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VOL. 123 | NO. 219 | Friday, November 07, 2008

GTx Outlines Drug Pipeline

By Tom Wilemon

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Executives at Memphis-based GTx on Thursday morning explained a promising pipeline of potential drug therapies that are moving closer to FDA approval and attracting investment partnerships from big pharmaceutical companies.

The drug therapies are to prevent prostate cancer, to treat advanced prostate cancer, to abate bone loss in men undergoing treatment for that cancer and to build body mass in people with cancer-induced muscle loss.

GTx has “multiple near-term, revenue-generating opportunities” while advancing its pipeline, said Dr. Mitch Steiner, the company’s chief executive officer.

The executives spoke during a conference call with industry analysts after releasing the company’s third quarter earnings report. GTx, which employs 139 people, had a net loss in earnings of $11.9 million for the quarter compared to a loss of $10.2 million for the same period a year ago.

The company is operating at a loss because its product lines are primarily in the research and development stage. However, it has no debts and $105.3 million in cash investments.

GTx did report $315,000 in net sales revenue from its breast cancer drug, Fareston, compared to sales of $268,000 for the third quarter of 2007. Most of GTx revenue came from collaborations with Ipsen Limited, which invested $1.5 million in its research, and Merck, which invested $1.3 million.

Marc Hanover, the company’s president and chief operating officer, said GTx anticipates receiving more disbursements from the pharmaceutical companies.

GTx is working closely with Merck on a drug for cancer-induced muscle loss called Ostarine that is in its phase two clinical trial.

“The good news is that we’re ahead of everybody else and the other good news is that it’s uncharted territory,” Steiner said.

He drew correlations between this new drug therapy and drug therapies for osteoporosis, noting that both affect large population groups and require the medical community to set baselines for when drug therapy is needed.

GTx is in phase three clinical trial of toremifene 20 milligrams, a drug to prevent prostate cancer, and a higher dosage to abate bones loss in prostate cancer patients. This is a partnership with Ipsen.

Administrative costs for GTx during the third quarter increased to $6.1 million from $3.2 million a year ago.

“The increase in general and administrative expenses was primarily the result of increased personnel, medical education and marketing expenses related to the planned commercialization of our toremifene product candidates,” the company said in its earnings report.

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