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Neurelis Expands IP Estate for Valtocco

A Patient-Centric Nasal Spray for Acute Treatment of Episodes of Frequent Seizure Activity

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Neurelis, Inc., a neuroscience-based company dedicated to enhancing therapeutic benefits and addressing significant unmet needs in managing central nervous system (CNS) disorders, announced that it has secured the issuance of United States Patent No. 11,241,414 (the ‘414 Patent) for VALTOCO® (diazepam nasal spray) CIV for acute treatment of episodes of frequent seizure activity in adult and pediatric patients age six and older.

“Our approach to innovation seeks to improve patient outcomes with constant feedback from our patient community,” said Craig Chambliss, President and Chief Executive Officer of Neurelis. “We continue to demonstrate this innovation through the issuance of the ‘414 patent and others under review at the U.S. Patent and Trademark Office. We remain optimistic about our ability to extend the exclusivity of VALTOCO beyond 2029.”

More than 50 million people worldwide live with epilepsy and, despite the availability of chronic, daily oral medications to help manage their seizures, many patients continue to experience recurring breakthrough seizures. If left untreated, these seizures can significantly impact quality of life and can potentially cause damage to the brain. In the U.S., as many as 170,000 of these patients deal with acute episodes of frequent seizure activity, sometimes referred to as “seizure clusters” or ‘’acute repetitive seizures.” As a therapy that can be both caregiver- and self-administered outside a medical setting to respond to these seizure emergencies, VALTOCO empowers patients and care partners to take a proactive role in managing their disease and improving their health outcomes.

“This additional patent for VALTOCO is a critical milestone that further memorializes our commitment in innovating patient-centric solutions in rare and broader CNS indications,” said Enrique Carrazza, MD, Chief Medical Officer of Neurelis. “Combined with a robust and growing body of clinical evidence supporting the safety and effectiveness of VALTOCO in the treatment of acute episodes of frequent seizure activity, this patent demonstrates our commitment and ability to overcome tough scientific challenges that are barriers to advancing care for patients with epilepsy.”

About Neurelis: 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’s 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 (previously known as BA-1049), an investigational, pre-clinical stage small molecule Rho kinase (ROCK) inhibitor, for the treatment of cerebral cavernous malformations (CCMS), a rare disorder of the central nervous system (CNS).

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