FDA-approved Winlevi® is the first novel topical mechanism for acne in nearly 40 years
Winlevi® (clascoterone) cream 1% is a prescription medicine used on the skin (topical) to treat acne vulgaris in people 12 years of age and older.
Our first-in-class topical androgen receptor inhibitor, Winlevi® tackles the androgen hormone component of acne in both males and females. Androgen receptor inhibitors act by limiting the effects of these hormones on increasing sebum production and inflammation.
In pivotal clinical trials, Winlevi® demonstrated treatment success and reductions in acne lesions and was well tolerated when used twice a day. The most frequently observed local skin reaction was mild erythema.
Winlevi® (clascoterone cream 1%) a first-in-class topical androgen receptor inhibitor is FDA approved for the topical treatment of acne vulgaris in patients 12 years of age and older.
OUR PARTNERS FOR WINLEVI®
Sun Pharma is our partner for Winlevi® in U.S., Canada, Japan, Australia, New Zealand, Brazil, Mexico and Russia
The U.S. and Canada rights to Winlevi® were licensed to Sun Pharmaceutical Industries Ltd. (NSE: SUNPHARMA) (“Sun Pharma”). Sun Pharma launched Winlevi® in the U.S. on November 1, 2021. According to the prescriptions generated, Winlevi® has been one of the most successful U.S. launches in the topical acne space in the last 15 years. The strong U.S. launch has resulted in demand from potential ex-U.S. commercial partners.
In July 2022, the partnership with Sun Pharma was expanded to make Winlevi® available to more patients around the world which now includes Japan, Australia, New Zealand, Brazil, Mexico and Russia.
Sun Pharma has the exclusive right to develop and commercialize Winlevi in these territories. Cosmo will be the exclusive supplier of the product.
3SBio is our partner for Winlevi® in Mainland China, Taiwan, Hong Kong and Macao (Greater China)
In July 2022, Cosmo and 3SBio announced the signing of a license agreement for Winlevi® in Mainland China, Taiwan, Hong Kong and Macao (“Greater China”). 3SBio has the exclusive right to develop and commercialize Winlevi® in Greater China. Cosmo will be the exclusive supplier for development and initial commercialization period.
Infectopharm is our partner for Winlevi® in Germany, Italy and Austria
In October 2022, Cosmo and Infectopharm announced the signing of a license agreement for Winlevi® in in Germany, Italy and Austria. Infectopharm has the exclusive right to commercialize Winlevi® in these countries. InfectoPharm is a well-established family-owned German company which operates internationally and enjoys high reputation among physicians, especially pediatricians and dermatologists. Cosmo will be the exclusive supplier of Winlevi® and be responsible for the submission of the centralized marketing authorization application (MAA) to the European Medicines Agency (EMA).
The company is exploring commercial partnerships for Winlevi® for other remaining territories.
Please see https://www.winlevi.com/ for more information on Winlevi.