Winlevi is U.S. Food and Drug Administration-approved for the topical treatment of acne in patients aged 12 years and older.

Hyphens Pharma International Limited’s subsidiary Hyphens Pharma Pte. Ltd.  has entered into exclusive license and supply agreements with Cassiopea S.p.A to develop and commercialize Winlevi (clascoterone) cream 1% and all future product extensions and/or improvemenst in the treatment of acne in 10 countries across Southeast Asia.

Cassiopea S.p.A is a subsidiary of Cosmo Pharmaceuticals N.V.

Winlevi is U.S. Food and Drug Administration-approved for the topical treatment of acne in patients aged 12 years and older. It is the first-in-class topical androgen receptor inhibitor that tackles the androgen hormone component of acne and is the first new type of acne medication approved by the FDA since 1982. 

Hyphens Pharma has a proprietary range of dermatological products for acne, atopic dermatitis, hyperpigmentation, and hair loss that are available through doctors including dermatologists, paediatricians, and general practitioners as well as major retail pharmacies.

"We are very pleased to partner with Hyphens Pharma. Their strong expertise in Southeast Asia gives us great confidence in their ability to gain regulatory approval and commercialize Winlevi in the region. The success of Winlevi in the U.S. has given us the opportunity to select the best partners in each region and to eventually make the product available to more patients around the globe," says Diana Harbort, President of Cosmo's Dermatology Division in a news release. 

"Acne is a medical condition that affects millions in the ASEAN region. Yet, the medical management of acne remained largely similar due to the absence of new drugs.  Winlevi is the first new class of topical drug for the treatment of acne that is approved by U.S. FDA in nearly 40 years. We are thus very proud to be able to bring Winlev® to doctors and patients in the entire ASEAN region,” says Lim See Wah, Executive Chairman and CEO of Hyphens Pharma. “We would like to thank Cosmo for this partnership and their confidence in Hyphens Pharma. This deal also affirms Hyphens Pharma's strength as ASEAN's leading specialty pharmaceutical company with a strong focus on skin health.  We will continue to innovate, as well as to bring to market relevant innovations from the world to our region, so as to continue serving our doctors and patients."