Safety and equivalence demonstrated in Phase III study.
Synthon today announced that it has successfully concluded multiple registration procedures for sevelamer tablets. Synthon received regulatory clearance for its product in 27 European countries. Scientific approval has been obtained for sevelamer carbonate 800 mg tablets.
Synthon's product is a fully generic and bioequivalent version of Renvela®* 800 mg tablets. The product contains the active ingredient sevelamer carbonate.
Synthon has successfully conducted a Phase III multicenter, randomized, double-blind, multiple-dose, crossover trial to compare safety and demonstrate equivalence of serum phosphate control of Synthon sevelamer tablets to Renvela® tablets in chronic kidney disease patients on hemodialysis. As sevelamer is a polymer that is not absorbed from the gastro-intestinal tract, a conventional bioequivalence study is not possible for this product. Synthon’s clinical equivalence study was set up following Scientific Advice from several European regulatory authorities. Synthon is the first company to have performed such a study for sevelamer and to obtain regulatory clearance in Europe.
Renvela® is a non-calcium based phosphate binder indicated for the control of serum phosphorus in patients with chronic kidney disease.
European sales of sevelamer in 2013 were EUR 150 million based on IMS Midas data.
* Renvela® is a trademark of Genzyme Corporation
Synthon, with headquarters in Nijmegen, The Netherlands, is an international pharmaceutical company and a leader in the field of generic medicines. Synthon’s generic products are currently approved by regulatory agencies in over 80 countries worldwide and marketed through strategic partnerships and – in dedicated areas – through direct sales. The company started its biopharmaceutical franchise in 2007 and is building a promising portfolio of next generation medicines. Synthon is developing rapidly into a specialty pharmaceutical company, focusing on the therapeutic areas of auto-immune diseases and oncology. Synthon employs about 1,400 staff worldwide, and in 2013 it recorded a turnover of EUR 215 million. For more information, go to www.synthon.com.