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VOL. 126 | NO. 42 | Wednesday, March 02, 2011

GTx, Ipsen Terminate Drug Collaboration

By Aisling Maki

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Memphis biopharmaceutical startup GTx Inc. said Wednesday it and French-based pharmaceutical giant Ipsen have mutually agreed to terminate their collaboration for the development and commercialization of toremifene.

The drug is designed to reduce the risk of fractures in the estimated 700,000 men with prostate cancer who undergo androgen deprivation therapy each year.

GTx, at 175 Toyota Plaza, had previously partnered with Merck & Co. on Ostarine, another drug that treats “cancer wasting.” When that collaboration ended, GTx reacquired the rights to Ostarine and the program that makes the drug work, SARM (selective androgen receptor modulator).

One week after ending the Merck partnership last March, GTx confirmed an expansion of its partnership with Ipsen to continue work on toremifene 80 mg.

“Ipsen has been an excellent and supportive partner,” GTx CEO Dr. Mitchell S. Steiner said in a statement. “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.”

In October 2009, GTx received word from the U.S. Food and Drug Administration regarding its New Drug Application for toremifene 80 mg that it would be rejected in its present form as a result of two clinical deficiencies.

GTx has had several meetings with the FDA since 2009, and the company has an agreement with the agency regarding the protocol for a single clinical trial, which would address the deficiencies in the drug.

But projected costs for this second Phase III clinical trial significantly exceeded a threshold amount stipulated in the March 2010 amended collaboration agreement between GTx and Ipsen. After analyzing the impact of the clinical trial cost, GTx and Ipsen decided to terminate the toremifene partnership.

In exchange for returning to its rights to GTx under the collaboration agreement, Ipsen will receive a low single-digit royalty on future net sales of toremifene 80 mg in the United States if the drug goes to market.

Late last month, the company released its latest earnings report, which included a $7.5 million net loss in the fourth quarter, but a $15.3 million profit for the full-year, ended Dec. 31.

Fourth quarter revenue for 2010 included collaboration revenue from a $336,000 partnership with Ipsen and $1.5 million of net sales of Fareston, a drug marketed for the treatment of advanced metastatic breast cancer in postmenopausal women.

Year-end revenue for 2010 included $1.9 million in collaboration revenue from Ipsen and $54.9 million from Merck.

As a result of the termination of a license and collaboration agreement with Merck, GTx recognized as collaboration revenue the remaining $49.9 million of unamortized deferred revenue in Q1 2010, as well as the final payment of $5 million of cost reimbursement for research and development activities that was received from Merck in December.

Full-year revenue for 2010 also included $3.8 million of net sales of Fareston.

GTx focuses on 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.

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