Hikma and Cosmo partner on exclusive licensing agreement for Winlevi®

Press Release Business Development 2 October 2023

Hikma and Cosmo partner on exclusive licensing agreement for Winlevi® (Clascoterone) for the Middle East and North Africa

London, 2 October 2023 – Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, today announces an exclusive license agreement with Cassiopea S.p.A., a subsidiary of Cosmo Pharmaceuticals N.V. (Cosmo). Cosmo is focused on developing and commercialising products to treat selected gastrointestinal diseases and dermatological conditions.

Under the terms of the agreement, Hikma has an exclusive license to commercialise Winlevi® (clascoterone) cream 1%, a novel drug used for the topical treatment of acne by targeting acne hormones in the skin, in 17 MENA countries.

Acne is considered to be one of the most prevalent skin conditions across the MENA region. This is due to its predominantly young population, with approximately 55% of the population under the age of 30. This agreement grants Hikma exclusive rights to commercialize Winlevi® in MENA markets, including Saudi Arabia, Egypt and UAE, which represent around 75% of the total acne market in MENA.

Commenting on the agreement, Mazen Darwazah, Hikma’s Executive Vice Chairman and President of MENA, said: “We are excited to partner with Cosmo to bring this novel dermatological treatment to our patients in MENA. Winlevi® has a unique method of action in which it can target the acne hormones in the skin. This agreement strengthens our dermatology portfolio, a key therapeutic area for Hikma. It also enables us to increase patients’ access to differentiated medicines in the region putting better health within reach. We look forward to working with Cosmo.”

Diana Harbort, President of Cosmo’s Dermatology Division, said: “We are delighted to partner with Hikma. Their significant experience in commercialization in the MENA region gives us great confidence in their ability to successfully register and market Winlevi®. We look forward to more acne patients around the globe having access to Winlevi®.”

About Winlevi®

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 since 1982. Winlevi® was launched in the US in November 2021 by Sun Pharma and quickly became the most prescribed branded topical acne drug in the US based on IQVIA data. Over 15,000 US health care providers have prescribed Winlevi® to date which represents 88% of total health care providers in dermatology. 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.

Youth at the Centre of Government Action, A Review of the Middle East and North Africa; June 2022

IQVIA data MAT Aug 2023

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