Pharma Focus Europe

Cosmo And Hyphens Announce Signing Of License And Supply Agreements For Winlevi® In Southeast Asia

Thursday, December 22, 2022

Cosmo Pharmaceuticals N.V. and Hyphens Pharma International Limited announced the signing of License and Supply Agreements for Winlevi® (clascoterone) cream 1% in Southeast Asia.

Under the terms of the agreements, Hyphens Pharma Pte. Ltd., a subsidiary of Hyphens, will receive from Cassiopea, a subsidiary of Cosmo, the exclusive right to develop and commercialize Winlevi® in Singapore, Indonesia, Malaysia, the Philippines, Vietnam, Thailand, Brunei, Cambodia, Laos and Myanmar. Cosmo will be the exclusive supplier of the product. Cassiopea will receive an upfront payment of US$1 million, potential regulatory and sales milestones totaling up to US$4 million and customary double-digit royalties on net sales.

Winlevi®has been approved by the United States Food & Drug Administration (FDA) as a 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 mechanism of action in acne approved by the FDA in 40 years. Winlevi® was launched in the US in November 2021 by Sun Pharma and is already the most prescribed branded topical acne drug in the US based on IQVIA data. Over 12,000 US physicians have prescribed Winlevi® to date. According to the prescriptions generated, Winlevi® has been one of the most successful US launches in the topical acne space in the last 15 years.

Hyphens is Singapore’s leading specialty pharmaceutical and consumer healthcare group with a diverse footprint in Southeast Asia. Dermatology is a strategic therapeutic area for Hyphens. Today, Hyphens has a proprietary range of dermatological products for acne, atopic dermatitis, hyperpigmentation, and hair loss. These are available through doctors including dermatologists, pediatricians and general practitioners as well as major retail pharmacies.

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 these affect their self-esteem.[2] As the first novel acne drug in decades, Winlevi® has huge potential to revolutionize the acne treatment space.

Diana Harbort, President of Cosmo’s Dermatology Division, said: “We are very pleased to partner with Hyphens. 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 US 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: “Hyphens is very pleased to partner with Cosmo in this deal. We are delighted to be granted the exclusive right to commercialize Winlevi® in 10 countries across Southeast Asia. As a region of more than 600 million people with millions of them afflicted by Acne, Winlevi® will bring new hope to doctors and patients alike.”

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