Sun Pharmaceuticals and Cassiopea SpA have signed licence and supply agreements for Winlevi (clascoterone cream 1%) in the United States (US) and Canada. Winlevi has been approved by the United States Food and Drug Administration (FDA) as a novel drug for the topical treatment of acne in patients aged 12 years and older, according to a statement.

The statement also said that under the terms of the above 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 Q4 calendar 2021, the statement added.

Speaking on the development, Abhay Gandhi, CEO, North America, Sun Pharma, said, “Sun Pharma is pleased to enter into a collaboration with Cassiopea SpA. Winlevi is a new class of topical medication and home medical products 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.”

Adding to it, Diana Harbort, CEO, Cassiopea SpA, commented, “We are pleased to partner with Sun Pharma that 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.”