Evry (France), Osaka (Japan), December 6, 2013 – Santen, a global pharmaceutical company specialized in the fields of ophthalmology, today announces that a European Marketing Authorization Application (MAA) for Ikervis® has been filed to the European Medicines Agency (EMA) for the treatment of Dry Eye Disease. In doing so, the EMA will begin its regulatory review process of the MAA. The application includes safety and efficacy data from Ikervis®’s clinical program which was conducted in Europe.
The filing of the application for Ikervis® to the European Medicines Agency is an important step forward in the development of the Santen’s Dry Eye franchise.
Founded in 1890, Santen is a global pharmaceutical company specialized in the fields of ophthalmology and ant-rheumatics, which is headquartered in Osaka, Japan. Among prescription ophthalmic pharmaceuticals, Santen holds the top share within the Japanese market and is one of the leading ophthalmic companies worldwide. Santen has subsidiaries in the U.S., Europe, and Asia, including its Emeryville, California based Santen Inc., its Tampere, Finland based Santen OY, its Evry, France based Santen SAS and Novagali Innovation Center, its Suzhou, China based Santen Pharmaceutical (China) Co., Ltd. and its Bangalore, India based Santen India Private Limited.
Nicolas Merigeau – NewCap. – firstname.lastname@example.org – Tel: +33-1-4471-9498
Geneviève GarrigosDirectorCorporate Communication EuropeSanten SAS1 rue Pierre Fontaine, Genavenir IV,F-91058 Evry FranceTel: +33-6-6554-6019
Takashi HibiGeneral ManagerCorporate Communication GroupSanten Pharmaceutical, Co., Ltd.4-20 Ofukacho,Kita-ku, Osaka 530-8552 JapanTel: +81-6-4802-3827
Information provided in this press release contains so-called “forward looking statements”. The realizations of these forecasts are 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 governments in Japan and other nations concerning medical system, drug pricing and other systems, as well as fluctuations in market variables such as interest and foreign exchange rates.