Sun Pharma jumps on receiving USFDA approval for Gleevec generic

Sun Pharmaceutical Industries rose 4% to Rs 755.95 at 11:04 IST on BSE after the company said that one of its subsidiaries has received final approval from US drug regulator for its generic version of Gleevec tablets.

The announcement was made during trading hours today, 4 December 2015.

Meanwhile, the BSE Sensex was down 222.92 points, or 0.86%, to 25,663.70.

On BSE, so far 6.33 lakh shares were traded in the counter, compared with an average volume of 2.99 lakh shares in the past one quarter.

The stock hit a high of Rs 773 and a low of Rs 722 so far during the day. The stock hit a record high of Rs 1,200.70 on 7 April 2015. The stock hit a 52-week low of Rs 706.40 on 24 November 2015.

The stock had underperformed the market over the past one month till 3 December 2015, sliding 16.28% compared with 2.65% decline in the Sensex. The scrip had also underperformed the market in past one quarter, falling 17.90% as against Sensex's 0.47% rise.

The large-cap company has an equity capital of Rs 240.67 crore. Face value per share is Rs 1.

Sun Pharmaceutical Industries announced that one of its subsidiaries has received final approval from US Food and Drug Administration (USFDA) for its abbreviated new drug Application (ANDA) for generic version of Gleevec, Imatinib Mesylate tablets 100 milligram (mg) and 400 mg.

Imatinib Mesylate tablets, 100 mg and 400 mg are therapeutic equivalents of Novartis' Gleevec tablets. As per IMS MAT August 2015, these tablets have annual sales of approximately $2.5 billion in the US. These tablets are indicated for the treatment of chronic myeloid leukemia.

The Sun Pharma subsidiary, being the first-to-file an ANDA for generic Gleevec with a para IV certification, is eligible for 180-days marketing exclusivity in the US. Under the terms of a settlement agreement with Novartis, the Sun Pharma subsidiary is permitted to launch its version of generic Gleevec in the United States on 1 February 2016. The commercial launch of this product is scheduled for 1 February 2016.

Sun Pharmaceutical Industries' consolidated net profit fell 46% to Rs 1106.66 crore on 14.7% decline in net sales to Rs 6803.31 crore in Q2 September 2015 over Q2 September 2014.

Sun Pharmaceutical Industries is the world's fifth largest specialty generic pharmaceutical company.

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