Servier Inks $530M Deal to Acquire Global Rights (Ex-U.S.) to Darovasertib, a Selective PKC Inhibitor for Uveal Melanoma

On September 2, Servier and IDEAYA Biosciences, a leading precision medicine oncology company, announced an exclusive licensing agreement to provide promising drugs for the treatment of rare cancers to patients worldwide.darovasteribAccording to the agreement, Servier has obtained the regulatory and commercial rights for darovasterib in all regions outside the United States. IDEAYA retains its rights to darovasterib in the United States. Darovasertib is a potent and selective protein kinase C (PKC) inhibitor being developed for the broad treatment of primary and metastatic uveal melanoma (UM).

Under the terms of the agreement, IDEAYA will receive an upfront payment of $210 million and is eligible for up to $100 million in regulatory approval milestone payments, up to $220 million in commercial milestone payments, and double-digit royalties on net sales in all regions outside the United States. Servier will be responsible for the regulatory and commercial activities of darovasterib in all regions outside the United States. IDEAYA and Servier will collaborate on the development of darovasterib and share associated costs.

Arnaud Lallouette, Executive Vice President of Global Medical and Patient Affairs at Servier, stated:"At Servier, our mission is to provide transformative therapies for patients with significant needs. Our collaboration with IDEAYA is aimed atdarovasterib"An important step in becoming a potential first-class treatment available to uveal melanoma patients worldwide. Currently, treatment options are limited, and there is an urgent need to improve patient outcomes. We look forward to leveraging our global oncology network and expertise in developing tumor-targeted therapies to make this breakthrough treatment accessible to patients around the world."

Yujiro S. Hata, CEO of IDEAYA Biosciences, stated:"Darovasertib addresses a significant unmet need, and we are thrilled to partner with Servier to develop it globally as a potential standard of care for patients with uveal melanoma worldwide. This collaboration enables IDEAYA and Servier to accelerate the global development of Darovasertib across three Phase 3 registration trials, aiming to improve patient outcomes in neoadjuvant, adjuvant, and metastatic settings."

Daniel Simon, Chief Business Officer of IDEAYA Biosciences, stated:"We believe that Servier's global footprint and strong track record of bringing new therapies to patients in major regions outside Europe and the United States will ensure that this potentially life-changing treatment can benefit as many patients as possible."

Darovasertib is currently being evaluated in multiple global clinical trials. These include a Phase 2/3 randomized trial assessing the efficacy of Darovasertib in combination with Crizotinib for first-line treatment of HLA-A2 negative metastatic uveal melanoma (UM) patients, with median progression-free survival readouts expected from the end of 2025 to the first quarter of 2026, and a Phase 3 randomized trial evaluating neoadjuvant Darovasertib as a monotherapy for primary UM, regardless of HLA status. IDEAYA Biosciences and Servier aim to initiate a global Phase 3 randomized clinical trial in 2026 to evaluate adjuvant.darovasteribEfficacy in primary UM, including HLA-A2-negative and positive patients.

Uveal Melanoma (UM) is a rare and aggressive cancer that originates in the uveal tract, including the iris, ciliary body, and choroid. Despite its rarity, it poses significant risks due to its potential to metastasize to other parts of the body, particularly the liver. Current treatment options include radiotherapy, surgical removal of the tumor, or, in severe cases, removal of the eye (enucleation).

Darovasertib has received Breakthrough Therapy Designation from the U.S. FDA as a neoadjuvant therapy for eye removal surgery, recommended for primary UM. Darovasertib in combination with Crizotinib has been granted Fast Track Designation for adult patients with metastatic UM. Darovasertib has also been designated as an Orphan Drug for UM by the U.S. FDA, including metastatic UM.

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