Results

AbbVie, Enanta post stellar hep C PhIII data, but no one is cheering


First, the good news about new Phase III data from AbbVie $ABBV and its partner Enanta $ENTA on their hep C combo for glecaprevir/pibrentasvir.

The data were absolutely stellar. Fully 99% of genotype 1, 2, 4, 5 or 6 patients — in 145 of 146 patients — saw their virus disappear after 12 weeks of treatment. They did that without ribavirin and without turning away a likely group of resistant patients.

Now the bad news.

Stellar data has become routine in the last few years, after Gilead claimed the bulk of the market with its new, highly tolerable, drugs of its own, followed by rivals from Merck and AbbVie. And since these drugs first went into combo clinical trials, the market has peaked and begun a painful retreat as the top players scramble to stay competitive.

A couple of months ago Baird’s Brian Skorney took a look at AbbVie’s work and concluded:

(W)e believe the Hep C heyday is well in the rearview mirror and AbbVie will be struggling to capture market share in a rapidly declining market.

Ouch.

The combo is currently under review at the EMA and the FDA, with a very high chance of approval at each agency. But is anyone waiting for a new hep C cure?

Not likely.

The new race in next-gen hep C drugs is putting a premium on faster cures, looking to reduce the regimen needed to conquer the virus, and presumably lower the price. Investigators have a lot to be proud of here, but marketers are likely going to pale at the challenge of carving out significant revenue.


The best place to read Endpoints News? In your inbox.

Full-text daily reports for those who discover, develop, and market drugs. Join 17,000+ biopharma pros who read Endpoints News by email every day.

Free Subscription

RAPS Regulatory Convergence 2017