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Sun Pharma, Cassiopea expand license, supply agreement for Winlevi

Sun Pharma and Cassiopea will bring Winlevi to patients in Japan, Australia, New Zealand, Brazil, Mexico and Russia.

Sun Pharma and Cassiopea, a subsidiary of Cosmo Pharmaceuticals have signed license and supply agreements for Winlevi (clascoterone) cream 1%, expanding the territory to include Japan, Australia, New Zealand, Brazil, Mexico and Russia.

In 2021, Sun Pharma and Cassiopea had signed license and supply agreements for the United States and Canada markets. Sun Pharma launched Winlevi in the U.S. market in November 2021.

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.

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"Winlevi is a new class of topical medication and it continues to generate significant interest amongst dermatologists in the U.S.," said Aalok Shanghvi, executive vice president & head of generic R&D, generic global BD and emerging markets at Sun Pharma. "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 specialty products.”

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Diana Harbort, president of Cosmo's dermatology division, said, “We are very 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 U.S. 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 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 a first-in-class mechanism of action in nearly 40 years, the company said.

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