Exelixis

Exelixis, Inc. is an American biopharmaceutical company headquartered in Alameda, California, whose business is centered on oncology drug discovery, development, licensing, and commercialization. The company is best known for cabozantinib, a small-molecule tyrosine kinase inhibitor marketed in the United States as Cabometyx for advanced renal cell carcinoma and as Cometriq for metastatic medullary thyroid cancer. Cabozantinib has also been developed in additional cancer settings and is marketed outside selected North American and Asian territories through licensing arrangements. Exelixis was established in 1994 by scientific founders Spyridon Artavanis-Tsakonas, Corey Goodman, and Gerry Rubin. Its initial scientific model was broader than conventional drug development: the company used functional genomics and model organisms, including fruit flies, nematodes, and zebrafish, to identify biological pathways with possible applications in medicine and agriculture. This work supported both pharmaceutical research and an agricultural subsidiary, Exelixis Plant Sciences. By the beginning of the 2000s, however, Exelixis had moved away from a broadly exploratory genomics strategy and concentrated its internal drug-discovery activities on cancer. The company's oncology approach emphasized multi-targeted inhibition of selected tyrosine kinases involved in tumor formation, growth, angiogenesis, and metastasis. This strategy differed from the highly selective single-target model that was common in the industry at the time. Exelixis built a large chemical library and entered a series of partnerships to advance programs that it could not efficiently develop alone. Major collaborators included GlaxoSmithKline, Daiichi Sankyo, Genentech, and Bristol Myers Squibb. These collaborations covered oncology, inflammatory disease, vascular biology, mineralocorticoid-receptor programs, and the MEK inhibitor that later became cobimetinib. Exelixis became a public company in 2000. George Scangos, who joined as chief executive in 1996, led the company's transition from a genomics platform business toward a focused drug-development enterprise. In 2010, Scangos left to lead Biogen, and Michael M. Morrissey, who had joined Exelixis in 2000, became president and chief executive officer. Under Morrissey, the company concentrated its resources on converting cabozantinib into a commercially significant oncology franchise. Cabozantinib became Exelixis's first approved medicine in 2012, when the U.S. Food and Drug Administration authorized Cometriq for metastatic medullary thyroid cancer. The medicine subsequently gained European approval. A major strategic turning point came after cabozantinib was returned to Exelixis by Bristol Myers Squibb. The company continued testing it across multiple tumor types despite setbacks, including failure of a Phase III prostate-cancer study in 2014. The failure led to severe cost reductions and a substantial workforce reduction, but Exelixis continued investing in indications where the drug showed clinical value. The company broadened its commercial position through the 2015 approval of cobimetinib, developed with Genentech, for certain melanoma indications. Cabozantinib then gained a tablet-based kidney-cancer indication in the United States in 2016, followed by European authorization, and received approval for first-line renal cell carcinoma treatment in the United States in 2017 and Europe in 2018. In 2016, Exelixis licensed Ipsen rights to commercialize cabozantinib in territories outside the United States, Canada, and Japan, creating an international commercial network while retaining important markets itself. Today, Exelixis is primarily identified with targeted oncology medicines and the continued lifecycle development of cabozantinib. Its operating model combines internal research and clinical development with licensing, co-development, and regional commercialization partnerships. The company remains publicly trade…

