Faced with a rising tide of red ink, Vertex (NASDAQ: VRTX) says it has begun rolling out its NDA for the potential blockbuster telaprevir and expects to wrap the app later this year. Banking on a treasure trove of positive Phase III results already in hand, Vertex is clearly hopeful about its chances with the closely watched hepatitis C drug. And it's laying the groundwork for another FDA campaign next year for its cystic fibrosis program.
Vertex will need to start ginning revenue quickly, assuming it wins an approval for telaprevir. The company projects a $750 million loss for 2010--significantly more than earlier estimates.
"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," says Vertex CEO Matthew Emmens in a statement that lays out the biotech's development strategy.
"Our Phase III registration program in cystic fibrosis is now fully enrolled, positioning us for the planned submission of a New Drug Application for VX-770 in the second half of 2011. There is an urgent need for new and more effective therapies in cystic fibrosis, and we are committed to working toward improving the lives of people affected by this disease."
- here's the press release on Vertex's pipeline strategy
- here's the story from Reuters