Eisai Co., Ltd. ADROTCPK - Current
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  • Thu, Jun. 2, 4:53 PM
    • With the aim of informing doctors, Novartis (NYSE:NVS) inks a deal with Eisai (OTC:ESALF)(OTCPK:ESALY) to co-promote Lenvima (lenvatinib) capsules in the U.S. The FDA approved it last month, in combination with Afinitor (everolimus), for the treatment of patients with advanced renal cell carcinoma who have been previously treated with an anti-angiogenic therapy. It was first approved in February 2015 for treatment-resistant thyroid cancer.
    • Under the terms of the agreement, the companies will promote the availability of the combination regimen to healthcare professionals nationwide and participate in certain joint medical education activities. Each company will continue to book sales of its respective product.
    | Thu, Jun. 2, 4:53 PM
  • Tue, May 17, 10:04 AM
    • Private investor PBM Capital acquires all of the shares of Eisai (OTC:ESALF)(OTCPK:ESALY) unit AkaRx and the global rights to develop, commercialize and manufacture avatrombopag, an investigational small molecule thrombopoietin (TPO) agonist currently in Phase 3 development for the treatment of thrombocytopenia (low blood platelets) in patients with chronic liver disease undergoing an elective procedure.
    • Financial terms are not disclosed.
    | Tue, May 17, 10:04 AM
  • Sun, May 15, 6:04 PM
    • Under its Priority Review process, the FDA approves Eisai's (OTC:ESALF)(OTCPK:ESALY) Breakthrough Therapy-tagged Lenvima (lenvatinib), in combination with Novartis' (NYSE:NVS) Afinitor (everolimus), for the treatment of patients with advanced renal cell carcinoma who have been previously treated with an anti-angiogenic therapy.
    • The data supporting the approval was generated in a Phase 2 clinical trial called Study 205. Patients receiving Lenvima plus Afinitor experienced a median increase in progression-free survival of over 165% (14.6 months versus 5.5 months) compared to those receiving Afinitor alone. The combination regimen also showed a 63% reduction in the risk of disease progression or death (hazard ratio: 0.37) compared to Afinitor as monotherapy. Other endpoints favoring the combination were objective response rate (37% versus 6%) and median overall survival (25.5 months versus 15.4 months).
    • The most common treatment-emergent serious adverse events were renal failure (11%), dehydration (10%); anemia (6%), thrombocytopenia (low blood platelets) (5%), diarrhea (5%), vomiting (5%) and dyspnea (difficulty breathing) (5%).
    • Lenvatinib is a receptor tyrosine kinase inhibitor that inhibits multiple VEGF (vascular endothelial growth factor) receptors which play key roles in the growth of cancer cells. Interfering with the receptors' activity slows the progression of cancer by restricting the blood supply to the tumors (antiangiogenesis).
    • The FDA first approved Lenvima in February 2015 for treatment-resistant thyroid cancer.
    | Sun, May 15, 6:04 PM
  • Mon, May 2, 8:35 AM
    • The FDA approves Eisai's (OTC:ESALF)(OTCPK:ESALY) FYCOMPA (perampanel) CIII Oral Suspension as adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures, and primary generalized tonic-clonic seizures in patients at least 12 years old with epilepsy. The oral suspension formulation is bioequivalent to the tablet formulation, approved by the FDA in October 2012.
    • The U.S. market launch will commence in June.
    | Mon, May 2, 8:35 AM
  • Mon, Apr. 18, 12:38 PM
    • A Phase 3 study, MORAb-003-004, assessing Eisai (OTC:ESALF)(OTCPK:ESALY) subsidiary Morphotek's farletuzumab, in combination with platinum-based chemo, in ovarian cancer patients who relapsed after chemo treatment failed to achieve its primary endpoint. The results were just published in the Journal of Clinical Oncology.  
    • All subjects received the chemo agents carboplatin plus paclitaxel or docetaxel. They were then randomized to receive either 1.25 mg/kg or 2.5 mg/kg of farletuzumab or placebo. Neither dose of farletuzumab beat control on the primary endpoint of progression-free survival (PGS) and there was no difference in overall survival (OS).
