Vertex and Ono Pharmaceutical Forge Strategic Partnership to Develop and Commercialize Povetacicept in Japan and South Korea
In a move that underscores the growing international collaboration in advancing treatment for autoimmune and kidney-related diseases, Vertex Pharmaceuticals Incorporated and Ono Pharmaceutical Co., Ltd. announced today a strategic, exclusive collaboration and licensing agreement to develop and commercialize povetacicept in Japan and South Korea. The agreement will focus on expanding access to this investigational therapy for patients suffering from immunoglobulin A nephropathy (IgAN), primary membranous nephropathy (pMN), and potentially other B cell-driven diseases.
Povetacicept is a recombinant fusion protein designed as a dual antagonist targeting two critical cytokines: BAFF (B-cell activating factor) and APRIL (a proliferation-inducing ligand). These molecules are instrumental in the survival and function of B cells, which play a central role in various autoimmune and inflammatory diseases. By simultaneously inhibiting BAFF and APRIL, povetacicept aims to modulate abnormal B cell activity more effectively than single-target agents, offering what Vertex refers to as best-in-class potential.
Details of the Agreement
Under the terms of the collaboration, Vertex will receive a significant upfront payment from Ono. While the exact figures have not been publicly disclosed, the deal includes a series of development, regulatory, and commercial milestone payments tied to the successful advancement and approval of povetacicept in the respective markets. Additionally, tiered royalties on net sales will be paid to Vertex based on future commercial performance in Japan and South Korea.
In return, Ono Pharmaceutical will take on critical responsibilities in the region. This includes clinical development support, regulatory submissions, and marketing authorization efforts for povetacicept. Once approved, Ono will exclusively handle commercialization activities across Japan and South Korea, leveraging its well-established footprint and deep-rooted expertise in the region’s healthcare ecosystems.
The agreement currently covers povetacicept’s development for IgAN and pMN, with an option to expand to additional B cell-mediated indications as development progresses and clinical data evolve.
Why This Partnership Matters
The partnership is strategically important for both companies. Vertex, headquartered in the United States and globally recognized for its breakthroughs in cystic fibrosis and other serious diseases, is looking to expand its footprint in immunology and nephrology. With povetacicept, the company is pushing into a field of medicine where chronic, progressive diseases like IgAN and pMN have limited treatment options and often result in end-stage renal disease or the need for dialysis or kidney transplantation.
By teaming up with Ono Pharmaceutical, Vertex gains a trusted regional partner with established development infrastructure, regulatory expertise, and a commercial presence in both Japan and South Korea—markets known for their stringent regulatory environments and high standards of care. Ono’s robust track record in launching and promoting specialty therapeutics, including in immunology and oncology, positions it as an ideal partner to help drive local access and adoption.
“Ono is a proven leader in Japan and South Korea, bringing established local relationships, infrastructure, and nephrology expertise that make them a perfect partner for Vertex,” said Dr. Reshma Kewalramani, Chief Executive Officer and President of Vertex Pharmaceuticals. “We are very pleased to partner with Ono and look forward to close collaboration as we continue to advance this potentially best-in-class treatment for IgAN, pMN and other serious B cell-mediated diseases.”
From Ono’s perspective, this collaboration strengthens its late-stage development pipeline, particularly in immunology, which is one of its strategic areas of focus. The company, headquartered in Osaka, has been actively expanding its portfolio through partnerships and in-house R&D to address unmet needs in autoimmune and inflammatory disorders.
“Vertex has a strong track record of developing innovative therapies for serious diseases,” said Toichi Takino, Representative Director, President and COO of Ono. “Through this strategic partnership, we can strengthen our late-stage pipeline in the immunology field. We look forward to collaborating with Vertex to provide this new therapeutic option for patients with IgAN and other autoimmune diseases in Japan and South Korea, and to maximize the value of this treatment.”
Scientific Background: Targeting BAFF and APRIL
BAFF and APRIL are TNF (tumor necrosis factor) family ligands that promote B-cell survival, proliferation, and immunoglobulin production. In diseases like IgAN and pMN, overexpression of these cytokines leads to pathological B-cell activation, contributing to tissue inflammation and kidney damage. Therapeutically targeting both ligands is believed to provide superior disease control compared to inhibiting BAFF or APRIL alone.
Povetacicept’s dual-antagonism mechanism is designed to effectively reduce B cell populations and dampen aberrant immune responses while preserving necessary immune functions. Early clinical and preclinical data suggest it may offer better efficacy and longer-lasting responses than current standards of care, especially for diseases where B-cell dysregulation plays a central pathological role.
Clinical Development Landscape
Vertex is currently conducting clinical trials of povetacicept in IgAN and pMN, with additional exploratory programs under consideration. The company has positioned povetacicept as a pipeline-in-a-product asset, meaning its mechanism of action could be broadly applicable to a range of autoimmune diseases.
IgAN, also known as Berger’s disease, is the most common primary glomerulonephritis globally and is characterized by the deposition of IgA antibodies in the kidney’s glomeruli, leading to progressive kidney damage. Similarly, primary membranous nephropathy is an autoimmune condition marked by immune complex deposition in the glomerular basement membrane, often leading to nephrotic syndrome and chronic kidney disease.
There is currently no cure for either disease, and available treatments focus on reducing proteinuria and slowing disease progression using steroids, RAAS inhibitors, and other immunosuppressants. The demand for safer and more effective therapies is growing, especially in Asia where the prevalence of IgAN is higher than in Western populations.
This agreement is not only a major milestone for Vertex’s immunology pipeline but also an important expansion move in the Asia-Pacific region, where partnerships are increasingly seen as essential for navigating regulatory complexities and achieving commercial success.
For Ono, the deal reinforces its commitment to bringing first-in-class and best-in-class therapies to patients in Japan and South Korea. The addition of povetacicept aligns with Ono’s strategy of building a diversified portfolio that includes not just oncology, where it has long been a leader (including its co-development of Opdivo with Bristol Myers Squibb), but also emerging areas like autoimmune nephrology.
The companies have not disclosed the expected timeline for regulatory submissions in Japan and South Korea, but with ongoing development in the U.S. and other global markets, more data will likely emerge in the coming quarters to guide regional strategies.
The collaboration between Vertex Pharmaceuticals and Ono Pharmaceutical marks a significant step forward in the global effort to address rare and serious autoimmune kidney diseases. Through this alliance, both companies aim to accelerate the development and eventual commercialization of povetacicept, providing new hope for patients living with IgAN, pMN, and other B cell-mediated diseases in Japan and South Korea. With complementary strengths in innovation, development, and market access, Vertex and Ono are poised to make a substantial impact in nephrology and immunology across the region.
