Our Partners
High Impact Relationships Accelerate Results
In medicine, we know that successful treatment regimens require an understanding of how to develop and deploy the right drug or drug combination at the right time. That’s why Exelixis has a long history of leveraging productive partnerships and collaborations to move our molecules and our business forward. Our model for value creation is built upon a disciplined use of resources and a vast oncology clinical development and commercialization network. Our strategy is enhanced by our history of prolific drug discovery, aptitude for recognizing the missed potential of validated targets and ability to focus on oncology assets that are asymmetrically valued or misunderstood. With a focused, nimble team, we fully commit to our programs and partnerships.
Today, we’re oriented around three types of collaborative relationships:
Maximizing the opportunities for our flagship product, cabozantinib: We have an extensive, long-term pipeline strategy for cabozantinib and are focused on optimizing the molecule through broad clinical development. With the support of our partners at Ipsen Pharma SAS (Ipsen) and Takeda Pharmaceutical Company Ltd. (Takeda), for example, we are able to significantly increase the scope of our clinical development program and ultimately expand the global footprint of cabozantinib. With Bristol-Myers Squibb Company (BMS) and Genentech, Inc. (a member of the Roche Group) (Genentech), we are evaluating cabozantinib’s potential to become the small molecule of choice to combine with leading checkpoint inhibitors (CPIs).
Exelixis discoveries moving forward in the hands of partners: Our history of productive drug discovery includes partnering multiple compounds and programs with leading pharmaceutical and biopharmaceutical companies such as BMS, Daiichi Sankyo Company Limited (Daiichi Sankyo), Genentech, Merck (known as MSD outside of the United States and Canada) and Sanofi. These relationships include opportunities in cancer, inflammation, and cardiovascular and metabolic diseases. As these partnered programs advance, they have the potential to generate revenues that can support our own internal discovery efforts.
Working together to identify the next generation of Exelixis medicines: In addition to conducting our own internal drug discovery activities, we are actively seeking in-licensing or acquisition opportunities to bring promising product candidates or other assets into our pipeline. In January 2018, for example, Exelixis entered into an exclusive licensing agreement with StemSynergy Therapeutics, Inc. (StemSynergy); StemSynergy will work with Exelixis on the discovery and development of novel oncology compounds.
Bristol-Myers Squibb Company
In October 2010, Exelixis entered into a worldwide collaboration with BMS to discover, optimize and characterize ROR modulators that could be subsequently developed and commercialized by BMS. BMS continues to advance the program and in 2017, filed a Clinical Trial Authorization in Europe for the first in-human study of a RORt inverse agonist. Exelixis is eligible for development, regulatory and commercial milestone payments, as well as royalties on commercial net sales, depending on the advancement of the product candidate and eventual product.
In February 2017, Exelixis entered into a clinical collaboration agreement with BMS for the purpose of conducting clinical studies combining CABOMETYX® (cabozantinib) tablets with BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab). As part of this collaboration, Exelixis and BMS initiated CheckMate 9ER, a phase 3 trial evaluating Opdivo in combination with CABOMETYX versus sunitinib in patients with previously untreated, advanced or metastatic renal cell carcinoma (RCC), and CheckMate 040, a phase 1/2 trial evaluating the same combination and also CABOMETYX with both Opdivo and Yervoy versus sorafenib in patients with both previously treated and previously untreated advanced hepatocellular carcinoma (HCC).
Daiichi-Sankyo
In March 2006, Exelixis entered into a collaboration agreement with Daiichi Sankyo for the discovery, development and commercialization of novel therapies targeting the mineralocorticoid receptor. One of the compounds developed during this research collaboration is esaxerenone (CS-3150), an oral, non-steroidal, selective blocker of the mineralocorticoid receptor (MR), which Daiichi Sankyo subsequently took forward. In February 2018, based on the results of a phase 3 trial, Daiichi Sankyo submitted a regulatory application for esaxerenone as a treatment for patients with hypertension to the Japanese Pharmaceutical and Medical Devices Agency. Exelixis is eligible to receive development, regulatory and commercialization milestone payments, as well as royalties on any sales of products commercialized under the collaboration.
Genentech
In December 2006, Exelixis out-licensed cobimetinib, which it discovered internally, to Genentech via a worldwide collaboration agreement. Approved in 2015 for the treatment of a form of advanced melanoma and marketed as COTELLIC®, Exelixis and Genentech share in commercialization costs and ultimately profits/losses from COTELLIC in the United States, where Exelixis also has co-promotion rights. Outside the U.S., Exelixis is eligible to receive and is receiving royalties on COTELLIC sales. In addition, Genentech’s clinical development program currently includes three ongoing phase 3 pivotal trials for the compound, including IMBLAZE 370, evaluating cobimetinib in combination with atezolizumab in third-line colorectal carcinoma patients.
In addition to its cobimetinib partnership, Exelixis is also collaborating with Genentech’s parent company, Roche, on a phase 1b dose escalation study evaluating the safety and tolerability of Exelixis’ other lead compound, cabozantinib, in combination with atezolizumab, Roche’s anti-PD-L1 CPI, in patients with locally advanced or metastatic solid tumors. Enrollment for the trial began in mid-2017, and in early 2018, Exelixis amended the trial’s protocol to allow for four additional cohorts of patients.
Ipsen
In February 2016, Exelixis entered into an exclusive licensing agreement with Ipsen for the commercialization and further development of cabozantinib. Ipsen is now Exelixis’ global partner for cabozantinib in all geographies outside of the United States and Japan. Exelixis has received to date significant development and regulatory milestone payments from this collaboration, and is eligible to receive additional capital from commercial milestones and royalties on net sales of cabozantinib in Ipsen’s territories. Ipsen can opt in to funding additional cabozantinib clinical trials, thereby gaining access to the results to support potential future regulatory submissions in its territories.
Merck
In December 2011 Exelixis granted an exclusive worldwide license to its PI3k-delta program, including XL499 and other related compounds. Merck retains the sole responsibility to research, develop and commercialize compounds from this program, one of which is currently the subject of a phase 1 trial. Exelixis is eligible for payments associated with the successful achievement of development and regulatory milestones for multiple indications of compounds within the PI3k-δ program.
Sanofi
In May 2009, Exelixis entered into an out-license agreement with Sanofi for two internally discovered compounds, SAR24508 (XL765) and SAR24509 (XL765), both of which are inhibitors of phosphoinositide-3-kinase (PI3K) and are available to be taken orally. Both compounds have been evaluated by Sanofi as single agents and in combination regimens within a variety of cancer indications.
StemSynergy Therapeutics
In January 2018, Exelixis entered into an exclusive licensing agreement with StemSynergy for the discovery and development of novel oncology compounds targeting Casein Kinase 1 alpha (CK1α), a component of the Wnt signaling pathway implicated in key oncogenic processes. Exelixis will contribute research and development funding and be solely responsible for commercialization of any products resulting from the collaboration. StemSynergy will be eligible to receive development, regulatory and commercial milestones, as well as royalties on worldwide sales.
