Sun Pharmaceutical Industries and Cassiopea, a speciality pharmaceutical company developing and preparing to commercialise prescription drugs with novel mechanisms of action (MOA) to address long-standing essential dermatological conditions announced the signing of License and Supply Agreements for Winlevi (clascoterone cream 1 per cent) in the US 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 commercialise Winlevi in the US 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. The agreements will close upon the expiration of the HSR waiting period. 

Winlevi is expected to be available in the US in the Q4 of 2021.

Abhay Gandhi, CEO, North America, Sun Pharma, said, "Sun Pharma is pleased to enter into a collaboration with Cassiopea. Winlevi is a new class of topical medication in dermatology and will complement our existing oral acne portfolio. The addition of Winlevi further strengthens our position in the acne segment and reinforces our deep commitment to caring and making a difference in the lives of patients."

Diana Harbort, CEO, Cassiopea, commented, “We are pleased to partner with Sun Pharma. Sun Pharma has a strong established US dermatology presence and will make Winlevi widely available to dermatology health care providers and their patients. Following this transaction, Cassiopea will be expecting substantial revenue streams for the foreseeable future and will be well funded to continue the development of its innovative dermatology pipeline.”

The FDA approved Winlevi (clascoterone cream 1 per cent) in August 2020 for the topical treatment of acne vulgaris in patients 12 years and older.