Osaka and Tokyo (Japan), July 7, 2017 – Maruho Co., Ltd (“Maruho”, Head Office: Osaka, Japan, President and CEO: Koichi Takagi) and Astellas Pharma Inc. (“Astellas”; Head Office: Tokyo, President and CEO: Yoshihiko Hatanaka) announce that from October 1, 2017, Maruho will succeed the marketing approval in Japan from Astellas, for anti-atopic dermatitis agent Protopic® Ointment 0.1% and Protopic® Ointment 0.03% for Pediatric (INN: tacrolimus hydrate, hereinafter referred to as “Protopic® Ointment”).

Protopic® Ointment was first approved in Japan in June 1999 with its anti-inflammatory action as a therapeutic agent for atopic dermatitis and launched in Japan in November 1999 by Fujisawa Pharmaceutical Co., Ltd. (currently Astellas). It is currently used in over 75 countries worldwide*. Maruho was assigned detailing/promotional activities in Japan for Protopic® Ointment in April 2011. Distribution rights in Japan for Protopic® Ointment were transferred to Maruho in April 2014. From October 2017, Maruho will provide and collect information as the manufacturer and distributor of Protopic® Ointment in Japan and will ensure a stable supply of this product.
*Transferred to LEO Pharma A/S outside Japan


As a pharmaceutical company specializing in dermatology, Maruho hopes to further contribute to patients suffering from atopic dermatitis through the succession of marketing approval for Protopic® Ointment.

About Protopic® Ointment
Protopic® Ointment (INN: tacrolimus hydrate) is a topical treatment for atopic dermatitis with a mechanism of action different from topical steroids. Protopic® Ointment 0.1% was approved in 1999 and Protopic® Ointment 0.03% for Pediatric was approved in 2003. Protopic® Ointment is used in more than 75 countries worldwide.

About Astellas
Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. We focus on Urology, Oncology, Immunology, Nephrology and Neuroscience as prioritized therapeutic areas while advancing new therapeutic areas and discovery research leveraging new technologies/modalities. We are also creating new value by combining internal capabilities and external expertise in the medical/healthcare business. Astellas is on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at www.astellas.com.

About Maruho
Maruho Co., Ltd. has its headquarters in Osaka and leads Japan in research and development, manufacturing and commercialization of dermatological products. Founded in 1915, Maruho has 1,398 employees (as of the end of September 2016), and net sales were approximately 70.1 billion yen in its 2016 fiscal year. Pursuing its long-term corporate vision of “Excellence in Dermatology,” Maruho is striving to improve the health and quality of life of people all over the world.
For more information, please visit www.maruho.co.jp/english

Contact Information:
Maruho Co., Ltd. Corporate Communications Dept.
TEL:: +81-(0)6-6371-8831  FAX: +81-(0)6-6376-8679
HP: https://www.maruho.co.jp/english

Astellas Pharma Inc. Corporate Communications
TEL: +81-(0)3-3244-3201  FAX: +81-(0)3-5201-7473
HP: https://www.astellas.com