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project info
Start date: 1 July 2018
End date: 31 December 2022
funding
Fund: European Regional Development Fund (ERDF)
Total budget: 1 425 922,49 €
EU contribution: 702 645,98 € (49,28%)
programme
Programming period: 2014-2021
Managing authority: Ministerstwo obsługujące ministra właściwego ds. rozwoju regionalnego

Development and implementation of an innovative combination of cardiovascular polytherapy with associated risk factors

The project will result in a combination of rosuvastatin and telmistartan, which has no counterpart on the European market. This medicine responds to the problems of patients with the treatment of cardiovascular conditions and associated cardiovascular risks. The therapeutic indication will be the treatment of hypertension in adult patients with a high estimated risk of a first cardiovascular event (prophylaxis of serious events of this type) or in co-existence of 1 of the following diseases: — primary hypercholesterolaemia (type IIa, including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb), is a homozygous family hypercholesterolaemia. 50 % of patients with hypertension, being one of the most frequently coexisting conditions with hypotension, will be expected to receive 5 million people in Poland and 25-30 million in the remaining 7 European markets where it will be implemented.The uniqueness of the combination developed in the Project is justified in the documented synergistic, pleiotropic effect of rosuvastatin and telmisartan, which will find its effects in the clinical area and additional benefits for the patient. The result of making the medicine available will also increase the level of patients’ adherence to doctor’s recommendations (by reducing the number of tablets taken) and cost optimisation of therapy for the patient and the payer.The achievement of the Project’s objective will result in the implementation of 6 stages of R & D work.Their system assumes the formulation of the drug in Steps 1 and 2 and its possible improvement based on the results obtained from the pilot bioequivalence study (Phases 3 and 4).Numer_referencjon_programme_ SA.41471(2015/X)Determination of public aid: Article: 25 EC Regulation No 651/2014 of 17 June 2014 declaring certain types of aid compatible with the internal market in the application of Articles 107 and 108 of the Treaty

Flag of Poland  Łódzki, Poland