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Exelixis Inc (EXEL) RSS Feed

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About Us

About Us

Exelixis, Inc., from the Greek word for “evolution,” is a biopharmaceutical company committed to developing and commercializing small molecule therapies with the potential to improve the treatment of cancer.

Over the past decade, we have established a broad development platform, laying the foundation for our continued efforts to bring new therapies for cancer to patients in need. The history of our lead compounds, cabozantinib and cobimetinib, tells the story of our evolution as a company. Each of these compounds were discovered in our own laboratories and advanced by us into clinical development.

In addition, we have leveraged our earlier stage drug discovery and development capabilities to establish multiple partnerships and collaborations with leading pharmaceutical and biopharmaceutical partners. These alliances are designed to advance the development of multiple Exelixis-discovered therapies, and allow Exelixis to focus on maximizing the potential of cabozantinib, our internally-discovered inhibitor of multiple tyrosine kinases.

We believe that cabozantinib has the potential to treat a wide variety of cancers. The medicine received its first regulatory approval in 2012; since then, alongside our collaborators, we have advanced a broad, global clinical development program that is exploring cabozantinib’s potential in approximately 45 planned or ongoing clinical trials. Most recently, data from a phase 3 pivotal trial led to a second U.S. approval for cabozantinib as a treatment for patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. Cabozantinib is marketed as CABOMETYX™ in the United States for that purpose. Click here for important safety information about CABOMETYX. Ipsen has an exclusive license to commercialize cabozantinib outside of the United States, Canada and Japan, and is pursuing European Union approval for the same indication.

A second Exelixis-discovered compound, cobimetinib, also has broad potential as a cancer treatment. It is subject to a worldwide collaboration between Exelixis and Genentech (a member of the Roche Group). Cobimetinib has received regulatory approval for its first indication in Switzerland, the United States, the European Union and Canada, where it is marketed under the trade name COTELLIC™. Genentech is also further exploring cobimetinib’s potential through a clinical development program pursuant to which it is being evaluated in combination with investigational and approved therapies, including immunotherapy agents.

Exelixis was founded and incorporated in 1994 and we are based in South San Francisco, California. Exelixis is dedicated to improving the care of, and outcomes for patients with cancer.

Management


Our leadership team is united by an unwavering commitment to creating value through the development of innovative new therapies to improve the treatment of cancer. Bringing together years of industry experience, our dedicated team shares the same vision to create therapies that make a meaningful difference in the lives of patients.

Michael M. Morrissey, Ph.D.

President and Chief Executive Officer

Michael M. Morrissey, Ph.D. has served as a director and as Exelixis’ President and Chief Executive Officer since July 2010. Dr. Morrissey has held positions of increasing responsibility at Exelixis since he joined the company in February 2000. From January 2007 until July 2010, he served as President of Research and Development, from January 2006 until December 2006, he served as Executive Vice President, Discovery, from January 2003 to December 2005, he served as Senior Vice President, Discovery, and from February 2000 through December 2002, he served as Vice President of Discovery Research. From 1991 to 2000, Dr. Morrissey held several positions at Berlex Biosciences, last holding the position of Vice President, Discovery Research. From 1986 to 1991, he served as a Senior Scientist and Project Team Leader in Medicinal Chemistry at CIBA-Geigy Corporation, a pharmaceutical company. He is the author of numerous scientific publications in medicinal chemistry and drug discovery and an inventor on 70 issued U.S. patents and 25 additional published U.S. patent applications. Dr. Morrissey holds a B.S. (Honors) in Chemistry from the University of Wisconsin and a Ph.D. in Chemistry from Harvard University.

Jeffrey J. Hessekiel, J.D.

Executive Vice President and General Counsel

Jeffrey J. Hessekiel, J.D., has served as Executive Vice President and General Counsel since February 2014. Prior to joining Exelixis, Mr. Hessekiel was Senior Counsel at Arnold & Porter LLP, where he advised emerging growth and public companies, primarily in the life sciences sector, on complex legal issues connected with strategic transactions, healthcare compliance programs and investigations, and regulatory matters. Previously, from 2002 to 2012, he held key legal and compliance roles at Gilead Sciences, Inc., rising to the positions of Vice President, Commercial Legal Affairs and Litigation, and then Chief Compliance and Quality Officer. Prior to joining Gilead, Mr. Hessekiel trained in the litigation and corporate practice groups at a number of Silicon Valley law firms. He also worked for several international non-governmental organizations. Mr. Hessekiel received his J.D. from George Washington University’s School of Law, and his B.A. from Duke University.





