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FDA Approves 2 New Drugs to Treat Glaucoma Patients

March 17, 2001|From Times Wire Services

The Food and Drug Administration approved two new drugs for glaucoma, a leading cause of blindness, for use in patients who aren't helped by existing treatments.

One of the drugs, Travatan, has been shown by one study to be particularly effective in African Americans, who are at special risk for the disease, according to its manufacturer, a unit of Nestle.

Irvine-based Allergan Inc. makes the other drug, Lumigan. The FDA's approval sets up a marketing battle between Lumigan and Pharmacia Corp.'s Xalatan, the No. 1 glaucoma drug. Both drugs are designed to lower pressure inside the eye, the primary symptom of glaucoma.

After the FDA approval was announced, Peapack, N.J.-based Pharmacia said Lumigan violates at least two of its Xalatan patents, and Pharmacia will "vigorously defend" its patent rights.

Allergan said earlier this month that it had filed a lawsuit against Pharmacia seeking a court ruling that Lumigan doesn't infringe on patents held by Pharmacia related to its Xalatan drug.

The lawsuit, filed in U.S. District Court in Delaware, also asked the court to rule that the Pharmacia patents are invalid.

"The availability of multiple medical alternatives provides physicians with additional treatment options for their patients whose glaucoma is difficult to manage," the FDA said in announcing the drug approvals.

Allergan had hoped to win clearance for Lumigan as a first-choice drug. Analysts said it would have been unusual for the FDA to issue such an approval based on the data the company submitted.

Still, Xalatan has similar "second-line" FDA clearance, and Allergan shouldn't have any trouble competing for market share, analysts said.

"We look forward to a horse race in the market, and we are ready to go," Allergan Chief Financial Officer Eric Brandt told Bloomberg News.

Studies presented last year showed that Lumigan, a once-a-day pill, worked better than a commonly used generic glaucoma drug, timolol, that needs to be taken twice a day.

Glaucoma afflicts about 3 million Americans and blinds about 80,000 of them a year. Black Americans are four times more likely than whites to suffer glaucoma, and it typically strikes blacks at younger ages, who go blind faster.

Shares of Allergan fell $2.22 to close at $68, and Pharmacia shares dropped $2.28 to $45.18, both on the New York Stock Exchange.

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