Characterization of dose-FEV1 response of tralokinumab, an investigational anti-IL13 monoclonal antibody in patients with uncontrolled asthma : a population pharmacokinetic/pharmacodynamic modeling analysis

2015-07-01·British journal of clinical pharmacology2区 · 医学

A pharmacokinetic comparison of anrukinzumab, an anti‐ IL‐13 monoclonal antibody, among healthy volunteers, asthma and ulcerative colitis patients

2区 · 医学

Article

作者: Hua, Fei ; Ribbing, Jakob ; Cataldi, Fabio ; Martin, Steven ; Reinisch, Walter

Aims:

Anrukinzumab is an anti‐IL13 monoclonal antibody. The goals of this study are to characterize the pharmacokinetics of anrukinzumab in healthy volunteers and different disease states and to identify covariates.

Methods:

A population pharmacokinetic (PK) model was developed in NONMEM, using data from five clinical studies including healthy volunteers, asthma and ulcerative colitis (UC) patients. Different dosing regimens including different routes of administration were also included in the data.

Results:

The PK of anrukinzumab were described by a two compartment model with first order absorption and elimination. The population estimates (relative standard error) of the volumes of distribution in the central (Vc) and peripheral (Vp) compartments were 3.8 (4.6%) and 2.2 l (8.7%), respectively. In non‐UC patients, the population estimate of the systemic clearance (CL) and inter‐compartmental CL was 0.00732 l h–1 (4.9%) and 0.0224 l h–1 (15.4%). For subcutaneous administration, the absorption rate constant was 0.012 h–1 (6.6%) and bioavailability was nearly 100% in healthy and mild to moderate asthma patients. Both V and CL increased with body weight. CL (but not V) decreased with increasing baseline albumin concentrations. UC patients had an increased CL of 72.3% (10.5%), after correction for differences in body weight and albumin. Moderate to severe asthma patients had decreased bioavailability compared with other populations.

Conclusions:

Anrukinzumab's PK behave like a typical antibody. UC patients were identified to have a faster CL of anrukinzumab than healthy volunteers and asthma patients. This finding suggests a higher dose level may be required for this population.

2014-01-01·Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology2区 · 医学

The effects of lebrikizumab in patients with mild asthma following whole lung allergen challenge

2区 · 医学

Article

作者: Harris, J. M. ; Jarjour, N. N. ; Lee, J. ; Choy, D. F. ; Zheng, Y. ; Erickson, R. W. ; Putnam, W. S. ; Scheerens, H. ; Matthews, J. G. ; Arron, J. R.

Summary:

Background:

Interleukin 13 (IL13) is a T‐helper type 2 (Th2) cytokine associated with inflammation and pathology in allergic diseases such as bronchial asthma. We have shown that treatment with lebrikizumab, an anti‐IL13 monoclonal antibody, significantly improves prebronchodilator forced expiratory volume in 1 s (FEV1) in a subset of subjects with uncontrolled asthma.

Objective:

To evaluate efficacy and safety of lebrikizumab in subjects with mild asthma who underwent bronchial allergen challenge.

Methods:

Twenty‐nine subjects were randomized 1 : 1–5 mg/kg lebrikizumab (n = 13) or placebo (n = 16) administered subcutaneously every 4 weeks over 12 weeks, a total of four doses. Primary efficacy outcome was late asthmatic response (LAR) at Week 13, defined as area under the curve of FEV1 measured 2–8 h following inhaled allergen challenge. Serum biomarkers were measured to verify IL13 pathway inhibition and identify patients with an increased response to lebrikizumab.

Results:

At Week 13, the LAR in lebrikizumab subjects was reduced by 48% compared with placebo subjects, although this was not statistically significant (95% confidence interval, −19%, 90%). Exploratory analysis indicated that lebrikizumab‐treated subjects with elevated baseline levels of peripheral blood eosinophils, serum IgE, or periostin exhibited a greater reduction in LAR compared with subjects with lower baseline levels of these biomarkers. Lebrikizumab exerted systemic effects on markers of Th2 inflammation, reducing serum immunoglobulin E (IgE), chemokine ligands 13 and 17 by approximately 25% (P < 0.01). Lebrikizumab was well tolerated.

Conclusion and Clinical Relevance:

Lebrikizumab reduced the LAR in subjects with mild asthma. Clinical trial number NCT00781443.

