TOKYO, July 2, 2018 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) today announced that it has received an approval for the marketing application of Dafclir® Tablets (generic name: fidaxomicin) for the treatment of infectious enteritis (including pseudomembranous colitis1) (susceptible strains: fidaxomicin susceptible Clostridium difficile (CD)2) in Japan. 

Dafclir® is an oral macrocyclic antimicrobial agent3 with a new mechanism of action and a selective antibacterial spectrum licensed from Merck & Co., Inc., known as MSD outside the U.S. and Canada (“Merck”). Astellas has developed the product in Japan based on an exclusive development and marketing agreement with Merck. In addition, our subsidiary Astellas Pharma Europe Ltd. has acquired exclusive license for the development and commercialization in Europe, where it is already being marketed as a CD infection treatment, and additional countries in the Middle East, Africa and the Commonwealth of Independent States (CIS)4.

CD, a bacterium that infects large intestine and produces toxins, causes nosocomial infections and antibacterial agent-associated colitis worldwide. Infection and proliferation result in colitis and severe diarrhea and in the most serious cases death. As difficulty in treatment of infectious enteritis caused by CD with the currently available pharmaceutical products, mainly due to the recurrence, has been reported in Japan, new treatment options have been needed.  Besides its potent antibacterial activity against CD, due to its narrow antibacterial spectrum, it minimally disrupts the balance of intestinal flora, and it inhibits spore formation5

Astellas will contribute to the advancement of the treatments of infectious enteritis caused by CD in Japan by providing Dafclir® as a new therapeutic option.

Astellas reflected the impact from this approval in its financial forecasts of the current fiscal year ending March 31, 2019.

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