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Oramed Pharmaceuticals Inc. (ORMP.OB) Submits Pre-IND Package to FDA for ORMD-0901 (oral exenatide), an Oral GLP-1 Analog for the Treatment of Type 2 Diabetes



9/3/2013 10:35:37 AM

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JERUSALEM, September 3, 2013 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (ORMP) (http://www.oramed.com), a developer of oral drug delivery systems, announced today that it has submitted a pre-Investigational New Drug (pre-IND) package to the U.S. Food and Drug Administration (FDA) for ORMD-0901, an orally administered exenatide capsule. Oramed's pre-IND package submission follows its recently announced meeting request letter submitted to the FDA. The submitted pre-IND package provides the FDA with information on Oramed's ORMD-0901 research conducted to-date, as well as a clinical trial outline for a proposed U.S. clinical trial. The FDA's response to the pre-IND package will serve as a guide to the Company for product development and preparation of a full IND application. 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 initiating Phase 2 clinical trials on patients with type 2 diabetes (T2DM) under an Investigational New Drug application with the U.S. Food and Drug Administration, and with its oral exenatide capsule (ORMD-0901; a GLP-1 analog), with trials on healthy volunteers (Phase 1b) and T2DM patients (Phase 2a) underway. Oramed is also moving forward with clinical trials of ORMD-0801 for the treatment of type 1 diabetes. 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.

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