Posted on March - 28 - 2010
Memphis-based GTx strengthen deals with French drugmaker Ipsen
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GTx Inc. and Ipsen have strengthened their partnership in a $58 million deal to push along the bone drug program that failed to get approval from the Food and Drug Administration late last year.
Paris, France-based Ipsen will pay Memphis-based GTx about $58 million in milestone payments upon the initiation, enrollment and progression of a second late-stage trial of the 80 milligram dose of toremifene.
GTx will give Ipsen the right to co-promote the drug in the U.S. instead of a co-promotion deal that would have given the company a double-digit royalty stream on net sales of the drug.
The deal will also give Ipsen marketing territories beyond Europe, including Australia, certain north African countries, the Middle East and Asia, excluding Japan.
Also, Ipsen won’t have to pay GTx remaining payments related to the European approval of the 80 milligram dose of toremifene. Ipsen will also get royalty payments fixed in the low teens instead of previous variable rate.
Ipsen will also get the right to first negotiations for GTx-758, a drug in studies to treat men with advanced prostate cancer, in Ipsen’s toremifene-licensed territories.
“Once the agreement is reached with the FDA on a final study protocol required for marketing approval, we will initiate the second phase III clinical trial later this year with toremifene 80 milligram to reduce fractures in men with prostate cancer on androgen deprivation therapy,” said GTx CEO, Dr. Mitchell S. Steiner.
Toremifene was developed by GTx as a daily tablet to treat the multiple, estrogen-related side effects of hormone treatments in men with prostate cancer. These treatments often increase the risk of bone fractures.
GTx has to show the FDA that 80 milligram toremifene lowers the incidence of new vertebral fractures.
“This new agreement with GTx gives us expanded market reach and rights for toremifene, in what we view as significant unmet medical needs for patients suffering from prostate cancer,” said Stéphane Thiroloix, Ipsen’s executive vice president of corporate development.
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