Moneycontrol Bureau
Shares of Sun Pharmaceutical Industries surged more than 6 percent intraday Friday after its subsidiary has received approval from the US health regulator for anti-cancer drug.
"The subsidiary today has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for generic version of Gleevec, imatinib mesylate tablets 100mg and 400mg," says the country's largest drug maker in its filing.
Imatinib mesylate tablets are therapeutic equivalents of Novartis’ Gleevec tablets. These tablets have annual sales of approximately USD 2.5 billion in the US, as per IMS MAT data in August 2015. These tablets are used for the treatment of chronic myeloid leukemia.
The company says Sun Pharma subsidiary, being the first-to-file an ANDA for generic Gleevec, is eligible for 180-days marketing exclusivity in the US.
Under the terms of a settlement agreement with Novartis Pharmaceuticals Corporation, the company is permitted to launch its version of generic Gleevec in the United States on February 1, 2016.
Sources say the company filed ANDA application for Gleevec generic from an alternate site and not from Halol plant that received a Form 483 after USFDA inspection last year. Its group company SPARC is not involved in Gleevec Generic.
On November 26, brokerages upgraded the stock and also revised target price. They said they believe recent fall in the stock price largely factored in negatives like Halol warning letter, Ranbaxy’s synergies etc. The stock had fallen 20 percent in November.
Barclays upgraded Sun Pharma to overweight from equalweight. JM Financial, which also upgraded the stock to buy and revised price target to Rs 815, said barring an import alert, it sees little scope for earnings cut considering that Sun Pharma has managed to de-risk Gleevec generic and with domestic business strong & one-off costs already incurred, there is scope for margin surprises in the coming quarters.
At 10:46 hours IST, the scrip of Sun Pharmaceutical Industries was quoting at Rs 764.65, up Rs 37.75, or 5.19 percent on the Bombay Stock Exchange. Group company Sun Pharma Advanced Research's share price rose 8.12 percent to Rs 376 amid high volumes.Posted by Sunil Shankar Matkar
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