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Oramed Announces Successful Results from Ex-US Pharmacokinetic Study of its Oral Insulin for the Treatment of Type 1 Diabetes

Company Additionally Anticipates Results from Phase 2a FDA Study for Type 2 Diabetes in January

JERUSALEM, Dec. 20, 2013 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today successful results in a clinical trial testing the pharmacokinetic dose response of its oral insulin capsule (ORMD-0801) in type 1 diabetes patients. 

Patients were treated with a different dose of oral insulin at each study visit; blood glucose and insulin levels were then monitored for the ensuing five hours.  Patient responses positively correlated with administered doses, as did the duration of the effect.

"Based on these and the notable results from our previous oral insulin trials in type 1 diabetes, we continue to move forward with this indication in parallel to our advanced clinical studies in type 2 diabetes," commented CEO Nadav Kidron.

Type 1 diabetes (T1DM) is an autoimmune disease wherein the body destroys its own insulin-producing cells, leaving patients completely dependent on external insulin sources. The disease, formerly known as juvenile diabetes, currently affects both young and adult populations. According to the International Diabetes Federation, T1DM is on the rise at a rate of 3% per year and currently affects approximately 36 million people worldwide - about 10% of the global diabetes population. The disease was formerly known as juvenile diabetes, and currently affects both young and adult populations.

About ORMD-0801 Oral Insulin and T1DM

T1DM is currently treated with two types of insulin replacement therapies: long-acting insulin (basal) to help maintain stable insulin levels during fasting periods, and pre-meal insulin (bolus) doses. Oramed proposes to introduce ORMD-0801 to replace the mealtime (bolus) insulin doses, which would significantly reduce the number of daily injections.  Additionally, oral administration offers the benefit of reduced systemic exposure and may enable tighter regulation of blood sugar levels by directly affecting glucose control in the liver.  For more information on ORMD-0801, the content of which is not part of this press release, please visit http://oramed.com/index.php?page=14

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 Protein Oral Delivery (PODTM) 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 in 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), which has been assessed in healthy volunteers (Phase 1b) and is currently being tested in T2DM patients (Phase 2a). 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 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, anticipated timeframe of trial results or revolutionizing the treatment of diabetes with our products. 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
Office: +972-2-566-0001       

US: +1-718-831-2512
Email: aviva@oramed.com 

SOURCE Oramed Pharmaceuticals Inc.

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