Sun Pharma , on July 26, said it had entered into a licensing and supply pact with Italian speciality drug maker Cassiopea SpA for topical cream Winlevi in US and Canada.
Winlevi or clascoterone cream 1 percent has been approved by the USFDA in August 2020 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 agreement, Sun Pharma will have the exclusive right to commercialize 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 which is 15-30 days.
Winlevi is expected to be available in the US in the Q4 calendar 2021.
"Winlevi is a new class of topical medication in dermatology and will complement our existing oral acne portfolio," said Abhay Gandhi, CEO, North America of Sun Pharma.
"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," Gandhi added.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.”
Acne is the most prevalent skin condition in the US that 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.