Monday, November 4, 2013

NYT Agrees, Tonight: Hep C "Cure" Is Here; Lead Drug Belongs To Gilead; Merck A Likely Secondary Player, With BMS And AbbVie


I'll not belabor the point, other than to reiterate the joy we should all feel -- in knowing that a chronic disease afflicting at least three million in the US alone -- is soon to be eradicated.

The only question now is. . . how late to the party will Merck's MK-5172 combo candidate actually be? One year? Or two years?

Here's a bit -- do go read it all:
. . . .There is no doubt we are on the verge of wiping out hepatitis C,” said Dr. Mitchell L. Shiffman, the director of the Bon Secours Liver Institute of Virginia and a consultant to many drug companies. . . .

Among the new drugs, the one garnering the most excitement is sofosbuvir, from Gilead Sciences, which is expected to be approved by the Food and Drug Administration by Dec. 8. It inhibits the virus’s polymerase enzyme, which builds new genomes out of RNA so the virus can replicate.

Sofosbuvir is an evil decoy of sorts. It looks like a building block of RNA. But once it is mistakenly incorporated into the RNA chain, the chain cannot grow and the virus cannot reproduce. . . .

Other companies, including AbbVie, Merck and Bristol-Myers Squibb, are in a heated race to also bring all-oral combinations to market in the next two years or so.

Liver specialists will be able to put together an all-oral regimen for genotype 1 very soon, however, by prescribing both sofosbuvir and simeprevir, a Johnson & Johnson protease inhibitor that is expected to win approval soon. One study has shown this combination to be extremely effective, though insurers may balk at paying for two expensive drugs. . . .


So it goes. Just I've been saying all weekend. The Gilead drug will be a license to print money; and access issues are sure to crop up, even among fully insured, Cadillac-style plan participants.

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