Sun Pharma gets boost with US FDA approval for Gleevec

Mumbai: After a considerable gap, India's largest drug maker Sun Pharmaceutical announced it received approval from the US FDA for generic copies of Gleevec, a drug that treats chronic myeloid leukemia, a rare form of blood cancer. Sun said it is permitted to launch its versions of Gleevec on Feb. 1, 2016.

At 11.20, (Friday) Sun Pharma stock jumped 4% to Rs. 756 on news of the approval.

Gleevec, whose active ingredient is imatinib mesylate, is patented by Novartis and has annual sales of $2.5 billion in the US. Sun said one of its subsidiaries received the final approval for 100 mg and 400 mg tablets.

Over earnings calls Sun Pharma management had informed analysts that it shifted its Gleevec product filings from Halol, a manufacturing site that is presently undergoing corrective actions on directions from the US FDA. Sun had warned it will see a drop in its sales and profit during the year, impacted by issues at its Key Halol site.

Experts said Sun may get a windfall sales of around $250 million during its 6-month exclusivity period. "We have $250 million sales booked for Sun Pharma in our model on basis of 50% market share and 60% price erosion for 6 months. WE assume Sandoz to launch AG in our base case assumption," said HSBC Girish Bakhru in his note to clients.

Recommending a "Buy" on the Sun Pharma stock, Bakhru said Sandoz may launch the authorized generic versions.

A few other Indian drug makers including Dr Reddy's is expected to launch the drug a few quarters after Sun Pharma.