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What’s going on?
Was good to see EXEL held its ground over
the last couple of weeks.
Goldman Sachs is bullish on biopharma in
a news artical in Seeking Alpha. Exel is
one of many there mentioned.
No doubt this stock is tucked away in my portfolio.On the other hand I have a few that are making me blue in the face......
Yes sir. Patience. $$$$
Yeah Harry I can see 50 plus within the next 6 months.Great stock to be in
40 is gone! Its now 50+, mark it in 2018! $$$$
Looks like we will close the year above 30 great year coming up
Great bio stock here to own. 40+ possible with approvals looming. $$$
Lets see this close above thirty for EOY.At least this baby roared in 2017 not like ADXS who shyte the bed
Up we again, never a doubt here. $$$
Holding his phone upside down?
There you go nice pop today back to the 30's we go
boom, hope many of you added that sell off as we did. told everyone this bio was going to be a winner! $$$
Yes nice pop today definetly moving forward from here.Welcome the thirties baby
Everything's coming up EXEL!
No debt, expanding indications (aka revenue).
Looking forward to hearing what they're looking at re: in-licensing/pipeline
sure does an yes it is
Happens to ADXS on a regular basis.Grand larceny
yeah, us to. added.
I hope SEC will do something if some are found guilty.. On the other hand I kinda like it because it did gave me a chance to buy some at mid $23..
someone got together a group to short this an make some serious cash in 1 day. im sure the sec will be looking into the fund managers asap on this one. just bought more! lmfao$$$)
Thanks elbiatcho1!
Downgrade by Leerink Partners.
EXEL in a very good position to be bought sooner vs later. $27 is very cheap right now.
This board is very quiet. Would've thought there would be many more posts and excitement about EXEL.
ESMO conf call was very well handled with some superb questions for over am hour. Dr Toni is a rock star. EXEL will be a BIG winner over the next coming weeks/months! BUY, BUY, BUY will be the recommendation!
Exelixis and Ipsen Announce Results from Phase 2 CABOSUN Trial of Cabozantinib versus Sunitinib in Previously Untreated Advanced Renal Cell Carcinoma at ESMO 2017
Sept. 9, 2017 22:09 UTC
– Independent Radiology Review Committee confirms primary endpoint analysis per investigator: cabozantinib provided statistically significant improvement of progression-free survival, with a 52 percent reduction in the rate of progression or death compared to sunitinib –
– Exelixis and Ipsen to host investor and media webcast from Madrid to discuss the data on Sunday, September 10 starting at 6:45 p.m. CEST –
SOUTH SAN FRANCISCO, Calif. & PARIS--(BUSINESS WIRE)-- Exelixis, Inc. (NASDAQ:EXEL) and Ipsen (Euronext:IPN; ADR:IPSEY) today announced updated results from the CABOSUN randomized phase 2 trial of cabozantinib in patients with previously untreated advanced renal cell carcinoma (RCC) with intermediate- or poor-risk disease per the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC). Principal investigator Toni K. Choueiri, M.D., will present detailed data from late-breaking CABOSUN abstract [#LBA38_PD] today in the Genitourinary Tumors, Non-Prostate poster discussion session, starting at 2:45 p.m. CEST (local Madrid time) / 8:45 a.m. EDT / 5:45 a.m. PDT at the European Society for Medical Oncology (ESMO) 2017 Congress, which is being held September 8-12, 2017 in Madrid, Spain.
CABOSUN is being conducted by The Alliance for Clinical Trials in Oncology as part of Exelixis’ collaboration with the National Cancer Institute’s Cancer Therapy Evaluation Program (NCI-CTEP). The data presented at ESMO 2017 included the analysis from a blinded independent radiology review committee (IRC), which confirmed the primary efficacy endpoint results of investigator-assessed progression-free survival (PFS), as well as an updated investigator-assessed analysis. Per the IRC analysis, cabozantinib demonstrated a clinically meaningful and statistically significant 52 percent reduction in the rate of disease progression or death (HR 0.48, 95% CI 0.31-0.74, two-sided P=0.0008). The median PFS for cabozantinib was 8.6 months versus 5.3 months for sunitinib, corresponding to a 3.3 month (62 percent) improvement favoring cabozantinib over sunitinib.
