LEO Pharma

The Swiss Agency for Therapeutic Products, Swissmedic, has approved Anzupgo®, making it the first topical pan-Janus kinase (JAK) inhibitor specifically indicated for the treatment of moderate to severe Chronic Hand Eczema (CHE) in adults who have had an inadequate response to topical corticosteroids, or for whom potent to very potent topical corticosteroids are not advisable.(1) The approval will bring a new treatment option to approximately 4.7% of adults in Switzerland living with CHE, a condition with a high unmet need for which no specifically approved topical treatment was previously available.(2,3) In addition to the results of the DELTA 1,2 and 3 trials, the marketing approval is supported by the head-to-head DELTA FORCE trial of Anzupgo against oral alitretinoin capsules, the only other existing specifically approved treatment for severe CHE.(4-7)

LEO Pharma is excited to announce strategic leadership changes to bolster growth, further professionalize the organization, and strengthen its commitment to strategy and transformation. Kristian Sibilitz has been appointed as the new Executive Vice President (EVP) of Technical Development and Supply and will join the Global Leadership Team on December 1, 2024. Effective immediately, Jean Monin, EVP of Thrombosis, and Anne Jensen, Vice President (VP) of Strategy, will also join the Global Leadership Team. Additionally, Anders Monrad Rendtorff will join as the new head of Global Communications.

Q3 2024 Trading Update (Unaudited)

Efter Europa Kommissionens produktgodkendelse i september bliver Danmark det næste og kun andet land i verden, hvor LEO Pharma lancerer sit nyeste lægemiddel, Anzupgo® (delgocitinib) creme, efter lanceringen i Tyskland tidligere på måneden. (1) Anzupgo® creme er den første godkendte topikale behandling for voksne med moderat til svært kronisk håndeksem, hvor topikale kortikosteroider er utilstrækkelige eller uhensigtsmæssige. (1) Lanceringen giver en ny behandlingsmulighed for de mange voksne danskere, som lever med moderat til svært kronisk håndeksem, som er en af de mest udbredte kroniske inflammatoriske hudsygdomme, der rammer 4,7% af befolkningen. (2,3)

Following the recent European Commission (EC) approval, Germany has become the first country worldwide where Anzupgo will be made available.(1) Anzupgo is the first topical treatment specifically indicated for adults with moderate to severe Chronic Hand Eczema (CHE) for whom topical corticosteroids are inadequate or inappropriate.(1) The launch brings a new treatment option for the estimated 3.9 million people in Germany living with CHE, a condition with a high unmet need for which no specifically approved topical treatment was previously available.(2,3)

A net-zero target is a natural continuation of our current commitments to run a sustainable business, LEO Pharma says.

Real-world findings showed that subgroup of patients treated with Adtralza® (tralokinumab) / Adbry® (tralokinumab-ldrm) and with head and neck (H&N) atopic dermatitis (AD) at baseline reported presence of AD in that area in 52.1% of patients after nine months of treatment.(1) As part of one of LEO Pharma’s most extensive scientific programs at EADV to date, the late-breaking presentation examined interim data from the real-world TRACE study of adult AD patients who have been prescribed Adtralza/Adbry for up to nine months.(1) Additional posters presented interim results of the TRACE study on effectiveness of Adtralza/Adbry treatment through various physician and patient reported outcomes such as improvements in Eczema Area and Severity Index (EASI), Investigator Global Assessment (IGA), itch, sleep disturbance and quality of life.(2,3)

LEO Pharma is seeking to expand the availability of Enstilar® (LEO 90100) to China, as the company announces the submission of a New Drug Application (NDA) to the National Medical Products Administration (NMPA). The NDA is supported by results from a phase 3 trial comparing the efficacy and safety of Enstilar with Daivobet® ointment in adult Chinese patients.(1,2) The Enstilar submission demonstrates LEO Pharma's commitment to providing additional treatment options for the estimated seven million adult patients living with plaque psoriasis in China.(3)

Results presented at the Late Breaker Session on September 26th at the European Dermatology Congress, European Academy of Dermatology & Venereology (EADV) 2024, showed that the investigational interleukin 22 receptor, alpha 1 (IL-22RA1) inhibitor temtokibart induced fast (Week 1) molecular responses(1) Markers of skin hydration (natural moisturizing factors) 2-pyrrolidone-5-carboxylic acid (PCA) and urocanic acid (UCA) were significantly improved from baseline at Week 1 in the temtokibart group (p<0.0001)(1) Both temtokibart and dupilumab led to comparable changes in eczema area and severity index (EASI) and itch numerical rating scale (NRS) at Week 16(1)

The full DELTA FORCE results, the first of three Anzupgo® (delgocitinib) cream late-breaking presentations at the congress, demonstrated that topical treatment with delgocitinib cream had a significantly higher efficacy compared to oral alitretinoin capsules among adult patients with severe CHE.(1) Six other pieces of investigational delgocitinib cream research form part of LEO Pharma’s extensive scientific program at EADV 2024.(2-7) Remaining abstracts include post hoc analysis of the DELTA 1, 2, and 3 trials showing efficacy data for delgocitinib cream across five different CHE subtypes, clinician-reported real-world findings, large-scale patient prevalence data, and detailed analysis of patient biopsy samples.(2-7)

