Cosmo and Hikma Sign License Agreement for Winlevi in 17 Middle Eastern and North African Countries

Cosmo Pharmaceuticals N.V. / Key word(s): Agreement Cosmo and Hikma Sign License Agreement for Winlevi in 17 Middle Eastern and North African Countries 02.10.2023 / 06:00 GMT/BST Dublin, Ireland – 02 October 2023: Cosmo Pharmaceuticals N.V. (SIX: COPN, XETRA: C43) (“Cosmo”) and Hikma Pharmaceuticals PLC (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (“Hikma”) today announced the signing of a license agreement for Winlevi (clascoterone) cream 1% in the Middle East and North Africa (MENA) region (Kingdom of Saudi Arabia, Jordan, Egypt, Morocco, Algeria, Tunisia, Sudan, Iraq, Lebanon, United Arab Emirates, Qatar, Kuwait, Oman, Bahrain, Yemen, Libya, and Syria).

Under the terms of the agreement, Hikma will receive from Cassiopea, a subsidiary of Cosmo, the exclusive right to register and commercialize Winlevi in 17 Middle Eastern and North African countries. Cassiopea will receive an upfront payment of USD 750,000 in addition to potential regulatory and sales milestones. Cassiopea will be the exclusive supplier of the product at a price calculated on the 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 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.  

Acne is considered one of the most prevalent skin conditions in the MENA region due to its predominantly young population, with approximately 55% of the population under the age of 30¹.This agreement grants Hikma exclusive rights to commercialize Winlevi in MENA markets, including Saudi Arabia, Egypt and UAE, which represent about 75% of the total acne market in MENA².