Sun Pharma teams up with Italy’s Cassiopea to deliver acne treatment medicine Winlevi to US and Canada markets

Ontario, Canada (CU)_ Sun Pharmaceutical Industries Ltd. of India has entered into an agreement with Cassiopea SpA of Italy to supply the acne treatment medicine Winlevi in the United States and Canada. Sun Pharma on Monday announced the signing of License and Supply Agreements with Italy’s specialty pharmaceutical firm Cassiopea SpA. 

Winlevi is projected to be available in the US market by the end of the year 2021. The US Food and Drug Administration or USFDA has authorized Winlevi as a new drug with a special mechanism of action (MOA) for the topical therapy of acne in individuals aged 12 and up.

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According to the terms of the agreement, Sun Pharma will be entitled to commercialize Winlevi in the United States and Canada markets, and the product will be supplied by Cassiopea. Cassiopea will be compensated with a $45 million upfront payment, $190 million in future commercial milestones, and traditional double-digit royalties.

When the HSR waiting duration expires, the agreements will come to an end. In August 2020, Winlevi was authorized by the FDA for the topical therapy of acne vulgaris in individuals aged 12 and up. Acne is one of the most common skin problems in the United States, affecting around 50 million people each year. The last time an acne medicine with a new MOA was approved by the FDA was approximately 40 years ago.


Abhay Gandhi, CEO of North America Sun Pharma, expressed delight over partnering with Cassiopea SpA. He said, “Sun Pharma is pleased to enter into a collaboration with 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.”

Cassiopea SpA’s CEO Diana Harbort expressed optimism about the new team. She said, “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.”

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