Regeneron Pharmaceuticals Secures FDA Approval for Eylea, a Breakthrough Treatment for Age-Related Macular Degeneration

Strategic Insights -

Regeneron Pharmaceuticals Inc has made significant strides in the medical field by securing approval from the U.S. Food and Drug Administration (FDA) to treat a prevalent cause of blindness, Eylea. This breakthrough treatment is expected to challenge Roche Holding AG's Lucentis, a leading competitor in the market. Eylea's approval has far-reaching implications, as it will be available for doctors to prescribe starting November 21, with deliveries expected to be made the following day.

Key Takeaways:

  • Regeneron Pharmaceuticals Inc has secured FDA approval for Eylea, a treatment for wet age-related macular degeneration, a leading cause of vision loss in people 60 and older.
  • Eylea will be administered every eight weeks, significantly reducing the frequency of injections compared to Roche's Lucentis, which requires monthly injections.
  • The treatment is expected to generate peak sales of $1.1 billion in 2021 as its use expands to other eye disorders.
  • Eylea will be priced at $1,850 per dose, making it more cost-effective than Lucentis, which costs $2,000 per dose.
  • The FDA initially delayed its decision on August 16 due to concerns regarding manufacturing controls, but Regeneron provided satisfactory answers to the agency's questions.
  • Regeneron's Eylea will be a significant competitor to Roche's Lucentis, which currently holds about 40% of the market and generated $1.4 billion in sales last year.
  • The approval of Eylea marks a significant milestone for Regeneron, a fully integrated biopharmaceutical company that discovers, commercializes, and develops medicines for treating serious medical conditions.

Statistics:

  • $1.1 billion: Expected peak sales of Regeneron's Eylea in 2021.
  • $16,000: Annual cost of Eylea treatment for a year.
  • $1,850: Price per dose of Eylea.
  • $2,000: Price per dose of Lucentis.
  • 8 weeks: Frequency of injections for Eylea.
  • 40%: Market share held by Lucentis.
  • $1.4 billion: Sales generated by Lucentis last year.
  • November 21: Start date for doctors to order Eylea.
  • November 22: Start date for Eylea deliveries.

Sources:

  • Bloomberg
  • Regeneron Pharmaceuticals Inc
  • Citigroup Inc
  • HT Syndication with permission from Stock Market Digital