Exelixis History
2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 |
2000 | 1999 |
1998 |
1997
2008
March 2008 :
Genentech, Inc. exercised its option to further develop and commercialize Exelixis' compound XL518, a selective and potent inhibitor of MEK, which is currently in a phase 1 clinical trial. Under the terms of the collaboration agreement, Exelixis received upfront and milestone payments totaling $40.0 million at the time the agreement was signed in January 2007. Selection of the compound and opt-in by Genentech triggered a payment of $3.0 million. Another $7.0 million is due when a phase 2 program is initiated by Genentech.
January 2008 :
Bristol-Myers Squibb Company (NYSE: BMY) exercised its option to develop and commercialize XL139. As a result, Exelixis is entitled to receive a $20 million milestone payment and to share U.S. profits 50/50.
GlaxoSmithKline (LSE: GSK; NYSE: GSK) decided not to exercise its option to license XL784 for further development and commercialization. Based on encouraging data from a subgroup analysis, the compound may nevertheless have potential to benefit patients with diabetic nephropathy and Exelixis is actively pursuing ways to monetize this asset.
Initiated a phase 1/2 trial of XL184 in patients with non-small cell lung cancer (NSCLC) who have had progressive disease while on a regimen containing erlotinib. For more information on our compounds, please visit the Pipeline section.
2007
December 2007 :
Submitted a comprehensive data report for IND candidate XL139 to Bristol-Myers Squibb (NYSE: BMY).
GlaxoSmithKline (GSK) (LSE: GSK; NYSE: GSK) exercised its option to exclusively license XL880 for further development and commercialization. XL880 is a small molecule compound currently being evaluated in phase 2 trials in patients with papillary renal cell carcinoma (PRC), gastric cancer and head and neck cancer.
Reported data from an ongoing phase 1 trial of XL019 in patients with myelofibrosis, a myeloproliferative disorder (MPD). The data was presented at the American Society of Hematology (ASH) annual meeting. For more information on our compounds, please visit the Pipeline section.
November 2007 :
Exelixis’ right to receive a milestone payment of $5 million from Bristol-Myers Squibb Company (NYSE: BMY) was triggered as a result of the acceptance of an Investigational New Drug application, or foreign equivalent, for a compound discovered and developed under the two companies' Liver X Receptor (LXR) collaboration.
Exelixis sold Taconic an 80.1% stake in its subsidiary Artemis Pharmaceuticals GmbH for approximately $20 million.
XL784 phase 2 data presented at American Society of Nephrology Renal Week 2007. For more information on our compounds, please visit the Pipeline section.
October 2007 :
XL647 phase 2 and phase 1 data presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics.
Interim phase 2 data for XL880 in papillary renal cell carcinoma presented at AACR-NCI-EORTC conference. For more information on our compounds, please visit the Pipeline section.
Updated XL184 phase 1 data presented at AACR-NCI-EORTC conference. For more information on our compounds, please visit the Pipeline section.
A phase 2 trial of XL784 does not meet its primary endpoint of reducing proteinuria compared with placebo in patients with proteinuria associated with diabetic nephropathy. Exelixis continues to analyze the data to assess whether further evaluation of the compound is warranted. For more information on our compounds, please visit the Pipeline section.
September 2007 :
Extension of Exelixis’ research collaboration agreement with Bristol-Myers Squibb Company to develop and commercialize novel therapies targeted against the Liver X Receptor (LXR), a nuclear hormone receptor implicated in a variety of cardiovascular and metabolic disorders.
Submission of XL880 data report to GlaxoSmithKline, following GlaxoSmithKline’s request for review of the XL880 data prior to achieving proof-of-concept in a phase 2 trial.
Promising preliminary phase 2 data for XL647 as first-line therapy for non-small cell lung cancer presented at the International Association for the Study of Lung Cancer’s (IASLC) 12th World Conference on the disease. For more information on our compounds, please visit the Pipeline section.
Exelixis Plant Sciences, a wholly owned subsidiary of Exelixis, Inc., and Dow AgroSciences LLC, a wholly owned subsidiary of The Dow Chemical Company sign a major research collaboration agreement which includes the purchase of selected assets by Dow AgroSciences' affiliate Agrigenetics Inc. The agreement is focused on the development of new tools for gene discovery and validation of novel crop traits.
