Aculys Pharma signed an exclusive licensing agreement with Neurelis, Inc. for the development and commercialization of VALTOCO®

Aculys Pharma signed an exclusive licensing agreement with Neurelis, Inc. for the development and commercialization of VALTOCO® (diazepam nasal spray), a nasal spray approved by the FDA in the United States for the acute treatment of seizure clusters in patients with epilepsy six years of age and older.

  • There are currently no approved nasal sprays available for the acute treatment of episodes of frequent epileptic seizure activity in Japan and the Asia-Pacific region*

Aculys Pharma, Inc. (“Aculys Pharma” Headquarters: Fujisawa City, Kanagawa Prefecture, Representative Director and CEO: Kazunari Tsunaba), a new biopharmaceutical company focused on the development and commercialization of new innovative drugs in the fields of neurology and psychiatry, announced that it has signed an exclusive licensing agreement with Neurelis, Inc. (headquartered in San Diego, CA, USA) for the clinical development and commercialization of Neurelis’  VALTOCO® (diazepam nasal spray) in Japan and the Asia-Pacific region.*  In 2020, the U.S. Food and Drug Administration approved Neurelis’ VALTOCO® (diazepam nasal spray) as an acute treatment for intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from an individual’s usual seizure pattern in adult and pediatric patients 6 years of age and older.

“We are very pleased to partner with Neurelis to develop Japan’s first nasal spray as an innovative treatment for seizure emergencies in Japan and the Asia-Pacific region”, said Kazunari Tsunaba, Co-founder, Chief Executive Officer and Representative Director of Aculys. “Early intervention is needed to prevent seizure progression to prolonged or repeated seizures that can lead to status epilepticus. We believe that, if successfully developed and approved in Japan, this medicine will fulfill a critical unmet medical need.”

“Diazepam is a drug that has been used in Japan for several years in medical institutions as well as outside of the medical setting by patients and caregivers.  Developing a new formulation of diazepam may enable for the safe and quick administration not only in medical institutions but also at homes, schools, offices, etc. by non-medical healthcare professionals. We believe that, if approved, this medicine will positively impact the future of epilepsy treatment as well as how patients, and families respond to seizure emergencies.”

Beyond the development and commercialization of new medicines, Aculys is committed to the patient experience, including the awareness, screening, diagnosis, personalized treatment and resolution of surrounding social issues for patients and their families confronted with neurological and psychiatric disease. The company looks to form comprehensive solutions through cross-sectional partnerships using new technologies to enhance the patient experience.

(*Asia Pacific: Australia, Brunei, Cambodia, Indonesia, South Korea, Laos, Malaysia, Myanmar, New Zealand, Philippines, Thailand, Vietnam)

■ About nasal spray (active ingredient: diazepam)

Diazepam has been used as a therapeutic agent for the treatment of epileptic seizure as an injectable for more than 60 years in Japan. It also has a history as a suppository for use by non-medical personnel such as patients and caregivers, outside of medical institutions.

■ About Neurelis, Inc.

Neurelis, Inc., is a commercial-stage neuroscience company focused on the development and commercialization of therapeutics for the treatment of epilepsy and orphan neurologic disorders characterized by high unmet medical need. In 2020, the FDA approved Neurelis’ VALTOCO® (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from an individual’s usual seizure pattern in adult and pediatric patients 6 years of age and older. VALTOCO is a proprietary formulation of diazepam incorporating the science of INTRAVAIL®. INTRAVAIL’s transmucosal absorption enhancement technology enables the noninvasive delivery of a broad range of protein, peptide and small-molecule drugs. In its approval of VALTOCO, the U.S. Food and Drug Administration also granted Neurelis Orphan Drug Exclusivity and recognized VALTOCO’s intranasal route of administration as a clinically superior contribution to patient care over the previously approved standard-of-care treatment (a rectal gel formulation of diazepam). For more information on VALTOCO, please visit www.valtoco.com. In addition to VALTOCO, Neurelis is developing NRL-2 for intermittent use to control acute panic attacks, NRL-3 as a noninvasive acute therapy to stop seizures that have progressed to status epilepticus, and NRL-4 as a noninvasive rescue therapy to address the escalation of acute agitation symptoms associated with schizophrenia and bipolar 1 mania in adults. In addition, Neurelis is developing NRL-1049, an investigational, preclinical stage small molecule Rho kinase (ROCK) inhibitor, for the treatment of cerebral cavernous malformations (CCMs), a rare disorder of the central nervous system (CNS). For more information on Neurelis, please visit www.neurelis.com.  For the latest scientific information on VALTOCO, please visit www.neurelismedicalaffairs.com.

■ About Aculys Pharma, Inc.

Aculys Pharma is a biopharmaceutical company focused on the development and commercialization of innovations in the fields of neurology and psychiatry. Its corporate name was created from the philosophy of “Catalyst to Access.”  Aimed to act as a bridge for innovative medical care in the field of neuropsychiatry, Aculys develops and commercializes novel pharmaceuticals and provides innovations for better medical care to patients, their families, healthcare professionals, and society.

http://www.aculys.com

Company name: Aculys Pharma, Inc.

Address: 1, 26-chome, Okahigashi 2-chome, Muraoka, Fujisawa-shi, Kanagawa, Japan

Representative: Kazunari Tsunaba

Established: Jan 2021

URL: https://www.aculys.com

Information concerning pharmaceutical product (compound under development) contained herein is not intended as advertising or as medical advice, but intended for disclosure of management information.

[Contact information for the press]

Aculys Pharma Public Relations Secretariat (within Brains Company, Inc.)
Assignment: Uka YOSO Tel: +81-3-4580-6124 
Mail: mailto:aculys_pr@pjbc.co.jp