To Whom It May Concern
KYORIN Co.,LtdApproval for an additional regimen and dose of Pentasa®for the treatment of ulcerative colitis inits active phase.

Tokyo－December 24,2008,KYORIN Co., Ltd. announces that its wholly owned subsidiary, KYORIN
Pharmaceutical Co., Ltd.(Headquarters :Tokyo, President :Itaru Kojo) obtained approval for anadditional regimen and dose (4,000 mg divided into two doses per day) of Pentasa® Tablets 250 andPentasa® Tablets 500 (generic name: mesalazine) for the treatment of ulcerative colitis in its activephase. These products are intended for the treatment of ulcerative colitis and Crohn’s disease.
Inflammatory bowel diseases (ulcerative colitis and Crohn’s disease) are intractable diseases thathinder social interaction, causing frequent diarrhea and melena. The causes have not been identified andthere is no radical treatment. Therefore, the therapeutic goals are suppressing symptoms in the active
phase, alleviating the symptoms and keeping the symptoms in a relieved state with the use of mesalazine
drugs like Pentasa and steroids.
In adult patients with less-severe ulcerative colitis, 1,500 mg is usually divided into three post-mealoral doses per day. The upper limit of the daily dose was 2,250 mg. The validity of the daily dose of
4,000 mg has been verified overseas. Based on this fact, KYORIN Pharmaceutical Co., Ltd. decided todevelop the above regimen and dose with the aim of giving new remission therapy to patients who had toswitch to steroids or other treatments because of their active-phase disease and the difficulty incontrolling their symptoms with the conventional upper dose limit. The new regimen and dose were also
intended to provide patients with greater convenience.
A domestic dose-comparison study on active-phase ulcerative colitis in adults showed a significant
difference between patients receiving 4,000 mg and those receiving 2,250 mg in the degree of
improvement of the UC-DAI score*, an important laboratory parameter.
By obtaining approval of the addition, KYORIN Pharmaceutical Co., Ltd. will continue to contributeto the treatment of ulcerative colitis and increase the clinical value of Pentasa®.
＊UC-DAI score
UC : ulcerative colitis
DAI score : disease activity index score
Frequency of bowel evacuation, blood in stool, endoscopic findings of mucous membranes and doctor’s overall
evaluation are each rated at one of four levels, 0 to 3. The sum of the numbers is the DAI score (0-12).

For further information, contact:
KYORIN Co.,Ltd
Management Planning Department
Telephone:+81-3-3293-3414
Fax:+81-3-3293-3454

Products Profile
1.Brand namePentasa® Tablets 250

Pentasa® Tablets 500

2.Nonproprietary name

Mesalazine

3.Indication

Ulcerative colitis (excluding severe cases) and Crohn’s disease

4.Dosageand Administration

Ulcerative Colitis
Normally, for adult patients, a daily dose of 1,500 mg is divided into threedoses and is administered orally after meals. The dose may be decreased orincreased according to the age and symptoms while the upper limit is2,250 mg per day.
In an active phase, however, 4,000 mg can be divided into two doses per
day if required.
Normally, for infant patients, a daily dose of 30 to 60 mg/kg of mesalazine
is divided into three doses and administered orally after meals. The dose
may be decreased or increased according to the age and symptoms whilethe upper limit is 2,250 mg per day.
Crohn’s Disease
Normally, for adult patients, a daily dose of 1,500-3,000 mg is divided into
three doses and is administered 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 and administered orally after meals. The dose
may be decreased or increased according to the age and symptoms.
Precautions for use regarding regimen and dose
1. The increase of the daily dose to 4,000 mg must be limited to patientswith ulcerative colitis that is moderate and categorized as arelapse/remission type, not a proctitis type.
2. Neither the efficacy nor safety of administering 4,000 mg/day for eightweeks has been established. Stay sufficiently updated on the patient’s
condition and avoid unnecessarily allowing the daily dose of 4,000 mg

5.NHI priceto be continued.
￥59.40 per tablet￥118.80 per tablet

6.Packaging

PTP 100,500 tablets

PTP 100 tablets

Reference:
1.Bland namePentasa® Enema 1g

2.Indications

Ulcerative colitis (excluding severe cases)

3.Dosageand Administration
4.NHI priceNormally, for adult patients, a bottle (1 g mesalazine) as a daily dose isinjected through the rectal route. The dose may be decreased according tothe age and symptoms.
￥872.90 per bottle (1g)

6.Packaging

100 ml ×7