The drugs: ABT-450/r + ABT-267 + ABT-333
The disease: Hepatitis C
The developer: AbbVie
Peak sales potential: Most projections seem to settle comfortably around $3 billion.
The scoop: When AbbVie ($ABBV) spun out of Abbott ($ABT) at the beginning of the year, it had a monster blockbuster (Humira) to rely on and a so-so rep in drug development circles. The pharma company has now set out to enhance its R&D reputation with an interferon-free approach to hepatitis C.
The FDA gave the combo its coveted breakthrough therapy designation based on some stellar mid-stage results for genotype 1 patients, with 99% of treatment-naïve patients seeing a sustained response after 12 weeks of therapy. Also, 93% of prior null responders hit SVR12 as well, setting a firm foundation for Phase III.
AbbVie has insisted that it has the potential to catch up with Gilead's ($GILD) sofosbuvir, the odds-on leader in this sphere. But even as a close second, analysts have provided some starry-eyed projections on its earning capacity. The treatment of hepatitis C is being revolutionized with all-oral cocktails that will bat down the virus without interferon injections. And with an enormous number of patients and their physicians eager to see new treatments come along, AbbVie does stand a good chance of carving out a big place for itself in the field.
It should be noted, though, that hepatitis C treatments have to clear a very high safety bar at the FDA. If any nagging questions appear, a combo like this could quickly find itself in limbo--like others before it. But at this stage of the game, AbbVie has improved its odds are a very quick pace. And tagging along on this blockbuster ride is Enanta ($ENTA), which just enjoyed a blockbuster reception for its IPO based on its partnership with AbbVie on the protease inhibitor 450.
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