Sun Pharmaceutical Industries shares jumped around 1 per cent on Thursday after the company informed stock exchanges on Wednesday (post market hours) that it has got USFDA approval for acne drug.
The share price of the phama major closed 0.91 per cent higher at Rs 935.65 on Thursday.
In a BSE filing, the company said, “The United States Food and Drug Administration (USFDA) has approved its Supplemented New Drug Application (Snda) for Ximino (Minocydine HCL) extended-release capsules 45mg, 90mg and 135mg.”
Ximino extended-release capsules are indicated for inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. This approval further strengthens the Company’s branded dermatology portfolio in the US. It expects XiminoTM extended-release capsules to be available for patients during the fourth quarter of 2015.
According to Angel Broking, the US market is the largest market for the global acne products with about 50 million (mn) suffering from acne in the country. As of January 31, 2015 is a $3.0 billion (bn) market in the US branded prescription market. The market is split between oral antibiotics ($1.7bn in sales) or lotions, creams and ointments ($1.3bn in sales). The acne market is so fragmented that numerous companies are selling hundreds of millions worth of drug treatments. Thus, the landscape is very competitive, with no dominant leader. The most prominent brand in the US Solodyn has US sales of $ 300-400 mn.
Given the generic competition, conservatively the brokerage house estimate the product can contribute around $ 50-80 mn to the annual sales of the company, with net profit around US$ 25-40 mn.