Sun Pharma, one of India’s largest pharmaceuticals manufacturers, said it has acquired the exclusive license to sell an acne cream in the US and Canada for an upfront payment of $45 million and potential milestone payments of up to $190 mln.
The rights to sell Winlevi branded clascoterone cream were acquired from Italy-based Cassiopea SpA.
“Winlevi is a new class of topical medication in dermatology and will complement our existing oral acne portfolio. The addition of Winlevi further strengthens our position in the acne segment and reinforces our deep commitment to caring and making a difference in the lives of patients,” the Indian company said.
Winlevi was approved by the US FDA in August 2020 for treating acne in patients 12 years and older.
“The last FDA approval of an acne drug with a new mechanism of action (MOA) occurred nearly 40 years ago,” Sun Pharma said.
The exact mechanism of action for Winlevi is unknown, the company said. But laboratory studies suggest the active ingredient, clascoterone, competes with androgens, specifically dihydrotestosterone (DHT), for binding to the androgen receptors within the sebaceous gland and hair follicles.
Acne affects up to about 5 cr (out of a total of 33 cr) Americans every year and is the most prevalent skin condition in the country.
Cassiopea focuses exclusively on developing treatments for skin diseases, particularly acne, androgenetic alopecia (or AGA) and genital warts. The company focuses on the research and development part, while tying up with partners for commercialization and marketing.
Sun Pharma, as one of the largest pharma manufacturers in Asia, has a well developed distribution mechanism across the world.
“Sun Pharma has a strong established U.S. dermatology presence and will make Winlevi widely available to dermatology health care providers and their patients. Following this transaction, Cassiopea will be expecting substantial revenue streams for the foreseeable future and will be well funded to continue the development of its innovative dermatology pipeline,” said Diana Harbort, CEO of Cassiopea.