Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries and/or associate companies) and Cassiopea SpA (SIX: SKIN), 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 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%), for which a press release was issued by both companies.
Sun Pharma now 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.
Abhay Gandhi, CEO, North America of Sun Pharma, 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.”
Diana Harbort, CEO of Cassiopea SpA, 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 annually3. 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.