An explosion of copycat generics of the blockbuster cancer drug Gleevec is likely to result the Swiss pharma giant, Novartis, taking an impact of as much as $2.5 billion on its annual sales, the company is learnt to have said.
The generic version of Gleevec was launched in the US recently by Sun Pharmaceuticals.
“For Gleevec, we assumed February entry of the first generic. We believe it will be exclusive for the first six months, and our working assumption is there will be multiple entrants after those six months,” Harry Kirsch, chief financial officer at Novartis told analysts in the company’s earnings call last week, according to some analysts who participated in the call.
Sun PharmaPharma’s generic has got 180 days of marketing exclusivity from the US Food and Drug Administration as it was the first to file on the generic. After that, there will be an explosion of copycat Gleevec generics, the company feels.
Natco and Teva pharma have already prepared with their generic Gleevec variants.
The patent expiry of Gleevec, which has been Novartis’ mainstay product since 2001, has put around $2.5 billion of annual sales at risk. In the US, Gleevec had the largest market share (12.5%) among cancer drugs and posted $4.7 billion in global revenue in 2015.
Novartis expects an impact on sales to the tune of $1 billion due to the ‘genericisation’ of Gleevec. “In 2016, the company expects genericisation of Gleevec to start in February in the US and December in Europe, contributing to the overall expected generic impact of $3.2 billion (against $2.2 billion in 2015) on sales,” Kirch told analysts.
In fact, the company feels the Gleevec episode could cause its revenue and profit for 2016 to stagnate at the previous year’s $49.4 billion level.
Asked about the analysts’ call, Novartis confirmed the information, but denied commenting on its plans to take on competition due to generic launches.
Gleevec, tagged as a wonder drug for cancer patients, costs about $90,000 annually in the US. The generic launched by Sun Pharma would bring the price down to roughly $60,000 for a year’s course. Proliferation of competition is likely to further reduce the prices.
Gleevec is used to treat adult and paediatric patients with chronic myeloid leukaemia and other blood diseases.