Early Access Program in Europe and financing of European subsidiary

Situation

  • Our client, a publicly listed North American chemistry-based biotech, required support on a range of key European strategic issues related to the commercialization of its leading phase III product (oncology):
    1. Potential of a European Early Access Program (EAP)
    2. Structure and cost of minimal European infrastructure to support development
    3. Feasibility of raising ring-fenced finance to fund European launch

Bionest Contribution

  • Pan-European EAP feasibility study including KOL interviews, financial modeling and roll-out plan
  • Preliminary European roll-out plan
  • Analysis of financing solutions, and identification of potential investors

Key Results

  • Detailed understanding of European regulatory, operational and related financial issues
  • European EAP structured to meet client needs