Almirall launches innovative Wynzora® CAL/BDP cream in Europe for the treatment of mild to moderate plaque psoriasis in adults including scalp

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Almirall, S.A.

18 Feb, 2022, 09:52 GMT

  • The product is now available in Spain, Germany, and the UK and rollout in the rest of EU countries will continue in 2022
  • Wynzora® is the first and only once-daily aqueous cream [1],[2] with a fixed combination of calcipotriene and betamethasone diproprionate (CAL/BDP) [3], based on PAD Technology formulation and drug delivery system, which enables a stable formulation, designed to enhance cosmetic quality and offers a favourable safety profile [2],[4] and patient convenience [2]
  • Wynzora® offers high efficacy and fast onset of action within 1 week [2],[4]. Results from Phase III clinical trials demonstrated that, after 8 weeks of once-daily use, CAL/BDP PAD-cream provided superior efficacy and patient quality of life (QoL) for the topical treatment of plaque psoriasis, including scalp, in comparison with the currently available topical CAL/BDP gel [4] 

BARCELONA, Spain, Feb. 18, 2022 /PRNewswire/ -- Almirall S.A. (BME: ALM), a global biopharmaceutical company focused on skin health, announced today the European commercial launch of Wynzora® cream (50 µg/g calcipotriol and 0.5 mg/g betamethasone as dipropionate), developed for the topical treatment of mild to moderate plaque psoriasis in adults including scalp. Spain, Germany, and the UK are the first European countries where the cream is available for prescription. Following the launch of this innovative topical, Almirall becomes the only biopharmaceutical company in Europe to offer psoriasis patients multiple options covering the entire spectrum of the disease, from topicals to oral systemics and biologics.

Wynzora® Cream is powered by PAD Technology, a new method of mixing oil and water, which makes it the only calcipotriene and betamethasone dipropionate topical that allows the combination of active ingredients in an aqueous cream [1],[2]. The technology enables a stable formulation [1] and offers a favourable safety profile [2],[4] and patient convenience [2].

Wynzora® offers high efficacy and fast onset of action within 1 week [2],[4]. The results from a pooled analysis of two randomized Phase III trials demonstrated that this CAL/BDP PAD-cream offered superior efficacy and patient quality of life in the topical treatment of psoriasis in comparison to the calcipotriene and betamethasone dipropionate gel formulation for all efficacy endpoints including PGA treatment success, mPASI, and PASI75 after 8 weeks of once-daily use [4]. 

The clinical investigation also showed that, after eight weeks of treatment, a significantly greater proportion of subjects treated with CAL/BDP PAD-cream reported that psoriasis had no effect at all on their life (DLQI 0 or 1) compared to CAL/BDP gel [4]. The patient acceptability of CAL/BDP PAD-cream was mainly due to the topical being a less greasy formulation based on the innovative PAD Technology [4]. The results from Phase III clinical trials were published in the Journal of the European Academy of Dermatology and Venereology (JEADV) [4].

Psoriasis is one of the world's most prevalent skin diseases, affecting approximately  at least 100 million individuals worldwide [5] and around 1.52% of the UK population (1.01 million people estimated) [6]. It negatively affects quality of life and represents a significant burden in the daily life of 71% of patients [7], affecting the overall emotional wellbeing of 88% of people who suffer from the condition [8]. "In recent years we have observed vast improvements in the treatments available for psoriasis, however, adherence to topical treatments remains low. The arrival of a new PAD-cream formulation of CAL/BDP is excellent news for the psoriasis community, who now have a treatment option that combines efficacy and safety profile of the well-established CAL/BDP active ingredients in a newest vehicle technology for patient convenience," stated Professor Anthony Bewley, Consultant Dermatologist, UK. 

Rollout of Wynzora® Cream to continue in the rest of Europe in 2022

Almirall started marketing Wynzora® Cream in the UK, Spain and Germany earlier this month and expects to roll out in other European countries during the coming months, once national marketing authorisations are granted. The product has received regulatory approval in Czech Republic, Denmark, France, Germany, Netherlands, Norway, Spain, Sweden, the UK, Finland, Portugal, Italy and Ireland  with the name Wynzora®, and with the name Winxory® in Austria.

"The launch of Wynzora® Cream in Europe represents a step forward in our commitment to offering innovative therapies that improve the quality of life of patients with psoriasis. Currently, 73% of patients are not adhering to topical treatments [4]. In view of this worrying lack of adherence to such treatments, Almirall is convinced that this new product, with proven efficacy and a patient-friendly formulation, will mark a turning point by improving psoriasis patients' satisfaction thanks to its less greasy formulation," said Gianfranco Nazzi, Chief Executive Officer of Almirall.

"The launch of Wynzora ® Cream in European countries marks another milestone in the global roll out of the product. This cream is a manifestation of the key properties of the novel formulation and drug delivery system PAD Technology. It is formulated with the aspiration to provide fast onset and high efficacy, a favorable safety profile and high convenience and satisfaction by patients in daily routines in a single product. We believe simplicity and adherence is the new efficacy,"  stated Jesper J. Lange, CEO of MC2 Therapeutics, developer of the PAD Technology.

In February 2021, Almirall and MC2 Therapeutics entered into a strategic agreement under which MC2 Therapeutics granted Almirall exclusive European rights to commercialise Wynzora® Cream for treatment of plaque psoriasis. Both companies announced the successful completion of a decentralised procedure in July 2021. The cream is also commercialized in the US by another company.

[1] Præstegaard M, et al. Phase 3 trial demonstrates superior patient treatment convenience of MC2-01 calcipotriene plus betamethasone dipropionate cream compared to current topical suspension. J of Skin. 2020;4(5):s62

[2] Stein Gold L, et al. A phase 3, randomized trial demonstrating the improved efficacy and patient acceptability of fixed dose calcipotriene and betamethasone dipropionate cream. J Drugs Dermatol. 2021;20(4): doi:10.36849/JDD.5653.

[3] WYNZORA® Cream Summary of Product Characteristics.

[4] Pinter A, et al. A pooled analysis of randomized, controlled, phase 3 trials investigating the efficacy and safety of a novel, fixed dose calcipotriene and betamethasone dipropionate cream for the topical treatment of plaque psoriasis. JEADV. 2021; 10.1111/JDV.17734. https://doi.org/10.1111/jdv.17734

[5]  World Health Organization. (‎2016)‎. Global report on psoriasis. World Health Organization. https://apps.who.int/iris/handle/10665/204417

[6] Global psoriasis atlas. Available at: https://www.globalpsoriasisatlas.org/en/

[7]   National Psoriasis Foundation 2008 Survey Snapshot. Available from: PTT-24087-quality-of-life-issues-and-measurement-in-patients-with-psor (researchgate.net)

[8] Armstrong AW, Schupp C, Wu J, et al. PLoS One. 2012;7(12):e52935

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