LEO Pharma

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

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 continues global rollout of Anzupgo® (delgocitinib) cream with submission of New Drug Application in China16.10.2025 15:30:00 CEST | Pressemeddelelse

LEO Pharma is seeking to expand the availability of Anzupgo® (delgocitinib) cream to China, as the company announces the submission of a New Drug Application (NDA) to the National Medical Products Administration (NMPA), which has been accepted for review for adult patients with moderate to severe chronic hand eczema. The NDA is supported by results from DELTA China, a phase 3 trial with Anzupgo in Chinese adults with moderate to severe chronic hand eczema (CHE)1 along with the full clinical program of delgocitinib, which includes data from DELTA 1,2 and 3, DELTA Force and DELTA Teen.2-7 The Anzupgo NDA submission demonstrates LEO Pharma's commitment to providing additional treatment options for patients living with skin diseases in China.

LEO Pharma closes deal for Spevigo®1.10.2025 09:00:00 CEST | Pressemeddelelse

Adding Spevigo® is a significant step forward in LEO Pharma’s focused growth strategy, to accelerate and expand patients’ access to treatments for medical dermatological conditions, including generalized pustular psoriasis (GPP), a rare and severe skin condition Spevigo® (spesolimab) is a first-in-class IL-36R antagonist successfully developed and launched by Boehringer Ingelheim and approved globally for the treatment and prevention of GPP flares Spesolimab is also being investigated for the treatment of other IL-36-mediated skin diseases

LEO Pharma Presents Late-Breaking Data at EADV 2025 Showing Week 16 Tralokinumab Response Predicts Long-Term Response in Moderate-to-Severe Atopic Dermatitis19.9.2025 16:00:00 CEST | Pressemeddelelse

Late-breaking data from the ECZTEND trial show that patients with moderate-to-severe atopic dermatitis (AD), who responded to Adtralza® (tralokinumab) / Adbry® (tralokinumab-ldrm) at Week 16, maintained stable, optimal treatment outcomes for up to three years.1 Additional data presented at EADV from the real-world TRACE study further support the long-term use of tralokinumab, with sustained improvements in disease severity, quality of life, sleep, and work productivity observed over 12 months of treatment.2-4 Presented as part of LEO Pharma’s most ambitious scientific program to date at the 2025 EADV Congress, the tralokinumab data reinforce the company’s leadership in medical dermatology and its commitment to advancing innovation across its biologics’ portfolio.

LEO Pharma Presents Late-Breaking Phase 3 Delgocitinib Cream Data in Adolescents with Moderate to Severe Chronic Hand Eczema (CHE)18.9.2025 15:45:00 CEST | Pressemeddelelse

The first late-breaking presentation was the phase 3 trial results for DELTA TEEN, showing delgocitinib cream had superior efficacy compared to cream vehicle and was generally well tolerated in adolescents, aged 12-17, with moderate to severe Chronic Hand Eczema (CHE) for whom topical corticosteroids are inadequate or inappropriate.1 In a second late-breaking presentation, pooled data from five phase 2b and phase 3 trials of delgocitinib cream confirmed a consistent safety profile for the treatment of moderate to severe CHE in adults.2 Fifteen other pieces of delgocitinib cream research formed part of LEO Pharma’s most ambitious scientific program to date at EADV 2025.3-17

LEO Pharma presents two late-breaking abstracts for temtokibart reporting positive Phase 2b efficacy, safety and biomarker results in moderate-to-severe atopic dermatitis at the 2025 EADV Annual Meeting in Paris17.9.2025 16:00:00 CEST | Pressemeddelelse

Results presented at EADV 2025 demonstrated that investigational agent temtokibart met its primary endpoint of percentage change in the Eczema Area and Severity Index (EASI) compared with placebo for the three highest doses (600 mg, 450 mg, and 300 mg).1 Significantly greater improvements in EASI were reported as early as Week 1 for temtokibart 450mg and 300mg, and Week 2 for 600mg, vs placebo; these results were maintained up to Week 32 in 600mg and 300mg arms, despite no treatment after Week 14.1 Safety analyses revealed that temtokibart was well-tolerated with no dose-dependent AEs, a low incidence of conjunctivitis, and no signal for herpes.1

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