[{"orgOrder":0,"company":"Lipidor AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lipidor Announces Positive Topline Results of AKP01 Phase III Clinical Study Using Calcipotriol Spray Against Psoriasis","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"SWEDEN","productType":"Small molecule","productStatus":"Approved","date":"January 2020","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase III"},{"orgOrder":0,"company":"Lipidor AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lipidor Presents Updated Project Plan - Initiates Phase III study of AKP02 in-House","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"SWEDEN","productType":"Small molecule","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase 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III"},{"orgOrder":0,"company":"EPI Health","sponsor":"MC2 Therapeutics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"MC2 Therapeutics Announces Collaboration with EPI Health on Commercialization of Newly Approved Psoriasis Drug, WYNZORA\u00ae Cream, in the US","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2020","url1":"","url2":"","graph1":"Dermatology","graph2":"Approved"},{"orgOrder":0,"company":"MC2 Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"MC2 Therapeutics Announces FDA Approval of Wynzora\u00ae Cream (calcipotriene and betamethasone dipropionate) for Adults with Plaque Psoriasis","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Approved","country":"DENMARK","productType":"Small 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Treatment","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Approved","country":"DENMARK","productType":"Small molecule","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Dermatology","graph2":"Approved"},{"orgOrder":0,"company":"Lipidor AB","sponsor":"Menarini","pharmaFlowCategory":"D","amount":"$83.1 million","upfrontCash":"Undisclosed","newsHeadline":"Lipidor AB Licence Agreement Grants Menarini Group Exclusive Rights to Two New Psoriasis Drug Candidates for Potential Value of MEUR 70","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"SWEDEN","productType":"Small molecule","productStatus":"Approved","date":"July 2021","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase III"},{"orgOrder":0,"company":"Lipidor AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lipidor- Update on the Company's Phase III Clinical Trial of Drug Candidate AKP02 for Treatment of Psoriasis","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"SWEDEN","productType":"Small molecule","productStatus":"Approved","date":"April 2021","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase III"},{"orgOrder":0,"company":"Lipidor AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lipidor Updates on Phase III Study of AKP02 In Treatment of Psoriasis - Half of Patients Now Recruited","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"SWEDEN","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase III"},{"orgOrder":0,"company":"MC2 Therapeutics","sponsor":"Hyphens Pharma","pharmaFlowCategory":"D","amount":"$2.7 million","upfrontCash":"Undisclosed","newsHeadline":"Hyphens Pharma licenses Wynzora\u00ae Cream for ASEAN countries from MC2 Therapeutics","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Approved","country":"DENMARK","productType":"Small molecule","productStatus":"Approved","date":"March 2024","url1":"","url2":"","graph1":"Dermatology","graph2":"Approved"},{"orgOrder":0,"company":"EPI Health","sponsor":"MC2 Therapeutics","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"EPI Health, a Novan Company, and MC2 Therapeutics Present WYNZORA\u00ae (calcipotriene and betamethasone dipropionate) Cream, 0.005%\/0.064% Subgroup Data Analysis at Skin of Color Update 2022 Conference","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Dermatology","graph2":"Approved"},{"orgOrder":0,"company":"Glenmark Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Glenmark Pharmaceuticals Receives ANDA Approval for Calcipotriene and Betamethasone Dipropionate Foam, 0.005%|0.064%","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"March 2023","url1":"","url2":"","graph1":"Dermatology","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals for Calcipotriol
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.
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