PHARMACY

Roche calls its R&D status ‘uniquely positioned’

BY Alaric DeArment

BASEL, Switzerland Roche leaders appear confident about their company’s research and development position, with several investigational drugs in or about to begin late-stage development, according to remarks made at a recent investor conference.

The Swiss drug maker said in a statement that it was “uniquely positioned” to deliver long-term growth in drugs for treating cancer, autoimmune disorders and psychiatric disorders.

“Our success derives from the diversity of approaches applied by our pharmaceuticals and diagnostics R&D centers, which offer outstanding scientific excellence and an unparalleled breadth and depth of expertise in translational medicine and clinical science,” CEO Severin Schwan said.

Drugs in development include treatments for cancer, autoimmune disorders, psychiatric disorders and diabetes. The company hopes to seek regulatory approval for the Type 2 diabetes treatment taspoglutide in 2011 and plans to present results of five phase 3 trials at an American Diabetes Association conference in June. Phase 3 trials are also underway for pertuzumab, a treatment for breast cancer, and a phase 3 trial will begin this year for RG1678, a schizophrenia drug.

But things haven’t all been rosy. Last Monday, a trial of the drug ocrelizumab in rheumatoid arthritis patients was stopped amid safety concerns, followed Friday by the announcement that the drug Avastin (bevacizumab) failed to extend survival time in men with prostate cancer. A trial of ocrelizumab in patients with multiple sclerosis is ongoing, and Avastin already has approval from the Food and Drug Administration for treating several other cancers.

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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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