Biotech Values

[mcbio]

Re: generic TNF-alpha biologics vs. RIGL/AZN's FosD

The TNF-alpha class will be a very big FoB payday for somebody, IMO.

Absolutely agree. What's the consensus timeframe for when these will start to hit the market? I'm thinking about this from the angle of potential RA competition down the road for RIGL and AZN's FosD, assuming the drug is successful in Phase 3 and makes it to market.

Notwithstanding the fact that the generic TNF-alpha biologics should be much cheaper by definition, I think FosD may be able to successfully compete against these drugs, because (1) RIGL thinks it may be able to differentiate FosD from the TNF biologics in Phase 3 by showing that the drug works quicker to prevent bone damage; (2) FosD is oral whereas the TNF biologics obviously are not; and (3) the price difference presumably won't be as great between FosD and the generic TNF biologics as it is with the branded TNF biologics because FosD is a pill and should by definition be much cheaper than a branded biologic.

Separately, I will say I'm curious as to why AZN is only running the Phase 3 trials for FosD in patients who have responded inadequately to DMARDs, including methotrexate, and in patients who have responded inadequately to anti-TNF therapy (http://www.astrazeneca.com/media/latest-press-releases/2010-new/fostamatinib_phase_III?itemId=11508115 ). Why wouldn't AZN run a head-to-head study to try to differentiate FosD from patients who have yet to try anti-TNF therapy? Is AZN afraid of a poor outcome on this front? Is this not a protocol that the FDA would approve? Does AZN assume if the FosD Phase 3 trials are successful, that doctors will extensively use FosD in patients who have yet to try anti-TNF therapy anyways, even if the FDA hasn't technically approved such a use?