It's always interesting to read about TKIs from the perspective of business. This week's BusinessWeek has an article featuring Novartis called "The Novartis Prescription To Avoid the 'Patent Cliff'".
I don't see a link to the article online yet, but here are the notable CML-related highlights for folks who are interested:
- The company's best selling drug, Diovan, goes off patent in 13 months ($6.1B in annual sales)
- The company's 2nd best selling drug, Gleevec, loses patents starting in 2014 ($4.27B in annual sales)
- Novartis shares are down 14% this year, making it the third-worst performer in the Bloomberg Europe Pharmaceutical Index
Here's a snippet from the article:
'Jimenez (the company's CEO) is following a different course to retain sales of Gleevec (as compared to Diovan), which will lose protection in Japan, the U.S., and Europe by 2016. He's ramping up sales of Tasigna, a medicine based on Gleevec which, like its cousin, is approved for use against leukemia. Tasigna had $399M in sales last year, but the drug could bring in more than $2B in 2015, according to the average estimate of analysts surveyed by Bloomberg. "We have time to convince physicians and the industry that patients are better off with Tasigna", Jimenez says.'
There's a graphic in the article that forecasts Gleevec revenue to cut in 1/2 around the 3rd year off-patent. This will be an interesting development, because I'm sure that insurance carriers will push (or maybe even require!) the generic version(s) once they are available in the U.S. Makes you wonder how many long-term Gleevec users would be comfortable making the switch from brand to generic.
One thing that the article doesn't share, but I'm interested in, are the annual costs associated with the production of Gleevec and Tasigna. Clearly they continue to recoup costs associated with the R&D, clinical trials, etc. -- but I'd be so curious to see their margins on these TKIs. I have to think that Novartis is charging a steep premium above and beyond what's needed to turn a profit after all of the R&D costs are paid for ... just because they know that a patient's ability to prolong her/his life is essentially 100% dependent on the drug. With the case of Diovan, I'm sure plenty of folks are willing to take some risk with hypertension ... and the market is saturated with a bunch of hypertension drugs.