Israel-based drug developer Oramed Pharmaceuticals Inc., (NASDAQ: ORMP) has revealed that a deal has been signed with its existing China-based partner, Hefei Tianhui Biotech Co., Ltd (HTIT), to establish a joint venture (JV). The non-binding term sheet signed by both parties outlines that the JV will focus on the development and worldwide commercialization of innovative products based on Oramed’s oral insulin and Protein Oral Delivery (POD) pipeline. A binding deal finalizing the terms is yet to be signed.
Equity Split and Initial Investments
The JV equity will be split equally between the two companies, with HTIT contributing an initial investment of USD 60 million and Oramed contributing USD 10 million. If the deal is finalized, the JV will immediately focus on initiating a Phase III study for Oramed’s oral insulin product in the United States.
Oramed’s Drug Delivery System and Partnership History
Oramed has developed a drug delivery system that allows drugs typically administered via injection to be absorbed through the stomach. This technology has initially been applied to the development of capsule-delivered insulin. Oramed and HTIT first formed a partnership in 2015, with China rights to the insulin product licensed to HTIT in a USD 50 million deal. HTIT has efficiently advanced the oral insulin candidate through China-based trials to an NDA filing, which Fineline Info & Tech data shows was accepted by the CDE in April this year. The oral insulin product is currently in the Phase III stage in the US and Europe.
Reasons for JV Formation and HTIT’s Role
The decision to form a JV reportedly reflects HTIT’s manufacturing capabilities and its ability to meet the demands of commercial supply at a global scale for the drug. This strategic partnership aims to leverage HTIT’s strengths in manufacturing and distribution to ensure the successful global launch of Oramed’s oral insulin product.-Fineline Info & Tech
