NEW YORK (CNNMoney.com) -- Wyeth filed with the FDA an application for an experimental drug that would extend the life of terminally ill kidney cancer patients, the company said Friday.

Wyeth (up $0.74 to $51.64, Charts), based in Madison, N.J., estimates that annual sales of the new drug, Torisel, would peak at $500 million if it is approved by the Food and Drug Administration.

Also on Friday, the company said it filed an application to the European Medicines Agency to market the drug in Europe.

Clinical tests have shown that Torisel prolongs the life of patients with renal cell carcinoma by an average of 3.6 months, or nearly 50 percent, according to Wyeth. The company said that terminally ill patients participating in the trial survived for 10.9 months on Torisel, compared to 7.3 months with those who took interferon, a more traditional form of treatment.

Renal cell carcinoma is the most common type of kidney cancer in adults, according to the National Institutes for Health, with 36,000 new cases every year in the United States and 12,000 deaths.

Prior to receiving the brand name Torisel, the drug went by the scientific name temsirolimus.

Torisel faces a crowded market. Likely competitors include Pfizer, (down $0.28 to $27.71, Charts) maker of the anticancer drug Sutent, and the Swiss drugmaker Novartis (down $0.38 to $57.92, Charts), which is working on a experimental drug to prolong life in kidney cancer patients. Torisel might also compete with Nexavar, a treatment that doubles the survival time of kidney cancer patients and is produced by the German drug giant Bayer Pharmaceuticals (down $1.20 to $50.50, Charts) and Onyx Pharmaceuticals (up $0.03 to $17.49, Charts) of Emeryville, Calif.

In addition, Torisel might face off with Schering-Plough (up $0.00 to $22.10, Charts), the Kenilworth, N.J.-based maker of the interferon Intro A, and the Swiss drug company Roche Holding (down $0.90 to $86.75, Charts), maker of the interferon Roferon-A.

Les Funtleyder, analyst for Miller Tabak, said it's difficult to gauge the impact of these products on the sales potential for Torisel. Torisel might be used in conjunction with these drugs rather than replace them.

Wyeth's Torisel filing to the FDA comes on the heels of the company's analyst day held in New York City on Thursday. At the meeting, the company said it had raised guidance for the full year 2006 to a range of $3.12 to $3.18 diluted earnings per share, from its previously announced guidance of $2.97 to $3.07. The newly announced guidance is an increase of 13 to 16 percent from 2005. The estimate is "pro forma," meaning that it excludes potential restructuring charges as the company carries on with cost-covering efforts, including the closing of plants.

Also at the meeting, Wyeth research head Emilio Emini said he expects annual sales for the blockbuster vaccine Prevnar to peak at $3 billion. The drug, which totaled $1.5 billion in 2005 sales, is used to prevent different types of bacterial infections in children that are responsible for pneumonia, ear infections and other ailments. Emini's projection is contingent on whether the FDA approves the vaccine for additional uses.

Prevnar could face competition from GlaxoSmithKline's (up $0.40 to $54.35, Charts) Streptorix, which is still in testing and not yet on the market. Al Rauch, analyst for AG Edwards, said the possibility of a Streptorix market launch brings uncertainty to Wyeth's sales projection for Prevnar.

"Although [Wyeth] seems confident that GlaxoSmithKline will not have enough time to penetrate the market, we look at the competition with caution as it relates to Wyeth's franchise," wrote Rauch in a note published Friday.

Wyeth is the sixth-largest drugmaker in America, behind Pfizer, Johnson & Johnson (down $0.20 to $64.91, Charts), Abbott Laboratories (down $0.01 to $46.34, Charts), Merck (up $0.49 to $41.91, Charts) and Bristol-Myers Squibb (down $0.13 to $24.39, Charts).

The analysts interviewed for this story do not own shares of company stocks mentioned here, but Wyeth was a client of AG Edwards within the past 12 months.

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