项与 DOM-1000P 相关的新闻（医药）

2023-07-24

·BioSpace

Almirall’s H1 2023 Results: Almirall Achieves Net Sales Growth of 7% to €466.1MM, Driven by Strong Growth in European Dermatology Business

The European dermatology business remains the key driver of Almirall’s growth with a robust 15% year-on-year increase, based on solid business momentum generated by our key growth and recently launched products. Total EBITDA amounted to €101.3 MM as the sales growth was offset by lower other income and increasing investments in launches and R&D projects Strong operational performance of Almirall’s growth drivers in the first half of 2023. Ilumetri® maintains strong growth across geographies, with good performances in Germany and Spain, while Wynzora® and Klisyri® continue to gain market share in Europe following a successful rollout in key countries The company is actively preparing the launch of lebrikizumab, a biologic for atopic dermatitis. During the first half of the year, Almirall continued to present new data that reinforces the robust body of evidence on lebrikizumab. The marketing authorisation by the European Commission, which is currently under review, is anticipated for late 2023 In June, Almirall successfully completed the pricing and closing of a €200 MM non-pre-emptive share capital increase to retain financial flexibility and agility to actively pursue and swiftly execute inorganic growth opportunities Based on the solid performance of the business in the first half, Almirall is reiterating its full year 2023 guidance Following its ESG roadmap, the Science-Based Targets Initiative (SBTi) has validated Almirall's 2030 emissions reduction targets and its goal of achieving net zero emissions by 2050 BARCELONA, Spain--(BUSINESS WIRE)-- Almirall, S.A. (ALM), the global biopharmaceutical company based in Barcelona, has announced its H1 2023 financial results. Financial highlights (€ rounded million) H1 2023 H1 2022 Variation Net Sales 466.1 436.6 6.8% Total EBITDA 101.3 107.6 -5.9% Net Income 12.0 27.3 -56.0% Normalized Net Income 11.6 27.6 -58.0% Summary of results Net Sales reached €466.1 MM, a +6.8% year-on-year increase boosted by the strong sales growth of the dermatology portfolio in Europe. Total EBITDA was at €101.3 MM, reflecting the lower contribution from Other Income due to Astra Zeneca / Covis milestones, compared to H1 2022. SG&A (Selling, General and Administrative) investment was €214.6 MM. 2.1% higher than last year, as expected, to support the upcoming lebrikizumab launch and recent launches of Wynzora® and Klisyri®, as well as the Ilumetri® rollout in key countries. Gross Margin of 65.4% was in line with expectations and reflects the impact of higher energy costs and the inflationary impact on certain input costs. R&D investment was €52.5 MM, reaching 11.3% of Net Sales, increasing 16.9% year-on-year as expected. Almirall finished H1 2023 with a very healthy balance sheet after the capital increase, with a positive net cash position. This will enable the company to continue pursuing inorganic growth opportunities, bolt-on acquisitions, in-licensing deals and reinforcing the pipeline. “Our European business has continued to perform well during the first half of the year, with robust growth in our medical dermatology business particularly driven by the success of Ilumetri®, our biologic treatment for moderate to severe plaque psoriasis. Moreover, we continue to prepare the organization for the expected approval of lebrikizumab at the end of the year and its successful launch. Recognizing its transformative potential, we want to ensure we capitalize on this innovative treatment, which holds significant opportunities for our company's future growth. During the first half, we also successfully completed a capital increase that will allow us to continue to maintain the financial discipline of recent years and provide the agility to pursue bolt-on acquisitions and in-licensing opportunities. In addition to the solid performance of our growth drivers that are strengthening our position in dermatology, we also continue to advance our exciting early-stage pipeline, which will help drive future growth. Carlos Gallardo Piqué, Chairman and CEO Growth Drivers Performance Psoriasis Ilumetri® (tildrakizumab), an anti-IL-23p19 biologic for moderate-to-severe plaque psoriasis, has continued to show strong growth and momentum, achieving overall Net Sales of €80.4MM, a 40% increase compared to H1 2022. Almirall is confident that its European business will continue to deliver a good performance due to the continued penetration of Ilumetri® across different geographies. The anti-IL23 class continues to lead the market amongst new patients in the German biologics market, with a share of around 40%. During the first half, initial results from the POSITIVE study were presented at the World Congress of Dermatology (WCD), which demonstrated that tildrakizumab significantly improved the wellbeing of patients with moderate to severe plaque psoriasis. The study showed that the product achieved a similar wellbeing status to the general population after 16 weeks, which was maintained up to week 28.i Additionally, Wynzora®, a once-daily aqueous cream with a fixed combination of calcipotriene and betamethasone diproprionate (CAL/BDP) indicated for the topical treatment of mild to moderate psoriasis vulgaris in adults, achieved sales of €7.7 MM in H1 2023, continuing to make solid progress since its launch last year. This treatment has already gained c.15% market share in Germany and c.19% share in Spain, and Almirall expects this solid traction to continue. The company expects to see growing contribution from new markets where the product has been launched, such as the UK, Denmark, the Netherlands, and Austria, as well as from additional EU countries in the upcoming quarters. Wynzora® is commercialized in Austria under a different tradename: Winxory. Actinic keratosis (AK) Klisyri® (tirbanibulin) ointment for actinic keratosis (AK) of the face or scalp achieved Net Sales of c.