Navigation Links
Neurelis Regains Rights to Intranasal Diazepam Program

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.


Craig C. Chambliss, President and CEO



SOURCE Neurelis, Inc.
Copyright©2014 PR Newswire.
All rights reserved

Related medicine technology :

1. Neurelis Enters into Option and Merger Agreement with Biotie Therapies
2. VirtualScopics Regains NASDAQ Compliance
3. Cell Therapeutics Regains Compliance with NASDAQ Minimum Bid Price Rule
4. Jazz Pharmaceuticals Announces Acquisition From Aerial Biopharma Of Rights To A Late Stage Investigational Compound For Excessive Daytime Sleepiness
5. Cell Therapeutics Reaches Agreement to Reacquire Rights to Two Anti-Cancer Compounds
6. Eddingpharm Acquired Global Rights to Oncology Assets, Including Telatinib, from ACT Biotech
7. Mylan Announces Acquisition of Rights to Novel LAMA Respiratory Compound from Pfizer
8. Pro-Dex, Inc. Announces Plans For Rights Offering To Shareholders
9. BMC to protect its rights in patent fight with ResMed
10. Lpath Withdraws From Pfizers Process to Assign iSONEP Rights
11. The OR Company Acquires Rights to Baltimore-Based Start-Up Technology
Post Your Comments:
(Date:11/25/2015)... , November 25, 2015 Kitov ... ) (TASE: KTOV), a biopharmaceutical company focused on the ... various clinical conditions, today announced the closing of its ... Shares ( ADSs ), each representing 20 ordinary shares ... 3,158,900 ADSs. The ADSs and warrants were issued in ...
(Date:11/25/2015)... , Nov. 25, 2015 Allergan ... pharmaceutical company, and Rugen Therapeutics, a start-up  biotechnology ... for unmet CNS disorders and funded by the ... they have entered into an exclusive collaboration to ... for Autism Spectrum Disorders (ASD) and Obsessive Compulsive ...
(Date:11/25/2015)... Israel , November 25, 2015 ... "New Investors"), pursuant to which BioLight and the New ... IOPtima Ltd. subsidiary ("IOPtima") via a private placement. The ... of its innovative IOPtimate™ system used in the treatment ... approval pathway process for the IOPtimate™ system with the ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... ... “While riding the bus, I saw a passenger in a wheelchair drenched from ... a convenient and comfortable way to protect them from bad weather, so I invented ... during cold or inclement weather. In doing so, it ensures that the user remains ...
(Date:11/25/2015)... , ... November 25, 2015 , ... ... (PHA) announces the nation’s Periwinkle Pioneers, individuals and groups responsible for advancing care ... disease. The Periwinkle Pioneers, nominated by the public, will receive special recognition throughout ...
(Date:11/25/2015)... ... November 25, 2015 , ... An unlikely combination ... in a way for homeless people to have a more dignified and comfortable ... initiative whereby they are repurposing plastic bags into sleeping mats for the homeless. ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... focused on providing comprehensive solutions involving adult stem cell therapies to patients with ... deemed the “Regenestem” name as a Registered Trademark (RTM). , Organizations are required ...
(Date:11/24/2015)... ... 2015 , ... Genesis Chiropractic Software helps practice owners automate ... between the practice owner and the patient that automatically manages all five aspects ... Click here to learn more. , According to Dr. Brian ...
Breaking Medicine News(10 mins):