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OUR PORTFOLIO
Immune inflammatory
diseases
diseases
Atopic Dermatitis
Atopic dermatitis (AD), or atopic eczema, is a non-contagious, chronic inflammatory disease characterized by recurrent skin inflammation, often associated with intense pruritus or itching. Beyond physical symptoms such as dryness, itchiness, redness, and inflammation, this condition significantly impacts emotional well-being and disrupts the academic, social, and professional lives of those affected 1
EBGLYSS®
(lebrikizumab)
EBGLYSS® (lebrikizumab) is a biologic treatment specially developed to selectively target the
protein IL-13 with high affinity, inhibiting its downstream signalling with high potency. 5
,6 ,7 ,8 . In November 2023, the European Commission (EC) approved EBGLYSS
(lebrikizumab) for the treatment of adult and adolescent patients (12 years and older with a body weight of
at least 40 kg) with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy.
The approval is based on the results of a range of studies, including the phase III studies ADvocate 1 and
ADvocate 2, which evaluated lebrikizumab when used in monotherapy, and ADhere, which assessed lebrikizumab
in combination with topical corticosteroids (TCS).
In these studies, lebrikizumab alone reduced disease severity by 75% in nearly 6 out of 10 patients. Similar
results were achieved in combination with TCS in nearly 7 out of 10 patients. Additionally, more than 80% of
patients who responded to and continued treatment in both studies experienced long-lasting clear skin, itch
relief, and reduced disease severity with monthly maintenance. Safety findings show most adverse events were
mild or moderate and no patients needed to discontinue treatment .
Cordran® Tape
(flurandrenolide)
A topical corticosteroid treatment prescribed to reduce itching, redness, and swelling that may occur with corticosteroid-responsive dermatosis, including AD. Cordran® is primarily effective because of its anti-inflammatory, antipruritic, and vasoconstrictive actions and is commercially available in Japan and the United States (the only corticosteroid available in a tape form).
Psoriasis
Physical symptoms can be painful and disfiguring, significantly impacting patients’ lives and mental health – with approximately one in ten patients11 experiencing clinical depression as a result. As psoriasis can have a wide variety of severities and therefore a different impact on each patient, we are dedicated to offering a range of unique and comprehensive treatments, including topical solutions, oral systemics, and biologics, to cater to the full spectrum of the condition.
⁓60 M
IMPACTED PEOPLE AROUND THE WORLD 10
Ilumetri®
(tildrakizumab)
Ilumetri® is humanized monoclonal antibody that targets the p19 subunit of interleukin-23 (IL-23) and inhibits the release of proinflammatory cytokines and chemokines while having limited impact on the rest of the immune system. It is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.
Our real-world evidence study, POSITIVE, and the innovative use of the WHO-5 questionnaire as a clinical endpoint revealed that psoriasis impacts patient well-being to a degree comparable to other serious conditions such as breast cancer 12,13. Results at 28 weeks also showed that treatment with tildrakizumab can significantly improve psoriasis patients’ well-being, reaching levels similar to that of the average European population. In addition to mental well-being, the study reinforced the effectiveness and safety of tildrakizumab in daily clinical practice, which has been widely demonstrated in more than 6,000 patients in RWE studies across Europe.
Wynzora® Cream
(alcipotriol/betamethasone)
A once-daily topical treatment for adults with mild to moderate plaque psoriasis, including the scalp14. Wynzora® cream is based on PAD Technology, which formulates an aqueous cream that is less greasy than a CAL/BDP gel . Wynzora® offers rapid results within one week, a favourable safety profile, and improved patient acceptability compared to CAL/BDP gel 16,17. An indirect comparison with CAL/BDP foam demonstrated comparable efficacy and quality of life improvements, along with even higher patient satisfaction 18. In real-world clinical practice settings, patients with body and scalp psoriasis reported high satisfaction and adherence, and preferred Wynzora® cream (calcipotriol/betamethasone) over their previous topical treatments.
Wynzora® cream (calcipotriol/betamethasone) is authorized in France, the UK, Spain, the Czech Republic, Denmark, Norway, Sweden, Finland, Germany, Portugal, Italy, Ireland, the Netherlands, and Austria under a different trade name: Winxory®. It has helped more than 240,000 patients in the past year and reached net sales of €26 million growing +53% vs the previous year 19.
Skilarence®
(dimethyl fumarate)
Skilarence® (dimethyl fumarate) is the first and only European Commission-approved fumaric acid ester oral medicine for treating adults with moderate to severe plaque psoriasis. Widely accessible and highly impactfull, it is commercialized in 16 European countries and South Korea.