€9.4 MM in the first half year vs. €5.9MM registered in the same period last year in Europe and the US. In Europe, the product is increasing its market share across the launched countries, such as Netherlands, Austria, Germany, the UK, Switzerland, Spain, and Italy. The company will continue the rollout in further EU countries throughout the year. In the US, Net Sales grew by 38% compared to the same period last year, a particularly good result for a product launched in a market with numerous generic alternatives. Almirall is working on the large field label expansion over the mid-term. The large field expansion launch is anticipated in H2 2024 in the US and 2026 in Europe. Late-stage pipeline with promising potential Atopic dermatitis (AD) Almirall continues to prepare for the successful launch of lebrikizumab, an anti-IL13 monoclonal antibody for the treatment of moderate to severe atopic dermatitis (AD). The company submitted a marketing authorization application to the EMA, which is currently under review, with approval expected in the fourth quarter of 2023. Atopic dermatitis is a chronic condition that requires long-term treatment. Almirall believes that the potential shown in the ADvocate trials to effectively control the disease with dosing of lebrikizumab every four weeks during the maintenance phase is suitable in achieving this, and we are in the advanced planning stages of an extension study to investigate lebrikizumab’s benefits over a period up to 5 years. The totality of the data and the pro lebrikizumab lead Almirall to believe that this treatment may become a first-line treatment option for people living with atopic dermatitis. Other indications Regulatory filings have been submitted by Almirall under the European decentralized procedure in 2022 for efinaconazole, for the treatment of mild-to-moderate fungal infection of the nail in adults and children (aged 6 years and older). This product will complement Ciclopoli®, thereby reinforcing Almirall’s onychomycosis franchise. In relation to the oral antibiotic Seysara® (sarecycline), Almirall plans to application to the Chinese National Medical Products Administration later this year, which will be completed once the positive results of the phase III clinical trial conducted in China have been presented. Autoimmune dermatological diseases Almirall is also building an exciting early pipeline with promising potential. In September 2022, the company initiated a phase I study of the anti-IL-1RAP monoclonal antibody ALM27134*, evaluating the safety, pharmacokinetics, pharmacodynamics, and clinical activity of this potential first-in-class fully human, high-affinity monoclonal antibody that targets the interleukin-1 receptor accessory protein. ALM27134, which was in-licensed in 2021 from Ichnos Science with exclusive global rights, has potential utility across different autoimmune skin diseases. *Previously referred to as ISB 880 Collaboration with CRG on non-melanoma skin cancer As part of its deep commitment to innovation, Almirall continues to explore and sign agreements to discover breakthrough treatments for skin diseases. The company has entered into a research collaboration with the Centre for Genomic Regulation (CRG), an international biomedical research institute of excellence, to develop and characterize new preclinical models that will help identify new treatments for non-melanoma skin cancer (NMSC). Advances in the ESG roadmap The Science-Base Targets initiative (SBTi), a project jointly driven by CDP, the United Nations Global Compact, the World Resources Institute (WRI) and WWF, has validated Almirall’s ESG targets to achieve net zero greenhouse gas (GHG) emissions across the value chain by 2050, under the 'Net-Zero Standard'. In this regard, the company has also committed to reducing absolute GHG emissions from its own and indirect sources, including energy procurement by 50% and indirect emissions produced in the value chain by 28% by 2030, compared to 2019. The targets set by Almirall belong to its new ESG Dashboard, which includes 25 ESG indicators for 2025 and 2030. The Science-Based Targets Initiative (SBTi) has confirmed that these targets are in line with what climate science considers necessary for global warming not to exceed 1.5°C above pre-industrial levels for Scopes 1 and 2, and a target of "well below 2°C" is set for Scope 3. 2023 Full Year Guidance & Investor Calendar Guidance reiterated: Net Sales growth of low to mid single-digit and Total EBITDA between €165 MM - €180 MM Investor calendar 2023 9M 2023 Financial Results – 8th November 2023 About Almirall Almirall is a global biopharmaceutical company focused on medical dermatology. We collaborate with scientists and healthcare professionals to address patient’s needs through science to improve their lives. Our Noble Purpose is at the core of our work: “Transform the patients' world by helping them realize their hopes and dreams for a healthy life”. We invest in differentiated and ground-breaking medical dermatology products to bring our innovative solutions to patients in need. The company, founded in 1944 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM). Throughout its 79-year history, Almirall has retained a strong focus on the needs of patients. Currently, Almirall has a direct presence in 21 countries and strategic agreements in over 70, with about 1,800 employees. Total revenue in 2022 was €878.5MM. For more information, please visit almirall.com Legal warning 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. i Mrowietz U, Augustin M, Sommer R. et al. Patient-reported well-being in value-based care using tildrakizumab in a real-world setting: 28-week interim data of the phase IV POSITIVE study. Abstract presented at 25th World Congress of Dermatology, Singapore, 3–8 July, 2023 View source version on businesswire.com: Contacts Media: Tinkle Laura Blázquez lblazquez@tinkle.es Phone: (+34) 600 430 581 Investors’ Relations Almirall Pablo Divasson del Fraile pablo.divasson@almirall.com Phone: (+34) 93 291 3087 Corporate Communications: Almirall Mar Ramírez mar.ramirez@almirall.com Phone: (+34) 659 61 41 73 Source: Almirall View this news release online at:

