Wynzora (calcipotriene/betamethasone dipropionate) / MC2 Therap, Almirall, Huadong Medicine - LARVOL DELTA

Almirall continues its sustained growth trajectory in 9M 2025 - delivering 12.8% net sales growth, strong dermatology performance, solid commercial execution in Europe, and further pipeline progress (PharmiWeb) - "Ebglyss, for the treatment of moderate to severe atopic dermatitis, generated €75.5 MM of sales during 9M 2025 – representing more than a 3x increase YoY, as European markets are ramping up after launch...Ilumetri, for the treatment of psoriasis, grew steadily in 9M 2025, with net sales increasing 12% YoY, to a total of €170.9 MM and remaining on track to meet the €300 MM peak sales target....Almirall’s broad dermatology product portfolio continues to show strong performance, further enhancing the company´s relevance to patients and dermatologists. In 9M 2025 Wynzora grew 32.3% YoY to a total of €25.4 MM, and Klisyri grew 22.6% YoY to a total of €20.1 MM."

Sales • Actinic Keratosis • Atopic Dermatitis • Psoriasis

psowyn: Evaluation of Tolerability, Efficacy and Adherence to Treatment With Wynzora Cream (clinicaltrials.gov) - P=N/A | N=30 | Completed | Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Not yet recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

Almirall Q1 2025 Results (Businesswire) - "Ilumetri (tildrakizumab for the systemic treatment of moderate-to-severe psoriasis) delivered double digit growth in Q1 2025 (12.7% increase YoY) and delivered solid Net Sales of €55.1 MM despite growing competition in the psoriasis market and some quarterly phasing impacts. Wynzora continued to grow in its main markets and delivered total Net Sales of €7.7 MM representing a 22.2% increase vs Q1 2024. The strong double-digit growth performance of Klisyri in Q1 2025 (€6.9 MM +25.5% YoY) is aligned with expectations of its increasing market share in key regions and was further supported by the US large field launch following the approval of the label extension by the FDA in 2024."

Sales • Psoriasis

PRO-SCALP: A Study to Assess Treatment Satisfaction, Patient-reported Outcomes, Effectiveness, and Safety of a Fixed-dose Combination of Calcipotriene/Betamethasone Dipropionate PAD Cream in the Treatment of Mild-to-moderate Plaque Psoriasis of the Scalp in Adults (clinicaltrials.gov) - P=N/A | N=291 | Completed | Sponsor: Almirall, S.A. | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

Almirall 2024 Full-Year Results: Almirall Surpassed Guidance for 2024 - Entering an Era of Sustained Growth and Further Advancing Its Medical Dermatology Pipeline (Businesswire) - "Ebglyss achieved 34% growth in Q4 compared to Q3, delivering a total of €33.2 MM sales in 2024, mainly in Germany....Sustained solid growth of the medical dermatology portfolio overall: 17.8% (total of €548.1 MM). Strong performance of Almirall´s broad dermatology portfolio: Wynzora grew 53.3% YoY (total of €25.9 MM), and Klisyri grew 17.8% YoY (total of €24.5 MM). Sustained solid growth of the medical dermatology portfolio overall: 17.8% (total of €548.1 MM)....Ilumetri: Almirall anticipates sustaining the momentum of Ilumetri in the short to mid-term and therefore has recently updated its peak sales guidance to above €300 MM by 2030....resulted in an upgrade of the peak sales forecast to above €800 MM. The positive momentum of the broad dermatology portfolio of products will deliver continued growth in the future - spearheaded by Klisyri and Wynzora in European markets."

