Agenix files IND, announces $14.3m loss

Brisbane’s Agenix [ASX: AGX, NASDAQ OTC: AGXLY] has filed an Investigational New Drug application with the US Food and Drug Administration (FDA) for its blood clot imaging technology, Thromboview.

The company also announced a surprise loss of $14.3 million, up from 811,000 in 2003. Major contributors to the loss were $3.8 million in legal fees associated with the now resolved Synbiotics patent case, costs associated with the terminated Peptech merger, and $4.4 million related to restructuring and asset writedowns at subsidiary Milton Pharmaceuticals.

Sales revenue declined by 4.9 percent to $32 million, primarily due to a 7 per cent fall in Milton Pharmaceuticals revenue to $16.4 million. As at June 30, Agenix had cash on hand of $3.2 million, as well as $16 million in unused bank facilities.

The FDA has 30 days to review Agenix's IND package -- excluding delays should Agenix need to respond to questions -- before Phase II trials for Thromboview can commence. "We don't think we'll go much over the 30 days, because we've had pre-IND meetings," said Agenix chief executive officer Don Home.

The company plans to commence Phase II clinical trials in Canada and the US, testing ThromboView against regulatory ‘gold standards’ for both deep vein thrombosis (DVT) and pulmonary embolism (PE). The current DVT gold standard is veinography and the PE standard is pulmonary angiography.

The trials are expected to last until the end of 2005.