Tirbanibulin

BARCELONA, Spain--( BUSINESS WIRE )-- Almirall, S.A. (ALM) , a global pharmaceutical company dedicated to medical dermatology, today announced its participation in the 33rd Congress of the European Academy of Dermatology and Venereology (EADV) , taking place in Amsterdam from September 25 to 28, 2024. This year, Almirall marks its 80th anniversary, celebrating eight decades of innovation and commitment to delivering products positively impacting people’s health and lives. At the congress, Almirall will present 34 abstracts detailing the latest research on lebrikizumab for moderate-to-severe atopic dermatitis in adolescents and adults, tildrakizumab and Almirall’s CAL/BDP cream for moderate-to-severe plaque psoriasis in adults, as well as tirbanibulin for actinic keratosis. The company will also host two symposia, providing a platform for experts to discuss current data, share insights, and facilitate discussions about the treatment of these chronic conditions with advanced biologics. Impact of the treatment of psoriasis on patient wellbeing: new data from the POSITIVE study Almirall will unveil new interim data on the treatment of adults with moderate-to-severe plaque psoriasis with tidrakizumab at 52 weeks from the POSITIVE clinical study. The POSITIVE study is the first clinical trial in dermatology to use the WHO-5 Wellbeing Index as a primary endpoint. The 5-item World Health Organization Wellbeing Index is a validated questionnaire that assesses health-related subjective psychological wellbeing in a variety of chronic diseases. The different sub-analyses presented during the congress reinforce the effectiveness of tildrakizumab on signs and symptoms in skin and beyond. Almirall will host the symposium "Advancing Psoriasis Management for Long-Term Patient Outcomes", featuring experts such as Prof. Dr. Diamant Thaçi from the University of Lübeck, Prof. Dr. Ulrich Mrowietz from the University Medical Center Schleswig-Holstein, and Prof. Anna López Ferrer from the Hospital de la Santa Creu i Sant Pau in Barcelona. The discussion will emphasize on the importance of tailoring treatments to individual patients , the latest real-world evidence, and practical strategies for clinical success managing psoriasis, with opportunities for interactive discussion with leading experts. Advancing atopic dermatitis disease management Almirall will also present new data on lebrikizumab, a biologic approved for the treatment of moderate-to-severe atopic dermatitis. The late-breaking presentation will report lebrikizumab’s data over three years of continuous treatment, alongside new data on the rates of absolute endpoints and its effectiveness in patients inadequately controlled or ineligible for cyclosporine. The Almirall symposium entitled "Precision in AD: How Lebrikizumab is Changing the Treatment Paradigm" will feature the experts Marjolein Bruin-Weller, from the National Expertise Center for Atopic Dermatitis at the Department of Dermatology and Allergology of the University Medical Center Utrecht; Andrew Blauvelt from Portland, US, and Sascha Gerdes from the Center for Inflammatory Skin Diseases of the University Medical Center Schleswig-Holstein Campus Kiel. Discussions will focus on the clinical impact of lebrikizumab and offer a chance for participants to engage with leading specialists in this field. Almirall celebrating 80 years of innovation 2024 marks a significant milestone for Almirall as the company celebrates 80 years of innovation and commitment to delivering impactful solutions to help improve patients’ lives. With a rich history in the pharmaceutical industry and a strong focus on medical dermatology, Almirall has built a robust pipeline addressing various diseases and using different therapeutic modalities. Leading innovating in medical dermatology is enabled by Almirall's close collaboration with the dermatology community and patient-centric mindset. Celebrating its 80 th anniversary, Almirall reaffirms its dedication to advancing skin science and developing novel treatments to benefit patients and the dermatology community around the world. For more information about Almirall’s 80th-anniversary celebrations, visit almirall80years.com ANNEX: 33 rd EADV Congress presentations and poster details: Satellite Symposium on psoriasis: Advancing Psoriasis Management for Long-Term Patient Outcomes - Chair, Prof. Dr. Diamant Thaçi, Lübeck, Germany - Prof. Dr. Anna López-Ferrer, Barcelona, Spain - Prof. Dr. Ulrich Mrowietz, Kiel, Germany Thursday 26th September at 17:45 (CEST) / Room G104-G105 (SAT 11.04). Satellite Symposium on atopic dermatitis : Precision in AD: how lebrikizumab is changing the treatment paradigm - Chair, Prof. Dr. Marjolein de Bruin-Weller, Utrecht, The Netherlands - Dr. Andrew Blauvelt, Lake Oswego, US - Prof. Dr. Sascha Gerdes, Kiel, Germany Friday 27th September at 13:00 (CEST) / Room G104-G105 (SAT 11.06). A total of 