Astellas Pharma : Launch of LINZESS® Tablets 0.25mg in Japan

Tokyo, March 22, 2017 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, 'Astellas') announced that it launched a guanylate cyclase-C (GC-C) receptor agonist, LINZESS Tablets (generic name: linaclotide, 'LINZESS') for irritable bowel syndrome with constipation ('IBS-C') in Japan today.

IBS-C is a functional but not organic disorder which is characterized by abdominal pain and/or discomfort along with abnormal defecation. These gastrointestinal symptoms persist for a long period with frequent remissions and exacerbations.

LINZESS locally binds to the GC-C receptor expressed on the intestinal epithelium. Activation of the GC-C receptor results in improved visceral hypersensitivity, increased intestinal fluid secretion and accelerated intestinal transit. It is estimated that 2.9% of adults in Japan suffer from IBS-C , and, until today, there were no prescription products available in Japan for the treatment of this indication.

Astellas entered into a license agreement with Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD, CEO: Peter Hecht, Ph.D.) in 2009 and was granted exclusive rights to develop and commercialize linaclotide in Japan. Astellas obtained marketing approval for LINZESSin Japan in December 2016 for patients with IBS-C.

Astellas expects that the launch of LINZESS will help patients in Japan who are suffering from IBS-C by providing a new therapeutic option.

Kubo M, Fujiwara Y, Shiba M, Kohata Y, Yamagami H, Tanigawa T, et al. Differences between risk factors among irritable bowel syndrome subtypes in Japanese adults. Neurogastroenterol Motil. 2011;23:249-54.

Brand Name: LINZESS Tablet 0.25 mg

Generic Name: linaclotide

Dosage Form/Content: Tablet containing 0.25 mg of linaclotide

Indication: Irritable bowel syndrome with constipation

Precautions with related to indication:

Application of this drug should be considered for adult patients whose symptom has not improved after dietary guidance and lifestyle guidance as the basics of the treatment for irritable bowel syndrome with constipation are provided.

Dosage and Administration:

The usual adult dosage is 0.5 mg as linaclotide taken orally once daily before eating.

The dosage may be reduced to 0.25 mg depending on the symptoms.

Precautions with related to dosage and administration:

Since occurrence of severe diarrhea is possible, investigators are instructed to evaluate patients' symptoms periodically so that continuous administration of this drug will not be done unthinkingly.