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March 30, 2016


ONO Enters Licensing Agreement with Santen for ONO-9054, FP/EP3 Dual Receptor Agonist


ONO PHARMACEUTICAL CO., LTD. (Osaka, Japan; President, Representative Director, Gyo Sagara; "ONO") announced today that it has entered a licensing agreement with Santen Pharmaceutical Co., Ltd. (Osaka, Japan; President, Representative Director, Akira Kurokawa "Santen") whereby ONO grants Santen exclusive right to manufacture, develop and commercialize globally ONO-9054, an FP and EP3 dual receptor agonist which was created and currently under development by ONO as an ophthalmologic topical formulation for the treatment of glaucoma and ocular hypertension.


Under the terms of the agreement, ONO will receive from Santen an upfront payment. In addition, ONO will also receive future milestone payments based upon achievement of certain development and its sales, as well as the sales-based royalties after the launch of the product.


ONO-9054 is a once-daily prostaglandin eye drop drug product with a novel, dual mode of action that activates both FP and EP3 receptors. ONO-9054 is expected to show a superior intraocular pressure lowering effect compared to FP receptor agonists. Phase II clinical trial of ONO-9054 has been completed for the treatment of glaucoma and ocular hypertension in the U.S. In future, Santen will seek manufacturing and marketing approval for ONO-9054 on a worldwide basis.


The arrangement will not affect ONO's forecasts for the full-year business performance ending March 31, 2016.


About FP/EP3 dual receptor agonist

Both FP and EP3 receptors are prostaglandin receptors. As it has been reported that both receptors have an effect in reducing intraocular pressure, ONO-9054, an FP/EP3 dual receptor agonist is expected to give a new therapeutic options for the treatment of glaucoma.


About Glaucoma

Glaucoma is a disease in which the optic nerve (which transmits visual images to the brain) is damaged, thereby causing gradual loss in the visual field. Elevated intraocular pressure (IOP) is believed to be the main cause of optic nerve damage, and IOP lowering is considered to be the most effective treatment for preserving visual function. It is said that in the Japanese population, 70% of glaucoma patients have "normal tension glaucoma (NTG)", a type of glaucoma that can occur even though intraocular pressure is within the normal range. Progression of NTG can also be delayed by IOP lowering.

About ONO PHARMACEUTICAL CO., LTD.

ONO PHARMACEUTICAL CO., LTD, headquartered in Osaka, Japan, is an R&D-oriented pharmaceutical company committed to creating innovative medicines in specific areas. It focuses especially on the oncology and diabetes areas. For more information, please visit the company's website at http://www.ono.co.jp/eng/index.html.


About Santen

As a specialty company dedicated to the ophthalmic field, Santen carries out research, development, sales, and marketing of pharmaceuticals. Santen is the market leader in Japan for prescription ophthalmic pharmaceuticals and sells products in over 50 countries. As a leading company in the field of ophthalmology, Santen aims to contribute to society by supplying valuable products and services to satisfy unmet medical needs. For more details, please see Santen's website (www.santen.com).


Contact

ONO PHARMACEUTICAL CO., LTD.

Corporate Communications public_relations@ono.co.jp

ONO Pharmaceutical Co. Ltd. issued this content on 30 March 2016 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 30 March 2016 06:03:16 UTC

Original Document: http://www.ono.co.jp/eng/news/pdf/sm_cn160330.pdf