Gleevec-the Novartis AG Wonder Drug

Life-extending cancer chemotherapy drug Gleevec went off patent in July 2015 and Tasigna rushed to market

Wednesday, December 20, 2017 - Gleevec was the first anti-cancer drug in a class of medications known as tyrosine kinase inhibitors. Researchers have found that tyrosine kinase stimulates uncontrolled white blood cell multiplication and that controlling that enzyme could control the spread of cancer cells as well.

Anti-cancer chemotherapy drug Gleevec was first brought to market in 2001 and at the time was hailed as a cancer wonder drug for its life-extending effects on patients with Chronic Myeloid Leukemia (CML), CML affects roughly 5000 people per year. Cancer patients taking Gleevec were reported to have lived a decade or more since beginning treatment with the drug. Such a positive prognosis as living for an additional 10-years was welcome news to CML patients that expected that their condition to be terminal within a year post-diagnosis. Prior to 2001, 33% of CML patients survived less than one year. Approximately 85% of CML patients that were given Gleevec 10 years ago are still alive and life expectancies approached that of a normal person. It was feared that Gleevec would increase the number of people developing heart-related and vascular conditions but studies of the drug concluded that such was not the case.

Gleevec's patent expired in July of 2016 and since then is experiencing stiff competition from less expensive, generic forms of the drug. Novartis AG recently reported that Gleevec revenues declined 33% and that the company was going through a transition. One study put the cost of generics at a fraction of that of Gleevec and a patient could save around $100,000 over a five year treatment period. Since 2001 the price of Gleevec has risen from $26,000 to over $120,000 per year paid for mostly from Medicare funds. In response to its signature cancer drug going off patent and the competition that would result, Gleevec manufacturer Novartis rapidly developed the Gleevec-replacement drug, Tasigna. Tasigna is a second-generation tyrosine kinase inhibitors approved for chronic myeloid leukemia. Being in the same class as Gleevec, Tasigna was able to circumvent many of the FDA's regulations and requirements placed upon new drugs and was quickly offered to specialty pharmacies and Novartis urged pharmacists to refill Gleevec prescriptions with Tasigna. One of the features touted by oncologists and pharmacists was that Tasigna was a stronger chemotherapy drug and needed to be taken only once every two weeks. It was not mentioned, however, that right from the start Tasigna patients were reporting cases of vascular disease and atherosclerosis, a thickening and narrowing of the vital arteries that lead to the extremities, back to the heart, as well as the brain.

Swiss pharmaceutical company Novartis AG has come under fire for the way in which the company marketed Tasigna as a Gleevec replacement drug. The company settled a $3.7 billion dollar lawsuit for $370 million as a result of then-director of marketing David Kester exposing the company's illegal marketing efforts getting specialty pharmacies to refill prescriptions with Tasigna and offering financial kickbacks to those pharmacies that sold the most. In addition, the life-threatening side effects of Tasigna causing atherosclerosis was glossed over and Tasigna was sold as a more effective cancer treatment.

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