Almirall and MC2 Therapeutics announce completion of decentralized procedure in Europe for the topical treatment of mild to moderate psoriasis vulgaris in adults

- The successful completion of a decentralized procedure is the final step before national marketing authorizations can be granted by the European countries

- MC2 Therapeutics has granted Almirall exclusive European rights to commercialize this topical treatment of mild to moderate psoriasis vulgaris in adults

BARCELONA, Spain and COPENHAGEN, Denmark, July 6, 2021 /PRNewswire/ -- Almirall S.A. (BME: ALM), a global biopharmaceutical company focused on skin health, and MC2 Therapeutics, a commercial stage pharmaceutical company developing a new standard within topical therapies for autoimmune and chronic inflammatory conditions, announced today the successful completion of a decentralized procedure in Europe for a topical treatment option (50 µg/g calcipotriol and 0.5 mg/g betamethasone as dipropionate) of mild to moderate psoriasis vulgaris in adults,  including scalp psoriasis. 

Earlier this year, MC2 Therapeutics granted Almirall exclusive European rights to commercialize the product, which was approved in the US by the FDA on July 2020 and is sold in that country under the trade name Wynzora® Cream.

"Our commitment to patients and to address unmet needs in skin diseases is reinforced today after the completion of the decentralized procedure. The topical treatment is the perfect addition to our growing psoriasis portfolio, which includes multiple treatment options that cover the whole spectrum of the disease. We are very happy that we will be able to offer it to European dermatologists and their patients," says Gianfranco Nazzi, CEO of Almirall.

"At MC2 Therapeutics we are very pleased with the outcome of the process and that years of dedicated efforts are now one step closer to bringing a new treatment option to European adult patients with mild to moderate psoriasis vulgaris," says Jesper J. Lange, CEO of MC2 Therapeutics.

The successful completion of a decentralized procedure is the final step before national marketing authorizations can be granted by the European countries.

About Psoriasis Vulgaris 

Psoriasis is a common, non-contagious, chronic skin disease, with no clear cause or cure. The negative impact of psoriasis on people's lives can be immense as it affects the appearance of the skin with red, scaly plaques. Psoriasis affects people of all ages, and in all countries. The reported prevalence of psoriasis in Europe varies from 0.6% to 6.5% with an average of approximately 3% of the population^[1],[2], making psoriasis a serious global problem with more than 100 million individuals affected worldwide.^[3] The flares of psoriasis can be unpredictable and significant comorbidities are common, including arthritis, cardiovascular diseases, metabolic syndrome, inflammatory bowel disease and depression.³ 

About the topical treatment of mild to moderate psoriasis vulgaris in adults  

The combination of 50 µg/g calcipotriol and 0.5 mg/g betamethasone as dipropionate is a well-established topical treatment for mild to moderate psoriasis vulgaris in adults. An aqueous cream formulation of calcipotriol and betamethasone dipropionate, based on PAD™ technology, allows optimal delivery of the active ingredients to the target tissue. The product was approved in the US by the FDA on 20th July 2020 and is commercialized in the country under the trade name Wynzora® Cream.

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 and is a member of the IBEX35 (ticker: ALM). Throughout its 78-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, through 13 subsidiaries, with about 1,800 employees. Total revenues in 2020 were 814.5 million euros.

For more information, please visit almirall.com 

About MC2 Therapeutics

MC2 Therapeutics is a privately held commercial stage pharmaceutical company committed to build leadership in topicals for autoimmune and chronic inflammatory conditions. Our focus is to develop and advance best in class or first in class therapies by understanding the pathophysiology and researching novel compounds. Our goal is to minimize the burden of disease for patients by addressing significant unmet needs. Using our patented PAD™ Technology we are introducing a new standard of topical treatment for the benefit of patients, physicians, payers, and societies. Our innovative pipeline is comprised of drug candidates within uremic pruritus, lichen sclerosis, Sjögren's syndrome dry eye, ocular rosacea, and atopic dermatitis. 

For additional information on MC2 Therapeutics Group, please visit www.mc2therapeutics.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.

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Reference:

^[1] Chandran, V., and S.P. Raychaudhuri. 2010. 'Geoepidemiology and environmental factors of psoriasis and psoriatic arthritis', J. Autoimmune, 34: J314-J21

^[2] Schafer, T. 2006. 'Epidemiology of psoriasis. Review and the German perspective', Dermatology, 212: 327-37

^[3] WHO Global report on Psoriasis 2016

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