PHARMACY

Novartis to acquire Protez in $400 million deal

BY Drew Buono

BASEL, Switzerland Novartis will buy Protez Pharmaceuticals in a deal worth up to $400 million that will strengthen the company’s portfolio of drugs in development for the treatment of hospital infections, according to published reports. According to the Center for Disease Control, hospital acquired infections occur in 1.7 million patients annually and account for 50 percent of all major hospital complications.

Novartis plans to fully acquire Protez for an initial payment of $100 million, with a potential for additional payments of up to $300 million, which are contingent upon success of the acquired company’s lead-drug, named PZ-601.

Novartis said Protez recently started a phase 2 clinical trial involving 100 patients on the drug, which is an antibiotic that promises to work against potentially fatal drug-resistant infections, so-called superbugs. If it passes testing successfully, the drug may enter the market in about five years, analysts say.

PZ-601 is a new antibiotic in a class of agents known as carbapenems. Medicines in this class are useful in treating life-threatening infections caused by Gram-negative and Gram-positive bacteria. PZ-601, which is administered by injection, was shown to have a broad spectrum of activity that could work against multidrug-resistant bacteria including MRSA, or methicillin resistant staphylococcus aureus, strains that are becoming an increasing public health challenge.

Separately, the drug maker gave an update on its emerging vaccines pipeline, saying it has several novel vaccines in early stage development that will be complementing the two meningitis vaccines, Menveo and MenB, that it plans to file for regulatory approval in 2009 and 2010, respectively.

The early-stage products include one for the prevention of Helicobacter pylori infections, a major cause of gastritis that can lead to gastric ulcers and gastric cancer. A second experimental vaccine, against Group B Streptococcus, has the potential to protect against 85 percent of neonatal sepsis and meningitis, Novartis said.

The company plans to open a new research site with up to 250 scientists in Cambridge, Mass., later in 2008 that will focus on viral vaccine discovery.

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PHARMACY

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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PHARMACY

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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