Past Partnerships
Strategic collaborations with other companies have been an important part of both our drug development process, and our growth and development as a biopharmaceutical company. Our collaborations are target-specific. Collaborating with other companies helps us leverage and expand our internal development capabilities, manage our cash expenditures and diversify risk. We expect collaborations to continue to be a strong focus going forward.
SARcode LFA-1 Out-License
In January 2007 Sunesis announced out-license of the company's LFA-1 inhibitor program to SARcode Corporation, a privately held biopharmaceutical company. SARcode intends to use the license to develop small-molecule drugs to treat inflammatory diseases. Sunesis had previously discontinued the LFA-1 inhibitor program, which is outside of the company's strategic focus on discovering and developing novel small-molecule therapeutics to treat cancer.
Sunesis received a license fee and a note convertible into preferred stock while SARcode received Series A funding. Under the terms of the license agreement, SARcode received an exclusive, worldwide license to all Sunesis LFA-1 patents and related know-how. In addition to cash and note payments already received, Sunesis may in the future receive additional license fees and convertible notes, development and marketing milestone payments, and royalties for the commercialization of a licensed compound.
SNS-032 In-License
In April 2005 Sunesis entered into a license agreement with BMS in which we obtained worldwide exclusive and non-exclusive diagnostic and therapeutic licenses, including rights to sublicense, to SNS-032 and any related compounds that are active against CDK-1, -2, -4, -7, and -9 and are covered by licensed intellectual property.
The agreement provides to BMS an upfront payment and milestone payments totaling for beginning Phase 1, Phase 2, and Phase 3 clinical testing, and for filing NDAs and receiving regulatory approval in the United States, Europe, and Japan as well as for achieving certain commercial milestones. The agreement also provides for royalty payments to BMS at rates that are based on total annual net sales.
Biogen Idec Kinase Collaboration
In August 2004, Sunesis entered into a collaboration agreement with Biogen Idec to discover, develop, and commercialize small-molecule inhibitors of Raf kinase and up to five additional targets. The primary focus of the program is to discover small-molecule inhibitors of kinases that play a role in oncology indications or in the regulation of the human immune system.
Sunesis received a significant upfront technology access fee. In addition, Biogen Idec made a significant equity investment in Sunesis. The initial research term is four years, and both parties agreed to dedicate the research personnel provided in the research plan. Biogen Idec will bear all costs related to this program for all targets through at least the completion of Phase 1 clinical trials, after which we have the right to participate in the co-development and co-promotion of product candidates for up to two targets.
Biogen Idec is required to pay Sunesis for Sunesis' personnel dedicated to the collaboration as well as pre-commercialization milestones per target and royalty payments depending on product sales. Royalty payments may be increased if Sunesis exercises the option on co-development and co-promotion rights.
The cornerstone of the Biogen Idec Kinase collaboration is Raf kinase. Raf kinase is an enzyme in the Ras pathway, a signaling pathway important to cell proliferation. The Ras pathway is believed to be abnormally activated in many human cancers by various mechanisms. In approximately 15% of human cancers, a Ras gene is activated by mutation. We believe that several inhibitors of kinases in the Ras pathway have shown evidence of clinical activity in clinical trials.
Sunesis provided Raf kinase inhibitors derived from Tethering® to the collaboration and have jointly with Biogen Idec optimized these molecules to show in vivo efficacy in animal models. Raf kinase is an enzyme in the Ras pathway, a signaling pathway important to cell proliferation. The goal of this program is to develop Raf kinase inhibitors with improved pharmaceutical properties as compared to other Raf kinase inhibitors in development. We expect Biogen Idec to file an IND and commence Phase 1 clinical trials in 2007. We have an option to co-develop and co-promote up to two drugs developed through this program on a worldwide basis.
Additionally, Sunesis is applying Tethering® to discover novel small-molecule leads that inhibit up to five additional oncology kinase targets. Together with Biogen Idec Sunesis is working together on the identification, optimization, and development of inhibitor drugs for these kinases.
Voreloxin In-License
In October 2003, Sunesis entered into a licensing agreement with Dainippon Pharmaceuticals Co., Ltd., now Dainippon Sumitomo Pharmaceuticals, under which we obtained a worldwide exclusive license, including the right to sublicense, to voreloxin and related compounds.