临床结果临床1期临床3期上市批准

2023-05-08

·BioSpace

Almirall’s First Quarter 2023 Results

Almirall's Net Sales reach € 232MM and increase by 6%, boosted by a solid European dermatology business The European dermatology business achieved excellent performance, with Net Sales increasing by 11.4% year-on-year, driven by solid business momentum from key products and positive trajectories of recently launched products Total EBITDA of €51.8 MM, reflecting a lower contribution from Other Income compared to Q1 2022 Growth drivers show steady increases. Ilumetri® maintains its positive momentum across geographies, with good performances in Germany and Spain, while Wynzora® and Klisyri® continue to gain market share in Europe following a successful rollout in key countries The company is preparing the launch of lebrikizumab, a promising biologic for atopic dermatitis. Positive Week 16 results from the Almirall phase IIIb study ADvantage. The marketing authorisation by the European Commission is expected in late 2023 Progress in the pipeline: Advancing in the extension label for Klisyri® (tirbanibulin) to treat a larger field. Almirall presented topline evidence that this product is well tolerated when applied on a surface up to 100 cm2 Regarding the early-stage, the phase I study of anti-IL1RAP is ongoing and the company aims to launch the phase I for IL-2-mu-Fc during the year Based on the good performance of the business in Q1, Almirall is reiterating its 2023 guidance BARCELONA, Spain--(BUSINESS WIRE)-- Almirall, S.A. (ALM), the global biopharmaceutical company based in Barcelona, has announced its Q1 2023 financial results. Financial highlights (€ rounded million) Q1 2023 Q1 2022 Variation Net Sales 232.0 218.8 6.0% Total EBITDA 51.8 59.6 (13.1%) Net Income 7.7 20.4 (62.3%) Normalized Net Income 7.7 20.5 (62.4%) Summary of results Net Sales reached €232.0 MM, a +6% year-on-year increase underpinned by the strong sales growth of the dermatology portfolio in Europe. Total EBITDA was at €51.8 MM, reflecting the lower contribution from Other Income due to Astra Zeneca / Covis milestones compared to Q1 2022. SG&A (Selling, General and Administrative) investment was €106.7 MM. 3.7% higher than last year, as expected, to support the upcoming and recent launches of Wynzora® and Klisyri® in the US and in the EU, and Ilumetri® rollout in key countries; as well as some internal launch readiness for lebrikizumab. Gross Margin of 65.4% was in line with expectations and reflects the impact of higher energy costs and the inflation affecting some material purchases. R&D investment was €23.9 MM, reaching 10.3% of Net Sales, increasing 13.3% year-on-year as expected. Almirall finished Q1 with a very healthy balance sheet with Net Debt of €216.0MM, an increase compared to Q4 2022 mainly explained by the high amount of investment we had in the first quarter, including Efficib®/Tesavel® extension deal, Physiorelax® acquisition, Ilumetri® and Klisyri® milestones and the Isolex upfront payment. 1.1 x Net Debt to EBITDA remains comfortable. “Q1 2023 marks a solid start for Almirall. We delivered an excellent operational performance that sets us on track to meet our 2023 guidance. Our European business is continuing its positive trend, driven by the consistent growth of key products such as Ilumetri®, Klisyri®, and Wynzora®. Our innovative late-stage pipeline and robust balance sheet pave the way for sustainable long-term growth. We remain focused on preparing the business for the expected approval of lebrikizumab in late 2023, a product with the potential to transform our company. We are building a strong position across key dermatology indications, and the significant progress of our early and late-stage pipeline demonstrates that we are on the right path to strengthen our leadership position in medical dermatology”. Carlos Gallardo Piqué, Chairman and CEO Growth Drivers Performance Psoriasis Ilumetri® (tildrakizumab), an anti-IL-23p19 biologic for moderate-to-severe plaque psoriasis, has continued to show resilient growth and maintain strong momentum, achieving an overall Net Sales of €38 MM, a 41% increase compared to Q1 2022. Almirall is confident that its European business will continue to flourish throughout 2023 with the contribution of new countries where Ilumetri® has been recently launched. Despite the entrance of some biosimilars in the market, the anti-IL23 class continues to lead the market share of new patients in the German biologics market, around 40% market share of new patients within biologics. Almirall has been the first to assess wellbeing in a dermatology clinical study, in a real-world setting. The protocol of the study, which evaluated patients receiving tildrakizumab, has been recently published in the British Medical Journal (BMJ). Additionally, Wynzora® cream, a once-daily aqueous cream with a fixed combination of calcipotriene and betamethasone diproprionate (CAL/BDP) indicated for the topical treatment of mild to moderate psoriasis vulgaris in adults, achieved sales of over €3.5 MM in Q1 2023, following the good progress since its launch in May 2022. Almirall expects that traction in the first countries launched will continue, improving double-digit market share in Germany and Spain, reaching c.19% and 14% respectively. The company is confident that it has potential for significant growth in markets where the product has been already launched, such as Germany, Spain, the UK, Denmark, the Netherlands, and Austria; as well as in additional EU countries in the upcoming quarters. Wynzora® is commercialized in Austria under a different tradename: Winxory. Actinic keratosis (AK) Klisyri® (tirbanibulin) ointment for actinic keratosis (AK) of the face or scalp achieved Net Sales of c.