GTx and Ipsen Terminate Their Toremifene Collaboration
MEMPHIS, Tenn.--(BUSINESS WIRE)--Mar 2, 2011 - 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.
Forward-Looking Information is Subject to Risk and Uncertainty
This press release contains forward-looking statements based upon GTx's current expectations. Forward-looking statements include, but are not limited to, statements relating to GTx's plans to initiate clinical trials for Ostarine™ (GTx-024) and Capesaris™ (GTx-758) and a potential additional clinical trial for toremifene 80 mg, and statements related to the therapeutic potential of GTx's product candidates. Forward-looking statements involve risks and uncertainties. GTx's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the risks (i) that GTx will not be able to commercialize its product candidates if clinical trials do not demonstrate safety and efficacy in humans; (ii) that GTx may not be able to obtain required regulatory approvals to commercialize its product candidates in a timely manner or at all; (iii) that clinical trials planned to be conducted by GTx may not be initiated or completed on schedule, or at all, or may otherwise be suspended or terminated; (iv) that GTx could utilize its available cash resources sooner than it currently expects and may be unable to raise capital when needed, which would force GTx to delay, reduce or eliminate its product candidate development programs or commercialization efforts. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release. GTx's Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission on November 9, 2010, contains under the heading, "Risk Factors", a more comprehensive description of these and other risks to which GTx is subject. GTx expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
Contact: GTx, Inc.
McDavid Stilwell, 901-523-9700
Director, Corporate Communications & Financial Analysis
Posted: March 2011
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