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Pharmaceutical industry

Bristol-Myers Squibb and Medarex Join Forces to Develop Cancer Treatment

Strategic Insights

— 1 min read

Bristol-Myers Squibb and Medarex, Inc. have announced a worldwide collaboration to develop and commercialize a new cancer treatment, MDX-010, a fully human antibody targeting the CTLA-4 receptor. This investigational product is currently in Phase III clinical development for the treatment of metastatic melanoma, a disease that affects over 160,000 people worldwide annually, resulting in 40,000 deaths. The companies will jointly continue to investigate the development of MDX-010 in additional tumor types, with Bristol-Myers Squibb responsible for development outside the United States and Europe.

Key Takeaways:

  • The partnership will develop and commercialize MDX-010, a fully human antibody targeting the CTLA-4 receptor, for the treatment of metastatic melanoma.
  • MDX-010 is currently in Phase III clinical development and has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of high-risk Stage II, Stage III, and Stage IV melanoma.
  • The FDA has granted Fast Track status to MDX-010 in combination with MDX-1379 for treatment of patients with late-stage unresectable metastatic melanoma who have failed or are intolerant to first-line therapy.
  • Bristol-Myers Squibb will be responsible for all development outside the United States and Europe, with Medarex receiving an initial cash payment of $50 million and up to $205 million in regulatory milestones.
  • Medarex will also have an option to co-promote and share profits with Bristol-Myers Squibb in the United States based on a pre-agreed percentage split.

Statistics:

  • Over 160,000 cases of melanoma are diagnosed worldwide annually.
  • 40,000 deaths are attributed to melanoma per year.
  • MDX-010 has received orphan drug designation from the FDA for the treatment of high-risk Stage II, Stage III, and Stage IV melanoma.
  • The FDA has granted Fast Track status to MDX-010 in combination with MDX-1379 for treatment of patients with late-stage unresectable metastatic melanoma.
  • Medarex has a diverse pipeline of antibody products, with 20 therapeutic products currently in human clinical testing.

Sources:

  • "Bristol-Myers Squibb and Medarex Partner in Global Collaboration to Develop and Commercialize Antibody Therapeutic for Treatment of Melanoma and Other Cancers" (September 9, 2004)
  • Bristol-Myers Squibb Company Form 10-K (2003)
  • Medarex, Inc. Form 10-K (2003)
  • Medarex, Inc. Press Release (June 2004)

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