First the mistake: ..."Despite significant investment in advertising Eli Lilly has also failed to convince physicians of the drug's risk-to-benefit profile. In clinical trials Xigris only reduced the relative risk of death by 6%. It seems with a $6,800 price tag this was insufficient to persuade physicians to prescribe the drug except in the more severe cases."...
6% is the ABSOLUTE decrease in mortality, the relative decrease is 20% quite good numbers (and a 6% relative does not bring an approval look at bpi).
The drug approval indication is FOR the most severe cases.
..."As if this wasn't enough, it has also emerged that in 3.5% of Xigris-treated patients (compared to 2% of placebo treated patients) the drug increased the risk of serious bleeding events."...
This is not proven to be so, but the drug mechannism of action is mainly an anticoagulant/antifibrin formation so it is plausible and it is the goal of the post marketing phase IV to establish the actual risk.
The report do not calculate the absolute risk for bleeding increase as 1.5% (a total of 3.5% sounds more dramatic, well they could have used the relative 75% increase IF THEY KNEW how to calculate and understand the data).
In any case, the antitoxins (Eisai drug E551 sounds code similar to xoma's E5 is it?, the antiTNFs are already proven failures in the past, Lilly's own antiphospholipase2 is a pathway that has been used many times (ibuprofen, indomethacin, aspirin, prostaglandins, antiprostaglandins)all with failure. Chiron will not deal with Tifacogin anymore cause the subjects bleed more than Xigris and zero efficacy.
Neuprex was nicely mentioned, and they even credited the drug right! a Baxtard/xoma drug. Surprisingly, in the group is the one with more chances (if ever goes to trial again). xomaDna changed the name to Raptiva (ex xanelim) maybe they can change neuprex to Captiva!
Medicare reimbursement of Xigris was recently announced, that will increase use, I do not think Lilly's marketing effort has been all that expensive, the reps has not visit many hospitals especially the Medicare population ones, not many dinners, and not even in many journals, they were probably waiting for the Medicare decision. Most insurances follow Medicare lead in compensation.
I doubt the drug will become less expensive, if at all they will increase the price soon.
Lilly has so many good drugs coming, and so many problems with Fda that the stock is a very good bargain. |
