Sun Pharmaceutical Industries Ltd. and Cassiopea SpA announced the signing of License and Supply Agreements for Winlevi® (clascoterone cream 1%) in the United States and Canada. Winlevi® has been approved by the United States Food & Drug Administration (FDA) as a novel drug with a unique mechanism of action for the topical treatment of acne in patients 12 years and older. 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. Cassiopea will receive an upfront payment of USD 45 million, potential commercial milestones totalling up to USD 190 million and customary double digit royalties. The agreements will close upon the expiration of the HSR waiting period. Winlevi® is expected to be available in the U.S. in Fourth Quarter calendar 2021. The FDA approved Winlevi® (clascoterone cream 1%) in August 2020 for the topical treatment of acne vulgaris in patients 12 years and older. Acne, being the most prevalent skin condition in the U.S., affects up to 50 million Americans annually3. The last FDA approval of an acne drug with a new mechanism of action (MOA) occurred nearly 40 years ago.