JERUSALEM, June 21, 2016 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (www.oramed.com), a developer of oral drug delivery systems, today announced that Hefei Tianhui Incubator of Technologies Co. Ltd. (HTIT) is transferring a $6.5 million milestone payment from the previously-announced license and investment agreement between Oramed and HTIT. The payment follows Oramed's positive top-line results from its Phase IIb U.S. Food and Drug Administration trial designed to evaluate the safety and efficacy of Oramed's oral insulin capsule ORMD-0801 in patients with type 2 diabetes.
Per the terms of the agreement signed in December 2015, Oramed granted HTIT exclusive rights for commercialization of ORMD-0801 in Greater China. The up to $50 million license deal includes multiple milestone payments aggregating $38 million, with a $3 million upfront payment received by Oramed upon execution of the agreement, plus a $12 million investment made by HTIT in Oramed at $10.39 per share in December 2015. Oramed will receive a 10% royalty on net sales of ORMD-0801 and related commercialized products in Greater China.
"The completion of this milestone signifies our deepening partnership with HTIT as we move closer to bringing oral insulin to the vast and growing Chinese diabetes market," said Nadav Kidron, CEO of Oramed.
"The positive Phase IIb data has further illustrated the huge potential this technology can have in China," said HTIT CFO & Oramed Board Member Xiaopeng Li. "We are working diligently to lay the groundwork for the successful production and commercialization of ORMD-0801 focused on the Greater China market."
About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, Oramed's Protein Oral Delivery (POD™) technology is based on over 30 years of research by 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).
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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 Phase IIb study, the potential to bring oral insulin to the Chinese market and its potential production and commercialization in China, or when we discuss 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 finally 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.
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SOURCE Oramed Pharmaceuticals Inc.