ALCHEMIA AWAITS APPROVAL
Written on the 6 April 2011
CONTINUING progress with its programs has not eased shareholder frustration with drug developer Alchemia due delays by the US Food and Drug Administration (FDA) to approve its new antithrombotic fondaparinux.
The company posted a net loss after tax of $6.7 million for the December half, with total income for the period of $784 000.
Managing director Pete Smith (pictured) says the company is working on other projects as it awaits approval of the injectible version of fondaparinux.
“We signed a partnership with US-based Emisphere Technologies to develop an oral formulation of the compound utilizing Eligen technology,” he says.
“This broad based drug delivery platform is designed to enhance the oral bioavailability of the drug without altering its chemical form or biological activity. An oral formulation of fondaparinux will expand the profile of the drug and potentially increase its market potential.”
The company has been preparing for the Phase 3 trial design for HA-Irinotecan, which will be initiated after approval for fondaparinux.
“The $25 million trial will be conducted in 60 sites in at least six countries and in July 2010 was adopted by the National Cancer Research network in the UK,” says Smith.
“This organisation provides the National Health Service in England, with the infrastructure to support cancer clinical trials and works closely with the cancer centers to provide clinical trial support across the UK.”
Over the past 12 months, the company has also spent significant time advancing its oncology platform, featuring HyACT tumor targeting technology.