Current Licenses and Collaborations
License and collaboration arrangements with other companies help us to leverage and expand our internal development capabilities, manage our cash expenditures and diversify risk. Existing significant license and collaboration arrangements that Sunesis is a party to are as follows.
Inlicense Agreement with Dainippon
In October 2003, Sunesis entered into a licensing agreement with Dainippon Pharmaceuticals Co., Ltd., now Sumitomo Dainippon Pharma Co., Ltd. (Sumitomo), under which we obtained a worldwide exclusive license to (and right to sublicense) vosaroxin and related compounds.
Sunesis made an initial upfront payment to Sumitomo and a subsequent milestone payment upon initiation of the VALOR trial, and under the terms of the agreement, may be required to make additional milestone payments for filing New Drug Applications (NDAs) or their foreign equivalents in the U.S., Europe and Japan, and for receiving regulatory approvals in these regions, for cancer-related indications. Upon commercialization, Sunesis is also obliged to make royalty payments to Sumitomo based on total annual net sales.
Licensing and Collaboration Agreements with Biogen Idec and Millennium
OverviewIn August 2004, Sunesis entered into a collaboration agreement with Biogen Idec MA, Inc. to discover, develop and commercialize small molecule inhibitors of the human protein Raf kinase, including family members Raf-1, A-Raf, B-Raf and C-Raf, collectively Raf, and up to five additional targets that play a role in oncology and immunology indications such as BTK and PDK1. In June 2008, the research element of this arrangement was terminated.
In March 2011, the collaboration agreement with Biogen Idec was amended to provide for the discovery, development and commercialization of small molecule BTK inhibitors by Biogen Idec. Under this agreement, we are eligible to receive pre-commercialization, event-based payments related to the development by Biogen Idec of the first two indications for licensed products against the BTK target. We are also eligible to receive royalty payments based on future product sales.
Concurrently, we entered into a license agreement with Millennium, under which we granted Millennium exclusive licenses to products against two oncology targets originally developed under the Biogen Idec agreement: Raf and PDK1, under substantially the same terms as under the Biogen Idec agreement.
Biogen Idec — Inlicense Agreement (BTK)In December 2013, we entered into a second amended to the Biogen Idec collaboration agreement to provide us with an exclusive worldwide license to develop, manufacture and commercialize SNS-062, a BTK inhibitor synthesized under the previous Biogen Idec agreement, solely for oncology indications. Under this second amended agreement, we may be required to make a milestone payment depending on our development of SNS-062 and royalty payments depending on related product sales of SNS-062. All other of our rights under the previous Biogen Idec agreement remained unchanged.
Millennium — Inlicense Agreement (PDK1)In January 2014, we entered into an amended license agreement with Millennium to provide us with an exclusive worldwide license to develop and commercialize preclinical inhibitors of PDK1. In connection with execution of this amended license agreement, we paid an upfront fee and may in the future be required to make pre-commercialization milestone payments depending on our development of PDK1 inhibitors and royalty payments depending on related product sales.
Millennium — Outlicense Agreement (RAF)With respect to the Raf target product rights that were licensed to Millennium in March 2011, we may in the future receive pre-commercialization, event-based payments related to the development by Millennium of the first two indications for each of the licensed products directed against the Raf target and royalty payments depending on related product sales. The agreement also provides us with future co-development and co-promotion rights.
MLN2480 is an oral pan-Raf kinase inhibitor which is being developed by Millennium under this license. In November 2014, Sunesis announced the presentation by Millennium of preclinical and clinical results on MLN2480 at the 26th EORTC-NCI-AACR Symposium. The presentations included data from a Phase 1, multicenter, open-label, dose escalation study designed to evaluate the safety, tolerability and maximum tolerated dose of single agent MLN2480. Based on results from this study, Millennium has initiated a multiarm, open-label Phase 1B Study of MLN2480 in combination with MLN0128, an oral mTORC 1/2 inhibitor; alisertib, an oral aurora A kinase inhibitor; or paclitaxel, in adult patients with advanced nonhematologic malignancies.