ("Biotie") to further develop NRL-1 (intranasal diazepam) and provide Biotie with the exclusive option, but not the obligation, to acquire all outstanding shares of Neurelis.
Under the terms of the option and merger agreement between Biotie and Neurelis, Biotie will make a payment of US$1.0 million to Neurelis for the exclusive option to acquire all of the outstanding shares of Neurelis. During the option period, Biotie will conduct the development program for NRL-1 and work with Neurelis on advancing the program with the FDA in preparation for the pivotal clinical work required for NDA submission. Under the terms of the option and merger agreement, if the option is exercised and the merger is consummated, Biotie will make a payment of US$8.75 million, subject to certain adjustments, to be paid in new ordinary shares of Biotie. Stockholders of Neurelis will also be eligible to receive additional milestone payments based on certain regulatory and commercial milestones.
"We are excited at the prospect of working with Biotie on the continued development of NRL-1, with the goal of bringing this promising and unique therapy to patients with epilepsy" stated Craig C. Chambliss, President and Chief Executive Officer of Neurelis. "The proven success of Biotie's development efforts and the potential of an intranasal diazepam program with unmatched bioavailability and a well-tolerated safety profile could significantly benefit patients who experience acute repetitive seizures."
NRL-1 (intranasal diazepam) is a proprietary formulation of diazepam delivered via a commercially available nasal sprayer. It is being developed for the management of patients who require intermittent use of diazepam to control bouts of acute repetitive seizure activity. 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 United States 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 (usually less than 10 years of age). 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.
Biotie is a specialized drug development company focused on the development of drugs for neurodegenerative and psychiatric disorders (e.g. Parkinson's disease, Alzheimer's disease and other cognitive disorders, alcohol and drug dependence (addiction) and post-traumatic stress disorder), and inflammatory and fibrotic liver disease. The company has a strong and balanced development portfolio with several innovative small molecule and biological drug candidates at different stages of clinical development. Biotie's products address diseases with high unmet medical need and significant market potential. Biotie ordinary shares are listed on NASDAQ OMX Helsinki Ltd.
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.
Craig C. Chambliss, President and CEO
SOURCE Neurelis, Inc.