Under the terms of the agreement, Sunesis provides Dainippon with an upfront payment and milestone payments for starting Phase 2 clinical testing, Phase 3 clinical testing, and for filing New drug Applications (NDAs) and receiving regulatory approval in the United States, Europe and Japan for cancer treatment. Upon commercialization, Sunesis will also make royalty payments to Dainippon.
Voreloxin is currently being evaluated as a single agent in a Phase 2 clinical trial (known as the REVEAL-1 trial) in previously untreated elderly Acute myeloid leukemia (AML) patients, in a Phase 1b/2clinical trial combining voreloxin with cytarabine for the treatment of patients with relapsed/refractory AML, and as a single agent in a Phase 2 clinical trial in platinum-resistant ovarian cancer. In clinical trials conducted to date, voreloxin has been generally well tolerated and has shown objective responses in both solid and hematologic tumor types.
Johnson & Johnson Collaboration
In May 2002, Sunesis entered into a collaboration agreement with Johnson & Johnson Pharmaceutical Research & Development to discover, develop, and commercialize small-molecule inhibitors of Cathepsin S, an enzyme that is important in regulating an inflammatory response. In this collaboration, Sunesis applied its proprietary Tethering® technology to discover small-molecule inhibitors of Cathepsin S, an enzyme involved in the activation of T-cells. Both companies believe that small-molecule Cathepsin S inhibitors would have the advantages of a novel mechanism of action, ease of oral administration, and ease of manufacturing.
Under the terms of the agreement, Sunesis received upfront payments, research funding, and research and development milestones, as well as royalty payments based on an exclusive, worldwide license to products resulting from the collaboration.
In December 2002, Sunesis announced it reached its first major milestone in this discovery collaboration—discovering and delivering a novel lead series of compounds to Johnson & Johnson PRD. Based on the initial success of the program, Johnson & Johnson announced that they would also increase its level of research funding support at Sunesis.
Johnson & Johnson PRD holds worldwide rights to commercialize any drugs resulting from this program. The initial research term was two years, and Johnson & Johnson PRD had the option to extend the research term for up to two additional one-year periods with the same level of research funding. Johnson & Johnson PRD exercised both options. The collaboration portion of this agreement ended on December 31, 2005 but Johnson & Johnson is still advancing the program.
Biogen TNF Collaboration
In December 2002 Sunesis entered into our first multi-target collaboration with Biogen, Inc. (now Biogen Idec) to discover and develop small-molecule modulators of up to four members of the TNF trimeric cytokine super-family, plus up to two additional targets for the treatment of inflammatory and autoimmune diseases. The collaboration centered around Sunesis applying its proprietary fragment-based drug discovery technology, Tethering®, to generate small-molecule leads that target select cytokines in the immune system, particularly TNF.
Under an exclusive worldwide license to compounds resulting from these efforts, Biogen had the right to develop, manufacture and commercialize collaboration compounds.
The research phase of this collaboration ended in June 2005, and Biogen is continuing the development of small-molecule inhibitors of one of the additional targets, a cancer target. The primary focus of this program is to discover small-molecule inhibitors of the additional target. Biogen Idec holds worldwide rights to commercialize any drugs resulting from this program. Results of the collaboration regarding TNF were published in the November 11, 2005 issue of Science.
Under the terms of the agreement, Sunesis received an up-front technology access fee, future quarterly payments, a minority equity investment, and a loan over the first 30 months of the collaboration. Sunesis is also eligible to receive significant pre-commercialization milestones, per target, and significant royalty payments based on product sales.
Chiesi Farmaceutici S.p.A.
In October 2001 Sunesis entered into its first research collaboration to discover and develop small molecules that inhibit a well-validated protein target involved in immunological diseases with Chiesi Farmaceutici S.p.A. Using its proprietary discovery technology, Sunesis was to generate development candidates and Chiesi was to have an exclusive option to enter into an exclusive license to develop and market resulting products in certain territories.
Chiesi paid Sunesis an upfront payment as well as research funding. Sunesis was also eligible to receive research and development milestones and royalty payments based on future events and sales. The upfront fee was recognized as revenue over the three-year term of the agreement. This agreement was concluded on December 31, 2002, and Sunesis completed its remaining performance obligations in 2003.
