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Exanta launched in first market

Published on 23/06/04 at 12:05pm

AstraZeneca's new oral anticoagulant Exanta has been launched in Germany, its first global market.

The drug is the first in a new class of drugs called direct thrombin inhibitors and AstraZeneca hopes its advantages over existing treatments will make it another of the company's 'megabrands', analysts predicting peak sales of $1.3 to $3 billion.

Exanta's first licence in Europe is for the prevention of venous thromboembolic events (VTE) in elective hip or knee surgery, which the company says is an important 'proof of principle' to pave the way for additional indications: prevention of stroke and other complications associated with atrial fibrillation and long-term secondary prevention of VTE following use of a standard treatment.

More than half of patients who have major orthopaedic surgery will develop blood clots without preventative anticoagulant treatment, with doctors increasingly prescribing injections of heparin or low molecular weight heparins such as Aventis' Clexane/Lovenox.

Exanta (ximelagatran) will be given to orthopaedic patients with an initial injection four to eight hours after surgery, switching to a pill-based 24mg dose twice daily for up to 11 days.  The transfer to an oral medication makes Exanta more convenient than heparin, which must be administered in hospital or low molecular weight heparins which only come in injectable formulations.

The global market for anticoagulants is around $4 billion and growing at 13% while the worldwide anti-thrombotic market is approximately $12 billion, increasing at 15% annually.

Further European launches are anticipated in the coming months, including France which approved the drug through the mutual recognition procedure, but has not yet agreed reimbursement terms with AstraZeneca. Sweden, Portugal and Iceland are likely to be the next countries to launch the drug, having all given final marketing clearance.

In May, the UK and Ireland took the rare step of dropping out of the mutual recognition procedure because of differences over the best timing and dosing of the first injection for post-orthopaedic surgery patients. AstraZeneca has stressed safety and efficacy was not an issue in the delay, and has pledged to work with the regulators on the matter.

In most countries the injectable formulation of the drug will be distinguished from the oral formulation by a different name, Melagatran.

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Tuesday , May 11, 2004



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