Eisai's Proton Pump Inhibitor Receives Agreement For Approval in All European Union Member States
Tokyo (October 7, 1998) - Eisai Co., Ltd. (President and CEO: Haruo Naito) today announced that the proton pump inhibitor, Pariet (rabeprazole sodium) has received agreement for approval in 14 EU member countries through the mutual recognition procedure after its first approval in the U.K. Pharmaceutical authorities in each country will issue marketing authorizations in the near future.
Pariet is classified as a proton pump inhibitor and is a new treatment for gastroesophageal reflux disease (GERD), duodenal and gastric ulcers. Pariet was synthesized by Eisai and developed in Japan, the U.S., and Europe. Eisai Ltd., an Eisai marketing subsidiary, received marketing authorization from the U.K. Medicines Control Agency (MCA) in May 1998. Sales began in Japan in December 1997 and September 1998 in the U.K. under the tradename of Pariet. A New Drug Application for marketing clearance was filed with the U.S. Food and Drug Administration in March 1998.
A copromotion alliance with Janssen Pharmaceutica (Headquarters: Beerse, Belgium) exists for Pariet sales in the U.K., Germany, and France. Sales in the other European countries will be through Janssen-Cilag, except for Belgium, the Netherlands, and Luxembourg where Janssen-Cilag does not have the license.
*EU Member countries are: the United Kingdom, Germany, France, Italy, Austria, Belgium, Luxembourg, Denmark, Finland, Greece, Ireland, Portugal, Sweden, the Netherlands, and Spain.
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 worldwide health care systems. The company reported sales of about $2.3 billion in 1997 with approximately 15 percent of sales spent for research and development.
Pariet is a trademark of Eisai Co., Ltd.