exelixis inc (EXEL) Key Developments
Exelixis, Inc. and Swedish Orphan Biovitrum AB Extend and Restructure Distribution Agreement for COMETRIQ® for Medullary Thyroid Cancer
Jan 7 15
Exelixis, Inc. announced that it has extended and restructured its agreement with Swedish Orphan Biovitrum AB to support the distribution and commercialization of COMETRIQ® (cabozantinib) for progressive, unresectable, locally advanced or metastatic medullary thyroid cancer (MTC) in the European Union (EU), Switzerland, Norway, Russia, and Turkey. The agreement, which was established in February 2013 and due to expire on December 31, 2015, will now extend to December 31, 2019. Moreover, the payment structure of the partnership will transition from fixed fees paid by Exelixis to Sobi to support initial build out of COMETRIQ European commercial infrastructure to a sales margin-based approach. Exelixis continues to maintain commercial rights for all other potential cabozantinib oncology indications on a global basis. Sobi exclusively markets, sells, and distributes COMETRIQ for its MTC indication in the covered territory of the European Union, Switzerland, Norway, Russia, and Turkey. In parts of the territory where COMETRIQ is not approved, Sobi administers a Named Patient Use program. Exelixis is responsible for regulatory approvals in the covered territory, and the company retains the ability to terminate the agreement at will at any time upon payment of certain pre-determined fees.
Exelixis Releases Results from the Final Analysis of COMET-2
Dec 1 14
Exelixis released results from the final analysis of COMET-2, a trial of cabozantinib in men with metastatic castration-resistant prostate cancer, showing the trial failed to meet its primary endpoint of alleviation of bone pain. The patients suffer from moderate to severe pain despite optimized narcotic medication, and whose disease has progressed following treatment with docetaxel as well as abiraterone and/or enzalutamide. In the trial, 15% of patients reported a pain response, compared with 17% of patients in the control group receiving mitoxantrone/prednisone. The difference in pain response wasn't statistically significant and the safety profile of cabozantinib in the trial was consistent with that observed in previous studies in mCRPC.
Exelixis, Inc. Presents at 26th Annual Piper Jaffray Healthcare Conference, Dec-02-2014 01:30 PM
Nov 25 14
Exelixis, Inc. Presents at 26th Annual Piper Jaffray Healthcare Conference, Dec-02-2014 01:30 PM. Venue: The New York Palace Hotel, 455 Madison Ave, New York, NY 10022, United States. Speakers: Michael M. Morrissey, Chief Executive Officer, President and Director.
Exelixis, Inc. Announces Positive Results from a Randomized Phase II Trial of Cabozantinib
Nov 18 14
Exelixis, Inc. announced positive results from a randomized Phase II trial of cabozantinib and erlotinib alone or in combination as second- or third-line therapy in patients with stage IV EGFR wild-type non-small cell lung cancer, or NSCLC. This trial (Study E1512) is sponsored by the US National Cancer Institute (NCI) through a Cooperative R&D Agreement between the Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis, NCI and Exelixis. Study E1512 was designed and is being conducted by the ECOG-ACRIN Cancer Research Group as part of Exelixis' collaboration with the NCI. Joel Neal, M.D., Ph.D., from ECOG-ACRIN member institution Stanford University/Stanford Cancer Institute, chairs the study. In the E1512 trial, 125 patients were randomized to one of the three arms: erlotinib, cabozantinib, or the combination. During a pre-planned interim ECOG-ACRIN Data Safety Monitoring Committee analysis for futility, it was found that the trial met its primary endpoint of improving progression-free survival (PFS) with cabozantinib alone and also with the combination of cabozantinib plus erlotinib, as compared to erlotinib alone, and the results were highly statistically significant. Safety data were consistent with those observed in other trials of cabozantinib.
Exelixis, Inc. Announces Positive Preliminary Data from an Investigator-Sponsored Phase 1 Trial of XL888 and Vemurafenib
Nov 16 14
Exelixis, Inc. announced preliminary results from a phase 1 investigator-sponsored trial evaluating the safety and activity of XL888, an Exelixis-discovered small molecule oral inhibitor of Heat Shock Protein 90, in combination with vemurafenib in patients with unresectable stage III/IV BRAF V600 mutation-positive melanoma. Safety and efficacy results support the further investigation of 90 mg of XL888 twice weekly and vemurafenib 960 mg twice daily in additional studies that would include a third agent. The trial results were presented by Keiran Smalley, Ph.D., an investigator on the trial and an associate professor at H. Lee Moffitt Cancer Center, Tampa, Florida, in a late-breaking oral presentation session at the Society for Melanoma Research 2014 International Congress, which is taking place November 13-16, 2014, in Zurich, Switzerland. Based on these results, as well as findings from coBRIM, the phase 3 pivotal trial of cobimetinib, an Exelixis-discovered MEK inhibitor, and vemurafenib in previously untreated metastatic melanoma patients with a BRAF V600 mutation, the Moffitt Center plans to initiate a phase 1b IST of the triple combination of vemurafenib, cobimetinib, and XL888 in a similar patient population.