Tokyo (January 16, 2002) - Eisai Co., Ltd. of Tokyo (President and CEO: Haruo Naito) announced that Eisai's U.S. pharmaceuticals subsidiary, Eisai Inc. (President: William Sheldon), has filed a marketing application with the U.S. Food and Drug Administration for a new indication of ACIPHEX, a proton pump inhibitor, for H. pylori eradication.
The application of the new indication for the treatment of peptic ulcer disease involves the usage of ACIPHEX in combination with appropriate antibiotics to eradicate H. pylori. H. pylori is a bacteria that exists in the lining of the stomach and is a cause of gastric and duodenal ulcers.
ACIPHEX is classified as a proton pump inhibitor and demonstrates strong proton pump inhibition at the final stage of acid secretion. ACIPHEX is currently 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. In addition, an application for the treatment of symptomatic GERD is currently under review by the FDA.
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. As of October 2001, ACIPHEX/PARIET had 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 is a registered trademark of Eisai Co., Ltd.
PARIET is a registered trademark of Eisai Co., Ltd.