March, 3,2008
To Whom It May Concern
Kyorin Co., Ltd.
Nisshin Kyorin Pharmaceutical Co., Ltd.
Pentasa® Tablets 250 Received Approvals For Additional Pediatric Indication
Nisshin Kyorin Pharmaceutical Co., Ltd. that had approval for manufacturing andmarketing of Pentasa acquired pediatric indication for Pentasa® Tablets 250 (genericname: mesalazine) on February 29.
Pentasa is a therapy for ulcerative colitis and Crohn’s disease that is currently
distributed by Kyorin Pharmaceutical Co., Ltd. (Tokyo; President: Ikuo Ogihara),
subsidiaries of Kyorin Co., Ltd. and Nisshin Kyorin Pharmaceutical Co., Ltd. (Tokyo;President: Takashi Matsuda)
Nisshin Kyorin Pharmaceuticals Co., Ltd. conducted clinical trials in Japan for the drug
developed by Ferring (Switzerland). Pentasa was designated as an orphan drug inNovember 1993 and was approved for manufacturing and marketing as an agent for
ulcerative colitis and Crohn’s disease in April 1996. Kyorin Pharmaceutical Co., Ltd.
and Nisshin Kyorin Pharmaceutical Co., Ltd. marketed the drug in July 1996. Since
then, the companies have contributed to the treatment of ulcerative colitis and Crohn’sdisease. Approval for pediatric indication will further satisfy the need for treatment ofinflammatory bowel diseases.
Inflammatory bowel diseases (ulcerative colitis and Crohn’s disease) are intractablediseases that hinder social interaction, causing frequent diarrhea and melena. The causes
have not been identified and there is no basic remedy. Therefore, therapeutic goals aresuppressing symptoms in the active phase, alleviating the symptoms and keeping thesymptoms in the relieved state with the use of Pentasa and other mesalazine drugs andsteroids. In addition, it has been hoped that added indications in pediatrics would beprovided because inflammatory bowel diseases occur even in childhood, affecting
children’s growth and learning.
Pentasa has extensive use experience in other countries: the indication for the drug for
ulcerative colitis in adults has already been approved in 43 countries, and for Crohn’sdisease in 39 countries, and the indication for inflammatory bowel diseases in infants
has been approved in 20 countries.

The profile of Pentasa® Tablets 250 is as follows:(1) A preparation made from 5-aminosalicylate (5-ASA)(2) A release-controlled preparation coated with ethylcellulose
Kyorin Pharmaceutical Co., Ltd. and Nisshin Kyorin Pharmaceutical Co., Ltd. willcontinue to contribute to the treatment of inflammatory enteric diseases by continuously
providing the latest information on Pentasa and inflammatory bowel diseases.
For further information, contact:
KYORIN Co., Ltd.
Management Planning Department
Telephone: +81-3-3293-3414
Nisshin Kyorin Pharmaceutical Co., Ltd.
Management Planning Division
Telephone: +81-3-5259-1461

Products Profile
1. Brand namePentasa® Tablets 250

2. Nonproprietary nameMesalazine

3. Indication

Ulcerative colitis (excluding severe cases) and Crohn’sdisease

4. Dosage andAdministration

Ulcerative Colitis
Normally, for adult patients, the daily dose of 1500 mg is
divided into three doses and is administered orally aftermeals. The dose may be decreased or increased
according to the age and symptoms while the upper limit
is 2250 mg per day.
Normally, for infant patients, a daily dose of 30 to 60
mg/kg of mesalazine is divided into three doses andadministered orally after meals. The dose may bedecreased or increased according to the age andsymptoms while the upper limit is 2250 mg per day.

Crohn’s Disease
Normally, for adult patients, a daily dose of 1500-3000
mg of mesalazine is divided into three doses andadministered orally after meals. The dose may bedecreased according to the age and symptoms.
Normally, for infant patients, a daily dose of 40 to 60
mg/kg of mesalazine is divided into three doses andadministered orally after meals. The dose may bedecreased or increased according to the age andsymptoms.
5. NHI price¥61.50 per tablet

6. Packaging

PTP 100,500 tablets

Reference:
1. Brand namePentasa® Enema 1g

2. Indications

Ulcerative colitis (excluding severe cases)

3 Dosage andAdministration

Normally, for adult patients, a bottle (1 g mesalazine) asa daily dose is injected through a rectal route. The dose
may be decreased according to the age and symptoms.

4. NHI price¥902.80. per bottle (1 g)

5. Packaging

100 ml x 7