Peter Lamb, Ph.D.

Executive Vice President, Discovery Research and Chief Scientific Officer

Peter Lamb, Ph.D., has served as Executive Vice President and Chief Scientific Officer since September 2009. Previously, he served as Senior Vice President, Discovery Research and Chief Scientific Officer from January 2007 until September 2009, as Vice President, Discovery Pharmacology from December 2003 until January 2007 and as Senior Director, Molecular Pharmacology and Structural Biology from October 2000 until December 2003. Prior to joining Exelixis, from June 1992 until September 2000, Dr. Lamb held positions of increasing responsibility at Ligand Pharmaceuticals, most recently serving as Director of Transcription Research. During this time, he led teams that implemented novel drug discovery approaches that led to the identification of the first small molecule activators of cytokine receptors. Dr. Lamb has held post-doctoral research fellowships at the Carnegie Institution, Department of Embryology, with Dr. S.L. McKnight and the University of Oxford with Dr. N.J. Proudfoot, working in the field of gene regulation. He has authored numerous articles in the fields of gene expression, signal transduction and oncology, and is an author on multiple issued and pending US patents. He has a Ph.D. in Molecular Biology from the ICRF/University of London and a B.A. in Biochemistry from the University of Cambridge.

Gisela M. Schwab, M.D.

Executive Vice President and Chief Medical Officer

Gisela M. Schwab, M.D., has served as Executive Vice President and Chief Medical Officer since January 2008. She joined Exelixis in 2006 as Senior Vice President and Chief Medical Officer. From 2002 to 2006, she held the position of Senior Vice President and Chief Medical Officer at Abgenix, Inc., a human antibody-based drug development company. She also served as Vice President, Clinical Development, at Abgenix from 1999 to 2001. Prior to working at Abgenix, from 1992 to 1999, she held positions of increasing responsibility at Amgen Inc., most recently as Director of Clinical Research and Hematology/Oncology Therapeutic Area Team Leader. Since August 2011, Dr. Schwab has served as a member of the board of directors of Topotarget A/S, a publicly-held biopharmaceutical company. She received her Doctor of Medicine degree from the University of Heidelberg, trained at the University of Erlangen-Nuremberg and the National Cancer Institute and is board certified in internal medicine and hematology and oncology.

Executive Vice President and Chief Financial Officer

Chris Senner has served as Executive Vice President and Chief Financial Officer since July 2015. Prior to joining Exelixis, Mr. Senner served as Vice President, Corporate Finance at Gilead Sciences, which he joined in March 2010. At Gilead, he was accountable for controllership and operational financial planning and analysis, including R&D, commercial operations, and tax and treasury planning. Before joining Gilead, Mr. Senner spent 18 years at Wyeth in various managerial roles of increasing responsibility, most recently serving as Vice President, Finance and Chief Financial Officer for Wyeth Pharmaceutical's U.S. Region, a position he held from July 2007 to November 2009. Before joining Wyeth, Mr. Senner worked as an accounting associate for the Research Board, an international think tank headquartered in New York. Mr. Senner obtained his B.S. in Finance from Bentley College.

Stelios Papadopoulos, Ph.D.

