October 28, 2002
AstraZeneca’s (NYSE: AZN) Exanta (ximelagatran) demonstrated a magnitude of prophylactic effect superior to Aventis’s (NYSE:
AVE) low molecular weight heparin formulation Lovenox in the 2,800-patient, randomized, double-blind, phase III EXPRESS clinical trial performed throughout Europe and in South Africa. Exanta recipients experienced a 63% relative risk reduction (2.3% vs. 6.3%, p=0.0000018) of clinically relevant major venous thromboembolism (VTE – proximal deep vein thrombosis [DVT] and pulmonary embolism [PE]).
Moreover, other clinically significant relative risk reduction advantages were observed for Exanta for:
- clinically relevant major VTE in patients undergoing total hip replacement – 67% (1.8% vs. 5.5%)
- clinically relevant major VTE in patients undergoing total knee replacement surgery – 60% (3.3% vs. 8.2%)
- total VTE – 24% (20.3% vs. 26.6%) reduction in the risk of total VTE.
Exanta’s adverse effect profile was reassuring. The risk of surgery-related bleeding was higher for Exanta recipients, but there were no differences for rates of clinically important bleeding events (defined as fatal, involving specific organs, or requiring re-operation).
Exanta is the first oral direct thrombin inhibitor to be submitted for regulatory review, AZN having submitted its dossier for European marketing authorization for the prevention of VTE following major orthopedic surgery in July 2002. AZN reports that the U.S.-based phase III prophylactic orthopedic surgery program, EXULT, “remains on track.” Our modeling estimates Exanta’s probability of FDA approval as 70-80%.
The first synthetic selective thrombin inhibitor to be marketed for anticoagulation in VTE prophylaxis is Sanofi-Synthelabo (NYSE:
SNY) and Organon’s (a division of Akzo Nobel, NASDAQ:
AKZOY) Arixtra. We expect that Arixtra’s label will eventually expand to include VTE treatment as well. High-powered efficacy-deriving Arixtra trials are ongoing in both the treatment of venous thrombosis and pulmonary embolism (phase III) and for treatment of arterial thrombosis (phase IIb). Arterial thrombosis is a key factor in the development of acute myocardial infarction (MI, heart attack) and unstable angina.
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