Sales • Sales projection • Dermatology • Immunology • Psoriasis

Almirall’s Nine-Month 2024 Results: Almirall Reports Strong Performance at Q3 2024 - Driven by Successful Commercial Execution of the Dermatology Portfolio, Fuelled by Biologics Growth (Businesswire) - "The successful launch of Ebglyss in the first markets in Europe generated €20.4 MM in the initial nine months of 2024, representing a 34% sales increase quarter-on-quarter...Total sales of tildrakizumab in the first 9 months of 2024 were €152.5 MM representing a 24.8% growth year-on-year. With its steadily growing market share, Ilumetri has cemented its strong position within the leading class of the Anti-IL 23 psoriasis treatments and is on track to achieve €250 MM peak sales...Almirall´s broad dermatology product portfolio continues to show strong performance growing 17.3% to a total of €404.9 MM in the first nine months of 2024 further driving the company´s relevance to patients and dermatologists. Wynzora grew 62.7% YoY to a total of €19.2 MM, and Klisyri grew 14.0% YoY to a total of €16.4 MM."

Sales • Actinic Keratosis • Atopic Dermatitis • Dermatitis • Immunology • Inflammation • Psoriasis

PRO-SCALP: A Study to Assess Treatment Satisfaction, Patient-reported Outcomes, Effectiveness, and Safety of a Fixed-dose Combination of Calcipotriene/Betamethasone Dipropionate PAD Cream in the Treatment of Mild-to-moderate Plaque Psoriasis of the Scalp in Adults (clinicaltrials.gov) - P=N/A | N=291 | Active, not recruiting | Sponsor: Almirall, S.A. | Recruiting ➔ Active, not recruiting | Trial completion date: Apr 2024 ➔ Aug 2024 | Trial primary completion date: Apr 2024 ➔ Aug 2024

Enrollment closed • Patient reported outcomes • Trial completion date • Trial primary completion date • Dermatology • Immunology • Psoriasis

psowyn: Evaluation of Tolerability, Efficacy and Adherence to Treatment With Wynzora Cream (clinicaltrials.gov) - P=N/A | N=30 | Not yet recruiting | Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Adherence • New trial • Dermatology • Immunology • Psoriasis

A novel calcipotriol and betamethasone dipropionate (CAL/BDP) PAD-cream demonstrates greater improvements in daily activities and personal relationships than CAL/BDP gel/TS: a post-hoc analysis of DLQI outcomes from two phase 3 placebo-controlled randomized clinical trials in mild-to-moderate psoriasis. (PubMed, J Eur Acad Dermatol Venereol) - No abstract available

Clinical • Journal • P3 data • Retrospective data • Dermatology • Immunology • Psoriasis

Calcipotriol and Betamethasone Dipropionate Cream Based on PAD Technology for the Treatment of Plaque Psoriasis: A Narrative Review. (PubMed, Dermatol Ther (Heidelb)) - "CAL/BDP PAD-cream and CAL/BDP foam showed equivalent efficacy and quality of life at their recommended treatment duration, whereas greater treatment satisfaction for CAL/BDP PAD-cream was found after one week of treatment. Overall, the high patient acceptability and treatment satisfaction observed with CAL/BDP PAD-cream in clinical trials may lead to improved adherence and hence higher efficacy in clinical practice."

Journal • Review • Dermatology • Immunology • Psoriasis

Greenberg Traurig Advises China's Huadong Medicine in Two Strategic Licensing Agreements (PRWeb) - "Greenberg Traurig, LLP represented Huadong Medicine Co., a Chinese publicly traded pharmaceutical company, in negotiating two strategic licensing agreements to develop and commercialize market-leading medications in Greater China and Southeast Asia. Most recently, the firm advised Hangzhou Zhongmei Huadong Pharmaceutical, a subsidiary of Huadong Medicine, in negotiating a licensing agreement with MC2 Therapeutics to develop and market MC2's Wynzora cream for treating plaque psoriasis in adults in Greater China. Copenhagen-based MC2 will receive $16 million in upfront and regulatory milestone payments and is eligible to receive an additional approximately $36 million plus royalties if the Huadong unit achieves certain sales milestones."

Licensing / partnership • Immunology • Psoriasis

Calcipotriene and Betamethasone Dipropionate PAD-Cream Demonstrates Greater Treatment Efficacy in Patients with Moderate-to-Severe Psoriasis Compared to Topical Suspension/Gel: A Subgroup Analysis of Two Phase 3 Studies. (PubMed, Dermatol Ther (Heidelb)) - P3 | "In this subgroup analysis, patients who had higher disease severity at baseline achieved greater efficacy than the total patient population when treated with 8 weeks of CAL/BDP PAD-cream as compared to a currently marketed active comparator. Additionally, as indicated by this analysis, CAL/BDP PAD-cream treatment may also be more convenient and less greasy, which may reduce the burden of daily treatment and improve adherence to therapy."

