Groundbreaking Diabetes Drug Derived from Gila Monster to Hit Pharmacies

Strategic Insights -

A first-of-its-kind diabetes drug, Byetta, is set to hit pharmacies by June 1, marking a significant milestone in the treatment of type 2 diabetes. Developed by Eli Lilly and Co. and Amylin Pharmaceuticals, Byetta works by stimulating the pancreas to produce natural insulin after meals, providing a unique solution for patients struggling to control their blood sugar levels. The injectable drug, approved by the FDA with some limitations, is expected to generate significant sales for Lilly, with estimates suggesting $320 million in revenues by 2007.

Key Takeaways:

  • Byetta is a first-of-its-kind diabetes drug derived from the saliva of the gila monster, a lizard native to Mexico and the southwestern United States.
  • The drug is approved for use in combination with oral diabetes drugs, not as a stand-alone treatment, with the FDA indicating it is "approvable" if given alone with additional data showing its effectiveness.
  • Byetta works by stimulating the pancreas to produce natural insulin after meals, filling a unique niche between oral therapies and insulin in treating patients with adult-onset diabetes.
  • The drug has been shown to be effective in clinical trials, with patients experiencing "clinically significant" improvements in control of their blood glucose, and an average weight loss of 2-5.5 pounds over seven months.
  • Byetta has the potential to bring significant health benefits to patients with diabetes, allowing them to delay taking insulin injections and improve their overall quality of life.
  • The commercial success of Byetta may depend on how many users are willing to undergo the twice-daily injections, with the potential for the drug to be a major product for Lilly and Amylin.
  • The partnership between Lilly and Amylin has been a fruitful one, with Byetta being the ninth drug Lilly has brought to market since 2001, and Amylin's second product.
  • The approval of Byetta marks a significant achievement for Lilly, which has been losing market share in the diabetes care market in recent years, and has helped solidify its long role as a leader in diabetes care.

Statistics:

  • Byetta is expected to generate $320 million in revenues for Lilly by 2007.
  • Of the 18 million Americans with diabetes, 90% have type 2 diabetes.
  • The average patient in clinical trials using Byetta and diabetes pills experienced clinically significant improvements in control of their blood glucose.
  • Patients using Byetta experienced an average weight loss of 2-5.5 pounds over seven months.
  • Byetta has been shown to trigger a feeling of satiety in the brain, leading to reduced appetite.
  • Side effects of Byetta include nausea and reduction in appetite.

Sources:

  • The Indianapolis Star, "Groundbreaking Diabetes Drug Derived from Gila Monster to Hit Pharmacies," April 30, 2005.
  • Food and Drug Administration, approval of Byetta.
  • Eli Lilly and Co., press release, "Lilly and Amylin Pharmaceuticals Announce FDA Approval of Byetta for the Treatment of Type 2 Diabetes," April 29, 2005.
  • Amylin Pharmaceuticals, press release, "Amylin and Lilly Receive FDA Approval for Byetta for the Treatment of Type 2 Diabetes," April 29, 2005.
  • American Diabetes Association, "Diabetes Facts," 2005.
  • Friedman, Billings, Ramsey & Co., estimate of Byetta sales potential.