作者: Aghamirza Moghim Aliabadi, Hooman ; Bayat, Elham ; Barkhordari, Farzaneh ; Farokhi-Fard, Aref ; Komijani, Samira ; Hashemi Aval, Negin Sadat ; Rahmati, Saman ; Davami, Fatemeh

Acute myeloid leukemia (AML) is an aggressive blood cancer with frequently poor clinical outcomes. This heterogeneous malignancy encompasses genetically, molecularly, and even clinically different subgroups. This makes it difficult to develop therapeutic agents that are effective for all subtypes of the disease. Therefore, a selective, universal, and adaptable delivery platform capable of carrying various types of anti-neoplastic agents is an unmet requirement in this area. Two multifunctional fusion proteins were designed for the delivery of biotinylated cargoes to human myeloid leukemia cells by fusing an anti-IL-1RAP single-chain antibody with streptavidin (tetramer or monomer), a cell-penetrating peptide (CPP), and an endosomolytic peptide in a single biomacromolecule. The designed fusions were analyzed primarily in silico, and the biofunctionality of the selected fusion was fully characterized via several binding assays, hemolysis assay, confocal microscopy and cell cytotoxicity assay after production via the Escherichia coli (E. coli) system. The refolded protein exhibited desirable binding activity to leukemic cells, pure antigen and biotinylated BSA. Further analyses revealed efficient cellular uptake, endosomolytic activity, and nuclear penetration without any detectable cytotoxicity toward normal epithelial cells. The described platform seems to have great potential for targeted delivery of different therapeutics to malignant myeloid cells.

项与 ISB-880 相关的新闻（医药）

2023-11-09

·BioSpace

Almirall’s Nine-month 2023 Results:

