Eisai Submits Marketing Authorization Application (MAA) in U.K. for a New Proton Pump Inhibitor
January 22, 1997 -- Eisai Co., Ltd. of Tokyo (President and CEO: Haruo Naito) today announced that Eisai Europe Ltd., an Eisai U.K subsidiary, submitted an MAA to the U.K. Medicines Control Agency (MCA) on January 17 for PARIET(TM)(rabeprazole sodium), or E3810, an investigational new drug for duodenal ulcers, gastric ulcers and gastroesophageal reflux disease.
PARIET(TM) is a proton pump inhibitor synthesized by Eisai in Japan. The compound is being developed by Eisai in Japan, Europe, the U.S. and Canada. The compound is under review for marketing approval by the Ministry of Health and Welfare in Japan and is in Phase III clinical trials in the U.S. Eisai plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in late 1997.
Eisai Co., Ltd. is a research-based human health care company which discovers, develops and markets products in more than 30 countries. Through its global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care systems. The company reported sales of $2.6 billion in fiscal year 1995 with approximately 14 percent of sales spent for research and development.