Ms. Amy Cairns reports

BAUSCH HEALTH CANADA ANNOUNCES EXPANDED PUBLIC REIMBURSEMENT FOR (PR)OKEDI(TM) (RISPERIDONE FOR EXTENDED-RELEASE INJECTABLE SUSPENSION) ACROSS CANADA FOR THE TREATMENT OF SCHIZOPHRENIA

Bausch Health Canada Inc., a subsidiary of Bausch Health Companies Inc. has expanded public reimbursement for PrOkedi (extended-release injectable suspension of risperidone) 75 milligrams and 100 mg, with coverage now available for eligible patients, subject to the applicable reimbursement criteria, through public drug plans in seven provinces and multiple federal drug plans.

PrOkedi is now listed in Ontario, Quebec, British Columbia, Alberta, Saskatchewan, Nova Scotia and Prince Edward Island, as well as through federal drug plans administered by the Non-Insured Health Benefits Program (NIHB), Veterans Affairs Canada (VAC), the Department of National Defence (DND) and Correctional Service Canada (CSC).

PrOkedi is a prolonged-release injectable suspension of risperidone indicated for the treatment of schizophrenia in adults. PrOkedi is designed to provide rapid attainment of clinically relevant risperidone plasma concentrations, followed by sustained release over the four-week dosing interval, without the need for oral supplementation or a loading dose.

"Expanding public access to treatment options is central to how we support Canadians living with schizophrenia," said Amy Cairns, general manager, Bausch Health Canada Inc. "We are pleased that PrOkedi is now accessible to eligible patients through public drug plans in seven provinces and through federal drug plans, and we remain committed to working with provinces and territories to further expand access across Canada."

"Broader reimbursement of PrOkedi, the newest long-acting injection antipsychotic, is an important step forward for people living with schizophrenia. Long-acting injectable treatments can help reduce the risk of relapse, support continuity of treatment, and give patients greater opportunity to maintain stability and pursue their personal goals. Improving access to these treatments means putting more options in the hands of patients and clinicians to support long-term recovery and quality of life," said Dr. Tom Hastings, MD, FRCPC, vice-president, EPI Canada.

"For some people living with schizophrenia, long-acting injectable medications can be an important treatment option. Research suggests these treatments may support treatment continuity and help reduce some of the challenges associated with daily medication use," said Kayla Nicholls, director of programs and impact, Institute for Advancements in Mental Health (IAMhealth). "Expanding public coverage helps reduce financial barriers and improves access to evidence-based treatment options for individuals and families."

About schizophrenia

Schizophrenia is a chronic and severe psychiatric disorder that typically emerges in late adolescence or early adulthood and affects about 1 per cent of the population. The illness is characterized by episodes of psychosis and loss of contact with reality, as well as emotional and cognitive symptoms. It affects how a person thinks, feels, behaves and relates to others, often impairing functioning, relationships, employment and quality of life.

Relapses are common throughout the course of schizophrenia and may be associated with worsening symptoms, hospitalization, functional decline and a more difficult course of illness, highlighting the importance of continuity of care. Although there is no cure for schizophrenia, the illness can be managed through a combination of antipsychotic medication, psychosocial support and community-based care, enabling many people to achieve stability, recovery and meaningful participation in daily life. Long-acting injectable antipsychotics may play an important role in supporting treatment continuity and reducing the risk of relapse in patients living with schizophrenia.

PrOkedi clinical data and safety information

In the pivotal Prisma-3 randomized, double-blind, placebo-controlled study in adults experiencing an acute exacerbation of schizophrenia, 438 patients were randomized to receive once-monthly PrOkedi 75 mg, PrOkedi 100 mg or placebo for 12 weeks. Both PrOkedi dose groups demonstrated statistically significant improvements from baseline in PANSS total score and CGI-S score compared with placebo at 12 weeks (p less than 0.0001). The most frequently reported treatment-emergent adverse events were increased blood prolactin, headache, hyperprolactinemia and weight increase. No new or unexpected relevant safety information was identified.

In the 12-month open-label extension study (Prisma-3 OLE; N equals 215), continued treatment with PrOkedi was associated with sustained improvements in PANSS and CGI scores in patients who entered the study with unstable or stabilized disease, while symptom stability was generally maintained in patients who entered the study in the stable group. The long-term safety profile was consistent with that observed in the pivotal study, with no new safety signals identified.

For patients who have never taken risperidone, tolerability with oral risperidone prior to initiating treatment with PrOkedi should be established. Health Canada has not authorized the use of PrOkedi in pediatric patients (less than 18 years).

Please consult the Canadian Product Monograph for complete information regarding indications, contraindications, warnings, precautions, adverse reactions, dosage and administration.

About Bausch Health Companies Inc.

Bausch Health Companies is a global, diversified pharmaceutical company enriching lives through the company's relentless drive to deliver better health outcomes. Bausch Health develops, manufactures and markets a range of products primarily in gastroenterology, hepatology, neuroscience, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through the company's controlling interest in Bausch + Lomb Corp. The company's ambition is to be a globally integrated health care company, trusted and valued by patients, HCPs, employees and investors.

The Bausch Health Canadian prescription treatment portfolio is focused on dermatology, chronic weight management, allergy, neuropsychiatry and cardio-metabolic conditions. Bausch Health also has two manufacturing facilities for prescription pharmaceuticals in Canada: in Laval, Que., and Steinbach, Man.

We seek Safe Harbor.