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Encysive Disputes FDA Decision to Defer Thelin Approval

The drugmaker challenges the agency's decision to withhold approval of hypertension drug Thelin.

Encysive Pharmaceuticals


reported a widened loss and filed for dispute resolution regarding the Food and Drug Administration's call on hypertension drug Thelin.

The company said Monday that it's formally disputing the FDA's decision to withhold approval of Thelin. This was expected as the company announced on July 13 that it held a formal Class A preliminary dispute resolution meeting with officials from the regulatory agency.

It follows the third approval letter from the FDA, issued on June 15, which maintained that the development program for Thelin didn't demonstrate the evidence of efficacy needed for approval.

"We continue to believe that we have fully complied with the design of our study as submitted and amended within the terms of FDA's guidelines,'' Encysive CEO George Cole said.

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The resolution process allows sponsors to challenge regulatory decisions by bringing the dispute to the attention of FDA supervisors. If the supervisors side with the agency's original decision, Encysive will need an additional clinical trial that the company says would prove costly and could take two years to conduct.

The company already announced

an overhaul in June that involved letting go of 70% of its workforce and swapping out its chief executive. Soon after, its CFO resigned.

For the quarter, Encysive reported a loss of $33.9 million, or 50 cents a share, vs. a loss of $28 million, or 48 cents a share, in the year-ago quarter. The Thomson Financial consensus target called for a loss of 43 cents a share.

The company reported revenue of $8.9 million vs. $3.7 million in the year-ago quarter. The growth was due to an increase in royalty income from higher sales of anticoagulant Argatroban. However, this income is used to pay outstanding Argratoban-related notes.

"We have significantly reorganized the company in order to better manage the challenges ahead and are taking the appropriate steps in order to maximize the value of the assets we have while reducing our expenses,'' Cole said.

Encysive's stock was down 15 cents, or 8%, to $1.74 in recent trading Tuesday.