Alchemia heartened by results from GSK drug

The market potential for Brisbane biopharma Alchemia's (ASX:ACL) generic version of GlaxoSmithKline's (GSK) anti-blood clot drug Arixtra has been significantly enhanced by clinical trial results finding that the Arixtra is safer and as effective as Sanofi-Aventis' Lovenox, the traditional therapy used for preventing heart attacks, death and ischemia in people with serious heart conditions.

Arixtra is a synthetic form of the natural anti-clotting agent heparin, and Alchemia has an identical, generic molecule ready for launch when GSK's five-year market exclusivity expires next year.

Clinical trial results from the world's largest study on acute coronary syndrome, reported at the European Society of Cardiology meeting in Sweden, found that Arixtra (fondaparinux) was associated with a 47 percent reduction in major bleeding compared to Lovenox (enoxaparin) and was as effective in preventing death, heart attacks and ischaemia.

"What they found was that this almost halved the rate of bleeding incidence in a head-to-head trial with Lovenox, which is the current gold standard," said Alchemia's CEO Tracie Ramsdale.

Patients on Arixtra also had a lower death rate six months after treatment than those given Lovenox.

"I think [the results] will drive a switch from Lovenox to Arixtra, which of course makes the marketing effort simplified when you're taking a share of an existing drug through a generic," she said.

The Canadian-led study involved 20,000 patients and was conducted at 576 sites in 41 countries.

Arixtra is not currently approved in the US or EU for patients with acute coronary syndrome, in announcing the results of the study GSK signalled its intent to submit the trial data to regulatory authorities globally to seek approval for its use in these patients.

However, Arixtra is currently approved in Australia, the United States and Europe for the prevention of venous thromboembolism, which includes deep vein thrombosis and pulmonary emobolism in patients undergoing surgery for hip fracture, knee replacement and hip replacement.

"A number of the key opinion leaders at the symposium when these results were announced felt the results were so compelling that it would actually prompt off label use, because it is already approved for quite a few other indications," said Ramsdale.

An abbreviated new drug application for Alchemia's generic synthetic heparin is expected to be filed by the company's US marketing partner Americal Pharmaceutical Partners in 2006, and the drug is expected to be launched in the US in 2008.