Addressing part of $174 billion diabetes treatment market in the U.S.
JERUSALEM, Israel I January 7, 2013 I Oramed Pharmaceuticals Inc. (ORMP) (http://www.oramed.com), a developer of oral drug delivery systems, announced today that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin a Phase 2 clinical trial of its orally ingested insulin candidate, ORMD-0801. The IND application was filed with the FDA on December 31, 2012. The trial is to include 147 type 2 diabetic patients in multiple centers across the United States. If Oramed does not receive comments from the FDA on the IND application within 30 days from filing, Oramed intends to immediately commence the trial to evaluate the safety, tolerability and efficacy of its oral insulin capsule on type 2 diabetic volunteers.
According to the 2011 National Diabetes Fact Sheet as reported by the Centers for Disease Control and Prevention (CDC) nearly 8.3% of Americans had diabetes in 2010 – approximately 25.8 million people. The same report noted that the 2007 expense for diabetes treatment in the Unites states was $174 billion, with direct costs for treatment representing $116 billion – a number that is 2.3 times higher than the medical costs of someone who does not have diabetes.
"This filing marks a major milestone for Oramed as it sets the ground for the largest trial on Oramed’s oral insulin to date. We look forward to receiving FDA approval and initiating the Phase 2 trial on Oramed’s oral insulin candidate. Its success will ultimately present a pathway to a better treatment option for diabetic patients," commented Nadav Kidron, CEO of Oramed.
About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a pharmaceutical company currently engaged in the research and development of innovative pharmaceutical solutions for the use of orally ingestible capsules or pills for delivery of polypeptides, such as insulin and vaccines. Established in 2006, Oramed’s technology is based on over 25 years of research by top research scientists at Hadassah Medical Center in Jerusalem. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary flagship product, an orally ingestible insulin capsule (ORMD-0801) currently approaching an FDA-approved Phase 2 clinical trial, and with its oral exenatide capsule (ORMD-0901), currently approaching Phase 1b/2a trials. Oramed’s corporate and R&D headquarters are based in Jerusalem.
SOURCE: Oramed Pharmaceuticals
Post Views: 185
Addressing part of $174 billion diabetes treatment market in the U.S.
JERUSALEM, Israel I January 7, 2013 I Oramed Pharmaceuticals Inc. (ORMP) (http://www.oramed.com), a developer of oral drug delivery systems, announced today that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin a Phase 2 clinical trial of its orally ingested insulin candidate, ORMD-0801. The IND application was filed with the FDA on December 31, 2012. The trial is to include 147 type 2 diabetic patients in multiple centers across the United States. If Oramed does not receive comments from the FDA on the IND application within 30 days from filing, Oramed intends to immediately commence the trial to evaluate the safety, tolerability and efficacy of its oral insulin capsule on type 2 diabetic volunteers.
According to the 2011 National Diabetes Fact Sheet as reported by the Centers for Disease Control and Prevention (CDC) nearly 8.3% of Americans had diabetes in 2010 – approximately 25.8 million people. The same report noted that the 2007 expense for diabetes treatment in the Unites states was $174 billion, with direct costs for treatment representing $116 billion – a number that is 2.3 times higher than the medical costs of someone who does not have diabetes.
"This filing marks a major milestone for Oramed as it sets the ground for the largest trial on Oramed’s oral insulin to date. We look forward to receiving FDA approval and initiating the Phase 2 trial on Oramed’s oral insulin candidate. Its success will ultimately present a pathway to a better treatment option for diabetic patients," commented Nadav Kidron, CEO of Oramed.
About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a pharmaceutical company currently engaged in the research and development of innovative pharmaceutical solutions for the use of orally ingestible capsules or pills for delivery of polypeptides, such as insulin and vaccines. Established in 2006, Oramed’s technology is based on over 25 years of research by top research scientists at Hadassah Medical Center in Jerusalem. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary flagship product, an orally ingestible insulin capsule (ORMD-0801) currently approaching an FDA-approved Phase 2 clinical trial, and with its oral exenatide capsule (ORMD-0901), currently approaching Phase 1b/2a trials. Oramed’s corporate and R&D headquarters are based in Jerusalem.
SOURCE: Oramed Pharmaceuticals
Post Views: 185