“These updated analyses from CABOSUN consistently show that cabozantinib provided a statistically significant decrease in the rate of disease progression or death compared to sunitinib, a current standard of care – potentially offering a new treatment option for physicians to treat patients in the first-line advanced renal cell carcinoma setting,” said Toni K. Choueiri, M.D., Director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute. “The CABOSUN trial included patients with intermediate or poor prognostic factors per the IMDC criteria; in addition, patients had a notable number of other independent adverse prognostic risk factors. These included a high rate of bone metastases, two or more sites of metastatic disease, ECOG 2 performance status, and lack of prior nephrectomy. This patient population fares poorly and is in need of new therapies to better control their disease.”
The following chart outlines data from the CABOSUN trial presented today at ESMO 2017, as compared to the data previously published in the Journal of Clinical Oncology (JCO) in October 2016:
JCO
Investigator-assessed
(April 11, 2016 Cut-off)
ESMO 2017
Investigator-assessed
(Sept 15, 2016 Cut-off)
ESMO 2017
IRC Review
(Sept 15, 2016 Cut-off)
Cabozantinib
N = 79
Sunitinib
N = 78
Cabozantinib
N = 79
Sunitinib
N = 78
Cabozantinib
N = 79
Sunitinib
N = 78
Progression-free survival
Median PFS, months
8.2
5.6
8.3
5.4
8.6
5.3
Stratified HR
(95% CI)
0.66 (0.46-0.95)
0.56 (0.37-0.83)
0.48 (0.31-0.74)
P value
0.012 (1-sided)
0.0042 (2-sided)
0.0008 (2-sided)
Tumor Response
Objective response rate (95% CI),a %
46 (34-57)
18 (10-28)
33 (23-44)
12 (5-21)
20 (12-31)
9 (4-18)
Disease control rate,b %
78
54
76
49
75
47
Progressive disease,c %
18
26
18
24
18
29
Not evaluable or missing, %
4
21
6
27
8
23
Any reduction in target lesions, %
87
44
85
38
80
50
a
One complete response was observed with cabozantinib for both investigator assessments, and one complete response was observed with sunitinib for the original investigator assessment, all other responses were partial responses; b Complete response + partial response + stable disease; c Progressive disease as best overall response.
The updated 2017 data sets and methods differ from the initial investigator analyses presented in 2016. The comprehensive image collection for IRC review used a later cut-off point (5 months) than the initial investigator analysis and followed a rigorous IRC review process. The analysis of IRC data applied U.S. Food and Drug Administration (FDA) guidance for PFS analyses in oncology studies, including recommended censoring rules (i.e., censoring at the last adequate tumor assessment prior to initiation of subsequent anti-cancer therapy, and censoring for events that occur after two or more missing adequate tumor assessments).1 Both the updated investigator assessment and IRC analysis demonstrated consistent and statistically significant improvement of PFS with cabozantinib as compared to sunitinib.
The updated overall survival (OS) analysis had a data cut-off of July 1, 2017, and showed a favorable trend for patients randomized to cabozantinib compared to sunitinib that was not statistically significant. Median overall survival was 26.6 months for patients receiving cabozantinib versus 21.2 months for those receiving sunitinib (HR= 0.80, 95% CI 0.53-1.21, two-sided P=0.29).
“We are very encouraged by the clinically meaningful and statistically significant efficacy results on the primary endpoint of progression-free survival, which formed the basis of the recent supplemental New Drug Application submitted to the U.S. Food and Drug Administration for cabozantinib in first-line advanced renal cell carcinoma,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. “The latest CABOSUN data continue to underscore the value that cabozantinib may offer patients with previously untreated renal cell carcinoma, and we are working tirelessly in our efforts to bring this option to patients and their physicians as quickly as possible.”
David Meek, Chief Executive Officer of Ipsen stated, “Following the recent European approval of cabozantinib for second-line treatment of patients with advanced renal cell carcinoma following prior VEGF-targeted therapy, the latest data from the CABOSUN study being presented this year at ESMO extends the clinical benefit of cabozantinib in first-line therapy setting for patients with advanced RCC. With our partner Exelixis, we are committed to strengthening the medical value of cabozantinib and to continuing to bring innovative therapeutic solutions for the treatment of patients with RCC."
