Recently, Bristol-Myers Squibb Co. (BMY) and Pfizer Inc. (PFE) announced that apixaban, a blood thinner being co-developed by the two companies, was found to be more effective than Sanofi-Aventis’ (SNY) Lovenox (enoxaparin) in a late stage randomized, double-blind, multicenter, head-to-head study. The candidate was found to be statistically superior to 40 mg once daily enoxaparin in reducing blood clots in the legs or lungs (venous thromboembolism) in patients undergoing total knee replacement surgery.
 
In the late-stage study, patients were administered either 2.5 milligrams of apixaban twice a day, or a daily 40-milligram injection of enoxaparin. The study revealed that 15.1 % of the patients treated with apixaban had a thromboembolism, a nonfatal pulmonary embolism, or died from any cause. 24.4% of patients treated with enoxaparin had at least one of those events. That was significant enough to meet the goals of the study.
 
The companies stated further that apixaban reduced the risk of major venous thromboembolism by half. However, the safety of the two drugs was comparable, as both of them raised levels of a liver enzyme in about 2 % of patients. The results further revealed numerically lower rates of major and clinically relevant non-major bleeding in patients treated with apixaban compared to those treated with the Sanofi drug. However, the reduction in bleeding in apixaban treated patients was not significant.
 
Pfizer and Bristol-Myers stated further that venous thromboembolism affects 40% to 60 % patients who undergo orthopedic surgery, including total knee replacement, but do not receive preventive care. Approximately 400,000 people undergo total knee replacement surgery annually across the world. Consequently, the threat of venous thromboembolism and the risks associated with it represent a growing challenge to doctors.
 
Post-Plavix Outlook
 
Bristol-Myers expects to earn a minimum of $1.95 (excluding special items) in 2013 which should be to be the first full year of impact following the loss of exclusivity of Bristol’s lead drug Plavix in the United States . Sustained growth is projected from 2014. The drug, an antiplatelet blood thinner indicated to reduce the risk of heart attack in patients with atherosclerosis (the build-up of plaque and hardening of the arteries), is co-marketed with Sanofi-Aventis.
 
The forecast for 2013 projects a drop in earnings between approximately 9% and 13% from the anticipated earnings of 2010 because of the loss of exclusivity of the blockbuster drug. The company intends to launch five other compounds – apixaban, belatacept, brivanib, dapagliflozin and ipilimumab – by 2012, subject to them being approved by regulatory authorities. The new launches are expected to drive growth in 2013 and beyond.
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