Form 8-K for GTX INC /DE/
26-Mar-2010
Entry into a Material Definitive Agreement
ITEM 1.01 Entry into a Material Definitive Agreement.
As previously announced, GTx, Inc. ("GTx") and Ipsen Biopharm Limited (successor-in-interest to Ipsen Developments Limited) ("Ipsen") entered into an amendment to that certain Collaboration and License Agreement, made effective as of September 7, 2006, by and between GTx and Ipsen (the "Collaboration Agreement"). The amendment to the Collaboration Agreement (the "First Amendment") was entered into and became effective on March 22, 2010.
Pursuant to the Collaboration Agreement, GTx granted to Ipsen exclusive rights to develop and commercialize toremifene in all indications except the treatment and prevention of breast cancer in the European Union, Switzerland, Norway, Iceland, Lichtenstein, and the Commonwealth of Independent States (collectively, the "European Territory"). Under the terms of the Collaboration Agreement, among other things, GTx was eligible for up to an aggregate of ?39.0 million in milestone payments depending on the successful development and launch of toremifene in certain countries of the European Territory for the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia (the "HGPIN Indication"), subject to certain conditions, and/or the treatment or prevention of the side effects of androgen deprivation therapy in men with prostate cancer (the "ADT Indication"). Under the Collaboration Agreement, Ipsen also agreed to pay GTx a royalty equal to a graduating percentage of aggregate net sales of products containing toremifene, with such rates dependent on whether such sales are for the HGPIN Indication or the ADT Indication.
Under the terms of the First Amendment, Ipsen agreed to pay to GTx up to ?42.0 million in clinical development milestone payments for the purpose of conducting a second pivotal Phase III clinical trial evaluating toremifene 80 mg to reduce fractures in men with prostate cancer on ADT, which trial will be designed to address the deficiencies identified by the FDA in the October 2009 Complete Response Letter GTx received from the FDA regarding its new drug application ("NDA") for toremifene 80 mg (such milestones, the "Development Milestone Payments"). Ipsen agreed to pay the Development Milestone Payments upon the completion of specific clinical development milestones throughout the course of such second pivotal Phase III clinical trial. Although Ipsen has agreed to make the Development Milestone Payments, if the projected cost of such second pivotal Phase III clinical trial of toremifene 80 mg exceeds ?42.0 million by a certain amount, GTx and Ipsen may determine not to initiate the trial, in which event, Ipsen would not be obligated to provide any of the Development Milestone Payments. In any event, any costs in excess of ?42.0 million related to such second pivotal Phase III clinical trial would be borne by GTx. In addition, if the FDA rejects GTx's proposed protocol for a second pivotal Phase III clinical trial and imposes additional requirements that GTx and Ipsen believe to be too burdensome and costly, GTx and Ipsen may determine not to pursue any additional clinical trials for toremifene 80 mg and to cease further development of the product candidate.
In exchange for the Development Milestone Payments, GTx released Ipsen of its obligation under the Collaboration Agreement to make certain potential milestone payments totaling ?18.0 million related to European regulatory approval of toremifene 80 mg and pricing approvals. In addition, the territory in which Ipsen has the right to develop and commercialize toremifene was expanded under the First Amendment to include, in addition to the European Territory, Australia and certain countries in North Africa, the
Middle East and Asia (excluding Japan) (collectively, the "Ipsen Territory"). Ipsen was also granted the right under the First Amendment to co-promote toremifene 80 mg for the ADT Indication in the United States based on a co-promotion agreement to be executed between the parties or, at Ipsen's election, in lieu of co-promotion, to receive a double digit royalty from GTx on U.S. net sales of toremifene 80 mg for the ADT Indication which declines as net sales increase beyond an established base. If Ipsen elects to retain its rights to the HGPIN Indication under the Collaboration Agreement, Ipsen may exercise its right under the First Amendment to be released from its obligation to pay up to ?20.0 million in aggregate milestone payments and its share of development and clinical trial expenses for the HGPIN Indication in exchange for a reduction in the royalty payable by GTx on U.S. net sales of toremifene 80 mg for the ADT Indication. Additionally, Ipsen's royalty obligation on net sales of toremifene 80 mg for the ADT Indication in the Ipsen Territory was reduced to a fixed low-teens rate (12%) under the First Amendment (versus the graduating royalty provided for under the original terms of the Collaboration Agreement). Finally, GTx granted to Ipsen a first right of negotiation under the First Amendment, subject to certain conditions, with respect to development, marketing, sale and distribution in the Ipsen Territory of GTx-758. The First Amendment will expire or terminate upon the expiration or termination of the Collaboration Agreement, unless earlier terminated by the parties.
The foregoing is only a brief description of certain of the terms of the Collaboration Agreement and the First Amendment, does not purport to be complete and is qualified in its entirety by reference to the Collaboration Agreement that was filed as Exhibit 10.37 to GTx's quarterly report on Form 10-Q for the quarter ended September 30, 2006, and the First Amendment that will be filed as an exhibit to GTx's quarterly report on Form 10-Q for the quarter ending March 31, 2010.
This current report on Form 8-K contains forward-looking statements [snip] |
