Sun Pharma to commercialise Winlevi in the US and Canada

Acne affects up to 50 million Americans annually. The last FDA approval of an acne drug with a new MOA occurred nearly 40 years ago

Sun Pharma has the exclusive right to commercialize Winlevi in the United States and Canada. Cassiopea will be the exclusive supplier of the product. Winlevi is expected to be available in the U.S. in Q4 calendar 2021.

This development precedes the announcement by Sun Pharmaceutical and Cassiopea SpA of the expiration of the applicable waiting period under the US Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act) in connection with the exclusive license and supply agreements signed by both companies for Winlevi (clascoterone cream 1%).

Sun Pharma North America CEO Abhay Gandhi said: "The expiration of the applicable waiting period under the HSR Act clears the path for making Winlevi available to patients and healthcare providers in the US and Canada. With Winlevi, a unique product with a new mechanism of action for the topical treatment of acne vulgaris, we have further expanded our basket of innovative products to serve patients better.”

Cassiopea SpA, CEO Diana Harbort, CEO commented: “We are very pleased that Winlevi will soon be widely available to dermatology healthcare providers and their patients in the US and Canada, benefiting from Sun Pharma’s strong established dermatology presence. This transaction now allows Cassiopea to focus on 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 annually. The last FDA approval of an acne drug with a new MOA occurred nearly 40 years ago. Most common adverse reactions occurring in 7 to 12% of patients are erythema/reddening, pruritus and scaling/dryness.