Santen and Cloudbreak execute a new licensing agreement for CBT-001, a topical treatment of pterygium

6 August 2024 – Osaka, Japan – Santen Pharmaceutical Co., Ltd. (head office: Osaka, Japan; hereinafter Santen), a specialist in ophthalmology, and Cloudbreak Pharma Inc. (head office: California, US; hereinafter Cloudbreak), a clinical stage ophthalmic drug company, announce the signing of a new licensing agreement for CBT-001, Cloudbreak’s investigational proprietary multi-kinase inhibitor developing for the indication of pterygium, for Japan, South Korea, and Southeast Asian countries of Vietnam, Thailand, Malaysia, Philippines, Singapore and Indonesia (hereinafter Territory). Under the terms and conditions of this agreement, Cloudbreak grants rights of CBT-001 to Santen to develop, manufacture and commercialize the drug products in the Territory.

CBT-001 is an emulsified nintedanib ophthalmic formulation being developed by Cloudbreak for the treatment of pterygium. Nintedanib is 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. An initial Phase II clinical study has been completed in the U.S. and a large-scale global multicenter Phase III clinical study is currently underway in the United States, Australia, New Zealand, China and India. CBT-001 is expected to provide physicians and patients with a new treatment option for pterygium by inhibiting disease progression with eye drops.

Pterygium is a non-malignant fibrovascular tissue growth that originates from the conjunctiva and advances onto the corneal surface. Pterygium is often considered as benign tumor due to its invasive growth tendency and propensity for recurrence, but not metastasis. Although pterygium is non-malignant, it can cause significant ocular symptoms, including hyperemia, irritation, pain, and foreign body sensation thus it impacts the patients' Quality of Life (QOL). Currently, there is no approved therapeutic product to treat pterygium. Physicians often prescribe off-label artificial tears and short courses of topical ocular steroids. However, these eye drops do not improve the symptoms of pterygium, or unsafe for prolonged use of steroids. Surgical excision is performed when there is encroachment on the visual axis or, less commonly, when hyperemia is persistent. Various surgical techniques are currently available for pterygium, but all techniques tend to recur¹, which is considered a challenge in pterygium surgery. On the other hand, surgery is not performed until the disease becomes severe, and follow-up observation is the main means of treatment. Although the cause of its onset is unknown, it is thought that ultraviolet light is closely related to the onset and progression of this disease². Pterygium patients are most commonly present in low latitudes, and it is estimated that about 10% of the world's population is affected³, with around 4 million patients in Japan⁴. The prevalence of pterygium is estimated to be 4% of those over 40 years of age in Japan⁵, 3.8% in Korea⁶, and 10.1% of those over 40 years of age in Vietnam, Malaysia, the Philippines, and Thailand⁷.

“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,” said Rie Nakajima, Director of the Board, Chief Operating Officer of Santen. “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.”

“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,” said Jinsong Ni, Ph.D., Founder and Chief Executive Officer of Cloudbreak.

Under the terms of the agreement, Cloudbreak will receive up to US$91 million of upfront and milestone payments. Cloudbreak is also eligible to receive royalty payment as the double-digit percentage of the products’ future net sales.

References

1. Tanaka et al, Journal of Japanese Ophthalmology 115:386-390, 2011
2. Modenese et al, Int J Environ Res Public Health 15(1):37 (2018)
3. Liu L et al. Geographical prevalence and risk factors for pterygium: a systematic review and meta-analysis. BMJ Open 2013;3:e003787. doi:10.1136/bmjopen-2013-003787
4. Estimated from epidemiological studies (4.4% (Minamiaizu Town, Fukushima Prefecture, 37°N) of those aged 40 and over and 7.2% (Monzen Town, Ishikawa Prefecture, 37°N) of those aged 50 and over)
5. Tano et al, Acta Ophthalmol 91(3):e232-6, 2013
6. Rim TH et al, PLOS One 12(3) e0171954, 2017
7. Ang M et al, Ophthalmology 119(8):1509e15, 2012

About Cloudbreak
Cloudbreak Pharma Inc. is an innovation-driven clinical-stage ophthalmology biotechnology company dedicated to the development of novel and differentiated treatments. Cloudbreak was first founded in 2015 at Irvine, California, USA as company’s headcounter and has since established its operations in Mainland China and Hong Kong as well. We are committed to the in-house discovery, development and commercialization of first-in-class and best-in-class ophthalmic therapies to address global unmet medical needs. Cloudbreak has established a broad and innovative pipeline of eight drug candidates covering major anterior and posterior ophthalmic diseases, with four clinical-stage drug candidates and four pre-clinical stage drug candidates. Our mission is to help people “Seeing Life Better Through Medicine”.
For more information, please visit our website https://cloudbreakpharma.com/

About Santen
As a specialized company dedicated to eye health, Santen aspires to contribute to the realization of “Happiness with Vision” by providing products and services to patients, consumers, and medical professionals around the world. Since its establishment, and guided by its CORE PRINCIPLE, “Tenki ni sanyo suru,” Santen has been committed to helping people maintain and improve their eye health for more than 130 years. Santen is engaged in the global research and development, manufacturing, and sales and marketing of pharmaceutical products in the field of eye care, supporting the eye health of approximately 50 million people in more than 60 countries and regions worldwide. Santen’s mission is to provide essential and significant value to patients and society in the prevention, diagnosis, and treatment of eye diseases through products and services created from its expertise in the ophthalmology field and from the patient's perspective. To create a future in which as many patients as possible can lead happy and fulfilling lives, Santen is committed to doing its utmost to realize a society in which people around the world can experience “Happiness with Vision.”
For more information, please visit Santen’s website https://www.santen.com/en.

Contact
Corporate Communications
Santen Pharmaceutical Co., Ltd.
E-mail: communication@santen.com   

Corporate Communications Department
Cloudbreak Pharma Inc.
Email: HongKongPR@cloudbreakpharma.com
Tel +852-2882-6582

This press release has been published in Japanese, Traditional Chinese, Simplified Chinese and English languages and in the event of any inconsistency, the English version shall prevail.