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Arilvax (PowderJect).

Alan D T Barrett1

  • 1Department of Pathology & Sealy Center for Vaccine Development University of Texas Medical Branch, Galveston 77555-0609, USA. abarrett@utmb.edu

Current Opinion in Investigational Drugs (London, England : 2000)
|August 21, 2002
PubMed
Summary
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PowderJect acquired Arilvax, a yellow fever vaccine, and planned a European relaunch after manufacturing upgrades. Acambis was developing the vaccine in the US, with a biologics license application submission anticipated by mid-2002.

Area of Science:

  • Vaccinology
  • Virology
  • Public Health

Background:

  • Arilvax, a live-attenuated yellow fever vaccine, was initially developed and launched in Europe by Celltech.
  • PowderJect acquired Arilvax in October 2000 as part of its acquisition of Celltech's vaccine business.
  • Acambis held exclusive US development rights, with Phase III trials ongoing by May 2000.

Purpose of the Study:

  • To track the development and regulatory progress of the Arilvax vaccine.
  • To document the business transactions and strategic shifts involving Arilvax.
  • To outline the anticipated timelines for vaccine relaunch and market entry.

Main Methods:

  • Review of company announcements and industry reports.
  • Tracking of regulatory milestones, including Biologics License Application (BLA) submissions.

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  • Analysis of projected market entry and sales forecasts.

    • Main Results:

    • PowderJect planned a UK and European relaunch of Arilvax by July 2001, pending manufacturing upgrades.
    • Acambis prepared for a US BLA submission, expected by mid-2002.
    • Initial sales projections for the US market were approximately $25 million annually.

    Conclusions:

    • The development and commercialization pathway for Arilvax involved significant corporate transitions and regulatory processes.
    • Successful relaunch and US market entry were contingent on manufacturing improvements and regulatory approvals.
    • The vaccine represented a potentially significant market opportunity in yellow fever prevention.