Tue May 29, 2012 8:10am EDT
(Reuters) - Vertex Pharmaceuticals Inc released corrected data involving its cystic fibrosis treatments on Tuesday that lowered the number of patients who showed certain levels of improved lung function, sending its shares down nearly 17 percent.
The initial data, released earlier this month, sent Vertex shares soaring on hopes the company could have a multibillion-dollar franchise in the treatment of cystic fibrosis, a life-threatening genetic disorder that affects about 70,000 people worldwide.
"The corrected data appear weaker than the original data," ISI Group analyst Mark Schoenebaum said.
The company also released data that showed patients on placebo saw a decline in lung function on average that was far greater than Schoenebaum had expected.
"This faster-than-expected rate of placebo decline may make the data less reproducible in a phase 3 setting," the analyst said.
Vertex said it still plans to start a pivotal study of its CF treatments.
The phase 2 study involves a combination of Vertex's new cystic fibrosis drug, Kalydeco, with an experimental drug called VX-809.
Kalydeco helps only about 4 percent of cystic fibrosis patients with a specific gene mutation. Vertex is testing combinations it hopes will eventually be able to address the larger CF population.
Cystic fibrosis causes the thin layer of mucus that helps keep the lungs free of germs to become thick, clogging airways and leading to infections that damage the lungs.
The study examined patient performance based on a measure of the maximum amount of air that can be exhaled in one second, known as FEV1.
On May 7, Vertex released data that it said showed that about 46 percent of patients experienced an improvement in lung function of 5 percentage points or more based on FEV1. On Tuesday, the company said that figure was actually about 35 percent.
The initial results also said about 30 percent of patients experienced an improvement of at least 10 percentage points. That number has been lowered to 19 percent.
Vertex said the error resulted from a misinterpretation of data from a vendor involved in the statistical analysis.
Vertex shares fell 16.7 percent to $54 in premarket trading on Nasdaq.
(Reporting By Lewis Krauskopf; editing by Jeffrey Benkoe and John Wallace)
- Link this
- Share this
- Digg this
- Email
- Reprints
0 comments:
Post a Comment