Oramed Announces Transformative Joint Venture to Accelerate Development and Commercialization of Oral Insulin
Rhea-AI Summary
Oramed Pharmaceuticals (NASDAQ: ORMP) announced a strategic joint venture to create OraTech Pharmaceuticals, focusing on oral drug delivery technology. The new company will receive Oramed's POD™ technology and oral insulin assets, backed by a $75 million combined investment from Oramed ($15M) and Hefei Tianhui Biotech (HTIT) ($60M).
Key aspects of the deal include: Oramed shareholders will receive a majority stake in OraTech, which is expected to list on Nasdaq; HTIT will provide manufacturing capabilities and a supply agreement for oral insulin capsules; and OraTech will hold global marketing rights to the POD™ technology. A new Phase 3 trial in the U.S. with a revised protocol is planned to begin this quarter, while in China, a Marketing Authorization Application has been submitted with commercialization preparations underway by HTIT.
Positive
- Formation of new joint venture with $75M in combined funding
- Oramed shareholders to receive majority stake in new Nasdaq-listed entity
- Secured manufacturing and supply agreement with HTIT
- Marketing Authorization Application submitted in China
- New Phase 3 trial starting this quarter with revised protocol
Negative
- Previous Phase 3 trial required protocol revision
- Additional capital investment required from Oramed ($15M)
News Market Reaction
On the day this news was published, ORMP gained 19.82%, reflecting a significant positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
New Standalone Company, OraTech Pharmaceuticals Inc., to Focus on Oral Drug Delivery with Strategic Investment and Advanced Manufacturing Capabilities
- Oramed shareholders to receive the right to a direct stake in OraTech, expected to go public on Nasdaq.
- OraTech will have global marketing rights to Oramed's POD™ oral protein delivery technology.
- HTIT to invest
$60 million $15 million - HTIT to provide a supply agreement for oral insulin capsules.
- New Phase 3 trial in the
U.S. with a revised protocol expected to begin this quarter. - OraTech to advance registration of oral insulin in the
U.S. and other countries. - OraTech to receive royalty payments from sales of oral insulin in
China , where a Marketing Authorization Application has been submitted, and commercialization preparations are underway by HTIT.
As part of the transaction, Oramed will transfer its proprietary oral insulin and POD™ technology, along with other pipeline assets, into OraTech. The definitive agreements call for Oramed shareholders to receive a majority of Oramed's equity interest in the new entity, allowing them to directly participate in its future success. Additionally, under the agreements, Oramed and HTIT will contribute a combined
"We are excited to launch OraTech, a company that brings together Oramed's technology and clinical development expertise with HTIT's state-of-the-art manufacturing capabilities," said Nadav Kidron, Chief Executive Officer of Oramed. "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
OraTech will leverage HTIT's expertise in capsule production and cost-efficient manufacturing, ensuring a robust, reliable, and scalable supply chain to support clinical trials and commercialization efforts.
With a clear focus on development and commercialization, strong financial backing, and a pipeline poised for clinical and regulatory advancements, OraTech is potentially set to redefine diabetes care and transform the future of oral biologics and chronic disease management.
Further details on Oramed's plans and initiatives will be provided in a shareholder letter in the coming weeks.
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
About HTIT
Hefei Tianhui Biotechnology Co., Ltd. (HTIT) owns and operates a state-of-the-art manufacturing facility in
Forward-looking statements: This press release contains forward-looking statements, which may generally be identified by the use of the words "anticipates," "expects," "intends," "plans," "should," "could," "would," "may," "will," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions and include statements that OraTech is designed to accelerate the development and commercialization of Oramed's ORMD-0801 oral insulin and other POD™-based innovative oral drug delivery technologies, Oramed's vision of revolutionizing diabetes and chronic disease treatments, that Oramed will transfer its proprietary oral insulin and POD™ technology, along with other pipeline assets, into OraTech, that Oramed shareholders will receive a majority of Oramed's holdings in OraTech, allowing them to directly participate in its future success, that Oramed and HTIT will contribute a combined
Company Contact:
+1-844-9-ORAMED
ir@oramed.com
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SOURCE Oramed Pharmaceuticals Inc.
FAQ
What is the value of the investment in OraTech Pharmaceuticals joint venture?
When will ORMP's new Phase 3 trial for oral insulin begin?
What will Oramed shareholders receive in the OraTech spin-off?
What are the key assets being transferred to OraTech from ORMP?
What is the status of ORMP's oral insulin approval in China?
