
Viatris Announces Launch of First Clozapine Orally Disintegrating Tablet (ODT) in Canada
ETOBICOKE, ON, May 27, 2025 /CNW/ — Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced the launch in Canada of Gen-Clozapine orally disintegrating tablets (ODT) (12.5 mg, 25 mg, 50 mg, 100 mg and 200 mg), providing a new treatment option for treatment-resistant schizophrenia patients. This marks the first availability in Canada of an orally disintegrating tablet of clozapine, which is the only approved antipsychotic for treatment-resistant schizophrenia1. It is estimated that 25% to 30% of individuals with schizophrenia meet the criteria for treatment-resistant schizophrenia.1
Dr. Ofer Agid, Medical Head of Ambulatory Services in the Schizophrenia Division at the Centre for Addiction and Mental Health (CAMH) in Toronto, commented, 'The introduction of Gen-Clozapine is welcome news for patients and physicians alike as this new clozapine formulation rapidly disintegrates when placed on the tongue or can be chewed, which provides a new option for some patients who may need it. This also gives physicians an alternative to the current tablet dosage form.'
Gen-Clozapine has been available in tablet form (not orally disintegrating) since 2003. Viatris has provided access to this medicine, and related care, to thousands of Canadian patients through the Gen-Clozapine Access Network (GenCAN) for over 18 years.
Viatris Canada's Country Manager Jeffrey Long commented, 'The launch of Gen-Clozapine orally disintegrating tablets demonstrates further evidence of our commitment to providing diversified treatment options to patients and healthcare professionals in Canada. Viatris' strong heritage in mental health, and experience with clozapine specifically, puts us in an excellent position to provide access to this new formulation which will impact patient treatment.'
Gen-Clozapine orally disintegrating tablets are available by prescription only and through the GenCAN patient support program. Through GenCAN, Viatris is committed to patient safety, continued advancement of clinical knowledge and applying technology solutions to simplify monitoring practices. The program supports more than 12,000 active patients across Canada, collaborating with healthcare teams for the safe and effective use of Gen-Clozapine.
For more information, please consult the Product Monograph at https://pdf.hres.ca/dpd_pm/00078407.PDF.
References:
Remington G, Addington D, Honer W, Ismail Z, Raedler T, Teehan M (September 2017). 'Guidelines for the Pharmacotherapy of Schizophrenia in Adults'. Canadian Journal of Psychiatry. Revue Canadienne de Psychiatrie. 62 (9): 604–616.
About Viatris Viatris Inc. (NASDAQ: VTRS) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health challenges, access takes on deep meaning at Viatris. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on LinkedIn, Instagram, YouTube and X (formerly Twitter).
Forward-Looking StatementsThis statement includes statements that constitute 'forward-looking statements.' These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include statements regarding new product launches. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: actions and decisions of healthcare and pharmaceutical regulators; our ability to comply with applicable laws and regulations; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; any regulatory, legal or other impediments to Viatris' ability to bring new products to market; Viatris' or its partners' ability to develop, manufacture, and commercialize products; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings; Viatris' failure to achieve expected or targeted future financial and operating performance and results; risks associated with international operations; changes in third-party relationships; the effect of any changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties and matters beyond the control of management, including general economic conditions, tariffs and trade restrictions, inflation and exchange rates; and the other risks described in Viatris' filings with the Securities and Exchange Commission (SEC). Viatris routinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Viatris undertakes no obligation to update these statements for revisions or changes after the date of this press release other than as required by law.

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