- JV will have global marketing rights to oral drug delivery technology
- HTIT to invest $60 million, Oramed to invest $10 million into JV
- HTIT to provide a supply agreement for oral insulin capsule
- JV to advance registration of oral insulin in the United States and other countries
NEW YORK, Aug. 2, 2023 /PRNewswire/ — Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE: ORMP) (www.oramed.com) announced today that it has signed a non-binding term sheet with Hefei Tianhui Biotech Co., Ltd. (“HTIT”) to establish a joint venture (“JV”) based on Oramed’s oral drug delivery technology. The proposed JV would focus on the development and worldwide commercialization of innovative products based on Oramed’s oral insulin and POD™ (Protein Oral Delivery) pipeline and HTIT’s manufacturing capabilities and technologies. The JV is subject to the execution of a binding definitive agreement.
“We are thrilled to further our relationship with HTIT, expanding the reach of our oral drug delivery technology to a global market,” said Oramed Chief Executive Officer, Nadav Kidron. “HTIT has successfully completed a Phase 3 oral insulin trial and submitted a New Drug Application (“NDA”) to the National Medical Products Administration (“NMPA”), with marketing approval currently pending in China. HTIT has state-of-the-art facilities, manufacturing capabilities and the know-how needed to produce oral insulin on an international scale. This JV is a true opportunity to leverage our strengths as well as those of our partners to fast-track our pipeline towards commercialization.”
Scope of the Joint Venture
The JV would be responsible for developing, marketing and commercializing drug products globally, focusing on Oramed’s oral insulin and POD™ technology, as well as other assets in the Oramed pipeline. The parties intend for the JV to initiate a Phase 3 oral insulin trial in the United States.
Structure of Joint Venture
Oramed and HTIT would initially hold equal shares in the JV, with each owning 50% of the equity. The Board of Directors would initially consist of equal representation from HTIT and Oramed, ensuring that both parties have an equal say in decision-making. As part of the Joint Venture, HTIT will make an initial investment of $60 million, while Oramed will invest $10 million.
About Oramed Pharmaceuticals
Oramed Pharmaceuticals (Nasdaq/TASE: ORMP) is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. The company’s novel Protein Oral Delivery (POD™) technology is designed to protect drug integrity and increase absorption. Oramed has offices in the United States and Israel. For more information, please visit www.oramed.com.
Hefei Tianhui Biotechnology Co., Ltd. (HTIT) has a state-of-the-art oral insulin manufacturing facility in Hefei, China. HTIT is a high-tech company focused on biopharmaceutical product manufacturing and R&D with an emphasis on the oral delivery of therapeutic macromolecules.
Forward-looking statements: This press release contains forward-looking statements. For example, we are using forward-looking statements when we discuss potential marketing approval by HTIT and commercialization in China, the potential to enter into definitive documentation with respect to the JV, which is currently still under negotiation according to the understanding set forth in the non-binding term sheet, the potential safety and efficacy of oral insulin and the potential of Oramed and/or the JV to move forward with its oral insulin product and fast-track its pipeline towards commercialization. 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 ability of the parties to reach agreement on a definitive JV agreement and the transactions contemplated by the term sheet, which may not occur; Oramed’s process to evaluate strategic options; the terms, timing, structure, benefits and costs of any strategic transaction and whether any transaction will be consummated at all; the impact of any strategic transaction on Oramed; the outcomes of any litigation, regulatory proceedings, inquiries or investigations to which Oramed may be subject; the ability to obtain financing or third-party approvals as needed; our ability to achieve the intended benefits of our strategic initiatives; 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; that products may harm recipients; and other factors discussed in the “Risk Factors” section of Oramed’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which are on file with the Securities and Exchange Commission and in other filings that Oramed makes with the Securities and Exchange Commission in the future. All of these factors 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.
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SOURCE Oramed Pharmaceuticals Inc.