Alchemia cheered by GSK drug results

Clinical trials have found that GlaxoSmithKline's anti-blood clotting drug Arixtra nearly halved the risk of blood clots in acutely ill patients, a result that is expected to boost the commercial prospects of Brisbane-based Alchemia's (ASX:ACL) generic version of the drug.

Alchemia's generic version of Arixtra is a synthetic form of the natural anti-clotting agent heparin, which it aims to launch when GSK's market exclusivity expires. "We're making the generic version of Arixtra, so obviously the market success of Arixtra is important to us," said Alchemia CFO Chris Neal.

Glaxo's latest study involved 849 patients at 35 sites across eight countries and evaluated the overall efficacy and safety of Arixtra in older, acutely ill patients. The results, published in the British Medical Journal, showed that the risk of venous thromboembolism (VTE) in these patients was reduced by 46.7 per cent, with no increased risk of major bleeding compared with the placebo.

VTE is a common disease comprising deep vein thrombosis (DVT) and pulmonary embolism. It is a major cause of death among hospitalised patients.

"This is not dissimilar to the previous results [Glaxo] had on the clinical trials in acute coronary syndrome, which they announced back in September. The same sort of positive results in terms of the safety and efficacy compared with the market leader," said Neal.

Arixtra is not currently approved in the US for acutely medically ill patients, which currently represents 23 per cent of the global sales of the largest selling heparin drug on the market, Lovenox, marketed by Sanofi-Aventis. In 2004, Lovenox had total sales over US$2 billion.

"Lovenox has approvals for a number of separate indications," said Neal. "Arixtra has approvals for more than half of those indications but [GSK is] obviously aiming to get FDA and EU approval for the remainder."

Glaxo's senior vice-president for cardiovascular and metabolic medicine development, Dr Lawson Macartney said in a statement that the results "may help to expand the application of Arixtra in clinical practice".

Alchemia's synthetic heparin recently went through a pilot scale process at the US facilities of its manufacturing partner Dow Chemical. "At this stage commercial manufacturing will commence during 2006 to enable us to meet our predicted launch date of 2008," said Neal.

Alchemia's marketing partner American Pharmaceutical Partners is responsible for primary operations, marketing and finance for Alchemia's synthetic heparin until the product's market launch.