Biotie Therapies Corp. (Biotie) has announced that it has obtained an exclusive option to acquire Neurelis, Inc. (Neurelis), a private specialty pharmaceutical company based in San Diego, CA, focused on developing products for epilepsy and other disorders of the central nervous system (CNS).
Neurelis' lead product, NRL-1, is a proprietary intranasal formulation of diazepam delivered via an already marketed nasal sprayer. It is being developed to help patients with epilepsy who require intermittent use of diazepam to manage bouts of acute and repetitive seizures.
Timo Veromaa, President and Chief Executive Officer of Biotie in a statement stated "Our interest in Neurelis is in line with our ongoing portfolio review, which is focused on ensuring that we are developing products that address areas of significant unmet medical need and have the greatest potential for creating value for our shareholders. We are now in a position to assess the potential of NRL-1 alongside our internal pipeline opportunities."
He said "NRL-1 is an exciting late-stage product for the control of epileptic seizures. We believe the product could offer a far better solution for patients and their caregivers who currently rely on rectal administration of diazepam or visits to the emergency room to control debilitating episodes. Importantly, NRL-1 could also provide a much needed treatment option for those individuals who are not willing to use rectal administration, a particular issue in the United States."
Under the terms of the option and merger agreement entered into today between Biotie, Neurelis and Neurelis' shareholders, Biotie will make a payment of US$1.0 million to Neurelis for the exclusive right, but not the obligation, to acquire all of the outstanding shares of Neurelis for a pre-defined amount of US$8.75 million, subject to certain adjustments, to be paid in new shares of Biotie to be issued on approval by the Board of Directors. Biotie may exercise the option right up until the start of the pivotal pharmacokinetic clinical studies that will form the basis of a 505 (b)(2) New Drug Application (but no later than December 3, 2014).
This is expected in approximately 12-18 months' time.
Biotie's decision to exercise its option will be dependent on, among other factors, the outcome of ongoing discussions with the FDA and further manufacturing and pre-clinical work which Biotie will be conducting.
If the acquisition is completed, Neurelis will become a wholly owned subsidiary of Biotie and former Neurelis shareholders would, in addition to the pre-defined acquisition payment, be entitled to receive additional milestone payments related to pre-determined regulatory and commercial milestones in respect of NRL-1 and NRL-2 in the United States and further milestones if further regulatory approvals are obtained, payable in shares of Biotie or cash as determined by the Board of Directors.
NRL-1 (intranasal diazepam) is a proprietary formulation of diazepam delivered via an already marketed 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 percent and 40 percent 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.
Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act in the United States was established to avoid unnecessary duplication of studies already performed on a reference drug, which in the case of NRL-1 is diazepam, in general and a rectally administered formulation of diazepam called Diastat®, in particular.
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 whilst Neurelis, Inc. is a 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 commercialisation 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.