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Tadalafil Lilly ICOS.

David P Rotella1

  • 1Bristol-Myers Squibb Company, Hopewell Discovery Chemistry, Princeton, NJ 08543-5400, USA. david.rotella@bms.com

Current Opinion in Investigational Drugs (London, England : 2000)
|March 11, 2003
PubMed
Summary
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Tadalafil, a phosphodiesterase type 5 inhibitor, is nearing market approval for erectile dysfunction treatment. It is expected to launch in Europe and the US in early 2003.

Area of Science:

  • Pharmacology
  • Urology
  • Drug Development

Background:

  • Erectile dysfunction (ED) is a significant health concern.
  • Phosphodiesterase type 5 (PDE5) inhibitors represent a key therapeutic class for ED.
  • Tadalafil is an emerging PDE5 inhibitor developed by Lilly ICOS.

Purpose of the Study:

  • To detail the development and regulatory status of Tadalafil for ED treatment.
  • To outline the global marketing and distribution strategy for Tadalafil.

Main Methods:

  • Review of regulatory submissions and marketing agreements.
  • Analysis of Tadalafil's classification as a PDE5 inhibitor.

Main Results:

  • European marketing approval granted in November 2002.

Related Experiment Videos

  • FDA approvable letter issued in April 2002.
  • Anticipated market launch in Europe and the US in the first half of 2003.

    • Conclusions:

    • Tadalafil is positioned for near-term market entry for erectile dysfunction.
    • A strategic collaboration between Eli Lilly & Co and ICOS Corp. will manage its commercialization.