Key Developments: Exelixis Inc (EXEL.O)
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Latest Key Developments (Source: Significant Developments)
Swedish Orphan Biovitrum AB Signs Distribution and Commercialization Agreement with Exelixis Inc Regarding COMETRIQ
Swedish Orphan Biovitrum AB (Sobi) announced that Sobi and Exelixis Inc have entered into a three-year agreement to support the distribution and commercialization of COMETRIQ (cabozantinib) for metastatic medullary thyroid cancer (MTC) in the European Union (EU) and potentially other countries. No other indication is covered by this agreement, and Exelixis maintains full commercial rights for COMETRIQ in MTC outside the covered territory and for all other indications on a global basis. On November 29, 2012, Exelixis announced that the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) for COMETRIQ for the proposed indication of treatment of progressive, unresectable, locally advanced, or metastatic MTC. Under the terms of the agreement, Exelixis will continue to be responsible for regulatory approvals in the covered territory. Sobi will serve as the exclusive distributor of COMETRIQ in the covered territory where applicable for NPU requests, and will, if approved by the EMA, promote, market, and sell COMETRIQ for MTC in the covered territory. Exelixis' payments to Sobi include certain pre-determined fixed fees as well as potential performance based milestones related to the commercialization of the product in the covered territory. Exelixis will book revenues based on product sold to Sobi. Exelixis has the ability to terminate the agreement at will at any time upon payment of certain pre-determined fees. Full Article
Exelixis Inc Reaffirms FY 2012 Revenue Guidance
Exelixis Inc announced that it continues to expects fiscal 2012 revenues in the range of $40.0 million to $60.0 million. According to I/B/E/S Estimates, analysts on an average are expecting the Company to report revenue of $45.7 million for fiscal 2012. Full Article
Exelixis Inc Announces Interim Data for Cabozantinib 40 mg Dose Cohort in Metastatic Castration-Resistant Prostate Cancer
Exelixis Inc announced interim data from 51 patients with metastatic castration-resistant prostate cancer (CRPC) and bone metastases receiving a 40 mg daily dose of cabozantinib in an ongoing non-randomized expansion (NRE) cohort of a phase 2 randomized discontinuation trial. The data suggest that the 40 mg daily dose has similar clinical activity to the 100 mg daily dose previously reported from this trial for key parameters, including reduction of metastatic bone and soft tissue disease, and reduction of bone-related pain and narcotic use, with apparent improvement in adverse event rates and tolerability. The interim results reported include data from 51 men enrolled in the 40 mg NRE cohort of an ongoing phase 2 randomized discontinuation trial. All patients had bone metastases on bone scan and 41% had measurable soft tissue disease. All patients had received prior docetaxel, 67% had received prior abiraterone or enzalutamide (MDV3100), and 25% had received prior cabazitaxel. Bone-directed therapies such as zoledronic acid, denosumab, and radionuclides were used in 45%, 41% and 6% of patients, respectively. 71% of patients had received at least 2 prior lines of therapy for CRPC. Clinically significant pain, defined as baseline pain score by Brief Pain Inventory (BPI) ≥4, was present in 53% of patients, with 45% of these patients receiving chronic narcotic administration. Full Article
Exelixis Inc Announces Preliminary Phase 1 Data for Cabozantinib in Japanese Patients
Exelixis Inc announced preliminary data from an ongoing phase 1 dose escalation study of cabozantinib in Japan. The primary objective of the phase 1, open label, multiple cohort dose escalation study is to determine the recommended phase 2 dose of cabozantinib administered once-daily over a 4-week cycle in Japanese patients with advanced or metastatic solid tumors. Doses evaluated were 40 mg, 60 mg, or 80 mg of cabozantinib in the capsule configuration. Secondary objectives are to assess the safety and tolerability of multiple doses of cabozantinib, plasma pharmacokinetics, and tumor response. As of the June 30, 2012 cut-off, 14 patients with a variety of solid tumors had been enrolled in the study: non-small cell lung cancer (NSCLC) (5), gastrointestinal stromal tumor (4), colorectal cancer (2), medullary thyroid cancer (1), thymic cancer (1), and leiomyosarcoma (1). The median number of prior treatments was 3 (range: 2-6) for all 14 patients, and 4 (range: 2-6) for the NSCLC subgroup. Dose-limiting toxicity of Grade 3 hypertension was reported in 2 patients, and the recommended phase 2 dose is 60 mg daily. Pharmacokinetic analyses show that cabozantinib exhibited dose-linear increases in exposure over the range of doses evaluated, and a 5- to 6-fold accumulation was observed on Day 19 following repeated daily dosing. These analyses also show that cabozantinib exposure in Japanese patients is approximately 2-fold higher than that observed in non-Japanese patients. Full Article
Exelixis, Inc. Announces Pricing Of Concurrent Offerings Of 30 Million Shares Of Common Stock And $250 Million Principal Amount Of Convertible Senior Subordinated Notes
Exelixis, Inc. announced the pricing of its concurrent underwritten public offering of 30 million shares of newly issued common stock at a price to the public of $4.25 per share and $250 million aggregate principal amount of its 4.25% convertible senior subordinated notes due 2019. Exelixis also granted the underwriters a 30-day option to purchase up to an additional 4.5 million shares of its common stock and up to an additional $37.5 million aggregate principal amount of the convertible senior subordinated notes in connection with the offerings. Exelixis anticipates that its aggregate net proceeds from the concurrent offerings will be $361.9 million after deducting the underwriting discount and estimated offering expenses payable by Exelixis (assuming no exercise of the underwriters' option to purchase additional shares of common stock and notes). The notes will bear interest at a rate equal to 4.25% per year, payable semiannually in arrears on February 15 and August 15 of each year, beginning on February 15, 2013. The notes will mature on August 15, 2019. Exelixis currently expects to use the net proceeds from the offerings for general corporate purposes, including for clinical trials, research and development, capital expenditures, working capital, funding the interest escrow account, and the payment of a consent fee to entities affiliated with Deerfield Management Company L.P. with respect to secured convertible notes Exelixis previously issued to such entities. Full Article
