Pharma Focus Asia

Teijin and NeuroSigma Enter into Exclusive License Agreement

Friday, October 18, 2019

Teijin Limited (Teijin) and NeuroSigma, Inc. (NeuroSigma), a Los Angeles-based bioelectronics company focused on developing Trigeminal Nerve Stimulation (TNS) technology for the treatment of neuropsychiatric and neurological indications, today announced entering into a partnership based on an exclusive license agreement that grants Teijin Pharma, the core company of Teijin's healthcare business, exclusive rights: (i) to NeuroSigma's TNS patent rights in Japan related to attention deficit hyperactivity disorder (ADHD) and (ii) to market the Monarch eTNS System® for the non-invasive treatment of ADHD in Japan. As part of the agreement, Teijin Pharma will seek regulatory approval in Japan for the Monarch eTNS System (Monarch) for the treatment of ADHD.

The Monarch® is the first non-drug treatment cleared by the US FDA for the treatment of pediatric ADHD. In the US, the prescription-only Monarch device is indicated for treatment of pediatric ADHD as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications. The device is intended to be used in the home under the supervision of a caregiver during periods of sleep. The most common side effects observed with Monarch use are: drowsiness, an increase in appetite, trouble sleeping, teeth clenching, headache and fatigue. No serious adverse events are associated with use of the device.

Teijin Pharma, a global leader in the use of home therapies to improve the quality of life for patients, seeks to expand its home healthcare product portfolio. NeuroSigma will support Teijin's activities in securing regulatory approval in Japan for the Monarch for the treatment of ADHD. Teijin Pharma also offers home healthcare services for respiratory conditions, including home oxygen therapy (HOT), and continuous positive airway pressure (CPAP) therapy for sleep apnea treatment.

"The Monarch eTNS System is a non-invasive, non-drug treatment for pediatric ADHD and is designed for home use. NeuroSigma's corporate strategy is to focus on the U.S. market while partnering with leading life sciences companies outside the U.S.," said Leon Ekchian, Ph.D., CEO of NeuroSigma. "As a leading global pharmaceutical and home healthcare company, Teijin Pharma is NeuroSigma's ideal partner for the commercialization of eTNS for the treatment of ADHD in Japan," added Ekchian.

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