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ALAMEDA, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (NASDAQ:EXEL) today appear a accord acceding with Roche to appraise cabozantinib (CABOMETYX®), Exelixis’ baby atom inhibitor of receptor tyrosine kinases, in aggregate with atezolizumab (TECENTRIQ®), Roche’s PD-L1 allowed checkpoint inhibitor, in patients with locally avant-garde or metastatic solid tumors. The analytic program, which will be co-funded by the companies, is accepted to accommodate three appearance 3 cardinal trials in avant-garde non-small corpuscle lung blight (NSCLC), castration-resistant prostate blight (CRPC) and renal corpuscle blight (RCC).
“Encouraging appearance 1 abstracts suggests this aggregate of cabozantinib and atezolizumab may advance outcomes for patients with prostate, lung and branch cancers, and we attending avant-garde to accommodating with Roche to apprentice added in these cardinal trials,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. “This analytic accord is an important added footfall in our committed efforts to aerate the amount of the cabozantinib authorization through these cost-sharing analytic collaborations in added high-impact indications, while architecture amount with new compounds from centralized and alien sources in 2020 and beyond.”
The analytic development accord builds on auspicious action empiric in the appearance 1b COSMIC-021 trial. The balloon is currently enrolling 24 amplification cohorts in 12 bump types including RCC, NSCLC and CRPC.
TECENTRIQ® (atezolizumab) is a registered brand of Genentech, a affiliate of the Roche Group.
About CABOMETYX® (cabozantinib)
In the U.S., CABOMETYX tablets are accustomed for the analysis of patients with avant-garde RCC and for the analysis of patients with hepatocellular blight who accept been ahead advised with sorafenib. CABOMETYX tablets accept additionally accustomed authoritative approvals in the European Union and added countries and regions worldwide.
About Exelixis’ Accord with Ipsen
On February 29, 2016, Exelixis and Ipsen accordingly appear an absolute licensing acceding for the commercialization and added development of cabozantinib break alfresco of the United States, Canada and Japan. On December 21, 2016, this acceding was adapted to accommodate commercialization rights for Ipsen in Canada. Beneath the parties’ accord agreement, if Ipsen opts to participate in allotment these appearance 3 trials, or approaching studies, Ipsen will accept admission to the corresponding abstraction after-effects to abutment abeyant approaching authoritative submissions in their territory.
About Exelixis’ Accord with Takeda
On January 30, 2017, Exelixis and Takeda accordingly appear an absolute licensing acceding for the commercialization and added development of cabozantinib break in Japan. Beneath the parties’ accord agreement, if Takeda opts to participate in allotment these appearance 3 trials, or approaching studies, Takeda will accept admission to the corresponding abstraction after-effects to abutment abeyant approaching authoritative submissions in their territory.
Exelixis holds the absolute rights to advance and commercialize cabozantinib in the United States.
U.S. Important Assurance Advice
Amuse see accompanying abounding Prescribing Advice https://cabometyx.com/downloads/CABOMETYXUSPI.pdf.
Founded in 1994, Exelixis, Inc. (NASDAQ:EXEL) is a commercially successful, oncology-focused biotechnology aggregation that strives to advance the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Following aboriginal assignment in archetypal arrangement genetics, we accustomed a ample biologic analysis and development belvedere that has served as the foundation for our connected efforts to accompany new blight therapies to patients in need. Our analysis efforts accept resulted in four commercially accessible products, CABOMETYX® (cabozantinib), COMETRIQ® (cabozantinib), COTELLIC® (cobimetinib) and MINNEBRO® (esaxerenone), and we accept entered into partnerships with arch biologic companies to accompany these important medicines to patients worldwide. Supported by revenues from our marketed articles and collaborations, we are committed to carefully reinvesting in our business to aerate the abeyant of our pipeline. We are addition our absolute ameliorative assets with targeted business development activities and centralized biologic analysis — all to bear the abutting bearing of Exelixis medicines and advice patients balance stronger and alive longer. Exelixis is a affiliate of the Accepted & Poor’s (S&P) MidCap 400 index, which measures the achievement of assisting mid-sized companies. For added advice about Exelixis, amuse appointment www.exelixis.com, chase @ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.
Exelixis Forward-Looking Statements
This columnist absolution contains advanced statements, including, after limitation, statements accompanying to: Exelixis’ apprehension that the analytic affairs co-funded by Exelixis and Roche will accommodate three appearance 3 cardinal trials evaluating the aggregate of cabozantinib and atezolizumab in NSCLC, CRPC and RCC; the abeyant for the aggregate of cabozantinib and atezolizumab to advance outcomes for patients with prostate, lung and branch cancers; Exelixis’ acceptance that it can aerate the amount of the cabozantinib authorization through these cost-sharing analytic collaborations in added high-impact indications, while architecture amount with new compounds from centralized and alien sources in 2020 and beyond; and Exelixis’ affairs to reinvest in its business to aerate the abeyant of the company’s pipeline, including through targeted business development activities and centralized biologic discovery. Any statements that accredit to expectations, projections or added characterizations of approaching contest or affairs are advanced statements and are based aloft Exelixis’ accepted plans, assumptions, beliefs, expectations, estimates and projections. Advanced statements absorb risks and uncertainties. Actual after-effects and the timing of contest could alter materially from those advancing in the advanced statements as a aftereffect of these risks and uncertainties, which include, after limitation: risks and uncertainties accompanying to authoritative analysis and approval processes and Exelixis’ acquiescence with applicative acknowledged and authoritative requirements; the abeyant abortion of the aggregate of cabozantinib and atezolizumab to authenticate assurance and/or adeptness in COSMIC-021 or in approaching appearance 3 cardinal trials; uncertainties inherent in the artefact development process; the costs of administering analytic trials, including the adeptness or alertness of Exelixis’ accord ally to advance in the assets all-important to complete the trials; Exelixis’ assurance on third-party vendors for the development, accomplish and accumulation of cabozantinib; Exelixis’ adeptness to assure its bookish acreage rights; bazaar competition, including the abeyant for competitors to access approval for all-encompassing versions of CABOMETYX; changes in bread-and-butter and business conditions; and added factors affecting Exelixis and its development programs discussed beneath the explanation “Risk Factors” in Exelixis’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on October 30, 2019, and in Exelixis’ approaching filings with the SEC. All advanced statements in this columnist absolution are based on advice accessible to Exelixis as of the date of this columnist release, and Exelixis undertakes no obligation to amend or alter any advanced statements independent herein.
Exelixis, the Exelixis logo, CABOMETYX, COMETRIQ and COTELLIC are registered U.S. trademarks. MINNEBRO is a Japanese trademark.
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