FDA requires company to conduct a sub study before it begins the clinical trial
JERUSALEM, February 14, 2013
Oramed Pharmaceuticals Inc. (ORMP) (http://www.oramed.com), a developer of oral drug delivery systems, announced today that it has been in communication with the U.S. Food and Drug Administration (FDA) regarding its Investigational New Drug (IND) application for oral insulin. The FDA has asked Oramed to perform a sub study in a controlled in-patient setting for up to a one-week period. In order to accommodate the FDA's request, Oramed will submit a new IND with a clinical protocol for the aforementioned sub study.
"We are very pleased to be in close and positive communications with the FDA, as well as having a clear path which meets the FDA's input. This positions us for imminent clearance from the FDA to proceed with our planned clinical studies," commented Nadav Kidron, CEO of Oramed.
About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs and vaccines currently delivered via injection. Established in 2006, Oramed's technology is based on over 30 years of research by top research scientists at Jerusalem's Hadassah Medical Center. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary flagship product, an orally ingestible insulin capsule (ORMD-0801) currently approaching Phase 2 clinical trials under U.S. IND, and with its oral exenatide capsule (ORMD-0901; a GLP-1 analog), currently approaching Phase 2a trials. The company's corporate and R&D headquarters are based in Jerusalem.
For more information, the content of which is not part of this press release, please visit http://www.oramed.com
The company's fact sheet can be viewed here.
Forward-looking statements: This press release contains forward-looking statements. For example, we are using forward-looking statements when we discuss receiving imminent clearance from the FDA as well as the projected commencement dates for our upcoming clinical trials. 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 final 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.