    • Subgroup analyses, however, showed patients with low CA125 (blood biomarker for ovarian cancer) levels correlated with longer PFS and OS with significantly lower risk of death (hazard ratios of 0.49 and 0.44, respectively) in the 2.5 mg/kg cohort, showing superiority to placebo.
    • Based on the subgroup findings, Morphotek has initiated a Phase 2 study, MORAb-003-011, to further investigate the efficacy of farletuzumab in low-CA125 ovarian cancer patients. According to, the estimated final data collection date for the primary endpoint, PFS, is November 2017. The estimated study completion date is August 2019.
    • Orphan Drug-tagged farletuzumab is an investigational humanized IgG1 antibody that binds to folate receptor alpha (FRA), a protein that is overexpressed in certain epithelial-derived cancers like ovarian, endometrial, breast, renal, lung and colorectal.
    | Mon, Apr. 18, 12:38 PM
  • Thu, Mar. 31, 7:01 AM
    • Dr. Reddy's Laboratories (NYSE:RDY) enters into a license agreement with Eisai (OTC:ESALF)(OTCPK:ESALY) for exclusive worldwide (except Japan and Asia) development and commercialization rights to investigational cancer agent E7777, including India.
    • Under the terms of the deal, Eisai will receive unspecified regulatory and sales-based milestones.
    • E777 is a fusion protein that combines the interleukin-2 (IL-2) receptor binding domain with diphtheria toxin fragments. It binds to IL-2 on the cancer cell surface enabling diphtheria toxins to enter the cell and inhibit protein synthesis. A Phase 2 study in cutaneous T-cell lymphoma or peripheral T-cell lymphoma is underway in Japan. A Phase 3 study in cutaneous T-cell lymphoma is being readied in the U.S.
    | Thu, Mar. 31, 7:01 AM | 1 Comment
  • Thu, Jan. 28, 1:45 PM
    • The FDA approves Eisai's (OTC:ESALF)(OTCPK:ESALY) Orphan Drug-tagged Halaven (eribulin mesylate) for the treatment of metastatic or unresectable liposarcoma, a rare type of soft tissue cancer that resembles fat cells when examined under a microscope. It occurs in 12K Americans each year. It is approved for patients who have received prior chemotherapy that contained an anthracycline drug.
    • Halaven is the first drug approved for liposarcoma that has shown an improvement in survival time. In a clinical study, patients receiving eribulin mesylate demonstrated median overall survival of 15.6 months compared to 8.4 months in those receiving dacarbazine.
    • Orphan Drug status qualifies Halaven for a seven-year period of market exclusivity for the indication.
    • Halaven was originally approved by the FDA in November 2010 for the third-line (or later) treatment of breast cancer.
    • Previously: FDA grants Priority Review for Eisai's eribulin mesylate sNDA for soft tissue sarcoma (Sept. 28, 2015)
    | Thu, Jan. 28, 1:45 PM
  • Mon, Jan. 4, 9:28 AM
    • Halozyme (NASDAQ:HALO) enters into a $150M credit agreement with Roche (OTCQX:RHHBY) and Baxalta (NYSE:BXLT) secured by future royalties of ENHANZE under its collaborations with the two firms. The deal, expected to close this month, will be facilitated through investment funds managed by Pharmakon Advisors and Athyrium Capital Management. Under the financing structure, Halozyme will form a wholly owned subsidiary, Halozyme Royalty LLC, which will borrow $150M at an interest rate of 8.75% plus three-month LIBOR (0.70 - 1.50%).
    • On the closing date, Halozyme will transfer to Halozyme Royalty the right to receive royalty payments from commercial sales of Herceptin SC and MabThera SC by Roche and Hyqvia sales by Baxalta. Halozyme will continue to record and report royalty revenues over the term of the loan, using the payments from its collaboration agreements to repay the principal and interest.