Almirall achieves Net Sales growth of 6.4%, driven by strong European dermatology performance Almirall's European Dermatology business continued to be the driving force behind Almirall's strong performance in the first nine months of 2023, with a growth rate of 15.9% underpinned by the success of Ilumetri® and other recently launched products Good performance of Key products in Europe: strong year-on-year growth of Ilumetri® (psoriasis) across geographies; Wynzora® (psoriasis) sales gaining traction, reinforced by recent country launches; and Klisyri® (actinic keratosis) rollout driving its favourable uptake Lebrikizumab (EBGLYSS®) received positive CHMP opinion for marketing authorization in patients with moderate-to-severe atopic dermatitis; EU approval is usually expected within two months of the CHMP's positive opinion. Pipeline development: based on the large field study data of tirbanibulin, the company submitted a supplementary New Drug Application (sNDA) in August 2023 and expects approval and a subsequent launch in H2 2024 The additional funds obtained from the capital increase executed in June allowed Almirall to take strategic steps to expand its capabilities. In the third quarter Almirall completed the acquisition of the rights of Prometax® in Spain, highly synergetic with Almirall’s existing neurology business in Spain. In parallel, the company continues to explore other opportunities for early and mid-stage assets Almirall is on track to meet mid-single net sales digit growth (vs. initial low- to mid-single guidance) and continues to expect total EBITDA between €165 MM - €180 MM BARCELONA, Spain--(BUSINESS WIRE)-- Almirall, S.A. (ALM), the global biopharmaceutical company based in Barcelona, has announced its 9M 2023. Financial highlights (€ rounded million) 9M 2023 9M 2022 Variation Net Sales 674.6 633.8 6.4% Core EBITDA 137.1 134.0 2.3% Total EBITDA 138.2 146.4 (5.6%) Net Income 13.6 10.9 24.8% Normalized Net Income 14.4 34.5 (58.3%) Summary of results Net Sales reached €674.6 MM, a +6.4% year-on-year increase driven by good performance of the dermatology portfolio in Europe. Total EBITDA was €138.2 MM, consistent with expectations and reflecting the lower contribution from Other Income due to Astra Zeneca / Covis milestones compared to 9M 2022. SG&A (Selling, General and Administrative) investment was €316.7 MM, 2.5% higher than last year, as expected. This increase reflects the company's ongoing investments in the premarketing ramp-up for lebrikizumab, as well as its investments in the recent launches of Wynzora® and Klisyri® in the US and EU, and the rollout of Ilumetri®. Gross Margin of 64.9% was in line with expectations and reflects the impact of high input costs and inflation affecting some material purchases. R&D investment was €78.4 MM, reaching 11.6% of Net Sales. R&D expenses are expected to normalize for the full year in the range of 12% of Net Sales. Almirall finished the first 9 months of 2023 with a favourable balance sheet and solid liquidity position at 0.2x Net Debt to EBITDA. “Almirall has delivered a consistently strong operational performance throughout the first nine months of 2023, and we are pleased to modestly upgrade our Net Sales guidance for the year. As we gear up for the lebrikizumab launch, we're embarking on a transformative journey for our company. The expected EMA approval, following the positive CHMP opinion, is just around the corner. We maintain confidence in the positive trajectory of our growth drivers as we continue to support their success. Moreover, we have strategically utilized the additional capital from our recent capital increase to strengthen our portfolio, while we continue to explore other opportunities to enhance our R&D portfolio. This reflects our commitment to advancing innovation in dermatology and positions us favourably to realize our ambition of becoming a leading dermatology company, paving the way in medical dermatology by providing innovative solutions that profoundly impact patients' lives.” Carlos Gallardo Piqué, Chairman and CEO Growth Drivers Performance Psoriasis Ilumetri® (tildrakizumab), an anti-IL-23 biologic for moderate-to-severe plaque psoriasis, has continued its strong performance in 9M 2023, posting 38% growth compared to 9M 2022 and achieving Net Sales of €42 MM in Q3 in Europe. Almirall expects Q4 to resume growth momentum and anticipates that the absolute growth for 2023 will be comparable to that of 2022. Penetration of the European market continues to be on track. Furthermore, Germany accounted for almost half of the sales, while other European countries contributed more than half, demonstrating the good traction of the product in other key markets. Almirall unveiled new data at the European Association of Dermatology and Venereology Congress 2023 demonstrating for the first time that tildrakizumab improved patients’ wellbeing in moderate-to-severe psoriasis, achieving levels similar to the general population after 16 