US FDA seeks more trial work on Encysive lung drug
Last Updated: 2006-03-27 15:00:27 -0400 (Reuters Health)
WASHINGTON (Reuters) - Encysive Pharmaceuticals Inc. said Friday U.S. regulators have requested additional clinical trial work before approving its drug Thelin for an often-fatal lung condition, and its shares fell 8 percent in extended trade.
The Houston-based company is seeking permission to sell Thelin as a treatment for treat pulmonary arterial hypertension (PAH), which causes severe shortness of breath and often kills.
The Food and Drug Administration sent an "approvable letter" to the company saying Thelin could be cleared if certain conditions were met, FDA spokeswoman Susan Cruzan said. She did not disclose the conditions.
Encysive said in a statement the letter contained "concerns and observations that must be satisfied prior to achieving approval, including a request for additional clinical trial work."
President and Chief Executive Officer Bruce Given said Encysive would work with the FDA "to clarify the path forward."
"We are hopeful that this can be accomplished without the need for additional clinical work, but that will require discussion with the agency before we can be sure," Given said.
Shares of Encysive fell 73 cents to $8.35 in after-hours trade on the Inet network, after closing down 3.9 percent at $9.08 in regular Nasdaq trade.
The failure to win full approval for Thelin will likely be viewed as positive for Swiss biotechnology company Actelion, which relies heavily on its PAH treatment Tracleer to sustain growth.
"Any delay would provide an upside to our Tracleer forecasts," Kepler Equities analyst Denise Anderson said in a note to clients.
While Tracleer once had the PAH market pretty much to itself, it is now facing increased competition from Pfizer Inc.'s Revatio, which contains the same active ingredient as Viagra.
Thelin would be another direct competitor for treating the rare condition that often leads to the need for a heart and lung transplant.
A fourth drug for PAH called ambrisentan is being developed by Myogen Inc.
