Tokyo (February 15, 2002) - Eisai Co., Ltd. of Tokyo (President and CEO: Haruo Naito) announced that its U.S. subsidiary, Eisai Inc. (President: William Sheldon) has received approval from the U.S. Food and Drug Administration for the marketing of ACIPHEX, a proton pump inhibitor, for the treatment of symptomatic gastroesophageal reflux disease or GERD.
ACIPHEX is currently widely used for the treatment of erosive gastroesophageal reflux disease. This indication expansion means that ACIPHEX can be used once daily for the treatment of symptomatic GERD. Symptomatic GERD is characterized by the presence of symptoms such as heartburn, regurgitation, belching, and early satiety(feeling of being full sooner than normal after eating less than usual), without endoscopic evidence of erosion to the esophagus.
ACIPHEX is classified as a proton pump inhibitor and demonstrates strong proton pump inhibition at the final stage of acid secretion. ACIPHEX is also approved in the U.S. for the healing of erosive gastroesophageal reflux disease (GERD), the maintenance of healed erosive GERD, for the healing of duodenal ulcers, and the treatment of pathological hypersecretory conditions including Zollinger-Ellison syndrome.
ACIPHEX, known under the trade name PARIET outside the U.S., was first launched in Japan in 1997, in Europe in 1998, and in the U.S. in 1999. A copromotion alliance with Janssen Pharmaceutica Inc. exists for product sales in the U.S., and with Janssen-Cilag in the U.K. and Germany. ACIPHEX / PARIET has been approved in 77 countries and launched in 59 countries. Eisai's sales of the product are expected to be approximately 84.0 billion (excluding licensed territories) in the current fiscal year.
Eisai Co., Ltd. is a research-based human health care company which discovers, develops and markets products in more than 30 countries. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care system. The Company reported sales of over $2.9 billion in 2000 with approximately 14 percent of sales spent for research and development.
ACIPHEX and PARIET are registered trademarks of Eisai Co., Ltd.