Teva Pharmaceutical Industries Ltd. (TEVA), the world’s largest generic-drug maker, is seeking to transform a compound once rejected by Sanofi into the first treatment to succeed insulin for Type 1 diabetes.
The therapy, DiaPep277, is made from a human protein that stops the immune system from destroying the pancreatic beta cells that secrete insulin, a hormone needed to convert sugar, starches and other food into energy. The drug also helps control sugar levels in the blood, a late-stage study has also shown. While the exact cause of Type 1 is unknown, scientists believe it occurs when the immune system attacks the pancreatic beta cells that produce insulin. By the time most patients are diagnosed with Type 1, 80% of their beta cells have been destroyed.
Shlomo Dagan, chief executive officer of Teva’s partner, Andromeda Biotech Ltd., says, “Right now the only treatment for Type 1 diabetes are insulin injections. This is not a therapy; it’s a replacement.”
DiaPep277, which modulates the immune system to prevent the destruction of insulin-secreting cells, was invented by Irun Cohen of the Weizmann Institute of Science in Rehovot, Israel. Since then it has been under development.
Teva licensed worldwide rights to DiaPep277 from Andromeda Biotech in June 2009, and invested $170 million in the company last year to fund a clinical trial to confirm earlier results for DiaPep277.
The drug met both the main and secondary goals of a study in the last of three stages of human testing generally needed for regulatory approval, Andromeda Biotech has reported that patients taking the medicine had stable C-peptide levels, which meant pancreatic cells secreted insulin on their own, while there was a decline in those levels among patients taking the placebo.
Patients taking DiaPep277 also maintained ‘good diabetic control’ compared with those taking the placebo. That means patients need fewer daily insulin doses. The trial included 457 newly diagnosed Type 1 diabetes patients between the ages of 16 and 45. They received one subcutaneous injection of DiaPep277 every three months, on top of their regular insulin injections.