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Details:
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.
Lead Product(s): Calcipotriol,Betamethasone Dipropionate
Therapeutic Area: Dermatology Product Name: Wynzora
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Hyphens Pharma
Deal Size: $2.7 million Upfront Cash: Undisclosed
Deal Type: Licensing Agreement March 12, 2024
Details:
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.
Lead Product(s): Calcipotriol,Betamethasone Dipropionate
Therapeutic Area: Dermatology Product Name: Enstilar-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 23, 2023
Details:
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.
Lead Product(s): Calcipotriol,Betamethasone Dipropionate
Therapeutic Area: Dermatology Product Name: Wynzora
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: MC2 Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 15, 2022
Details:
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.
Lead Product(s): Calcipotriol,Betamethasone
Therapeutic Area: Dermatology Product Name: AKP02
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 20, 2022
Details:
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.
Lead Product(s): Calcipotriol,Beclomethasone Dipropionate
Therapeutic Area: Dermatology Product Name: AKP01
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Menarini
Deal Size: $83.1 million Upfront Cash: Undisclosed
Deal Type: Licensing Agreement July 01, 2021
Details:
AKP02 is a drug candidate for psoriasis that combines calcipotriol and betamethasone and is based on Lipidor’s patented AKVANO® technology.
Lead Product(s): Calcipotriol,Betamethasone
Therapeutic Area: Dermatology Product Name: AKP02
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 22, 2021
Details:
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.
Lead Product(s): Calcipotriol,Betamethasone Dipropionate
Therapeutic Area: Dermatology Product Name: Wynzora
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Almirall
Deal Size: Undisclosed Upfront Cash: $18.0 million
Deal Type: Collaboration February 17, 2021
Details:
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.
Lead Product(s): Calcipotriol,Betamethasone Dipropionate
Therapeutic Area: Dermatology Product Name: Enstilar
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 22, 2020
Details:
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.
Lead Product(s): Calcipotriol,Betamethasone Dipropionate
Therapeutic Area: Dermatology Product Name: Wynzora
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: MC2 Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration August 24, 2020
Details:
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.
Lead Product(s): Calcipotriol,Betamethasone
Therapeutic Area: Dermatology Product Name: Wynzora
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 22, 2020
Details:
The MAA is supported by two comprehensive Phase 3 trials1 including a trial conducted in EU evaluating the efficacy and safety of Wynzora® Cream compared to vehicle and active comparator Dovobet/Daivobet® Gel in patients with psoriasis vulgaris.
Lead Product(s): Calcipotriol,Betamethasone
Therapeutic Area: Dermatology Product Name: Wynzora
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 16, 2020
Details:
Lipidor AB has penned an agreement with Cadila Pharmaceuticals to conduct a Phase III study for Lipidor’s drug candidate AKP-02. AKP-02 is an antipsoriasis medicine that combines the active substances calcipotriol and betamethasone with Lipidor’s spray-based AKVANO technology.
Lead Product(s): Calcipotriol,Betamethasone
Therapeutic Area: Dermatology Product Name: AKP-02
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Lipidor AB
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement July 07, 2020
Details:
Company has successfully completed Phase III study of calcipotriol spray (AKP01) against mild to moderate plaque psoriasis and is planning for a licensing project.
Lead Product(s): Calcipotriol,Betamethasone
Therapeutic Area: Dermatology Product Name: AKP02
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 07, 2020
Details:
Both Lipidor's AKP01 and the comparator had a statistically significantly better efficacy compared to the placebo.
Lead Product(s): Calcipotriol
Therapeutic Area: Dermatology Product Name: AKP01
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 24, 2020
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