The most common all-causality grade 3 or 4 adverse events in more than 5 percent of patients for cabozantinib (N=78) and sunitinib (N=72), respectively, were diarrhea (10 vs. 11 percent), hypertension (28 vs. 21 percent), fatigue (6 vs. 17 percent), increased alanine aminotransferase (ALT; 5 vs. 0 percent), decreased appetite (5 vs. 1 percent), palmar-plantar erythrodysesthesia syndrome (PPES; 8 vs. 4 percent), decreased platelet count (1 vs. 11 percent) and stomatitis (5 vs. 6 percent). Twenty-one percent of patients in the cabozantinib arm and 22 percent of patients in the sunitinib arm discontinued treatment due to adverse events.
Exelixis filed a supplemental New Drug Application based on the CABOSUN data with the FDA for cabozantinib as a treatment for previously untreated advanced RCC on August 16, 2017. Ipsen also submitted to EMA the regulatory dossier for cabozantinib as a treatment for first-line advanced RCC in the European Union on August 28, 2017; on September 8, 2017, Ipsen announced that the EMA validated the application.
About the CABOSUN Study
On May 23, 2016, Exelixis announced that CABOSUN met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in PFS compared with sunitinib in patients with advanced intermediate- or poor-risk RCC as determined by investigator assessment. The CABOSUN trial is being conducted by The Alliance for Clinical Trials in Oncology as part of Exelixis’ collaboration with the NCI-CTEP. These results were first presented in a plenary session by Dr. Toni Choueiri at the ESMO 2016 Congress, and published in the JCO.2 In June 2017, a blinded IRC confirmed that cabozantinib provided a clinically meaningful and statistically significant improvement in the primary efficacy endpoint of investigator-assessed PFS.
CABOSUN is a randomized, open-label, active-controlled phase 2 trial that enrolled 157 patients with advanced RCC determined to be intermediate- or poor-risk by the IMDC criteria. Patients were randomized 1:1 to receive cabozantinib (60 mg once daily) or sunitinib (50 mg once daily, 4 weeks on followed by 2 weeks off). The primary endpoint was PFS. Secondary endpoints included OS and objective response rate.
Eligible patients were required to have locally advanced or metastatic clear-cell RCC, ECOG performance status 0-2 and had to be intermediate or poor risk per the IMDC criteria (Heng, JCO, 2009).3 Prior systemic treatment for RCC was not permitted. Baseline characteristics included:
Characteristic
Cabozantinib
(N=79)
Sunitinib
(N=78)
ECOG performance status, %
0
46
46
1
42
41
2
13
13
IMDC risk group, %
Intermediate
81
81
Poor
19
19
Bone metastasis per IxRS,a %
Yes
37
36
No
63
64
Prior nephrectomy, %
Yes
72
77
No
28
23
Number of metastatic sites per investigator, %
1
22
33
2
47
26
≥3
32
41
a interactive voice/web response system
Please see Important Safety Information below and full U.S. prescribing information at https://cabometyx.com/downloads/cabometyxuspi.pdf.
Webcast for the Financial Community and Media
Exelixis and its partner Ipsen will jointly host a live webcast on Sunday, September 10. The webcast will begin at 6:45 p.m. CEST (local Madrid time) / 12:45 p.m. EDT / 9:45 a.m. PDT. During the webcast, Exelixis and Ipsen management and invited guest speakers will review results from the CABOSUN trial, along with the other relevant data sets presented at the conference.
To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the webcast to ensure adequate time for any software download that may be required to view the program. To listen to an audio-only version of the program by phone, please dial (855) 793-2457 (domestic) or (631) 485-4921 (international/toll dial) and use passcode 68961937. A telephone replay will be available until 11:59 p.m. EDT on September 17, 2017. Access numbers for the telephone replay are: 855-859-2056 (domestic) and 404-537-3406 (international); the passcode is 68961937. A webcast replay will also be available archived on www.exelixis.com for one year.
