Glenmark Specialty SA has signed an agreement with Cosmo Pharmaceuticals NV for the distribution of Winlevi in Europe and South Africa. Glenmark will be responsible for product registration in South Africa and the United Kingdom
Glenmark Pharmaceuticals was trading up almost 2 percent in the morning of September 27 after its subsidiary Glenmark Specialty SA signed an agreement with Cosmo Pharmaceuticals NV for distribution and licensing agreements for an acne cream in Europe and South Africa.
At 11:24 am, Glenmark Pharmaceuticals was trading at Rs 777 on the National Stock Exchange, up 1.94 per cent from the previous close.
Under the terms of the agreements, Glenmark will receive from Cassiopea, a subsidiary of Cosmo, the exclusive right to market Winlevi (clascoterone cream 1%) in 15 EU countries, including Denmark, Finland, France, Netherlands , Norway and Spain. such as in South Africa and the United Kingdom.
Cassiopea will be responsible for centralized marketing authorization with the European Medicines Agency (EMA), and Glenmark will be responsible for registering the product in South Africa and the United Kingdom, it said.
Cosmo will be the exclusive supplier of the product. Cassiopea will receive an upfront payment of $5 million, other double-digit regulatory and commercial milestones and agreed-upon double-digit royalties on net sales.
Winlevi was approved by the U.S. Food & Drug Administration as a new drug with a unique mechanism of action for the topical treatment of acne in patients 12 years of age and older.
Winlevi has become the most prescribed branded topical acne medication in the United States, with over 88% of all dermatology healthcare providers having prescribed Winlevi to date (according to IQVIAMAT June 2023).
Based on prescriptions generated by IQVIA data, Winlevi has been one of the most successful U.S. launches in topical acne over the past 15 years.
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“Winlevi is the perfect addition to our European dermatology portfolio and we look forward to leveraging our half-century of experience in dermatology to make this new option available to patients and address the current unmet medical need in the acne treatment,” Glenn Saldanha, president. & Managing Director Glenmark Pharmaceuticals, said in a press release.
European guidelines discourage the use of topical antibiotics for acne due to the risk of antibiotic resistance.
Through its antibiotic-free approach, Winlevi aims to address the European acne market, which is expected to grow from $928.7 million in 2021 to $1,297.0 million in 2028.
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