Regulatory, market and medical verification of novel pharmaceutical product - focus on US
| Reference number | |
| Coordinator | Gesynta Pharma AB |
| Funding from Vinnova | SEK 900 000 |
| Project duration | June 2019 - September 2020 |
| Status | Completed |
| Venture | Innovative Startups |
| Call | Innovative Startups stage 2 - spring 2019 |
Important results from the project
** Denna text är maskinöversatt ** We have conducted a study of international market and medical use of an mPGES-1 inhibitor (GS-248) with a focus on USA, and produced an orphan drug designation application for USFDA. We have also utilized the commercial, medical and regulatory information generated in the project to seek venture funding for the company to be able to conduct a clinical concept study (Fas IIa).
Expected long term effects
We have 1. established contact with pharma companies for further discussion on development efforts 2. designed and submitted protocol to international regulatory authorities of multinational Phase II trial 3. devised US regulatory plan and prepared ODD application 4. presented clinical program and commercial case to international investors, which resulted in funding to cover company activities, including upcoming Phase II study
Approach and implementation
** Denna text är maskinöversatt ** The project has essentially been carried out according to plan. During the course of the work, we learned that an application for orphan drug designation in Europe would require Phase 2 clinical data, which will not be available until next year, and we therefore made such application USFDA only. The overall goal, to strengthen the commercial potential of the product, has been achieved by devising development plans and securing funding for the next development phase.