PHARMACY

Merck, Portola release results of mid-stage betrixaban trial

BY Alaric DeArment

ATLANTA An investigational pill reduced bleeding in patients with atrial fibrillation better than a widely available generic, according to results of a mid-stage clinical trial.

Merck & Co. and Portola Pharmaceuticals announced the results of the EXPLORE-Xa, a 508-patients phase 2 trial comparing the drug, betrixaban, with the anticoagulant warfarin. Data were presented at the annual scientific session of the American College of Cardiology in Atlanta.

Researchers found that betrixaban administered once a day reduced the incidence of clinically relevant non-major bleeding episodes better than warfarin when given to patients with non-valvular atrial fibrillation or atrial flutter and at least one risk factor for stroke.

“Given that bleeding can be a significant safety issue for patients who take warfarin, there is a critical unmet need for anticoagulant therapy options,” study coordinator and Jefferson Medical College professor Michael Ezekowitz said.

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PositiveID releases white paper about the health, economic burdens of diabetes

BY Allison Cerra

DELRAY BEACH, Fla. PositiveID has published a white paper that describes the health and economic burden of diabetes on Americans and the U.S. economy, the company said Wednesday.

“Fixing the Black Hole in Diabetes Management” discusses how patient care and overall health improves when there is a high quality of patient-clinician collaboration. Additionally, PositiveID noted that diabetics who follow recommended self-monitoring blood-glucose testing-level guidelines may not share the test results with their healthcare providers — the test results are not being used to improve glycemic control and achieve long-term goals, thus getting lost in a “black hole.”

PositiveID pointed out that the use of such monitoring systems as its iGlucose system, which uses wireless SMS messaging to automatically communicate a diabetic’s glucose levels in real-time, can be beneficial to diabetic patients. Citing a a 2009 study, “Excessive Hospitalizations and Its Associated Economic Burden among People with Diabetes in the United States,” found that in 2005, hospital charges alone and medical costs for individuals with diabetes exceeded $171 billion and $90 billion, respectively.

Scott Silverman, PositiveID chairman and CEO said, “We believe the benefits of the iGlucose system are obvious. It can provide improved health outcomes through real-time disease management, simplifying patients’ lives and enhancing vital communication between patients and their healthcare providers. iGlucose also has the ability to decrease fraud and healthcare costs for providers and insurers by automatically creating compliant patient testing logs, which are required to comply with Medicare Part B reimbursement regulations.”

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Pending court ruling, Teva to delay marketing Temodar generic

BY Alaric DeArment

JERUSALEM Teva Pharmaceutical Industries will start marketing its version of a brain tumor drug only if the Federal Circuit of the U.S. District Court upholds a ruling that declared the branded version’s patent unenforceable, Teva announced Wednesday.

The generic drug maker said it had entered an agreement with Schering, now part of Merck & Co., whereby it will market the drug only if the Federal Circuit upholds the U.S. District Court for the District of Delaware’s January ruling that would allow Teva to market a generic version of Schering’s Temodar (temozolomide). The regulatory approval application for the drug was originally filed by Barr Labs, which Teva acquired in 2008.

The agreement also gives Teva to begin selling its version of the drug in August 2013.

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