Exelixis was founded in 1994 by Spyridon Artavanis-Tsakonas, then associated with Yale, and Corey Goodman and Gerry Rubin, then associated with the University of California, Berkeley. The founders designed the company around functional genomics and the use of model organisms to identify biological pathways that could be relevant to agriculture and human medicine. Fruit flies, nematodes, and zebrafish were among the experimental systems used in this early platform strategy. The company later created Exelixis Plant Sciences to pursue agricultural applications. George Scangos joined Exelixis as chief executive in 1996. During the second half of the 1990s, the company developed its genomics capabilities and assembled a large compound library. By 2000, it had moved away from the most exploratory phase of its platform work and increasingly presented itself as a drug-discovery company. Exelixis completed its initial public offering in 2000 after postponing an earlier attempt and raised capital in difficult market conditions. The company narrowed its pharmaceutical strategy in the early 2000s, concentrating internal work on oncology. Its scientific approach involved identifying groups of tyrosine kinases that support cancer development and progression and designing compounds capable of affecting several related targets. At the time, this multi-target strategy was viewed as unconventional because many drug companies emphasized high selectivity for a single protein. Exelixis used partnerships to extend the reach of this research. In 2002, it entered a broad discovery alliance with GlaxoSmithKline covering cancer, inflammatory disease, and vascular conditions. Later collaborations included a mineralocorticoid-receptor program with Daiichi Sankyo and a MEK inhibitor program with Genentech. The latter produced cobimetinib, originally identified within Exelixis's XL-518 program. In 2008, Exelixis partnered its lead cancer candidate XL-184, later named cabozantinib, and another oncology candidate with Bristol Myers Squibb. Bristol Myers Squibb returned cabozantinib rights to Exelixis in 2010 and returned rights to the other candidate in 2011. The recovery of cabozantinib made Exelixis responsible for financing and directing a more extensive development program. In 2010, Scangos left Exelixis to become chief executive of Biogen. Michael M. Morrissey, who had joined Exelixis in 2000 as vice president of discovery research, became president and chief executive officer. Cabozantinib delivered Exelixis's first regulatory success in 2012, when the FDA approved Cometriq for metastatic medullary thyroid cancer. European approval followed in 2014. Exelixis then pursued the medicine in several additional tumor types. A Phase III prostate-cancer failure in 2014 created a major financial and organizational crisis, and the company reduced its workforce by approximately 70 percent. Rather than abandoning the compound, Exelixis concentrated on settings in which cabozantinib's clinical profile appeared strongest. A separate collaboration with Genentech produced the 2015 FDA approval of cobimetinib for certain melanoma patients. In 2016, Exelixis granted Ipsen rights to commercialize cabozantinib in territories outside the United States, Canada, and Japan. The same year, Cabometyx, the tablet formulation of cabozantinib, was approved in the United States for a later-line renal cell carcinoma indication and subsequently in Europe. The FDA expanded the medicine to first-line renal cell carcinoma treatment in 2017, with European first-line approval following in 2018. Exelixis subsequently developed its identity as a focused oncology company rather than a general genomics platform. Its business combines internal research, clinical development, regulatory work, commercial operations, and regional partnerships. Cabozantinib remains the central product franchise, while the company continues to seek additional oncology products and indications. The company's pricing practices have also drawn external scrutiny: in 2023, ICER cited Cabometyx in a review of high-expenditure drugs with significant net price increases that the organization considered insufficiently supported by new clinical evidence.

1. 2018European first-line kidney-cancer approval

   European regulators approve cabozantinib for first-line renal cell carcinoma treatment.

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2. 2017First-line kidney-cancer approval in the United States

   Cabozantinib receives FDA approval for first-line treatment of renal cell carcinoma.

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3. 2016Cabozantinib rights are licensed to Ipsen

   Ipsen receives rights to commercialize cabozantinib outside the United States, Canada, and Japan.

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4. 2016Cabometyx enters renal cell carcinoma treatment

   The FDA approves tablet-form cabozantinib for a later-line kidney-cancer indication.

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5. 2015Cobimetinib is approved for melanoma

   The FDA approves cobimetinib for specified forms of melanoma following the Genentech collaboration.

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6. 2014European Cometriq approval and restructuring

   Cabozantinib receives European approval for its thyroid-cancer indication, while a failed prostate-cancer Phase III study leads to extensive workforce reductions.

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7. 2012First drug approval

   The FDA approves Cometriq, the cabozantinib formulation for metastatic medullary thyroid cancer.

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8. 2010Leadership changes and cabozantinib rights return

   George Scangos leaves for Biogen, Michael Morrissey becomes CEO, and Bristol Myers Squibb returns rights to XL-184.

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9. 2008Cabozantinib is partnered with Bristol Myers Squibb

   Exelixis licenses XL-184, later called cabozantinib, together with another oncology candidate to Bristol Myers Squibb.

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10. 2007MEK inhibitor program is partnered with Genentech

    Exelixis partners its XL-518 MEK inhibitor program with Genentech; the compound later becomes cobimetinib.

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11. 2006Daiichi Sankyo collaboration expands

    The companies collaborate on mineralocorticoid-receptor compounds, including the program that led to esaxerenone.

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12. 2002GSK discovery alliance begins

    Exelixis enters a broad research alliance with GlaxoSmithKline spanning cancer, inflammatory diseases, and vascular conditions.

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13. 2000Exelixis goes public

    The company completes its public offering and reports a large small-molecule compound library as it shifts toward pharmaceutical discovery.

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14. 1996George Scangos becomes chief executive

    Scangos joins the company as CEO and leads its early transition from platform research toward drug discovery.

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15. 1994Exelixis is founded

    Spyridon Artavanis-Tsakonas, Corey Goodman, and Gerry Rubin establish Exelixis as a functional-genomics and model-organism research company.

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A focused oncology innovator built around targeted small-molecule therapies and the lifecycle expansion of cabozantinib.

• CabometyxOncology medicine2016

  Cabometyx is Exelixis's tablet formulation of cabozantinib. It is used in renal cell carcinoma, including later-line treatment and, following subsequent regulatory expansion, first-line treatment in specified settings. The product is the core of Exelixis's commercial oncology franchise and has been studied across multiple advanced cancers, both alone and in combination with other therapies.

• CometriqOncology medicine2012

  Cometriq is the cabozantinib formulation approved for metastatic medullary thyroid cancer. It was Exelixis's first approved product and established the company's commercial presence in oncology. Although Cabometyx became the more prominent formulation in kidney cancer, Cometriq remains associated with the thyroid-cancer indication.