€4.7 MM in the first quarter vs. €3.0MM registered in the same period of the last year in Europe and the US. In Europe, the product is increasing market share across countries launched, such as Netherlands, Austria, Germany, the UK, Switzerland, Spain, and Italy, and the company expects to launch the product in further EU countries throughout the year. In the US, Klisyri® received a strong recommendation in the American Academy of Dermatology (AAD) guidelines. Net Sales grew by 57% in the US and EU compared to the same period last year, an excellent result for a product launched in a market with numerous generic alternatives. Around 5,700 healthcare professionals have prescribed Klisyri® since its launch and continues to receive positive feedback with good patient engagement. While Almirall continues to focus on driving demand by differentiating Klisyri® from what is already available on the market based on efficacy, tolerability and convenience, the company is also working on the large field (surface up to 100 cm2) label expansion over the mid-term. Large field indication launch is anticipated in 2024 in the US and 2026 in Europe. Acne Seysara® (sarecycline), an innovative oral antibiotic, showed continued volume growth throughout Q1 2023 along with a sales increment of 12% vs Q1 2022, achieving Net Sales of €4.8 MM and a TRx volume of 64,000 as Almirall continues to focus on gaining market access via commercial payer coverage expansion during Q1 2023. During Q1 2023, Seysara® achieved a 5.8% market share in the oral antibiotic market. The company remains focused on driving demand and boosting pro productivity (TRx/HCP), which is key to continued growth. Late-stage pipeline with promising potential Atopic dermatitis (AD) Almirall submitted a marketing authorization application to the EMA for lebrikizumab, an anti-IL13 monoclonal antibody for the treatment of moderate-to-severe atopic dermatitis (AD). This application is currently under review, and approval is expected in Q4 2023. In the first quarter of 2023, Almirall announced several positive clinical updates on lebrikizumab. The ADvantage phase IIIb study met the primary endpoint at the Week 16 analysis. The randomized, double-blind, placebo-controlled phase lllb study evaluated the efficacy and safety of lebrikizumab in combination with topical corticosteroids in adult and adolescent patients with moderate-to-severe atopic dermatitis not adequately controlled with cyclosporine or for whom cyclosporine is not medically advisable. Safety was consistent with the known pro lebrikizumab. Atopic dermatitis is a chronic condition that requires long-term treatment. Almirall believes that the potential shown in the ADvocate trials to effectively control the disease with dosing of lebrikizumab every four weeks during the maintenance phase is suitable in achieving this, and we are in the advanced planning stages of an extension study to investigate lebrikizumab’s benefits over a period up to 5 years. The totality of the data and the pro lebrikizumab lead Almirall to believe that this treatment has the potential to be a first-line treatment option for people living with atopic dermatitis and their healthcare professionals. Lebrikizumab showed a consistent pro a clinical development program, whether in monotherapy or in combination with topical corticosteroids, and in both adult and adolescent populations. In maintaining patients who responded to treatment at week 16, the Q4W dosing shows strong results similar to the Q2W dosing. The evidence has been published in several peer-reviewed scientific journals, such as the New England Journal of Medicine (NEJM), the British Journal of Dermatology (BJD), and JAMA Dermatology. Other indications Almirall has submitted regulatory filings under the European decentralized procedure in 2022 for efinaconazole, for the treatment of mild-to-moderate fungal infection of the nail in adults and children (aged 6 years and older). This product would reinforce Almirall’s onychomycosis franchise by complementing Ciclopoli®. As for the oral antibiotic Seysara® (sarecycline), Almirall plans to application to the Chinese National Medical Products Administration later this year, after presenting positive results of a phase III clinical trial conducted in this country. Autoimmune dermatological diseases Almirall is also building an exciting early pipeline with promising recent in-licensing assets. The company is carrying on a phase I study for the anti-IL-1RAP monoclonal antibody, which has potential utility across different autoimmune skin diseases. In September 2022, Almirall announced the initiation of the phase I study evaluating the safety, pharmacokinetics, pharmacodynamics, and clinical activity of ALM27134*, a potential first-in-class fully human, high-affinity monoclonal antibody that targets IL-1RAP (interleukin-1 receptor accessory protein) for the treatment of autoimmune dermatological diseases. Almirall in-licensed in 2021 exclusive global rights from Ichnos Science to develop and commercialize ALM27134. *Previously referred to as ISB 880 2023 Full Year Guidance Guidance reiterated: Net Sales growth of low to mid single-digit and Total EBITDA between €165 MM - €180 MM Dividend and Investor Calendar 2023 On May 5, in the General Shareholders' Meeting, the distribution of a dividend charged to unrestricted reserves for the amount of €34.5 million (equivalent to €0.19 per share) was approved. For the purposes of this dividend distribution, it was approved to use the scrip dividend shareholder remuneration system, which has already been applied in previous years. Investor calendar 2023 H1 2023 Financial Results – 24th July 2023 9M 2023 Financial Results – 13th November 2023 About Almirall Almirall is a global biopharmaceutical company focused on skin health. We collaborate with scientists and healthcare professionals to address patient’s needs through science to improve their lives. Our Noble Purpose is at the core of our work: “Transform the patients' world by helping them realize their hopes and dreams for a healthy life”. We invest in differentiated and ground-breaking medical dermatology products to bring our innovative solutions to patients in need. The company, founded in 1943 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM). Throughout its 79-year history, Almirall has retained a strong focus on the needs of patients. Currently, Almirall has a direct presence in 21 countries and strategic agreements in over 70, with about 1,800 employees. Total revenue in 2022 was €878.5MM. For more information, please visit almirall.com Legal warning 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. View source version on businesswire.com: Contacts Media: Tinkle Laura Blázquez lblazquez@tinkle.es Phone: (+34) 600 430 581 Investors’ Relations Almirall Pablo Divasson del Fraile pablo.divasson@almirall.com Phone: (+34) 93 291 3087 Corporate Communications: Almirall Mar Ramírez mar.ramirez@almirall.com Phone: (+34) 659 61 41 73 Source: Almirall, S.A. View this news release online at:

