Sun Pharmaceutical Industries rose 3.44% to Rs 559.05 at 9:41 IST on BSE after the company said that US drug regulator has accepted a new drug application for OTX-101, used in treating dry eye disease.
The announcement was made before trading hours today, 27 December 2017.Meanwhile, the S&P BSE Sensex was up 72.85 points, or 0.21% to 34,083.46.
On the BSE, 1.64 lakh shares were traded in the counter so far, compared with average daily volumes of 2.30 lakh shares in the past two weeks. The stock had hit a high of Rs 559.30 and a low of Rs 543.15 so far during the day. The stock hit a 52-week high of Rs 728.45 on 14 March 2017. The stock hit a 52-week low of Rs 433.15 on 14 August 2017.
Sun Pharmaceutical Industries announced that the US Food and Drug Administration (USFDA) has accepted a new drug application (NDA), filed by its wholly owned subsidiary, for OTX-101 (cyclosporine A, ophthalmic solution) 0.09%, a novel nanomicellar formulation of cyclosporine A 0.09% in a clear, preservative-free aqueous solution. OTX-101 is now under review for approval by the USFDA, marking an important developmental milestone for Sun Pharma's dry eye candidate.
Post the US FDA approval, OTX-101 will be commercialized in the US by Sun Ophthalmics, the branded ophthalmics division of Sun Pharma's wholly owned subsidiary, based in Princeton, New Jersey. Sun Ophthalmics, founded in 2015, currently markets BromSite (bromfenac ophthalmic solution) 0.075% to eye care practitioners across US.
OTX-101 is being evaluated for the treatment of dry eye disease. It is a patented, novel, proprietary nanomicellar formulation of cyclosporine A, 0.09%. It is a clear, preservative-free, aqueous solution.
On a consolidated basis, Sun Pharmaceutical Industries' net profit fell 59.5% to Rs 1001.79 crore on 15% decline in net sales to Rs 6590.06 crore in Q2 September 2017 over Q2 September 2016.
Sun Pharmaceutical Industries is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company.
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