The world’s leading generics company Teva Pharmaceuticals Industries has suffered a setback in terms of its innovative R&D efforts after a mid-stage trial of its experimental compound for lupus failed to meet its goals.
The Israeli drugmaker said that its synthetic peptide, TV-4710 (edratide), did not meet its primary endpoint in the PRELUDE trial, a Phase II study in patients with systemic lupus erythematosus, though the drug, administered as a subcutaneous weekly injection, was shown to be safe and well-tolerated. PRELUDE enrolled 340 patients from 12 countries but data have shown that edratide failed to reduce lupus disease activity over a 26-week treatment period.
Teva noted that analyses of edratide's performance in other secondary endpoints measured in the trial are still ongoing, and any potential further development plans will not be determined until these have been completed.
Teva to supply more drugs to Germany
There was some better news for Teva, however, as the company announced that its tender to supply more products during 2008/09 to Allgemeinen Ortskrankenkassen (AOK), Germany's largest health insurance company, has been successful. In a tender earlier this year, the company was awarded the right to supply only six molecules.
AOK represents 25 million of the approximately 70 million publicly-insured people in Germany, Europe's largest generic market with about 8 billion euros in sales. Recent changes in the country's laws mean that health funds to negotiate discounts for products directly with manufacturers. Drugmakers selected by AOK will become one of three preferred suppliers of a specific product over a two-year period.