临床结果临床1期临床3期上市批准财报

2023-02-20

·Business Wire

Almirall’s Full-Year 2022 Results

BARCELONA, Spain--( BUSINESS WIRE )-- Almirall, S.A. (ALM) a global biopharmaceutical company based in Barcelona, has announced its full-year 2022 financial results today. Financial highlights (€ rounded million) 2022 2021 Variation Total Revenues 878.5 836.5 5.0% Net Sales 863.2 827.2 4.4% Other Income 15.3 9.3 64.5% Gross Profit 572.9 571.3 0.3% % of sales 66.4% 69.1% EBITDA 198.3 235.6 (15.8%) Normalized Net Income 33.5 81.4 (55.8%) * Core results excludes AstraZeneca/Covis contribution: Deferred Income and Other Income. From 2022 onwards, there is no difference between Core Net Sales and Net Sales as no additional Deferred Income from AstraZeneca is registered, the difference related to Core EBITDA and EBITDA is explained by the other income related to AstraZeneca and Covis. "We are pleased to see that Almirall achieved strong financial results in 2022, delivering our guidance thanks to the excellent evolution of our core dermatology business, which continues to perform well and is driven by our recently launched products and strength in the European business. In the meantime, we have also made good progress with our pipeline. We started 2023 on a high note. We are confident that Almirall’s growth drivers will continue their positive trajectory during 2023 while we keep preparing for Lebrikizumab’s launch. We are very well-positioned for mid and long-term growth. Our strong balance sheet and flexible capital structure will allow us to continue to explore inorganic growth options that align with our corporate strategy.” Carlos Gallardo, Chairman and CEO. Summary of results Net Sales * at €863.2 MM represent a 6.6% year-on-year growth, driven by strong EU Dermatology portfolio performance. Total EBITDA* reached €198.3 MM, a 15.8% year-on-year decrease, and was impacted by due to higher R&D, SG&A investment related to new and coming launches, US sales decrease. Almirall closed 2022 with a healthy balance sheet and solid liquidity position at 0.8x Net Debt to EBITDA. Core Gross Margin of 66.4%, as expected, was impacted by higher energy costs and inflation affecting purchase costs of certain materials. Research & Development investment of €103.2 MM, increasing as expected reaching 12% of Core Net Sales, driven by investment in studies for lebrikizumab and Klisyri ® (tirbanibulin), as well as the acquisition of earlier stage assets, such as the anti IL1-Rap and the IL-2 mu-Fc. Selling, General & Administrative expenses were €409.7 MM, up 4.3%, due to supporting recent launches of Wynzora ® , Klisyri ® in Europe and Ilumetri ® rollout in new countries. Divestment of Motilex ® in Italy, with a positive impact of €18.5 MM in Q4 2022, broadly in line with the positive divestment impact of €16m in 2021. * Core results excludes AstraZeneca/Covis contribution: Deferred Income and Other Income. From 2022 onwards, there is no difference between Core Net Sales and Net Sales as no additional Deferred Income from AstraZeneca is registered, the difference related to Core EBITDA and EBITDA is explained by the other income related to AstraZeneca and Covis. Growth Drivers Performance Psoriasis Ilumetri ® , an anti-IL-23 high-affinity humanized monoclonal antibody indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis, had a strong performance in 2022 reaching Net Sales of over €124.6 MM and achieving a 52.1% sales increase year-on-year. Growth was boosted by the positive contribution from new country launches, and sales in Germany, where the new patient market is clearly driven by the anti-IL23 class, with over 40% market share of new patients within biologics. This growth trend is expected to continue during 2023, with added contribution of new country launches. Almirall strengthened its psoriasis franchise with the successful rollout of Wynzora ®* cream, a once-daily aqueous cream with a fixed combination of calcipotriene and betamethasone diproprionate (CAL/BDP) indicated for the topical treatment of mild to moderate psoriasis vulgaris in adults. The launch of this product also reinforces Almirall's position as the only company with an entire portfolio of psoriasis products covering the treatment paradigm. Wynzora ® keeps increasing its market share in key countries, achieving Net Sales of c. €7 MM in 2022, driven by the strong performance in Germany and Spain where the product reached double digit market share. The product also had a successful rollout campaign during 2022 in the UK, Denmark, Netherlands, and Austria and Almirall is confident that Wynzora ® will have a good uptake in these markets as well as in additional EU countries in the upcoming quarters. * Wynzora ® is authorized with this name in France, the UK, Spain, the Czech Republic, Denmark, Norway, Sweden, Finland, Germany, Portugal, Italy, Ireland, and The Netherlands. In Austria, it is authorized under a different tradename: Winxory ® . Actinic Keratosis (AK) Klisyri ® * (tirbanibulin), a microtubule inhibitor for the topical treatment of actinic keratosis (AK) of the face or scalp, delivered a solid performance and positive uptake in Europe thanks to the positive feedback among users and physicians due to its convenience and safety profile. The product reached Net Sales of c.