BioTie Therapies Corp. Will Not Exercise Option To Buy Neurelis, Neurelis Regains Rights To Intranasal Diazepam Program
Published: Jul 11, 2014
Biotie Decides Not To Exercise Option To Acquire Neurelis, Inc. But Retains Economic Interest In Future Success Of NRL-1
Biotie Therapies Corp. ("Biotie") today announced that it has decided not to exercise its exclusive option to acquire Neurelis, Inc. ("Neurelis"), a private specialty pharmaceutical company. In consideration of the timely transfer of the program to Neurelis, Biotie and Neurelis have agreed that Biotie may recover the cost of its investment to date in Neurelis' lead product NRL-1 through a share of future revenue generated by Neurelis. Neurelis plans to commence the remaining development program and proceed with clinical trials which have been agreed with the FDA. NRL-1 is a proprietary intranasal formulation of diazepam for pediatric and adult epilepsy patients who experience acute repetitive seizures.
Timo Veromaa, President and Chief Executive Officer of Biotie said "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. Biotie remains committed to starting Phase 3 with tozadenant in Parkinson's disease in the first half of 2015, and we look forward to the start of Phase 2 studies for SYN120 in Parkinson's disease dementia and BTT-1023 for Primary Sclerosing Cholangitis by the end of 2014, and delivering top-line data from the ongoing Phase 2 study with nepicastat in cocaine dependence, also around end 2014."
Turku, 11 July 2014
Biotie Therapies Corp.
President and CEO
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Timo Veromaa President and CEO
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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.
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 (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.
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 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.
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