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News Release

FOR IMMEDIATE RELEASE
September 3, 2001

PARIET* (RABEPRAZOLE) RECEIVES APPROVAL FOR
THE TREATMENT OF SYMPTOMATIC GORD
IN THE EUROPEAN UNION



PARIET* (RABEPRAZOLE) RECEIVES APPROVAL FOR
THE TREATMENT OF SYMPTOMATIC GORD
IN THE EUROPEAN UNION

Eisai Co., Ltd.
Janssen-Cilag Ltd.

September 3, 2001, Tokyo, Japan, and London, U.K. Pariet* (rabeprazole), a proton pump inhibitor, received regulatory approval for the symptomatic treatment of moderate to very severe gastro-oesophageal reflux disease (Symptomatic GORD) within the European Union via the Mutual Recognition Procedure.


Pariet* is currently widely used for the treatment of (erosive) GORD. This license extension means that Pariet* 10mg once daily can now be used in the symptomatic treatment of patients with moderate to very severe symptoms of GORD. Symptomatic GORD is defined as the presence of reflux symptoms, primarily heartburn, in patients who do not have oesophagitis (oesophageal erosion). In Europe, Pariet is co-promoted by Eisai and Janssen-Cilag in Germany and the U.K. and by Janssen-Cilag in all other European Countries.


Heartburn is the most common symptom of GORD and prevalence rates in the adult population of the Western world are estimated to range from 20-49%1. Only one third of patients with heartburn actually develop erosive GORD2,3, which suggests that the majority of patients with symptoms of GORD have normal oesophageal mucosa. Thus patients who suffer from non erosive GORD would benefit from fast and effective heartburn relief.



For further information please contact:

Eisai Public Relations Department
Eisai Co., Ltd.
+81 3 3817 5120
Siegfried Marynissen,
Global Pharmaceutical Communications
Johnson & Johnson
+32 14 60 54 09

Claire Olivier
Burson-Marsteller
+44 20 7300 62 94



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.
Further information on Eisai can be found at http://www.eisai.co.jp


Janssen Pharmaceutica N.V. is a wholly owned subsidiary of Johnson & Johnson, the world's most comprehensive manufacturer of healthcare products and related services. Known as Janssen-Cilag in most countries, Janssen is a leader in the research and development of therapies for gastrointestinal disorders with 32 affiliates worldwide. Other areas of research focus include analgesia, neurology and psychiatry.
Further information on Janssen-Cilag can be found at: http://www.janssen-cilag.com


Notes  
  Symptomatic GORD is also sometimes referred to as non erosive reflux disease. In Europe, Pariet* is currently indicated for the treatment of:
Active duodenal ulcers
Active benign gastric ulcers
Symptomatic erosive or ulcerative GORD
GORD maintenance
  And, when used in combination with appropriate antibacterial treatments, for the:
Eradication of H. pylori in patients with peptic ulcer disease

Rabeprazole sodium was discovered by Eisai Co., Ltd. Janssen Pharmaceutica N.V. and Eisai Co., Ltd. have a strategic alliance in which Eisai and Janssen-Cilag co-promote the drug in Germany and the U.K. In the US rabeprazole sodium is co-promoted under the brand name AcipHex(R) by Eisai Inc. and Janssen Pharmaceutica Inc. Pariet* is available through Janssen-Cilag in most other countries excluding Japan and some Asian countries.


Eisai Ltd. in the U.K. submitted a Type II variation application for Pariet* to the MCA in March 2001. Eisai Inc. recently submitted a supplemental New Drug Application (sNDA) for AcipHex(R) to the U.S. Food and Drug Administration for the treatment of symptomatic gastroesophageal reflux disease (GERD, also known as GORD in Europe).


* Pariet*/Aciphex(R) are trademarks of Eisai Co., Ltd., Tokyo, Japan.



References
1) Talley, NJ. Presentation made at an international workshop: Gastroenterology into the next Millennium. 13 March 1999; Madrid, Spain.
2) Dent, J. Gastro-esophageal reflux disease. Digestion. 1998; 59: 433-445.
3) Carlsson R, Dent J, Watts R et al. Gastro-esophageal reflux disease in primary care: an international study of different treatment strategies with omeprazole. Euro J Gastroenterol Hepatol. 1998; 10: 119-124.