Oramed Announces Transformative Joint Venture to Accelerate Development and Commercialization of Oral Insulin
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.
Oramed Pharmaceuticals (NASDAQ: ORMP) ha annunciato una joint venture strategica per creare OraTech Pharmaceuticals, focalizzandosi sulla tecnologia per la somministrazione orale dei farmaci. La nuova azienda riceverà la tecnologia POD™ di Oramed e gli asset dell'insulina orale, supportata da un investimento combinato di 75 milioni di dollari da parte di Oramed (15 milioni di dollari) e Hefei Tianhui Biotech (HTIT) (60 milioni di dollari).
Tra gli aspetti chiave dell'accordo vi sono: gli azionisti di Oramed riceveranno una partecipazione di maggioranza in OraTech, che ci si aspetta sarà quotata al Nasdaq; HTIT fornirà capacità di produzione e un accordo di fornitura per le capsule di insulina orale; e OraTech deterrà i diritti di marketing globale per la tecnologia POD™. È previsto l'inizio di una nuova sperimentazione di Fase 3 negli Stati Uniti con un protocollo rivisto, mentre in Cina è stata presentata una domanda di autorizzazione alla commercializzazione con i preparativi di commercializzazione in corso da parte di HTIT.
Oramed Pharmaceuticals (NASDAQ: ORMP) anunció una asociación estratégica para crear OraTech Pharmaceuticals, enfocándose en la tecnología de entrega de medicamentos por vía oral. La nueva empresa recibirá la tecnología POD™ de Oramed y los activos de insulina oral, respaldados por una inversión combinada de 75 millones de dólares de parte de Oramed (15 millones) y Hefei Tianhui Biotech (HTIT) (60 millones).
Los aspectos clave del acuerdo incluyen: los accionistas de Oramed recibirán una participación mayoritaria en OraTech, que se espera que cotice en Nasdaq; HTIT proporcionará capacidades de fabricación y un acuerdo de suministro para las cápsulas de insulina oral; y OraTech tendrá los derechos de marketing global para la tecnología POD™. Se planea comenzar un nuevo ensayo de Fase 3 en EE. UU. con un protocolo revisado este trimestre, mientras que en China se ha presentado una Solicitud de Autorización de Comercialización y se están llevando a cabo los preparativos de comercialización por parte de HTIT.
오라메드 제약 (NASDAQ: ORMP)는 경구 약물 전달 기술에 중점을 둔 오라텍 제약(OraTech Pharmaceuticals)이라는 전략적 합작 회사를 발표했습니다. 새로운 회사는 오라메드의 POD™ 기술과 경구 인슐린 자산을 받게 되며, 오라메드(1500만 달러)와 허페이 티안후이 바이오텍(HTIT)(6000만 달러)의 합계 7500만 달러의 투자 지원을 받습니다.
이번 거래의 주요 사항은: 오라메드의 주주가 오라텍에서 대다수 지분을 받게 된다는 것입니다. 오라텍은 나스닥에 상장될 것으로 예상됩니다; HTIT는 경구 인슐린 캡슐을 위한 제조 능력 및 공급 계약을 제공할 것입니다; 그리고 오라텍은 POD™ 기술의 글로벌 마케팅 권리를 보유할 것입니다. 미국에서는 수정된 프로토콜로 새로운 3상 시험이 이번 분기에 시작될 예정이며, 중국에서는 상업화 준비가 진행 중인 마케팅 승인 신청이 제출되었습니다.
Oramed Pharmaceuticals (NASDAQ: ORMP) a annoncé un partenariat stratégique pour créer OraTech Pharmaceuticals, axé sur la technologie de délivrance de médicaments par voie orale. La nouvelle entreprise bénéficiera de la technologie POD™ d'Oramed et des actifs d'insuline orale, soutenue par un investissement combiné de 75 millions de dollars de la part d'Oramed (15 millions de dollars) et de Hefei Tianhui Biotech (HTIT) (60 millions de dollars).
Les aspects clés de l'accord incluent : les actionnaires d'Oramed recevront une participation majoritaire dans OraTech, qui devrait être cotée au Nasdaq ; HTIT fournira des capacités de fabrication et un accord de fourniture pour les capsules d'insuline orale ; et OraTech détiendra les droits de marketing mondiaux pour la technologie POD™. Un nouvel essai de phase 3 aux États-Unis avec un protocole révisé est prévu pour débuter ce trimestre, tandis qu'en Chine, une demande d'autorisation de mise sur le marché a été soumise, avec les préparatifs de commercialisation en cours par HTIT.
Oramed Pharmaceuticals (NASDAQ: ORMP) kündigte ein strategisches Joint Venture zur Gründung der OraTech Pharmaceuticals an, das sich auf die orale Arzneimittelliefertechnologie konzentriert. Das neue Unternehmen erhält die POD™-Technologie von Oramed sowie die Vermögenswerte der oralen Insulintherapie, unterstützt von einer kombinierten Investition von 75 Millionen US-Dollar, einschließlich 15 Millionen US-Dollar von Oramed und 60 Millionen US-Dollar von Hefei Tianhui Biotech (HTIT).
Wichtige Aspekte des Deals umfassen: Oramed-Aktionäre werden eine Mehrheit beteiligung an OraTech erhalten, welches voraussichtlich an der Nasdaq gelistet wird; HTIT wird Fertigungskapazitäten bereitstellen und eine Liefervereinbarung für orale Insulinkapseln treffen; und OraTech wird die globalen Marketingrechte für die POD™-Technologie halten. Eine neue Phase-3-Studie in den USA mit einem überarbeiteten Protokoll ist geplant, in diesem Quartal zu beginnen, während in China ein Antrag auf Marktzulassung eingereicht wurde und die Vorbereitungen für die Kommerzialisierung durch HTIT im Gange sind.
- 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
- Previous Phase 3 trial required protocol revision
- Additional capital investment required from Oramed ($15M)
Insights
This strategic restructuring represents a transformative deal that significantly de-risks Oramed's oral insulin development while preserving substantial upside for current shareholders. The
The deal structure offers several key advantages:
- Shareholders maintain exposure to the upside through direct OraTech ownership
- The spin-off creates a focused entity with dedicated resources and expertise
- HTIT's manufacturing capabilities provide cost advantages and supply chain reliability
- Dual-market strategy with U.S. Phase 3 trial and Chinese regulatory submission
The Chinese market opportunity is particularly compelling, with a Marketing Authorization Application already submitted and HTIT's established presence. The royalty structure from Chinese sales could provide significant recurring revenue while the U.S. development progresses.
The revised Phase 3 protocol suggests lessons learned from previous trials have been incorporated, potentially increasing probability of success. The combination of strong financial backing, manufacturing expertise and clear regulatory pathways positions OraTech favorably in the competitive landscape for oral biologics delivery.
The formation of OraTech marks a sophisticated approach to addressing the technical and commercial challenges of oral protein delivery. The POD™ technology platform's potential extends beyond insulin to other biological drugs, representing a broader market opportunity in the $350 billion injectable biologics market.
Critical success factors include:
- HTIT's advanced manufacturing capabilities ensure consistent protein stability and bioavailability
- Dual regulatory strategy leverages China's potentially faster approval pathway
- Revised Phase 3 protocol suggests optimization of drug delivery parameters
- Platform technology applications beyond insulin provide multiple shots on goal
The timing of the U.S. Phase 3 trial initiation this quarter, combined with the Chinese regulatory submission, creates multiple near-term catalysts. The manufacturing partnership addresses one of the key historical challenges in oral protein delivery - cost-effective, scalable production while maintaining biological activity.
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
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