SAMPAProject ID: 666795
H2020-EU.2.3.1. - Mainstreaming SME support, especially through a dedicated instrument
Scale-up of an Advanced Manufacturing process to produce a Pharmaceutical product Application (SAMPA).
Total cost:EUR 2 307 500
EU contribution:EUR 1 600 000
Topic(s):NMP-25-2014 - Accelerating the uptake of nanotechnologies, advanced materials or advanced manufacturing and processing technologies by SMEs
Call for proposal:H2020-SMEINST-2-2014See other projects for this call
Funding scheme:SME-2 - SME instrument phase 2
Sigmoid Pharma has developed an innovative product, CyCol®, to treat patients with moderate-severe ulcerative colitis, a disease that affects 1 million patients in Europe. CyCol® is enabled using Sigmoid’s proprietary SmPill® nanoemulsion-based technology to target a known and powerful drug, cyclosporine, directly to inflamed colons. In Phase II human studies, CyCol® was proven to be effective and safe. CyCol®, on oral product, will compete with injected, expensive drugs that have a risk of serious side effects.
Successful development and commercialisation of CyCol® will pivot on scaling up the advanced manufacturing process from the current ~5kg to the ~50kg batch size required for Phase III human studies.
SAMPA (Scale-up of an Advanced Manufacturing process to produce a Pharmaceutical product Application) project is focused on achieving 50kg batches. It will involve leading EU-based specialist SME technology and equipment suppliers as well as a number of knowledge providers. The requested budget is €1.6M and will be completed in 21 months.
Successful completion of this project will retain and enhance intellectual property and know-how in Sigmoid, increase long term high skill jobs. In parallel, the project will unlock the value inherent not only of CyCol®, but also the underlying SmPill® technology platform. Furthermore, the project will increase the probability of overall company success and increase significantly the NPV to more than €500M.
EU contribution: EUR 1 600 000
THE INVENT CENTRE, DUBLIN CITY UNIVERSITY