BALLERUP, Denmark–(BUSINESS WIRE)–LEO Pharma A/S, a global leader in medical dermatology, today announced it 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 Limited. 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.
“This new agreement underlines our commitment to expand our successful dermatology portfolio into innovative therapies and new indications,” said Catherine Mazzacco, President and CEO of LEO Pharma. “The burden of living with psoriasis is often underestimated, and we want to help patients at all stages of their condition. With the brodalumab agreement, we are bringing a new option to many more people across the globe living with psoriasis.”
Brodalumab received marketing authorization 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.1
For more information about LEO Pharma, visit www.leo-pharma.com.
NOTE TO EDITORS
An estimated 125 million people worldwide live with psoriasis.2 It is a common, chronic, immune-mediated, inflammatory disease that primarily involves the skin.3 The most frequently reported symptoms include thickening and scaling of the skin, itching and erythema (superficial reddening of the skin, usually in patches).3
Psoriasis can be a painful, disabling and stigmatising condition with substantial social and psychological impact on a person’s life.3 People with psoriasis, especially those with more severe symptoms, are also at increased risk of developing other serious associated conditions,4 including heart disease5,6,7 and metabolic diseases (a combination of diabetes, high blood pressure and obesity).8 Mental health complications, such as depression and anxiety, are also more common in people with psoriasis.9 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.3
About LEO Pharma
LEO Pharma helps people achieve healthy skin. The company is a leader in medical dermatology with a robust R&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 76 million patients in 130 countries. In 2018, the company generated net sales of DKK 10,410 million.
1 European Commission, Community register of medicinal products for human use, Kyntheum (brodalumab). Available at: http://ec.europa.eu/health/documents/community-register/html/h1155.htm (Accessed March 2019).
2 The International Federation of Psoriasis Associations. Available at: https://ifpa-pso.com/ (Accessed March 2019).
3World Health Organization (WHO). Global Report on Psoriasis. Available at: http://apps.who.int/iris/bitstream/10665/204417/1/9789241565189_eng.pdf (Accessed March 2019).
4 Reich K. Eur Acad Dermatol Venereol 2012;26(2):3–11.
5 Gelfand JM, et al. JAMA 2006;296:1735–41.
6 Ahlehoff O, et al. Eur Heart J 2012;33:2054–64.
7 Lowes MA, et al. Ann Rev Immunol 2014;32:227–35.
8 Langan SM, et al. J Invest Dermatol 2012;132(3 Pt 1):556–562.
9 Dalgard F, et al. JID 2015;135(4):984 –991.