About Advanced Renal Cell Carcinoma
The American Cancer Society’s 2017 statistics cite kidney cancer as among the top ten most commonly diagnosed forms of cancer among both men and women in the U.S.4 Clear cell RCC is the most common type of kidney cancer in adults.5 If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 12 percent, with no identified cure for the disease.6 Approximately 30,000 patients in the U.S. and 68,000 globally require treatment, and an estimated 14,000 patients in the U.S. each year are in need of a first-line treatment for advanced kidney cancer.7
The majority of clear cell RCC tumors have lower than normal levels of a protein called von Hippel-Lindau, which leads to higher levels of MET, AXL and VEGF.8,9 These proteins promote tumor angiogenesis (blood vessel growth), growth, invasiveness and metastasis.10-13 MET and AXL may provide escape pathways that drive resistance to VEGF receptor inhibitors.8,9
About CABOMETYX® (cabozantinib)
CABOMETYX is the tablet formulation of cabozantinib. Its targets include MET, AXL and VEGFR-1, -2 and -3. In preclinical models, cabozantinib has been shown to inhibit the activity of these receptors, which are involved in normal cellular function and pathologic processes such as tumor angiogenesis, invasiveness, metastasis and drug resistance. CABOMETYX is available in 20 mg, 40 mg or 60 mg doses. The recommended dose is 60 mg orally, once daily.
On April 25, 2016, the FDA approved CABOMETYX tablets for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy. In February of 2016, Exelixis and Ipsen jointly announced an exclusive licensing agreement for the commercialization and further development of cabozantinib indications outside of the United States, Canada and Japan. This agreement was amended in December of 2016 to include commercialization rights for Ipsen in Canada. On September 9, 2016, the European Commission approved CABOMETYX tablets for the treatment of advanced RCC in adults who have received prior vascular endothelial growth factor (VEGF)-targeted therapy in the European Union, Norway and Iceland.
On January 30, 2017, Exelixis and Takeda Pharmaceutical Company Limited announced an exclusive licensing agreement for the commercialization and further clinical development of cabozantinib for all future indications in Japan, including RCC.
CABOMETYX is not indicated for the treatment of previously untreated advanced RCC.
U.S. Important Safety Information
Hemorrhage: Severe hemorrhage occurred with CABOMETYX. The incidence of Grade ≥3 hemorrhagic events was 2.1% in CABOMETYX-treated patients and 1.6% in everolimus-treated patients. Fatal hemorrhages also occurred in the cabozantinib clinical program. Do not administer CABOMETYX to patients that have or are at risk for severe hemorrhage.
Gastrointestinal (GI) Perforations and Fistulas: Fistulas were reported in 1.2% (including 0.6% anal fistula) of CABOMETYX-treated patients and 0% of everolimus-treated patients. GI perforations were reported in 0.9% of CABOMETYX-treated patients and 0.6% of everolimus-treated patients. Fatal perforations occurred in the cabozantinib clinical program. Monitor patients for symptoms of fistulas and perforations. Discontinue CABOMETYX in patients who experience a fistula that cannot be appropriately managed or a GI perforation.
Thrombotic Events: CABOMETYX treatment results in an increased incidence of thrombotic events. Venous thromboembolism was reported in 7.3% of CABOMETYX-treated patients and 2.5% of everolimus-treated patients. Pulmonary embolism occurred in 3.9% of CABOMETYX-treated patients and 0.3% of everolimus-treated patients. Events of arterial thromboembolism were reported in 0.9% of CABOMETYX-treated patients and 0.3% of everolimus-treated patients. Fatal thrombotic events occurred in the cabozantinib clinical program. Discontinue CABOMETYX in patients who develop an acute myocardial infarction or any other arterial thromboembolic complication.
Hypertension and Hypertensive Crisis: CABOMETYX treatment results in an increased incidence of treatment-emergent hypertension. Hypertension was reported in 37% (15% Grade ≥3) of CABOMETYX-treated patients and 7.1% (3.1% Grade ≥3) of everolimus-treated patients. Monitor blood pressure prior to initiation and regularly during CABOMETYX treatment. Withhold CABOMETYX for hypertension that is not adequately controlled with medical management; when controlled, resume CABOMETYX at a reduced dose. Discontinue CABOMETYX for severe hypertension that cannot be controlled with anti-hypertensive therapy. Discontinue CABOMETYX if there is evidence of hypertensive crisis or severe hypertension despite optimal medical management.
