To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Issues Approvable Letter for Sanvar (Vapreotide) for Esophageal Variceal Bleeding URL: http://www.pslgroup.com/dg/248D66.htm Doctor's Guide January 4, 2005
MONTREAL, QC -- January 4, 2005 -- H3 Pharma Inc., a Montreal-based pharmaceutical product development company, announced today that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for Sanvar® IR (vapreotide) in the treatment of acute esophageal variceal bleeding (EVB) secondary to portal hypertension. In the letter, the FDA requests additional supportive efficacy data on the product candidate and additional information related to manufacturing aspects of the product. H3 Pharma intends to address the issues raised by the FDA within the first quarter of 2005. Sanvar IR (vapreotide) was approved by the Mexican Health Authority for this indication as well as four other indications, in August 2004. "We are very pleased to have received this approvable letter from the FDA," said Dr. Loic Maurel, President and CEO of H3 Pharma. "Following the successful completion of our Phase III study in 2000, an additional confirmatory study was performed in Eastern Europe involving 280 patients. This study has just been completed and an analysis of the results will allow us to follow up with the FDA within a short timeframe," he added. Sanvar immediate release (IR) formulation is the only somatostatin analog to demonstrate statistically significant benefits in the treatment of EVB in association with endoscopic therapy in a placebo controlled clinical study (Cales et al. New England Journal of Medicine, 2001). It is also the only somatostatin analog that is stable at room temperature for extended periods of time. Sanvar has been granted orphan drug status in the United States, which will provide seven years market exclusivity for the product in the U.S., once launched. The global market for somatostatin analogues is expected to reach US $1.1 billion this year. The previous Phase III clinical study in France was conducted with 227 patients in 22 centres. Sanvar IR was shown to significantly reduce active bleeding. Survival with hemostasis at 5 days was achieved significantly (p equals 0.021) more often with Sanvar IR than with placebo. In patients with control of bleeding at day 5, Sanvar IR significantly (p equals 0.006) increased hemostasis and survival through day 42. Sanvar IR could therefore provide important incremental benefits compared to endoscopic treatment alone in achieving hemostasis in patients presenting with acute variceal bleeding. EVB is a complex medical emergency with a high mortality rate. It affects some 650,000 people in North America and Europe where it accounts for about 7% of episodes of gastrointestinal bleeding. This complication occurs in approximately 30% of patients with portal vein hypertension caused by cirrhotic liver disease. SOURCE: H3 Pharma --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.