Viatris Announces Positive Top-Line Results from Phase 3 Study of VR-205 in Japanese Adults with Primary Immunoglobulin A Nephropathy

This document is a Japanese translation of the news release distributed by Viatris Inc. on June 29, 2026 (US local time) (Viatris Announces Positive Top-Line Results from Phase 3 Study of VR-205 in Japanese Adults with Primary Immunoglobulin A Nephropathy - Jun 29, 2026). English is the official language, and its content and interpretation shall take precedence.

VR-205 Achieved Primary and Key Secondary Endpoints and Demonstrated Generally Good Tolerability

Efficacy and Safety Profile of VR-205 in Japanese Patients Consistent with Known Profile from Global Clinical Trials

Marketing Authorization Application Planned for 2026

Pittsburgh / Tokyo – June 29, 2026 – Viatris Inc. (NASDAQ: VTRS), a global healthcare company, today announced positive top-line results from a Phase 3 study evaluating the efficacy and safety of VR-205 (budesonide targeted-release formulation) (Nefecon®) in adult Japanese patients with primary IgA nephropathy (IgAN) at risk of developing end-stage renal disease (ESRD).

The Phase 3 study is a multi-center, interventional, open-label study evaluating the efficacy and safety of VR-205 administered at 16 mg in adult Japanese patients with primary IgA nephropathy (IgAN). Participants received treatment for 9 months, followed by a 3-month follow-up period.

The study met its primary endpoint, demonstrating a 33.75 percent (95% CI: -45.27 to -19.80; p < 0.001) reduction in the geometric mean of the urine protein-to-creatinine ratio (UPCR) at 9 months compared to baseline. These results were statistically significant and clinically meaningful, consistent with the results from the global Phase 3 study of the product. A summary of the study results is provided below:

In addition to statistically significant and clinically meaningful reductions in UPCR at 6 and 12 months, VR-205 showed a significant increase in estimated glomerular filtration rate (eGFR), a decrease in serum creatinine, and a reduction in the urine albumin-to-creatinine ratio (UACR) at 9 months compared to baseline.

The overall treatment effect of VR-205 was further supported by improvements in microscopic hematuria and sustained reduction in proteinuria.

No participants progressed to dialysis, kidney transplant, or severe renal impairment (eGFR <15 mL/min/1.73 m2) by the end of the study.

VR-205 demonstrated generally good tolerability over the 9-month treatment period, consistent with the known safety profile of budesonide targeted-release formulation in non-Japanese patient populations.

"We are very pleased with these positive top-line results," said Philippe Martin, Chief Research and Development Officer at Viatris Inc. "This demonstrates the efficacy and safety of VR-205 as a meaningful therapeutic option with potential disease-modifying effects for patients with IgA nephropathy. The favorable benefit-risk profile observed in this study suggests that VR-205 could become the only orally administered, targeted-release budesonide therapy specifically for IgA nephropathy in Japan, where the highest prevalence rates in the world have been reported. We are focused on building a more innovative and differentiated product portfolio in Japan, prioritizing the delivery of treatments that offer meaningful value and address serious unmet needs. We believe the positive results from this study reflect these ongoing efforts at Viatris."

"IgA nephropathy is a designated intractable disease and a condition with high unmet medical needs, as it follows a chronic course and carries the risk of progressing to end-stage renal failure, yet lacks a fundamental cure. We believe these study results are an important step towards providing a new treatment option for patients with IgA nephropathy and healthcare professionals in Japan," said Yuko Asami, Head of R&D at Viatris Pharmaceutical Ltd.

Viatris plans to submit a marketing authorization application in Japan in 2026.

In 2022, Calliditas Therapeutics AB and Viatris Pharmaceutical Ltd. (formerly Viatris Pharmaceutical Co., Ltd., now Viatris Pharmaceutical Ltd.), a subsidiary of Viatris Inc., entered into an exclusive license agreement for the domestic manufacturing, marketing, and sales of VR-205 (approved and marketed in the U.S. as Tarpeyo® and in Europe as Kinpeygo®) for the treatment of primary IgA nephropathy in Japan.

