Oramed Pharmaceuticals Files Investigational New Drug Application with the FDA for Oral Insulin
Addressing part of $174 billion diabetes treatment market in the U.S.
JERUSALEM, January 7, 2013 /PRNewswire/ --
Oramed Pharmaceuticals Inc. (OTCBB:ORMP.OB) (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.
The company's fact sheet can be viewed here.
For more information, the content of which is not part of this press release, please visit http://www.oramed.com
Forward-looking statements: This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal Securities laws. Statements preceded by, followed by, or that otherwise include the words "expects," "anticipates," "intends," "plans," "planned expenditures," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements, but are not deemed to represent an all-inclusive means of identifying forward-looking statements. Additionally, statements concerning future matters are forward-looking statements. For example, we are using forward-looking statements when we discuss the projected commencement of our upcoming clinical trials, the amount of patients to be included in the trials, or the impact the study may have on the treatment options of diabetics. These forward-looking statements are based on the current expectations of the management of Oramed only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for our product candidates; competition from other pharmaceutical or biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; laboratory results that do not translate to equally good results in real settings; our patents may not be sufficient; and that products may harm recipients, all of which could cause the actual results or performance of Oramed to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Oramed undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Oramed, reference is made to Oramed's reports filed from time to time with the Securities and Exchange Commission.
SOURCE Oramed Pharmaceuticals Inc.
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