Santen Licenses Cloudbreak Topical Pterygium Candidate for Japan, Korea, and Southeast Asia

Japan’s Santen announced Aug. 6 that it had signed an agreement to license CBT-001, a topical pterygium treatment candidate from Cloudbreak Pharma.

The deal covers the territories of Japan, South Korea, and the Southeast Asian countries of Vietnam, Thailand, Malaysia, Philippines, Singapore, and Indonesia.

Under the agreement, Cloudbreak will receive up to $91 million up front, plus milestone payments. Cloudbreak, of Irvine, California, is also eligible to receive double-digit royalties on future net sales.

Pterygium is a non-malignant fibrovascular growth that originates from the conjunctiva and advances onto the corneal surface. It is often considered a benign tumor due to its propensity to recur. There is no therapeutic product to treat pterygium, though doctors do prescribe off-label artificial tears and short courses of topical ocular steroids. The problem is often addressed surgically.

CBT-001 is a topical ophthalmic formulation of nintedanib, a multi-kinase inhibitor that acts on the VEGF (vascular endothelial growth factor) receptor, PDGF (platelet derived growth factor) receptor, and FGF (fibroblast growth factor) receptor to inhibit angiogenesis and fibrosis.

A Phase II trial has been completed in the US, and a global multicenter Phase III trial is underway in the US, Australia, New Zealand, China, and India.