In the lead-up to a new late-stage clinical trial ordered by the FDA, GTx has renegotiated its partnership with France's Ipsen, inking a new deal for the bone loss drug toremifene that will deliver study-related milestones reaching up to $58 million in exchange for broader global marketing rights.
For its part, Ipsen will receive either co-promotion rights in the U.S. or double digit royalties, along with a lengthy list of new countries to add to its European marketing rights. Ipsen is also off the hook for milestones related to a European approval. The $58 million in milestones is tied to the "initiation, enrollment and progression" of the second Phase III clinical trial.
"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 mg to reduce fractures in men with prostate cancer on androgen deprivation therapy," says GTx CEO Mitchell Steiner.
Shares of GTXI tumbled badly last November when the word got out that the FDA was demanding a new Phase III trial. The developer then cancelled bonuses and axed more than a quarter of its workforce.
- check out the GTx press release for more info