Merck Canada and the pan-Canadian Pharmaceutical Alliance (pCPA) successfully complete negotiations for WINREVAIR® (sotatercept)

20.11.25 13:00 Uhr

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KIRKLAND, QC, Nov. 20, 2025 /CNW/ -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that it has successfully completed negotiations with the pan‑Canadian Pharmaceutical Alliance (pCPA) for WINREVAIR® (sotatercept). The pCPA negotiates on behalf of the provinces, territories, and federal drug programs serving as a critical step in bringing WINREVAIR® closer to public reimbursement.

Merck Logo (PRNewsfoto/Merck)

WINREVAIR® is indicated in combination with standard pulmonary arterial hypertension (PAH) therapy, for the treatment of adults with World Health Organization [WHO] Group 1 PAH and Functional Class (FC) II or III.

"Pulmonary arterial hypertension is a life-limiting disease that affects patients' ability to work, engage in daily activities, and maintain independence. Ensuring broad and equitable access to innovative therapies like WINREVAIR® is essential," said Jamie Myrah, Executive Director at Pulmonary Hypertension Association of Canada.

"Having additional therapeutic options that target different pathways is important for clinicians as we tailor treatment plans to individual patient needs with the aim of helping to improve their symptoms, function, quality of life, and overall outcomes," said Dr. Jason Weatherald, pulmonologist at the University of Alberta. "Completion of this negotiation is a meaningful step toward improving greater access to therapies with demonstrated benefits for patients living with PAH."

The next step involves provincial and territorial governments, and federal drug programs implementing equitable reimbursement to ensure appropriate access to WINREVAIR® based on the established patient eligibility criteria from our Health Technology Assessment (HTA) bodies.

About pulmonary arterial hypertension (PAH)
PAH is a serious, progressive condition in which the small arteries that carry blood from the heart to the lungs become narrowed by excess cell growth and scarring. That narrowing reduces blood flow to the lungs and lowers oxygen levels in the blood. PAH can be idiopathic, inherited, or linked to other conditions. Common symptoms include increasing shortness of breath (especially with exertion), fatigue, swelling of the feet and legs, chest pain, dizziness and fainting — symptoms that often develop slowly and can be mistaken for deconditioning or other heart and lung problems. Left untreated, PAH places strain on the heart, which can lead to reduced mobility, heart failure and reduced life expectancy.

About Merck
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable, and healthy future for all people and communities. For more information about our operations in Canada, visit www.merck.ca and connect with us on LinkedIn @MerckCanada.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA 
This news release of Merck & Co., Inc., Rahway, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2023 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).

® Merck Sharp & Dohme B.V. Used under license.
© 2025 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved.

Media Contact:
Merck Canada Media Relations:
1-833-906-3725
mediacanada@merck.com

SOURCE Merck

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