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Eisai Preps Eritoran Phase III Sepsis Trial Based On Phase II Cut In Mortality

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Eisai will commence a Phase III study of eritoran (E5564) for severe sepsis by the first quarter of 2006 after a Phase II trial showed a 6.4% mortality reduction versus placebo at 28 days, the firm said Aug. 29

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Cephalon buys Zeneus for Euro oncology franchise: Cephalon's $360 mil. cash purchase of privately held Zeneus will accelerate Cephalon's entry into the European oncology market, the firm says. Announced Dec. 6, the deal includes Zeneus' already commercialized Myocet (liposomal doxorubicin) cardio-protective chemotherapy agent for late-stage breast cancer, Targretin (bexarotene) for cutaneous T-cell lymphoma and Abelcet (amphotericin B lipid complex) anti-fungal. Cephalon submitted an NDA in September for its OraVescent effervescent buccal fentanyl product for breakthrough cancer pain. The company already markets Actiq (oral transmucosal fentanyl) for breakthrough cancer pain. In the second quarter, Cephalon completed the acquisition of Salmedix, which brings the late-stage non-Hodgkin's lymphoma candidate Treanda (bendamustine). Last June, the company also bought Trisenox (arsenic trioxide), a marketed therapy for relapsed or refractory acute promyelocytic leukemia, from Cell Therapeutics. Cephalon is developing a Phase II tyrosine kinase inhibitor (CEP-701), which is being evaluated as an acute myelogenous leukemia treatment (Pharmaceutical Approvals Monthly July 2005, p. 26). In 2006, Cephalon expects the Zeneus deal to add $100 mil. to its top line and be "neutral to earnings"...

Licensing In Brief

Cephalon buys Zeneus for Euro oncology franchise: Cephalon's $360 mil. cash purchase of privately held Zeneus will accelerate Cephalon's entry into the European oncology market, the firm says. Announced Dec. 6, the deal includes Zeneus' already commercialized Myocet (liposomal doxorubicin) cardio-protective chemotherapy agent for late-stage breast cancer, Targretin (bexarotene) for cutaneous T-cell lymphoma and Abelcet (amphotericin B lipid complex) anti-fungal. Cephalon submitted an NDA in September for its OraVescent effervescent buccal fentanyl product for breakthrough cancer pain. The company already markets Actiq (oral transmucosal fentanyl) for breakthrough cancer pain. In the second quarter, Cephalon completed the acquisition of Salmedix, which brings the late-stage non-Hodgkin's lymphoma candidate Treanda (bendamustine). Last June, the company also bought Trisenox (arsenic trioxide), a marketed therapy for relapsed or refractory acute promyelocytic leukemia, from Cell Therapeutics. Cephalon is developing a Phase II tyrosine kinase inhibitor (CEP-701), which is being evaluated as an acute myelogenous leukemia treatment (Pharmaceutical Approvals Monthly July 2005, p. 26). In 2006, Cephalon expects the Zeneus deal to add $100 mil. to its top line and be "neutral to earnings"...

Lilly’s Search For Sepsis Biomarkers Could Provide Early Signal For Xigris Use

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