Journal • P3 data • Dermatology • Immunology • Oncology • Psoriasis • IL23A • TNFA

Randomised Phase 3 trial demonstrating high efficacy, favourable safety, and convenience of a novel calcipotriol and betamethasone dipropionate cream for the treatment of psoriasis. (PubMed, J Eur Acad Dermatol Venereol) - "CAL/BDP PAD-cream is a novel topical treatment of psoriasis that has a high efficacy and a favourable safety profile combined with a superior patient reported treatment convenience."

Journal • P3 data • Dermatology • Immunology • Psoriasis

Enhanced Skin Deposition of Betamethasone Dipropionate from a Novel Formulation and Drug Delivery Technology. (PubMed, Dermatol Ther (Heidelb)) - "The novel PAD technology-based cream formulation delivered more BDP into the upper stratum corneum and lower epidermis than a traditional topical suspension."

Journal • Dermatology • Immunology • Psoriasis

Sensory properties analysis of a calcipotriol and betamethasone dipropionate cream vehicle formulated with an innovative PAD Technology for the treatment of plaque psoriasis on the skin and scalp. (PubMed, Drugs Context) - "The oleogel formulation had good sensory properties, similar to CAL/BDP PAD-cream vehicle, but with lower integrity of shape, lower wetness and higher greasiness. Overall, CAL/BDP PAD-cream vehicle has the desirable requirements for a topical product for the treatment of psoriasis, with better sensory properties than ointment and easier manipulation than oleogel, which may lead to greater acceptance and adherence."

Journal • Dermatology • Immunology • Psoriasis

A novel, fixed-dose calcipotriol and betamethasone dipropionate cream for the topical treatment of plaque psoriasis: Direct and indirect evidence from phase 3 trials discussed at the 30 EADV Congress 2021. (PubMed, J Eur Acad Dermatol Venereol) - P3 | "Indirect evidence showed that treatment with CAL/BDP cream was associated with a trend for greater QoL improvement than CAL/BDP foam when DLQI improvement was assessed at the recommended treatment duration of 8 weeks for CAL/BDP cream and 4 weeks for CAL/BDP foam. CAL/BDP cream was statistically superior versus CAL/BDP foam in four out of five treatment satisfaction domains."

Journal • P3 data • Review • Dermatology • Immunology • Pruritus • Psoriasis

How the innovation works: clinical evidence of Wynzora CAL/BDP cream in patients with plaque psoriasis (EADV 2022) - "Sponsored by Almirall"

Clinical • Dermatology • Immunology • Psoriasis

Polyaphron Dispersion Technology, A Novel Topical Formulation and Delivery System Combining Drug Penetration, Local Tolerability and Convenience of Application. (PubMed, Dermatol Ther (Heidelb)) - P3 | "Example data are presented of enhanced drug penetration from PAD formulations, including dermal delivery of calcipotriene, betamethasone dipropionate and tacrolimus as well as ocular delivery of ciclosporin A. Local tolerability is an important safety parameter for topical formulations, where high levels of surfactants can cause skin irritation...PAD formulations can generally be designed to meet these criteria. In conclusion, PAD technology provides high flexibility in topical drug design and can be applied to several body locations without compromising efficacy, safety or convenience of therapy.Clinical Trial Register: Clinicaltrials.gov: NCT03802344."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Psoriasis

An anchored matching-adjusted indirect comparison of fixed-dose combination calcipotriol and betamethasone dipropionate (Cal/BDP) cream versus Cal/BDP foam for the treatment of psoriasis. (PubMed, J Dermatolog Treat) - "Cal/BDP cream and Cal/BDP foam have equivalent efficacy and HRQoL (measured in DLQI) outcomes when used for the topical treatment of plaque psoriasis at their recommended treatment durations. Comparison of treatment satisfaction assessments after 1 week of treatment, demonstrated that patients find Cal/BDP cream to be more convenient than foam."