Diarrhea: Diarrhea occurred in 74% of patients treated with CABOMETYX and in 28% of patients treated with everolimus. Grade 3 diarrhea occurred in 11% of CABOMETYX-treated patients and in 2% of everolimus-treated patients. Withhold CABOMETYX in patients who develop intolerable Grade 2 diarrhea or Grade 3-4 diarrhea that cannot be managed with standard antidiarrheal treatments until improvement to Grade 1; resume CABOMETYX at a reduced dose. Dose modification due to diarrhea occurred in 26% of patients.
Palmar-Plantar Erythrodysesthesia Syndrome (PPES): Palmar-plantar erythrodysesthesia syndrome (PPES) occurred in 42% of patients treated with CABOMETYX and in 6% of patients treated with everolimus. Grade 3 PPES occurred in 8.2% of CABOMETYX-treated patients and in <1% of everolimus-treated patients. Withhold CABOMETYX in patients who develop intolerable Grade 2 PPES or Grade 3 PPES until improvement to Grade 1; resume CABOMETYX at a reduced dose. Dose modification due to PPES occurred in 16% of patients.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS): RPLS, a syndrome of subcortical vasogenic edema diagnosed by characteristic finding on MRI, occurred in the cabozantinib clinical program. Perform an evaluation for RPLS in any patient presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue CABOMETYX in patients who develop RPLS.
Embryo-fetal Toxicity: CABOMETYX can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with CABOMETYX and for 4 months after the last dose.
Adverse Reactions: The most commonly reported (≥25%) adverse reactions are: diarrhea, fatigue, nausea, decreased appetite, PPES, hypertension, vomiting, weight decreased, and constipation.
Drug Interactions: Strong CYP3A4 inhibitors and inducers: Reduce the dosage of CABOMETYX if concomitant use with strong CYP3A4 inhibitors cannot be avoided. Increase the dosage of CABOMETYX if concomitant use with strong CYP3A4 inducers cannot be avoided.
Lactation: Advise a lactating woman not to breastfeed during treatment with CABOMETYX and for 4 months after the final dose.
Reproductive Potential: Contraception?Advise females of reproductive potential to use effective contraception during treatment with CABOMETYX and for 4 months after the final dose. Infertility ?CABOMETYX may impair fertility in females and males of reproductive potential.
Hepatic Impairment: Reduce the CABOMETYX dose in patients with mild (Child-Pugh score [C-P] A) or moderate (C-P B) hepatic impairment. CABOMETYX is not recommended for use in patients with severe hepatic impairment.
Please see full Prescribing Information at https://cabometyx.com/downloads/cabometyxuspi.pdf.
About Exelixis
Founded in 1994, Exelixis, Inc. (Nasdaq: EXEL) is a commercially successful, oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Following early work in model genetic systems, we established a broad drug discovery and development platform that has served as the foundation for our continued efforts to bring new cancer therapies to patients in need. We discovered our lead compounds, cabozantinib and cobimetinib, and advanced them into clinical development before entering into partnerships with leading biopharmaceutical companies in our efforts to bring them to patients globally. With growing revenues from the three resulting commercialized products – CABOMETYX®, COMETRIQ®, and COTELLIC® – we are reinvesting in our business to maximize the potential of our pipeline, which we intend to supplement with targeted business development activities and internal drug discovery, all to deliver the next generation of Exelixis medicines and help patients recover stronger and live longer. For more information about Exelixis, please visit www.exelixis.com or follow @ExelixisInc on Twitter.
About Ipsen
Ipsen is a global specialty-driven pharmaceutical group with total sales exceeding €1.4 billion in 2015. Ipsen sells more than 20 drugs in more than 115 countries, with a direct commercial presence in more than 30 countries. Ipsen’s ambition is to become a leader in specialty healthcare solutions for targeted debilitating diseases. Its fields of expertise cover oncology, neurosciences and endocrinology (adult & pediatric). Ipsen’s commitment to oncology is exemplified through its growing portfolio of key therapies improving the care of patients suffering from prostate cancer, bladder cancer and neuro-endocrine tumors. Ipsen also has a significant presence in primary care. Moreover, the Group has an active policy of partnerships. Ipsen's R&D is focused on its innovative and differentiated technological platforms, peptides and toxins, located in the heart of the leading biotechnological and life sciences hubs (Les Ulis/Paris-Saclay, France; Slough/Oxford, UK; Cambridge, US). In 2015, R&D expenditure totaled close to €193 million. The Group has more than 4,600 employees worldwide. Ipsen’s shares are traded on segment A of Euronext Paris (stock code: IPN, ISIN code: FR0010259150) and eligible to the “Service de Règlement Différé” (“SRD”). The Group is part of the SBF 120 index. Ipsen has implemented a Sponsored Level I American Depositary Receipt (ADR) program, which trade on the over-the-counter market in the United States under the symbol IPSEY. For more information on Ipsen, visit www.ipsen.com.
