SangStat
Executive Summary
Company expects approvals for SangStat's thymoglobulin and cyclosporine for prevention of graft rejection in patients undergoing organ transplant "very, very soon," SangStat CEO Philippe Pouletty announced Oct. 6 at the Warburg Dillon Read analyst conference. FDA has told the company that the approvals are imminent, Pouletty said. If approved, SangStat cyclosporine (Sang-35) will be the first branded generic cyclosporine in the U.S. Novartis' Neoral (cyclosporine microemulsion) earned $1.3 bil. last year, according to SangStat estimates. In the pivotal trial for Sang-35, the drug showed 99% bioequivalence to Neoral, the company said. SangStat plans to compete with Novartis by offering a 15%-20% discount over Neoral, which can cost up to $7,000 per year