PHARMACY

Biovail, Alexza develop inhaled mental health treatment

BY Alaric DeArment

MOUNTAIN VIEW, Calif. An inhaled mental health drug could appear on the market in the near future under a collaboration announced Wednesday by Biovail Corp. and Alexza Pharmaceuticals.

Biovail subsidiary Biovail Labs International SRL and Alexza said they would work together to develop and commercialize AZ-004 (loxapine) in the United States and Canada. The drug is based on Alexza’s proprietary Staccato technology and is an inhaled drug designed to treat agitation in patients with bipolar disorder and schizophrenia. Alexza submitted an approval application for the drug to the Food and Drug Administration in December 2009.

Under the terms of the deal, Biovail will pay Alexza $40 million upfront and up to $90 million in milestone payments, if the drug is approved, as well as royalty payments of 10% to 25%.

“We are very excited to be partnering our lead program with Biovail,” Alexza president and CEO Thomas King said in a statement. “Their key strategic focus and their [central nervous system] commercial plans match our view of an ideal partner for AZ-004. We believe that AZ-004, if approved, has the potential to change the treatment practices for acute agitation, as the only product able to meet both the patients’ desire for quickly and comfortably gaining control of their agitation and the clinicians’ goal of rapidly and reliably calming an agitated patient.”

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FDA approves expanded use of Crestor

BY Alaric DeArment

WILMINGTON, Del. The Food and Drug Administration has approved a new use for a cardiovascular drug made by AstraZeneca, the drug maker announced Monday.

The FDA approved Crestor (rosuvastatin calcium) for reducing the risk of stroke, heart attack and surgical restoration of blood flow – known as arterial revascularization – in patients without obvious coronary heart disease but an increased risk of cardiovascular disease based on age, presence of risk factors for cardiovascular disease and quantities of high-sensitivity C-reactive protein in the blood of 2-mg per liter or more. Crestor already had approval for treating other cardiovascular health risks when used along with changes in diet.

“Not only is this approval a significant milestone for AstraZeneca, but it is also important for the patients who could now benefit from Crestor therapy under this approved indication,” AstraZeneca chief medical officer Howard Hutchinson stated.

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CMS: U.S. health spending hits $2.5 trillion as Rx costs reach $246 billion

BY Jim Frederick

WASHINGTON Healthcare spending in the United States climbed 5.7% to $2.5 trillion in 2009, despite the impact of a struggling economy, according to projections issued by the Centers for Medicare and Medicaid Services and published in the journal Health Affairs.

Healthcare expenditures now comprise 17.3% of the nation’s total gross domestic product, CMS estimated. Over the next decade, the agency predicted, health spending will jump at an average rate of 6.1% a year, versus a projected average annual gain of 4.4% for the overall GDP.

With more Americans losing their insurance and Medicaid enrollments rising, public spending for health care will continue to grow faster than health spending in the private sector, the government predicted.

The rise in total health costs was not quite matched by the growth of prescription drug spending, CMS economists estimated. Total prescription drug spending rose a projected 5.2% last year, the agency reported in Health Affairs, to a U.S. total of $246.3 billion.

That marks an accelerating trend for drug spending, according to the journal, which cited “an increase in per person use of drugs, driven by the need for antiviral drugs to treat H1N1, and by higher price growth in brand-name drugs.”

Long-term growth of both overall healthcare expenditures and the prescription drug market will continue at a steady clip, government analysts predict. CMS pegs total drug expenditures at $457.8 billion by 2019, Health Affairs reported, “with spending growth expected to accelerate over the projection period due primarily to increases in drug prices.”

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