Non-melanoma
skin cancer
skin cancer
Actinic keratosis (AK)
Klisyri®
(tirbanibulin)
A topical treatment with a selective antiproliferative mechanism of action, Klisyri® represents a significant step forward in the treatment of AK due to its short-term treatment protocol (once-daily application for 5 consecutive days), with proven effectiveness, safety, and tolerability. It’s indicated for non-hypertrofic, non-hyperkeratotic AK on the face and/or scalp.
Klisyri® received a recommendation in both the German and European AK treatment guidelines, published in 2023 and 2024, respectively. Klisyri® was also strongly endorsed in the Journal of the American Academy of Dermatology, supported by compelling evidence of its efficacy. In the U.S., phase l and phase lll studies were completed in 2023 to support its use in large areas of the skin (100cm2). Subsequently, in August 2024, the FDA approved the request to extend the treatment area to a “large field” application, covering up to 100 cm2.
Klisyri® is already commercialized in the United States, Germany, the United Kingdom, Switzerland, Austria, the Netherlands, Italy, Spain, Ireland, Denmark, and Belgium. Since its launch, around 400,000 patients have benefitted from Klisyri®22.
Actikerall®
(fluorouracil/salicylic acid)
Actikerall® is a lesion-directed topical indicated for the treatment of actinic keratosis lesions (grade I/II). Applied once daily directly to the lesion, Actikerall® is the only approved combination therapy for AK.
Solaraze®
(diclofenac sodium)
A nonsteroidal anti-inflammatory topical treatment, Solaraze® is used to treat AK lesions and adjacent sun-damaged skin, reducing angiogenesis and cellular proliferation. Highly effective and tolerable as a long-term treatment, it is especially suitable for AK patients who have received organ transplants.
Solaraze® is now marketed in over 10 European countries as well as Australia and is the leader is Spain and Italy with a market share above 34% in both countries (YTD Units Dec/24).
Other
skin diseases
skin diseases
Leadership in medical dermatology means offering a broad range of dermatology products to patients and the medical community. Therefore, our portfolio includes treatments across a variety of different diseases including, for example, acne and fungal infections.
Acne
Seysara®
(sarecycline)
Onychomycosis
Ciclopoli®
(ciclopirox)
Key & strategic products of our portfolio
1 Koszorú K, Borza J, Gulácsi L, Sárdy M. Quality of life in patients with atopic dermatitis. Cutis. 2019 Sep;104(3):174-177.
2 Barbarot S, et al. Epidemiology of atopic dermatitis in adults: Results from an international survey. Allergy. 2018 Jun;73(6):1284-1293. doi: 10.1111/all.13401. Epub 2018 Feb 13. PMID: 29319189.
3 Silverberg J, et al. Atopic dermatitis in the pediatric population: A cross-sectional, international epidemiologic study. Ann Allergy Asthma Immunol. 2021;126(4):417-428.
4 Bernardo D, et al. Lebrikizumab for the Treatment of Moderate-to-Severe Atopic Dermatitis. Am J Clin Dermatol. 2023;24, 753– 764.
5 Moyle M, et al. Understanding the immune landscape in atopic dermatitis: The era of biologics and emerging therapeutic approaches. Exp Dermatol. 2019;28(7):756–768.
6 Gonçalves F, et al. Selective IL-13 inhibitors for the treatment of atopic dermatitis. Drugs Context 2021;10:2021-1-7.
7 Okragly A, et al. Binding, Neutralization and Internalization of the Interleukin-13 Antibody, Lebrikizumab. Dermatol Ther (Heidelb). 2023;13(7):1535-1547.
8 Ultsch M, et al. Structural Basis of Signaling Blockade by Anti-IL-13 Antibody Lebrikizumab. J Mol Biol. 2013;425(8):1330-1339.
9 Guttman-Yassky E, et al. Long-Term Efficacy and Safety of Lebrikizumab Is Maintained in Patients With Moderate-to-Severe Atopic Dermatitis: Results Up to 3 Years From ADjoinEfficacy and Safety of Lebrikizumab Is Maintained to Two Years in Patients With Moderate-to-Severe Atopic Dermatitis. Presented at the Fall Clinical Dermatology Conference; October 20, 20243.
10 Parisi R, Iskandar IYK, Kontopantelis E, Augustin M, Griffiths CEM, Ashcroft DM et al. National, regional, and worldwide epidemiology of psoriasis: systematic analysis and modelling study. BMJ. 2020 May;36:m1590. doi:10.1136/bmj.m1590.
