Sun Pharmaceutical Industries Limited, “Sun Pharma” and includes its subsidiaries and/or associate companies) and Cassiopea, a subsidiary of Cosmo Pharmaceuticals N.V. “Cosmo” announced the signing of addendums to the 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 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 US$ 7 million, potential regulatory and sales milestones and customary doubledigit royalties on net sales.
A first-in-class topical androgen receptor inhibitor, WINLEVI was approved by the U.S. 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 a first-in-class mechanism of action in nearly 40 years.
Androgens are widely recognized as the most important of all hormones in terms of regulating sebum production. Within the skin, androgens bind to androgen receptors, causing increased sebum production and inflammation. In particular, the skin of patients with acne vulgaris produces higher levels of the androgens testosterone and DHT than the skin of healthy individuals. Current oral hormonal therapies have been shown to be effective in treating acne regardless of whether androgen levels are elevated. However, whereas certain oral hormonal therapies are recommended for use in some female patients with acne, their use in males has been limited due to the potential risk of systemic side effects such as gynecomastia (overdevelopment or enlargement of breast tissue) and the inability to grow a beard.
WINLEVI is supplied in an epoxy-lined aluminum tube. Each gram of WINLEVI contains 10 mg of clascoterone in a white to almost white cream. Patients are instructed to cleanse the affected area gently, and after the skin is dry, to apply a uniform layer of WINLEVI twice per day, in the morning and the evening.