November 27, 2017, Osaka, Japan – Santen Pharmaceutical Co., Ltd. (hereinafter, Santen) and Ube Industries, Ltd. (hereinafter, Ube Industries) announced today the filing for manufacturing and marketing approval of glaucoma and ocular hypertension treatment DE-117 (JAN*: Omidenepag Isopropyl) to the Japanese Ministry of Health, Labour and Welfare on November 22, 2017.
Santen and Ube Industries entered into a license and collaboration agreement with DE-117, and co-developed DE-117 ophthalmic solution as a treatment for glaucoma and ocular hypertension. Omidenepag Isopropyl, the active pharmaceutical ingredient in DE-117, is a selective EP2 receptor agonist and an ocular hypotensive agent with a new mechanism of action.
Santen and Ube Industries expect DE-117 will offer an important new treatment option for glaucoma patients, leading to their improved quality of life.
* Japanese Accepted Names for Pharmaceuticals
|Dosage form||sterilized aqueous ophthalmic solution|
|Indication (at the filing)||glaucoma and ocular hypertension|
|Dosage (at the filing)||1 drop/time, once daily|
As a specialized company dedicated to the ophthalmic field, Santen carries out research, development, marketing, and sales of pharmaceuticals. Santen is the market leader in Japan for prescription ophthalmic pharmaceuticals and sells products in approximately 60 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 (http://www.santen.com).
Centering on Chemicals business, Ube Industries operates Pharmaceutical / Cement & Construction Materials / Machinery / Energy & Environment businesses. Among them, the pharmaceutical business is positioned as one of active growth businesses of the company. Ube Industries endeavors to expand the pharmaceutical business by both "drug discovery" by its own / joint research and development, and "manufacturing (in-house discovered APIs, contract, generic)." For more details, please see Ube Industries' website (http://www.ube-ind.co.jp/ube/en/).
Information provided in this press release contains forward-looking statements. The achievement of these forecasts is subject to risk and uncertainty from various sources. Therefore, please note that the actual results may differ significantly from the forecasts. Business performance and financial conditions are subject to the effects of changes in regulations made by the governments of Japan and other nations concerning medical insurance, drug pricing and other systems, and to fluctuations in market variables such as interest rates and foreign exchange rates.