Editing Exelixis (section)

==History==

Exelixis was founded in 1994; the scientific founders were Spyridon Artavanis–Tsakonas, at Yale at that time, and Corey Goodman and [[Gerald M. Rubin|Gerry Rubin]] who were then at the University of California, Berkeley.<ref name=2005profile/>  [[George Scangos]] joined the company as CEO in 1996.<ref name=XconomyScangosGoes>{{cite news|last1=McBride|first1=Ryan|title=Reports: Biogen Picks Exelixis Chief George Scangos as New CEO |url=http://www.xconomy.com/boston/2010/06/30/reports-biogen-picks-exelixis-chief-george-scangos-as-new-ceo/|work=Xconomy|date=30 June 2010}}</ref>  The business plan was to use [[model organisms]] (fruit flies, nematodes, and zebrafish) and [[functional genomics]] to identify pathways and [[biological target]]s that could be exploited in the fields of agriculture and medicine. It eventually set up a subsidiary, Exelixis Plant Sciences, for the agricultural work.<ref name=2005profile/>

By 2000 it had left the radical exploratory phase behind and became focused on [[drug discovery]] and had a [[chemical library]] of 4 million compounds.<ref name=2005profile>{{cite journal|last1=McCarthy|first1=Alice A.|title=Exelixis: Integrated Drug-Discovery and Development Platform for Human Therapeutics|journal=Chemistry & Biology|date=April 2005|volume=12|issue=4|pages=407–408|doi=10.1016/j.chembiol.2005.04.004|pmid=15850973|url=http://www.cell.com/cell-chemical-biology/pdf/S1074-5521(05)00097-9.pdf|doi-access=free}}</ref>   The company went public that year, after withdrawing its offering the week before; it raised $118 million in a down market.<ref>{{cite news|title=Exelixis IPO defies ill-tempered market|url=http://www.marketwatch.com/story/exelixis-ipo-defies-ill-tempered-market|url-status=dead|archive-url=https://web.archive.org/web/20151126052836/https://www.marketwatch.com/story/exelixis-ipo-defies-ill-tempered-market|archive-date=2015-11-26|work=MarketWatch|date=Apr 11, 2000}}</ref>

In 2002 the company signed a broad alliance with [[GlaxoSmithKline|GSK]] to discover new drugs in the fields of cancer, inflammatory diseases, and vascular conditions; GSK paid it $30 million in cash, bought $14 million in stock at twice the market rate, and committed to providing Exelixis with $90 million in research funding; it also offered loan financing of up to $85 million.<ref>{{cite news|last1=Pollack|first1=Andrew|title=Glaxo Forms An Alliance In Biotech|url=https://www.nytimes.com/2002/10/29/business/glaxo-forms-an-alliance-in-biotech.html?rref=collection%2Ftimestopic%2FExelixis%20Inc.|work=The New York Times|date=29 October 2002}}</ref>

By 2002 the company had limited its internal efforts to cancer, and had settled its strategy on discovering and developing drugs that could inhibit targeted small sets of [[tyrosine kinase]]s that are needed for cancer formation, growth, and metastasis.  The sets of TKs had been identified by means of its prior functional genomics work.  This approach was controversial at the time; most companies try to selectively target just one protein in their discovery efforts.<ref name=2005profile/>

In 2006 Exelixis partnered with [[Daiichi Sankyo]] on compounds that targeted [[mineralocorticoid receptor]]s; [[esaxerenone]] was part of this collaboration.<ref>{{cite news|title=Press release: Daiichi Sankyo Initiates Phase 3 study of CS-3150, a Novel Mineralocorticoid Receptor Antagonist for Treatment of Essential Hypertension |url=http://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/006512.html|work=Daiichi Sankyo|date=September 27, 2016|language=en}}</ref>  In 2007, the company partnered its [[MEK inhibitor]] program with [[Genentech]]; [[cobimetinib]] (at that time XL-518) was part of this collaboration.  Exelixis had filed an IND on XL-518 prior to the partnership, committed to funding and running the Phase I trial, and retained rights to co-market it in the US.<ref>{{cite news|title=Exelixis, Genentech Enter Onco-Development Pact|url=http://www.contractpharma.com/contents/view_breaking-news/2007-01-03/exelixis-genentech-enter-onco-development-pact/|work=Contract Pharma|date=January 3, 2007}}</ref>

In 2008 the company partnered its lead cancer drug candidate, XL-184 (which would become called [[cabozantinib]]) and another cancer candidate, XL-281, with [[Bristol Myers Squibb]]; BMS returned the rights to XL-184 to Exelixis in 2010 and returned the rights to other drug candidate in 2011.<ref>{{cite news|last1=Leuty|first1=Ron|title=Exelixis falls as BMS returns cancer drug|url=https://www.bizjournals.com/sanfrancisco/stories/2010/06/21/daily6.html|work=San Francisco Business Times|date=June 21, 2010}}</ref><ref>{{cite news|last1=Leuty|first1=Ron|title=Bristol-Myers Squibb returns rights to Exelixis cancer drug|url=https://www.bizjournals.com/sanfrancisco/blog/biotech/2011/07/exelixis-bristol-myers-squibb-cancer.html|work=San Francisco Business Times|date=July 14, 2011}}</ref>

