Navigation Links
Oramed Submits Pre-IND Meeting Request to FDA for its Oral Exenatide Capsule ORMD-0901

JERUSALEM, July 30, 2013 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP) (, a developer of oral drug delivery systems, announced today that it submitted a pre-Investigational New Drug (pre-IND) meeting request to the U.S. Food and Drug Administration (FDA) for a US-based trial on its orally ingestible exenatide capsule, ORMD-0901.

Nadav Kidron, CEO of Oramed, commented, "We are very pleased to have submitted this pre-IND meeting request letter as part of our efforts to advance ORMD-0901 into US clinical trials. We look forward to the FDA's response and preparing ourselves accordingly in our efforts leading up to full IND submission on our second product."

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. 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

Forward-looking statements: This press release contains forward-looking statements. For example, we are using forward-looking statements when we discuss our clinical trials, any future meetings with the FDA, our anticipated IND submission regarding ORMD-0901, or revolutionizing the treatment of diabetes with our products. These forward-looking statements and their implications 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
Office: +972-2-566-0001   
Mobile: +972-54-792-4438    


SOURCE Oramed Pharmaceuticals Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Oramed Pharmaceuticals to Present at the 11th National Life Science & Technology Week ILSI-BIOMED Conference; Tel Aviv, Israel, 2012
2. Oramed Pharmaceuticals Granted Core Technology Patent in New Zealand
3. Oramed Pharmaceuticals to Present at the 12th Annual Diabetes Technology Society Meeting in Bethesda, MD, Nov 8-10, 2012
4. Oramed Pharmaceuticals Completes $5.6 Million Funding to Advance Clinical Trials
5. Oramed Pharmaceuticals Inc. to Webcast, Live, at on February 7th
6. Shares of Oramed Pharmaceuticals Are Approved for Listing on the Nasdaq Capital Market
7. Oramed Pharmaceuticals to Present at the 4th Annual Drug Delivery & Formulation Summit in Berlin
8. Oramed Pharmaceuticals Granted Japanese Patent for its Core Technology in Oral Delivery of Proteins
9. Oramed Submits New IND Application for Oral Insulin Trial in the US
10. Oramed Pharmaceuticals Appoints New Chief Operating Officer and VP of Business Development
11. Oramed Pharmaceuticals Chosen to Present at the 5th International Congress on Prediabetes and the Metabolic Syndrome in Vienna, Austria; April 18-20, 2013
Post Your Comments:
(Date:12/1/2015)... 1, 2015 --> ... Drugs Market by Type of Drug (Monoclonal Antibodies, Interferon-Alpha, Interleukins, ... and Pipeline Analysis - Global Forecast to 2020", published by ... USD 73,529.2 Million by 2020 from USD 40,281.6 Million in ... Browse 37 market data ...
(Date:12/1/2015)... BANGALORE, India and ... (NASDAQ, TASE: MYL) today announced that it expects to ... for developing country markets funded by international donors, TLE400 ... + Efavirenz 400 mg) for $99 per patient, per ... (CHAI) to develop TLE400. The significantly reduced price could ...
(Date:12/1/2015)... 1, 2015  AccuTEC Blades, a leader in ... logo and brand identity program. The new logo ... of bladed products where "the edge makes all ... --> Serving manufacturers and distributors of medical, ... equipment, AccuTEC,s product lines include those acquired when ...
Breaking Medicine Technology:
(Date:12/1/2015)... ... , ... Integrated Rental Services (“Integrated Rental”), a growing medical ... , With support from JII, Integrated Rental is poised for expansion while improving ... research labs and medical facilities across the United States. , General Manager Robert ...
(Date:12/1/2015)... (PRWEB) , ... December 01, 2015 , ... Califia ... today announced that its iconic bottle has won top honors in Beverage World Magazine’s ... The Company also announced that it has been selected as a 2015 U.S.A. Taste ...
(Date:12/1/2015)... ... December 01, 2015 , ... ... we have seen vast improvements in scientific research and discoveries, leading us to ... increased hope and relief to those affected by HIV/AIDS. Mediaplanet’s cross-platform edition of ...
(Date:12/1/2015)... ... December 01, 2015 , ... The importance of ... is the focus of numerous abstracts accepted for presentation here, at the 101st ... Nine abstracts highlight the use of Volpara Solutions’ quantitative breast imaging software tools ...
(Date:12/1/2015)... ... December 01, 2015 , ... Next ... selected as a finalist in this year’s Fierce Innovation Awards: Healthcare Edition, an ... was recognized as a finalist in the category of Digital Solutions for its ...
Breaking Medicine News(10 mins):