Oramed Pharmaceuticals has agreed to spin off its Protein Oral Delivery (POD) technology into a newly formed joint venture with biotech company Hefei Tianhui Biotech (HTIT).
The venture, OraTech Pharmaceuticals, will focus on POD technology. POD is intended to protect drug integrity and increase absorption.
The spin-off aims to speed up the development and commercialisation of Oramed’s ORMD-0801 oral insulin and other oral drug delivery innovations.
Nasdaq-listed Oramed is a clinical-stage pharmaceutical firm focused on developing oral drug delivery platforms. The partnership supports its mission to advance diabetes and chronic disease treatments.
Under the definitive agreement, the pharmaceutical firm will transfer its proprietary oral insulin and POD technology, along with other pipeline assets, to OraTech.
Oramed shareholders will receive the majority and direct stake in OraTech’s equity interest, enabling them to benefit from its future success. The new venture is expected to go public on Nasdaq.
Additionally, Oramed and China-based HTIT will together invest $75m, with some funds allocated for a supply agreement. HTIT will invest $60m, while Oramed will contribute $15m to the new entity.
The capital will support OraTech’s development, commercialisation, and clinical advancement.
Oramed CEO Nadav Kidron said: “OraTech will be singularly focused on bringing oral insulin to market and unlocking the broader potential of oral drug delivery for additional therapeutic targets.
“With strong capital investment, an experienced leadership team, and world-class manufacturing support from HTIT, the company is uniquely positioned to advance its programs, including the planned reinitiation of a pivotal Phase 3 clinical trial in the US.”
OraTech will hold global marketing rights for the POD oral protein delivery technology.
OraTech will tap into HTIT’s expertise in capsule production and cost-effective manufacturing. This ensures a reliable, scalable supply chain for clinical trials and commercialisation activities.
According to the oral drug delivery platforms developer, OraTech will advance diabetes care and the future of oral biologics for chronic diseases using financial support, a promising pipeline, and a focus on development.
A new Phase 3 trial in the US with a revised protocol is set to begin this quarter.
OraTech will drive the registration of oral insulin in the US and other countries. The new venture will also receive royalties from oral insulin sales in China, where HTIT has submitted a Marketing Authorization Application.
In May 2023, Oramed Pharmaceuticals announced that its partner HTIT completed its Phase 3 trials of oral insulin in type 2 diabetes in China.
