Novartis AG wants patients to stop taking one of its best-selling drugs.
The Swiss company revolutionized leukemia treatment with Gleevec, a drug that turned a deadly blood cancer into a chronic disease more than a decade ago. Many doctors have since come to believe that the drug, typically taken for life, may heal some patients for good, allowing treatment to be discontinued. The findings highlight one of the company’s biggest challenges: Gleevec, which generated $4.7 billion last year, loses patent protection and sales in 2014.
In a bid to head off the loss, Novartis has started a campaign to convince patients to take a new drug called Tasigna. The company has begun trials to show that Tasigna may permit an even larger portion of patients to halt treatment once their cancers are controlled.
“Novartis’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,” Andrew Weiss, an analyst with Bank Vontobel AG in Zurich, said in a telephone interview.
Novartis has every reason to push its new drug hard: It risks losing dominance in the $6 billion market for leukemia drugs. Gleevec accounted for the bulk of those sales last year, followed by Bristol Myers-Squibb Co.’s Sprycel, with $803 million in sales, and Tasigna, with $716 million.
Those drugs have recently been joined by Pfizer Inc.’s Bosulif, which won U.S. regulatory approval in September. Ariad Pharmaceuticals Inc.’s ponatinib may be approved in the first quarter of 2013.
The increased competition combined with the winding down of the Gleevec patent is why it is critical for Novartis to show that Tasigna works even better than the older drug. The plan is to do everything possible to steer patients away from Gleevec, which will become an inexpensive generic, and toward Tasigna.
If a series of so-called discontinuation trials show Tasigna to be more effective than Gleevec, doctors, patients, insurers and governments may well be drawn to Tasigna. The company plans to discuss the trials Nov. 8, when it updates investors on experimental drugs.
Novartis wants Tasigna to “cannibalize” Gleevec until the older drug loses patent protection, Herve Hoppenot, who oversees the company’s cancer drugs, said at a conference last month. “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.
The company’s shares have risen 11 percent this year including reinvested dividends, compared with a 15 percent return in the Bloomberg Europe Pharmaceutical Index of 19 stocks.
For patients and insurers, the drug’s efficacy shown in the discontinuation trials may justify the newer medicine’s higher price if it means Tasigna’s greater potency would result in a shortened treatment.
At the moment, both Gleevec and Tasigna cost a couple of thousand dollars a month. A generic version of Gleevec would probably retail for a fraction of the cost, possibly even as little as $500 for a year of therapy, Weiss said.
“If you’re reducing drug cost to nothing for them for 20 years, it would justify a higher-costing drug,” said David Ross, a hematologist who led an earlier Gleevec discontinuation trial at Flinders Medical Centre in Australia. Ross has received funding from Novartis.
The treatments belong to a group scientists call tyrosine-kinase inhibitors or TKIs, which interfere with cell communication and growth, and dramatically changed the treatment of chronic myeloid leukemia, or CML.
The disease starts mainly in the white blood cells of the bone marrow and spreads to other organs, according to the American Cancer Society’s website. About 5,430 cases of the blood cancer will be detected this year and 610 people will die from it, according to the research and advocacy group.
Before Gleevec was introduced in 2001, patients could opt for bone marrow transplantation, a painful and often fatal procedure, or daily infusions with interferon. Just under a third of those treated survived for five years. Today about 90 percent of CML sufferers taking TKI drugs will survive to reach the five-year mark.
A definitive answer on whether Tasigna works better than Gleevec is still years away. In addition to the Novartis trials, several independent studies also are getting under way. A group of European blood cancer hubs will run one such trial dubbed Euro-SKI. It receives no funding from pharmaceutical companies, and will follow about 500 patients quitting their drugs.
The study has started enrolling patients who have been taking Gleevec, Tasigna or Sprycel for at least three years and have little trace of the disease in their blood for a third of this time. Results of the trial are due in 2017, according to the trial’s lead investigator, Susanne Saussele, a hematologist at the University of Mannheim in Germany.
Not everyone will be able to halt treatment, Saussele said. At the moment, doctors think about 4 in 10 patients can discontinue therapy, and of those, 40 percent will be clear long-term, she said. Overall, this means less than one-fifth of those with CML may in time no longer need constant medication, she said.
Whether that can be considered a cure is open to debate, said Richard Clark, a hematologist at the University of Liverpool.
“It really depends on what your definition of cure is,” he said. “Is someone who no longer remains on treatment and remains well cured? We can really only say someone is cured if they get hit by a bus when they are 80.”
Doctors say the trials will help them determine which drug lets the largest portion of patients quit their treatment for good.
Levels of a flawed protein called Philadelphia chromosome may be one possible indicator, said Ross, the hematologist in Australia. Doctors currently think undetectable counts are a strong sign that patients may achieve lasting remission.
Because Tasigna has been found to clear patients’ blood faster and more thoroughly of the defective chromosome, it may be possible that twice as many patients achieve healing that lasts on this drug compared with Gleevec, Ross said. Some early data hint that Tasigna may allow as many as 40 percent of patients who stop the drug to stay treatment-free long-term, he said.
“The key is that on more effective treatment the number of patients who can stop might be higher,” said Ross.