Oralis, The first oral human insulin treatment for Type 2 Diabetes Mellitus

Project Information

Oralis

Grant agreement ID: 887907

DOI

10.3030/887907

Project closed

EC signature date 4 November 2019

Start date 1 December 2019

End date 31 March 2020

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

ORAMED LTD
Israel

Periodic Reporting for period 1 - Oralis (Oralis, The first oral human insulin treatment for Type 2 Diabetes Mellitus)

Reporting period: 2019-12-01 to 2020-03-31

Summary of the context and overall objectives of the project

The incidence of diabetes is growing worldwide due to unhealthy lifestyle and aging of the population and it is estimated that by 2045 more than 700 million patients globally will live with diabetes. Diabetes is a chronic condition that require life-long treatment to prevent complications, such as cardiovascular diseases, nerve damage, kidney damage and visual loss. Despite the availability of many classes of antidiabetics, it is estimated that up to 45% of patients with Type 2 diabetes fail to achieve adequate glucose control due to poor medical adherence. Insulin, the only therapeutic that act via natural pathways, can be currently administered only by injections. The patient´s burden associated with injecting insulin contributes to the non-adherence to therapy. We have identified an unmet medical need of adequate diabetes control to prevent long term complications. We have developed protein oral delivery technology (PODTM) that permit to orally deliver peptides and proteins. The technology was used to developed oralis, an orally bioavailable human insulin in a convenient, easily swallowed gel capsule. Oralis has successfully passed Phase 1 and 2 clinical trials and is currently the most advanced orally available insulin in the development.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

We have evaluated the technical, commercial and financial feasibility of the first orally available human insulin, oralis. To launch oralis on the market, a successful completion of Phase 3 clinical trial is necessary in order to apply for marketing authorization. We have identified contract research manufacturers and suppliers to assure a sufficient production for clinical trial in accordance with regulatory standards. We have identified a clinical research organization that will conduct the clinical trial. Moreover, we will hold a scientific meeting with European Medicine Agency before starting the clinical trial to ensure successful approval. Our commercialization strategy based on a B2B licensing approach is commercially feasible as we have already signed one licensing deal with with Hefei Tianhui (HTIT) that grant an exclusive commercialization licence in Greater China. Moreover, we are in advanced discussion with pharma companies to market oralis on the EU and US market and we predict to sign 2-3 license agreements before 2027. We have evaluated technical and commercial risks and proposed mitigation measures. Oralis will become profitable already the second year on the market (2024) with a cumulative profit of €77M over the five years. Considering the total need for investment of €10 million, the predicted ROI will reach 6.7 in between 2020 and 2027. Additionally, it is estimated that at least 45 new jobs will be created before the 5th year on the market.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Our revolutionary PODTM technology enables the delivery of peptides and proteins that are currently administered only by injections. Our main focus is to be the first on the market offering orally available insulin. Oral delivery will increase patient´s adherence to therapy and will result in decreased morbidity and mortality. Moreover, it is estimated that increased medical adherence in diabetic patients could save globally €4.2 billion in health care costs.

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