***PRESS-RELEASE: NICE Publishes Final Appraisal Document Recommending the Use of Adtralza® (tralokinumab) for Adult Patients With Moderate-to-Severe Atopic Dermatitis

The National Institute for Health and Care Excellence (NICE) has published a Final Appraisal Document (FAD) approving Adtralza® (tralokinumab) for adult patients with moderate-to-severe atopic dermatitis (AD) based on cost-effectiveness and a demonstration of positive patient outcomes.1

Adtralza is the first approved biologic available for use within NHS England and Wales to specifically target the interleukin (IL)-13 cytokine, a driver of AD signs and symptoms.1,2,3

This recommendation is supported by data from four Phase 3 studies (ECZTRA 1, 2, 3 and 7).4,5,6

NOT FOR DISTRIBUTION IN THE UK

BALLERUP, Denmark - June 29, BUSINESS WIRE - LEO Pharma A/S, a global leader in medical dermatology, today announced that the National Institute for Health and Care Excellence (NICE) has issued a positive Final Appraisal Document (FAD) which recommends Adtralza® (tralokinumab) for use within NHS England and Wales. NICE recommends Adtralza for the treatment of moderate-to-severe atopic dermatitis (AD) in adult patients who are candidates for systemic therapy and have not responded to at least one systemic immunosuppressant, or these are not suitable.1

The NICE recommendation makes Adtralza the first and only recommended biologic for use within NHS England and Wales that specifically targets the interleukin (IL)-13 cytokine, a driver of AD signs and symptoms.1,2,3 AD affects approximately 3.5% of adults across Europe.7

"We are thrilled that today's decision from NICE will help pave the way for atopic dermatitis patients in England and Wales to have access to Adtralza, as we continue to work alongside UK authorities to ensure reimbursement for this important therapy," said Christophe Bourdon, Chief Executive Officer, LEO Pharma A/S. "As a global leader in medical dermatology, we are dedicated to ensuring that our efforts to introduce innovative therapies are matched with providing the necessary support for patients and their families who are living with this chronic and often debilitating condition."

The evidence supporting the efficacy and safety profile of Adtralza comes from four randomized, multicenter, double-blind, placebo-controlled, Phase 3 studies: ECZTRA 1, ECZTRA 2, and ECZTRA 3 in patients with moderate-to-severe atopic dermatitis, and ECZTRA 7 in patients with severe atopic dermatitis.4,5,6

Adtralza was approved in June 2021 by the European Commission (EC) in Europe and by the Medicines & Healthcare products Regulatory Agency (MHRA) in Great Britain for adults with moderate-to-severe AD who are candidates for systemic therapy.The MHRA and EC decisions are valid in the UK and all European Union Member States, Iceland, Norway, and Liechtenstein. Adtralza also is approved for use in Canada, the United Arab Emirates, and Switzerland, and in the United States under the tradename AdbryTM. In January 2022, the Scottish Medicines Consortium (SMC) decided to reimburse Adtralza for use within NHS Scotland.

About the pivotal ECZTRA 1, 2, 3 and ECZTRA 7 Trials

ECZTRA 1 and ECZTRA 2 (ECZema TRAlokinumab trials Nos. 1 and 2) were randomized, double-blind, placebo-controlled, multinational 52-week trials, which included 802 and 794 adult patients, respectively, to evaluate the safety and efficacy of Adtralza (300 mg every other week) as monotherapy in adults with moderate-to-severe atopic dermatitis who were candidates for systemic therapy.4

ECZTRA 3 (ECZema TRAlokinumab trial No. 3) was a double-blind, randomized, placebo-controlled, multinational 32-week trial, which included 380 adult patients, to evaluate the safety and efficacy of Adtralza (300 mg every other week) in combination with TCS as needed in adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.5

ECZTRA 7 (ECZema TRAlokinumab trial No. 7) was a double-blind, randomized, placebo-controlled, multinational 26-week trial, which included 277 adult patients, to demonstrate that Adtralza in combination with TCS is superior to placebo in combination with TCS in treating severe AD in subjects who are not adequately controlled with or have contraindications to oral cyclosporine A (CSA).6

About atopic dermatitis

Atopic dermatitis is a chronic, inflammatory, skin disease characterized by intense itch and eczematous lesions.8 Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.9 Type 2 cytokines, including IL-13, play an important role in atopic dermatitis pathophysiology.3

About Adtralza® (tralokinumab)

Adtralza® (tralokinumab) is a high-affinity human monoclonal antibody developed to bind to and inhibit the interleukin (IL)-13 cytokine, which plays a role in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms. Adtralza specifically binds to the IL-13 cytokine, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).2,3

About LEO Pharma

LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities. LEO Pharma is headquartered in Denmark with a global team of 5,800 people, serving millions of patients across the world. In 2021, the company generated net sales of DKK 9,957 million.

References

National Institute for Health and Care Excellence. 2022. Final appraisal document | Abrocitinib, tralokinumab or upadacitinib for treating moderate to severe atopic dermatitis. Available at: < https://www.nice.org.uk/guidance/gid-ta10856/documents/final-appraisal-determination-document> [Accessed June 29 2022].

Popovic B, et al. Structural Characterization reveals mechanism of IL-13-neutralising monoclonal antibody tralokinumab as inhibition of binding to IL-13Rα1 and IL-13Rα2. J Mol Biol. 2017 Jan 20;429(2):208-219.

Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.

Wollenberg A, et al. Tralokinumab for moderate‐to‐severe atopic dermatitis: results from two 52‐ week, randomized, double‐blind, multicentre, placebo‐controlled phase III trials (ECZTRA 1 and ECZTRA 2). Br J Dermatol. 2021; 437-449.

Silverberg JI, et al. Tralokinumab plus topical corticosteroids for the treatment of moderate‐to‐severe atopic dermatitis: results from the double‐blind, randomized, multicentre, placebo‐controlled phase III ECZTRA 3 trial. Br J Dermatol. 2021; 450-463.

Gutermuth J, et al. Tralokinumab plus topical corticosteroids in adults with severe atopic dermatitis and inadequate response to or intolerance of ciclosporin A: a placebo‐controlled, randomized, phase III clinical trial (ECZTRA 7). Br Journal of Dermatol. 2021.

Barbarot, S., Auziere, S., Gadkari, A., Girolomoni, G., Puig, L., Simpson, E., Margolis, D., Bruin‐Weller, M. and Eckert, L., 2018. Epidemiology of atopic dermatitis in adults: Results from an international survey. Allergy. 73(6), pp.1284-1293.

Weidinger S, Beck LA, Bieber T, Kabashima K, Irvine AD. Atopic dermatitis. Nat Rev Dis Primers. 2018 Jun 21;4(1):1.

Boguniewicz M, et al. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011; 242(1):233-46.

MAT-58207 June 2022

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Contacts:

Henrik Heskjaer

LEO Pharma, Global External Communications

+45 3140 6180

HDTK@leo-pharma.com

David Patti

LEO Pharma, Global Product Communications

973.796.7706

DAPAI@leo-pharma.com

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