Sun Pharma and Cassiopea SpA Announce Signing of License and Supply Agreements for Winlevi (clascoterone cream 1%) in US and Canada

Sun Pharmaceutical Industries Ltd. “Sun Pharma” and includes its subsidiaries and/or associate companies) and Cassiopea SpA, a specialty pharmaceutical company developing and preparing to commercialize prescription drugs with novel mechanisms of action (MOA) to address long-standing essential dermatological conditions, today announced the signing of License 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 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 US $45 million, potential commercial milestones totalling up to US $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 U.S. in Q4 calendar 2021.

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, commented: “We are very pleased to partner with Sun Pharma. 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.”

The FDA approved Winlevi® (clascoterone cream 1%) 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 annually3. The last FDA approval of an acne drug with a new mechanism of action (MOA) occurred nearly 40 years ago.