Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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…

You may also be interested in...



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)...

Topics

UsernamePublicRestriction

Register

PS012935

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel