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India's Sun Pharma In Deal With Italy's Cassiopea To Supply Acne Treatment Winlevi In US, Canada

India's Sun Pharmaceutical Industries Ltd. announced Monday the signing of License and Supply Agreements with Italian specialty pharmaceutical company Cassiopea SpA for acne treatment drug Winlevi (clascoterone cream 1%) in the United States and Canada.

Winlevi is expected to be available in the U.S. in the fourth quarter of calendar 2021.

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

Under the deal terms, 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 totaling up to $190 million and customary double digit royalties.

The agreements will close upon the expiration of the HSR waiting period.

The FDA approved Winlevi 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 annually.

The last FDA approval of an acne drug with a new MOA occurred nearly 40 years ago.

Abhay Gandhi, CEO, North America of Sun Pharma, said: "Sun Pharma is pleased to enter into a collaboration with Cassiopea SpA. 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 of Cassiopea SpA, "Sun Pharma has a strong established U.S. 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."

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