�Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc (NYSE: PFE) provided an update on the apixaban clinical development program today. The companies announced that new Phase II information in piercing coronary syndrome patients (ACS) will be presented at the forthcoming meeting of the European Society of Cardiology (ESC). In addition, Bristol-Myers Squibb and Pfizer reported that an early evaluation of results from a Phase III subject field of apixaban for the prevention of venous thromboembolism (VTE) in patients undergoing total knee replacement indicates that the primary terminus of this study was not met.
The Phase III VTE prevention written report known as ADVANCE-1 compared apixaban, a novel, oral Factor Xa inhibitor granted at a dose of 2.5 mg, twice daily, to the FDA-approved dose of enoxaparin, 30 mg tending twice everyday. The primary efficacy result was a composite of symptomatic or asymptomatic deep vein thrombosis, pulmonary embolism, and destruction by whatsoever cause. The rate of the primary efficacy termination on apixaban was numerically similar to that ascertained with enoxaparin (9.0% vs. 8.9%, p=.064), simply did non meet the pre-specified statistical criteria for non-inferiority compared to enoxaparin. The factual enoxaparin VTE rate of 8.9 percent was lower than the expected VTE rate of 16 percent seen in late similar clinical trials, resulting in an inability to demonstrate non-inferiority.
In ADVANCE-1, there were no unexpected findings in adverse events for apixaban compared to enoxaparin. The major hemorrhage event pace for apixaban was numerically lower, but was not significantly lour, than enoxaparin (0.7% vs. 1.4%, p=.053). The composite rate of clinically relevant non-major bleeding and major haemorrhage was significantly less in patients wHO received apixaban than those who received enoxaparin (2.9% vs. 4.3%, p =.034).
Full results of the ADVANCE-1 trial have been submitted to the American Society of Hematology Meeting (ASH) for presentation in December.
ADVANCE-1 results confirm the characteristics of apixaban as reported antecedently in phase angle II studies. The companies are considering further studies with different protocols in preventing VTE in knee surgery and will non submit the U.S. filing for VTE prevention in the 2nd half of 2009, as previously communicated. The results of ADVANCE -1 do not demand any changes in protocols of whatever other on-going apixaban studies. Programs directed towards prevention of VTE including EMEA registrational studies, treatment of VTE, and in the prevention of stroke in atrial fibrillation continue as planned.
"Bristol-Myers Squibb and Pfizer stay enthusiastic and committed to the clinical development programme for apixaban," said Jack Lawrence, vice president, Research and Development, Bristol-Myers Squibb. "Bristol-Myers Squibb and Pfizer anticipate that the results of APPRAISE-1 being presented at ESC will provide important penetration into the potential use of apixaban for the secondary prevention of cardiovascular events in patients with acute coronary thrombosis syndrome, which affects an estimated 2.7 gazillion people around the mankind every year."
About the Apixaban Clinical Program
Apixaban, an oral, factor Xa inhibitor in a new class of agents that have shown therapeutic potential to foreclose and treat blood clots, is presently being explored in the EXPANSE clinical trial programme which includes eight Phase III clinical studies involving approximately 45,000 patients worldwide. The ADVANCE-2 and 3 trials are investigating the safety and efficacy of apixaban 2.5 mg double daily compared to enoxaparin 40 mg once casual in patients undergoing major orthopedic surgery. The ADOPT study is investigating apixaban for one month compared to standard of attention (enoxaparin 40 mg one time daily for at least 6 years followed by placebo) for the prevention of VTE in hospitalized patients wHO are medically ill and at risk of VTE.
Apixaban is also in Phase III trials studying the bar of cVA and other thromboembolic events in patients with atrial fibrillation (AF). The AF program consists of two trials. The ARISTOTLE trial is investigating apixaban compared to coumadin in or so 15,000 patients with atrial fibrillation. The AVERROES trial is investigating apixaban compared to aspirin in approximately 5,600 patients with atrial fibrillation world Health Organization are ineligible for vitamin K antagonists (VKA) treatment or haven't tolerated previous VKA discourse.
The VTE treatment program consists of two trials. The AMPLIFY trial is a 6-month trial investigating apixaban compared to enoxaparin plus coumadin in roughly 4,800 patients with acute DVT or PE. The AMPLIFY-EXT trial is a 12-month trial investigating apixaban compared to placebo for extended treatment to prevent perennial VTE in approximately 2,400 patients who let completed 6 to 12 months of treatment for DVT or PE.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to extend and enhance human lifetime. For more information confab http://www.bms.com.
About Pfizer
Founded in 1849, Pfizer is the world's largest research-based pharmaceutic company. Pfizer is taking new approaches to advancing better health as it discovers, develops, manufactures and delivers quality, safe and effective prescription medicines to treat and help prevent disease for both hoi polloi and animals. For more information natter http://www.pfizer.com.
Bristol-Myers Squibb Forward-Looking Statement
This urge on release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialisation of products. Such innovative statements ar based on current expectations and involve inherent risks and uncertainties, including factors that could delay, deviate or change any of them, and could cause actual outcomes and results to disagree materially from current expectations. No advanced statement bum be guaranteed. Among other risks, there can be no warrant that the clinical trials described in this release will support a regulative filing or that the product will receive regulative approval. There can be no assurance that if approved, the product described in this release testament be commercially successful. Forward-looking statements in the press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's line, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year concluded December 31, 2007, its Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update whatever forward-looking statement, whether as a upshot of unexampled information, next events, or otherwise.
Pfizer Forward-Looking Statement
The information contained in this release is as of August 26, 2008. Pfizer assumes no obligation to update forward-looking statements contained in this tone ending as the result of new info or succeeding events or developments.
This release contains forward-looking info about a product prospect, apixaban, including its potential difference benefits that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; decisions by regulatory government regarding whether and when to okay any drug applications that may be filed for such ware candidate as well as their decisions regarding labeling and other matters that could affect its accessibility or commercial potential; and competitive developments.
A further description of risks and uncertainties can buoy be institute in Pfizer's Annual Report on Form 10-K for the fiscal year concluded December 31, 2007 and in its reports on Form 10-Q and Form 8-K.
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