Licensing In Brief
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Pfizer expands anti-infective portfolio with Vicuron buy: Pfizer's $1.9 bil. acquisition of Vicuron includes the near-term antibiotic candidate dalbavancin, currently pending at FDA with a Sept. 21 user fee date . Vicuron has targeted an early 2006 launch for the once-weekly therapy for chronic skin and soft tissue infections (1Pharmaceutical Approvals Monthly May 2005, In Brief). Announced June 16, the merger builds on Pfizer's experience in the anti-infective market and extends its existing portfolio, which includes the antifungal agents Diflucan (fluconazole) and Vfend (voriconazole), and the antibiotics Zithromax (azithromycin) and Zyvox (linezolid). The Vicuron deal also gives Pfizer a new antifungal agent, anidulafungin, deemed "approvable" at FDA in May 2004. The firms' combination marks the culmination of a six-year collaboration to develop new antibiotic candidates…
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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"...
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"...
Vicuron’s second anidulafungin NDA
Vicuron submits an NDA Aug. 18 for use of its antifungal anidulafungin in invasive candidiasis/candidemia, putting a user fee date at June 18, 2006. The NDA includes a "Phase III trial demonstrating superiority of anidulafungin versus fluconazole [Pfizer's Diflucan and generics]," Vicuron says. Pfizer is acquiring Vicuron for $1.9 bil. (1Pharmaceutical Approvals Monthly July 2005, p. 26). An anidulafungin NDA for esophageal candidiasis has a Nov. 27 user fee deadline; invasive candidiasis was originally part of that submission, but Vicuron split the indications to speed approval (2Pharmaceutical Approvals Monthly October 2004, p. 14)...