€9 MM in 2022 in Europe with strong performance in Germany, where Klisyri ® was awarded “Most Innovative Product 2022” at the Pharma Trend Image & Innovation Awards. It is also gaining strong traction in countries like the Netherlands, Austria, Switzerland, Spain, and Italy. In the US, where AK is the second most common diagnosis made by dermatologists, Klisyri ® received a recommendation in the AAD guidelines. The product continues to gain penetration in the AK topical market with around 70,000 prescriptions since its launch in February 2021, a result that highlights the product's good performance despite being a new product launched in a market with numerous generic alternatives. Since its launch, Klisyri ® has been prescribed by over 5,000 healthcare professionals, who have reported positive feedback and successful patient engagement. The product now has a greater than 70% commercial coverage. Acne Seysara ® , an oral antibiotic derived from tetracycline and specifically designed to treat acne, has registered continued volume recovery during 2022. With over 250,000 TRx, the product achieved 22% growth year-on-year in prescriptions. The product continues to make good progress on market access with 75% commercial payer coverage. Furthermore, Seysara ® achieved a 6% market share in the oral antibiotic market and Almirall continues to focus its efforts on driving demand and improving the commercial profile and productivity (TRx/HCP) which will be key for continued growth. Progressing promising late-stage pipeline, while building early stage Atopic Dermatitis (AD) In October 2022, Almirall submitted a Marketing Authorisation Application (MAA) to the EMA for Lebrikizumab , an anti-IL13 monoclonal antibody for the treatment of moderate-to-severe atopic dermatitis (AD). AD is an underserved, large and growing market, estimated to have more than 5 million moderate-to-severe patients in Europe by 2026. 1 . The application of lebrikizumab is currently under review, and the approval is expected in Q4 2023. Lebrikizumab showed a consistent safety profile across a clinical development program with more than 2000 patients. Consistent across geographies, whether in monotherapy or in combination with topical corticosteroids, in adults as well as in adolescents and across ethnicities. In terms of clinical updates, the Advantage Phase 3b study is fully recruited. This study is a randomised, double-blind, placebo-controlled Phase 3 clinical trial to assess the efficacy and safety of Lebrikizumab in combination with Topical Corticosteroids in Adult and Adolescent Patients with Moderate-To-Severe Atopic Dermatitis that are not adequately controlled with cyclosporine or for whom cyclosporine is not medically advisable. The results for the Week 16 readout are expected in H1 2023. In addition, a paediatric study was initiated by Almirall’s partner The data presented to date demonstrate the potential benefit that lebrikizumab could bring to HCPs and patients and confirm the potential of lebrikizumab to be a first-line advanced biologic treatment for moderate-to-severe atopic dermatitis. Onychomycosis Efinaconazole is a triazole antifungal compound indicated for the treatment of mild-to-moderate fungal infection of the nail in adults and children (aged 6 years and older). Almirall has submitted regulatory filings under the European decentralised procedure. The German regulatory authority is acting as the Reference Member State. The outcome of the filing is expected in 2023. With the potential launch of this antifungal expected in 2023, Almirall will reinforce its onychomycosis franchise by complementing Ciclopoli ® , Almirall's OTC product indicated to treat this condition. Acne The Phase III clinical trial conducted in China for the oral antibiotic Seysara® (sarecycline) met primary and key secondary endpoints and Almirall plans to file the application to the Chinese National Medical Products Administration later this year. Autoimmune dermatological diseases Almirall is working on building its early-stage pipeline with some promising recent in-licensing. In 2022 Almirall entered into a licensing agreement with Simcere Pharmaceutical Group for Simcere’s IL-2 mutant fusion protein (IL-2muFc) autoimmune drug candidate, ALM223* (previously SIM0278). This molecule, developed utilising Simcere’s protein engineering platform, activates regulatory T-cells. Preclinically, ALM223 exhibits an improved PK profile and the potential to restore immune balance. The start of the Phase I clinical trial is expected in the second half of 2023. Under the agreement signed with Simcere Pharmaceutical Group, Almirall