News
ORBUS Pharma Inc. announces successful bioequivalence results in its fluvastatin extended release drug development
Orbus Pharma Inc. today announced the successful results of the most demanding phase of the bioequivalence studies in its European drug development of a once per day formulation for FLUVASTATIN extended release ("XR") tablets, a cholesterol reducing drug.
The Orbus XR formulation is a generic version of Novartis's Lescol XR(R) (Fluvastatin extended Release) which has reported 2005 annual worldwide sales of US$ 767 million.
Bioequivalence studies are required to demonstrate that a generic formulated product results in the same level of medication in the blood as the innovator brand product. The most demanding of these studies is the "Fed" study, which the Orbus formulation has now successfully fulfilled. Orbus will be completing the remaining two bioequivalence studies to demonstrate therapeutic equivalence to the brand product Lescol XR (R) and results are expected near the end of the second quarter of 2007 and the tentative submission date is planed in the fourth quarter 2007 with approval expected 12 to 18 months thereafter.
All batches of the XR product used for regulatory submissions are manufactured in Orbus's Markham, Ontario plant. Orbus is currently in licensing negotiations with European companies for the marketing and manufacturing of the once per day Fluvastatin product. Additionally, Orbus has a U.S. patent pending covering the in house developed delivery system for this product. "Our once-a-day formulation of Fluvastatin using our proprietary in house developed controlled release technology is a major milestone for Orbus and we are very confident that our product will gain regulatory approval in Europe" says Jeff Renwick, President and CEO of Orbus Pharma Inc.