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Related Experiment Videos

Technology evaluation: adalimumab, Abbott laboratories.

Hanns M Lorenz1

  • 1Rheumatology/Institute for Clinical Immunology, Department of Medicine III, University of Erlangen-Nuremberg, Germany. Hannes.Lorenz@med3.imed.uni-erlangen.de

Current Opinion in Molecular Therapeutics
|June 5, 2002
PubMed
Summary

Adalimumab, a TNF-alpha neutralizing antibody, is in late-stage development for inflammatory diseases like rheumatoid arthritis. Regulatory filing and market launch were anticipated for 2002-2003, with significant sales projected.

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Area of Science:

  • Immunology
  • Pharmacology

Background:

  • Adalimumab (D2E7) is a human monoclonal antibody targeting Tumor Necrosis Factor alpha (TNFa).
  • It is developed for inflammatory disorders including rheumatoid arthritis (RA) and Crohn's disease, with potential applications in coronary heart disease.

Purpose of the Study:

  • To report on the development status and market projections for adalimumab.
  • To summarize the clinical trial progress and anticipated regulatory timelines.

Main Methods:

  • Review of clinical trial phases (Phase II for Crohn's disease, Phase III for RA).
  • Analysis of financial and market predictions from investment firms (Lehman Brothers, Merrill Lynch, ABN AMRO).

Main Results:

  • Phase III trials for RA were completed by January 2002.

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  • Anticipated US approval filing in Q2 2002, with a potential 2003 market launch.
  • Projected peak US sales ranging from $600 million to $392 million annually between 2007-2008.
  • Conclusions:

    • Adalimumab demonstrated significant development progress through 2001-2002.
    • High market potential was predicted, with a 70% probability of reaching the market.