Eisai Receives Marketing Authorization For Pariet (rabeprazole sodium),A Proton Pump Inhibitor, From the U.K. Medicines Control Agency.
Tokyo (May 13, 1998) - Eisai Co., Ltd. of Tokyo (President and CEO:Haruo Naito) today announced that Eisai Ltd., an Eisai marketing subsidiary, has received notice of marketing authorization from the U.K. Medicines Control Agency (MCA) on May 11 for the proton pump inhibitor, Pariet(rabeprazole sodium, research code name: E3810) a new treatment for the healing for gastrooesophageal reflux disease (GERD), duodenal and gastric ulcers.
From now Eisai Ltd. will pursue European marketing authorizations according to the EU Mutual Recognition Procedure utilizing the U.K. as the reference member state. In January 1997, a marketing authorization application was filed with the U.K. MCA. Marketing authorization applications will now be made to other EU countries.
In April 1997 Eisai and Johnson and Johnson's subsidiary, Janssen Pharmaceutica in Belgium, announced the formation of a strategic alliance for the copromotion of rabeprazole sodium in the U.S., U.K., Germany, and France. A new drug application was filed with the U.S. Food and Drug Administration in March.
Rabeprazole sodium is classified as a proton pump inhibitor and was synthesized by Eisai in Japan. The compound has been developed by Eisai in Japan, Europe, and the US. Rabeprazole sodium demonstrates strong proton pump inhibition at the final stage of acid secretion by blocking the function of the enzyme responsible for stomach acid production. Sales began in Japan in December 1997 under the tradename of Pariet.
Janssen Pharmaceutica is a wholly owned subsidiary of Johnson & Johnson, the world's most comprehensive manufacturer of healthcare products and related services. Janssen is a leader in the research and development of therapies for gastrointestinal disorders and is headquartered in Beerse, Belgium with affiliates in 32 countries,
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 $2.3 billion in 1996 with approximately 14 percent of sales spent for research and development.
Pariet is a trademark of Eisai Co., Ltd.