    • Under the terms of the agreement, Halozyme Royalty will not be required to apply any of the royalty payments to repay the loan in 2016. All interest accrued this year will be capitalized and added to the outstanding balance. It will be required to apply 50% of the royalty payments in 2017 to the loan and 100% thereafter. The loan's final maturity date is December 31, 2050. The repayment is the sole obligation of Halozyme Royalty with no recourse to Halozyme Therapeutics or its subsidiaries.
    • Proceeds will fund the initiation of its Phase 3 study in pancreatic cancer, ongoing studies in non-small cell lung cancer and gastric cancer and the start of its breast cancer trial with Eisai (OTC:ESALF)(OTCPK:ESALY).
    | Mon, Jan. 4, 9:28 AM
  • Nov. 30, 2015, 10:31 AM
    | Nov. 30, 2015, 10:31 AM | 1 Comment
  • Nov. 17, 2015, 11:50 AM
    • The FDA's Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee meets on Thursday to determine if AbbVie (ABBV +1.4%) or Eisai (OTC:ESALF)(OTCPK:ESALY) are interested in developing pediatric indications for two products in development for adults, AbbVie's ABT-414 for high grade glioma (brain tumor) and Eisai's Lenvima (lenvatinib), cleared by the FDA in February for difficult-to-treat thyroid cancer and in mid-stage development for kidney cancer. The discussion will address the diseases of interest, targeted patient populations and potential study designs.
    • ABT-414 is an anti-EGFR (epidermal growth factor receptor) monoclonal antibody drug conjugate. It is designed to be stable in the bloodstream and only release its cytotoxic agent once inside cancer cells.
    • Lenvatinib is a receptor tyrosine kinase inhibitor that inhibits multiple VEGF (vascular endothelial growth factor) receptors which play key roles in the growth of cancer cells. Interfering with the receptors' activity slows the progression of cancer by restricting the blood supply to the tumors (antiangiogenesis).
    • FDA briefing doc
    • FDA briefing doc errata
    • AbbVie briefing doc
    • Eisai briefing doc 
    | Nov. 17, 2015, 11:50 AM
  • Oct. 27, 2015, 4:34 PM
    • Arena Pharmaceuticals (NASDAQ:ARNA) announces an initiative to reduce costs and improve efficiency. Key points:
    • Resources will be focused on advancing APD334, ralinepag (APD811) and APD371; supporting Eisai (OTC:ESALF) (OTCPK:ESALY) in BELVIQ CV outcomes trial and regulatory clearance of BELVIQ XR; maintaining its core research function; assessing strategic collaboration opportunities and meeting manufacturing obligations while reducing overhead.
    • 35% (80 employees) of the company's U.S. workforce will be cut by year end which will reduce annual cash expenses by ~$11M per year. Additional cost saving measures will be instituted at the company's Swiss manufacturing facility, Arena Pharmaceuticals GmbH. The company will take a $3.3M restructuring charge in Q4.
    • Shares are up 2% after hours on increased volume.
    | Oct. 27, 2015, 4:34 PM | 2 Comments
  • Sep. 28, 2015, 3:29 PM
    • The FDA accepts under Priority Review Eisai's (OTC:ESALF) (OTCPK:ESALY) supplemental New Drug Application (sNDA) seeking approval of eribulin mesylate (Halaven) for the new indication of patients with inoperable soft tissue sarcoma (leiomyosarcoma and liposarcoma) who have received prior chemotherapy for advanced/metastatic disease.
    • Halaven is currently cleared for the third-line treatment of metastatic breast cancer.
    • Priority Review status shortens the review clock to six months from ten.
    | Sep. 28, 2015, 3:29 PM
  • Sep. 2, 2015, 10:33 AM
    • The FDA approves Tesaro's (TSRO +4.4%) VARUBI (rolapitant), in combination with other antiemetic agents, for the prevention of delayed nausea and vomiting associated with chemotherapy (CINV) in adult patients. Up to 50% of chemo patients experience delayed CINV (25 - 125 hours after treatment) even when taking a 5-HT3 receptor antagonist (Novartis' Zofran, formerly Glaxo's) and a corticosteroid.
