Replies to post #2061 on Biotech Values

[DewDiligence]

>> the companies have no interest in testing to see if the drugs help people with mutant genes. the companies have no interest in testing to see if the drugs help people with mutant genes. Since the drugs are approved they would rather give it to everyone. They get more money that way. <<

You could be right with respect to Iressa –AstraZeneca may just leave the clinical work for the government.

But Tarceva is not approved yet, and hence the FDA might see an opening to require OSIP/DNA to do more work testing for the mutant EGFR. The fact that Iressa is already approved in the exact same indication gives the FDA considerable bargaining power to make these kinds of demands.

[poorgradstudent]

If the EGF-R mutation is an inherited one, it can be easily tested for, at any time, using some DNA extracted from the blood. If it is a mutation that is gained following birth, then an actual biopsy sample from the tumour is needed. Assuming that material is available, the test can be done at any time.


Second, I do not think that this test will have a huge impact on the income derived from the EGF-R inhibitors. If the test is validated and used, then the companies like AZN and OSIP will be able to offer a more tailored therapy with a heavily increased chance of therapeutic benefit. This will likely prompt the companies to increase the cost of their drugs in a manner analogous to Genzyme's enzyme therapies.

Furthermore, selecting a patient population that is very likely to benefit also means that you're focusing on a population that will take the drug for a longer average duration. Coupled with a price increase, the companies involved will do their best to make the economics work.

As for the FDA delaying Tarceva because they already offer Iressa... anything is possible, but I doubt it would fly. If I'm not mistaken, the patient populations that Iressa and Tarceva were tested on were not identical. Iressa patients had failed 2 previous regimens whereas, Tarceva's had failed at least 1. Furthermore, such an action by the FDA would really be a large blow to many of us biotech investors... especially if we can no longer count on life extension as a fundamental step towards FDA approval.