will be granted an exclusive right to develop and commercialise ALM223 for all indications outside the Greater China region (Mainland China, Hong Kong, Macau and Taiwan). *ALM223 in licensed from Simcere. Formally referred to as SIM-0278, worldwide ex-Greater China. In September 2022, Almirall announced the initiation of the phase I study evaluating the safety, pharmacokinetics, pharmacodynamics and clinical activity of ALM27134*, a first-in-class fully human, high-affinity monoclonal antibody that targets IL-1RAP (Interleukin-1 Receptor Accessory Protein) for the treatment of autoimmune dermatological diseases. Almirall in-licensed in 2021 exclusive global rights from Ichnos Science to develop and commercialise ALM27134. The company is confident that this monoclonal antibody could bring the opportunity to address the unmet needs in several autoimmune dermatology indications. *Previously referred to as ISB 880 Agreement with Isolex to develop novel approaches for IgE-mediated diseases Recently, Almirall has entered a collaboration and option to license agreement with the biotechnology company Isolex with the aim of identifying and developing a novel class of medicines that modulates Immunoglobulin E (IgE). The signed Option and Licensing Agreement will allow the teams to develop a biotherapeutic treatment that utilises a novel mechanism of action to target IgE. The research project brings together Almirall’s strong knowledge in Medical Dermatology with the expertise of Isolex team, leveraging the technology developed between Combikine Biotechnology Ltd and King’s College London. Board of Directors of Almirall The Board of Directors of Almirall views very positively the evolution, performance, and momentum of the Company towards its key priorities over the last few months. Therefore, it has asked Carlos Gallardo to remain as CEO and has suspended the search for a new CEO for the time being. Carlos Gallardo has accepted, and he will also continue in the role of Chairman of the Board of directors. Additionally, the Board will set up a new Governance Committee to check and balance the position of the Chairman-CEO. Conclusions Almirall achieved its 2022 guidance, delivering a good operational performance driven by the excellent momentum of its Medical Dermatology business in Europe. Almirall’s focused strategy on the Medical Dermatology space positions the company well for the mid and long term. Its growth drivers are expected to continue their trajectory during 2023 while keeping the focus on important near-term launches such as the biologic lebrikizumab. Ilumetri® should continue to show strong performance thanks to growing contribution from new country launches. The rollouts of Klisyri® and Wynzora® in Europe are also expected to continue driving positive trends during the year. The company will also remain focused on unlocking the value of its late-stage pipeline, while strengthening the early-stage with exciting new assets, ensuring sustained growth in the medium and long term. Almirall is fully committed to creating long-term shareholder value with growth expected to accelerate in the coming years with recent and future launches. The company has a good credit rating, reflecting its healthy balance sheet, and which gives management the flexibility in the current environment to actively pursue bolt-on acquisitions and in-licensing opportunities that align with its corporate strategy. Board proposals to the Annual General Meeting: Dividend The AGM will be proposed a dividend of €0.19 per share for approval May 5 th 2023. 2023 Full Year Guidance Core Net Sales: low to mid-single-digit growth vs. previous year (€863 MM) Total EBITDA: between €165 MM and €180 MM Investor Calendar 2023 Q1 2023 Financial Results – 8th May 2023 H1 2023 Financial Results – 24th July 2023 9M 2023 Financial Results – 13th November 2023 About Almirall Almirall is a global biopharmaceutical company focused on skin health. We collaborate with scientists and healthcare professionals to address patient’s needs through science to improve their lives. Our Noble Purpose is at the core of our work: “Transform the patients' world by helping them realize their hopes and dreams for a healthy life”. We invest in differentiated and ground-breaking medical dermatology products to bring our innovative solutions to patients in need. The company, founded in 1943 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM). Throughout its 79-year history, Almirall has retained a strong focus on the needs of patients. Currently, Almirall has a direct presence in 21 countries and strategic agreements in over 70, with about 1,800 employees. Total revenues in 2022 were €878.5MM. For more information, please visit almirall.com . Legal warning 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. _______________________ 1 Atopic Dermatitis/Atopic Eczema –Disease Landscape & Forecast, DRG Dec 2017.

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