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FDA Wants More Data From Barr

The company receives conditional approval for Seasonique, a contraceptive.

Barr Pharmaceuticals


said the Food and Drug Administration wants more information on an experimental oral contraceptive that reduces the number of periods in a woman's menstrual cycle to four from 13 per year.

Barr received conditional approval from the FDA for Seasonique, known as an extended-cycle oral contraceptive. Bruce L. Downey, the chairman and CEO, said Thursday in a prepared statement that Barr wants to meet with the FDA within 30 days to discuss how it "might satisfy FDA's request for additional information."

Barr has several ongoing studies for Seasonique, but if the FDA requires more testing, the product's launch could be pushed back by a year. If the FDA had approved the drug, analysts thought it could have been available this fall.

The news pushed Barr's stock down 10 cents to $46.42 in early afternoon trading.

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Deborah A. Knobelman, of Piper Jaffray, calls the FDA decision a "modest negative," adding in a Thursday research report that "we did not perceive this drug as critical to Barr's future revenues."

Knobelman still expects Seasonique to be launched during the company's current fiscal year, which ends June 30, 2006, but she adds that a worst-case scenario of a 12-month delay would cut 4 cents from her fiscal 2006 earnings-per-share estimate of $2.87. She has an outperform rating on the stock. She doesn't own shares, and her firm is a market maker in the stock.

Seasonique represents a next-generation version of Barr's oral contraceptives that reduce the number of periods. Barr's first entry, Seasonale, has been on the market since November 2003. Barr says more than 1 million Seasonale prescriptions have been written.

Seasonale contributed $24 million in sales for Barr's third quarter, which ended March 31. Total sales for the quarter were $265 million.

Barr's biggest specialty is women's health care. During the third quarter, it sold $94 million in generic oral contraceptives, or about half of its generic-product sales. Total brand-name sales, including Seasonale, accounted for $72 million of third-quarter revenue.

The Seasonale treatment requires women to take a combination pill of the drugs levonorgestrel and ethinyl estradiol for 84 days, then take a placebo for 7 days. The Seasonique treatment requires 84 days of the combination pill, then an ethinyl estradiol pill for seven days.

Barr also is seeking FDA approval for a lower-dose version of Seasonale called Seasonale Lo.