    • VARUBI, the company's first approved product, is an antagonist of human substance P/neurokinin 1 (NK-1) receptors with a plasma half-life of ~seven days. Phase 3 results showed a significant reduction in CINV or use of rescue medication when patients were administered a 180 mg dose one - two hours prior to chemo in combination with a 5-HT3 antagonist and dexamethasone.
    • Related tickers: (NVS -0.1%)(HRTX +0.2%)(OPK +1%)(INSY +2.7%)(RDHL +1%) (OTC:ESALF) (OTCPK:ESALY) (GALE +0.6%)(GWPH +1.1%)(MRK -0.1%)
    | Sep. 2, 2015, 10:33 AM | 4 Comments
  • Jul. 31, 2015, 8:24 AM
    • Halozyme (HALO) and Eisa (OTC:ESALF), (OTCPK:ESALYsign a collaboration agreement for the development of Eribulin in combination with PEGPH20 for women with first line HER2-negative metastatic breast cancer.
    • Eisa's Eribulin is the first in the halichondrin class of microtubule dynamics inhibitors with a novel mechanism of action. It is a modified and synthetically produced analog of halichondrin B, and is believed to work by inhibition of the growth phase of microtubule dynamics which prevents cell division. Eribulin is indicated for patients with metastatic breast cancer who have received at least two chemotherapeutic regimes.
    • Halozyme's PEGPH20 is an investigational drug administered intravenously that targets degradation of hyaluronan, a chain of natural sugars throughout the body that can build up around cancer cells to inhibit other therapies. The collaborative study of Eribulin and PEGPH20 will analyze whether or not the combination can improve overall response rate in patients with high levels of hyaluronan.
    • The companies will jointly share the costs of a phase 1b/2 clinical trial.
    | Jul. 31, 2015, 8:24 AM
  • Jul. 30, 2015, 9:52 AM
    • Tesaro (TSRO -3.8%) secures an exclusive license agreement with China-based Jiangsu Hengrui Medicine Co. for the development, registration, manufacture and commercialization of rolapitant in China. Specific financial terms are not disclosed.
    • Rolapitant is an investigational neurokinin-1 (NK-1) receptor antagonist under development for the prevention of chemotherapy-induced nausea and vomiting (CINV). The company's NDA is currently under FDA review with a PDUFA date of September 5.
    • CINV-related tickers: (GALE -1.8%)(HRTX -2.2%)(MRK -0.1%)(RDHL -0.1%) (OTC:ESALF) (OTCPK:ESALY) (OPK -1.3%)(INSY -2.3%)(GWPH -2.1%)
    | Jul. 30, 2015, 9:52 AM | 2 Comments
  • Jul. 6, 2015, 11:28 AM
    • Evercore ISI's Mark Schoenebaum says there is a 65% probability of success in the upcoming Phase 3 clinical trial evaluating Axovant Sciences' (AXON +0.7%) lead product candidate, RVT-101, in mild-to-moderate Alzheimer's disease (AD) patients. If successful, peak sales could reach $3.5B. If it fails, then AXON shares could lose 90% of their value. Just how Mr. Shoenebaum arrived at his precise prediction is unclear, but this is yet another superb example of the binary event nature of biotech investing. It's feast or famine.
    • Axovant's story is interesting. It acquired RVT-101, a 5-HT6 inhibitor, from GlaxoSmithKline (GSK -1%) for a mere $5M. Fast forward to last month's IPO and the value of the company, based entirely on the potential of RVT-101, is almost $2B. This is a dramatic turnaround for a drug that failed four straight mid-stage trials about five years ago.
    • The basis for the bullish outlook is the potential for RVT-101 to slow the rate of cognitive decline in AD patients. In an earlier study assessing the combination of RVT-101 and Pfizer's (PFE +0.2%) Aricept (donepezil), the rate of decline was lower than placebo. This is where Axovant will focus on its Phase 3 study, expected to yield results in H2 2017. Stoking the optimism are statements from the FDA that it will be more flexible in how it judges AD drugs in the future, after years of setbacks for drug developers.
    • Related tickers: (OTCPK:ESALY) (OTC:ESALF)
    | Jul. 6, 2015, 11:28 AM | 12 Comments