Journal • Dermatology • Immunology • Psoriasis

Calcipotriol and betamethasone dipropionate cream show high treatment success in patients with scalp psoriasis (FOBI 2022) - "scalp involvement in pso is common and usual requires topical therapy that are effective and comfortable for the patient. CAL/BDP CREAM IS A NOVEL TOPICAL Treatment for Plaque PSO Based on Pad Technology. CAL/BDP CREAM Demonstrated High Treatment Response, Rapid Onset of Action, and A Favorable Safety Profiles in Scalp-Pso Patients."

Clinical • Dermatology • Immunology • Psoriasis

A pooled analysis of phase 3 Randomized Controlled Trials Evaluating the Efficacy and Safety of a Novel, fixed-dose Combination Calcipotriol and Betamethasone Dipropionate Cream for the Topical Treatment of Plaque Psoriasis (PSO) (FOBI 2022) - "The results Showed A Statistical Aally Significant Higher Efficacy in Favor of Cal/Bdp Cream on All Efficacy Endpoints Including PGA Treatment Success, MPASI75 Compared to CAL/BDP Gel. Because of Its High Efficacy and Safety Profile, As Well as Its Ease of Use, Cal/BDP CREAM CAN Be Used AS A First-Line Topical Therapy for the PSO."

P3 data • Retrospective data • Dermatology • Immunology • Psoriasis

A pooled analysis of phase 3 Randomized Controlled Trials Evaluating the Efficacy and Safety of a Novel, fixed-dose Combination Calcipotriol and Betamethasone Dipropionate Cream for the Topical Treatment of Plaque Psoriasis (PSO) (FOBI 2022) - "The results Showed A Statistical Aally Significant Higher Efficacy in Favor of Cal/Bdp Cream on All Efficacy Endpoints Including PGA Treatment Success, MPASI75 Compared to CAL/BDP Gel. Because of Its High Efficacy and Safety Profile, As Well as Its Ease of Use, Cal/BDP CREAM CAN Be Used AS A First-Line Topical Therapy for the PSO."

P3 data • Retrospective data • Dermatology • Immunology • Psoriasis

A pooled analysis of phase 3 Randomized Controlled Trials Evaluating the Efficacy and Safety of a Novel, fixed-dose Combination Calcipotriol and Betamethasone Dipropionate Cream for the Topical Treatment of Plaque Psoriasis (PSO) (FOBI 2022) - "The results Showed A Statistical Aally Significant Higher Efficacy in Favor of Cal/Bdp Cream on All Efficacy Endpoints Including PGA Treatment Success, MPASI75 Compared to CAL/BDP Gel. Because of Its High Efficacy and Safety Profile, As Well as Its Ease of Use, Cal/BDP CREAM CAN Be Used AS A First-Line Topical Therapy for the PSO."

P3 data • Retrospective data • Dermatology • Immunology • Psoriasis

Calcipotriol and betamethasone dipropionate cream show high treatment success in patients with scalp psoriasis (FOBI 2022) - "scalp involvement in pso is common and usual requires topical therapy that are effective and comfortable for the patient. CAL/BDP CREAM IS A NOVEL TOPICAL Treatment for Plaque PSO Based on Pad Technology. CAL/BDP CREAM Demonstrated High Treatment Response, Rapid Onset of Action, and A Favorable Safety Profiles in Scalp-Pso Patients."

Clinical • Dermatology • Immunology • Psoriasis

Calcipotriol and betamethasone dipropionate cream show high treatment success in patients with scalp psoriasis (FOBI 2022) - "scalp involvement in pso is common and usual requires topical therapy that are effective and comfortable for the patient. CAL/BDP CREAM IS A NOVEL TOPICAL Treatment for Plaque PSO Based on Pad Technology. CAL/BDP CREAM Demonstrated High Treatment Response, Rapid Onset of Action, and A Favorable Safety Profiles in Scalp-Pso Patients."

Clinical • Dermatology • Immunology • Psoriasis