Stelios Papadopoulos, Ph.D., a co-founder of Exelixis, has been a director since December 1994 and the Chairman of the Board since January 1998. Dr. Papadopoulos retired as Vice Chairman of Cowen & Co., LLC in August 2006 after six years as an investment banker with the firm, where he focused on the biotechnology and pharmaceutical sectors. Prior to joining Cowen & Co., he spent 13 years as an investment banker at PaineWebber, Incorporated, where he was most recently Chairman of PaineWebber Development Corp., a PaineWebber subsidiary focusing on biotechnology. He joined PaineWebber in April 1987 from Drexel Burnham Lambert, where he was a Vice President in the Equity Research Department covering the biotechnology industry. Prior to Drexel, he was a biotechnology analyst at Donaldson, Lufkin & Jenrette. Before coming to Wall Street in 1985, Dr. Papadopoulos was on the faculty of the Department of Cell Biology at New York University Medical Center. He continues his affiliation with New York University Medical Center as an Adjunct Associate Professor of Cell Biology. Dr. Papadopoulos is a co-founder of Anadys Pharmaceuticals, Inc., a publicly-held drug discovery and development company acquired by Hoffmann-La Roche Inc. in November 2011. Dr. Papadopoulos served as a member of the board of directors of Anadys Pharmaceuticals from 2000 to 2011 and as its chairman in 2011 prior to its acquisition. Dr. Papadopoulos has served as a member of the board of directors of BG Medicine, Inc., a publicly-held life sciences company, since 2003. Since July 2008, Dr. Papadopoulos has also served as a member of the board of directors of Biogen Idec Inc., a publicly-held biopharmaceutical company focused on the treatment of serious diseases. Dr. Papadopoulos previously served as a member of the board of directors of GenVec, Inc., a publicly-held biotechnology company from August 2003 until October 2006 and as a member of the board of directors of SGX Pharmaceuticals, Inc. from July 2001 to September 2006 prior to its acquisition by Eli Lilly and Company. Dr. Papadopoulos is a co-founder and member of the board of directors of Cellzome Inc., a privately-held drug discovery company, a member of the board of directors of Joule Unlimited, Inc., a privately-held biotechnology company and a member of the board of directors of Regulus Therapeutics Inc., a privately-held biotechnology company. In the not-for-profit sector, Dr. Papadopoulos is a co-founder and Chairman of Fondation Santé and a member of the board of visitors of Duke University Medical Center. Dr. Papadopoulos holds a Ph.D. in Biophysics and an M.B.A. in Finance, both from New York University.

Charles Cohen, Ph.D.

Charles Cohen, Ph.D. has been a director since November 1995. Since May 2007, Dr. Cohen has been a managing director of Advent Healthcare Ventures, a venture capital firm. From 2003 to 2007, Dr. Cohen was Vice President of Advent International, a global private equity firm. From 2000 to 2002, Dr. Cohen was the Chief Executive Officer of Cellzome AG, a post-genomics biotechnology company. Prior to that time, Dr. Cohen co-founded Creative BioMolecules, Inc., a biotechnology company, in 1982 and was one of its directors and its Chief Executive Officer from 1985 to 1995. Currently, Dr. Cohen is the Chairman of the Supervisory Board of Cellzome AG. Dr. Cohen has served as a member of the board of directors of various publicly-held biopharmaceutical companies, including Anadys Pharmaceuticals, Inc. from 2000 to 2005 and Anesiva, Inc. from 2005 to 2007. Dr. Cohen serves on the board of directors and as a Chief Executive Officer of several Advent Healthcare Ventures privately-held portfolio companies. Dr. Cohen has also served as the Chief Executive Officer of several other companies. Dr. Cohen received his Ph.D. from New York University School of Medicine.

Carl B. Feldbaum, Esq.

Carl B. Feldbaum, Esq. has been a director since February 2007. Mr. Feldbaum is currently a member of the board of directors of Actelion, Ltd, a biopharmaceutical company, and previously served as a member of the board of directors of Connetics Corporation from 2005 until its acquisition by Stiefel Laboratories, Inc. in 2006. In 2009, Mr. Feldbaum was elected as chairman of BIO Ventures for Global Health, a non-profit organization, where he has served as a member of the board of directors since its inception in 2004. Mr. Feldbaum also serves as a member of the board of directors of the Biotechnology Institute, a non-profit organization dedicated to biotechnology education. Mr. Feldbaum is president emeritus of the Biotechnology Industry Organization (BIO), which represents more than 1,000 biotechnology companies, academic institutions and state biotechnology centers internationally. Mr. Feldbaum served as president of BIO from 1993 until his retirement in 2005. Prior to joining BIO, Mr. Feldbaum was chief of staff to Senator Arlen Specter of Pennsylvania. He also was president and founder of Palomar Corporation, a national security “think tank” in Washington, D.C. Before founding Palomar Corporation, Mr. Feldbaum was Assistant to the Secretary of Energy and served as the Inspector General for defense intelligence in the U.S. Department of Defense. Mr. Feldbaum received an A.B. in Biology from Princeton University and his J.D. from the University of Pennsylvania Law School.