weeks and which was maintained up to week 28.1 Additionally, tildrakizumab demonstrated its effectiveness, improving patients’ health-related quality of life (HRQoL), with high rates of treatment satisfaction in patients with moderate-to-severe plaque psoriasis after 28 weeks in a real-world setting,2 with no new safety signals and a reassuring safety pro >3 consistent with previous randomized clinical trials (RCT) and real-world studies.4,5 The new evidence on the TRIBUTE study demonstrated that tildrakizumab improved other important patient-reported outcomes (PROs) such as sleep quality, which is highly correlated with itch, pain, quality of life, and work productivity and not with PASI.6,7 The results also revealed that tildrakizumab demonstrated similar efficacy and safety regardless of the baseline characteristics of the patients.8,9 Almirall also reported results from the TILOT study that demonstrated sustained efficacy and safety of tildrakizumab over 2 years in patients with moderate-to-severe plaque psoriasis in routine clinical practice including sensitive areas and improvements of itch.10 This was reflected in significant improvements in all measured parameters, including treatment satisfaction and quality of life.11 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 €11.8 MM in 9M 2023 vs €4.5 MM in 9M 2022. The growth of the product was primarily driven by recent country launches and the continuous expansion in key countries. The cream has maintained strong performance throughout the year. Notably, both healthcare professionals and patients have expressed positive feedback about the product, emphasizing its efficacy, quick absorption, and non-sticky feel texture. 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, Italy 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) on the face or scalp achieved net sales of €14.4 million in Europe and the United States during the first nine months of 2023, representing a 57% increase compared to the €9.2 MM recorded in the same period in 2022. Klisyri® showed robust performance in key markets and its presence in the EU continues to grow. The product has experienced solid adoption in key countries where it has been launched. In the US, Almirall continues to focus on driving demand by differentiating Klisyri® from what is already available on the market based on efficacy, tolerability, and convenience. As a result, Klisyri® usage is associated with high overall patient satisfaction and a strong willingness to repeat treatment, as reported by dermatologists and patients.12 Prometax® In September 2023, Almirall announced the acquisition of exclusive rights to Prometax® in Spain. The product is a transdermal patch with rivastigmine to treat Alzheimer’s Disease, increasing the level of the neurotransmitter acetylcholine which helps reduce the symptoms of Alzheimer’s. The product is highly synergetic with Almirall’s existing neurology business in Spain. The transaction was agreed based on an upfront payment of €45 MM and potential milestones of up to €15 MM. Late-stage pipeline with promising potential Atopic dermatitis (AD) In the third quarter of 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending the marketing authorization of lebrikizumab (EBGLYSS) for the treatment of adult and adolescent patients (12 years and older with a body weight of at least 40 kg) with moderate-to-severe atopic dermatitis (AD), who are candidates for systemic therapy. The positive CHMP opinion is now being reviewed by the European Commission (EC). The approval in the European Union is expected in November and its launch in the first European country could take place soon after. The company expects regulatory decisions for lebrikizumab in moderate-to-severe AD in additional European markets. Regarding the UK, approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) is expected by the end of the year, following the EC's Reliance Procedure. In Switzerland, Almirall submitted the MAA in June 2023 and approval is expected by the end of 2024. In addition to the regulatory milestone, Almirall announced several positive clinical updates on lebrikizumab. At the European Academy of Dermatology and Venereology (EADV) Congress in October, lebrikizumab showed clinical improvements in combination with topical corticosteroids (TCS) in adult and adolescent patients with moderate-to-severe AD not adequately controlled with cyclosporine or for whom cyclosporine was not medically advisable, who were assessed over 16 weeks in the Phase III ADvantage study.13 The study met the primary endpoint at Week 16. At Week 16, lebrikizumab 250mg Q2W plus TCS significantly improved signs and symptoms of AD measured by EASI75* in 68.4% of patients, while only 40.8% of patients on placebo plus TCS achieved EASI75. Consistent benefit was also seen in additional endpoints such as EASI90, IGA, or Pruritus NRS*. Additional data presented at the EADV Congress showed sustained depth of response in patients