Atlanta, GA 5/7/12 (StreetBeat) -- Vertex Pharmaceuticals Inc's (Nasdaq: VRTX) new cystic fibrosis drug Kalydeco, when combined with its experimental treatment for the disease led to significant improvement in lung function in a mid-stage study, sending Vertex shares soaring 57 percent.Kalydeco, which in January became the first approved drug to treat the underlying cause rather than symptoms of the life-shortening lung disease, 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.
The interim analysis of the study looked at 37 patients who completed 56 days of treatment with the Kalydeco/VX-809 combination, and 11 patients who received a placebo. It found a statistically significant lung function improvement for those on the study drugs.
"These improvements were clinically very, very meaningful for these patients," said Brian Skorney, an analyst with Brean Murray, Carret & Co. "This is really a game-changing combination therapy."
The data could be the clearest sign yet that Vertex will soon be as well known for its cystic fibrosis medicines as its hepatitis C treatments. Vertex's Incivek has transformed care for hepatitis C patients in the past year, but investors are concerned a new generation of drugs will unseat the Vertex drug for addressing the infectious disease in the next few years.
In the data released on Monday, about 46 percent of patients who received the drugs experienced lung function improvement of 5 percentage points or more based on FEV1 -- a measure of the maximum amount of air that can be exhaled in one second, Vertex said.
About 30 percent who received Kalydeco and VX-809 had a lung function improvement of at least 10 percentage points. None of the placebo patients achieved a 5 percent improvement from baseline to day 56, the company said.
"The fact that it showed improvements in lung function in this small-sized trial I think is very impressive," Skorney said.
Complete data from the Phase II study are expected to be available in the middle of this year, Vertex said.
Cystic fibrosis, a life threatening genetic disorder, affects about 30,000 people in the United States and 70,000 worldwide.
The drugs were generally well tolerated with serious adverse events similar between the treatment and placebo groups, the company said.
Vertex shares soared 57.2 percent to $58.80 in premarket trading on Monday.
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