Alan M. Garber, M.D., Ph.D.

Alan M. Garber, M.D., Ph.D. has been a director since January 2005. He became Provost of Harvard University, Mallinckrodt Professor of Health Care Policy at Harvard Medical School, and a Professor in the Harvard Kennedy School of Government and in the Department of Economics at Harvard in September 2011. Before moving to Harvard, from 1998 until August 2011, he was the Henry J. Kaiser Jr. Professor, a Professor of Medicine, and a Professor (by courtesy) of Economics, Health Research and Policy, and of Economics in the Graduate School of Business at Stanford University. Dr. Garber also served as the Director of the Center for Primary Care and Outcomes Research and the Center for Health Policy at Stanford. During his tenure at Stanford University, Dr. Garber also served as a Senior Fellow at the Freeman Spogli Institute for International Studies and as a staff physician at the VA Palo Alto Health Care System. Dr. Garber is a member of the Institute of Medicine of the National Academy of Sciences, the American Society of Clinical Investigation, the Association of American Physicians and the Board on Science, Technology, and Economic Policy at the National Academies. He is a Fellow of the American College of Physicians and the Royal College of Physicians. Dr. Garber is also a Research Associate with the National Bureau of Economic Research and served as founding Director of its Health Care Program for nineteen years. He has also served as a member of the National Advisory Council on Aging at the National Institutes of Health, as a member of the Board of Health Advisers of the Congressional Budget Office and as Chair of the Medicare Evidence Development and Coverage Advisory Committee at the Centers for Medicare and Medicaid Services. Dr. Garber is on the editorial board of acclaimed scientific journals and has received numerous awards and honors. Dr. Garber holds an A.B. summa cum laude, an A.M. and a Ph.D., all in Economics, from Harvard University, and an M.D. with research honors from Stanford University.

Vincent Marchesi, M.D., Ph.D.

Vincent T. Marchesi, M.D., Ph.D.  has been a director since May 2001. Since 1973, Dr. Marchesi has been a Professor of Pathology and Cell Biology at Yale University and, since 1991, the Director of the Boyer Center for Molecular Medicine at Yale University. In 1982, Dr. Marchesi co-founded Molecular Diagnostics, Inc., a diagnostic development company. Dr. Marchesi was formerly Chair of Pathology at the Yale-New Haven Hospital. Dr. Marchesi holds an M.D. from Yale University and a Ph.D. from Oxford University, and is a member of the National Academy of Sciences and the Institute of Medicine.

Michael M. Morrissey, Ph.D.

Michael M. Morrissey, Ph.D. has served as a director and as Exelixis’ President and Chief Executive Officer since July 2010. Dr. Morrissey has held positions of increasing responsibility at Exelixis since he joined the company in February 2000. From January 2007 until July 2010, he served as President of Research and Development, from January 2006 until December 2006, he served as Executive Vice President, Discovery, from January 2003 to December 2005, he served as Senior Vice President, Discovery, and from February 2000 through December 2002, he served as Vice President of Discovery Research. From 1991 to 2000, Dr. Morrissey held several positions at Berlex Biosciences, last holding the position of Vice President, Discovery Research. From 1986 to 1991, he served as a Senior Scientist and Project Team Leader in Medicinal Chemistry at CIBA-Geigy Corporation, a pharmaceutical company. He is the author of numerous scientific publications in medicinal chemistry and drug discovery and an inventor on 70 issued U.S. patents and 25 additional published U.S. patent applications. Dr. Morrissey holds a B.S. (Honors) in Chemistry from the University of Wisconsin and a Ph.D. in Chemistry from Harvard University

George Poste, DVM, Ph.D.

