Sun Pharma signs in-licensing deal to sell skincare drug in US

The Mumbai based Sun Pharmaceutical Industries has signed an in-licensing agreement with Italian pharmaceutical company Cassiopea SpA to sell 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, according to a company statement.

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 $45 million, potential commercial milestones totalling up to $190 million and customary double digit royalties.

Acne, being the most prevalent skin condition in the US, affects up to 50 million Americans annually. The last FDA approval of an acne drug with a new mechanism of action (MOA) occurred nearly 40 years ago. Winlevi is expected to be available in the US in Q4 calendar 2021, added the statement.

"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," said Abhay Gandhi, CEO, North America of Sun Pharma.

“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,” said Diana Harbort, CEO of Cassiopea SpA.