Almirall has secured exclusive rights to commercialize Wynzora for the treatment of plaque psoriasis in Europe from MC2 Therapeutics. The agreement is worth up to €15 million ($18 million) in upfront to launch payments to MC2, with “significant” sales milestones to follow if the drug hits the market.
MC2 developed the topical formulation of calcipotriol and betamethasone dipropionate using its PAD technology. Using PAD, MC2 creates oil-in-water dispersions. Encapsulation in a multimolecular robust aqueous film of emulsifiers stabilizes the internal oil phase. Through that approach, MC2 can maintain physical-chemical stability while reducing emulsifier use by as much as 15-fold.
Lowering emulsifier use is intended to make the formulations tolerable to sensitive tissue. MC2 put that idea to the test in two phase 3 clinical trials that linked the formulation to a higher response rate than a vehicle control and a better treatment satisfaction score than Leo Pharma’s Daivobet.
MC2 won FDA approval on the strength of the data last year. Now, Almirall has picked up rights to Wynzora in Europe, where the drug candidate is currently under regulatory review. MC2 expects to win approval this year.
Once approved, Almirall will handle commercialization, leveraging its dermatology capabilities, and MC2 will be responsible for manufacturing and supply. Other products that contain the same active ingredients as Wynzora, calcipotriene and betamethasone dipropionate, account for approximately a 35% share of market volumes and annual sales of more than $300 million.
Multiple companies are targeting the market. As well as the market incumbents, Almirall may face competition from new drugs in development at companies including Arcutis Biotherapeutics, Bristol Myers Squibb and Dermavant. MC2 CEO Jesper Lange thinks Wynzora can compete.
“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,” Lange said in a statement.