Sun Pharmaceuticals announces approval of Winlevi® in Australia

Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) ("Sun Pharma") announced that the Australian Therapeutic Goods Administration (TGA) has granted regulatory approval for Winlevi® (clascoterone cream 1%). Winlevi® is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

As stated by Hellen de Kloet, Business Head – Western Europe, Australia and New Zealand, Sun Pharma "Winlevi® is an exciting addition to our expanding dermatology portfolio of innovative medicines in Australia. Winlevi's novel mechanism of action will be a welcome addition to the physician's toolkit while treating acne."

Diana Harbort, President of the Dermatology Division of Cosmo, said: "We are very pleased that Winlevi® will soon be available to patients in Australia. This is another achievement in the mission of Cosmo and Sun Pharma to improve the lives of patients affected by skin conditions."

Winlevi® is approved for the topical treatment of acne vulgaris in people 12 years of age and older. Although the exact mechanism of action for Winlevi® is unknown, laboratory studies suggest the active ingredient, clascoterone, competes with androgens, specifically dihydrotestosterone (DHT), for binding to the androgen receptors within the sebaceous gland and hair follicles.

Androgens are widely recognized as the most important of all hormones in terms of regulating sebum production. Within the skin, androgens bind to androgen receptors, causing increased sebum production and inflammation. In particular, the skin of patients with acne vulgaris produces higher levels of the androgens testosterone and dihydrotestosterone (DHT) than the skin of healthy individuals.

Winlevi® binds to the androgen receptor competing with androgens such as DHT on cells within the sebaceous gland. Although its precise mechanism of action is unknown, studies suggest Winlevi® inhibits androgen receptors in the skin and reduces production of sebum and inflammation. Additionally, Winlevi® is rapidly metabolized in the skin, limiting systemic absorption.

Sun Pharma has received from Cosmo the exclusive right to develop and commercialize WINLEVI in US, Japan, Australia, New Zealand, Brazil, Mexico and Russia.

Winlevi® will be available in Australia this June. For more information visit https://sunpharma.com/australia

Shares of Sun Pharmaceutical Industries Limited was last trading in BSE at Rs. 1571.45 as compared to the previous close of Rs. 1547.60. The total number of shares traded during the day was 25503 in over 1845 trades.

The stock hit an intraday high of Rs. 1575.30 and intraday low of 1543.95. The net turnover during the day was Rs. 39851130.00.

Source : Equity Bulls

Keywords

SunPharmaceuticalIndustries INE044A01036 TGA Australia RegulatoryApprovla Winlevi ClascoteroneCream