Exelixis Forward-Looking Statement Disclaimer
This press release contains forward-looking statements, including, without limitation, statements related to: the presentation of detailed data from CABOSUN at ESMO; the therapeutic potential of cabozantinib as a treatment for patients with previously untreated RCC; the commitment of Exelixis its partner Ipsen to strengthening the medical value of cabozantinib and to continuing to bring innovative therapeutic solutions for the treatment of patients with RCC; and the continued development of cobimetinib and its potential in a variety of forms of cancer. Words such as “will,” “potentially,” “may,” “committed,” “continue,” or other similar expressions identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements are based upon Exelixis’ current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the availability of data at the referenced times; risks related to the potential failure of cabozantinib to demonstrate safety and efficacy in clinical testing; risks and uncertainties related to regulatory review and approval processes and Exelixis’ compliance with applicable legal and regulatory requirements; Exelixis’ dependence on its relationship with Genentech/Roche with respect to cobimetinib and Exelixis’ ability to maintain its rights under the collaboration; Exelixis’ ability to protect the company’s intellectual property rights; market competition; changes in economic and business conditions, and other factors discussed under the caption “Risk Factors” in Exelixis’ quarterly report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 2, 2017, and in Exelixis’ future filings with the SEC. The forward-looking statements made in this press release speak only as of the date of this press release. Exelixis expressly disclaims any duty, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Exelixis’ expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
Exelixis, the Exelixis logo, CABOMETYX, COMETRIQ and COTELLIC are registered U.S. trademarks.
References
1. Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics. U.S. Department of Health and Human Services Food and Drug Administration; May 2007.
2. Choueiri, T.K., et al. Cabozantinib versus Sunitinib as Initial Targeted Therapy for Patients with Metastatic Renal Cell Carcinoma of Poor or Intermediate Risk: The Alliance A031203 CABOSUN Trial. Am J Clin Oncol. 2016; 35:591-597.
3. Heng D.Y., Xie W., Regan M.M., et al. Prognostic factors for overall survival in patients with metastatic renal cell carcinoma treated with vascular endothelial growth factor-targeted agents: Results from a large, multicenter study. Am J Clin Oncol. 2009; 27:5794-5799.
4. American Cancer Society. Cancer Facts & Figures 2017. Atlanta: American Cancer Society; 2017.
5. Jonasch, E., Gao, J., Rathmell, W. Renal cell carcinoma. BMJ. 2014; 349:g4797.
6. Ko, J., Choueiri, T., et al. First-, second- third-line therapy for mRCC: benchmarks for trial design from the IMDC. Br J Cancer. 2014; 110:1917-1922.
7. Decision Resources Report: Renal Cell Carcinoma. October 2014 (internal data on file).
8. Harshman, L., and Choueiri, T. Targeting the hepatocyte growth factor/c-Met signaling pathway in renal cell carcinoma. Cancer J. 2013; 19:316-323.
9. Rankin, et al. Direct regulation of GAS6/AXL signaling by HIF promotes renal metastasis through SRC and MET. Proc Natl Acad Sci U S A. 2014; 111:13373-13378.
10. Zhou, L., Liu, X-D., Sun, M., et al. Targeting MET and AXL overcomes resistance to sunitinib therapy in renal cell carcinoma. Oncogene. 2016; 35:2687-2697.
11. Koochekpour, et al. The von Hippel-Lindau tumor suppressor gene inhibits hepatocyte growth factor/scatter factor-induced invasion and branching morphogenesis in renal carcinoma cells. Mol Cell Biol. 1999; 19:5902–5912.