LEO Pharma will demonstrate true leadership in medical dermatology by presenting one of its largest ever scientific programs to date at this year’s EADV congress, with 5 late-breaking presentations and 23 scientific posters in total.(1-28) New late-breaking Anzupgo® (delgocitinib) cream data will include the full results of the Phase 3 head-to-head DELTA FORCE trial, as well as a wide range of associated clinical and real-world findings on delgocitinib cream and moderate to severe chronic hand eczema (CHE).(1-6) Additional late-breaking data includes a presentation of Adtralza® (tralokinumab)/Adbry ® (tralokinumab-ldrm) interim data from the real-world TRACE study on the effectiveness of Adtralza/Adbry in adults with moderate to severe head and neck atopic dermatitis (AD).(27) Finally, a late-breaking presentation will discuss the first randomized trial comparing clinical and molecular effects of temtokibart and dupilumab in moderate to severe AD.(28)

Anzupgo® is the first topical treatment to be specifically indicated for adult patients living with moderate to severe CHE across the European Union (EU) for whom topical corticosteroids are inadequate or inappropriate. The approval follows the recent positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) and is based on results from the DELTA phase 3 program.(1-5)

LEO Pharma is expanding upon its ambitions in the United States (U.S.) as the FDA has accepted for filing the company’s New Drug Application (NDA) for delgocitinib cream, an investigational innovative topical treatment for Chronic Hand Eczema (CHE). The application has been accepted for filing and, if approved, delgocitinib cream would become the first treatment in the U.S. specifically indicated for adults with moderate to severe CHE. CHE is a condition with a high unmet need that affects approximately 4.7% of the population globally.(1)

· The CHECK (patient-reported) and RWEAL (physician-reported) studies form the largest multinational CHE surveys conducted in the adult population. (1-5) · Findings show that CHE is common in the general population, with around 5.6% of study participants self-reporting the condition in the last 12 months. (1-5) · Among people self-reporting CHE, one in five (21.5%) attribute the condition to their occupation, and one in ten (12.2%) of those reporting CHE in relation to occupation or daily activities have changed work assignments or reduced their working hours.(2)

Six-month interim report (H1) 2024 (Unaudited) - NOT FOR UK USE / NOT INTENDED FOR UK MEDIA

Results from the randomized, double-blind period of the phase 3 clinical trial with TMB-001 – the ASCEND trial – show that the primary and key secondary endpoints were not met. The trial investigated TMB-001 in patients 6 years or older with moderate to severe congenital ichthyosis. The majority of adverse events observed were non-serious localized skin reactions of mild or moderate severity. The trial results do not support submission of a New Drug Application to the US FDA. NOT FOR UK USE – NOT INTENDED FOR UK MEDIA

Ballerup, Denmark, July 31, 2024 – Today, LEO Pharma A/S announced that non-executive director Jan van de Winkel has decided to step down from the Board of Directors of LEO Pharma effective August 1, 2024 due to increasing time commitments from his primary executive position as Chief Executive Officer of Genmab A/S. Jan van de Winkel joined the Board of Directors in March, 2017. Chair of the Board of Directors, Jesper Brandgaard said: “I would like to express my sincere gratitude to Jan for his loyal service and valuable contributions to LEO Pharma as a non-executive board member throughout times of great change and transformation. I am pleased that Jan has offered to provide his advice to the Chairmanship in the process leading up to the potential public listing of LEO Pharma.”

The positive opinion marks the latest step towards marketing authorization in the European Union (EU), with a final decision from the European Commission (EC) now pending. If approved, delgocitinib cream will be the first topical treatment specifically indicated for adults with moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate. The positive opinion is based on results from the DELTA phase 3 program, which includes the randomized, vehicle-controlled DELTA 1 and DELTA 2 clinical trials, (1,2,3) and the DELTA 3 open-label extension trial.(4)

The Lancet publishes data from the pivotal DELTA 1 and DELTA 2 trials, marking the first time an investigational topical pan-Janus kinase (JAK) inhibitor for chronic hand eczema (CHE) has been featured in the journal.1 The DELTA 1 and DELTA 2 trials investigated the safety and efficacy of investigational delgocitinib cream in adult patients with moderate to severe CHE.2,3

LEO Pharma today announced that Nathalie Daste, Executive Vice President of Global People & Corporate Affairs, has decided to resign her position and leave LEO Pharma due to personal reasons. Christophe Bourdon, CEO of LEO Pharma, said: “I want to express heartfelt gratitude to Nathalie for her dedication to the journey we are currently on. In the Global Leadership Team, we will miss Nathalie, her engagement, and her fresh ideas, but I fully understand the need to put family first.” Nathalie Daste said: “It is with mixed emotions that I share the news of my departure from this remarkable organization. Due to unforeseen family circumstances, I have made the difficult decision to step away from my role. While it is hard to bid farewell to such a talented and dedicated team, I am confident that the organization will continue to thrive and achieve great things.” Effective immediately, Michael Meyer, currently Head of HR Business Partnering and an experienced HR leader, will step in until a