FDA approval of Gleevec generic may boost fortunes of India's Sun Pharma

After suffering through a year of U.S. Food and Drug Administration warnings over quality lapses, a slumping share price, and falling profits, India's Sun Pharmaceutical Industries was handed an early Christmas gift after the American regulator approved the company's generic version of the expensive cancer drug Gleevec (imatinib).

The Mumbai-based generic giant said it would start selling the myeloid leukemia treatment on Feb. 1.

Gleevec was originally developed and marketed by Switzerland's Novartis ($NVS) in 2003 to great acclaim for its ability to turn chronic myeloid leukemia from a nearly always fatal disease to a manageable one with long-term medication.

Gleevec is Novartis' top-selling medication with global sales of $4.75 billion last year, according to an Associated Press report. Novartis sells Gleevec/Glivec for about $10,000 a month.

With the FDA's approval, Sun receives exclusive rights to sell its generic version for 6 months.

The approval also means Sun can expect to add between $250 million and $400 million to its sales revenues and the drug could account for up to 10% of the company's U.S. sales of $2.5 billion, according to a report in the Economic Times.

- here's the AP story
- and one from the Economic Times