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Oramed Pharmaceuticals Inc. (ORMP) Reports Last Patient Out In Phase Iia Trial For ORMD-0801 In Type 1 Diabetes



8/7/2014 8:14:26 AM

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JERUSALEM, August 7, 2014 /PRNewswire via COMTEX/ -- JERUSALEM, August 7, 2014 /PRNewswire/ --

Oramed Pharmaceuticals Inc. ORMP +1.74% ( http://www.oramed.com ), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, today reports that the last patient has completed treatment in its Phase IIa clinical trial of ORMD-0801, the Company's proprietary oral insulin capsule, to treat type 1 diabetes, and top-line data is expected to be reported in the fourth quarter of 2014. The trial was conducted in the United States under a Food and Drug Administration Investigational New Drug protocol.

The prospective, randomized, double-blind, placebo controlled study in patients with established type 1 diabetes is evaluating the safety and impact of ORMD-0801 on the exogenous insulin requirements in 24 type 1 diabetics patients.

About Type 1 Diabetes

Type 1 diabetes is an autoimmune disease in which the pancreatic beta cells responsible for insulin secretion are attacked by the immune system. In the absence of self-produced insulin and the concomitant glycemic control, there is a need to supply extraneous insulin in order to regain glycemic control and prevent future disease complications that include heart disease, blood vessels disease, nerve and eye disease, infections, hypoglycemic events and many more ailments. According to the International Diabetes Federation, type 1 diabetes 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 pediatric and adult populations.

About Oramed Pharmaceuticals

Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, Oramed's Protein Oral Delivery (POD[TM]) 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 ), having completed separate Phase IIa clinical trials, and anticipating the initiation of separate Phase IIb clinical trials, in patients with both type 1 and type 2 diabetes under an Investigational New Drug application with the U.S. Food and Drug Administration, and with its oral GLP-1 analog capsule ( ORMD-0901 ). 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 within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, we are using forward-looking statements when we discuss our clinical trials, including the expected timing thereof, timing for reporting data from our clinical trials, the anticipated safety of ORMD-0801 and 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 Guiloff Office: +972-2-566-0001 ext. 2 US: 1-718-831-2512 ext. 2

Email: aviva@oramed.com

US Investor Relations Contact: LHA Anne Marie Fields Senior Vice President US: 212-838-3777 Email: afields@lhai.com

SOURCE Oramed Pharmaceuticals Inc.

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