37 abstracts have been accepted by the EADV for their annual meeting. Ebglyss® (lebrikizumab ) 1. Late breaking news: Efficacy and safety of lebrikizumab is maintained up to 3 years in patients with moderate-to-severe atopic dermatitis: ADvocate 1 and ADvocate 2 to ADjoin long-term extension trial 2. Absolute EASI response achieved by lebrikizumab over 16 weeks in patients with moderate-to-severe atopic dermatitis 3. Absolute itch and quality of life response with lebrikizumab through 52 weeks 4. Absolute EASI response achieved with lebrikizumab over 52 weeks in patients with moderate-to-severe atopic dermatitis 5. Absolute response of lebrikizumab at Week 52 in patients with moderate-to-severe atopic dermatitis who did not achieve protocol-defined response after initial 16 weeks of treatment 6. Improvement across disease dimensions with lebrikizumab in combination with topical corticosteroids in atopic dermatitis inadequately controlled or ineligible to cyclosporine: results from the ADvantage study 7. Lebrikizumab improves signs and symptoms of moderate-to-severe atopic dermatitis in patients inadequately controlled or ineligible for cyclosporine: week 52 results of a phase 3 clinical study (ADvantage) 8. Lebrikizumab in monotherapy improves the signs of moderate-to-severe atopic dermatitis across different body regions including the head and neck over one year of treatment 9. Number needed to treat with lebrikizumab in monotherapy at Week 16 in patients with moderate-to-severe atopic dermatitis Ilumetri® (tildrakizumab) 1. Improving the well-being of patients with moderate to severe plaque psoriasis and involvement of impactful areas with Tildrakizumab 2. Effectiveness and Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA) of tildrakizumab patients with nail psoriasis: 52-week results from the phase IV POSITIVE Austrian subset. 3. Effectiveness of tildrakizumab in patients with moderate-to-severe psoriasis located in special areas: 52-week results from the POSITIVE study 4. High effectiveness of tildrakizumab in bio-naïve and bio-experienced patients with moderate-to-severe psoriasis: 52-week results from the POSITIVE study 5. High effectiveness of tildrakizumab regardless of baseline characteristics in patients with moderate-to-severe psoriasis: 52-week results from the POSITIVE study 6. Patient-reported well-being using tildrakizumab for psoriasis in a real-world setting: 52-week interim data of the phase IV POSITIVE study 7. Safety of tildrakizumab in patients with moderate-to-severe psoriasis: 52-week data from the phase IV POSITIVE study 8. Effectiveness of tildrakizumab for itch, pain, and fatigue in patients with moderate-to-severe psoriasis: 52-week results from the real-world POSITIVE study 9. Quality of life, work productivity and treatment satisfaction with tildrakizumab in moderate-to-severe psoriasis patients: 52-week interim data of the real-world POSITIVE study 10. Impact of patient psoriasis on partner well-being in a real-world setting: 52-week interim data of the phase IV POSITIVE study 11. Efficacy and safety of tildrakizumab through Week 28 in patients with early vs late-onset moderate-to-severe plaque psoriasis: A post hoc analysis of reSURFACE 1 and reSURFACE 2 Wynzora® (CAL/BDP) 1. Impact of calcipotriene and betamethasone dipropionate cream with PAD technology (CAL/BPD PAD cream) on scalp-PGA success, S-mPASI and clinician satisfaction among patients with mild-to-moderate scalp psoriasis in routine clinical practices in Europe. An interim analysis of the PRO-SCALP study. 2. Impact of calcipotriene and betamethasone dipropionate cream with PAD technology (CAL/BPD PAD cream) on patient symptoms, functioning, emotions, level of itching, and sleep quality among patients with mild-to-moderate scalp psoriasis in routine clinical practices in Europe. An interim analysis of the PRO-SCALP study. 3. Patient preference over other topicals, perception of cream usability, treatment adherence and satisfaction among patients with mild-to-moderate scalp psoriasis using calcipotriene and betamethasone dipropionate cream with PAD technology (CAL/BPD PAD cream) in routine clinical practices in Europe. An interim analysis of the PRO-SCALP study. 4. Best responders to calcipotriol and betamethasone dipropionate PAD-cream: post-hoc analysis from pooled MC2-01-C2 and MC2-01-C7 phase III trials at week 4 and week 8. 5. Cost per responder analysis of calcipotriol plus betamethasone dipropionate cutaneous PAD cream for the topical treatment of mild to moderate plaque psoriasis in Italy. 