Navigation Links
Oramed Pharmaceuticals Moves Forward with Investigational New Drug Application for Oral Insulin
Date:2/14/2013

JERUSALEM, February 14, 2013 /PRNewswire/ --

Oramed Pharmaceuticals Inc. (NASDAQ: 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.

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. Bioassociate Announces Initiation of Coverage on Oramed Pharmaceuticals, Inc.
2. Oramed Pharmaceuticals Announces Reverse Stock Split
3. Oramed Pharmaceuticals Granted 2nd Patent in New Zealand; 3rd Patent for Core Technology on Oral Delivery of Proteins
4. Auxilium Pharmaceuticals, Inc. to Present at the Leerink Swann Global Healthcare Conference
5. Auxilium Pharmaceuticals to Announce Fourth Quarter and Full Year 2012 Results and Conduct Conference Call on Tuesday, February 26, 2013
6. Keryx Biopharmaceuticals to Present at the 15th Annual BIO CEO & Investor Conference Presentation Scheduled for Monday, February 11th at 2:30 PM ET
7. DelMar Pharmaceuticals Announces Acquisition and $5.4 Million Private Placement to Advance Novel Cancer Therapies
8. Todays Research on Mylan and Watson Pharmaceuticals: One Drug Makers Sorrow is Another Ones Joy
9. Biscayne Pharmaceuticals Closes $1.5 Million Financing To Advance Recent Discoveries Of Pioneering Endocrine Drug Researcher
10. UPM Pharmaceuticals Enhances its Pre-Formulation Capabilities
11. Biosim Pharmaceuticals, Manufacturers of Generic ACTHAR, to Participate at Biotech Showcase 2013
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/23/2016)... ... May 23, 2016 , ... PrecisionAg® ... Farming in 2017 and Beyond. The paper outlines the key trends that are ... industry. , “We’ve witnessed a lot of highs and lows as the precision ...
(Date:5/23/2016)... Oxitec CEO Hadyn Parry will testify ... before the United States House Committee on Science, Space and ... controlling the spread of the Aedes aegypti mosquito, ... (Logo: http://photos.prnewswire.com/prnh/20150630/227348 ) Oxitec has pioneered ... in Brazil , Panama ...
(Date:5/23/2016)... ... May 23, 2016 , ... RoviSys, a leading independent ... Aurora, Ohio, has broken ground on a new building in Holly Springs, NC. ... this new location solidifies a commitment to business in the region. The new ...
(Date:5/22/2016)... ... , ... Doctors in Rome say micronutrients found in certain foods have the ... has just posted an article on the new research. Click here to read ... and Translational Medicine evaluated more than 150 studies on polyphenols in cancer for their ...
Breaking Biology Technology:
(Date:3/21/2016)... Massachusetts , March 22, 2016 ... facial recognition with passcodes for superior security   ... ), a leading provider of secure digital communications services, ... their biometric technology and offer enterprise customers, particularly those ... secure facial recognition and voice authentication within a mobile ...
(Date:3/14/2016)... March 14, 2016 NXTD ) ("NXT-ID" ... commerce market, announces the airing of a new series of ... week of March 21 st .  The commercials will air ... popular Squawk on the Street show. --> NXTD ... growing mobile commerce market, announces the airing of a new ...
(Date:3/10/2016)... BLUE BELL, Pa. , March 10, 2016   ... U.S. Customs and Border Protection (CBP) is testing ... in San Diego to help identify ... United States . The test, designed to help determine ... outdoor, pedestrian environment, began in February and will run until ...
Breaking Biology News(10 mins):