Sun Pharmaceutical Industries Ltd. and Cassiopea SpA, a specialty pharmaceutical company on Monday announced the signing of licence 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 agreements, Sun Pharma will have the exclusive right to commercialise Winlevi in the United States and Canada, and Cassiopea will be the exclusive supplier of the product.
Cassiopea will receive an upfront payment of $45 million, potential commercial milestones totalling up to $190 million and customary double-digit royalties.
Winlevi is expected to be available in the U.S. in Q4 calendar 2021, Sun Pharma said in a statement.