The race between Merck and Vertex--which is partnered with Johnson & Johnson--to gain approval of a new hepatitis C therapy is coming down to the wire. And the stakes are enormous.
Currently about half of all hepatitis C patients can't take existing therapies. The other half consume $2 billion a year in drugs. A whole host of hep C patients are being "warehoused" now, waiting for new drugs to come onto the market. And Geoff Porges, an analyst with Sanford C. Bernstein, tells Bloomberg that the approval of new drugs could expand the market to $10 billion in just five years.
Merck's boceprevir and Vertex's telaprevir-a pair of protease inhibitors-are gaining the most attention for now. Both are expected to produce pivotal data later in the year, with applications planned before the end of 2010. The winner of the race, says Porges, is expected to net major gains as many of those warehoused patients, as many as o9ne in five in many practices, come down off the fence to try the therapy.
The next step in the process will be the arrival of polymerase and NS5A inhibitors, a second wave of hep C drugs now in the pipeline. New hep C drugs were in the spotlight over the past few days during the annual meeting of the European Society for the Study of the Liver in Vienna, where a number of analysts and investigators have now been stuck as air traffic on the continent has been roiled by a cloud of volcanic ash.
- here's the article from Bloomberg
ALSO: Human Genome Sciences, meanwhile, says that Novartis has pulled its European application for its hepatitis C drug (called Zalbin in the U.S.) saying that regulatory feedback led the company to conclude that they would ask for new drug data that could not be submitted "within the timeframe allowed." Release