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 convenience1
-- Marketing Authorization Application (MAA) in Europe of Wynzora Cream has been filed and approval is expected this year
BARCELONA, Spain and COPENHAGEN, Denmark, Feb. 17, 2021 /PRNewswire/ -- 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 annually2. 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 trials1, 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.