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VIDEOMore Catalysts Ahead for Vertex Pharmaceuticals
The biotech expects to release pivotal data on its hepatitis C drug telaprevir in the coming months.
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While the biotech announced Wednesday that it posted a wider loss in the second quarter than it did in the corresponding period in the year prior, Vertex also announced some news that could mean its fortunes will be turning around.
Vertex told investors and analysts on Wednesday that it has initiated a rolling New Drug Application for its hepatitis C drug telaprevir. The drug is one of a few that has shown late-stage promise for the chronic condition. Telaprevir and Merck’s (MRK) boceprevir are competing to become the new standard of care for the disease.
Hepatitis C, or HCV, is a disease that leads to swelling of the liver. The disease is asymptomatic and most people don't know they have it until severe liver damage is discovered. It's the leading cause of liver cancer, cirrhosis, and the main reason that people in the US need a liver transplant. According to the Center for Disease Control and Prevention, 3.2 million Americans are living with chronic hepatitis C and another 1.2 million Americas have chronic hepatitis B.
"We remain on track to complete the New Drug Application submission process for telaprevir later this year and to complete the buildout of our commercial function in advance of the potential launch of telaprevir," said Vertex Chairman Matthew Emmens. "In the first half of this year, we established a seasoned commercial leadership team with broad experience in the area of infectious diseases, and we continue to bolster the internal infrastructure needed to support a field-based sales force for telaprevir and other potential future medicines.”
A rolling application allows the company to submit pieces of data as they become available. Vertex says the application will be complete by the second half of the year.
But before that, investors can expect two catalysts that will likely bump up the stock.
Data from two more phase III trials is expected in the next couple of months. The remaining results from the Illuminate trial are expected in August and the Realize trial in September. While the company didn’t give exact timing for when it's going to release the data (most biotechs don’t), this gives investors a good chance to take a closer look at the stock before these events.
“Realize is likely the biggest source of potential near-term upside. We continue to view data from Realize in previous HCV treatment-failures as the telaprevir trial with the most potential to surprise to the positive versus Phase 2 results,” said Robert W. Baird analyst Tom Russo.
Vertex also announced that it will be kicking off the phase III Bid trial in the fourth quarter. The trial design won’t be announced until the trial is underway. Results from the study will be available in 2012. “We view this update as confirmatory of the path forward toward future commercially important labeling and in-line with expectations that Phase 2 study C208 alone would not be enough,” wrote Russo. “This new, larger Phase 3b study will be the vehicle for that. The previously successful C208 study explored telaprevir twice-daily, but at more rigid every 12 hour intervals. Having true BID dosing would be more flexible and thus desirable commercially.”
Investors interested in other companies working on HCV drugs can check out Gilead (GILD), Pharmasset (VRUS), and Idenix Pharmaceuticals (IDIX).Twitter: @biowriterchik
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