GTx has established strategic collaborations that serve to strengthen and deepen our R&D and expedite commercialization of our product candidates. These relationships build upon our expertise in urology and oncology and in the discovery and development of small molecule selective receptor modulators. They provide GTx with the opportunity for near-term revenue while reducing the risks associated with the failure of a particular product development program. Partners also help GTx extend our reach globally and into general and specialty medical fields beyond our own established relationships in urology and oncology.
Current licenses and collaborative relationships include:
GTx Licenses Toremifene European Rights to Ipsen
In September 2006, GTx entered into a partnership with Ipsen to market GTx’s toremifene in Europe. Ipsen is a European pharmaceutical company with 2007 sales exceeding $1.3 billion. Ipsen has a successful prostate cancer-focused sales effort distributing Decapeptyl®, an androgen deprivation therapy drug with 2007 sales exceeding $300 million.
Ipsen has paid to GTx approximately $30 million upfront (based on September 2006 exchange rates) to license commercial rights to toremifene 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 toremifene. Ipsen will pay all clinical development, regulatory and launch expenses to commercialize toremifene in the European territory. Ipsen may pay a portion of GTx’s ongoing toremifene 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 Noninvasive Diagnostic Test for High Grade PIN
The collaborations are focusing on the development of a commercial tissue, blood or urine test that 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 toremifene 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 has developed the first PSA test approved for the detection of prostate cancer.
- 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.
GTx Has Licensed Toremifene and FARESTON® from Orion Pharma
In March 2000, GTx acquired the license and supply rights from Orion to develop and commercialize products containing toremifene. In December 2004, GTx replaced the original contract with an amended and restated license and supply agreement to purchase specified Fareston related assets.