Olysio: J&J's hep C approval marks the end of an era

Project name: simeprevir
Disease: Hepatitis C
Peak sales estimate: $400 million
Approved: Nov. 25
Companies: Medivir and Janssen (Johnson & Johnson)

The Scoop:
Throughout the year, Johnson & Johnson's ($JNJ) Janssen pulled in promising results for its non-nucleoside polymerase inhibitor simeprevir, a hep C candidate licensed from Medivir. But the question in 2013 remained: Would it be able to compete with rivals Gilead ($GILD), AbbVie ($ABBV) and Bristol-Myers Squibb ($BMY) simply by getting the long-awaited hep C treatment to the market?

It turns out J&J won the small battle, bringing simeprevir, sold as Olysio, to FDA approval in late November. But a trio of all-oral, interferon-free options could threaten its viability as a preferred combination treatment. Gilead's sofosbuvir, or Sovaldi, snagged approval in early December, and AbbVie and Bristol-Myers aren't far behind with their own.

The much-hyped simeprevir will likely have a place in the market as well, though, as part of cocktail therapies meant to reduce the amount of interferon needed to treat a patient with hep C. The drug won a priority review from the FDA in May and then overwhelmingly positive feedback from a regulatory panel in October.

This has been a hotly contested race for a while now. Back in 2011, the approval of Vertex's ($VRTX) protease inhibitor Incivek gave the company a blockbuster, with sales of the drug shooting to the roof. But because the drug could only be used with interferon, which comes with a host of side effects, it proved to be a short-term success. It was clear that the new generation was on its way and that reducing or eliminating the use of interferon would be the priority. Merck's ($MRK) Victrelis faced similar concerns. Both drugs are in the same class as simeprevir.

Simeprevir is an NS3/4A protease inhibitor designed to treat the most common genotype of hep C. The drug is meant to be combined with other treatments such as interferon and ribavirin, but it's also touted as a potential addition to those interferon-free cocktails.

Three Phase III studies bolstered simeprevir's panel recommendation, too, demonstrating that the drug cured about 80% of treatment-naïve hep C patients, as well as 79% of patients who had relapsed after earlier interferon-based treatment.

The panel recommendation came with a snag, though, that could leave the drug even more open to competition. A polymorphism of hep C that exists in about 48% of the genotype 1a population was shown to prevent simeprevir's effectiveness. Patients with the variant didn't benefit from the treatment, faring about the same as patients in the control arm of the study. That's a large subset of the population to weed out of the approval.

But the panel still had good things to say about simeprevir at the time: "The results of the clinical development program indicate that SMV + PR is a well-tolerated and effective therapeutic alternative for HCV-infected patients. Simeprevir 150 mg once daily for 12 weeks + PR is associated with high SVR rates, a good tolerability and drug-drug interaction profile, a simple 24-week regimen in all treatment-naïve and prior relapser patients including cirrhotics, and a convenient single capsule once daily dosing that could reduce treatment burden on patients."

So the success of simeprevir comes with a big asterisk as a less-advanced precursor to the new wave of all-oral treatments. -- Michael Gibney (email | Twitter)

For more:
Special Report: Hep C pill race report 2012: Gilead, others rush toward pharma gold
J&J wins FDA panel blessing for hep C blockbuster hopeful
FDA gives J&J a thumbs-up--with a catch--on hep C drug simeprevir
J&J's hep C drug simeprevir gets inside track at the FDA
Gilead's sofosbuvir cures some of the toughest hepatitis C cases

Olysio: J&J's hep C approval marks the end of an era

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