Johnson & Johnson (NYSE:JNJ)‘s hepatitis C drug, simeprevir, recently received Priority Review status from the FDA. It was a surprising validation for Johnson & Johnson (NYSE:JNJ)’s mid-stage project. But there are stronger candidates from Gilead Sciences, Inc. (NASDAQ:GILD) and AbbVie Inc (NYSE:ABBV) further ahead in the pipes.
Simeprevir does have a trick up its sleeve. The drug could offer near perfect efficacy when used in combo therapies — if the right company agrees to a partnership. That sort of deal could help Johnson & Johnson (NYSE:JNJ) secure a front seat in a market that’s predicted to hit $14.4 billion by 2015.
But will it happen?
HCV treatment primer
The hepatitis C virus, or HCV, is typically passed via blood contact and can remain asymptomatic in mild cases or degenerate to the point of cirrhosis in chronic cases. The most common genotype in the United States is genotype 1, which is the metric to watch while examining HCV trial results.
The standard treatments for chronic HCV have involved a combination of the oral drug ribavirin and an interferon injection. Interferon produces nasty flu-like side effects that can persist over the lengthy course of treatment. And this duo alone has so-so cure rates.
Merck and Vertex helped improve combo therapy cure rates with the protease inhibitors Victrelis and Incivek, respectively. But those treatments still involved interferon and its side effects.
But now there’s a new batch of drugs on the horizon that could offer interferon-free treatment and much higher cure rates. And simeprevir’s drug could play a major role in this new market.
All-oral treatment race
Gilead Sciences, Inc. (NASDAQ:GILD)’s drug sofosbuvir has moved the furthest down the pipelines. But the recently reported phase 3 trials involved interferon in the best performing genotype 1 arm. An ongoing mid-stage trial combines sofosbuvir with another Gilead HCV project for an all-oral treatment for genotype 1. Those will be the results to watch for Gilead Sciences, Inc. (NASDAQ:GILD).
AbbVie Inc (NYSE:ABBV) has already reported phase 2b results that include three of the company’s oral HCV drugs paired with ribavirin in genotype 1. Treatment-naive patients achieved a phenomenal 99% cure rate.
What could beat that?
As Brian Orelli reported, Johnson & Johnson’s simeprevir paired with Gilead Sciences, Inc. (NASDAQ:GILD)’s sofosbuvir achieved 100% cure rates in a mid-stage trial. And that result came with or without ribavirin added to the mix. There is an asterisk since it’s interim data in a trial where patients were still progressing through the treatment process. But there’s also a strikethrough, since Gilead Sciences, Inc. (NASDAQ:GILD) wants to develop its own combo therapy and is unlikely to let Johnson and Johnson use its drug.