Mochida files MD-0901 for approval for ulcerative colitis in Japan

4 November 2015

Mochida Pharmaceutical (TYO: 4534) has filed a New Drug Application for MD-0901, for the treatment of patients with ulcerative colitis with the Japanese Ministry of Health, Labor and Welfare (MHLW).

MD-0901 is once-daily oral formulation of mesalazine (5-aminosalicylic acid, 5-ASA), which is designed to release the medication to and throughout the colon (the site of the inflammation in ulcerative colitis). It has been approved in 37 countries since 2007, when it was first launched with its brand name Lialda in the USA.

Mochida has developed MD-0901 in Japan under a license agreement with Ireland-headquartered Shire (LSE: SHP). Lialda generated sales of $176.6 million for Shire in the third quarter of this year.

Ulcerative colitis is an intractable disease with the repetition of remissions and exacerbation. The number of ulcerative colitis patients in Japan is estimated to be 150,000 or more.
Mochida will make the utmost effort to obtain the approval for MD-0901 and contribute to supporting patients with ulcerative colitis in Japan.

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