Vertex Pharmaceuticals ($VRTX) stands at the verge of a potential and much-anticipated FDA approval of its standout hepatitis C drug telaprevir. With a PDUFA date of May 23 for its telaprevir application, Vertex is expected to get a green light for U.S. marketing of the experimental treatment after an advisory panel gave the drug its unanimous backing last month.
Many industry watchers have already moved on to discussing the hep C showdown expected between Vertex and Merck ($MRK), which gained FDA approval earlier this month for a similar drug called Victrelis (boceprevir), which also snagged a possitive opinion announced today from an EMA committee recommending its approval for the European market. Vertex might have the edge with results from one study that showed it could wipe out the liver disease in 79 percent of patients, but Merck made things more interesting with its recent deal to join forces with fellow Big Pharma player Roche in marketing and developing cocktail treatments against hep C.
Vertex, whose telaprevir shined in multiple late-stage trials, has the most at stake in the brewing hep C battle. The Cambridge, MA-based company has racked up an accumulated deficit of more than $3.6 billion, much of which has been spent on developing telaprevir. The med has the potential to greatly improve the way patients with the disease are treated. Vertex could see its coffers quickly fill up if the drug meets revenue expectations on Wall Street. Needham & Co. biotech analyst Alan Carr believes the drug can attain blockbuster status next year, with potential 2012 sales of about $1.5 billion.
An FDA approval of telaprevir would continue Vertex's incredible streak with its pipeline over the past year. In addition to a string of late-stage trial success with its hep C drug, the company has shined with impressive results from Phase III trials for its cystic fibrosis drug VX-770.
- here's the Merck release about the positive EMA panel opinion