Epix Evaluating Options After FDA Turns Down Appeal to Approve Vasovist Blood Imaging Agent

Biotech drug maker Epix Pharmaceuticals Inc. said Monday that the Food and Drug Administration turned down its appeal to get an approval for its blood imaging agent Vasovist, placing pressure on shares.

Shares of Epix fell 91 cents, or 13 percent, to $6.30 in early Nasdaq trading.

Epix said the FDA turned down its request for an advisory committee meeting to review data. The agency also suggested that the company conduct two clinical trials as a safer course of action to get the product approved.

In June, the company appealed the agency's decision requiring another clinical trial for Vasovist. That decision came in an "approvable letter" in November, following another earlier letter that had requested more data from the company.

The product is an injectable agent that when used with imaging technology can show blood flow throughout the vascular system. Vasovist is aimed at detecting blood clots.

"We are evaluating several options available to us as next steps with Vasovist in the United States, including the option to appeal this decision to the next level at the FDA, and will update the market accordingly," said Andrew Uprichard, Epix' president, in a statement.

Vasovist is already approved in Europe and was recently recommended for approval in Australia.