Navigation Links
Oramed Submits Pre-IND Package to FDA for ORMD-0901 (oral exenatide), an Oral GLP-1 Analog for the Treatment of Type 2 Diabetes
Date:9/3/2013

JERUSALEM, September 3, 2013 /PRNewswire/ --

Oramed Pharmaceuticals Inc. (NASDAQCM: 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

Forward-looking statements: This press release contains forward-looking statements. For example, we are using forward-looking statements when we discuss our clinical trials, revolutionizing the treatment of diabetes with our products, and ORMD-0901 being a more patient-friendly form of treatment or it addressing a significant market. 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.

Company Contact:
Oramed Pharmaceuticals
Aviva Sherman
Cell:   +972-54-792-4438
Office: +972-2-566-0001       
Email: aviva@oramed.com 


'/>"/>
SOURCE Oramed Pharmaceuticals Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related biology technology :

1. Oramed CEO to be Panelist at BIO International Convention Breakout Session on Israel Becoming Biotech Leader
2. Oramed Pharmaceuticals Moves Forward with Investigational New Drug Application for Oral Insulin
3. Bioassociate Announces Initiation of Coverage on Oramed Pharmaceuticals, Inc.
4. Oramed Pharmaceuticals Announces Reverse Stock Split
5. Oramed Pharmaceuticals Granted 2nd Patent in New Zealand; 3rd Patent for Core Technology on Oral Delivery of Proteins
6. Marrone Bio Innovations Submits New Bioherbicide for EPA Registration
7. Janssen Submits Additional Marketing Applications for ZYTIGA® in the U.S. and European Union
8. iBio, Inc. Submits Plan to Satisfy NYSE Amex Continued Listing Standards
9. WellnessFX Launches New Products e-HealthAnswers and Womens Fertility Package
10. XY Precision Positioning Stage Provides Nanometer Incremental Motion in a Small Package: PI introduces Affordable 2-Axis Piezo Positioner, Model P-763
11. FDA/PhUSE Collaboration: Study Data Reviewer’s Guide Work Package v1.1 Available
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/22/2017)... Feb. 22, 2017 Scientists propose in ... organ damage in Gaucher and maybe other lysosomal storage ... lower costs than current therapies. An international ... Center , which also included investigators from the University ... their data Feb. 22. The study was conducted in ...
(Date:2/22/2017)... , ... February 22, 2017 , ... ... tech innovators, engineers, and scientists from around the world, is pleased to announce ... February 22 and 23, 2017. This premier, online-only conference focused on the development ...
(Date:2/22/2017)... , Feb. 22, 2017 Origin (Origin Agritech, LLC, ... trait and seed provider, and Arcadia (Arcadia ... that develops and commercializes agricultural productivity traits and nutritional products, today ... corn biotechnology product developed in China to ... regulatory trials. ...
(Date:2/22/2017)... Switzerland (PRWEB) , ... February 22, 2017 , ... ... ., announced the addition of Tom Perkins as European director. Operating from Pennside’s ... experience to Pennside. , Perkins joins Pennside after more than a decade ...
Breaking Biology Technology:
(Date:1/23/2017)... 2017  The latest mobile market research from Acuity ... dramatically. The quarterly average price of a biometric smartphone ... Q4 2016.  There are now 120 sub-$150 models on ... from just 28 a year ago at an average ... Maxine Most , Acuity Market Intelligence Principal, "Biometric Smartphones ...
(Date:1/19/2017)... , Jan. 19, 2017 Sensory ... experience and security for consumer electronics, and ... processing systems and cybersecurity solutions, today announced a ... and financial institutions worldwide to bolster security of ... end-to-end secure user authentication platforms they offer, innerCore ...
(Date:1/13/2017)... 2017 Sandata Technologies, LLC, a leading ... industry, including Electronic Visit Verification™ (EVV™), announced today ... as Senior Vice President of Product Management. ... homecare experience to Sandata, where he will be ... align Sandata,s suite of solutions with the needs ...
Breaking Biology News(10 mins):