PHARMACY

Indevus likely to receive FDA request for more Nebido data

BY Drew Buono

LEXINGTON, Mass. Indevus Pharmaceuticals expects the Food and Drug Administration to request additional safety data on the firm’s testosterone drug Nebido, delaying a ruling on the product’s approval by two years, company officials said. The announcement Wednesday caused Indevus’ stock price to drop by more than 60 percent.

The firm expects the FDA to request more safety information due to the agency’s concern about a side effect of Nebido injections that causes patients to cough, experience shortness of breath and in rare cases become dizzy. Company officials said they expect to file again for approval of Nebido in 18 months, after which it anticipates a six-month review by the FDA.

Indevus initially filed for FDA approval of Nebido in August 2007 and expects the agency to formally rule on that application by June 27, 2008, according to the company.

The company licensed U.S. rights to Nebido from Bayer Schering Pharma in July 2005. The drug is intended to treat male hypogonadism, a condition that causes a decrease in hormone and sperm production.

Indevus, which markets such products as Sanctura for overactive bladder syndrome, reported a 2007 net loss of $103.8 million on revenue of $66.1 million.

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Antibody drug found cost-effective against allergic asthma

BY Alaric DeArment

NEW YORK A review of seven studies has found the antibody drug Xolair to be cost-effective in treating allergic asthma, according to a report published in the journal Allergy.

The report, by University of Washington researcher Sean Sullivan and Dr. F. Turk of Novartis Pharma showed that Xolair, Novartis’ brand name for omalizumab, showed the drug was cost-effective in treating allergic asthma for which common asthma medications were inadequate.

The studies also found some evidence that Xolair may not be as cost-effective in treating other forms of asthma.

Novartis and Genentech market Xolair in the U.S. Genentech reported U.S. sales of $472 million for the drug in 2007, according to Novartis financial data.

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First DataBank settles lawsuit for $1 million

BY Drew Buono

BOSTON First DataBank, a provider of integrated databases of information about medications, has agreed to pay $1 million to settle a lawsuit alleging it conspired with McKesson to manipulate the average wholesale price of drugs.

The case, New England Carpenters Health Benefits Fund vs. First DataBank, filed in 2005, alleges that First DataBank and McKesson “wrongfully increased the so-called wholesale acquisition cost to AWP markup factor applied to numerous prescription pharmaceuticals through a scheme begun in late 2001 and 2002,” which meant that the plaintiffs in the class action lawsuit made “substantial excess payments.”

First DataBank denies any wrongdoing or liability and “has valid and complete defenses to the claims asserted against [it] in the class action,” which it is settling to avoid the expense and inconvenience of further litigation, the settlement says.

The case, filed in the U.S. District Court for the District of Massachusetts, explicitly excludes government entities from joining the class action suit. The San Francisco Health Plan and the state of Connecticut have filed suits with similar charges that McKesson and First DataBank inflated the spread between WAC and AWP from 20 percent to 25 percent, costing state Medicaid and other health programs untold sums.

First DataBank is not named as a defendant in the two new lawsuits. McKesson continues to defend itself in all three cases.

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