Sun Pharma, Cassiopea SpA ink license and supply agreements for acne treatment drug Winlevi

NEW DELHI: Drug major Sun Pharma on Monday said it has signed license and supply agreements with Cassiopea SpA for acne treatment drug Winlevi in the US and Canada.

Sun Pharmaceutical Industries and Cassiopea SpA on Monday announced the signing of license and supply agreements for Winlevi (clascoterone cream 1 per cent) in the United States and Canada, according to a regulatory filing.

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 filing added.

Cassiopea is a specialty pharmaceutical company developing and commercializing prescription drugs with novel mechanisms of action to address long-standing and essential dermatological conditions, particularly acne, androgenetic alopecia (or AGA) and genital warts.

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

Winlevi has been approved by the United States Food and Drug Administration (USFDA) as a novel drug with a unique mechanism of action for the topical treatment of acne in patients 12 years and older.

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

Diana Harbort, CEO of Cassiopea SpA said 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 USFDA approved Winlevi (clascoterone cream 1 per cent) in August 2020, for the topical treatment of acne vulgaris in patients 12 years and older.