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.
Will Johnson find a friend?
Johnson & Johnson (NYSE:JNJ) is pushing simeprevir through the FDA based on mid-stage genotype 1 trials that produced results around 90% — but included interferon. That’s not going to earn Johnson & Johnson a nice piece of the HCV market, and the company knows that.
The good news is that Gilead Sciences, Inc. (NASDAQ:GILD) and AbbVie Inc (NYSE:ABBV) are the only ones with enough drugs in-house to try to push their own combo therapies. Everyone else is scrambling around trying to find partners. Simeprevir is involved in ongoing trials using oral projects from the likes of Bristol Myers Squibb Co. (NYSE:BMY) and Vertex.
It’s too early to say what will happen with these partnership trials. But pulling off another 100% cure rate might convince one of these other companies to pair up with Johnson & Johnson (NYSE:JNJ). It would serve the best interest of both companies when trying to take on Gilead and AbbVie Inc (NYSE:ABBV).
Foolish final thoughts
Gilead and AbbVie Inc (NYSE:ABBV) stand in the strongest positions right now because they’ve turned up good data and have the resources to produce in-house combo therapies. But Johnson & Johnson (NYSE:JNJ) could still find a place in the market if simeprevir maintains an 100% cure rate with another drug owned by a willing partner.
The article Watch This HCV Player originally appeared on Fool.com and is written by Brandy Betz.
Brandy Betz has no position in any stocks mentioned. The Motley Fool recommends Gilead Sciences and Johnson & Johnson. The Motley Fool owns shares of Johnson & Johnson. Brandy is a member of The Motley Fool Blog Network — entries represent the personal opinion of the blogger and are not formally edited.
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