Glenmark Pharmaceuticals in South Africa

Glenmark Pharmaceuticals Expands Dermatology Portfolio in South Africa with Winlevi Distribution Agreement

Johannesburg, South Africa – September 27, 2023

Glenmark Pharmaceuticals has announced a strategic partnership with Cosmo Pharmaceuticals NV to distribute Winlevi (clascoterone cream 1%) in South Africa. This agreement grants Glenmark the exclusive rights to commercialize Winlevi in South Africa, along with 15 European Union countries, including France, Germany, and the United Kingdom. (business-standard.com)

Winlevi is a topical treatment approved by the U.S. Food and Drug Administration for the management of acne in patients aged 12 and older. It represents a novel mechanism of action in acne therapy, addressing the androgen hormone component of the condition. The product has gained significant traction in the U.S., becoming the most prescribed branded topical acne medication. (business-standard.com)

Under the terms of the agreement, Cosmo’s subsidiary, Cassiopea, will be responsible for obtaining the Centralized Marketing Authorization from the European Medicines Agency (EMA). Glenmark will oversee the registration process in South Africa and the UK. Cosmo will serve as the exclusive supplier of Winlevi. Cassiopea is set to receive an upfront payment of $5 million, along with double-digit royalties on net sales. (business-standard.com)

The European acne treatment market is projected to grow from $928.7 million in 2021 to $1,297 million by 2028. Acne affects over 90% of individuals aged 11 to 30 in Europe, indicating a substantial demand for effective treatments. (business-standard.com)

This partnership aligns with Glenmark’s strategic focus on expanding its dermatology portfolio and enhancing its presence in key international markets. The company aims to leverage its extensive experience in dermatology to address the unmet medical needs of patients in South Africa and Europe. (business-standard.com)

Glenmark Pharmaceuticals is an integrated, research-led global pharmaceutical company with a presence across branded, generics, and over-the-counter segments. The company operates in over 80 countries and has a strong focus on therapeutic areas such as respiratory, dermatology, and oncology. (glenmarkpharma.com)

The introduction of Winlevi is expected to strengthen Glenmark’s position in the dermatology market and provide South African patients with access to an innovative acne treatment option.

Glenmark’s Strategic Expansion in Dermatology:

• Glenmark announces license agreements for Winlevi in Europe and S Africa | Company News – Business Standard
• Glenmark, Cosmo partner to bring acne treatment Winlevi to Europe, S Africa | Company News – Business Standard
• Glenmark inks agreement to market Cosmo Pharma’s acne cream in Europe, South Africa – CNBC TV18