Kite Pharma, Inc. (NASDAQ:KITE) Files An 8-K Entry into a Material Definitive AgreementItem 1.01. Entry into a Material Definitive Agreement
On January 5, 2017, Kite Pharma EU B.V. (“Kite”), a wholly owned indirect subsidiary of Kite Pharma, Inc., entered into a Collaboration and License Agreement (the “Agreement”) with Daiichi Sankyo Company, Limited (“DS”) to which Kite has granted to DS an exclusive license to develop and commercialize axicabtagene ciloleucel, also known as KTE-C19, in Japan. Axicabtagene ciloleucel, Kite’s lead product candidate, is an investigational therapy in which a patient’s T cells are engineered to express a chimeric antigen receptor (“CAR”) to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias, and redirect the T cells to kill cancer cells.
In addition, under the Agreement, DS has a certain period of time to exclusively license, at its option, additional Kite product candidates in Japan, including KITE-718, Kite’s T cell receptor (“TCR”) product candidate targeting MAGE-A3/A6 and certain other product candidates that proceed to an U.S. investigational new drug application filing over the next three years. If the parties agree to include a licensed product in Japan in a global development program, then DS will be responsible for the associated incremental costs. Under the Agreement, Kite will provide certain technology transfer services relating to the licensed products to DS.
In connection with the execution of the Agreement, DS will make an upfront payment to Kite of $50 million. Kite will be eligible to receive future payments totaling up to $200 million for development and commercial milestones relating to axicabtagene ciloleucel. In addition, for each additional product candidate for which DS exercises its option to acquire an exclusive license, the option exercise and milestone payments to Kite could equal up to $200 million. Kite is also entitled to receive tiered royalties in the low to mid double digit range on DS’s sales of licensed products for the term of the Agreement, subject to certain reductions.
The term of the Agreement will continue on a licensed product-by-licensed product basis until DS permanently ceases at its sole discretion all development, manufacture and commercialization of such licensed product in Japan. Either party may also terminate the agreement with written notice upon material breach by the other party, if such breach has not been cured within a defined period of receiving such notice, or in the event of the other party’s bankruptcy. Kite may terminate the Agreement if DS challenges certain of Kite’s patents. DS may terminate the Agreement with respect to a licensed product if Kite later acquires additional necessary intellectual property for such licensed product, and a license or sublicense to such intellectual property is not available to DS on terms that DS deems to be commercially reasonable.
Contemporaneously with execution of the Agreement, Kite Pharma, Inc. and DS executed a guarantee agreement to which Kite Pharma, Inc. guarantees Kite’s performance under the Agreement.
The foregoing description of the Agreement is only a summary and is qualified in its entirety by reference to the Agreement. Kite intends to file a copy of the Agreement as an exhibit to its Quarterly Report on Form 10-Q for its fiscal quarter ending March 31, 2017, portions of which will be subject to a FOIA Confidential Treatment Request to the Securities and Exchange Commission to Rule 24b-2 under the Securities Exchange Act of 1934, as amended, for certain portions of the Agreement. The omitted material will be included in the request for confidential treatment.
About Kite Pharma, Inc. (NASDAQ:KITE)
Kite Pharma, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on the development and commercialization of cancer immunotherapy products to eradicate cancer cells. The Company offers engineered autologous cell therapy (eACT), which is an approach to the treatment of cancer. It is conducting over four pivotal studies of its lead product candidate, KTE-C19, a CAR-based therapy. It is conducting a Phase II clinical trial (ZUMA-1) of KTE-C19 in patients with refractory diffuse large B cell lymphoma (DLBCL), including primary mediastinal B cell lymphoma (PMBCL) and transformed follicular lymphoma (TFL). It is also conducting a Phase II clinical trial (ZUMA-2) of KTE-C19 in patients with relapsed/refractory mantle cell lymphoma (MCL), a Phase I-II clinical trial (ZUMA-3) of KTE-C19 in adult patients with relapsed/refractory acute lymphoblastic leukemia (ALL), and a Phase I-II clinical trial (ZUMA-4) of KTE-C19 in pediatric patients with relapsed/refractory ALL. Kite Pharma, Inc. (NASDAQ:KITE) Recent Trading Information
Kite Pharma, Inc. (NASDAQ:KITE) closed its last trading session up +0.75 at 51.99 with 789,142 shares trading hands.