George Poste, D.V.M., Ph.D., FRS  has been a director since August 2004. Since February 2009, Dr. Poste has been the Chief Scientist at Complex Adaptive Systems Initiative and Regents’ Professor and Del E. Webb Professor of Health Innovation at Arizona State University. From May 2003 to February 2009, Dr. Poste served as the director of the Biodesign Institute at Arizona State University. Dr. Poste has served as the Chief Executive Officer of Health Technology Networks, a consulting company that specializes in the application of genomic technologies and computing in healthcare, since 2000. From 1992 to 1999, he was the Chief Science and Technology Officer and President, R&D of SmithKline Beecham Corporation, a pharmaceutical company. Dr. Poste served on the Defense Science Board of the U.S. Department of Defense from 2001 to 2010 and is a member of other organizations dedicated to advance the defense against bioweapons and biowarfare. Since February 2003, Dr. Poste has served as a member of the board of directors ofMonsanto Company, a publicly-held provider of agricultural products and solutions. From April 2000 until August 2009, Dr. Poste served as the Non-Executive Chairman of Orchid Cellmark, Inc., a publicly-held DNA forensics company. Dr. Poste currently serves as a Board Member of Caris Life Sciences, a privately held medical diagnostics company. Dr. Poste is a Fellow of the Royal Society, the UK Academy of Medical Sciences, Hoover Institution, Stanford University, and various other prestigious organizations and has been awarded honorary doctorates from several universities. Dr. Poste holds a D.V.M. in veterinary medicine and a Ph.D. in Virology from the University of Bristol, England.

George A. Scangos, Ph.D.

George A. Scangos, Ph.D. has been a director since October 1996. Since July 2010, Dr. Scangos has served as Chief Executive Officer and as a member of the board of directors of Biogen Idec  Inc. From October 1996 to July 2010, Dr. Scangos served as our President and Chief Executive Officer. From September 1993 to October 1996, Dr. Scangos served as President of Biotechnology at Bayer Corporation, a pharmaceutical company, and was responsible for research, business and process development, manufacturing, engineering and quality assurance. Dr. Scangos has served as a member of the board of directors of various publicly-held companies, including Anadys Pharmaceuticals, Inc. from 2003 to 2010 and Entelos, Inc. from 1997 to 2010. Dr. Scangos also served as a member of the board of directors of our former subsidiary, TaconicArtemis GmbH (previously known as Artemis Pharmaceuticals GmbH) until 2010. Dr. Scangos previously served as the Chair of the California Healthcare Institute (CHI), as a member of the Board of the Global Alliance for TB Drug Development and as a member of the board of directors of BayBio. Dr. Scangos currently serves as a director of Fondation Santé. Dr. Scangos is also a member of the Board of Advisors of the University of California, San Francisco School of Pharmacy and the National Board of Advisors of the University of California, Davis School of Medicine. Dr. Scangos was a Jane Coffin Childs Post-Doctoral Fellow at Yale University and a faculty member at Johns Hopkins University. Dr. Scangos currently holds an appointment as Adjunct Professor of Biology at Johns Hopkins University. Dr. Scangos holds a B.A. in Biology from Cornell University and a Ph.D. in Microbiology from the University of Massachusetts.

Lance Willsey, M.D.

Lance Willsey, M.D.  has been a director since April 1997. Dr. Willsey was a founding partner of DCF Capital, a hedge fund focused on investing in the life sciences, from July 1998 to March 2002, and currently is a consultant to institutional investors in the field of oncology. Since 2000, Dr. Willsey has served on the Visiting Committee of the Department of Genitourinary Oncology at the Dana Farber Cancer Institute at Harvard University School of Medicine. From July 1997 to July 1998, Dr. Willsey served on the Staff Department of Urologic Oncology at the Dana Farber Cancer Institute. From July 1996 to July 1997, Dr. Willsey served on the Staff Department of Urology at Massachusetts General Hospital at Harvard University School of Medicine, where he was a urology resident from July 1992 to July 1996. From 2000 to 2010, Dr. Willsey served a member of the board of directors of Exact Sciences Corporation, a publicly-held biotechnology company. Dr. Willsey holds a B.S. in Physiology from Michigan State University and an M.S. in Biology and an M.D., both from Wayne State University.

