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Wyeth's Hormones Still Raging


Pharmaceutical Executive

Pharmaceutical ExecutivePharmaceutical Executive-03-07-2007
Volume 0
Issue 0

HRT franchise grows despite lawsuits, new safety fears.

Despite its uncertain legal future, Wyeth's franchise of hormone-replacement therapies (HRT) has achieved blockbuster status. The company's overall pharmaceutical revenue grew nine percent, and officials cited Premarin and its cousin Prempro as key growth drivers.

A Philadelphia jury last month came out against the drug maker, siding with a woman who claimed HRT had caused her to develop breast cancer. The $3 million verdict is Wyeth's second loss in the four cases that have been decided, and the company insisted that it would appeal.

Yet so far the backlash has not put a damper on sales. With HRT still widely prescribed--albeit in lower doses--for severe symptoms of menopause, the Premarin family earned $1.05 billion in 2006 revenue, a 16 percent increase over the previous year. The company has also launched a new marketing campaign for the products, including the Web site, www.knowmenopause.com.

There are currently 5,200 pending HRT cases involving 8,400 women who suffered predominantly from breast cancer, but also from ovarian cancer, stroke, and heart disease. The company is taking a legal strategy similar to Merck's Vioxx team in pledging to fight each suit individually rather than under class-action status.

"We intend to defend the litigation case by case for as long as it takes," chairman and CEO Robert Essner told investors last week. "We are not interested in settling--we do believe we have strong cases." As if to reinforce the point, Essner added that the company has not set aside legal reserves to cover unfavorable verdicts.

Attorneys believe that because each plaintiff has a unique medical history, it's often to a drug company's advantage to address each suit on its own. In addition, judges have dismissed two HRT cases on the basis that labeling questions--whether Wyeth had adequately warned patients--were matters for FDA to decide, and that the company had done what was required of it.

The next trial is scheduled for mid-April. The number of cases has leveled off since the fourth anniversary of the release of the Women's Health Initiative data, which first raised the red flag about cardiovascular and other risks related to HRT. Yet there are clouds on the horizon. In December, researchers reported that breast-cancer rates have dropped 7.2 percent in the two years since women began abandoning HRT.

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