"AAD 2025: Almirall's Bold Moves in Dermatology"

The 2025 American Academy of Dermatology (AAD) Annual Meeting was a stage for Almirall, a global pharmaceutical company, to showcase its latest advancements in dermatology. The company presented compelling data on tirbanibulin, a topical treatment for actinic keratosis (AK), and progress on its early-stage pipeline asset LAD191. This presentation underscored Almirall's commitment to innovation and patient-centered care, but it also raised questions about the broader implications for the dermatology market and the ethical responsibilities of pharmaceutical companies.



Almirall's presentation at AAD 2025 was a masterclass in strategic communication. The company highlighted the real-world effectiveness and patient satisfaction of tirbanibulin, a topical treatment for actinic keratosis (AK). The data presented showed that tirbanibulin demonstrated consistent treatment response across phase IV and real-world evidence studies, with high levels of response and patient satisfaction. This was supported by the PROAK study, which evaluated patient- and clinician-reported outcomes during 24 weeks of follow-up among adult patients with AK on the face or scalp who were administered tirbanibulin 1% ointment in real-world community practices in the United States. The study found that at week 8, a statistically significant difference (P<0.03) was observed for Skindex-16 domains in all assessed subgroups, indicating improved quality of life (QoL) as early as week 8. Additionally, clinicians and patients reported high global satisfaction (mean [SD] scores of 74.9 [23.9] and 72.0 [24.6], respectively) at week 24, with overall skin appearance improving from baseline to week 24 (83.6% clinicians; 78.5% patients). IGA success (IGA score of 0-1) was achieved by 71.9% of patients at week 24, with a similar percentage at week 8 (73.8%), suggesting stable effectiveness over time. About 5% of patients reported at least one adverse event, 4% reported at least one serious adverse event, and no patients reported serious adverse drug reactions. At week 8, the most frequently reported local skin reactions were mild/moderate erythema (47.6%) and flaking/scaling (49.6%). These findings are consistent with the phase I data of the early-stage pipeline asset LAD191, which is expected to impact immune-modulated skin diseases by blocking multiple proinflammatory pathways. The data from phase III, phase IV, and real-world studies provide further evidence for tirbanibulin's tolerability, safety profile, and patient satisfaction. This consistency between real-world evidence and clinical trial results suggests that Tirbanibulin is effective and well-tolerated in real-world settings, which is crucial for its market positioning and adoption by healthcare providers. The positive patient satisfaction and high levels of treatment success reported in real-world settings are likely to drive increased adoption and market share for Tirbanibulin.

Almirall's focus on early-stage pipeline progress is driven by several key factors, which align with the company's long-term goals and market trends in dermatology. Firstly, the company recognizes the significant unmet needs in medical dermatology, where many skin conditions still have limited treatment options. This is evident from the statement, "Medical dermatology remains a field with significant unmet needs, as many skin conditions still have limited treatment options." This recognition drives Almirall to invest in early-stage pipeline assets to address these unmet needs and provide innovative solutions for patients.

Secondly, Almirall's strategy is supported by the strong performance of its European Dermatology business, which has shown significant growth. For instance, in 2024, the European Dermatology business grew by 22.5% year-on-year, totaling €484.1 MM in sales. This financial success provides the necessary resources for Almirall to invest in research and development, as seen in the sustained investment in R&D at 12.6% of net sales in 2024. This investment is crucial for progressing early-stage pipeline assets and ensuring the company's continued growth and innovation.

Thirdly, Almirall's focus on early-stage pipeline progress aligns with the company's commitment to delivering transformative dermatological solutions. The company's dedication to innovation and patient care is evident in its presentation of new data on tirbanibulin and the progress of its early-stage asset LAD191 at the 2025 American Academy of Dermatology (AAD) Annual Meeting. This presentation demonstrates Almirall's commitment to finding novel solutions for skin diseases and its dedication to the medical community and patients living with skin diseases.

Lastly, the market trends in dermatology support Almirall's strategy. The dermatology market is forecasted to show significant growth potential in the foreseeable future, with an estimated annual growth rate of +7.5% over the next five years, projected to reach €71 billion by 2030. This growth potential, coupled with the increasing scientific understanding of skin diseases and a resulting stream of new product launches, provides a favorable environment for Almirall to progress its early-stage pipeline and deliver innovative treatments to patients.

The patient-centered approach highlighted in the AAD 2025 presentations on Tirbanibulin significantly influences the overall treatment landscape for actinic keratosis (AK) by emphasizing the importance of patient satisfaction and adherence to treatment protocols. According to Dr. Darrell rigel, MD MS and Clinical Professor, Mount Sinai icahn School of Medicine, "Patient satisfaction is a significant aspect of treatment outcomes. The results of these studies with tirbanibulin indicate notable improvements in patient satisfaction in real-world scenarios, which supports adherence to AK treatment protocols thus paving the way for more sustainable outcomes." This focus on patient experience and addressing their needs can enhance the effectiveness of therapies, leading to an overall improvement in the quality of care.

For Almirall, this patient-centered approach presents an opportunity to solidify its position as a leader in dermatology by demonstrating its commitment to delivering impactful data on established products and progressing its early-stage pipeline. The company's dedication to understanding the needs of the dermatology community and patients is evident in its presentation of new data on tirbanibulin and the progress of its early-stage asset LAD191 at the AAD 2025 conference. This strategy aligns with Almirall's goal of finding novel solutions for skin diseases and improving patient outcomes.

However, this approach also presents challenges for Almirall and its competitors. The emphasis on patient satisfaction and real-world effectiveness means that companies must invest in research and development to continuously improve their products and address unmet needs in medical dermatology. As Dr. Volker Koscielny, Almirall’s Chief Medical Officer, stated, "Our close collaboration with the dermatology community and patients allows us to better understand their needs and develop effective solutions." This requires sustained investment in R&D and clinical trials, as well as the ability to adapt to changing patient preferences and treatment landscapes.

For competitors, the focus on patient-centered care means that they must also prioritize patient satisfaction and real-world effectiveness in their product development and marketing strategies. Companies that fail to do so may struggle to compete with Almirall and other leaders in the field who are successfully addressing these needs. Overall, the patient-centered approach highlighted in the AAD 2025 presentations on Tirbanibulin is reshaping the treatment landscape for actinic keratosis, with both opportunities and challenges for Almirall and its competitors.