Guilty Until Proven Innocent


There's something to be said for a company that can read the writing on the walls of the Food and Drug Administration and is willing to cut its losses rather than throw more money at a drug that's unlikely to be approved. It's even harder when there's nothing wrong with the drug, in theory at least.

So, kudos to Idenix Pharmaceuticals that's throwing in the towel, dropping development of two hepatitis C compounds, IDX184 and IDX19368 .

The drugs haven't been directly associated with any adverse events. But the FDA put both drugs on clinical hold because a related drug, Bristol-Myers Squibb's BMS-986094, caused cardiac issues. Bristol dropped development of its hepatitis-C drug and even offered to help Idenix sort out the reason for the side effects.

Idenix believed that its drugs were different enough from Bristol's that it could get the hold lifted. Proving that was apparently a little more difficult than the company would have hoped.

Rather than continue the back and forth, trying to convince the FDA that the drugs were safe enough to continue clinical trials, Idenix decided to stop development. It's a disappointing decision, but when a drug is guilty until proven innocent, it's difficult to exonerate it.

This was my pick for a company that would have a better 2013 than its 2012, and it might still get there, but it won't be because of IDX184 and IDX19368. Idenix needs a hit from its now-lead-compound IDX719, which it recently partnered with Johnson & Johnson's hepatitis-C drugs simeprevir and TMC647055. Positive data -- or perhaps just the anticipation of the data -- might result in shares being positive this year. Results are less important for Johnson & Johnson, which has partnerships with a couple of other companies.

Idenix also has a preclinical uridine nucleotide analog. The drug has a distinct enough structure from IDX184, IDX19368, and BMS-986094 that it shouldn't run into any concerns from the FDA. Vertex Pharmaceuticals' VX-135 is also a uridine nucleotide analog, and the FDA has kept it off clinical hold.

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Fool contributor Brian Orelli has no position in any stocks mentioned. The Motley Fool recommends Johnson & Johnson and Vertex Pharmaceuticals. The Motley Fool owns shares of Johnson & Johnson. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

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Originally published