Sun Pharma and specialty pharma firm Cassiopea SpA on Tuesday announced consummation of their exclusive licence and supply agreements for Winlevi cream used for treatment of acne vulgaris in patients 12 years and older.
The agreements are effective from August 31, 2021, according to a joint statement.
Sun Pharma now has the exclusive right to commercialise Winlevi in the US and Canada. Cassiopea will be the exclusive supplier of the product, which is expected to be available in the US in the fourth quarter of 2021, it added.
Sun Pharma, North America CEO Abhay Gandhi said the expiration of the applicable waiting period under the US Hart-Scott-Rodino Antitrust Improvements Act of 1976 (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," he added.
The US Food and Drug Administration (USFDA) approved Winlevi (clascoterone cream 1 percent) in August 2020 for the topical treatment of acne vulgaris in patients 12 years and older, the statement said.
"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," Cassiopea SpA CEO Diana Harbort said.
This transaction now allows Cassiopea to focus on its innovative dermatology pipeline, she added.