Osmotic Wearable Bolus Injector (oWBI) for viscous drug delivery

Informations projet

oWBI

N° de convention de subvention: 808021

DOI

10.3030/808021

Projet clôturé

Date de signature de la CE 20 Janvier 2018

Date de début 1 Février 2018

Date de fin 30 Avril 2018

Financé au titre de

• INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies - Information and Communication Technologies (ICT)

Coût total

€ 71 429,00

Contribution de l’UE

€ 50 000,00

Coordonné par

SUBCUJECT APS
Denmark

Periodic Reporting for period 1 - oWBI (Osmotic Wearable Bolus Injector (oWBI) for viscous drug delivery)

Période du rapport: 2018-02-01 au 2018-04-30

Résumé du contexte et des objectifs généraux du projet

There is a continuous growth of drugs coming onto the market as combination products (drug products paired with delivery devices). Pharmaceuticals are paying closer attention to integrated delivery systems, especially Wearable Bolus Injectors (WBIs) for patients subcutaneously (SC) self-administrating a large dose of medication.

Intravenous (IV) drug administration in healthcare facilities is costly, being estimated that 30-70% savings are obtained if the same therapy is self-administered SC. Furthermore, it is rapidly increasing the number of biologic therapeutics demanding delivery of large (>2ml) and highly viscous doses that must be injected slowly over minutes rather than seconds. These two facts support the strong need for WBIs.

oWBI main goal is to complete the development cycle of the Subcuject device platform (a disruptive WBI for subcutaneous self- administration of drugs) and implement the necessary business-related activities to overcome the remaining barriers for rapid and efficient market uptake.

Travail effectué depuis le début du projet jusqu’à la fin de la période considérée dans le rapport et principaux résultats atteints jusqu’à présent

During the feasibility study, we have interviewed several pharma companies and other stakeholders. We performed the following tasks: (1) Market analysis: Investigation of the SC delivery systems market (main competitors, reimbursement policies, end-user profiling, etc). The most promising and low risk class drugs to bundle with Subcuject were identified. (2) Modular design refinement. (3) Certification and regulatory requirements analysis. (4) IPR strategy definition: 2 patents were filled and a Freedom to Operate analysis carried out - no IPR roadblocks were identified. (5) Business plan elaboration. (6) Plan the innovation project (Phase 2), incl. formal engagement of partners for the demonstration activities.

Progrès au-delà de l’état des connaissances et impact potentiel prévu (y compris l’impact socio-économique et les conséquences sociétales plus larges du projet jusqu’à présent)

The outcome of this innovation project will include the following advantages: (1) Cost-effectiveness (production price 75-86% lower than competitive solutions). (2) Flexibility and versatility through a modular design allowing different dosage amounts and dosing time. (3) Can be refrigerated due to the absence of electronics. (4) Eco-friendly / Sustainable. (5) Intuitive and user friendly. (6) Discretion and comfort.

Subcuject’s impact and benefits reach not only the customers (Pharma companies) and end-users (Patients) but also other players across the supply chain/value chain, such as payers, prescribes and the overall society.

Subcuject concept and its Unique Selling Points