INDUSTRIAL RESEARCH FOR THE DEVELOPMENT OF NIEDANIB ORAL SOLUTION

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Project Code:ΤΑCL1-0496261
  Project Title:INDUSTRIAL RESEARCH FOR THE DEVELOPMENT OF NIEDANIB ORAL SOLUTION
Project budget1.250.000,00 €
EU funding750.000,00 €

The objective of the R&D project implemented in the framework of the action “Reform of the clawback system and offsetting it with research and investment costs” of the Recovery and Resilience Fund is the development of a new pharmaceutical product with high added value, concerning the development of nintedanib formulation in a new pharmaceutical form, oral solution, with the aim of improving the cooperation of patients receiving medication as well as the additional coverage of therapeutic needs.

The existing drug form is an oral medication used to treat idiopathic pulmonary fibrosis (IPF) and along with other medications for certain types of non-small cell lung cancer. Nintedanib does not cure IPF, but Nintedanib may slow the progression of this disease.

Nintedanib is a triple angiokinase inhibitor that blocks vascular endothelial growth factor receptor (VEGFR 1-3), platelet-produced growth factor receptors (PDGFR α and β) and fibroblast growth factor receptors (FGFR 1-3). Nintedanib binds competitively to the adenosine triphosphate (ATP) binding site of these receptors and blocks intracellular signal transfer that is essential for the proliferation and survival of endothelial as well as perivascular cells (pericytes and vascular smooth muscle cells).

According to the Anatomical/therapeutic/chemical (ATC) classification it bears code L01EX09 (L Antineoplastic and immunomodulating agents, L01 Antineoplastic drugs, L01E Protein kinase inhibitors, L01EX Other protein kinase inhibitors).

The project includes the development of an oral solution of nintedanib with optimal organoleptic characteristics and stability, the safety and efficacy of which will be confirmed through simulations of its pharmacokinetic behaviour in silico as well as through a properly designed bioequivalence study in healthy volunteers in phase 2.  The aim of FARAN S.A. is the R&D and submission of a dossier for approval as a Hybrid (article 10.3 of Directive 2001/83/EC) with a Bioequivalence Study against the reference formulations Ofev & Vargatef® 150mg soft-gel capsules. The aim is to combine the indications of all 2 products in the one and only pharmaceutical form under development, which is the Innovative Element of the industrial research research proposal.

The R&D project is inextricably linked to the industry’s business strategies defined based on technological developments, Smart Specialization findings and the exploitation of comparative domestic advantages. The development of the pharmaceutical formulation began in 2022 and was completed in 2023 with the submission of a patent acquisition file to OBI. The development of the new pharmaceutical form includes -5- working modules with the corresponding deliverables as presented in the table below.

The project is implemented under the National Recovery and Resilience Plan “Greece 2.0”, funded by the European Union – NextGenerationEU.