• Winlevi® is a first-in-class topical drug for the treatment of acne approved by U.S. FDA in August 2020.
• It will reinforce our Proprietary Brand segment's dermatological franchise.

Winlevi® (www.winlevi.com) is a U.S. Food & Drug Administration ("FDA") approved novel drug with a unique mechanism of action 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. As the only topical cream to treat hormonal acne directly in the skin, it offers a non-antibiotic approach for acne-sufferers everywhere. Winlevi® inhibits sebum production and inflammation by targeting the androgen receptors in the sebaceous gland cells. Oral treatments are typically prescribed to address hormonal acne, but usually only prescribed to females. With Winlevi®, males suffering from acne, as well as females who don't want to take oral medications, can now benefit from this first-in-class treatment, making Winlevi® a game-changer in the fight against acne.

Launched in the U.S. in November 2021, Winlevi® is already the most prescribed branded topical acne drug in the U.S. based on IQVIA data. Over 12,000 U.S. physicians have prescribed Winlevi® to date. 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. 

In a study involving 3,888 Singapore Chinese subjects, the estimated prevalence of acne vulgaris is 53.8%^[1]. Acne can have profound social and psychological effects on adolescents or young adults when it affects their self-esteem^[2]. As the first novel acne drug in decades, Winlevi® has huge potential to revolutionize the acne treatment space. Winlevi® will be Hyphens Pharma's first innovative therapeutics, deepening its dermatology pipeline.

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

Diana Harbort, President of Cosmo's Dermatology Division, said: "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 commercialise 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."

Lim See Wah, Executive Chairman and CEO of Hyphens Pharma, said: "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 Winlevi® to doctors and patients in the entire ASEAN region. 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."