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News Release

FOR IMMEDIATE RELEASE
July 18, 2003

PARIET (R) 10 mg Receives Approval for
Maintenance Therapy for Gastroesophageal Reflux Disease

Eisai Co. Ltd. (Headquarters: Tokyo, President: Haruo Naito) received on July 18 an approval letter from the Ministry of Health, Labor and Welfare in Japan for PARIET R 10 mg tablets, a proton pump inhibitor, as a maintenance therapy for gastroesophageal reflux disease (GERD). PARIET R10 mg is already approved for GERD treatment, but its period of administration has been limited to eight weeks. With this approval, PARIET R 10 mg may be administered for more than eight weeks as maintenance therapy for recurrent GERD. In the U.S. and Europe, the product (ACIPHEX R in the U.S.) is already approved for GERD maintenance therapy.


In gastroesophageal reflux disease, reflux of acidic stomach contents results in erosion and ulceration of the esophageal mucosa causing symptoms such as frequent heartburn, and dyspepsia. Even after successful therapy, recurrence is common, thus appropriate maintenance therapy is necessary. As the Japanese population ages and their diet becomes more westernized, the number of patients with GERD has increased. Therefore, maintenance therapy for this disease will become even more important in the future.


Since its establishment, Eisai has been committed to developing drugs in the area of gastroenterology among other specialties. The company hopes to contribute further to the treatment of acid-related diseases with this approval.


PARIET R was first launched in Japan in 1997, in Europe in 1998, and in the U.S. in 1999 under the trade name ACIPHEX R . Currently, the product has been launched in 70 countries worldwide.



[Contents of the approval and an explanation of terms are below]

[Description of the Approval]
Product name : PARIET R 10 mg
Dosage and Administration: Gastroesophageal reflux disease (GERD)
In routine cases, 10 mg, and in special cases 20 mg, of sodium rabeprazole is orally administered once daily for an adult. Generally, the treatment term is limited to eight weeks. In maintenance therapy for recurring GERD, 10 mg is orally administered once a day.
[Characteristics of PARIET R 10 mg]
PARIET R 10 mg demonstrated quick and reliable blocking of acid secretion in clinical studies. In the newly approved maintenance therapy for recurring GERD , the daily dosage for both treatment and maintenance is 10 mg, and treated patients can shift to maintenance therapy without changing the dose.
 
[Explanation of Terms]
1. Maintenance Therapy of Gastroesophageal Reflux Disease (GERD)
GERD often recurs when medicinal treatment is interrupted. Therefore, continued administration of medicine is effective to control recurrence even after the treatment is completed. Maintenance therapy will contribute to an improvement in quality of life (QOL) of GERD patients.
2. Gastroesophageal Reflux Disease (GERD)
GERD occurs when acidic stomach contents such as stomach acid make their way from the stomach into the esophagus and damage the esophageal mucosa. In recent years, the number of GERD cases has been increasing along with an increase in factors which cause acid reflux, such as acid hypersecretion, loosening of the esophageal sphincter at the opening of the stomach because of high fat meals or aging, and high abdominal pressure caused by obesity. Heartburn during the day or night associated with GERD lowers the quality of life (QOL) of patients. Therefore, appropriate treatment is required. For GERD, a proton pump inhibitor (PPI), which directly blocks the function of the proton pump responsible for gastric acid secretion, demonstrates significant efficacy and contributes to reducing the incidence of heartburn and replenishing damaged esophageal mucosa, while suppressing acid secretion during the day and at night.

Approximately 1.2 to 2.0% of the U.S. population suffers from GERD (American Journal of Medicine and others), and a report noted that 16.3% of people undergoing upper digestive tract examination in Japan were found to be suffering from GERD (GERD Guideline Workshop Report 2002).
3. Acid-Related Diseases
Acid-related disease is a general term for several diseases of the upper digestive tract including gastroesophageal reflux disease (GERD), gastric ulcers, and duodenal ulcer. The primary treatment for these diseases is proton pump inhibitor (PPI) administration in the U.S. and Europe. In Japan PPI therapy for acid-related diseases is expected to become more prevalent in the future.

The number of potential acid-related disease cases was estimated in a report to be about 30% of the total U.S. population, and about 12% of the population in Japan. (Data Monitor, Stakeholder Perspectives: Gastrointestinal Disorders, 02/2003)