JERUSALEM, Jan. 19, 2018 /PRNewswire/ — Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE: ORMP) (www.oramed.com)
All the hard work and dedication in 2017 has successfully positioned Oramed to initiate a U.S. based multicenter 90-day treatment study under a FDA IND focused on the lowering of HbA1c in type 2 diabetic patients later this quarter. This is just one of many milestones achieved in 2017 and one of the forward-looking milestones we anticipate in the coming year.
2017 Major Milestones Achieved
– Building U.S. based management team which includes:
- Chief Strategy Officer, Dr. Ron Law joins Oramed
- VP Medical Affairs, Dr. Simon Bruce joins Oramed
- CEO, Nadav Kidron’s relocation to Oramed’s NYC office
– Oramed begins dual listing on the Tel Aviv Stock Exchange (TASE)
– Approval from the Israel Ministry of Health to begin two exploratory human trials for NASH and Leptin
– Successful call with the FDA for oral insulin (ORMD-0801)
- BLA indication (12 years marketing exclusivity, if approved)
- Identified pathway to Phase 3 trials
– ~$40 million in cash and investments at year end; no debt
2018 Major Anticipated Milestones
– ORMD-0801 (oral insulin)
- HbA1c study initiation
- NASH study initiation
– ORMD-0901 (oral GLP-1)
- IND submission
- Phase 1 PK study initiation and completion
- Phase 2 study initiation
– Leptin study initiation
– HTIT – Chinese partner
- HTIT continuing work on building manufacturing capabilities in China
– Continuing big pharma collaboration
– Strong balance sheet
Oral insulin (ORMD-0801) Completes Successful Meeting with FDA
On August 31, 2017, Oramed had a call with the FDA. At this meeting, the FDA advised that the regulatory pathway for the submission of ORMD-0801 would be a Biologics License Application (BLA). Such a pathway would grant 12 years of marketing exclusivity for ORMD-0801, if approved, and an additional six months of exclusivity may be granted if the product also receives approval for use in pediatric patients. Oramed plans to initiate a 90-day treatment HbA1c trial under an FDA IND this quarter.
GLP-1 Headed into Phase II
Our oral GLP-1 analog (ORMD-0901) development is rapidly proceeding. We anticipate submitting an IND with the FDA and the initiation of a Phase II study in the United States in 2018.
Chinese Partnership Strengthens
We have successfully completed multiple milestones outlined in our license agreement with China-based HTIT. This has triggered some $30 million in payments received from HTIT to date. HTIT is investing substantial funds to build the manufacturing infrastructure to make oral insulin a reality in China. If approved, HTIT plans to manufacture and sell ORMD-0801 in China, with 10% royalties on any future net sales paid to Oramed.
Strong Balance Sheet
2018 kicks off with roughly $40 million in cash and investments. This capital enables us to successfully execute on our planned late-stage clinical studies for oral insulin and GLP-1 as we move towards commercialization. Our balance sheet puts Oramed in a positive position as we enter into and continue discussions with potential strategic partners.
We believe that 2018 will be an exciting and event driven year. We anticipate that the advancement of our late-stage clinical pipeline in 2018 will contribute to real value creation. We look forward to keeping you posted on our achievements throughout the year.
Sincerely,Nadav KidronChief Executive Officer
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 (PODTM) technology is based on over 30 years of research by top 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). The Company completed multiple Phase II clinical trials under an Investigational New Drug application with the U.S. Food and Drug Administration. In addition, Oramed is developing an oral GLP-1 analog capsule (ORMD-0901).
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 2018 anticipated milestones, the BLA pathway, that our cash positions us to execute our studies and puts us in a positive position and the timing of expected clinical development programs and clinical trials and FDA submissions. 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 U.S. Securities and Exchange Commission.
Oramed PharmaceuticalsJosh HexterOffice: +972-2-566-0001 ext. 2
U.S.: +1-844-9-ORAMED ext. 2
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SOURCE Oramed Pharmaceuticals Inc.