12. Takahashi, A., Sasaki, H., Kim, S., et al. Markedly increased amounts of messenger RNAs for vascular endothelial growth factor and placenta growth factor in renal cell carcinoma associated with angiogenesis. Cancer Res. 1994; 54:4233-4237.
13. Nakagawa, M., Emoto, A., Hanada, T., Nasu, N., Nomura, Y. Tubulogenesis by microvascular endothelial cells is mediated by vascular endothelial growth factor (VEGF) in renal cell carcinoma. Br J Urol. 1997; 79:681-687.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170909005044/en/
Contacts
Exelixis, Inc.
Investors
Susan Hubbard, 650-837-8194
EVP, Public Affairs and Investor Relations
shubbard@exelixis.com
or
Media
Lindsay Treadway, 650-837-7522
Director, Public Affairs and Advocacy Relations
ltreadway@exelixis.com
Source: Exelixis, Inc.
ESMO this weekend and Morgan conf next week. Looking for big recovery today and Monday.
Thank you PW! Trading is all about timing and having that discipline to know when to pull the trigger..
Would like to see $26 or better after the closing bell..
Nice profit! You were wise to not get greedy and take the profits. Bird in the hand is better than two birds in the bush. Although i've learned over the years to not take it all off the table, rather just 50-75% and then let the rest ride. The errors in my ways is with having the discipline to EXIT to minimize losses.
I'm more of a hybrid between swing trading (ST) and trend following. I have a boat load of RTM scans for ST, and I use the Hawkeye pro suite of tools for trend following. I also use the APA Zones for support/resistance identification coupled with APA PAF for entry/exits signals. I don't DT though.
Thanks... I agree... Haven't traded a lot of pharmaceuticals lately so haven't looked at the FDA calendar recently, but agree, that's the key tool... I hope the FDA doesn't derail EXEL too badly though...
Likewise... TradeStation is what I use... Basically, I Daytrade... Just starting to dabble with options...
I rode from $3s and sold at $21s. I regretted selling too soon especially when it hit $29.. I saw the dropped this morning and I thought it might be good time to get back..
I wouldn't be surprise if EXEL is up $1-$2 tomorrow
as a general rule I don't trade biotechs because of the very reason you mention. But EXEL showed up as a signal from one my tradestation scans and I bought it without first checking for biotech or near-term earnings reports. Live and learn.
thanks... I use Seeking Alpha all the time but hadn't been following EXEL that closely, until I saw the drop this morning...
These really bring things into light. Kind of makes a crap-shoot out of the whole deal... I was really into pharmaceuticals about 5 years ago, but they really are volatile, so moved to other areas... We'll have to see what happens...
This may also be the reason for the selloff...
https://seekingalpha.com/news/3294186-exelixis-9-percent-bristol-myers-successful-study-opdivo-yervoy-rcc
I was checking the PR and it looks like one of the outfits reporting out on the news misquoted and stated that the stock should have support around it's 200 day moving average around 5 dollars or so. Maybe some readers took that as fact and dumped in panic. I show the 200/SMA at 21.57. That's a long way from 5 bucks!!
I caught it on the way down, so baought at 26.30, 26.00 & 25.34 for an ave of 25.88... Didn't think it was going to go as low as it did...
Sitting at the 25.88 for now...
If it gets up to that, and it isn't shooting upward, I might drop half in anticipation of dropping back down... It's really been bouncing a lot... and I agree with the comment a minute ago about exel being our friend...
Bought some back at $25.30s
BMY success does not mean EXEL failure. They are our friends.
Future is Cabo + Opdivo + Yervoy
Wowsa below 25 cant believe it dropped on no bad news looks like a buying opp.
If you missed exel today, it opened at 28.17 and dropped all the way to 24.67... Like wow..!
On the way back up...! or down..?
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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.
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.
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.
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.
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., 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. 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. 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. 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 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. 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, 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. 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. 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 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.
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.
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™ 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® 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
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COTELLIC® | 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 The following can occur in patients treated with COTELLIC:
USE IN SPECIFIC POPULATIONS: Lactation DRUG INTERACTIONS 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. |
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.
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, 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 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.
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
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Please see additional Important Safety Information for COMETRIQ® (cabozantinib), including Boxed Warnings, at www.COMETRIQ.com.
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
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