Jack L. Wyszomierski

Jack L. Wyszomierski has been a director since February 2004. From June 2004 to June 2009, Mr. Wyszomierski served as the Executive Vice President and Chief Financial Officer of VWR International, LLC, a supplier of laboratory supplies, equipment and supply chain solutions to the global research laboratory industry. From 1982 to 2003, Mr. Wyszomierski held positions of increasing responsibility within the finance group at Schering-Plough Corporation, a health care company, culminating with his appointment as Executive Vice President and Chief Financial Officer in 1996. Prior to joining Schering-Plough, he was responsible for capitalization planning at Joy Manufacturing Company, a producer of mining equipment, and was a management consultant at Data Resources, Inc. Mr. Wyszomierski has served as a member of the board of directors of XOMA Ltd., a publicly-held company that discovers, develops and manufactures novel antibody therapeutics, since August 2010 and as a member of the board of directors of Athersys, Inc., a publicly-held company engaged in the discovery and development of therapeutic product candidates, since June 2010. Since January 2011, Mr. Wyszomierski has served as a member of the board of directors of HGI Global Holdings, Inc., a privately held distributor of home healthcare products, and since April 2012, Mr. Wyszomierski has served as a member of the board of directors of Unigene Laboratories, Inc., a publicly-held biopharmaceutical company. Mr. Wyszomierski holds a M.S. in Industrial Administration and a B.S. in Administration, Management Science and Economics from Carnegie Mellon University.

Collaborations

Exelixis has a history of productive drug discovery, and we have partnered multiple compounds and programs with leading pharmaceutical and biopharmaceutical companies, including Bristol-Myers Squibb Company, Genentech (a member of the Roche Group), Sanofi, Merck (known as MSD outside of the United States and Canada), and Daiichi-Sankyo Company Limited. These collaborations cover a variety of compounds and programs with potential for use in the treatment of cancer, inflammation, and cardiovascular and metabolic diseases.
 

Ipsen

Medicines

Since its founding, Exelixis has been committed to the discovery and development of new medicines with the potential to improve care and outcomes for people with cancer. To date, three medicines that were discovered by Exelixis researchers have progressed through clinical development and received regulatory approval.

CABOMETYX

CABOMETYX™

Cabozantinib tablets

CABOMETYX™ is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. For more information about CABOMETYX, visit www.cabometyx.com.

Please see Important Safety Information for CABOMETYX, including warnings for hemorrhage and gastrointestinal perforations and fistulas, by clicking here, and full Prescribing Information.

COMETRIQ

COMETRIQ®

Cabozantinib 80 mg and 20 mg capsules

COMETRIQ® is indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC). For more information about COMETRIQ, visit www.cometriq.com.

IMPORTANT SAFETY INFORMATION

WARNING: PERFORATIONS AND FISTULAS, and HEMORRHAGE

  • Perforations and Fistulas: Gastrointestinal perforations occurred in 3% and fistula formulation in 1% of COMETRIQ®-treated patients.  Discontinue COMETRIQ® in patients with perforation or fistula.
     
    Hemorrhage: Severe, sometimes fatal, hemorrhage including hemoptysis and gastrointestinal hemorrhage occurred in 3% of COMETRIQ®-treated patients. Monitor patients for signs and symptoms of bleeding.  Do not administer COMETRIQ® to patients with severe hemorrhage.


Please see additional Important Safety Information here, and full Prescribing Information here.

COMETRIQ

COTELLIC®
Cobimetinib tablets

COTELLIC® (cobimetinib) is indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib.

For more information about COTELLIC, click here.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS
Review the Full Prescribing Information for vemurafenib for information on the serious risks of vemurafenib.

The following can occur in patients treated with COTELLIC:

  • New primary malignancies, including cutaneous and non-cutaneous malignancies
    Hemorrhage, including major hemorrhages
    Cardiomyopathy, defined as symptomatic and asymptomatic decline in left ventricular ejection fraction
    Severe dermatologic reactions, including rash and other skin reactions
    Serous retinopathy and retinal vein occlusion
    Hepatotoxicity
    Rhabdomyolysis
    Severe photosensitivity
    Embryo-fetal toxicity

USE IN SPECIFIC POPULATIONS: Lactation
Do not breastfeed while taking COTELLIC and for 2 weeks after the final dose.

DRUG INTERACTIONS
Avoid concomitant administration of COTELLIC with strong or moderate CYP3A inducers or inhibitors.

Most Common Adverse Reactions

The most common (≥20%) adverse reactions with COTELLIC were diarrhea (60%), photosensitivity reaction (46%), nausea (41%), pyrexia (28%), and vomiting (24%). The most common (≥5%) Grade 3-4 laboratory abnormalities are increased GGT (21%), increased CPK (14%), hypophosphatemia (12%), increased ALT (11%), lymphopenia (10%), increased AST (8%), increased alkaline phosphatase (7%), and hyponatremia (6%).

