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Licensing In Brief

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Pfizer to fund Phase III ProMune trials for lung cancer under licensing pact valued at up to $505 mil., plus royalties. Medicis gains Botox competitor in $2.8 bil. Inamed purchase. Baxter gets U.S. rights to Cangene WinRho SDF for bleeding disorder. More licensing deals in brief

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Pfizer/Coley lung cancer agent starts Phase III

Coley and partner Pfizer have initiated a Phase III program evaluating the toll-like receptor agonist PF-3512676 (formerly ProMune) for first-line treatment of advanced non-small cell lung cancer, Coley says Nov. 28. Two 800-patient studies are being conducted under an FDA special protocol assessment and will evaluate the drug in combination with current standard-of-care chemo regimens; the primary endpoint is overall survival. Pfizer and Coley entered into a development and commercialization agreement for PF-3512676 in March (Pharmaceutical Approvals Monthly April 2005, p. 26)...

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"...

Pfizer/Coley lung cancer agent starts Phase III

Coley and partner Pfizer have initiated a Phase III program evaluating the toll-like receptor agonist PF-3512676 (formerly ProMune) for first-line treatment of advanced non-small cell lung cancer, Coley says Nov. 28. Two 800-patient studies are being conducted under an FDA special protocol assessment and will evaluate the drug in combination with current standard-of-care chemo regimens; the primary endpoint is overall survival. Pfizer and Coley entered into a development and commercialization agreement for PF-3512676 in March (Pharmaceutical Approvals Monthly April 2005, p. 26)...

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