Toremifene 80mg is used for the reduction of fractures in men with advanced prostate cancer on androgen deprivation therapy (ADT) and Toremifene 20mg is indicated for the prevention of prostate cancer in high risk patients with High Grade Prostatic Intraepithelial Neoplasia lesions (HGPIN).
As per the terms of the amended collaboration agreement, Ipsen is expected to pay GTx up to EUR42m in milestone payments upon 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 US or, in lieu of co-promoting in the US, the right to a double digit royalty stream on net sales of Toremifene 80mg in the US.
GTx has also granted 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) and has relief Ipsen from its previous contractual obligations, notably to pay GTx potential remaining milestones related to the European approval of toremifene 80mg.
Mitchell Steiner, CEO of Gtx, said: “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 80mg to reduce fractures in men with prostate cancer on androgen deprivation therapy. We are excited to expand our toremifene clinical and commercial partnership with Ipsen.”
Stephane Thiroloix, executive vice president of corporate development at Ipsen said: “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. It will strengthen Ipsen’s franchise in hormone-dependent cancers and broaden our drug range in the oncology area.”