Exelixis, Inc. Announces Proposed Concurrent Public Offerings Of Common Stock And Convertible Debt
Exelixis, Inc. announced that it plans to offer, subject to market and other conditions, 20,000,000 shares of its common stock and $225 million aggregate principal amount of convertible senior subordinated notes due 2019 in concurrent underwritten public offerings. The Company expects to grant the underwriters 30-day options to purchase up to an additional 3,000,000 shares of common stock and up to an additional $33.75 million aggregate principal amount of convertible senior subordinated notes in connection with the offerings. All of the shares of common stock and the convertible senior subordinated notes in the offerings will be sold by Exelixis. Goldman, Sachs & Co. and Cowen and Company are acting as joint book-running managers and Piper Jaffray & Co., Stifel Nicolaus Weisel and William Blair & Company, L.L.C. are acting as co-managers for the common stock offering. Goldman, Sachs & Co. is acting as sole book running manager, Cowen and Company, LLC is acting as joint lead manager, and Citigroup, Credit Suisse Securities (USA) LLC and Morgan Stanley & Co. LLC are acting as co-managers for the convertible senior subordinated note offering. Full Article
Exelixis Inc Reaffirms FY 2012 Revenue Guidance-Conference Call
Exelixis Inc announced that for fiscal 2012, it expects revenue of $40 million to $60 million. According to I/B/E/S Estimates, analysts on an average are expecting the Company to report revenue of $52 million for fiscal 2012. Full Article
Exelixis, Inc.'s Thyroid Cancer Drug Gets FDA Priority Review-Reuters
Reuters reported that U.S. health regulators granted a priority review for Exelixis, Inc. experimental drug to treat a rare form of thyroid cancer. Exelixis said the U.S. Food and Drug Administration set a review date of November 29 for the drug, cabozantinib, designed to treat medullary thyroid cancer. Medullary thyroid cancer, which starts in cells that release a hormone called calcitonin, accounts for about 4% of thyroid cancers. The FDA grants priority review to expedite the review of drugs to treat serious diseases and fill unmet medical needs. Full Article
Exelixis, Inc. Announces Initiation Of Cabozantinib Investigator-Sponsored Trials In Non-Small Cell Lung Cancer And Multiple Myeloma
Exelixis, Inc. announced the initiation of two investigator-sponsored trials (ISTs) of cabozantinib, which simultaneously targets MET, VEGFR2 and RET. Naiyer Rizvi, M.D., a lung cancer specialist at Memorial Sloan Kettering Cancer Center (MSKCC), is conducting a phase II clinical trial of cabozantinib in non-small cell lung cancer (NSCLC) patients who have tested positive for gene fusions that activate RET. Anuj Mahindra, MBBS, member of the hematology staff at Massachusetts General Hospital (MGH), is conducting a pilot phase I clinical trial of cabozantinib in patients with relapsed or refractory multiple myeloma, a disease for which there is evidence of MET’s role in pathogenesis. The phase II NSCLC trial is designed to enroll 25 patients with KIF5B/RET or related variant RET fusions in their tumors. These patients will receive a daily 60 mg dose of cabozantinib administered orally. The primary endpoint of the trial is overall response rate. Secondary endpoints include progression-free survival, overall survival, and safety. Investigators will also seek to determine the frequency of KIF5B/RET and related variant RET fusions in patients whose tumors are negative for previously identified oncogenic activating mutations or translocations (including those involving EGFR, KRAS, and ALK). Full Article
Exelixis, Inc.'s Cabozantinib Demonstrates Evidence of Anti-Tumor Effects in Heavily Pretreated Patients with Hepatocellular Carcinoma
Exelixis, Inc. reported positive updated interim data from the cohort of hepatocellular carcinoma (HCC) patients participating in the ongoing phase 2 randomized discontinuation trial (RDT) of cabozantinib. The results comprise data from 41 patients with advanced hepatocellular carcinoma with measurable disease at baseline and documented progressive disease per RECIST criteria. Patients in the open label 12-week Lead-In Stage of the trial received a daily dose of 100 mg cabozantinib. Eligible patients had Child-Pugh Score A. 8% had received 1-2 prior lines of systemic therapy: 56% had prior tyrosine kinase inhibitor (TKI) therapy, including 51% previously treated with sorafenib. At baseline, extrahepatic spread of disease (which is associated with a poorer prognosis) was present in 73% of subjects, 39% had hemoglobin (Hb) < 11 g/dL, 34% had thrombocytopenia, and median alpha-fetoprotein (AFP) level was 368 ng/ml. Tumor assessments per original RECIST 1.0 were conducted using conventional CT/MRI at baseline and every 6 weeks thereafter. The week 12 disease control rate (partial response [PR] and stable disease [SD] at week 12) was 66%. Evidence of objective tumor regression was observed in 78% of patients, including those with or without prior sorafenib therapy. The best radiologic response per RECIST in the Lead-In stage of the study for 36 patients with at least one post-baseline measurement was PR in 2 patients (5%) and SD in 32 patients (78%). Full Article
FDA approves Exelixis' cabozantinib for thyroid cancer
WASHINGTON - The U.S. Food and Drug Administration on Thursday approved Exelixis Inc's cabozantinib as a treatment for medullary thyroid cancer that has spread to other parts of the body.
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