Biotech Tracker - Data Continue to Support Arixtra Use

BiotechTracker - Data Continue to Support Arixtra Use

July 16, 2003 Continued evidence of Arixtra’s broad utility in the management of venous thromboembolic disorders were presented at the XIXth Congress of the International Society on Thrombosis and Haemostasis, which is ongoing in the U.K. Sanofi-Synthelabo (NYSE: SNY) and Organon’s (a division of Akzo Nobel, NASDAQ: AKZOY) Arixtra (fondaparinux) is the first direct thrombin inhibitor indicated for use in the management of VTE, including deep vein thrombosis (DVT) and pulmonary embolism (PE). Arixtra was launched in mid-February 2002, indicated to help prevent DVT that may lead to PE in patients undergoing hip fracture surgery, hip replacement surgery, or knee replacement surgery. Recently, Arixtra gained approval for extended use in the prevention of DVT in patients undergoing hip fracture surgery. The drug is being studied for expanded use in more high-risk VTE prevention scenarios, VTE treatment, and even acute coronary syndrome treatment.

The current presentations suggest utility of Arixtra both over a broader swath of acutely ill, relatively immobile hospitalized patients at high-risk for VTE regardless of indication for hospitalization, and over a greater range of high-VTE risk patients admitted for surgical indications. Arixtra eventually will compete with, and often will complement, AstraZeneca’s (NYSE: AZN) Exanta (ximelagatran), an oral direct thrombin inhibitor with massive clinical potential currently in large scale phase III testing.

The results of the 849-patient, randomized, double-blind, placebo-controlled ARTEMIS (ARixtra for ThromboEmbolism prevention in a Medical Indications) trial show that Arixtra 2.5 mg once daily significantly reduces VTE risk for acutely ill hospitalized admitted for various medical indications. A group of standard care recipients experienced a 10.5% probability of developing VTE whereas an Arixtra group experienced a 5.6% risk of such adversity (p=0.029). A significant (p=0.029) risk reduction for fatal PE was also observed for the Arixtra group. Day 32 trends favored Arixtra recipients in terms of overall mortality reduction (from 6.0% to 3.3%) as well, but this clinically significant advantage did not reach statistical significance.

The results of the 2,927-patient, randomized, double-blind, dalteparin-controlled, PEGASUS (PEntasaccharide in GenerAl SUrgery Study) trial show that Arixtra use is at least as safe and efficacious as a low molecular weight heparin (dalteparin) for the prevention of VTE following major abdominal surgery. For the overall study population, Arixtra was more efficacious than dalteparin in this regard (4.6% versus 6.1%, p=0.14). Although not attaining statistical significance, this trend toward Arixtra advantage is clinically significant. For study subjects undergoing abdominal cancer surgery (approximately 70% of the overall sample), VTE incidence was significantly reduced for Arixtra recipients compared to dalteparin recipients (4.7% to 7.7%, p=0.02). Arixtra’s adverse effect profile was reassuring in both investigational settings.

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