that participated in the Phase III monotherapy ADvocate 1 & 2 studies treated with lebrikizumab over 52 weeks. Deep responses, defined as total skin clearance (Investigator's Global Assessment (IGA), Eczema Area and Severity Index (EASI 100) and itch relief (NRS 0,1), were achieved in 20% and 31% of patients by Week 16 respectively and were maintained or increased through Week 52.14 These results suggest that lebrikizumab treatment can potentially allow patients and healthcare providers to elevate their expected treatment goals in AD beyond EASI75 and NRS 0/1 response. New data on this biologic were also presented at the 43rd Annual Fall Clinical Dermatology Conference this quarter. The long-term extension study ADjoin showed patients with moderate-to-severe AD who continued treatment with lebrikizumab for up to two years experienced sustained skin clearance, itch relief and reduced disease severity with monthly maintenance dosing.15 Nearly 80% of patients with moderate-to-severe AD maintained clear or almost-clear skin with lebrikizumab monthly maintenance dosing at two years. The data set makes Almirall confident that lebrikizumab has the potential to be a first-line biologic and may support less frequent dosing. The company is working with partner Eli Lilly on further clinical studies to maximize the value of lebrikizumab, which it believes is the best antibody targeting IL-13, the key pathogenic driver of AD. Almirall looks forward to its expected approval and launch by the end of the year, while steadily intensifying its internal efforts to be ready for a successful commercial launch. *EASI=Eczema Area and Severity Index; EASI 75=at least 75% improvement from baseline in EASI; EASI 90=at least 90% improvement from baseline in EASI; IGA=Investigator’s Global Assessment; IGA (0,1)=IGA response of clear or almost clear; NRS=numeric rating scale; Q2W=every 2 weeks; Q4W=every 4 weeks (monthly) Actinic keratosis (AK) Almirall has completed the clinical study of tirbanibulin (Klisyri®) addressing the expansion to Large Field in the US. This phase III clinical study, multi-centre, open-label, single-arm study evaluated the safety and tolerability of tirbanibulin ointment 1% applied to a field of approximately 100 cm2 on the face or balding scalp in about 100 adult patients with actinic keratosis. The administration of Klisyri was well tolerated. Based on these data Almirall submitted a supplementary NDA in August 2023 and expects approval and subsequent launch in the US in H2 2024. Autoimmune dermatological diseases The company is also building an exciting early pipeline with promising recent in-licensed assets. The company is continuing its 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). Almirall in-licensed exclusive global rights from Ichnos Science in 2021 to develop and commercialize ALM27134. In addition, Almirall expects to initiate a phase I clinical study for IL-2muFc autoimmune drug candidate around the end of 2023. 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 pro the potential to restore immune balance. 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). *Previously referred to as ISB 880 ** ALM223 in licensed from Simcere. Formally referred to as SIM-0278, worldwide ex-Greater China. Bispecific antibodies In October, Almirall and EpimAb Biotherapeutics announced a license agreement for the development of bispecific antibodies for up to three undisclosed target pairs. Under the terms of this agreement, Almirall will gain a license to utilize EpimAb’s proprietary Fabs-In-Tandem Immunoglobulin (FITIg®) platform technology to generate, develop and commercialize bispecific antibodies, for which Almirall will have exclusive global rights. EpimAb Biotherapeutics shall retain all rights to the FITIg® Technology. 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®. The regulatory approval is expected in the second half of 2024. As for the oral antibiotic Seysara® (sarecycline), the phase III clinical study conducted in China met primary and key secondary endpoints and Almirall has submitted a dossier with the Chinese National Medical Products Administration at the end of September 2023. The regulatory approval is expected in 2024. 2023 Full Year Guidance Net sales guidance upgraded: mid-single digit net sales growth (vs. initial low- to mid-single guidance) and total EBITDA between €165 MM - €180 MM. Investor Calendar 2024 Full year 2023 Financial Results – February 19th, 2024 Q1 2024 Financial Results – 13th May 2024 H1 2024 Financial Results – 22nd July 2024 9M 2024 Financial Results – 11th November 2024 About Almirall Almirall is a global biopharmaceutical company focused on medical dermatology. We collaborate with scientists and healthcare professionals to address patients' 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 focused intensely on patients' needs. Almirall has a direct presence in 21 countries and strategic agreements in over 70, with about 1,800 employees. Total revenue in 2022 was €878.5 MM. 