Travere Therapeutics has entered into a licensing agreement with Everest Medicines to acquire exclusive rights to the oral BTK inhibitor civorebrutinib for rare kidney diseases, committing $112.5 million upfront and up to $1.03 billion in potential development, regulatory and commercial milestone payments.
Announced on June 2, the agreement gives Travere exclusive rights to develop and commercialize civorebrutinib in all global markets except China and certain countries in East and Southeast Asia. In addition to the upfront and milestone payments, Everest will receive tiered royalties ranging from high-single-digit to double-digit percentages on future net sales in the licensed territories.
Civorebrutinib is an oral, reversible Bruton’s tyrosine kinase (BTK) inhibitor designed to treat immune-mediated kidney diseases. The therapy works by inhibiting BTK, a key mediator of B-cell receptor signaling that is involved in B-cell activation, maturation, proliferation, and differentiation into antibody-producing cells.
The companies plan to evaluate civorebrutinib in several rare and immune-mediated kidney diseases, including primary membranous nephropathy (PMN), focal segmental glomerulosclerosis (FSGS) and minimal change disease. According to Travere, a Phase 1/2 study in patients with PMN demonstrated reductions in anti-PLA2R autoantibodies and proteinuria, while also showing high rates of immunologic and clinical remission and stable kidney function through 52 weeks of follow-up.
Analysts at Guggenheim Securities described the transaction as a capital-efficient approach to expanding Travere’s rare kidney disease portfolio. In a note to investors, the firm said civorebrutinib’s immune-mediated mechanism could complement Travere’s existing kidney disease therapy, Filspari.
Filspari, which is approved by the U.S. Food and Drug Administration for IgA nephropathy and focal segmental glomerulosclerosis, operates through a different mechanism. The therapy targets endothelin and angiotensin II receptors, helping reduce proteinuria and kidney inflammation while also limiting kidney fibrosis and glomerular damage.
Following discussions with Travere management, Guggenheim analysts said the company views civorebrutinib and Filspari as distinct therapies with complementary profiles. While Travere considers it too early to begin formal combination studies, the company believes there is a mechanistic rationale for exploring the two approaches together over time.
Travere Chief Executive Officer Eric Dube said civorebrutinib is a strategic addition to the company’s rare kidney disease portfolio and has the potential to become a best-in-class therapy across multiple immune-mediated rare kidney diseases, including focal segmental glomerulosclerosis and IgA nephropathy.
“With proof-of-concept data in primary membranous nephropathy, a differentiated profile as an oral, reversible BTK inhibitor, and expected broad mechanistic applicability across diseases such as immune-mediated FSGS, minimal change disease and beyond, we believe civorebrutinib has the potential to meaningfully advance the treatment paradigm for rare kidney disease patients,” Dube said.
Everest licensed civorebrutinib from Sinovent and SinoMab in 2021 under a deal valued at up to $561 million.
The licensing agreement follows the FDA’s full approval of Filspari for focal segmental glomerulosclerosis in April. The drug became the first medicine to receive full FDA approval for the rare kidney disease indication and generated $322 million in revenue last year.
Travere Therapeutics has announced a major licensing agreement with Everest Medicines, securing rights to Civorebrutinib in a transaction valued at up to $1.14 billion. The deal represents a significant strategic move for Travere as the company seeks to expand its pipeline and strengthen its long-term growth prospects within the specialty pharmaceutical market.
The agreement underscores Travere’s commitment to acquiring innovative therapies that address serious medical conditions while diversifying its portfolio of development-stage assets.
Travere Expands Its Development Pipeline
The acquisition of Civorebrutinib provides Travere with access to a promising therapeutic candidate that could support future growth initiatives. Licensing agreements of this scale demonstrate how Travere is actively investing in new opportunities to enhance its research and development portfolio.
For Travere, the addition of Civorebrutinib aligns with its broader strategy of building a pipeline focused on addressing areas of significant unmet medical need.
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