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What: Shares of Enanta Pharmaceuticals (NASDAQ:ENTA), a developer of small-molecule drugs to treat infectious diseases, rallied as much as 18% after it and development partner AbbVie (NYSE:ABBV) reported positive results from its late-stage hepatitis-C trial involving AbbVie's direct-acting antiviral combo.
So what: According to the press release, the DAA combo drug, of which Enanta supplied ABT-450, successfully demonstrated efficacy and safety in its final four trials involving genotype 1 patients, the most common, but most difficult to treat variation of the disease. Although I would strongly encourage you to look at the results from each individual trial to gauge performance, the primary conclusion is that sustained virologic response -- with the exception of the genotype 1a, treatment-naïve study utilizing the DAA combo without ribavirin which produced "only" a 90% SVR after 12 weeks – was 92% to 100% throughout its four studies. In fact, the majority of studies delivered an eradication of detectable levels of the virus of 96% to 99%.
Now what: Clearly these are strong results, and they're very likely to merit an approval from the Food and Drug Administration before 2014 is over barring some unforeseen curveball. Plenty of investors are worried about competition from Gilead Sciences' (NASDAQ:GILD) Sovaldi, which is more convenient in that there are fewer pills for a patient to take on a daily basis. I would contend, though, that based on the overwhelmingly strong efficacy of both drugs, that each has the opportunity to share the space and attain blockbuster status. I'd urge you not to count your chickens before they are hatched, but if my arm were twisted I'd say Enanta and AbbVie are both sitting on a potentially lucrative hepatitis-C therapy at the moment.
Sean Williams has no material interest in any companies mentioned in this article. You can follow him on CAPS under the screen name TMFUltraLong, track every pick he makes under the screen name TrackUltraLong, and check him out on Twitter, where he goes by the handle @TMFUltraLong.
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