Partnership Agreement for a Gel Formulation of betamethasone dipropionate in Japan: Treatment for Psoriasis Vulgaris

TOKYO, Japan, 22 June 2017 - LEO Pharma K.K. (Headquarters: Chiyoda-ku, Tokyo; President, Japan Representative Director: Stefan Sakurai), LEO Pharma K.K.’s parent company LEO Pharma A/S (Head office: Ballerup, Denmark; President & CEO: Gitte P. Aabo), and Kyowa Hakko Kirin Co., Ltd. (Headquarters: Chiyoda-ku, Tokyo; President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") are pleased to announce that the three companies entered into a distribution and co-promotion agreement on 21 June 2017 for a gel formulation of betamethasone dipropionate. LEO Pharma K.K. has filed an application for the manufacturing and marketing approval of this product for psoriasis vulgaris in Japan.

The agreement covers a fixed dose combination of a topical product containing calcipotriol hydrate (active vitamin D3) and betamethasone dipropionate (a steroid), which has been approved in more than 90 countries worldwide, including the U.S., since being launched in Denmark in 2001. This product was launched in Japan in September 2014, and LEO Pharma K.K. and Kyowa Hakko Kirin have been jointly conducting marketing activities since then.

Under the agreement reached by the three companies, LEO Pharma K.K. is responsible for supplying the product after obtaining marketing approval, while Kyowa Hakko Kirin is responsible for product distribution and provision of information to healthcare institutions by Medical Representatives (MRs). Both companies will jointly conduct marketing activities. Kyowa Hakko Kirin will share profits with LEO Pharma K.K. and will also pay milestone payments depending on sales.

LEO Pharma A/S is a world leader in topical psoriasis treatment and has significantly expanded its portfolio over recent years to cover several dermatology indications. This is thanks to the recent transfer of a global dermatology business from Astellas Pharma.

The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

About psoriasis vulgaris
Psoriasis is a chronic skin disorder. Typical symptoms include systemic erythema with clearly demarcated lesions, induration and hyperplasia inducing silver white plaques on the skin. Itching, inflammatory arthritis and abnormal nail morphology may also manifest.

About LEO Pharma K.K.
LEO Pharma K.K. was established in June 2010 as the wholly owned Japanese subsidiary of LEO Pharma A/S in Denmark. The company aims to establish a solid position as a specialty pharmaceutical company in Japan with expertise in the field of dermatology. For more information, visit www.leo-pharma.jp.

About Kyowa Hakko Kirin
Kyowa Hakko Kirin Co., Ltd. is a research-based life sciences company, with special strengths in biotechnologies. In the core therapeutic areas of oncology, nephrology and immunology/ allergy, Kyowa Hakko Kirin leverages leading-edge biotechnologies centred on antibody technologies, to continually discover innovative new drugs and to develop and market those drugs world-wide. In this way, the company is working to realise its vision of becoming a Japan-based global specialty pharmaceutical company that contributes to the health and wellbeing of people around the world. You can learn more about the business at: www.kyowa-kirin.com.

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