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exelixis inc (EXEL) Details

Exelixis, Inc., a biotechnology company, develops small molecule therapies for the treatment of cancer in the United States. The company focuses primarily on developing and commercializing COMETRIQ, an inhibitor of multiple receptor tyrosine kinases for the treatment of progressive and metastatic medullary thyroid cancer. It is also evaluating COMETRIQ in two ongoing Phase III pivotal trials for metastatic castration-resistant prostate cancer; an Phase III pivotal trial for metastatic renal cell cancer; and an Phase III pivotal trial for advanced hepatocellular cancer. In addition, the company develops cobimetinib, an inhibitor of MEK, which is in Phase III clinical trial evaluating the combination of cobimetinib with vemurafenib versus vemurafenib. Exelixis, Inc. has collaborations with Genentech, Inc., GlaxoSmithKline, Bristol-Myers Squibb Company, Sanofi, Merck, and Daiichi Sankyo Company Limited for the development and commercialization of various compounds. The company was formerly known as Exelixis Pharmaceuticals, Inc. and changed its name to Exelixis, Inc. in February 2000. Exelixis, Inc. was founded in 1994 and is headquartered in South San Francisco, California.

227 Employees
Last Reported Date: 02/20/14
Founded in 1994

exelixis inc (EXEL) Top Compensated Officers

Chief Executive Officer, President and Direct...
Total Annual Compensation: $1.1M
Chief Medical Officer and Executive Vice Pres...
Total Annual Compensation: $681.7K
Executive Vice President
Total Annual Compensation: $617.6K
Chief Commercial Officer and Executive Vice P...
Total Annual Compensation: $577.3K
Total Annual Compensation: $689.2K
Compensation as of Fiscal Year 2013.

exelixis inc (EXEL) Key Developments

Exelixis Inc. Announces Results from Phase 3 Pivotal Trial of Cobimetinib in Combination with Vemurafenib in Patients with BRAF V600 Mutation-Positive Advanced Melanoma

Exelixis Inc. announced the positive results from coBRIM, the phase 3 pivotal trial conducted by Exelixis' collaborator Genentech, a member of the Roche Group, evaluating cobimetinib, a specific MEK inhibitor discovered by Exelixis, in combination with vemurafenib in previously untreated patients with unresectable locally advanced or metastatic melanoma harboring a BRAF V600 mutation. The trial met its primary endpoint of demonstrating a statistically significant increase in investigator-determined progression-free survival (PFS). The median PFS was 9.9 months for the combination of cobimetinib and vemurafenib versus 6.2 months for vemurafenib alone (hazard ratio [HR]=0.51, 95% CI 0.39-0.68; p<0.0001), demonstrating the combination reduced the risk of the disease worsening by half (49%). The median PFS by independent review committee (IRC), a secondary endpoint, was 11.3 months for the combination arm compared to 6.0 months for the control arm (HR=0.60, 95% CI 0.45-0.79; p=0.0003). Objective response rate (ORR), another secondary endpoint, was 68% for the combination versus 45% for vemurafenib alone (p<0.0001). Overall survival data are not yet mature (HR=0.65, 95% CI 0.42-1.00; p=0.046), and at the interim analysis the p-value did not cross the prespecified boundary for significance. The safety profile of the combination was consistent with that observed in a previous study. The coBRIM data will be presented at ESMO 2014 on September 29, during the Presidential Symposium by Professor Grant McArthur, Peter MacCallum Cancer Centre, Australia and are also part of the official press program. Roche has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency, and Genentech plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration later 2014. The coBRIM trial is an international, randomized, double-blind, placebo-controlled Phase III study evaluating the safety and efficacy of 60 mg once daily of cobimetinib in combination with 960 mg twice daily of vemurafenib, compared to 960 mg twice daily of vemurafenib alone. In the study, 495 patients with BRAF V600 mutation-positive unresectable locally advanced or metastatic melanoma (detected by the cobas(R) 4800 BRAF Mutation Test) and previously untreated for advanced disease, were randomized to receive vemurafenib every day on a 28-day cycle plus either cobimetinib or placebo for days 1-21. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent. Median follow up was 7.4 months for the combination arm and 7.2 months for the control arm. There was a higher overall frequency of Grade 3 or higher adverse events in the combination arm (65 versus 59%), with close to half of these due to lab abnormalities. Common adverse events of any grade that occurred in more than 20% of patients and were observed at a higher frequency in the combination arm compared to the vemurafenib arm included diarrhea (57 versus 28%), nausea (39 versus 24%), photosensitivity (28 versus 16%), lab abnormalities (increased alanine aminotransferase [24 versus 18%], increased aspartate aminotransferase [22 versus 13%], increased creatine phosphokinase [an enzyme released by muscles, 30 versus 3%]), and vomiting (21 versus 12%). Common adverse events observed at a lower frequency in the combination arm included hair loss (14 versus 29%), thickening of the outer layer of the skin (10 versus 29%), and joint pain (33 versus 40%). Most instances of each common adverse event were grade 1 or 2 in severity. Other select adverse events that were lower in the combination arm included cutaneous squamous cell carcinomas (3 versus 11%; all grades) and keratoacanthomas (<1 versus 8%; all grades). Serous retinopathy (collection of fluid under the retina) was observed at a higher frequency in the combination arm (20 versus <1%) with most of these events either Grade 1 or 2 and temporary in nature. Specific adverse events leading to withdrawal from treatment were similar in both study arms, as was the overall discontinuation rate from treatment (13 versus 12%).

Exelixis, Inc. Promotes Deborah Burke to Senior Vice President and Chief Financial Officer

On September 19, 2014, Exelixis, Inc. promoted Deborah Burke to the position of Senior Vice President and Chief Financial Officer from her previous position of Vice President and interim Chief Financial Officer (and in such capacity, Ms. Burke will continue to serve as Exelixis' principal financial officer and principal accounting officer, as defined under applicable securities laws).

Exelixis, Inc. Cuts Workforce by 70%

Exelixis, Inc. announced that the company will reduce its workforce by 70%, or approximately 160 employees, resulting in approximately 70 remaining employees.


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