Oramed spins off protein oral delivery tech in joint venture with Hefei Tianhui Biotech
Clinical-stage company Oramed Pharmaceuticals announced it is spinning off its protein oral delivery (POD) technology in a new joint venture, OraTech Pharmaceuticals (OraTech), with China’s Hefei Tianhui Biotech.
Oramed will transfer its proprietary oral insulin and POD technology, along with other pipeline assets, to OraTech. Hefei Tianhui Biotech is investing $60 million in the venture, while Oramed is providing $15 million.
The deal is meant to accelerate the development and commercialization of Oramed’s ORMD-0801 oral insulin and other POD-based innovative oral drug delivery technologies. The company’s novel POD technology is designed to protect drug integrity and increase absorption, according to Oramed.
OraTech will tap Hefei Tianhui Biotech’s “expertise in capsule production and cost-efficient manufacturing, ensuring a robust, reliable, and scalable supply chain to support clinical trials and commercialization efforts,” according to the announcement.
Hefei Tianhui Biotech, which owns and operates a manufacturing facility in Hefei, China, is focusing on biopharma product manufacturing and R&D with an emphasis on the oral delivery of therapeutic macromolecules. Oramed has offices in Israel and the United States.
OraTech brings together Oramed’s technology and clinical development expertise with Hefei Tianhui Biotech’s state-of-the-art manufacturing capabilities, according to Oramed CEO Nadav Kidron, who said in a statement that the joint venture will be “singularly focused on bringing oral insulin to market and unlocking the broader potential of oral drug delivery for additional therapeutic targets.”
In January 2023, Oramed announced that its ORMD-0801 oral insulin failed to meet both primary and secondary endpoints in a key Phase 3 trial in patients with type 2 diabetes.
Kidron in Tuesday’s announcement said OraTech is “uniquely positioned to advance its programs, including the planned reinitiation of a pivotal Phase 3 clinical trial in the United States.”
Oramed previously announced that the company has “proactively engaged in constructive dialogue” with the FDA regarding a new Phase 3 protocol based on specific patient subgroups identified as significant responders through an analysis of Phase 2 and Phase 3 data. “By leveraging these insights, we aim to optimize the potential for success in our potential upcoming trial.”