Metaglidasen, is a partial agonist of the PPAR-ã receptor and selectively modifies gene expression needed for insulin sensitisation without activating the genes responsible for weight gain and oedema.
The biotechnology company are confident that the drug has the potential to capture a large share of the global market for insulin sensitizers, which in 2004 totalled more than $4bn.
Addressing insulin resistance can treat and possibly prevent the onset of type 2 diabetes, yet concerns about the adverse effect profile have limited the use of currently marketed insulin sensitizers.
The European patent further strengthens Metabolex's intellectual property position surrounding metaglidasen, which Metabolex is now evaluating in a pivotal Phase 2/3 trial of patients with type 2 diabetes.
The Company has 14 issued patents covering the use of metaglidasen, including four US patents and more than 60 pending patent applications covering the use, manufacture and formulation of metaglidasen.
Metabolex in June entered into a strategic alliance with Ortho-McNeil, Inc., a Johnson & Johnson company, giving Ortho-McNeil an exclusive license for worldwide development and commercialisation of the drug.
"This patent expands the protection for metaglidasen and adds to our existing intellectual property portfolio," said President and Chief Executive Officer Harold Van Wart..
"We believe that metaglidasen will offer patients a unique combination of benefits with an improved side-effect profile compared to current therapies."
Metaglidasen has a different chemical structure and mechanism of action than the insulin sensitizers currently on the market. Unlike Actos and Avandia, metaglidasen is not a thiazolidinedione (TZD).
Drugs from the TZD class are full agonists of the PPAR-ã receptor and target both the genes responsible for insulin sensitivity as well as those linked to adverse effects.