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see full COTELLIC Prescribing Information for additional Important Safety Information.
 

Pipeline

The Exelixis pipeline includes our lead compounds, cabozantinib and cobimetinib, as well as other programs that are the subject of partnerships and collaborations with other biopharmaceutical companies. An additional wholly-owned compound, XL888, is the subject of ongoing clinical research through our Investigator-Sponsored Trial program. Safety and efficacy for these compounds in the unapproved uses or indications described below have not yet been established.

Cabozantinib

Exelixis focuses its internal development efforts primarily upon cabozantinib, a targeted agent that inhibits the activity of receptor tyrosine kinases including MET, VEGF Receptors, AXL, and RET. These receptor tyrosine kinases are involved in both normal cellular function and in pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, and maintenance of the tumor microenvironment. Exelixis discovered cabozantinib, internally and maintains exclusive rights to commercialize the product in the United States and Canada, and also in Japan, where it is seeking a commercial partner. Per an agreement announced in February 2016, Exelixis has granted Ipsen exclusive commercialization rights for current and future indications outside of those territories. Both companies will collaborate on the development of cabozantinib for current and future indications as well.

For information on approved uses of cabozantinib, please visit our Medicines page.

Cobimetinib

Cobimetinib, an Exelixis-discovered compound, is a selective inhibitor of MEK, part of the RAS/RAF/MEK/ERK pathway that is frequently dysregulated in human tumors. Cobimetinib is being developed by Genentech (a member of the Roche Group) under a collaboration agreement with Exelixis and is the subject of a broad clinical development program in combination with a variety of investigational and approved therapies.

Cobimetinib is commercially available in the United States for the treatment of unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib, where it is marketed as COTELLIC® for that use. COTELLIC is also approved in the European Union, Switzerland and Canada for the treatment of people with BRAF V600 mutation-positive advanced melanoma. For more information on COTELLIC, including important safety information, please click here.

XL888

XL888 is a highly potent, orally bioavailable ATP-competitive inhibitor of HSP90, a molecular chaperone protein that affects the activity and stability of a range of key regulatory proteins, including kinases such as BRAF, MET, and VEGFR2. Exelixis discovered XL888 and owns the compound exclusively.

Partnered Compounds

We have established multiple partnerships and collaborations with other leading pharmaceutical and biopharmaceutical companies. These partnerships are designed to advance the development of a variety of potential therapies for cancer and other serious diseases.

WARNING: PERFORATIONS AND FISTULAS, and HEMORRHAGE

  • Perforations and Fistulas: Gastrointestinal perforations occurred in 3% and fistula formulation in 1% of COMETRIQ®-treated patients.  Discontinue COMETRIQ® in patients with perforation or fistula.
    Hemorrhage: Severe, sometimes fatal, hemorrhage including hemoptysis and gastrointestinal hemorrhage occurred in 3% of COMETRIQ®-treated patients.  Monitor patients for signs and symptoms of bleeding.  Do not administer COMETRIQ® to patients with severe hemorrhage.

Please see additional Important Safety Information for COMETRIQ® (cabozantinib), including Boxed Warnings, at www.COMETRIQ.com.

