Policy & Regulation
LEO Pharma A/S Acquires Rights to Develop and Market brodalumab for Moderate-to-Severe Psoriasis Outside of Europe
14 August 2019 - - Danish drugmaker LEO Pharma A/S has acquired the exclusive rights to develop and market brodalumab (marketed as Kyntheum in the European Union) for the treatment of moderate-to-severe psoriasis outside of Europe through a new sub-licencing agreement with Bausch Health Ireland Ltd., the company said.

The new agreement includes countries with significantly high unmet need, such as Australia, Brazil, Egypt, Mexico, Russia and Saudi Arabia.

This complements the ongoing licensing agreement between LEO Pharma A/S and AstraZeneca to develop and market brodalumab for the treatment of moderate-to-severe psoriasis in Europe.

To date, LEO Pharma A/S has successfully launched brodalumab in 18 countries. Outside of the EU, Bausch Health Companies Inc. through a licensing agreement with AstraZeneca, has owned the global commercial rights for brodalumab except in Japan and other Asian countries, where the rights are owned by Kyowa Kirin Co., Ltd.

Under the new arrangement terms, Bausch Health has granted LEO Pharma A/S an exclusive license to its global rights to brodalumab but continues to hold the rights for the US and Canada.

Brodalumab received marketing authorisation by the European Commission in July 2017 and is currently indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.

An estimated 125 m people worldwide live with psoriasis. It is a common, chronic, immune-mediated, inflammatory disease that primarily involves the skin.

The most frequently reported symptoms include thickening and scaling of the skin, itching and erythema (superficial reddening of the skin, usually in patches).

Psoriasis can be a painful, disabling and stigmatising condition with substantial social and psychological impact on a person's life.

People with psoriasis, especially those with more severe symptoms, are also at increased risk of developing other serious associated conditions, including heart disease and metabolic diseases (a combination of diabetes, high blood pressure and obesity).

Mental health complications, such as depression and anxiety, are also more common in people with psoriasis.

According to the World Health Organization, the burden of living with psoriasis is underestimated and it urges for action to fight stigma and improve treatment.

LEO Pharma helps people achieve healthy skin. The company is in medical dermatology with a robust R and D pipeline, a wide range of therapies and a pioneering spirit.

Founded in 1908 and owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, setting new standards of care for people with skin conditions.

LEO Pharma is headquartered in Denmark with a global team of 5,500 people, serving 76m patients in 130 countries.

In 2018, the company generated net sales of DKK 10,410m.