Merck & Co posted Q4/2006 sales of US$ 42 mln with its first-in-class dipeptidyl peptidase IV (DPP-IV) inhibitor Januvia. FDA’s recent request for more clinical data to meet conditions set forth in the approvable letter of Novartis’ NDA of the DPP-IV inhibitor Galvus will aid Merck to maintain and extend its competitive edge in the field. At least 13 further DPP-IV inhibitors are in clinical development with eight in advanced phase II or III stages. However, the first Big Pharma companies have abandoned the field, partly due to undisclosed safety issues, unsatisfactory clinical results or better alternatives. Available data show differences in duration of action and anticipated dosing frequency.
The high interest of the pharmaceutical industry in DPP-IV inhibitors reflects the market attractivity. The WHO estimates that globally over 170 mln people have diabetes, with type 2 diabetes accounting for 90 % to 95 %. By 2030, the prevalence of diabetes is predicted to double, driven by adverse lifestyle changes. Dipeptidyl peptidase IV is an enzyme that rapidly inactivates the insulinotropic hormone glucagon-like peptide-1 (GLP-1). Inhibition of dipeptidyl peptidase IV by DPP-IV inhibitors enhances the hormone activity of GLP-1 and other bioactive peptides (GIP, PACAP38 and GRP), thereby stimulating the release of insulin and reducing the secretion of glucagon. Both effects contribute to regulation of the elevated blood glucose levels in type 2 diabetic patients as measured by hemoglobin A1c (HbA1c).
Available clinical data suggest that long term treatment with DPP-IV inhibitors was well tolerated with very low rates of hypoglycemia and was not associated with weight gain or gastrointestinal disturbances. The DPP-IV inhibitors are being evaluated as both monotherapy and in combination with other standard antidiabetic drugs, e.g. metformin. The major advantages of DPP-IV inhibitors are the ability to achieve sustainable reductions in HbA1c with an orally administered, well tolerated agent. Other classes of new antidiabetic medications include GLP-1 agonists and dual PPAR agonists. However, GLP-1 agonists require administration by injection and dual PPAR agonists are associated with safety concerns.
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