Cosmo Pharmaceuticals N.V. has launched Winlevi (clascoterone) cream 1% in Singapore and Malaysia, introducing the first topical acne treatment with a novel mechanism of action in over 40 years to Southeast Asia. The launch represents a significant milestone in dermatology therapeutics, bringing a first-in-class treatment option to patients aged twelve years and older with acne vulgaris.
Novel Mechanism of Action Addresses Acne Pathogenesis
Winlevi's active ingredient, clascoterone, represents a breakthrough as the first commercially available topical androgen receptor inhibitor. The drug acts directly in the sebaceous glands without producing systemic anti-androgen effects, enabling safe use in both males and females. This targeted approach is believed to help reduce sebum production and intervene early in acne pathogenesis.
The treatment's safety profile and gender-neutral application address a significant gap in acne therapeutics, where many existing treatments carry gender-specific restrictions or systemic side effects.
Phase III Studies Demonstrate Clinical Efficacy
Two identical Phase III studies validated Winlevi's therapeutic potential in patients with facial acne vulgaris. The trials demonstrated that clascoterone cream 1%, applied topically twice daily for twelve weeks, was more effective than vehicle cream in achieving the Investigator's Global Assessment (IGA) of success. The treatment also showed superior performance in reducing both non-inflammatory lesion count (NILC) and inflammatory lesion count (ILC).
Clinical data indicated that clascoterone cream 1% was generally well tolerated across the study population, supporting its safety profile for long-term acne management.
Strategic Partnership Expands Regional Access
The launch follows a December 2022 agreement between Cosmo Pharmaceuticals and Hyphens Pharma International Limited, granting distribution rights across ten Southeast Asian countries including Singapore, Malaysia, Indonesia, Philippines, Vietnam, Thailand, Brunei, Cambodia, Laos, and Myanmar. Registration in additional Southeast Asian markets is currently underway, with a progressive regional rollout planned.
Giovanni Di Napoli, Chief Executive Officer of Cosmo, emphasized the strategic importance of the launch: "The launch of Winlevi in Southeast Asia is an important step in our ongoing global expansion and directly supports our 2030 vision of driving sustainable revenue growth through strategic geographic expansion. Together with Hyphens Pharma, we are bringing a truly differentiated dermatology innovation to a rapidly growing market with increasing demand for advanced acne care."
Addressing Significant Medical Need
Acne vulgaris represents one of the most prevalent skin conditions globally, impacting more than 90% of the world's population at some point in their lives. The condition extends beyond physical symptoms, carrying significant psychological and social implications that affect individuals' self-esteem and mental health.
Lim See Wah, Executive Chairman and CEO of Hyphens Pharma, highlighted the treatment's potential impact: "Acne affects millions in the region, yet for decades, patients have had limited treatment options. This launch marks a significant advancement in acne care, our dermatology portfolio and partnership with Cosmo. Acne isn't just skin-deep – it can impact psychosocial well-being. By expanding access to Winlevi, we aim to support doctors in their practice and empower patients to manage acne with greater confidence, improving their quality of life."
The collaboration underscores both companies' commitment to addressing unmet medical needs in dermatology while expanding access to innovative therapeutics across rapidly growing Southeast Asian healthcare markets.
