ILEX Oncology and Millennium Pharmaceuticals Submit Biologics License Application for CAMPATH

Strategic Insights -

ILEX Oncology and its partner, Millennium Pharmaceuticals, have submitted a Biologics License Application to the United States Food and Drug Administration (FDA) for CAMPATH, an investigational humanized monoclonal antibody. This application is part of the companies' efforts to secure marketing approval for CAMPATH, which has been granted "fast track" designation by the FDA and is expected to undergo a priority review under the Prescription Drug User Fee Act. CAMPATH has also received orphan drug designation from the FDA. ILEX Oncology and its subsidiary, LeukoSite, have a distribution and development agreement with Schering AG, granting the company exclusive marketing and distribution rights to CAMPATH in the United States, Europe, and other regions.

Key Takeaways:

  • ILEX Oncology and Millennium Pharmaceuticals have submitted a Biologics License Application to the FDA for CAMPATH, a humanized monoclonal antibody.
  • CAMPATH has received "fast track" designation and is expected to undergo a six-month priority review under the Prescription Drug User Fee Act.
  • The FDA has granted orphan drug designation to CAMPATH, indicating its potential for treating rare diseases.
  • ILEX Oncology has a distribution and development agreement with Schering AG, granting exclusive marketing and distribution rights to CAMPATH in certain regions.
  • Millennium Pharmaceuticals employs over 1,000 people and uses an integrated science and technology platform for drug discovery and development.
  • ILEX Oncology focuses on accelerated drug development for diseases and offers contract development services through its ILEX Oncology Services subsidiary.

Statistics:

  • Over 1,000 people are employed by Millennium Pharmaceuticals and its affiliates.
  • CAMPATH has received "fast track" designation from the FDA.
  • The FDA has granted orphan drug designation to CAMPATH.
  • The priority review period for CAMPATH is expected to last six months.

Sources:

  • ILEX Oncology, Inc.
  • Millennium Pharmaceuticals, Inc.
  • United States Food and Drug Administration (FDA)
  • Schering AG
  • Prescription Drug User Fee Act
  • LeukoSite, Inc.