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news.Santen Pharmaceutical has entered into a licensing agreement with Cloudbreak Pharma to develop, manufacture, and commercialise CBT-001, a topical pterygium treatment, for certain territories.
The licensing agreement stipulates that Cloudbreak will receive up to $91m in upfront and milestone payments. Credit: National Cancer Institute on Unsplash.
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The territories include Japan, South Korea, and several Southeast Asian countries, including Vietnam, Thailand, Malaysia, the Philippines, Singapore, and Indonesia.
CBT-001 is an investigational emulsified nintedanib ophthalmic formulation designed to treat pterygium, a condition that can affect vision.
Nintedanib is a multi-kinase inhibitor targeting VEGF, PDGF, and FGF receptors, which play a role in angiogenesis and fibrosis.
The licensing agreement stipulates that Cloudbreak will receive up to $91m in upfront and milestone payments.
Additionally, Cloudbreak is entitled to royalties based on a double-digit percentage of the product’s future net sales in the designated territories.
Santen chief operating officer and board director Rie Nakajima said: “Until now, pterygium has generally been treated with surgery to remove severe cases. We are very pleased to be working with Cloudbreak to develop and launch CBT-001, which has the potential to treat this disease with eye drops, in Japan and Asia.
“By adding CBT to our development pipeline as a new therapeutic area, and by leveraging our knowledge and experience as a company specializing in ophthalmology, we will strive to deliver new treatment options that address the unmet needs of patients with pterygium as quickly as possible.”
A Phase II clinical study of CBT-001 has been concluded in the US, and a large-scale global multicentre Phase III clinical trial is in progress across the US, Australia, New Zealand, China, and India.
Cloudbreak grants rights of CBT-001 to Santen to develop, manufacture and commercialise the drug products in the territory.
Cloudbreak founder and CEO Jinsong Ni said: “We are excited to partner with Santen, a company renowned for its commitment to quality, innovation and patient eye health.
“Our shared vision and combined expertise mark a significant step forward in our mission to bring this promising disease-modifying therapy to market swiftly to patients with pterygium in Japan and around the world.”