July 2007 :
Retention of rights to XL647 after GlaxoSmithKline opts not to exercise its rights to develop the compound. Exelixis retains the right to develop and commercialize XL647 either independently or in collaboration with third parties.
June 2007 :
Integrated XL999 phase 2 data presented at ASCO. For more information on our compounds, please visit the Pipeline section.
Comprehensive XL880 phase 1 data presented at ASCO. For more information on our compounds, please visit the Pipeline section.
May 2007 :
Initiation of a Phase 2 trial of XL647 in non-small cell lung cancer patients who previously benefited from EGFR inhibitors or have the T790M mutant form of EGFR. For more information on our compounds, please visit the Pipeline section.
April 2007 :
Reinitiation of XL999 clinical development in patients with non-small cell lung cancer. For more information on our compounds, please visit the Pipeline section.
January 2007 : Established a co-development partnership with Genentech focused on the development of XL518, a small-molecule inhibitor of MEK. Under the terms of the agreement, Exelixis will receive upfront and milestone payments totaling $40 million upon signing of the agreement and with the submission of the IND for XL518 to the FDA. Exelixis is responsible for developing XL518 or other MEK inhibitors through the end of Phase I and if Genentech exercises its option to further develop XL518, Exelixis will receive an additional payment and Genentech will be responsible for further development, including all further development costs. Exelixis has the option to co-promote in the United States along with Genentech. Exelixis has a substantial share in the marketing and commercialization costs, as well as an initial equal share in profits in the United States, which will decrease as sales increase. Exelixis will receive royalties on any sales of the product which may be commercialized outside the United States.
2006
December 2006 : Established an additional alliance with Bristol-Myers Squibb to discover, develop and commercialize novel targeted therapies for the treatment of cancer. Exelixis received a $20 million upfront payment, and will receive an additional $20 million for each of up to three drug candidates selected by BMS at IND. The companies plan to share development costs, commercial profits and co-promotion responsibilities equally in the United States. Exelixis will also receive royalties on product sales outside of the United States. For each program selected by BMS, Exelixis may opt out of the co-development or co-promotion in the United States, in which case Exelixis would receive milestones and royalties in lieu of a U.S. profit share.
December 2006 : Initiation of a Phase II clinical trial of XL880 in patients with metastatic, poorly differentiated diffuse gastric cancer.
November 2006: Helsinn Healthcare SA discontinues enrollment of new patients in the becatecarin (XL119) Phase III clinical trial program in biliary tract tumors. Helsinn reported that despite some evidence of becatecarin activity, preliminary analysis of the Phase III data by an Independent Data Monitoring Committee indicated that the comparator agent 5-fluorouracil (5-FU) demonstrated a greater than expected survival benefit, making it statistically improbable that the final study results could achieve the planned objectives for the trial. Exelixis in-licensed becatecarin from Bristol-Myers Squibb in 2001 and subsequently out-licensed it to Helsinn in June 2005.
November 2006: Exelixis suspends enrollment of new patients in the XL999 clinical trial program after a preliminary review of patient data relating to cardiovascular adverse events for the month of October. Because 115 of the 131 subjects enrolled in the XL999 clinical program to date have received repeated doses of XL999 (every week or every other week) ranging from 2 doses (2 weeks) to 53 doses (approximately 2 years) with no reported cardiac toxicities, the company has elected to allow patients already enrolled to continue to receive XL999.
November 2006 : Data from the Phase I trials of XL999, XL880, XL647, XL820 and XL184 presented at 18th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics. For more information on these compounds, please visit the Pipeline section.
October 2006 : Successful completion of a public offering of common stock, raising net proceeds of $90.5 million.
August 2006 : Initiation of a Phase II clinical development program for XL647 in patients with metastatic non-small cell lung cancer.
June 2006 : Initiation of a Phase II clinical development program for XL880 in patients with papillary renal cell carcinoma.
June 2006 : Data from a Phase I trial of XL647 in patients with advanced solid tumors presented at ASCO. For more information on XL647, please visit the Pipeline section.
June 2006 : Data from a Phase I trial of XL880, the first c-MET inhibitor to enter clinical development, presented at ASCO. For more information on XL880, please visit the Pipeline section.
March 2006 : Initiation of a Phase II clinical development program for XL784 in patients with diabetes who have proteinuria, a marker for renal damage.
