GTx has established and will continue to pursue strategic alliances and partnerships with pharmaceutical companies and academic institutions to further the development and commercialization of our products. Current licenses and collaborative relationships include:

 

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GTx, Inc. and Merck & Co., Inc. Enter Global Strategic Collaboration for the Development of SARMs, a Novel Investigational Class of Drugs to Treat Muscle Loss and other Musculoskeletal Conditions

On November 6, 2007, GTx and Merck & Co., Inc. announced an agreement providing for a research and development and global strategic collaboration for selective androgen receptor modulators (SARMs), a new class of drugs with the potential to treat age-related muscle loss (sarcopenia) as well as other musculoskeletal conditions. This collaboration includes GTx's lead SARM candidate, Ostarine™, which is currently being evaluated in a Phase II clinical trial for the treatment of muscle loss in patients with cancer, and establishes a broad SARM collaboration under which GTx and Merck will pool their programs and partner to discover, develop, and commercialize current as well as future SARM molecules.

 

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Ipsen has paid to GTx approximately $30 million upfront (based on current exchange rates) to license commercial rights to ACAPODENE in the European Union, Switzerland, Norway, Iceland, Lichtenstein and the Commonwealth of Independent States (“European Territory”) and to reimburse GTx for certain development costs. GTx may receive from Ipsen up to an additional $50 million in milestone and other payments based on the successful development and European launch of ACAPODENE. Ipsen will pay all clinical development, regulatory and launch expenses to commercialize ACAPODENE in the European Territory. Ipsen may pay a portion of GTx’s ongoing ACAPODENE development costs in the U.S. if certain conditions are met. Ipsen will pay for cost of supply. Ipsen will pay to GTx a royalty based on net sales graduating from the mid teens to the mid twenties. GTx will pay all upstream royalties.

 

GTx is collaborating with leading diagnostic companies to develop a non-invasive diagnostic test for high grade PIN

The collaborations are focusing on the development of a commercial blood or urine test, which could detect high grade PIN in the millions of men who unknowingly harbor this precancerous lesion of the prostate and who are therefore at high risk for developing prostate cancer. GTx is providing clinical samples from its completed Phase IIb clinical trial program, which evaluated ACAPODENE® (toremifene citrate) for the prevention of prostate cancer in men with high grade PIN, a premalignant lesion that has the potential to progress to prostate cancer. The diagnostic labs currently involved in collaborations with GTx are:

• Beckman Coulter
  Beckman Coulter developed the first PSA test approved for the detection of prostate cancer.
• diaDexus
  diaDexus is one of the first companies to recognize the potential of genomics to generate valuable diagnostic tests.
• Onconome
  Onconome is developing diagnostic tests that are many times more sensitive and more accurate than other methods currently used.
• MacroArray Technologies, Inc.
  MacroArray has identified ABCA5 as a tissue and urine diagnostic marker for high grade PIN. MacroArray presented details of its findings at the annual meetings of the American Association of Cancer Research in April 2006 and of the American Society of Clinical Oncologists in June 2006.
• Gen-Probe, Inc.
  Gen-Probe and GTx have formed an exploratory collaboration to test the sensitivity to high grade PIN of Gen-Probe’s research-stage PCA3 diagnostic test.