Press release

Otsuka America, Inc’s. Data and Technology Company will Support Rejoyn™ Commercialization & Personalized Patient Engagement

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Sponsored by Businesswire

Otsuka America, Inc. (OAI) announces Otsuka Precision Health, Inc. (OPH), a company that will serve as a catalyst for delivering the right interventions at the right time along patients’ and caregivers’ unique health journeys, ranging from connected health solutions to digital therapeutics, all powered by advanced analytics tools like artificial intelligence. OPH will focus on the patient experience as a core piece of improving how better outcomes might be achieved across nephrology, mental health, and beyond.

The recent U.S. Food and Drug Administration (FDA) clearance of Rejoyn™, the first prescription digital therapeutic authorized for the adjunctive treatment of major depressive disorder (MDD) symptoms, is a proof-point for the possibilities of what OPH can bring to the market to enable a better patient experience. OPH will serve to commercialize Rejoyn™.

“Changes are needed to realize the potential of technology in health, and we’re ready to boldly address the barriers patients face in receiving care by taking a fundamentally new approach,” said Sanket Shah, president of OPH. “This Company will allow us to build on our commitment to the digital and technology space and continue building momentum with products such as, Rejoyn™, in a way that traditional pharmaceutical companies have not been able to explore.”

Combining the evidence-based rigor of pharma with a data-first focus on a more individualized approach to supporting patients, OPH has a unique opportunity to bring promising innovations to market quickly. Otsuka is deepening its commitment to the meaningful role technology can play in the lives of patients and the care teams that surround them.

“At this time there is a great desire for alternative therapies and treatments in the mental health space, especially given the outpaced demand in recent years,” said Shah. “New interventions that better connect, engage, and personalize care will be welcomed by patients and providers.”

OPH will be exhibiting Rejoyn™ for the first time at the 2024 American Psychiatric Association (APA) Annual Meeting in New York City from May 4 to May 8 and will participate in the meeting’s Mental Health Innovation Zone on May 4 and May 6.

About Otsuka Precision Health

Combining the rigor of pharma with a data-first focus on patient experience, Otsuka Precision Health, Inc. focuses on bringing to market prescription digital therapeutics, other innovative technologies, and provides non-promotional patient support services. The company is committed to personalizing care, unlocking doors to access, and uniting a fragmented experience. OPH’s current focus areas include a variety of technological interventions that help unearth personal health needs and address them as a true collaborator within the broader healthcare ecosystem.

OPH is a subsidiary of Otsuka America, Inc. (Otsuka), which is a subsidiary of Otsuka Pharmaceutical Co., Ltd. headquartered in Tokyo, Japan.

For more information, please visit https://otsuka-oph.com/.

About Rejoyn

Rejoyn™ (developed as CT-152), is the first prescription digital therapeutic authorized in the U.S. for the adjunctive treatment of major depressive disorder (MDD) symptoms. Otsuka America, Inc. (OAI) and Click Therapeutics, Inc., signed a collaboration agreement to develop and commercialize prescription digital therapeutics for treatment of MDD, with the intent to address unmet medical needs among this patient population and to improve outcomes. Rejoyn™ is the first FDA-cleared treatment resulting from this collaboration.

Rejoyn™ requires a prescription from a healthcare provider and is expected to be available for download from app stores for iOS® and Android™ operating systems in the latter half of 2024. To learn more about Rejoyn™ and sign up for updates regarding its availability, go to www.rejoyn.com. Healthcare providers can visit www.rejoynhcp.com.

INDICATION and SAFETY INFORMATION for Rejoyn

INDICATION:

Rejoyn™ is a prescription digital therapeutic for the treatment of Major Depressive Disorder (MDD) symptoms as an adjunct to the clinician-managed outpatient care for adult patients with MDD age 22 years and older who are on antidepressant medication. It is intended to reduce MDD symptoms.

SAFETY INFORMATION:

Rejoyn™ is not intended to be used as a standalone therapy or a substitute for medication. Patients should continue their current treatment as directed.

Rejoyn™ does not monitor the patient’s symptoms or clinical status and cannot send or receive alerts or warnings to the prescriber.

Patients should be clearly instructed that if they believe their depression is worsening or if they have feelings or thoughts of harming themselves or others, to contact a healthcare professional, dial 911, or go to the nearest emergency room immediately.

About the Otsuka and Click Therapeutics Collaboration

Otsuka America, Inc. (OAI) and Click Therapeutics, Inc., signed a collaboration agreement in 2019 to develop and commercialize prescription digital therapeutics for the treatment of MDD, with the intent to address unmet medical needs among this patient population and to improve outcomes. Rejoyn™ is the first FDA-cleared treatment resulting from this collaboration.

About Click Therapeutics

Click Therapeutics, Inc., develops, validates, and commercializes software as prescription medical treatments for people with unmet medical needs. As a leading innovator of Digital Therapeutics™, we deliver accessible, clinically proven, FDA-regulated prescription treatments to the smartphone in your hand. Our treatments are defined by our commitment to applying technical and scientific rigor and patient-centric design to the development process. This results in uniquely engaging experiences that achieve compelling clinical outcomes for patients seeking new treatment options. We are continuously expanding and refining our shared platform technologies with novel cognitive, behavioral and neuromodulatory mechanisms of action and advanced data-driven tools such as artificial intelligence and machine learning.