• CabozantinibSmall-molecule tyrosine kinase inhibitor2012

  Cabozantinib is a multi-targeted small-molecule tyrosine kinase inhibitor originally developed as Exelixis candidate XL-184. Its development covers medullary thyroid cancer and renal cell carcinoma, with additional clinical investigation in other metastatic cancers. Exelixis has retained key commercial rights while using regional partnerships to support international distribution.

• CobimetinibMEK inhibitor2015

  Cobimetinib originated in Exelixis's XL-518 MEK inhibitor program and was developed with Genentech. It received FDA approval in 2015 for specified melanoma treatment. The asset illustrates Exelixis's historical model of discovering or advancing targeted oncology candidates through larger-company partnerships.

• Esaxerenone programMineralocorticoid-receptor antagonist program

  Esaxerenone was associated with Exelixis's collaboration with Daiichi Sankyo on compounds targeting mineralocorticoid receptors. The program represents an important non-oncology research partnership from the period when Exelixis still maintained a broader discovery portfolio.

• 2016License international cabozantinib rights to IpsenM&A

  Exelixis needed a commercial structure for markets outside the United States, Canada, and Japan as cabozantinib entered broader oncology development.

  What changed. The company granted Ipsen rights to market cabozantinib in those international territories.

  Aftermath. The agreement extended cabozantinib's international reach while allowing Exelixis to retain direct control of selected core markets.

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• 2016Launch the Cabometyx renal-cell-carcinoma franchiseProduct launch

  Clinical and regulatory work showed that cabozantinib could serve patients with advanced renal cell carcinoma in addition to its original thyroid-cancer indication.

  What changed. Exelixis introduced the tablet formulation Cabometyx for a later-line renal cell carcinoma indication in the United States and subsequently Europe.

  Aftermath. Cabometyx became the company's principal commercial product and later gained first-line treatment approvals.

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• 2014Restructure after prostate-cancer trial failureStrategy

  A Phase III study of cabozantinib in prostate cancer failed, placing pressure on a company that was investing heavily in the medicine's expansion.

  What changed. Exelixis reduced its workforce substantially and redirected resources toward cancer indications with stronger clinical prospects.

  Aftermath. The company preserved cabozantinib development and later expanded the product into renal cell carcinoma.

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• 2010Resume control of cabozantinib developmentStrategy

  Bristol Myers Squibb returned rights to XL-184, the candidate that became cabozantinib.

  What changed. Exelixis took back responsibility for the compound and continued its clinical development under new leadership.

  Aftermath. Cabozantinib became the company's principal development and commercial priority and ultimately produced Exelixis's first approved medicines.

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• 2002Concentrate internal research on oncologyStrategy

  Exelixis had originated as a broad functional-genomics company with potential applications in agriculture and medicine. Its research increasingly identified cancer-related kinase pathways as the most commercially promising area.

  What changed. The company limited its internal pharmaceutical efforts primarily to targeted oncology drug discovery, while using partnerships for selected programs outside its core focus.

  Aftermath. This decision created the scientific and organizational foundation for the cabozantinib and cobimetinib programs.

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• 2023External criticism of Cabometyx pricingControversy

  The Institute for Clinical and Economic Review included Cabometyx in a review of high-expenditure medicines whose net price increases were considered insufficiently supported by new clinical evidence. The criticism concerned pricing and payer burden rather than an allegation of product safety misconduct.

• 2017Cabozantinib receives first-line kidney-cancer approval

  The FDA expanded cabozantinib's use to first-line treatment of renal cell carcinoma. A corresponding European first-line authorization followed in 2018.

  Product launchProduct generation
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• 2016Exelixis grants Ipsen international cabozantinib rights

  Exelixis licensed Ipsen rights to commercialize cabozantinib outside the United States, Canada, and Japan.

  M&A
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• 2016Cabozantinib expands into kidney-cancer treatment

  The FDA approved the tablet formulation of cabozantinib for a later-line renal cell carcinoma setting, broadening the product's commercial role beyond thyroid cancer.

  Product launchProduct generation
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• 2015Cobimetinib receives FDA approval for melanoma

  The FDA approved cobimetinib, developed through the Exelixis-Genentech collaboration, for specified melanoma treatment.

  Product launch
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• 2014Cabozantinib fails a Phase III prostate-cancer study

  A late-stage prostate-cancer study of cabozantinib did not meet its objectives. Exelixis responded with major cost reductions and a substantial workforce reduction while retaining its focus on other oncology indications.

  Other
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• 2012Exelixis receives first U.S. approval for cabozantinib

  The FDA approved cabozantinib, marketed as Cometriq, for metastatic medullary thyroid cancer, giving Exelixis its first approved medicine.

  Product launchProduct generation
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1. Exelixis