PHARMACY

Mass. D.A. looking into Vioxx allegations against Merck

BY Drew Buono

WHITEHOUSE STATION, N.J. The U.S. Attorney’s Office for the District of Massachusetts is investigating Merck over the promotion of its painkiller Vioxx, which was pulled from the market in 2004, according to the Wall Street Journal. The investigation is over whether Merck promoted the drug to health care professionals for uses other than those approved for by the Food and Drug Administration.

In February 2007, Merck released in its regulatory filings that the Justice Department issued a subpoena requesting information relating to the company’s research, marketing and sales of Vioxx as part of a federal investigation under criminal statutes.

Merck disclosed in that filing that 31 state attorneys general and the District of Columbia are investigating its sales and marketing of Vioxx. The company said it is cooperating with authorities in all of these investigations.

Merck withdrew Vioxx after a study linked it to increased risk of heart attacks and strokes. The company faced some 27,000 lawsuits from people alleging injuries from the drug. In November, Merck struck a tentative $4.85 billion settlement. The grand-jury investigation comes at a time when thousands of plaintiffs are weighing whether to enroll in the pending settlement.

Justice Department probes into drug marketing have resulted in settlements of $875 million with TAP Pharmaceuticals in 2001 and $355 million with AstraZeneca in 2003. Eli Lilly is negotiating with federal investigators regarding its marketing of antipsychotic drug Zyprexa.

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PHARMACY

Despite solid fourth quarter, Wyeth cautious about 2008

BY Drew Buono

MADISON, N.J. Wyeth released its 2007 fourth-quarter report and it showed that while the company profited in the fourth quarter, the company expects 2008 to be an off year, according to published reports.

Wyeth said net income for the three months that ended Dec. 31 rose to $1.02 billion from $855.4 million. Wyeth’s fourth-quarter sales rose 10 percent to $5.76 billion from $5.22 billion a year earlier. Sales of Effexor rose 3 percent to $968 million.

Wyeth, though, now is facing trouble for 2008, and it comes in the form of generic competition. Generic manufacturers recently began selling copycat versions of Wyeth’s drug Protonix, for heartburn, which is expected to erode sales of Wyeth’s product.

Wyeth said it planned on seeking lost profits and other damages from the generics companies in a patent-infringement trial expected later this year. Protonix had $1.9 billion in sales in 2007. Wyeth also faces potential new generic competition for two other major drugs, the antidepressant Effexor and antibiotic Zosyn.

Sales of Effexor rose 3 percent to $968 million, but those sales might take a hit if Sun Pharmaceuticals launches a tablet version of the extended release version of Effexor in the summer.

Protonix sales rose 10 percent to $461 million. But Wyeth has lost U.S. market exclusivity for the drug after generic drugmakers Teva Pharmaceuticals and Caraco Pharmaceutical Labs—owned by Sun—launched copycat versions, despite the existence of a patent set to expire in 2010. Wyeth this week began selling its own generic Protonix in partnership with Prasco Laboratories.

Wyeth said it now expects 2008 earnings of $3.35 to $3.49 per share, excluding certain items, representing a decrease of 1 to 5 percent from 2007 levels. Analysts had expected 2008 earnings of $3.54 per share. The company also expects to cut its 50,000-employee workforce by 4-to-6 percent during the middle of this year,

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Teva launches generic Protonix

BY Drew Buono

NORTH WALES, Pa. Teva has launched its newest drug, a generic version of the Wyeth acid reflux drug Protonix. The drug is named Pantoprazole Sodium Delayed-Release.

The drug will be available in both strengths of the brand, 20 and 40 mgs in bottles of 90.

“Our customers count on Teva for a continuous supply of new generic products,” stated John Denman, vice president of. Sales and Marketing. “With the launch of pantoprazole sodium delayed-release tablets we add another quality product to our broad line of affordable generic pharmaceuticals.

This launch comes just a day after Wyeth released their own generic version of the drug, in hopes of keeping some of the market share they would have lost due to generic competition. Near the end of this year, Teva and Sun Pharma had received approval to launch a generic version of Protonix.

The drug had sales of $2.5 billion in 2007, according to Wyeth.

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