LeukoSite, ILEX, and Schering AG Partner for CAMPATH(R) Development and Distribution

Strategic Insights -

LeukoSite, Inc. and ILEX Oncology, Inc. have entered into a distribution and development agreement with Schering AG for the humanized monoclonal antibody CAMPATH(R), which is in late-stage development for the treatment of chronic lymphocytic leukemia (CLL). Under the agreement, Schering AG will have exclusive marketing and distribution rights for CAMPATH(R) in the U.S., Europe, and the rest of the world, except Japan and East Asia, where LeukoSite and ILEX have retained rights.

The companies plan to submit the final segment of the Biologics License Application (BLA) for CAMPATH(R) with the U.S. Food and Drug Administration (FDA) later this year. CAMPATH(R) has shown promising results in a recent Phase II clinical trial, and if approved, it may offer a new treatment option for patients with CLL, which is a fatal disease affecting approximately 120,000 patients in the U.S. and Europe.

The agreement grants Schering AG exclusive marketing and distribution rights to CAMPATH(R) in exchange for a payment of up to $30 million, as well as royalties equivalent to the rate of profit sharing expected in the U.S. LeukoSite and ILEX intend to use the funds to advance the development of CAMPATH(R) for other oncology indications and non-oncology indications.

Key Takeaways:

  • LeukoSite, ILEX, and Schering AG have entered into a distribution and development agreement for the humanized monoclonal antibody CAMPATH(R).
  • CAMPATH(R) is in late-stage development for the treatment of chronic lymphocytic leukemia (CLL).
  • Schering AG will have exclusive marketing and distribution rights for CAMPATH(R) in the U.S., Europe, and the rest of the world, except for Japan and East Asia.
  • The companies plan to submit the final BLA for CAMPATH(R) with the FDA later this year.
  • CAMPATH(R) has shown promising results in a recent Phase II clinical trial.
  • The agreement grants Schering AG exclusive marketing and distribution rights to CAMPATH(R) in exchange for a payment of up to $30 million and royalties equivalent to the rate of profit sharing expected in the U.S.
  • LeukoSite and ILEX intend to use the funds to advance the development of CAMPATH(R) for other oncology indications and non-oncology indications.

Statistics:

  • 120,000 patients in the U.S. and Europe are affected by CLL.
  • The companies plan to submit the final BLA for CAMPATH(R) with the FDA later this year.
  • Schering AG will make payments of up to $30 million for rights to CAMPATH(R) and for the achievement of certain regulatory milestones in CLL.
  • LeukoSite and ILEX intend to use the funds to advance the development of CAMPATH(R) for other oncology indications and non-oncology indications.
  • CAMPATH(R) has received "fast track" designation from the FDA and is expected to undergo a six-month priority review under the Prescription Drug User Fee Act.

Sources:

  • "LeukoSite, ILEX Oncology and Schering AG Announce Development and Distribution Agreement for CAMPATH(R)". PRNewswire, August 24, 1999.
  • "LeukoSite and ILEX Oncology Plan to Submit Final BLA for CAMPATH(R)". LeukoSite, Inc. press release, date not specified.
  • "ILEX Oncology, Inc. - News". ILEX Oncology, Inc. website, date not specified.
  • "Schering AG - Products & Services". Schering AG website, date not specified.