Sun Pharma extends gain after US FDA approval for generic Gleevec

The stock was trading higher by 3% at Rs 780, extending its Friday's 4% gain on the BSE.

Sun Pharmaceutical Industries is trading higher by 3% at Rs 780, extending its Friday’s 4% gain on the BSE, after the company announced that one of its subsidiaries has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for generic version of Gleevec, Imatinib Mesylate tablets 100mg and 400mg.

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 US$ 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.

Angel Broking, recommend a ‘BUY’ rating on the stock with a price target of Rs 1,000.

“On a conservative basis, the product can easily contribute sales of around US$ 250-300 million during the six-month exclusivity and net profit of around US$ 75-90 million during the period. The product can easily enhance the EPS of the company in FY2017 by 8-9%,” Ms. Sarabjit Kour Nangra, VP Research - Pharma, said in a client note.