Sun Pharmaceutical Industries and Cassiopea, a subsidiary of Cosmo Pharmaceuticals announced the signing of addendums to the License and Supply Agreements for WINLEVI (clascoterone) cream 1 per cent expanding the territory to include Japan, Australia, New Zealand, Brazil, Mexico and Russia. In 2021, Sun Pharma and Cassiopea signed License and supply agreements for the US and Canada markets. Sun Pharma launched WINLEVI in the US market in November 2021. 

Under the terms of the above-referred agreements, Sun Pharma will receive from Cassiopea the exclusive right to develop and commercialize WINLEVI in Japan, Australia, New Zealand, Brazil, Mexico and Russia. Cosmo will be the exclusive supplier of the product. Cassiopea will receive an upfront payment of $7 million, potential regulatory and sales milestones and customary double-digit royalties on net sales. 

Aalok Shanghvi, EVP & Head - Generic R&D, Generic Global BD and Emerging Markets, Sun Pharma said, “WINLEVI is a new class of topical medication and it continues to generate significant interest amongst dermatologists in the US. The expansion of our agreement with Cosmo will enable us to make this new acne treatment available to patients in many more countries and is in line with our strategy to build a global portfolio of speciality products.”

Diana Harbort, President, Cosmo Dermatology Division, said, “We are pleased to expand our agreement with Sun Pharma making WINLEVI available to more patients around the world. Sun Pharma’s early success with WINLEVI in the US makes us highly confident of their ability to maximize the opportunity in the expanded territory.” 

A first-in-class topical androgen receptor inhibitor, WINLEVI was approved by the US Food and Drug Administration (FDA) in August 2020 for the topical treatment of acne vulgaris in patients 12 years of age and older. Although its exact mechanism of action is unknown, laboratory studies suggest that WINLEVI works by inhibiting the effects of androgen receptors in cells of the sebaceous glands (oil-producing glands in the skin) to help reduce sebum (oil) production and inflammation. It is suitable for use in both males and females. WINLEVI is the first FDA-approved acne drug with the first-in-class mechanism of action in nearly 40 years.