Press Releases
Date Title  
09/14/16 European Commission Approves CABOMETYX™ (cabozantinib) Tablets for the Treatment of Advanced Renal Cell Carcinoma Following VEGF-Targeted Therapy Printer Friendly Version
09/06/16 Exelixis Announces Outcome from First Planned Interim Analysis of the Phase 3 CELESTIAL Trial of Cabozantinib in Patients with Advanced Hepatocellular Carcinoma Printer Friendly Version
08/31/16 Exelixis-discovered Compounds To Be Featured in 15 Presentations at the ESMO 2016 Congress Printer Friendly Version
08/31/16 Exelixis to Present at the Morgan Stanley Global Healthcare Conference on September 13 Printer Friendly Version
08/24/16 Exelixis Announces Redemption of All Remaining 4.25% Convertible Senior Subordinated Notes Due 2019 Printer Friendly Version
08/03/16 Exelixis Announces Second Quarter and Year to Date 2016 Financial Results and Provides Corporate Update Printer Friendly Version
07/22/16 Ipsen and its Partner Exelixis Receive Positive CHMP Opinion for Cabometyx™ (Cabozantinib) for the Treatment of Advanced RCC in Adults Following Prior VEGF-Targeted Therapy Printer Friendly Version
07/12/16 Exelixis to Release Second Quarter 2016 Financial Results on Wednesday, August 3, 2016 Printer Friendly Version
06/06/16 Exelixis and Its Partner Ipsen Announce Positive Overall Survival Results from Subgroup Analyses of Phase 3 Trial of CABOMETYX™ (cabozantinib) Tablets in Advanced Renal Cell Carcinoma at 2016 ASCO Annual Meeting Printer Friendly Version
06/05/16 Exelixis and Its Partner Ipsen Announce Phase 3 Trial Results of CABOMETYX™ (Cabozantinib) Tablets Demonstrating Significant Overall Survival Benefit for Previously Treated Patients with Advanced Renal Cell Carcinoma Presented at ASCO Printer Friendly Version
06/05/16 Exelixis Announces Genentech Presentation of Preliminary Phase 1B Trial Results for the Combination of Cobimetinib and Atezolizumab at ASCO 2016 Annual Meeting Printer Friendly Version
05/23/16 Exelixis Announces Results from Randomized Phase 2 Trial CABOSUN Demonstrate Cabozantinib Significantly Improved Progression-Free Survival versus Sunitinib in Previously Untreated Advanced Renal Cell Carcinoma Printer Friendly Version
05/05/16 Exelixis to Present at the Bank of America Merrill Lynch 2016 Health Care Conference on May 10 Printer Friendly Version
05/04/16 Exelixis Announces First Quarter 2016 Financial Results and Provides Corporate Update Printer Friendly Version
04/26/16 Exelixis to Release First Quarter 2016 Financial Results on Wednesday, May 4, 2016 Printer Friendly Version
04/25/16 Exelixis Announces FDA Approval of CABOMETYX™ (Cabozantinib) Tablets for Patients with Advanced Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy Printer Friendly Version
04/20/16 Exelixis-Discovered Compounds to Be Featured in 18 Presentations at 2016 ASCO Annual Meeting Printer Friendly Version
03/03/16 Exelixis to Present at Two Investor Conferences in March Printer Friendly Version
02/29/16 Exelixis Announces Fourth Quarter and Full Year 2015 Financial Results and Provides Corporate Update Printer Friendly Version
02/29/16 Exelixis and Ipsen Enter into Exclusive Licensing Agreement to Commercialize and Develop Novel Cancer Therapy Cabozantinib in Regions Outside the United States, Canada and Japan Printer Friendly Version
02/15/16 Exelixis to Release Fourth Quarter and Full Year 2015 Financial Results on Monday, February 29, 2016 Printer Friendly Version
02/04/16 Exelixis to Present at the Leerink Partners 5th Annual Global Healthcare Conference on February 10 Printer Friendly Version
02/01/16 Exelixis Announces Positive Overall Survival Results from METEOR, the Phase 3 Pivotal Trial of Cabozantinib in Advanced Renal Cell Carcinoma Printer Friendly Version
01/28/16 Exelixis Announces U.S. FDA Deems New Drug Application Sufficiently Complete and Grants Priority Review for Cabozantinib as a Treatment for Advanced Renal Cell Carcinoma Printer Friendly Version
01/28/16 Exelixis Announces European Medicines Agency Acceptance of Marketing Authorization Application for Cabozantinib as a Treatment for Advanced Renal Cell Carcinoma Printer Friendly Version
01/11/16 Exelixis Submits Marketing Authorization Application in the European Union for Cabozantinib as a Treatment for Advanced Renal Cell Carcinoma Printer Friendly Version
01/04/16 Exelixis Announces Positive Results From Subgroup Analyses of the METEOR Phase 3 Pivotal Trial of Cabozantinib in Advanced Renal Cell Carcinoma to be Presented at ASCO 2016 Genitourinary Cancers Symposium

 




Share Structures: PER 10Q
Autorized Shares: 400,000,000  A/O AUGUST 11, 2015
Issued Shares: 196,381,220  A/O AUGUST 11, 2015
Outstanding Shares: 195,895,769  A/O AUGUST 11, 2015

 

Exelixis, Inc.

210 East Grand Avenue
So. San Francisco, CA 94080
(650) 837-7000 phone
(650) 837-8300 fax

 


 

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