August 16, 2012
Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.
What: Shares of hepatitis-C-focused biotechnology firm Idenix Pharmaceuticals (Nasdaq: IDIX ) crashed as much as 35% after receiving unfavorable news for its leading experimental drug candidate, IDX184.
So what: Idenix Pharmaceuticals received word from the Food and Drug Administration in a letter today that it was placing a hold on IDX184, a mid-stage treatment for hepatitis C that had shown significant efficacy in recent studies. According to the FDA, the reason for the hold stems from an adverse cardiac event that happened with a competitors' nucleotide polymerase inhibitor. That letter is referring to Bristol-Myers Squibb (NYSE: BMY ) , which suspended its phase 2 trial of BMS-986094 which it acquired when it purchased Inhibtex for $2.5 billion earlier this year. Gilead Sciences (Nasdaq: GILD ) , whose GS7977 has been at the forefront of hepatitis C innovation, dropped as well since its drug is also a nucleotide-based inhibitor.
Now what: Don't for one second think this is a reason to run out and buy Achillion Pharmaceuticals (Nasdaq: ACHN ) since it has a non-nucleotide-based treatment, because it's not! There's very little reason here to believe that Gilead Sciences will have any long-term effect from Idenix's bad news; I hold this as even more evidence that Gilead has the clear path to be the first non-interferon-based hepatitis C treatment to be approved by the FDA. Until that time, the hepatitis C market is Vertex Pharmaceuticals' (Nasdaq: VRTX ) to lose and Incivek will remain the premier treatment. Idenix clearly has a lot of hurdles to overcome and there just may not be much of the hepatitis C pie left by the time it works out all of its kinks.
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