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 Sommer R, et al. Patient-reported well-being using tildrakizumab in a real-world setting: 28-week interim data of the phase IV POSITIVE study. Presented at the 32nd European Academy of Dermatology and Venereology (EADV) Congress, 11 – 14 October 2023, Berlin, Germany. Abstract 3490. 2 Augustin M, et al. Real-world effectiveness, quality of life, and treatment satisfaction with tildrakizumab in patients with moderate-to-severe psoriasis: 28-week interim data of the phase IV POSITIVE study. Presented at the 32nd European Academy of Dermatology and Venereology (EADV) Congress, 11 – 14 October 2023, Berlin, Germany. Abstract 3492. 3 Mrowietz U, et al. Real-world safety of tildrakizumab in patients with moderate-to-severe psoriasis: 28-week interim data of the phase IV POSITIVE study. Presented at the 32nd European Academy of Dermatology and Venereology (EADV) Congress, 11 – 14 October 2023, Berlin, Germany. Abstract 3491. 4 Thaçi D, et al. Five-year efficacy and safety of tildrakizumab in patients with moderate-to-severe psoriasis who respond at week 28: pooled analyses of two randomized phase III clinical trials (reSURFACE 1 and reSURFACE 2). Br J Dermatol. 2021 Aug;185(2):323–34. doi: 10.1111/bjd.19866. 5 Drerup KA, et al. Effective and Safe Treatment of Psoriatic Disease with the Anti-IL-23p19 Biologic Tildrakizumab: Results of a Real-World Prospective Cohort Study in Nonselected Patients. Dermatology. 2022;238:615–19. doi: 10.1159/000519924. 6 Costanzo A, et al. Tildrakizumab improves sleep quality and psoriasis-related pruritus and pain in patients with moderate-to-severe plaque psoriasis in conditions close to real clinical practice. Presented at the 32nd European Academy of Dermatology and Venereology (EADV) Congress, 11 – 14 October 2023, Berlin, Germany. Abstract 3122. 7 Costanzo A, et al. Tildrakizumab improves sleep quality, quality of life and work productivity in patients with moderate-to-severe plaque psoriasis in conditions close to real clinical practice. Presented at the 32nd European Academy of Dermatology and Venereology (EADV) Congress, 11 – 14 October 2023, Berlin, Germany. Abstract 3123. 8 Costanzo A, et al. Super responders to tildrakizumab treatment in moderate-to-severe chronic plaque psoriasis in conditions close to real clinical practice. Presented at the 32nd European Academy of Dermatology and Venereology (EADV) Congress, 11 – 14 October 2023, Berlin, Germany. Abstract 3121. 9 Costanzo A, et al. Tildrakizumab demonstrates high efficacy regardless of baseline characteristics in patients with moderate-to-severe chronic plaque psoriasis in conditions close to real clinical practice. Presented at the 32nd European Academy of Dermatology and Venereology (EADV) Congress, 11 – 14 October 2023, Berlin, Germany. Abstract 3120. 10 Tsianakas A, et al. Sustained efficacy and safety of tildrakizumab over 2 years in patients with moderate to severe plaque psoriasis in routine clinical practice: interim results in week 100 from the non-interventional, prospective, multicenter study TILOT. Presented at the 32nd European Academy of Dermatology and Venereology (EADV) Congress, 11 – 14 October 2023, Berlin, Germany. Abstract 3110. 11 Tsianakas A, et al. Tildrakizumab improves signs and symptoms in patients with moderate to severe plaque psoriasis in a real-world setting: a holistic approach. Presented at the 32nd European Academy of Dermatology and Venereology (EADV) Congress, 11 – 14 October 2023, Berlin, Germany. Abstract 3106. 12 PROAK: Patient-reported Outcomes for Tirbanibulin Effectiveness and Safety in Actinic Keratosis. SKIN The Journal of Cutaneous Medicine 2023. 13 Warren RB, et al. Efficacy and safety of lebrikizumab in combination with topical corticosteroids in patients with moderate-to-severe atopic dermatitis not adequately controlled or non-eligible for cyclosporine: a placebo-controlled, randomized Phase 3. 14 Simpson E, et al. Raising the bar of efficacy in atopic dermatitis: depth of response in patients treated with lebrikizumab over 52 weeks Presented at the 32nd European Academy of Dermatology and Venereology (EADV) Congress, 11 – 14 October 2023, Berlin, Germany. Abstract 3117. 15 Guttman-Yassky E, et al. Efficacy and Safety of Lebrikizumab Is Maintained to Two Years in Patients With Moderate-to-Severe Atopic Dermatitis. 2023 Fall Clinical Dermatology Conference. 20th October, 2023. View source version on businesswire.com: Contacts Media contact Almirall Tinkle Laura Blázquez lblazquez@tinkle.es Phone: (+34) 600 430 581 Corporate Communications Almirall Mar Ramírez mar.ramírez@almirall.com Phone: (+34) 659 614 173 Investors’ Relations Almirall Pablo Divasson del Fraile pablo.divasson@almirall.com Phone: (+34) 93 291 3087 Source: Almirall S.A. View this news release online at:

临床结果临床3期上市批准并购引进/卖出

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

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