In 2010 Scangos departed as CEO to take over at [[Biogen]]<ref name=XconomyScangosGoes/> and the company appointed Michael M. Morrissey as president and CEO; Morrissey had joined the company in 2000 as Vice President of Discovery Research.<ref>{{cite news|title=Press release: Exelixis Inc Announces Appointment of New CEO Michael Morrissey|url=http://www.biospace.com/News/exelixis-inc-announces-appointment-of-new-ceo/185972|work=Exelixis via Biospace|date=June 30, 2010}}</ref> At that time the company had eight drugs in clinical trials.<ref>{{cite news|last1=Herper|first1=Matthew|title=Biotech's Comeback Kid|url=https://www.forbes.com/sites/matthewherper/2012/12/04/biogen-idec-biotechs-comeback-kid/print/|work=Forbes|date=December 4, 2012|language=en}}</ref>

Exelixis' first drug approval came in 2012, when cabozantinib was approved for [[medullary thyroid cancer]], an [[orphan drug|orphan indication]].<ref name=FDA2012>{{cite web |url=https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm330143.htm |title=Press release: FDA approves Cometriq to treat rare type of thyroid cancer |date= 29 November 2012|publisher=FDA|archiveurl=https://web.archive.org/web/20140707053649/https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm330213.htm|archivedate=July 7, 2014}}</ref>  It was approved in Europe in 2014.<ref>{{cite web|title=Cometriq Summary|url=http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002640/human_med_001726.jsp&mid=WC0b01ac058001d124|publisher=EMA|accessdate=8 August 2017|language=en|archive-date=20 June 2018|archive-url=https://web.archive.org/web/20180620164643/http://www.ema.europa.eu/ema//index.jsp?curl=pages/medicines/human/medicines/002640/human_med_001726.jsp&mid=WC0b01ac058001d124|url-status=dead}}</ref> 

Exelixis invested heavily in exploring cabozantinib in other cancers, betting the future of the company on the drug.  In 2014 the drug failed a Phase III trial in prostate cancer, and the company laid off 70% of its employees.<ref>{{cite news|last1=Lash|first1=Alex|title=At Exelixis, Morrissey Dreams Of Getting the Band Back Together|url=http://www.xconomy.com/san-francisco/2015/06/01/at-exelixis-morrissey-dreams-of-getting-the-band-back-together/#|work=Xconomy|date=1 June 2015}}</ref>

In 2015 Genentech and Exelixis won FDA approval for cobimetinib for certain forms of melanoma.<ref>{{cite news|last1=Leuty|first1=Ron|title=Big new-drug win for skin cancer patients, two Bay Area biotechs|url=https://www.bizjournals.com/sanfrancisco/blog/biotech/2015/11/genentech-exelixis-exel-cotellic-cobimetinib-exel.html|work=San Francisco Business Times|date=November 10, 2015}}</ref>

In March 2016 Exelixis licensed to [[Ipsen]] worldwide rights (outside the US, [[Canada]], and [[Japan]]) to market [[cabozantinib]].<ref>{{cite news|last1=Garde|first1=Damian|title=Ipsen bets up to $855M on Exelixis' once-failed cancer drug|url=http://www.fiercebiotech.com/partnering/ipsen-bets-up-to-855m-on-exelixis-once-failed-cancer-drug|work=FierceBiotech|date=March 1, 2016|language=en}}</ref>

In April 2016 the FDA granted approval for marketing the tablet formulation as a second line treatment for [[kidney cancer]]<ref>[https://web.archive.org/web/20160430053730/http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm497483.htm FDA Approval Announcement, April 2016]</ref> and the same was approved in Europe in October of that year.<ref>{{cite web|title=Cabometyx summary|url=http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004163/human_med_002018.jsp&mid=WC0b01ac058001d124|publisher=EMA|accessdate=8 August 2017|language=en|archive-date=20 June 2018|archive-url=https://web.archive.org/web/20180620060152/http://www.ema.europa.eu/ema//index.jsp?curl=pages/medicines/human/medicines/004163/human_med_002018.jsp&mid=WC0b01ac058001d124|url-status=dead}}</ref>

In December 2017, the FDA granted approval for the use of cabozantinib for first line treatment of kidney cancer<ref>[https://web.archive.org/web/20180126010432/https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm589842.htm FDA grants regular approval to Cabometyx for first-line treatment of advanced renal cell carcinoma]</ref> and in May 2018 approval for first-line treatment was approved in Europe.<ref>[https://www.nasdaq.com/article/exelixis-cabometyx-gets-eu-nod-for-first-line-kidney-cancer-cm964931 Exelixis' Cabometyx Gets EU Nod for First-Line Kidney Cancer]</ref>