First oral thrombin inhibitor reaches market

The drug is the first new anticoagulant to reach the market since the introduction of warfarin more than 60 years ago. It acts by inhibiting the clotting factor thrombin

Exanta has a number of advantages over warfarin, including that it can be administered as a fixed oral dose, has a rapid onset and offset of action and exhibits low potential for food and drug interactions. Furthermore, coagulation monitoring is not required with the new drug, reducing the burden of patient care.

While the initial indication is in orthopaedic surgery, the real pay-off for AstraZeneca will come if Exanta can gain approval in another indication - the prevention of stroke and other thromboembolic complications associated with atrial fibrillation (AF). It is currently under regulatory review in Europe for this indication.

The company has high hopes for the drug, and these are shared by market research firm Decision Resources. Last year, the latter forecasted that Exanta will revolutionise the prevention of stroke in cases of AF and that sales of the drug will reach more than $1.5 billion (€1.2bn) in 2007 and top $2.4 billion in 2012.

Meanwhile, a report by analysts at Morgan Stanley forecasts the global market for thrombosis treatments to increase from $5.1 billion in 2002 to $16.2 billion in 2010, with 65 per cent of this revenue growth expected to come from the US market.

The launch of Exanta in Germany follows the recent successful completion of the European Union's Mutual Recognition Procedure, for which France acted as the reference member state.

Filings have also been submitted to the US Food and Drug Administration (FDA) at the end of December 2003 for use of Exanta in the prevention of VTE in patients undergoing knee replacement surgery, as well as for the preventionof stroke and other thromboembolic complications associated with AF and long-term secondary prevention of VTE.