11 Dowlatshahi EA, Wakkee M, Arends LR, Nijsten T. The prevalence and odds of depressive symptoms and clinical depression in psoriasis patients: A systematic review and meta-analysis. J Invest Dermatol. 2014 Jun;134(6):1542–1551. doi: 10.1038/jid.2013.508. Epub 2013 Nov 27. PMID: 24284419.
12 Mrowietz U, et al. Presented at the 25th World Congress of Dermatology (WCD) July 3-8 ,2023, Singapore, Abstract 799
13 Topp CW, et al. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84:167–76.
14 Pinter A, et al, Green LJ, Selmer J, Praestegaard M, Gold LS, Augustin M; trial investigator group. A pooled analysis of randomized, controlled, phase 3 trials investigating the efficacy and safety of a novel, fixed dose calcipotriene and betamethasone dipropionate cream for the topical treatment of plaque psoriasis. J Eur Acad Dermatol Venereol. 2022 Feb;36(2):228–236. doi: 10.1111/jdv.17734.
15 Præstegaard M, et al. Phase 3 trial demonstrates superior patient treatment convenience of MC2-01 calcipotriene plus betamethasone dipropionate cream compared to current topical suspension. J of Skin. 2020;4(5):s62. doi: 10.25251/skin.4.supp.61.
16 Præstegaard M, et al. Phase 3 trial demonstrates superior patient treatment convenience of MC2-01 calcipotriene plus betamethasone dipropionate cream compared to current topical suspension. J of Skin. 2020;4(5):s62. doi: 10.25251/skin.4.supp.61.
17 Stein Gold L, et al. A phase 3, randomized trial demonstrating the improved efficacy and patient acceptability of fixed dose calcipotriene and betamethasone dipropionate cream. J Drugs Dermatol. 2021 Apr;20(4):420-425.
18 Bewley A, et al. An anchored matching-adjusted indirect comparison of fixed-dose combination calcipotriol and betamethasone dipropionate (Cal/BDP) cream versus Cal/BDP foam for the treatment of psoriasis. J Dermatolog Treat. 2022 33 (8): 3191-3198.
19 PsO PowerBI Dashboard (IQVIA Midas data).
20 Fuchs A, Marmur E. The kinetics of skin cancer: progression of actinic keratosis to squamous cell carcinoma. Dermatol Surg. 2007 Sep;33(9):1099-101. doi: 10.1111/j.1524-4725.2007.33224. x.
21 Wilmer EN, Gustafson CJ, Ahn CS, Davis SA, Feldman SR, Huang WW. Most common dermatologic conditions encountered by dermatologists and nondermatologists. Cutis. 2014 Dec;94(6):285-92.
22 AK PowerBI Dashboard (IQVIA Midas data).
23 Tan JKL, Bhate K. A global perspective on the epidemiology of acne. Br J Dermatol. 2015 Jul;172 Suppl 1:3-12. doi: 10.1111/bjd.13462. PMID: 25597339.
24 Dalgard F, Gieler U, Holm JØ, Bjertness E, Hauser S. Self-esteem and body satisfaction among late adolescents with acne: results from a population survey. J Am Acad Dermatol. 2008 Nov;59(5):746-51. doi: 10.1016/j.jaad.2008.07.013. PMID: 19119094.
25 Maskan Bermudez N, et al. Onychomycosis: Old and New. Journal of Fungi. 2023; 9(5):559.
26 Sigurgeirsson B, Baran R. The prevalence of onychomycosis in the global population: a literature study. J Eur Acad Dermatol Venereol. 2014 Nov;28(11):1480-91.
27 Ciclopoli® (Ciclopirox) SmPC.
28 Monti D et al,. In vitro transungual permeation of ciclopirox from a hydroxypropyl chitosan-based, water-soluble nail lacquer. Drug Dev Ind Pharm. 2005 Jan;31(1):11-7.
29 Sparavigna M, et al. Physical and microbiological properties of a new nail protective medical device. J Plastic Dermatol. 2008;4(1):5-12.
30 Monti D, et al. Hydrosoluble medicated nail lacquers: in vitro drug permeation and corresponding antimycotic activity. Br J Dermatol. 2010 Feb;162(2):311-7.
31 Iorizzo M et al,. Ciclopirox 8% HPCH nail lacquer in the treatment of mild-to-moderate onychomycosis: A randomized, amorolfine controlled study using a blinded evaluator. Skin Appendage Disord. 2016 Feb;1(3):134-40.
