ELIQUIS® (apixaban), Multiple Data Presentations By Bristol-Myers Squibb and Pfizer.

Bristol-Myers Squibb And Pfizer Announce Data Presentations For Apixaban At European Society of Cardiology Congress 2011

New Data Presentations from Largest Phase 3 Clinical Trial Program for Stroke Prevention in Atrial Fibrillation

Multiple data presentations for ELIQUIS® (apixaban), an oral direct Factor Xa inhibitor being developed by Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE), will be given at the European Society of Cardiology Congress, August 27-31, 2011, in Paris, France.

Globally-conducted registrational studies evaluating ELIQUIS for the prevention of stroke in patients with atrial fibrillation will be presented during the congress. Of note is the first presentation of the comprehensive analysis of ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) during the Hot Line session on Sunday, August 28th.

Presentations on ELIQUIS at the Congress include:

About Atrial Fibrillation

Atrial fibrillation is the most common sustained cardiac arrhythmia. It is estimated that more than 5 million Americans and 6 million individuals in the European Union have AF. The lifetime risk of atrial fibrillation is estimated to be approximately one in four for individuals 40 years of age or older. The underlying threat of atrial fibrillation is the increased risk of stroke, which is five times higher in people with atrial fibrillation than those without atrial fibrillation. In fact, 15 percent of all strokes in the U.S. are attributable to atrial fibrillation.

About ARISTOTLE and AVERROES

The ELIQUIS stroke prevention in atrial fibrillation clinical trial program was designed to comprehensively evaluate ELIQUIS in approximately 24,000 patients with atrial fibrillation requiring stroke prevention, including patients who are expected or demonstrated to be unsuitable for vitamin K antagonist therapy.

ARISTOTLE, a double-blind, multicenter, head-to-head Phase 3 trial, randomized more than 18,000 patients with atrial fibrillation from over 1,000 centers in about 40 countries. Patients were randomized to receive either ELIQUIS 5 mg twice daily (2.5 mg twice daily in selected patients) or dose-adjusted warfarin (titrated to a target INR range of 2.0 to 3.0). The key study outcomes were prespecified in a hierarchical manner that sequentially tested ELIQUIS versus warfarin for noninferiority on the composite endpoint of stroke or systemic embolism; superiority on the composite endpoint of stroke or systemic embolism; superiority on major bleeding; and superiority on all-cause death.

The AVERROES study evaluated ELIQUIS compared to aspirin in 5,599 patients with atrial fibrillation at risk for stroke who were demonstrated or expected to be unsuitable for vitamin K antagonist therapy.

About ELIQUIS

ELIQUIS is the approved trade name for apixaban in Europe and the proposed trade name in the United States. ELIQUIS is not approved in any country for the prevention of stroke in patients with atrial fibrillation. Bristol-Myers Squibb and Pfizer recently announced the first regulatory approval for ELIQUIS in the 27 countries of the European Union (EU) for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. Apixaban is not currently approved in the United States.

ELIQUIS is being investigated within the EXPANSE Clinical Trials Program, which is projected to include nearly 60,000 patients worldwide across multiple indications and patient populations and includes a total of nine completed or ongoing, randomized, double-blind Phase 3 trials, including ARISTOTLE and AVERROES.

In addition to stroke prevention in patients with atrial fibrillation and the prevention of VTE in patients who have undergone total hip or total knee replacement surgery, ELIQUIS is being investigated in Phase 3 trials for the treatment of VTE and the prevention of VTE in hospitalized acutely ill medical patients.

About the Bristol-Myers Squibb/Pfizer Collaboration

In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialize ELIQUIS, an investigational oral anticoagulant discovered by Bristol-Myers Squibb. This global alliance combines Bristol-Myers Squibb’s long-standing strengths in cardiovascular drug development and commercialization with Pfizer’s global scale and expertise in this field.

Via Pfiser

Generic Drug Makers Ready Pay FDA User Fees.

Generic Drug industry is pushing forward an unified plan on proposal to pay user fees to the FDA. These user fees, like the branded drug manufactures pay, will speedup approval of drugs and plant inspections. Generic drugs now take an average of 2½ years to get approval.

In a conversation with WSJ Health Blog, Mylan President Heather Bresch has indicated that the Generic Drug Industry is willing to pay in order to get a level playing filed with brand name drugs.
Talking about the drugs that being imported in to USA (More than half of both generic and Brand Name Drugs are imported from various parts of the world);
“You’re giving those drugs to your children, Don’t you want to know that they were made in safe conditions?  We are ready to put our money where our mouth is,” says Bresch who presides over Mylan which has 18 processing facilities, 11 of them overseas.
Faster approval will help generic drug companies in producing and selling drugs like Pfizer’s Lipitor and Bristol-Myers Squibb and Sanofi-Aventis’s Plavix, whose patents are set to expire this year and next.

WSJ

Onglyza (saxagliptin), New Drug To Treat Type 2 Diabetes, Approved By FDA

For Immediate Release: July 31, 2009

Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Approves New Drug Treatment for Type 2 Diabetes

The U.S. Food and Drug Administration today approved Onglyza (saxagliptin), a once-daily tablet to treat Type 2 diabetes in adults. The medication is intended to be used with diet and exercise to control high blood sugar levels.

The hormone insulin keeps blood sugar (glucose) levels within a narrow range in people who don’t have diabetes. People with Type 2 diabetes are either resistant to insulin or do not produce enough insulin to maintain normal blood sugar levels.

Onglyza is in a class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors which stimulate the pancreas to make more insulin after eating a meal.

“Keeping blood sugar levels in adequate control is essential to the good health of the 24 million people in the United States with Type 2 diabetes,” said Mary Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “High blood sugar levels can cause blurry vision and excessive urination and eventually result in such serious conditions as kidney and eye disease.”

The most common side effects observed with Onglyza are upper respiratory tract infection, urinary tract infection, and headache. Other side effects include allergic-like reactions such as rash and hives.

Approval of Onglyza was primarily based on the results of eight clinical trials. The application seeking FDA approval was submitted before December 2008 when the agency recommended that manufacturers of new diabetes drugs carefully design and evaluate their clinical trials for cardiovascular safety. Although Onglyza was not associated with an increased risk for cardiovascular events in patients who were mainly at low risk for these events, the FDA is requiring a postmarket study that will specifically evaluate cardiovascular safety in a higher risk population.

Onglyza is manufactured by Bristol-Myers Squibb Co. of Princeton, N.J., and marketed by Bristol-Myers and AstraZeneca Pharmaceuticals LP, of Wilmington, Del.

Tags: Onglyza, saxagliptin, Type 2 Diabetes, FDA Approval, dipeptidyl peptidase-4, Bristol-Myers Squibb