Pharmacy News Article

Nov. 10Net losses for GTx Inc. widened in 2009's third quarter on rising administration costs despite reductions to the company's research and development spending.

The Memphis-based pharmaceutical company lost $12.9 million in its fiscal third quarter, up from $11.9 million in losses in the year-ago quarter.

The company spent roughly $8.1 million on research and development in the three months ended Sept. 30, less than the $9.2 million it spent in the same period last year. A company spokesman said the decline was due to a reduction in clinical trials not associated with work on its toremifene 80 milligram dose.

However, administration costs soared 31 percent to $8 million in the quarter, from $6.1 million last year. The spokesman said those costs are up as the company has brought on a "core team we will need to commercialize our late-stage clinical products."

So far, the company has reported losses of $35.4 million nine months into its fiscal year. However, that is slightly better than the $37.9 million the company had reported in losses by the same time last year.

GTx, which employs 150 in Memphis, got bad news last week as the Food and Drug Administration effectively rejected its application for a new drug. The FDA issued the company a complete response letter on its 80 milligram dose of toremifene, a drug to reduce fractures in men with prostate cancer on hormone therapy.

The letter requested more data from the company regarding the drug's safety and effectiveness. GTx CEO Mitchell Steiner said his company has more information that he hoped would answer the FDA's questions. Another clinical trial, he said, could take five years and cost $30 million to $35 million. But Steiner said the letter was not a "game over" response from the FDA.

"We're really trying to get our arms around a path to approval," Steiner said in a conference call Monday.

However, Rodman and Renshaw LLC analyst Simos Simeonidis said the letter is "the end of the line for toremifene 80 milligram."

"We believe that the agency will stick to its decision and require the company to do at least one more major phase III trial, if not two," Simeonidis said.

Toby Sells: 529-2742

GTx Inc.

What: Company developing a pipeline of other drugs, including other dosages of toremifene.

Expenses: $24.7 million for the third quarter

Revenues:$3.6 million

Contact: (901) 523-9700

More: gtxinc.com

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