Better Late Than Never? Maybe.


Hot on the heels of the successful launch of Incivek, Vertex Pharmaceuticals (NAS: VRTX) is going after another large market. Unlike hepatitis C, though, the biotech isn't the front runner for rheumatoid arthritis. Not even close.

The data released today from a phase 2a trial looked pretty good. There was a nice dose response for VX-509, which is a good sign that the results are due to the drug and not just random. At the top two doses, VX-509 showed statistically significant improvement across four different measurements of rheumatoid arthritis symptoms.

But there are plenty of oral rheumatoid arthritis drugs headed quickly toward the market already. Pfizer's (NYS: PFE) tofacitinib has already posted phase 3 trial results and it'll likely be on the market next year. Incyte (NAS: INCY) and Eli Lilly's (NYS: LLY) LY3009104 and Rigel Pharmaceuticals (NAS: RIGL) and AstraZeneca's (NYS: AZN) fostamatinib are both ahead of VX-509.

While the data for VX-509 looks good, it's nearly impossible to compare it to the clinical trials run by Vertex's competitors. Pain is one of the major symptoms of rheumatoid arthritis and is quite subjective, resulting in placebo effects that can vary considerably. In one of Pfizer's trials, for instance, 26.7% of patients receiving placebo reported a 20% improvement in their symptoms, while in another trial, 31.2% of placebo patients reported the same improvement.

The market for rheumatoid arthritis drugs is certainly big enough for three or four players. It's currently dominated by three multi-billion-dollar drugs, but they have to be injected or infused, so they're ripe to be picked off by the oral drugs.

Vertex's investors will just have to take a wait-and-see attitude here. The company plans to run a phase 2b trial, which will test the drug for twice as long as the most recent trial. And then it'll need a couple of phase 3 trials to get on the market. Being late to the game, Vertex needs to hope that its competitors slip up or that the efficacy and/or safety data for VX-509 differentiates it from the leaders.

At the time thisarticle was published

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