Well, Given was right, the FDA's issue was not what everybody thought: it's not a safety, but an efficacy issue. ENCY will do the dispute resolution thing. I am traveling still, and can't get to the webcast for a couple of days. Did anyone hear what the timeline was on the dispute process? Meanwhile, unsurprisingly, Ambrisentan is approved. I had thought there was some chance it would get an approvable, too, but had come to regard the odds as about 3:1 against approvable. The outright approval is a good thing for GILD and patients, if not for ENCY.
>>FDA Issues Third Approvable Letter for Thelin (Sitaxsentan Sodium)
Friday June 15, 7:31 pm ET
Conference Call Scheduled for Monday at 8:00 a.m. ET
HOUSTON, June 15, 2007 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals Inc. (NasdaqGM:ENCY - News) today announced that the Company has received its third approvable letter from the U.S. Food and Drug Administration (FDA) for THELIN(tm) (sitaxsentan sodium), which is under review for the treatment of pulmonary arterial hypertension (PAH).
In this third approvable letter, the FDA stated that Encysive's development program for THELIN did not demonstrate the evidence of effectiveness needed for approval. The FDA did note, however, that the THELIN development program provides some evidence that THELIN improves exercise tolerance in PAH. The FDA encouraged the Company to conduct an additional study to demonstrate the drug's effectiveness in exercise capacity as measured by change in six-minute walk distance.
``We believe we adequately addressed the issue raised by the FDA in the second approvable letter and we are deeply disappointed in their decision. Encysive remains committed to THELIN in Europe, Australia and Canada, where it has been approved for sale,'' commented Bruce Given, M.D., President and CEO of Encysive Pharmaceuticals Inc. ``We greatly appreciate the PAH patients and clinicians in the U.S. and worldwide who have been so supportive of the THELIN development program,'' he added.
Encysive plans to discuss the most recent approvable letter with the FDA as soon as possible to determine the appropriate path forward.
The Company may be required to make significant reductions in its infrastructure and workforce in the U.S. as a result of the decision by FDA. The Company is reviewing its strategic alternatives and intends to communicate its plans at a later date.
Conference Call Information
Encysive will host a conference call on Monday, June 18, 2007, at 8:00 a.m. ET, to discuss the FDA approval of THELIN. You may access the call either through the call-in number below or through the audio webcast. Please dial in 15 minutes prior to the start time to allow for call processing. The access number for the call is:
Number: (480) 248-5088
Passcode: Encysive Pharmaceuticals
This call is being webcast and can be accessed via Encysive's web site at encysive.com.
A replay of the webcast will be available on the Company's web site through July 18, 2007. Additionally, a replay of the call will be available until Friday, June 22, 2007 at 11:59 p.m. ET. The call replay can be accessed by calling:
Number: (320) 365-3844
Access Code: 877197<<
>> LOS ANGELES, June 18 (Reuters) - Encysive Pharmaceuticals Inc. (ENCY.O: Quote, Profile , Research) plans to dispute the U.S. Food and Drug Administration failure to approve its hypertension drug Thelin, news that sent company shares down 43 percent to $2.32 on Monday.
The company said late on Friday that the FDA had declined approve its flagship drug, which is approved as a treatment for pulmonary arterial hypertension (PAH) in Canada and Europe.
According to Houston-based Encysive, the FDA said Thelin did not demonstrate the effectiveness required for approval as a treatment for PAH, a life-threatening type of hypertension.
The company said the FDA saw some evidence that Thelin improved exercise tolerance in people with PAH and encouraged the company to do another study.
Encysive said it plans to enter formal dispute resolution with the FDA, charging that regulators did not follow certain agreed-upon guidelines when they analyzed trial results.
"We felt early on that the FDA basically had reached a conclusion in error ... We wanted to give them the opportunity to rectify that error in a sort of quiet and sort of noninflammatory atmosphere," Given told analysts.
"That's no longer possible," he said.
The company said the FDA's decision may force it to make significant cost cuts. It reported a cash balance of about $54 million and restricted cash of around $10 million as of June 15.
Encysive's rival Gilead Sciences Inc. (GILD.O: Quote, Profile , Research) won FDA approval for its hypertension drug Letairis, which industry analysts estimate could have sales of more than $1 billion a year, on Friday. <<
Cheers, Tuck |
