Novartis plans for upcoming Gleevec patent expiry with shift to Tasigna: report

Novartis is looking to overcome the upcoming loss of patent exclusivity on Gleevec (imatinib) in 2014 by switching patients with chronic myeloid leukaemia (CML) to its newer therapy Tasigna (nilotinib), Bloomberg reported. Bank Vontobel analyst Andrew Weiss noted that the company's "strategy is to portray Tasigna as the best treatment on the market, so good that there will be talk about it being a cure."

Gleevec generated sales of $4.7 billion last year and currently dominates the $6-billion market for leukaemia drugs, followed by Bristol Myers-Squibb's Sprycel (dasatinib), with $803 million in sales, and Tasigna, with $716 million in revenue. However, the FDA recently cleared Pfizer's Bosulif (bosutinib) for certain patients with CML and the regulator also accepted Ariad Pharmaceuticals' regulatory filing for ponatinib this month, with a decision on approval expected by March 27.

Novartis is currently conducting a series of so-called discontinuation trials, which are designed to show that Tasigna may allow a greater number of patients to halt treatment once their cancers are controlled than compared with Gleevec. The company plans to discuss the studies at an investor day next month. In addition, several independent studies are beginning, with a European trial called Euro-SKI enrolling patients who have been taking Gleevec, Tasigna or Sprycel for at least three years and have had little trace of the disease in their blood for a third of this time. Results of the study are due in 2017, according to lead investigator Susanne Saussele.

Both Gleevec and Tasigna cost around $2000 per month, but Weiss noted that a generic version of Gleevec will retail for as little as $500 for a year of treatment. "If you’re reducing drug cost to nothing for them for 20 years, it would justify a higher-costing drug," remarked said David Ross, who led an earlier Gleevec discontinuation trial. However, Saussele suggested that not everyone will be able to halt treatment with the drugs, with about 40 percent of patients currently able to discontinue therapy, and of those, 40 percent will be clear in the long-term. Saussele said that this means less than one-fifth of patients with CML may in time no longer need constant drug therapy.

Herve Hoppenot, president of Novartis' oncology unit, noted that the company wants Tasigna to "cannibalise" Gleevec until the latter loses patent protection. "It's going to create a fairly large amount of the Gleevec business that will be indirectly protected because it was switched already to Tasigna," he said.

For further analysis, read Spotlight On: Defence of key brands remains paramount at Sanofi and Novartis.

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