March 2006 : Establishment of a new collaboration agreement with Sankyo Company (a wholly owned subsidiary of DAIICHI SANKYO COMPANY, LIMITED) to discover, develop and commercialize novel therapies targeted against the mineralocorticoid receptor (MR), a nuclear hormone receptor (NHR) implicated in a variety of cardiovascular and metabolic diseases. Exelixis received a $20 million upfront payment and will receive research funding, substantial development, regulatory and commercialization milestone payments as well as double-digit royalties on the sale of any products commercialized under the collaboration.
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2005
December 2005 : Licensed compounds targeting the farnesoid X receptor (FXR), a nuclear hormone receptor implicated in a variety of metabolic and liver disorders, to Wyeth Pharmaceuticals. Exelixis received a $10 million upfront payment and will receive up to an additional $147.5 million in development and commercialization milestone payments as well as royalties on the sale of products commercialized under the collaboration.
December 2005 : Initiation of comprehensive Phase II development program for XL999. Four trials in various solid tumors are open for enrollment; two additional trials in hematologic malignancies are expected to initiate shortly.
December 2005 : Establishment of a new collaboration agreement with Bristol-Myers Squibb to discover, develop and commercialize novel therapies targeted against the Liver X Receptor (LXR), a nuclear hormone receptor implicated in a variety of cardiovascular and metabolic disorders. Upfront payments, research funding and milestone payments total approximately $167.5 million.
November 2005 : Data from a Phase I trial of XL999 in patients with advanced solid tumors presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. Study results identified a maximum tolerated dose and demonstrated preliminary evidence of clinical activity with no cumulative toxicities.
November 2005 : Data from a Phase I trial of XL647 in patients with advanced solid tumors presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. XL647 is generally well tolerated and has excellent pharmacokinetics. At the time of the presentation, a maximum tolerated dose had not yet been reached.
November 2005 : Data from a Phase I trial of XL880 in patients with advanced solid tumors presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. Results indicate that XL880 has very favorable safety and pharmacokinetic profiles, and that a maximum tolerated dose (MTD) has not yet been reached.
September 2005 : Initiation
of Phase I clinical trial of XL784, a potent inhibitor
of the ADAM-10 matrix metalloprotease (MMP) enzyme that
plays an important role in blood vessel formation and
cell proliferation which is implicated in diabetic nephropathy.
September 2005 :
Initiation of Phase I clinical trial of XL184, a potent
inhibitor of the various growth factor receptors and
RTKs.
September 2005 :
Initiation of Phase I clinical trial of XL844, a potent,
selective inhibitor of the kinase pathway that may
play a fundamental role in the development and progression
of cancer.
July 2005 : Initiation
of Phase I clinical trial of XL820, a novel small molecule
anticancer compound targeting RTKs implicated in tumor
proliferation and vascularization.
June 2005 :
Establishment of Symphony Evolution, Inc. (SEI), a
third-party funding vehicle providing up to $80 million
to fund the Phase II clinical development XL647, XL999
and XL784.
June 2005 : Establishment
of agreement with Helsinn Healthcare S.A. for the further
development and commercialization of XL119 (becatecarin).
June 2005 : Establishment
of collaboration with Genentech for the discovery and
development of therapeutics to target cancer, inflammatory
diseases, and tissue growth and repair.
May 2005 : Achievement
of $35 million milestones from GSK.
March 2005 : Amendment
of GenOptera agreement.
March 2005 : Initiation
of Phase I clinical trial of XL880, a novel, orally
administered small molecule for the treatment of cancer
that targets multiple RTKs that play synergistic roles
in promoting tumor growth and angiogenesis.
January 2005 : Expansion
of GSK collaboration provides accelerated milestone
payments to Exelixis and allows third-party development
and funding of certain programs.
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2004
October 2004 : Initiation
of Phase I clinical trial of XL999 a proprietary novel
anticancer compound that targets multiple RTKs implicated
in tumor angiogenesis.
October 2004 : Acquisition
of X-Ceptor Therapeutics, a leader in the discovery
and development of small molecules that modulate nuclear
hormone receptors (NHRs). Transaction enhances
Exelixis' development pipeline by adding compounds
that target important metabolic and cardiovascular
diseases and that complement Exelixis' cancer drug
development programs.
June 2004: Initiation
of the Phase III clinical trial of XL119 (becatecarin)
as a potential treatment for patients with bile duct
cancer.
