MEMPHIS, Tenn.--(BUSINESS WIRE)--GTx, Inc. (Nasdaq: GTXI) today announced that the company and Ipsen have mutually agreed to terminate their collaboration for the development and commercialization of toremifene.
"Ipsen has been an excellent and supportive partner," said Dr. Mitchell S. Steiner, MD, CEO of GTx. "We spent significant time analyzing the business case for toremifene 80 mg and have concluded that the most appropriate course is to terminate our collaboration."
GTx has been developing toremifene 80 mg for the reduction of risk of fractures in men with prostate cancer receiving androgen deprivation therapy. In October 2009, GTx received a Complete Response Letter from the United States Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for toremifene 80 mg notifying the company that the NDA would not be approved in its present form as a result of certain clinical deficiencies.
Since November 2009, GTx has met with FDA several times and has agreement with the agency on the protocol for a single clinical trial which would address the two deficiencies cited in the toremifene 80 mg Complete Response Letter. Current projected costs of this second Phase III clinical trial significantly exceed a threshold amount stipulated in the March 2010 amended collaboration agreement between GTx and Ipsen. Having analyzed the impact of the cost of this second Phase III clinical trial on the business prospects for their collaboration, GTx and Ipsen have mutually agreed to terminate the toremifene partnership.
In exchange for returning to GTx Ipsen's rights under the collaboration agreement, as amended, Ipsen will receive a low single digit royalty on future net sales of toremifene 80 mg in the United States if the product candidate is commercialized.
GTx, Inc., headquartered in Memphis, Tenn., is a biopharmaceutical company dedicated to the discovery, development, and commercialization of small molecules that selectively target hormone pathways for the treatment of cancer and the side effects of anticancer therapy, cancer supportive care, and other serious medical conditions.