Sun Pharmaceutical has announced that one of its wholly owned subsidiaries has entered into two exclusive licensing agreement with a subsidiary of China Medical System Holdings Ltd. (CMS) for the development and commercialization of Cyclosporine A 0.09% (CsA) eye drops, an innovative formulation, for dry eye disease; and for the development and commercialization of Tildrakizumab, an innovative biologic product, for psoriasis and psoriatic arthritis in Greater China (including Mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region and Taiwan).

Under terms of the license agreement, CMS will pay Sun Pharma an initial upfront payment, regulatory and sales milestone payments, and royalties on net sales, the terms of which are confidential. CMS will be responsible for development, regulatory filings and commercialization of the product in China. The initial tenure of the agreement shall be 15 years from the first commercial sale of CsA in Greater China, and may be extended for additional 3 years subject to certain conditions defined in the agreement.

Kirti Ganorkar, Executive Vice President and Head, Global Business Development, Sun Pharma said, “We are pleased to enter into a licensing arrangement with CMS, a leading pharmaceutical company in Greater China. Dry Eye disease represents an area of high unmet medical need, with a significant number of patients having moderate to severe form of this disease. Sun Pharma is committed to growing its global ophthalmology franchise, with cyclosporine as its lead product.”

Cyclosporine A 0.09% ophthalmic solution (CsA) is a patented, novel, proprietary nanomicellar formulation in a clear, preservative-free, aqueous solution.

Dilip Shanghvi, Managing Director, Sun Pharma said, “This licensing agreement marks our entry into the Greater China market which is the second largest pharmaceutical market globally. Sun Pharma is committed to growing its dermatology franchise, with Tildrakizumab as its lead product. We continue to build our pipeline and capabilities in this important therapeutic area of significant unmet need. We are excited to be partnering with a leading pharmaceutical company like CMS to offer Tildrakizumab as an alternative treatment for psoriasis and psoriatic arthritis in Greater China.”

Tildrakizumab-asmn is a humanized lgG1/k monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor, leading to inhibition of the release of pro-inflammatory cytokines and chemokines. It was approved by USFDA in March 2018 and is being currently marketed in the US under the ILUMYATM brand name.

It is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.