Eisai Submits NDA For Aciphex - New Drug Developed to Treat Gastroesophageal Reflux Disease (GERD) and Ulcers
April 1, 1998 - Eisai Co., Ltd. of Tokyo today announced the submission of a New Drug Application (NDA) for Aciphex (rabeprazole sodium) delayed-release tablets, a new treatment for the healing of gastroesophageal reflux disease (GERD), GERD maintenance, duodenal and gastric ulcers, and pathological hypersecretory conditions, including Zollinger-Ellison Syndrome. The NDA for Aciphex was submitted to the U.S. Food and Drug Administration by Eisai Inc., a U.S. subsidiary of Eisai Co., Ltd.
If cleared for marketing in the United States, Aciphex will be sold by Eisai Inc. and co-promoted with Janssen Pharmaceutica, a wholly owned subsidiary of Johnson & Johnson.
"For the marketing of Aciphex, Eisai wanted Janssen as a partner because of its depth of knowledge and experience in the gastrointestinal market." said Haruo Naito, President and CEO of Eisai Co., Ltd. "We look forward to working with Janssen as a partner in bringing Aciphex to the American market." Synthesized by Eisai in Japan, Aciphex is a new member of the class of compounds known as proton pump inhibitors (PPIs). PPIs can be used to treat ulcers and GERD.
GERD is a widespread disorder caused by the reflux of acid and other gastric contents into the esophagus. Prolonged esophageal contact with gastric acid can cause painful symptoms such as heartburn and complications such as erosive esophagitis (inflammation of the mucosa lining the esophagus). Because gastric acid plays a key role in the disease, GERD is also known as acid reflux disease. Zollinger-Ellison Syndrome is a condition characterized by excessive production of stomach acid, which can result in severe ulcer disease and pancreatic tumors.
"GERD is one of the most common health conditions that can interfere with people's lives," noted Bruce Given, MD, Group Vice President for Janssen Pharmaceutica. "Data from clinical trials indicate that Aciphex should be safe and effective for the treatment of GERD and the other submitted indications."
"Today's NDA submission represents many years of dedicated effort by personnel in the United States and Japan," said Mr. Naito. "We sincerely hope that Aciphex will be an important treatment for patients diagnosed with GERD, duodenal ulcers and gastric ulcers, and contribute to the advancement of human healthcare worldwide." Rabeprazole was cleared for marketing in Japan in 1997 and an application for marketing approval has been filed in the United Kingdom.
Aciphex is the second NDA submission by Eisai in the U.S. In 1996, Eisai submitted an NDA for Aricept (donepezil hydrochloride) tablets, a once-a-day treatment for mild to moderate Alzheimer's disease. Aricept, was cleared for marketing in November 1996 and is co-promoted by Eisai and Pfizer Inc.
Eisai Co., Ltd. is a research-based human health care company which discovers, develops and markets products in over 30 countries. Through its global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system. The company reported $2.3 billion in sales in 1996 with approximately 14 percent of sales spent on research and development.
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. Janssen currently markets Propulsid (cisapride), a promotility agent and has submitted an NDA for Motilium (domperidone). Other areas of focus include psychiatry, neurology, analgesia, mycology, oncology and allergy. Headquartered in Beerse, Belgium, with affiliates in 32 countries, Janssen's U.S. operations are based in Titusville, NJ.
For further information about Janssen Pharmaceutica, please contact Pamela Rasmussen at (609) 730-2986,