Backed with a treasure trove of data from three solidly positive late-stage studies, Vertex ($VRTX) announced this morning that it had completed its NDA submission for the closely-watched hepatitis C drug telaprevir. And the biotech asked regulators to cut their usual review down to a quick six months to clear the way for a commercial launch in the middle of 2011 as it scrambles to beat Merck to a mega-blockbuster marketplace.
"This submission is a milestone in our more than 15-year effort to change the way hepatitis C is treated," said Matthew Emmens, the CEO of Vertex.
The developer has a compelling case for regulators. Phase III data indicates that an overwhelming majority of hepatitis C patients who registered a quick response to a telaprevir-based cocktail were effectively cleared of the virus after 24 weeks, making further treatments unnecessary. And that indicates the new hep C drug could cut the current standard treatment time in half for a large group of patients. Subjects with an extended rapid viral response, or eRVR, had a cure rate of 92 percent at 24 weeks and 88 percent at 48 weeks.
With data like that, some analysts have pegged peak sales at $3 billion a year. One of the biggest potential threats to telaprevir has been Merck's late-stage boceprevir, which should be filed for an approval soon. Significantly, though, boceprevir's late-stage data was good, but telaprevir continued to look even better in comparison.
- here's the Vertex release
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