Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that Moizerto^® Ointment (difamilast) has received manufacturing and marketing approval in Japan for the indication of adult and pediatric (two years of age and older) atopic dermatitis.

Moizerto Ointment, in 1% and 0.3% formulations, is a non-steroidal topical phosphodiesterase type 4 inhibitor (PDE4 inhibitor). Moizerto Ointment was discovered by Otsuka in our Tokushima Research Institute and is the first topical PDE4 inhibitor approved in Japan for the treatment of atopic dermatitis.

PDE4 inhibitors improve the signs and symptoms of atopic dermatitis through suppression of the production of chemical mediators such as pro-inflammatory cytokines and through other anti-inflammatory effects.

There are approximately 4.34 million people in Japan who have been diagnosed with atopic dermatitis, a number which is steadily increasing.* There has been a need for an anti-pruritic, anti-inflammatory topical medication that is safe for longer-term use, tolerable, and able to be applied to pediatric skin, and sensitive skin areas. Otsuka expects that Moizerto Ointment, with its novel mechanism of action, will serve as a new treatment option for atopic dermatitis patients in Japan.

Otsuka entered into a licensing agreement with Medimetriks Pharmaceuticals, Inc. in 2016 which granted Medimetriks development, marketing, and manufacturing rights for difamilast in the United States.