GTx and Ipsen expand partnership on toremifene; Ipsen shareholder sells stake in firm

French drugmaker Ipsen and the USA's GTx have expanded their partnership for the development and commercialization of toremifene 80mg for the reduction of fractures in men with advanced prostate cancer on androgen deprivation therapy (ADT) and toremifene 20mg for the prevention of prostate cancer in high risk patients with High Grade Prostatic Intraepithelial Neoplasia lesions (HGPIN).

Under the terms of the amended collaboration agreement, Ipsen will pay GTx up to 42 million euros (approximately $58 million, based on current exchange rates) in milestone payments on the initiation, enrollment and progression of the second toremifene 80mg Phase III clinical trial. In return, GTx has granted Ipsen:

' The right to co-promote toremifene 80mg in the USS or, in lieu of co-promoting in the US, the right to a double digit royalty stream on net sales of the drug at this dose in the USA;
' An expansion of Ipsen's licensed territory for marketing toremifene products beyond Europe, including Australia and certain countries in North Africa, the Middle East, and Asia (excluding Japan);
' Relief from Ipsen's previous contractual obligations, notably to pay GTx potential remaining milestones related to the European approval of toremifene 80mg;
' Royalties on Ipsen's net sales of toremifene 80mg set at a fixed low teens rate compared to a variable rate previously; and
' A first right of negotiation under certain conditions for rights to GTx-758, currently in Phase II clinical trial for the first-line treatment of men with advanced prostate cancer, in Ipsen's licensed toremifene territories.