Sun Pharma and Cassiopea announce expiry of HSR Act process and consummation of Winlevi agreement

Sun Pharmaceuticals and Cassiopea SpA 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 on 26th July, 2021. The agreements are effective as of 31st August, 2021, the companies said in a joint statement.

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

Speaking in this regard, Abhay Gandhi, CEO, North America, 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.”

Adding to it, Diana Harbort, CEO, Cassiopea SpA, commented, “We are pleased that Winlevi will soon be widely available to dermatology healthcare providers and their patients in the US and Canada, benefitting 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 US, affects up to 50 million Americans annually. The last FDA approval of an acne drug with a new MOA occurred nearly 40 years ago. The most common adverse reactions occurring in seven to 12 per cent of patients are erythema/reddening, pruritus and scaling/dryness, according to the statement.