The marathon race to bring the next hepatitis C drug to the market is coming to a close. In the last couple of weeks, both Schering-Plough
That means investors can pretty much guess when data from the trials should be available. The timetable for hepatitis C trials is pretty clear, unlike cancer drugs, where the trials often conclude when enough events, like deaths or progression of the disease, have taken place, which makes the timing of their conclusion somewhat unpredictable. For instance, the results of Dendreon's
Schering's Sprint-2 trial testing boceprevir and Vertex's Illuminate trial testing telaprevir have a maximum of 48 weeks of treatment and a 24-week follow up to see if the virus has been eradicated, so the subjects that just started treatment now should be done in about 17 months. Add a month or two to process the data, and investors should get results before the end of the summer next year.
Both companies are also testing the drug in patients who have failed the current treatments: Roche's Pegasys and Schering's Pegintron. Vertex is expecting final data from a phase 2 trial, confusingly called Prove 3, in the first half of this year. It's still a possibility that the company could file a marketing application with just that data given the unmet need, but the company needs to see the data and discuss it with the Food and Drug Administration first. If it can get approved with the phase 2 data, great -- Vertex would likely be first to market. But if that doesn't work out, it has a backup plan with a phase 3 trial that is expected to be fully enrolled this quarter. Schering's phase 3 trial for treatment-failure patients concluded enrollment last November.
Watch your back
Telaprevir and boceprevir are the two drugs getting the most attention, but Vertex and Schering aren't the only ones developing drugs to fight hepatitis C.
There are two drugs in development that are hoping to upstage the current treatment (Pegasys and Pegintron). Human Genome Sciences'
There are also other drugs set up to be used with the current treatment's pegylated interferons, rather than replace them. Roche, InterMune
A long road
Hepatitis C is clearly a large market -- Pegintron and Pegasys combined for around $1.7 billion in sales through the first nine months of last year. The first company to hit the market with a new drug will have a clear advantage, but it doesn't look like it'll last for very long. In the drug world, there's always someone on your tail.
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