News Release

Partnership Agreement for a Gel Formulation of Dovobet® in Japan: Treatment for Psoriasis Vulgaris

June 22, 2017

Notice: This press release is an English translation of the original Japanese version.

Tokyo, Japan – June 22, 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") announce that the three companies entered into a distribution and co-promotion agreement on June 21, 2017 for a gel formulation of Dovobet®, which is a new form of Dovobet® in Japan. LEO Pharma K.K. has filed an application for the manufacturing and marketing approval of this product for psoriasis vulgaris in Japan.

Dovobet® is 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, including the U.S., since being launched in Denmark in 2001 as a topical drug for psoriasis vulgaris, and is widely used as a first-line treatment for psoriasis. Dovobet® Ointment was launched in Japan in September 2014. From which time LEO Pharma K.K. and Kyowa Hakko Kirin have been jointly conducting marketing activities.

A gel formulation of Dovobet® has already been approved in more than 80 countries since being launched in the U.S. in 2008. LEO Pharma K.K. recently filed for the manufacturing and marketing approval of a gel formulation of Dovobet® in Japan as a treatment for psoriasis vulgaris. The gel formulation is easier to apply to the scalp, which is one of the most frequently affected sites in patients with psoriasis, and greater convenience is expected to improve adherence to treatment. Thus, making the gel formulation product available in addition to the conventional ointment should contribute to improving the quality of life for patients with psoriasis.

Under the agreement reached by the three companies, similar to "Dovobet® Ointment", 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.

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.

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.

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 adherence
Adherence refers to whether patients take their medications as prescribed.
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.
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About LEO Pharma A/S
LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions. Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions. LEO Pharma A/S is headquartered in Denmark and employs around 5,000 people worldwide.
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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.
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