6. Patient benefit assessment of topical treatment in psoriasis: Validation of the PBI-TOP questionnaire in a longitudinal study. Klisyri® (tirbanibulin) and actinic keratosis 1. Lack of correlation between number of baseline actinic keratoses and local tolerability signs severity in patients treated with tirbanibulin over a 100 cm2 area: results from a Phase 3 study 2. Real-world evidence of tirbanibulin for actinic keratosis in Germany. Insights into patient-reported outcomes, safety and effectiveness 3. Efficacy and safety of tirbanibulin 1% ointment for the treatment of actinic keratosis in conditions close to routine clinical practice in Spain and Italy (TIRBASKIN study) 4. Patient and physician-reported outcomes with tirbanibulin 1% ointment for actinic keratosis in conditions close to routine clinical practice in Spain and Italy (TIRBASKIN study) 5. Enhancement of sun-damaged skin qualities with tirbanibulin (SunDamage Study) 6. Actinic cheilitis: Diagnosis and monitoring after treatment with Tirbanibulin using optical coherence tomography 7. Diagnosis and treatment of patients with actinic keratosis in France: REAKT study Actinic keratosis in France: an avoidable risk of skin cancer, unexpectedly also for people aged under 65 years (REAKT study) 8. Actinic keratosis in France: disease perceptions, expectations, and behaviors of patients (REAKT study). Poster availability date and time : From 25 September 2024 (07.00 CEST) until 3 months post congress. Location : https://eadv.org/congress/ , and e-poster area About Almirall Almirall is a global pharmaceutical company dedicated to medical dermatology. We closely collaborate with leading scientists, healthcare professionals, and patients to deliver our purpose: to transform the patients' world by helping them realize their hopes and dreams for a healthy life . We are at the forefront of science to deliver ground-breaking, differentiated medical dermatology innovations that address patients´ needs. Almirall, founded in 1944 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM, total revenue in 2023: €898.8 MM, 1900 employees globally). Almirall products help to improve the lives of patients every day and are available in over 100 countries. For more information, please visit https://www.almirall.com/ Legal notice: This document includes only summary information and is not intended to be exhaustive. The facts, figures, and opinions contained in this document, in addition to the historical ones, are "forward-looking statements." These statements are based on the information currently available and the best estimates and assumptions that the Company considers reasonable. These statements involve risks and uncertainties beyond the control of the Company. Therefore, actual results may differ materially from those declared by such forward-looking statements. The Company expressly waives any obligation to revise or update any forward-looking statements, goals, or estimates contained in this document to reflect any changes in the assumptions, events, or circumstances on which such forward-looking statements are based, unless required by the applicable law.

Almirall has announced that Klisyri (tirbanibulin) has received expanded approval from the US Food and Drug Administration (FDA) to treat actinic keratosis (AK), a common precancerous condition. The approval follows the company’s supplemental new drug application (sNDA) to expand the use of the microtubule inhibitor ointment on areas of the face or scalp to up to 100 cm2. Characterised by rough, scaly patches of skin, AK is estimated to be responsible for 60% of all squamous cell carcinoma cases, the second most common form of skin cancer. According to a recent survey by Almirall as part of AK Global Day 2024, AK has an estimated prevalence of 13.3% in Europe and 50% of the population experiences sunburn at least once a year. First approved by the FDA in December 2020, the recent approval was supported by an additional phase 3 clinical safety study involving more than 100 adult AK patients in the US, which met all primary endpoints of the study. Results for the safety and tolerability of Klisyri conducted on an area of 100 cm2 on the face or balding scalp of patients was consistent with the original pivotal trials conducted on an area of 25 cm2 for both local skin reactions and treatment-related adverse events, while also showing a percent reduction in AK lesion count in line with the one reported in the original studies. Commenting on the approval, Karl Ziegelbauer, chief scientific officer, Almirall, said: “The FDA’s approval of the use of Klisyri for AK on an extended surface of the face or scalp is a significant step forward for both patients and treating dermatologists. “With patients experiencing AK over larger surface areas, dermatologists are looking for ways to treat the entire affected area to help prevent further lesion progression.” Klisyri has already received several approvals, including from the EU and UK in 2021, as a one-application daily treatment for five days for AK of the face and scalp in adults. In March 2024, Almirall and Eloxx Pharmaceuticals entered into an exclusive agreement to license an oral therapy, ZKN-013, for rare dermatological diseases in a deal worth more than $470m.