June 2004 : Initiated
a Phase I clinical trial to evaluate the safety, tolerability
and pharmacokinetic profile of XL647, a proprietary
novel anticancer compound that demonstrates potent
inhibition in vitro against multiple receptor tyrosine
kinases (RTKs) implicated in tumor proliferation and
vascularization (angiogenesis).
March 2004 : Discovery
of novel cancer targets in the PTEN and B-catenin signaling
pathways presented at American Association for Cancer
Research (AACR).
March 2004 : FDA
grants orphan drug designation to XL119, an experimental
treatment for bile duct tumors.
February 2004 : Scientists
at Exelixis publish two landmark articles as the cover
story in Nature Genetics describing the most
complete functional genetic toolkit for studying a
multicellular organism, the fruit fly Drosophila
melanogaster . The Exelixis collection
includes specific disruptions in a majority of Drosophila
genes.
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2003
December 2003 : Exelixis
and BMS extend oncology collaboration.
September 2003 :
Reach agreement with U.S. Food and Drug Administration
(FDA) on Special Protocol Assessment
(SPA) for XL119 Phase III trial.
June 2003 : Successful
completion of a public offering of common stock, raising
net proceeds of $74.7 million.
June 2003 : Phase
II data on XL119 in hepatobiliary tumors presented
at American Society of Clinical Oncology (ASCO). The
data showed encouraging results relative to tolerability,
overall survival and progression free survival.
2002
October 2002 : Formation
of broad alliance with GlaxoSmithKline to discover,
develop and commercialize novel therapeutics in the
areas of vascular biology, inflammatory disease and
oncology.
May 2002 : Establishment
of chemistry collaboration with Merck for the joint
design and generation of small molecule compound libraries
for high-throughput drug screening.
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2001
December 2001 :
Acquisition of the bio-informatics and financial assets
of Genomica Corporation.
August 2001-December 2001 :
Establishment of four combinatorial chemistry collaborations,
with Elan, Scios, Cytokinetics and Schering-Plough
Research Institute to jointly design custom high-throughput
screening compound libraries.
July 2001 : Establishment
of new collaboration with BMS to discover novel cancer
targets. Exelixis also in-license XL119 (becatacarin)
from BMS.
June 2001 : Announcement
of first-ever "Functional Map" linking genes
to biological activity in vertebrates by functionally
identifying the majority of essential genes involved
in the structure and function of the heart, bone, cartilage,
blood vessels and nervous system of a zebrafish vertebrate.
May 2001 : Establishment
of collaboration with Protein Design Labs to discover
and develop humanized antibodies for the diagnosis,
prevention and treatment of cancer.
April 2001 : Acquisition
of remaining assets of Artemis, continuing the company's
strategy to optimize all aspects of the drug discovery
process from target identification to clinical development.
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2000
December 2000 :
Acquisition of Agritope, joint venture with Aventis
Crop Science providing Exelixis with key intellectual
property, technology and expertise in plant biology.
July 2000 : Establishment
of research collaboration with Dow AgroSciences to
identify the mechanism of action of herbicides and
fungicides.
April 2000 : Completion
of successful initial public offering (IPO) including
the exercise of the overallotment, raising $126 million.
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1999
December 1999 :
Expansion of Bayer collaboration to form Genoptera
LLC, a joint venture to discover and develop insecticides
and nematicides for crop protection.
September 1999 :
Establishment of research collaboration with Bristol-Myers
Squibb (BMS) to identify the mechanism of action of
key molecular targets. This agreement included
the acquisition of BMS' combinatorial chemistry in
a technology exchange.
July 1999 : Acquisition
of the assets of Metaxen, a major step in Exelixis'
evolution into an integrated pharmaceutical drug discovery
company.
July 1999 : Exelixis
Plant Sciences (formerly known as Agritope) and Aventis
CropScience form an equally owned joint venture, Agrinomics
LLC, to focus on research, development and commercialization
of products in agricultural functional genomics.
March 1999 : Establishes
research collaboration with Pharmacia & Upjohn.
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1998
April 1998 : Establishes
agricultural partnership with Bayer Corporation.
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1997
December 1997 : Company
establishes Artemis Pharmaceuticals as a partially
owned subsidiary located in Germany.
January 1997 : Company
moves its headquarters to South San Francisco, California.
November 1994 : Exelixis,
founded in Cambridge, Massachusettes, is incorporated
in 1994.
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