Orion has been informed that GTx's toremifene citrate 80 mg meets primary and key endpoints in phase III trial in advanced prostate cancer patients on androgen deprivation therapy (ADT). Results show a 50 percent reduction in incidence of androgen deprivation induced osteoporosis related vertebral fractures and it met other key endpoints, including bone mineral density, lipid profiles, and gynecomastia.
Based on these findings, GTx plans to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) by the summer of 2008. In addition, GTx plans to present the full data set at an upcoming medical meeting.
GTx, headquartered in Memphis, Tenn., is a biopharmaceutical company dedicated to the discovery, development, and commercialization of small molecules that selectively target hormone pathways to treat cancer, osteoporosis and bone loss, muscle wasting and other serious medical conditions.
GTx licensed from Orion Corporation the rights to toremifene citrate for all indications worldwide, except breast cancer outside the United States.
Orion Corporation is dedicated to treating and preventing disease by discovery and developing innovative medicinal treatments. In 2007, Orion Corporation generated sales of EUR 683.6 million, invested EUR 97.6 million in research and development and employed approximately 3,180 people. Orion corporate headquarters are in Espoo, Finland. For more information, please visit: http://www.orion.fi/english/.
Liisa Hurme, Senior Vice President, Proprietary Products, phone +358 10 426 2874
Timo Lappalainen Olli Huotari
President and CEO Senior VP, Corporate Functions
Orionintie 1A, FI-02200 Espoo