Sun Pharmaceutical Industries and Cassiopea, a subsidiary of Ireland-based Cosmo Pharmaceuticals, have announced the signing of addendums to the License and Supply Agreements for WINLEVI (clascoterone) cream 1 per cent expanding the territory to include Japan, Australia, New Zealand, Brazil, Mexico and Russia. 

Under the terms of the agreements, Sun Pharma will receive from Cassiopea the exclusive right to develop and commercialize WINLEVI in Japan, Australia, New Zealand, Brazil, Mexico and Russia. Cosmo will be the exclusive supplier of the product. Cassiopea will receive an upfront payment of $ 7 million, potential regulatory and sales milestones and customary double-digit royalties on net sales. 

A first-in-class topical androgen receptor inhibitor, WINLEVI was approved by the U.S. Food and Drug Administration (FDA) in August 2020 for the topical treatment of acne vulgaris in patients 12 years of age and older. WINLEVI is the first FDA-approved acne drug with a first-in-class mechanism of action in nearly 40 years.