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Find Clinical Drug Pipeline Developments & Deals for Calcipotriene Hydrate
Through the license agreement, MC2 will gain the commercialization rights for Wynzora consisting of Calcipotriene and Betamethasone dipropionate. It is an approved product indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older.
The product is the combination of calcipotriene hydrate as a synthetic vitamin D3 analog and betamethasone dipropionate as a synthetic corticosteroid. It is indicated for the topical treatment of plaque psoriasis.
WYNZORA is a cream-based fixed dose combination of calcipotriene and betamethasone dipropionate for topical treatment of plaque psoriasis. It is based on PAD™ Technology, which enables stability of both calcipotriene and betamethasone dipropionate in aqueous formulation.
Positive results from the Phase III study with Lipidor’s drug candidate AKP02, which is based on calcipotriol alone & in combination with betamethasone, show that AKVANO® technology works well for drugs for treatment of psoriasis.
Under the terms of this agreement, RELIFE S.r.l shall register, promote, distribute and market Lipidor's calcipotriol based drug candidates for the treatment of psoriasis in EU, Turkey, UK, Switzerland, CIS, and Balkan countries.
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.
U.S. Prescribing Information (USPI) updated to include PSO-LONG clinical trial data concerning long-term use (52 weeks) of twice-weekly topical treatment with Enstilar® (calcipotriene and betamethasone dipropionate) Foam in adults with plaque psoriasis.
Collaboration accelerates a Q1 2021 comprehensive launch of MC2’s WYNZORA® Cream to patients with plaque psoriasis in the US. WYNZORA® Cream is the first drug based on PADTM Technology – providing innovative solutions to unmet needs in chronic inflammatory conditions.
The FDA approval is based on the results of the US Phase 3 clinical trial1 against active comparator Taclonex® Topical Suspension (calcipotriene and betamethasone dipropionate.