Pharmion and GPC Biotech Announce Co-Development and License Agreement for Satraplatin

Strategic Insights -

Pharmion Corporation and GPC Biotech AG have entered into a co-development and license agreement for satraplatin, an oral platinum-based compound in advanced clinical development. Satraplatin has shown promising safety and efficacy in a randomized study of first-line treatment of patients with hormone-refractory prostate cancer (HRPC) and is currently the subject of a Phase 3 registrational trial as second-line chemotherapy treatment for patients with HRPC.

Key Takeaways:

  • The co-development and license agreement grants Pharmion exclusive commercialization rights for Europe, Turkey, the Middle East, Australia, and New Zealand, while GPC Biotech retains rights to the North American market and all other territories.
  • Pharmion will provide an upfront payment of $37.1 million to GPC Biotech, including $18 million reimbursement for past satraplatin clinical development costs and $19.1 million for funding of ongoing and certain future clinical development.
  • The companies will pursue a joint development plan to evaluate development activities for satraplatin in a variety of tumor types and will share global development costs, with Pharmion committing an additional $22.2 million.
  • Pharmion will also pay GPC Biotech $30.5 million based on the achievement of certain regulatory filing and approval milestones and up to an additional $75 million for up to five subsequent EMEA approvals for additional indications.
  • GPC Biotech will receive royalties on sales of satraplatin in Pharmion's territories at rates of 26 to 30 percent on annual sales up to $500 million and 34 percent on annual sales over $500 million.
  • Patrick J. Mahaffy, Pharmion's president and chief executive officer, stated that satraplatin has the potential to provide significant additional benefits in the well-characterized platinum treatment class.
  • Satraplatin is expected to form the basis of a Marketing Authorization Application (MAA) in Europe and a New Drug Application (NDA) in the U.S. for the treatment of HRPC.
  • The Phase 3 SPARC trial, which assesses the safety and efficacy of satraplatin in combination with prednisone as second-line chemotherapy in patients with HRPC, has achieved target enrollment of 912 patients.

Statistics:

  • $37.1 million: Upfront payment from Pharmion to GPC Biotech, including $18 million reimbursement for past clinical development costs and $19.1 million for funding of ongoing and certain future clinical development.
  • $22.2 million: Additional commitment from Pharmion to share global development costs for satraplatin.
  • $30.5 million: Amount Pharmion will pay GPC Biotech based on the achievement of certain regulatory filing and approval milestones.
  • $75 million: Maximum amount Pharmion will pay GPC Biotech for up to five subsequent EMEA approvals for additional indications.
  • 26-30%: Royalty rates on annual sales of satraplatin in Pharmion's territories up to $500 million.
  • 34%: Royalty rate on annual sales of satraplatin in Pharmion's territories over $500 million.
  • 912: Number of patients targeted for enrollment in the Phase 3 SPARC trial.

Sources:

  • Pharmion Corporation
  • GPC Biotech AG
  • European Organization for Research and Treatment of Cancer (EORTC)
  • American Society for Clinical Oncology (ASCO)
  • U.S. Food and Drug Administration (FDA)
  • European Medicines Agency (EMEA)