Sun Pharma, SPARC rally on USFDA nod for generic Gleevec

Shares of Sun Pharmaceutical Industries and Sun Pharma Advanced Research Company (SPARC) have rallied by up to 11% on the BSE after Sun Pharma announced that its subsidiary has received final approval from the US Food and Drug Administration (USFDA) for anti-cancer drug.

SPARC has rallied 11% to Rs 385, while Sun Pharma surged 6% to Rs 773 on the BSE in intra-day trade after the announcements.

“One of the subsidiaries has received final approval from USFDA for Abbreviated New Drug Application (ANDA) for generic version of Gleevec, Imatinib Mesylate tablets 100mg and 400mg,” Sun Pharma said in a press release.

Imatinib Mesylate tablets, 100 mg and 400 mg are therapeutic equivalents of Novartis’ Gleevec tablets. These tablets are indicated for the treatment of chronic myeloid leukemia.

These tablets have annual sales of approximately US$ 2.5 billion in the US, as per IMS MAT data in August 2015, it added.

The Sun Pharma said its 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 February 1, 2016. The commercial launch of this product is scheduled for February 1, 2016, it added.

At 11:18 AM, SPARC was up 7% at Rs 373, while Sun Pharma up 4% at Rs 754 on the BSE as compared to 0.84% decline in the S&P BSE Sensex.