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Last updated on April 18, 2014 at 17:24 EDT

Oramed Pharmaceuticals to Collaborate With Leading Contract Research Organization Medpace for Phase II FDA Trial on Oral Insulin

October 3, 2012

JERUSALEM, October 3, 2012 /PRNewswire/ –

Oramed Pharmaceuticals Inc. (OTCBB:ORMP.OB) (http://www.oramed.com), a developer
of oral drug delivery systems, announced today that its subsidiary, Oramed Ltd., has
signed an agreement with Medpace, Inc. to retain Medpace as a Clinical Research
Organization (CRO) for Oramed’s upcoming Phase II clinical trial on its oral insulin
capsule, ORMD-0801. The FDA-approved trial will assess the safety and efficacy of Oramed’s
oral insulin in 147 patients at multiple centers across the United States. Oramed plans to
file an Investigative New Drug application (IND) with the FDA in this quarter and commence
the trial following approval of the IND.

Medpace is led by top therapeutic and regulatory experts with comprehensive experience
in the advancement of pharmaceutical agents for use in multiple therapeutic specialties,
and will oversee the entire operation and data management of Oramed’s Phase II clinical
trial. Dr. David Orloff, Medpace’s Vice President of Medical and Regulatory Affairs, is
playing a major role in the design and implementation of the upcoming trial. Dr. Orloff is
a past director of the FDA’s Division of Metabolism and Endocrinology Products and, with
Medpace’s exemplary standards as a CRO, is well-positioned to advance the most efficient
and cost-effective path to drug approval for Oramed.

“We are excited about this collaboration, which represents a significant milestone for
the company,” commented Nadav Kidron, CEO of Oramed. “After much due diligence, we decided
to join forces with the experts at Medpace and look forward to working with them on the
FDA-approved clinical trial of our oral insulin capsule.”

About Medpace

Medpace was established in 1992, and has partnered with leading pharmaceutical,
biotechnology, and medical device companies to bring promising new drugs to market. As a
full-service CRO, Medpace combines efficient clinical trial management
[http://www.medpace.com/WhatWeDo/ClinicalOperations/TrialManagement.aspx?a=ClinicalTrialManagement ]
, comprehensive regulatory consulting
[http://www.medpace.com/WhatWeDo/RegulatoryAffairs/Default.aspx?a=RegulatoryAffairs ], and
innovative technologies [http://www.medpace.com/HowWeWork/Technology/Default.aspx ] to
create a customized approach
[http://www.medpace.com/HowWeWork/CustomSolutions.aspx?a=CustomSolutions ] that ensures
powerful solutions for its partners around the globe.

For more information, please visit Medpace’s website at http://www.medpace.com
[www.medpace.com ].

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 25 years of research by top research scientists at Jerusalem’s
Hadassah Medical Center. Oramed is seeking to revolutionize the treatment of diabetes
through its patented flagship product, an orally ingestible insulin capsule currently
approaching FDA-approved Phase 2 clinical trials, and with its GLP-1 analog capsule,
currently approaching Phase 1b/2a trials, the results of which are expected by the end of
the calendar year. The company’s corporate and R&D headquarters are based in Jerusalem.

The company’s fact sheet can be viewed here [http://oramed.com/ufiles/fact sheet -
June 2012.pdf ].

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.
For example, we are using forward looking statements when we discuss our FDA approved
trial, its expected timing, purpose and Medpace’s role in it. 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 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; we may encounter delays or
obstacles in launching our clinical trials; our technology may not be validated as we
progress further and our methods may not be accepted by the scientific community; we may
be unable to retain or attract key employees whose knowledge is essential to the
development of our products; unforeseen scientific difficulties may develop with our
process; our products may wind up being more expensive than we anticipate; results in the
laboratory may not translate to equally good results in real settings; our patents may not
be sufficient; our products may harm recipients; changes in legislation; inability to
timely develop and introduce new technologies, products and applications; loss of market
share and pressure on pricing resulting from competition, 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
        Cell: +972-54-792-4438
        Email: aviva@oramed.com

SOURCE Oramed Pharmaceuticals Inc.


Source: PR Newswire