EISAI'S U.S. SUBSIDIARY RECEIVES FDA MARKETING CLEARANCE FOR ACIPHEX A PROTON PUMP INHIBITOR
Tokyo (August 20, 1999) - Eisai Co., Ltd. of Tokyo (President and CEO: Haruo Naito) today announced that the company's U.S. pharmaceutical subsidiary, Eisai Inc., has received marketing clearance from the U.S. Food and Drug Administration for ACIPHEX (generic name: rabeprazole sodium; Eisai Research Code Number: E3810), a proton pump inhibitor, for the healing of duodenal ulcers, the healing of erosive gastroesophageal reflux disease (GERD), the maintenance of healed erosive GERD, and the treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
ACIPHEX is classified as a proton pump inhibitor and demonstrates strong proton pump inhibition at the final stage of acid secretion by blocking the function of the enzyme responsible for stomach acid production. ACIPHEX is available as 20 mg. enteric-coated tablets prescribed once daily for the healing and symptom relief of duodenal ulcers and erosive gastroesophageal reflux disease (GERD).
ACIPHEX was synthesized by Eisai and developed in Japan, the U.S., and Europe. A marketing application was filed with the U. S. Food and Drug Administration in March 1998. In Europe, the product has been approved by all 15 EU member countries and is marketed under the brand name PARIET in Japan, the U.K., and Germany. A copromotion alliance with Janssen Pharmaceutica exists for product sales in the U.S., U.K., and Germany.
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 $2.3 billion in 1998 with greater than 15 percent of sales spent for research and development.
ACIPHEX is a trademark of Eisai Co., Ltd.