The drug major said that it now has the exclusive right to commercialize Winlevi (clascoterone cream 1%) in the United States and Canada.
Winlevi (clascoterone cream 1%) is approved for the topical treatment of acne vulgaris in people aged 12 and older.
Sun Pharma and Cassiopea SpA 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, the statement for which was release on 26 July 2021.
Following the the expiry of the HSR Act process, 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.
Cassiopea SpA is a specialty pharmaceutical company developing and preparing to commercialize prescription drugs with novel mechanisms of action (MOA) to address long-standing essential dermatological conditions.
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.
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.
Sun Pharmaceutical Industries is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company.
The company reported a consolidated net profit of Rs 1,444.17 crore in Q1 FY22 as against a net loss of Rs 1,655.80 crore in Q1 FY21. Net sales rose 29.2% YoY to Rs 9669.43 crore during the quarter.
The scrip rose 0.88% to currently trade at Rs 793.50 on the BSE.
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