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Details:

Winlevi (clascoterone) cream is an androgen receptor inhibitor, recently received approval form the TGA to commercilize in the australian market. It is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.


Lead Product(s): Clascoterone

Therapeutic Area: Dermatology Product Name: Winlevi

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 20, 2024

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Winlevi (clascoterone) cream 1% is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.


Lead Product(s): Clascoterone

Therapeutic Area: Dermatology Product Name: Winlevi

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 28, 2023

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Results from two pivotal clinical trials of WINLEVI (clascoterone) cream 1% for the topical treatment of acne vulgaris (acne)showed favorable safety and efficacy data for WINLEVI in patients with acne aged 12 years and older.


Lead Product(s): Clascoterone

Therapeutic Area: Dermatology Product Name: Winlevi

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Cassiopea

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 25, 2022

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Curia has been named as the exclusive supplier of the active pharmaceutical ingredient (API) in Cassiopea SpA’s (SIX: SKIN) recently approved acne treatment, Winlevi® (clascoterone) cream 1%.


Lead Product(s): Clascoterone

Therapeutic Area: Dermatology Product Name: Winlevi

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Cassiopea

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement October 30, 2020

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Under the agreements, Glenmark will receive from Cassiopea, the exclusive right to commercialize Winlevi (clascoterone cream), used on the skin (topical) to treat acne vulgaris in people 12 years of age and older, in 15 EU countries as well as in South Africa and the UK.


Lead Product(s): Clascoterone

Therapeutic Area: Dermatology Product Name: Winlevi

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Glenmark Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: $5.0 million

Deal Type: Licensing Agreement September 27, 2023

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Details:

WINLEVI (clascoterone) cream 1% is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.


Lead Product(s): Clascoterone

Therapeutic Area: Dermatology Product Name: Winlevi

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Hyphens Pharma

Deal Size: $5.0 million Upfront Cash: $1.0 million

Deal Type: Licensing Agreement December 21, 2022

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Under the terms of the above referred agreements, Sun Pharma will receive from Cassiopea the exclusive right to develop and commercialize WINLEVI (clascoterone) in Japan, Australia, New Zealand, Brazil, Mexico and Russia.


Lead Product(s): Clascoterone

Therapeutic Area: Dermatology Product Name: Winlevi

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Sun Pharmaceutical Industries Limited

Deal Size: Undisclosed Upfront Cash: $7.0 million

Deal Type: Licensing Agreement July 25, 2022

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Under the terms of the above referred agreements, Sun Pharma will have the exclusive right to commercialize Winlevi® in the United States and Canada, and Cassiopea will be the exclusive supplier of the product.


Lead Product(s): Clascoterone

Therapeutic Area: Dermatology Product Name: Winlevi

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Sun Pharmaceutical Industries Limited

Deal Size: $235.0 million Upfront Cash: $45.0 million

Deal Type: Licensing Agreement July 26, 2021

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Details:

Winlevi (clascoterone cream 1%) is approved for the treatment of acne vulgaris in people aged 12 and older. In pivotal clinical trials, WINLEVI demonstrated treatment success and reductions in acne lesions and was well tolerated when used twice a day.


Lead Product(s): Clascoterone

Therapeutic Area: Dermatology Product Name: Winlevi

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Cosmo Pharmaceuticals

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 27, 2020

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The study demonstrated that Clascoterone cream 1%, has favorable long-term safety for the treatment of acne with low rates of treatment related adverse events (AEs).


Lead Product(s): Clascoterone

Therapeutic Area: Dermatology Product Name: CB-03-01

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 June 23, 2020

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