FDA Approves Lyrica for Nerve Pain and Seizures

Strategic Insights -

The Food and Drug Administration has granted approval to Lyrica, a new medication developed by Pfizer Inc. to treat nerve pain associated with diabetes and shingles. Lyrica, which is expected to be available in the United States in 2005, is a successor to Pfizer's epilepsy drug Neurontin, which generated $2.2 billion in sales in 2003 before facing competition from generic alternatives. According to analysts, Lyrica has the potential to reach $2.9 billion in worldwide sales by 2008, with pain being its most significant indication. However, the company has not announced a price for the drug or a specific launch date.

Key Takeaways:

  • Lyrica, developed by Pfizer Inc., has been approved by the FDA to treat nerve pain associated with diabetes and shingles.
  • The medication is expected to be available in the United States in 2005 and has the potential to reach $2.9 billion in worldwide sales by 2008.
  • Pain is the most significant indication for Lyrica, with epilepsy being a "very small opportunity" according to Trevor Polischuk, a pharmaceuticals analyst at Orbimed Advisors.
  • Lyrica will compete with Eli Lilly's Cymbalta antidepressant, which was cleared by the FDA in September for peripheral neuropathic pain.
  • Pfizer's CEO, Henry A. McKinnell Jr., is counting on new drugs like Lyrica to increase sales as some of the company's biggest products face competition.
  • Lyrica is expected to face competition from generic versions of Pfizer's Neurontin, which generated $2.2 billion in sales in 2003.

Statistics:

  • $2.2 billion: Sales of Neurontin in the United States in 2003 (Source: Pfizer Inc.)
  • $2.9 billion: Estimated worldwide sales of Lyrica by 2008 (Source: Sena Lund, Cathay Financial)
  • 18 million: Number of Americans with diabetes (Source: National Institutes of Health)
  • 50%: Proportion of Americans with diabetes who will develop nerve pain (Source: Pfizer Inc.)
  • 12 cents: Decline in Pfizer's stock price on the New York Stock Exchange (Source: New York Stock Exchange composite trading)

Sources:

  • Pfizer Inc.
  • The New York Times (September 2004 article cited)
  • Orbimed Advisors (quote by Trevor Polischuk)
  • National Institutes of Health (diabetes statistics)
  • Cathay Financial (quote by Sena Lund)