ZURICH India's Sun Pharma (SUN.NS) launched a generic version of Novartis's (NOVN.VX) leukaemia drug Gleevec on Monday in the United States and hopes to poach a third of sales in six months by pricing the copycat some 30 percent cheaper, its Sun's North American chief executive said.
Gleevec, or imatinib mesylate, costs up to about $90,000 annually in the United States, implying Sun's price could be roughly $60,000. Gleevec posted $4.7 billion in global revenue in 2015, and Swiss-based Novartis has said the U.S. patent expiry puts around $2.5 billion in annual sales at risk.
Last week, Novartis blamed Gleevec's expiration as the major reason its total 2016 revenue and profit would stagnate at last year's $49.4 billion level. It has been one of the Basel-based drug company's mainstay products since 2001.
In a phone interview, Sun North American CEO Kal Sundaram said initial shipments of the generic, made at the company's U.S. facilities, should be on pharmacy shelves within two or three days.
"I'm expecting a steady pickup from here on," Sundaram said from New York. "If we pick up a 30 percent share, we'll be happy."
Sun's version was granted 180 days of marketing exclusivity by the U.S. Food and Drug Administration because it was the first to file on the generic.
Imatinib mesylate is a kinase inhibitor to treat adult and paediatric patients with chronic myeloid leukaemia and other blood diseases.
Sun makes half its $4.5 billion sales in the United States, where 6,600 new cases of chronic myeloid leukaemia are diagnosed annually, with 1,140 annual deaths.
Gleevec's introduction 15 years ago transformed the blood cancer into a chronic disease. One study found 90 percent of patients were still alive five years after starting treatment.
Novartis could have faced Gleevec competition from Sun earlier, but reached a court settlement with the Mumbai-based company in 2014 that delayed its version's introduction until this month.
Its arrival comes at a time when U.S. debate over pharmaceuticals pricing has reached a fever pitch, with Democratic presidential hopefuls Hillary Clinton and Bernie Sanders sparring over how to reduce costs.
"I anticipate that the healthcare system in the country will have savings in the order of 30 percent," Sundaram said, on the generic's price, adding first-year sales may depend on whether doctors prescribe Gleevec or the cheaper alternative for first-time leukaemia patients.
"I would anticipate the insurance companies to be taking an active role," he added.
Novartis has been touting its newer drug Tasigna, saying studies show it is better than Gleevec in some instances. But in 2015, Tasigna sales worldwide were just a third of Gleevec's, at $1.6 billion.
(Reporting by John Miller; Editing by Alison Williams)
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Updated Date: Feb 02, 2016 04:00 AM