GTx, Ipsen deal

GTx and Ipsen terminated a 2006 deal to develop and commercialize GTx's toremifene 80 mg to reduce the risk of fractures in men with prostate cancer receiving androgen deprivation therapy. GTx said the projected costs of an additional Phase III trial requested by FDA in a 2009 complete response letter significantly exceed the amount stipulated under the deal. Ipsen had agreed to pay GTx up to €42 million ($58 million) in milestones to conduct the additional trial. As part of the termination, Ipsen is eligible for low single-digit royalties if toremifene 80 mg is commercialized in the U.S., but GTx said it does not plan to further invest in the program. Ipsen also lost its first right of negotiation to Capesaris. Capesaris is an oral selective estrogen receptor alpha agonist in Phase II testing for the first-line treatment of men with advanced prostate cancer (see BioCentury, Nov. 9, 2009).

Under the deal, which was expanded last year, Ipsen had rights to develop and commercialize the product in Europe, as well as exclusive rights to commercialize it in Australia and certain countries in North Africa, the Middle East and Asia, excluding Japan. GTx has worldwide rights to toremifene for indications other than breast cancer, to which it has U.S. rights only, from Orion Corp. (HSE:ORNAV; HSE:ORNBV, Espoo, Finland). GTx markets toremifene 60 mg as Fareston in the U.S. for breast cancer (see BioCentury, March 29, 2010). ...