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FDA Asks Pharmacia for More Data Before It Will Decide on Painkiller

By RACHEL ZIMMERMAN
Staff Reporter of THE WALL STREET JOURNAL
 

Pharmacia Corp. Friday disclosed that the Food and Drug Administration wants more data before ruling on the company's application for a new injectable painkiller, paracoxib sodium.

The FDA's decision, which came in a so-called nonapprovable letter citing deficiencies in the filing, is a setback for Pharmacia, a Peapack, N.J., pharmaceutical concern that is developing the medicine to treat moderate to severe pain primarily for hospital patients after surgery.

Fred Hassan, Pharmacia's chief executive, downplayed the significance of the letter and said the company will supply additional clinical data to the FDA within 12 to 18 months. "These kinds of questions from the FDA are not unusual," Mr. Hassan said in an interview. "We are trying to satisfy the FDA's questions. It means the ball is back in our court."

The product would be the first injectable Cox-2 inhibitor, a class of drugs that in pill form have achieved blockbuster sales as a treatment for arthritis pain. The class includes Pharmacia's Celebrex, which it co-markets with Pfizer Inc. Last year, global sales of Celebrex were $2.6 billion. Pharmacia is counting on the injectable version to expand its franchise in the pain-killing market.

Analysts had projected sales for paracoxib to be about $100 million to $200 million next year. In addition, the drug is viewed as strategically important to the marketing of valdecoxib, Pharmacia's second generation Cox-2 inhibitor, which is being reviewed by the FDA.

"Part of Pharmacia's strategy was to utilize the acute-care injectable [paracoxib] for something like knee surgery and then send the patient home with a vial of valdecoxib," Tony Butler, analyst with Lehman Brothers Inc., told Dow Jones Newswires. The nonapprovable letter could undermine that plan, he said.

Pharmacia, which filed to market the drug last October, wouldn't characterize the nature of the deficiencies in its application or supply a copy of the FDA letter.

The company said it didn't expect delays in the paracoxib application to have a financial impact in 2001. Pharmacia will release second-quarter earnings later this month.

On Friday, shares of Pharmacia ended the regular session at $46.85, up 63 cents, or 1.4%, in 4 p.m. composite trading on the New York Stock Exchange. The shares fell 87 cents to $45.98 in after-hours trading.

-- Beth Mantz contributed to this article.

Write to Rachel Zimmerman at rachel.zimmerman@wsj.com²

URL for this Article:
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Hyperlinks in this Article:
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(2) mailto:rachel.zimmerman@wsj.com
 

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