Navigation Links
Oramed Submits Pre-IND Meeting Request to FDA for its Oral Exenatide Capsule ORMD-0901
Date:7/30/2013

JERUSALEM, July 30, 2013 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP) (www.oramed.com), 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 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, 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    
Email: aviva@oramed.com 

 


'/>"/>
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 RetailInvestorConferences.com 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:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ ) ... Improvements Act of 1976, as amended ("HSR"), with respect ... Nasdaq: CPXX ) expired effective June 24, ... As previously announced on May 31, 2016, Jazz Pharmaceuticals ... which Jazz Pharmaceuticals has commenced a tender offer for ...
(Date:6/24/2016)... , June 24, 2016  Consumers have ... and regulators/payers have placed more emphasis on patient ... patient support programs in the pharmaceutical industry have ... medications. Consequently, pharmaceutical companies are focusing on becoming ... are providing products and services that improve health. ...
(Date:6/24/2016)... 2016   Bay Area Lyme Foundation , ... Center for Tick Borne Illness , Harvard Medical ... Hacking Medicine, University of California, Berkeley, and the ... five finalists of Lyme Innovation , the ... 100 scientists, clinicians, researchers, entrepreneurs, and investors from ...
Breaking Medicine Technology:
(Date:6/26/2016)... Michigan (PRWEB) , ... June 26, 2016 , ... ... to fertility once they have been diagnosed with endometriosis. These women need a ... they also require a comprehensive approach that can help for preservation of fertility ...
(Date:6/25/2016)... Aliso Viejo, California (PRWEB) , ... June 25, 2016 , ... ... preset to fit their specific project," said Christina Austin - CEO of Pixel Film ... all fully customizable and all within Final Cut Pro X . Simply select ...
(Date:6/25/2016)... ... ... Friday, June 10, Van Mitchell, Secretary of the Maryland Department of Health and Mental ... exemplary accomplishments in worksite health promotion. , The Wellness at Work Awards took place ... BWI Marriott in Linthicum Heights. iHire was one of 42 businesses to receive an ...
(Date:6/24/2016)... ... ... June 19, 2016 is World Sickle Cell Observance Day. In an effort to ... treatments, Serenity Recovery Center of Marne, Michigan, has issued a pain management ... (SCD) is a disorder of the red blood cells, which can cause episodes of ...
(Date:6/24/2016)... ... June 24, 2016 , ... Dr. Amanda ... orthodontic treatment. Dr. Cheng has extensive experience with all areas of orthodontics, including ... accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary adjunct to orthodontic treatment. ...
Breaking Medicine News(10 mins):