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Vertex Skids on Cystic Fibrosis Trial Data

From Associated Press (June 28, 2012)

NEW YORK -- Shares of Vertex Pharmaceuticals International Inc. slumped Thursday after the company reported additional data from a mid-stage clinical trial of its cystic fibrosis drugs Kalydeco and VX-809.

Vertex said the drug cocktail improved patients’ lung function after eight weeks of treatment in the mid-stage clinical trial, but its shares lost $9.93, or 16.2 percent, to $51.18 Thursday. Patients were treated with increasing doses of VX-809 for four weeks, and continued to take the drug for four more weeks while also receiving either Kalydeco or a placebo.

The Cambridge, Mass., company said it plans to start late-stage trials of the drug regimen in early 2013.

Cystic fibrosis is a disease that causes sticky mucus to build up in the lungs and other organs. The Food and Drug Administration approved Kalydeco in January as a treatment for a rare type of cystic fibrosis. VX-809 has not been approved.

Citi Investment Research analyst Yaron Werber said the results were encouraging and were good enough to get VX-809 approved, but he said Vertex has not done a good job reporting results from this trial. He said patients appeared to get worse over the first four weeks of treatment, which makes it less clear if the drug cocktail worked well.

On May 29 Vertex said it made errors in calculating other data from the study. The mistake made Kalydeco and VX-809 look more effective at improving lung function in patients with the common type of cystic fibrosis. Vertex shares are down 21 percent since then.

In after-hours trading, Vertex Pharmaceuticals stock fell 6 cents to $51.12.


Posted: June 2012