New diabetes drug superior to Lantus, says Lilly
pharmafile | July 29, 2004 | News story | |Â Â Â
Amylin Pharmaceuticals and partners Lilly say patients taking their new diabetes drug exenatide achieved similar glycaemic control to those on Aventis' market leader Lantus, but lost weight.
The results from the 500-patient study could be significant for the partnership, who need to position the new drug as a credible alternative to Lantus, which is well positioned to be the biggest selling diabetes product within just a few years.
The study evidence, which showed patients using the drug lost an average of 5lbs in weight compared to a gain of 3lbs for those on Lantus, will be significant, but exenatide must be taken twice daily before breakfast and dinner compared to once-daily Lantus.
Exenatide is the first in a new class of drugs called incretin mimetics, exhibiting many of the same effects as the human incretin hormone glucagon-like peptide-1 (GLP-1). Like the hormone, exenatide has effects on multiple organs that work together to improve blood sugar levels.
Exenatide will initially focus on patients who are not using insulin and are not achieving target blood glucose concentrations with a combination of diet and metformin and/or sulfonylureas.
This group of patients was estimated to number around 11.9 million in the US, France, Germany, Italy, Japan, Spain and the UK in 2001. Current treatment options available to them are usually associated with weight gain side-effects.
Amylin plans to market exenatide in an injectible pen/cartridge delivery system, subject to receiving the necessary regulatory approvals.
The drug was filed with the FDA in June, and once approved, could earn $1 billion in peak year sales, but Amylin will have quite a challenge to catch Lantus.
Worldwide sales of Lantus rose by 96.5% in the second quarter and it is the leading branded insulin by total prescriptions in the US and France and holds 50% of the long-acting (basal) insulin market in Germany.
