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July 4, 2014

Topical Combination Drug Dovobet® Ointment Approved to Treat Psoriasis Vulgaris

Tokyo, Japan, July 4, 2014 --- Kyowa Hakko Kirin Co., Ltd. (headquarters: Chiyoda-ku, Tokyo; President and CEO: Nobuo Hanai; "Kyowa Hakko Kirin") announced today that LEO Pharma K.K. (headquarters: Chiyoda-ku, Tokyo; General Manager and Japan Representative Director: Stefan Sakurai; "LEO Pharma K.K.") obtained Japanese manufacturing and marketing approval on July 4, 2014 for Dovobet® Ointment to treat psoriasis vulgaris.

Dovobet® Ointment is a topical combination of active vitamin D3 calcipotriol and the corticosteroid betamethasone dipropionate. LEO Pharma K.K. filed an application for approval to the Ministry of Health, Labour and Welfare (MHLW) in August 2013.

Psoriasis is a chronic and intractable skin disease that affects one or two in every 1,000 people in Japan. Psoriasis can be treated using topical preparations, such as active vitamin D3 and steroids, phototherapy, or oral medications. Recently, biological products have been developed to treat patients with severe psoriasis. However, the majority of psoriasis patients are mild or moderate in severity, so topical methods like active vitamin D3 and steroids are the most common form of treatment, using single agents, combination use of two agents, and mixed preparations. Improved efficacy and increased patient convenience have been expected of topical products used for the treatment of psoriasis.
Dovobet® Ointment will be the first topical combination of active vitamin D3 and a corticosteroid to be available in Japan that can be applied once daily to rapidly improve the dermatological symptoms of psoriasis. This Ointment was approved for the indication of psoriasis vulgaris following clinical studies in Japan that demonstrated the efficacy and safety. Compared with conventional topical agents used to treat psoriasis vulgaris, this Ointment will offer increased efficacy and patient convenience in the treatment of psoriasis vulgaris, thus offering a new and highly satisfactory therapeutic option for patients with this disease.

Dovobet® Ointment was developed by LEO Pharma K.K.'s parent company LEO Pharma A/S (headquarters: Ballerup, Denmark; President and CEO: Gitte P. Aabo) and was launched in Denmark in 2001 as a topical agent to treat psoriasis vulgaris. This Ointment has since been approved in 97 countries worldwide, including the US, and is widely used as one of the first-line therapy for psoriasis vulgaris.

Kyowa Hakko Kirin entered into a distribution and co-promotion agreement for Dovobet® Ointment with LEO Pharma K.K. and LEO Pharma A/S on December 19, 2013. Under the agreement, LEO Pharma K.K. is responsible for supplying the product to Kyowa Hakko Kirin. Kyowa Hakko Kirin is responsible for distribution and product detailing by Medical Representatives (MRs). Both companies will jointly conduct marketing activities.

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.

Dovobet® Ointment Product Summary

Product name Dovobet® Ointment
Nonproprietary name Calcipotriol hydrate/betamethasone dipropionate
Composition 1g contains 52.2μg calcipotriol hydrate (as 50.0μg calcipotriol), 0.643mg betamethasone dipropionate
Indication Psoriasis vulgaris
Dose and administration Usually applied once daily in the required amount to the affected site
Precautions related to the dosage and administration Do not use more than 90g in 1 week
Packaging Tube: 15g x 1, 15g x 10, 30g x 1
Approval date July 4, 2014
Distributed by Kyowa Hakko Kirin Co., Ltd.
Marketing authorization holder LEO Pharma K.K.


Kyowa Hakko Kirin
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