About the Phase 3 Study (VR-205A-01-CAZ-3001)

This Phase 3 study is a multi-center, interventional, open-label study evaluating the efficacy and safety of the oral formulation of VR-205 (budesonide targeted-release formulation) in adult Japanese patients with primary IgA nephropathy (IgAN) at risk of developing end-stage renal disease (ESRD). A total of 39 participants enrolled in the study received 16 mg (4 capsules) once daily during the 9-month treatment period.

Following the treatment period, participants transitioned to a 3-month follow-up period. At the start of the follow-up, a 2-week dose reduction period was implemented, reducing the VR-205 dose to 8 mg (2 capsules) once daily.

About IgA Nephropathy

IgA nephropathy (IgAN) is a progressive, immune-mediated kidney disease and the most common primary glomerulonephritis worldwide. In Japan, it is estimated to occur in 39-45 cases per million population annually, with the highest reported incidence rates globally. The peak age at diagnosis is concentrated between 30-39 years. In Japan, adult-onset IgA nephropathy has a reported 15-20% probability of progressing to end-stage renal failure requiring dialysis or transplantation within 10 years. Many patients who reach end-stage renal failure require decades of dialysis treatment. The total medical cost for maintenance hemodialysis in Japan amounts to approximately 1.5 trillion yen annually, with chronic glomerulonephritis (primarily IgA nephropathy) accounting for 23.4% of over 340,000 dialysis patients in Japan. Despite these economic and physical burdens, treatments that target the fundamental immunological factors of IgA nephropathy and maintain kidney function long-term are still limited, and the realization of treatments that improve the disease itself (disease-modifying therapies) is still strongly desired.

About Viatris

Viatris is a global healthcare company committed to helping people live healthier lives at every stage of life. We address the needs of patients worldwide through bold action with ingenuity and unwavering determination. We provide large-scale, sustainable, and effective solutions, from developing new medicines to ensuring the reliable supply of needed medicines and pursuing bold innovation. We were established with the goal of making an impact on society through a broad and agile portfolio, ranging from generics and proven branded medicines to innovative medicines in areas with significant unmet medical needs. Viatris is headquartered in the United States, with global centers in Pittsburgh, Pennsylvania; Shanghai, China; and Hyderabad, India. For more information, visit viatris.com and investor.viatris.com, as well as X (formerly Twitter), LinkedIn, Instagram, and YouTube.

Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the safe harbor rules of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this document may include the following statements regarding the results of clinical trials:

Positive top-line results from a Phase 3 study evaluating the efficacy and safety of VR-205 (budesonide targeted-release formulation) (Nefecon®) in adult Japanese patients with primary IgA nephropathy (IgAN) at risk of developing end-stage renal disease.

VR-205 achieved primary and key secondary endpoints and demonstrated generally good tolerability.

The efficacy and safety profile of VR-205 in Japanese patients was statistically significant and clinically meaningful, consistent with the known profile from global clinical trials.

We are pleased to have obtained top-line results suggesting that VR-205 could become a meaningful therapeutic option with potential disease-modifying effects for patients with IgA nephropathy.

This indicates that VR-205 could become the only orally administered, targeted-release budesonide therapy specifically for IgA nephropathy in Japan, where the highest incidence rates of IgA nephropathy in the world have been reported.

This achievement demonstrates the steady progress of Viatris' strategy to build a differentiated and innovative product portfolio in Japan. We are focused on providing truly valuable treatments to patients and addressing serious unmet medical needs.

These top-line results represent an important step towards expanding treatment options for patients and healthcare professionals.

Viatris plans to submit a New Drug Application (NDA) in Japan in 2026.

"Forward-looking statements" are subject to risks and uncertainties. Therefore, actual future results may differ materially from those expressed or implied by such "forward-looking statements." Factors that may cause or contribute to such differences include, but are not limited to, the following events:

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