Cosmo Announces Launch of Winlevi(R) for Treatment of Acne in Singapore and Malaysia

Rhea-AI Summary

Cosmo Pharmaceuticals (OTC:CMOPF) has launched Winlevi® (clascoterone) cream 1% in Singapore and Malaysia through its partnership with Hyphens Pharma, marking its first entry into Southeast Asia. Winlevi® is the first topical androgen receptor inhibitor for acne treatment in over 40 years, approved for patients aged 12 and older.

The treatment demonstrated superior efficacy in two Phase III studies, showing significant improvements in both non-inflammatory and inflammatory lesion counts. Hyphens Pharma has in-licensed the product for distribution across ten Southeast Asian countries, with progressive rollout planned for other markets in the region.

This launch aligns with Cosmo's 2030 vision for sustainable revenue growth through geographic expansion, addressing a market where acne affects over 90% of the population at some point in their lives.

Positive

• First-in-class topical acne treatment launched in 40 years with novel mechanism of action
• Successful Phase III clinical trials demonstrating superior efficacy versus vehicle cream
• Geographic expansion into 10 Southeast Asian markets through strategic partnership
• Addresses large market opportunity with 90% of population affected by acne

Negative

• Progressive rollout to other Southeast Asian markets still pending regulatory approvals

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Dublin, Ireland--(Newsfile Corp. - July 17, 2025) - Cosmo Pharmaceuticals N.V. (SIX: COPN), a global leader in AI-driven healthcare and specialty pharmaceuticals, is pleased to announce the launch of Winlevi^® (clascoterone) cream 1% in Singapore and Malaysia, marking its first entry into Southeast Asia through the partnership with Hyphens Pharma International Limited (“Hyphens Pharma”). Winlevi^® is a topical treatment for acne vulgaris in patients aged twelve years and older, marking a significant milestone in the commitment of both companies to providing innovative, patient-focused dermatology solutions.

Winlevi^® is the first topical acne treatment in over 40 years with a first-in-class mechanism of action. Its active ingredient, clascoterone, is the first commercially available topical androgen receptor inhibitor acting directly in the sebaceous glands with no systemic anti-androgen effects; as such, it can be used safely in both males and females. This approach is believed to help reduce sebum production and intervene early in acne pathogenesis. Two identical Phase III studies demonstrated that clascoterone cream 1%, applied topically twice daily for twelve weeks, was more effective than the application of vehicle cream in achieving the Investigator’s Global Assessment (IGA) of success, reducing non-inflammatory lesion count (NILC) and inflammatory lesion count (ILC) in patients with facial acne vulgaris. Clascoterone cream 1% was found to be generally well tolerated.

As part of the agreement signed in December 2022, Hyphens Pharma has in-licensed the product from Cosmo Pharmaceuticals for distribution across ten Southeast Asian countries (Singapore, Malaysia, Indonesia, Philippines, Vietnam, Thailand, Brunei, Cambodia, Laos and Myanmar), bringing this innovative therapy first to Singapore and Malaysia markets. Registration in other Southeast Asian markets is currently underway, with a progressive rollout planned across the region in due course. This collaboration underscores the dedication of Cosmo and Hyphens Pharma to expanding its dermatology portfolio and addressing the unmet needs of patients with acne vulgaris, a condition that affects millions of individuals worldwide and can cause both physical discomfort and psychological distress.

Giovanni Di Napoli, Chief Executive Officer of Cosmo, commented: “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. This partnership demonstrates tangible progress in executing our long-term growth strategy and underscores our shared commitment to addressing unmet medical needs while delivering meaningful impact for patients across Asia.”

Lim See Wah (林世华), Executive Chairman and CEO of Hyphens Pharma, added: “We’re proud to be the first to introduce Winlevi^® to Southeast Asia. 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. We appreciate their trust in us to bring this transformative treatment to the region. 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.”  

Acne vulgaris is one of the most common skin conditions, impacting more than 90% of the world’s population at some point in their lives. It can have both physical and emotional consequences, affecting individuals’ self-esteem and mental health.

About Hyphens Pharma International Limited
Hyphens Pharma International Limited and its subsidiaries (the "Group") is Singapore’s leading specialty pharmaceutical and consumer healthcare group, leveraging its diverse footprint in ASEAN countries. The Group has a direct presence in Singapore, Vietnam, Malaysia, Indonesia and the Philippines, and is supplemented by a marketing and distribution network covering 15 other markets – Bangladesh, Brunei, Cambodia, Hong Kong S.A.R., Macau S.A.R., Myanmar, South Korea, Sri Lanka, Thailand and Gulf Cooperation Council countries, including Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and United Arab Emirates. The Group is headquartered in Singapore, where its strategic planning, finance, regulatory affairs, research and development, legal, business development and logistics operations are based. The Group’s core business comprises the following segments: Specialty Pharma Principals, Proprietary Brands, and Medical Hypermart & Digital. Besides marketing and selling a range of specialty pharmaceutical products in selected ASEAN countries through exclusive distributorship or licensing and supply agreements with brand principals mainly from Europe and the United States, the Group also develops, markets and sells its own proprietary range of dermatological products and health supplement products. In addition, the Group operates a medical hypermart for healthcare professionals, healthcare institutions and retail pharmacies, to supply pharmaceutical products and medical supplies and an online pharmacy for doctors to prescribe and have medications delivered to their patients’ homes. For more information, visit www.hyphensgroup.com.

About Cosmo
Cosmo is a life sciences company focused on MedTech AI, dermatology, gastrointestinal diseases, and contract development and manufacturing (CDMO). We design, develop, and manufacture advanced solutions that address critical medical needs and raise the standard of care. Our technologies are trusted by leading global pharmaceutical and MedTech companies and reach patients and healthcare providers around the world. Guided by our purpose - Building Health Confidence - our mission is to empower patients, healthcare professionals, and partners by innovating at the intersection of science and technology. Founded in 1997, Cosmo is headquartered in Dublin, Ireland, with offices in San Diego (USA), and in Lainate, Rome, and Catania (Italy).
For more information, visit www.cosmohealthconfidence.com.

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For further information, please contact:
investor.relations@cosmohc.com

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To view the source version of this press release, please visit https://www.newsfilecorp.com/release/259110

FAQ

What is Winlevi and how does it work for acne treatment?

Winlevi (clascoterone) cream 1% is the first topical androgen receptor inhibitor that acts directly in sebaceous glands without systemic anti-androgen effects. It helps reduce sebum production and can be used safely in both males and females aged 12 and older.

What were the results of Winlevi's Phase III clinical trials?

Two identical Phase III studies showed that Winlevi cream 1%, applied twice daily for 12 weeks, was more effective than vehicle cream in achieving Investigator's Global Assessment success and reducing both non-inflammatory and inflammatory lesion counts.

In which Southeast Asian countries will Winlevi be available?

Winlevi is currently launched in Singapore and Malaysia, with planned expansion to Indonesia, Philippines, Vietnam, Thailand, Brunei, Cambodia, Laos, and Myanmar pending regulatory approvals.

How significant is the market opportunity for Winlevi in Southeast Asia?

The market opportunity is substantial as acne affects more than 90% of the population at some point in their lives, with both physical and psychological impacts on patients.

Who is distributing Winlevi in Southeast Asia?

Hyphens Pharma International Limited has in-licensed Winlevi from Cosmo Pharmaceuticals for distribution across ten Southeast Asian countries through an agreement signed in December 2022.