LEO Pharma

LEO Pharma A/S acquires rights to develop and market brodalumab for moderate-to-severe psoriasis outside of Europe

13.8.2019 11:30:00 CEST | LEO Pharma | Press release

Share

New sub-licensing agreement allows LEO Pharma to help more people around the world with an additional treatment option for psoriasis. 

August 13th, 2019, Ballerup, Denmark: 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.

Facebook: www.facebook.com/LEOPharmaAS

LinkedIn: www.linkedin.com/company/leo-pharma

Twitter: www.twitter.com/leohealthyskin

YouTube: www.youtube.com/leopharmaglobal

#ENDS#

 

NOTE TO EDITORS

About psoriasis

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 disease[5],[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.

 

Contact:

Henrik Kyndlev
+45 3140 6180
hdtdk@leo-pharma.com

  

References

[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).

[3]       World 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.

About LEO Pharma

LEO Pharma
LEO Pharma
Industriparken 55
2750 Ballerup

4494 5888http://www.leo-pharma.com/

Subscribe to releases from LEO Pharma

Subscribe to all the latest releases from LEO Pharma by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from LEO Pharma

LEO Pharma presents new data on delgocitinib cream at EADV 2026 highlighting real-world outcomes in adults and new adolescent data in Chronic Hand Eczema (CHE)1.10.2026 12:00:00 CEST | Pressemeddelelse

Interim results from the German REACHED study provide the first real-world evidence on the effectiveness of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema (CHE), with 28.6% of patients assessed as clear or almost clear after eight weeks of treatment, from none at baseline.1 New post hoc analyses from the phase 3 DELTA TEEN trial show greater reductions in daily HESD itch and pain scores with delgocitinib cream than with cream vehicle in adolescents aged 12-17 with moderate to severe CHE.2 In an oral presentation, new post hoc analyses from DELTA TEEN show that a higher proportion of adolescents reported no impact on quality of life at Week 16 with delgocitinib cream than with cream vehicle (27.0% vs 0%)3

LEO Pharma presents new tralokinumab data at EADV 2026 highlighting real-world outcomes and quality of life in adults and adolescents with atopic dermatitis (AD) involving high-burden areas1.10.2026 10:30:00 CEST | Pressemeddelelse

New findings from a subgroup analysis of the 12-month TRACE study show that more than 70% of adults whose Atopic Dermatitis (AD) affected multiple high-burden areas – such as the head and neck, hands and feet, or genitals – had reduced involvement of those areas after 12 months of treatment with tralokinumab.1 New pre-specified and post hoc analyses from the phase 3 ADHAND trial show significantly greater improvements in quality of life, daily function and sleep at Week 16 with tralokinumab monotherapy than with placebo in adults with AD and moderate-to-severe hand involvement, with the two treatment groups separating within two weeks.2,3 In a post hoc analysis, adolescents aged 12-17 years treated across the phase 3 ECZTRA 6 trial and its ECZTEND extension, response rates remained high and stable through most of the extension period, and no new safety concerns were identified.5

LEO Pharma to showcase its broadest ever scientific program at EADV 202624.9.2026 09:00:00 CEST | Pressemeddelelse

LEO Pharma will present 28 accepted abstracts at the 2026 European Academy of Dermatology and Venereology Congress, taking place from 30 September to 3 October in Vienna, Austria. The EADV 2026 program reflects the strength and breadth of LEO Pharma’s portfolio, showcasing what’s now and what’s next in medical dermatology with new evidence across nine disease areas, six routes of administration and nine modes of action; including biologic injectables, topical formulations, and covering data across established dermatology brands and new innovation. The program underscores LEO Pharma’s continued commitment to advancing medical dermatology through evidence that addresses both highly prevalent chronic skin diseases and complex or rare, hard-to-treat conditions with significant unmet needs.

LEO Pharma receives positive CHMP opinion recommending Anzupgo® (delgocitinib) cream for adolescents with moderate to severe chronic hand eczema in the EU18.9.2026 10:00:00 CEST | Pressemeddelelse

The Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the use of Anzupgo® (delgocitinib) cream to adolescents aged 12 to 17 years with moderate to severe chronic hand eczema for whom topical corticosteroids are inadequate or inappropriate. If approved by the European Commission, Anzupgo® would become the first therapy in the EU specifically approved for adolescents with moderate to severe chronic hand eczema, a patient population for whom there are currently no specifically approved treatment options. The positive CHMP opinion is supported by results from DELTA TEEN, a phase 3 trial investigating the efficacy and safety of Anzupgo® in adolescents with moderate to severe chronic hand eczema.1

LEO Pharma announces FDA acceptance of dersimelagon NDA with Priority Review and closes acquisition from Tanabe Pharma18.9.2026 09:00:00 CEST | Pressemeddelelse

The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for dersimelagon for filing and granted it Priority Review, with a Prescription Drug User Fee Act (PDUFA) date expected by the end of February 2027. LEO Pharma has successfully closed the acquisition of dersimelagon from Tanabe Pharma, strengthening its late-stage pipeline and further leveraging its global dermatology platform. Dersimelagon is an investigational, once-daily oral melanocortin 1 receptor (MC1R) agonist for the treatment of erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP), two rare genetic skin diseases with significant unmet medical need.

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye