Novartis Quick to Borrow From Big Pharma's Old Bag of Tricks

Continued from Novartis Gears Up to Showcase US Health Care Shortcomings

In 2000, the FDA had approved exactly zero tyrosine kinase inhibitors (TKI) for the treatment of chronic myeloid leukemia (CML).

In 2001, Novartis delivered Gleevec (imatinib), a TKI for the treatment of CML.

In 2006, Bristol-Meyers Squib said, "Me Too!" and delivered Sprycel (dasatinib).

In 2007, Novartis said, "Me Too!" and delivered Tasigna (nilotinib).

In September 2012, Pfizer said, "Me Too!" and delivered Bosulif (bosutinib)

A month later, Teva delivered Synribo (omacetaxine mepesuccinate), which is not a TKI but rather an alkaloid, meant for patients whose CML has progressed despite treatment with at least two TKI's.

Five drugs developed chiefly to treat the same disease.

Five drugs—two by the same company—tailored to treat a patient population that Novartis once considered far too small to be profitable.

Were patients with every cancer subtype so lucky as to have four major pharmaceutical companies scrambling to make treatments for them?

Novartis's Tricks

One might think that $20-30 billion in revenue might be enough for Novartis. Gleevec has made so much money for that company in so little time it's hard to fathom.

So why would they want to discredit Gleevec now? Why would they want to move current Gleevec users over to Tasigna now when not a single, independent study has shown that one is better than the other? Why would Bloomberg BusinessWeek quote Andrew Weiss, an analyst with Bank Vontobel AG in Zurich, as saying the following...

"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."

The simple truth is that Novartis's patent on Gleevec expires in 2014. Prices on a generic version could go as low as a few hundred dollars per year. Novartis needs a replacement, and that replacement must appear to be significantly better than Gleevec so that the company can charge a confiscatory rate.

A few years ago they launched a set of discontinuation trials—trials designed to showcase Tasigna's efficacy over Gleevec. These trials are ongoing.

In 2008, Novartis carried out the TOPS study—Tyrosine Kinase Inhibitor Optimization and Selectivity—in which they learned that if you doubled the dose of Gleevec, you got a better response in patients than if you gave them the standard dose of 400 mg.

Novartis then ran the ENESTnd study ("Evaluating Nilotinib Efficacy and Safety in Clinical Trials of newly diagnosed Ph+ CML patients") which pitted Tasigna against Gleevec. Despite having learned that 800 mg of Gleevec was better than 400 mg, they only tested Tasigna against Gleevec 400 mg, which is the standard dose.

Their conclusion was that Tasigna outperformed Gleevec, and that is what they will continue to conclude in every trial they run for the next several years, even if it means they have to stack the deck in Tasigna's favor by manipulating the dosages.

Conclusion

Novartis was granted orphan drug designation by the FDA for Gleevec. That designation is there to allow the company market exclusivity on the product so that they can make their money back and see a profit.

They have had that opportunity and then some, especially considering how little money they actually invested in the research and development of Gleevec in the first place.

Despite having been given all the favors the government and the taxpayers will allow, and despite reaping staggering profits as a consequence, Novartis still seeks to violate the US taxpayer by getting the doctors of CML patients to switch them to the more expensive drug despite a dearth of evidence suggesting it's any better.

Many CML patients who thought they might get some relief when the price of Gleevec goes down will instead be directed to another expensive Novartis product.

It will be a glorious day when the folks at Novartis do something truly innovative, instead of just ripping off the work of others and then squeezing the outcome for all its worth using the same old bag of patent and Me-Too tricks that have fueled the pharmaceutical industry for decades.