Almirall and MC2 Therapeutics Enter a License, Collaboration and Commercialization Agreement for European Rights to Wynzora® Cream for Treatment of Plaque Psoriasis

Almirall and MC2 Therapeutics Enter a License, Collaboration and Commercialization Agreement for European Rights to Wynzora® Cream for Treatment of Plaque Psoriasis

In this collaboration Almirall will commercialize Wynzora® Cream for treatment of plaque psoriasis in Europe and MC2 Therapeutics will be responsible for manufacturing and supply.

• MC2 Therapeutics and Almirall partner to make Wynzora® Cream a leading topical product for Plaque Psoriasis in Europe
• In a large European based Phase 3 clinical trial (n=490), Wynzora® Cream has demonstrated substantial efficacy with a PGA treatment success of 51% and beneficial treatment convenience (1)
• Marketing Authorization Application (MAA) in Europe of Wynzora® Cream has been filed and approval is expected this year

BARCELONA, Spain and COPENHAGEN, Denmark, February 17, 2021 / B3C newswire / -- Almirall S.A. (BME: ALM), a global biopharmaceutical company and MC2 Therapeutics, a commercial stage pharmaceutical company developing a new standard within topical therapies for autoimmune and chronic inflammatory conditions, announced today an agreement under which MC2 Therapeutics has granted Almirall exclusive European rights to commercialize Wynzora® Cream for treatment of plaque psoriasis. In exchange, MC2 Therapeutics is eligible to receive upfront to launch payments of EUR 15 million in addition to significant sales milestone payments and double-digit royalties on the European sales of Wynzora® Cream. Almirall and MC2 Therapeutics partner to make Wynzora® Cream a leading topical product for treatment of plaque psoriasis in Europe - a market, which currently is more than 25 million units in sales volume annually (2). The market represents a significant opportunity for Wynzora® Cream as the calcipotriene and betamethasone dipropionate segment accounts for approximately 35% of share of volume and annual sales of more than $300 million (2). 

Wynzora® Cream (50 µg/g calcipotriol and 0.5 mg/g betamethasone as dipropionate) received US FDA approval on 20th July 2020. Wynzora® Cream is currently under review in Europe supported by two Phase 3 trials (1), including an EU head-to-head trial against active comparator Dovobet/Daivobet® Gel. The Physician Global Assessment (PGA) treatment success defined as a minimum two-point decrease in the PGA score to clear or almost clear disease at Week 8 was 51% for Wynzora® Cream vs. 6% for vehicle (p<0.0001). The treatment satisfaction score using the Psoriasis Treatment Convenience Scale (PTCS) was superior compared to Dovobet/Daivobet® Gel. Using MC2 Therapeutics' PAD™ Technology, Wynzora® Cream was uniquely designed to provide patients a new treatment option in their daily routines by combining the three essentials of a topical therapy in one single product namely high efficacy, a favorable safety profile and convenience of use.

Mike Mcclellan, Chief Financial Officer (CFO) and interim Chief Executive Officer (CEO) said: "We are thrilled with this agreement with MC2 Therapeutics. Wynzora® Cream has demonstrated significant improvements in the skin clearance of psoriasis patients. It is the perfect addition to our growing psoriasis portfolio, which includes multiple treatment options, covering the whole spectrum of the disease. We are delighted that soon we will be able to offer this novel topical treatment to European dermatologists and their patients."  

Jesper J. Lange, CEO of MC2 Therapeutics, commented: “We are excited to partner with Almirall, an established company with deep expertise in dermatology and psoriasis and with the focus to improve patients’ needs. Bringing together Almirall's excellence in commercial operations and MC2 Therapeutics' commitment to ensure a global roll-out of Wynzora® Cream we will, upon approval, ensure a strong launch of Wynzora® Cream for the benefit of the many patients living with plaque psoriasis and for the healthcare practitioners who provide care. We believe that the unique combination of compelling clinical efficacy, a favorable safety profile and treatment convenience are key components to treatment adherence and overall better patient satisfaction in topical treatment of plaque psoriasis in a real-world setting.”

Link to the press release

About Plaque Psoriasis 
Psoriasis is a common, non-contagious, chronic skin disease, with no clear cause or cure. The negative impact of plaque 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 (3,4), making psoriasis a serious global problem with more than 100 million individuals affected worldwide (5). The flares of psoriasis can be unpredictable and significant comorbidities are common, including arthritis, cardiovascular diseases, metabolic syndrome, inflammatory bowel disease and depression (4).

About Wynzora® Cream  
Wynzora® Cream (50 µg/g calcipotriol and 0.5 mg/g betamethasone as dipropionate) is under review in Europe as a topical treatment of plaque psoriasis in adults. Wynzora® Cream is based on PAD™ Technology, enabling an aqueous cream formulation of both calcipotriol and betamethasone as dipropionate and optimal delivery of active ingredients into the target tissue. Wynzora® Cream was approved in the US by the FDA on 20th July 2020.

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 groundbreaking medical dermatology products to bring our innovative solutions to patients in need. 
The company, founded in 1943 and headquartered in Barcelona, is public traded on the Spanish Stock Exchange and is a member of the IBEX 35 (BME: ALM). Throughout its 77-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 2019 were 908.4 million euros.

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 ultimate goal is to minimize the burden of disease for patients by addressing unmet needs.

Using PAD™ Technology we are introducing a new standard of topical treatment experience for the benefit of patients, physicians, payers and societies. Our innovative pipeline is comprised of drug candidates within uremic pruritus, lichen sclerosis, Sjogren’s syndrome dry eye, ocular rosacea and atopic dermatitis.

                         
Forward-Looking Statements 
The above information contains forward-looking statements that provide our expectations or forecasts of future events. This can be such as the impact of the global COVID-19 pandemic on our business, new product introductions, clinical development activities and anticipated results, product approvals, financial performance. Terms used may be “aspire”, “believes,” “potential,” “proposed,” “continue,” “designed,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words or expressions referencing future events, conditions or circumstances that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements are subject to risks and uncertainties. This may cause actual results to differ materially from expectations and it may cause any or all our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include the impact of the global COVID-19 pandemic, interest rate and currency exchange rate fluctuations, delay or failure of clinical trials and other development activities, production problems, unexpected contract breaches or terminations.

Contacts

Almirall
Corporate Communications
Mar Ramírez
mar.ramirez@almirall.com
(+34) 659 614 173

Investors Relations
Pablo Divasson del Fraile
pablo.divasson@almirall.com
(+34) 93 291 30 87

MC2 Therapeutics 
Corporate Communications, Media and Investors
Susanne Andersen Fitch
saf@mc2therapeutics.com
(+45) 3131 5119

References

1. Clinical trial IDs: NCT03802344 and NCT03308799 on Clinicaltrials.gov
2. IQVIA MIDAS®
3. Chandran, V., and S.P. Raychaudhuri. 2010. 'Geoepidemiology and environmental factors of psoriasis and psoriatic arthritis', J. Autoimmune, 34: J314-J21
4. Schafer, T. 2006. 'Epidemiology of psoriasis. Review and the German perspective', Dermatology, 212: 327-37
5. WHO Global report on Psoriasis 2016

Keywords: Humans; Ointments; betamethasone dipropionate, calcipotriol; calcipotriene; Prostaglandins A; Patient Satisfaction; Drug Users; Betamethasone; Calcitriol; betamethasone-17,21-dipropionate; Taclonex; Psoriasis; Drug Combinations; Treatment Outcome; Marketing; Licensure; Europe