APPLICATION SUMMARY:
MEDITOP Pharmaceuticals Ltd. and Semmelweis University successfully completed a joint research and development project supported by the National Research, Development and Innovation Fund
Project title: Pharmacotechnology, pharmacology and clinical studies on the centrally acting muscle relaxant
Project ID No: 2018-1.3.1-VKE-2018-00030
Call for proposals: Application project supported by the National Research, Development and Innovation Office under the call for proposals for Competitiveness and Excellence Collaborations.
Total project budget: 1,568 HUF billion
Amount offunding: HUF 1.082.561.031
Semmelweis University cost HUF 456.6 million, provided by the Office with 100% aid intensity.
The MEDITOP Pharmaceuticals Ltd. received 56.3% of its HUF 1.112 billion costs, HUF 625.9 million in subsidies, with 43.7% of the costs being covered by the Office's own resources.
Project duration: 01.01.2019 - 31.12.2023.
The project was carried out at the premises of MEDITOP Pharmaceutical Ltd. in Pilisborosjenő (2097, Pilisborosjenő, Ady Endre u. 1.) and at Semmelweis University (1085, Budapest, Üllői út 26.).
The main objective of the project was for MEDITOP Pharmaceuticals Ltd. as the consortium leader to conduct pharmacological and clinical trials with a product containing an original Hungarian active pharmaceutical ingredient, in the framework of applied research and experimental development studies, which will provide directly applicable new technical and scientific drug development results.
The development has resulted in the creation of a new, improved, state-of-the-art formulation. The modernised pharmaceutical technology process also allows for a rationalised and optimised production process from an economic and environmental point of view.
APPLICATION SUMMARY:
Project title: Bilateral R&D collaboration for prototype development of various herbal active ingredients and proposal for industrial scale-up
Project ID No: 2022-1.2.2-TÉT-IPARI-UZ-2022-00006
Lead beneficiary: University of Debrecen
Total cost of the tender: HUF 74 520 000
Amount of funding: HUF 70 000 000
Aid intensity (%): 93.93%
Total cost of MEDITOP Pharmaceutical Ltd.: HUF 18 130 000
Project duration: 01.12.2022 - 30.11.2025
In the framework of the Hungarian-Uzbek cooperation in applied research and development announced by the National Research, Development and Innovation Office, the University of Debrecen's proposal "Bilateral R&D cooperation for prototype development of various herbal active ingredients and proposal for industrial scale-up" received a grant of HUF 70 000 000.
Within the framework of the project, the University of Debrecen and the Tashkent Institute of Pharmacy, together with MEDITOP Pharmaceutical Ltd. as a Hungarian consortium partner, aim to develop prototypes containing various herbal extracts. The research will result in a significant transfer of scientific and technological knowledge.
Within the framework of the project, the University of Debrecen is involving a pharmaceutical industry player as a consortium partner in the project, which will provide professional support in the realisation of the industrial production potential and analytical tests of the developed prototypes.
CLINICAL TRIALS
Project identification number:
2018-1.3.1-VKE-2018-00030
Project title:
"Pharmacotechnology, pharmacology and clinical trials with the active substance muscle relaxant of central action"
Within the framework of the proposal, MEDITOP Pharmaceuticals Ltd. as consortium leader will conduct pharmacological and clinical studies with a formulation containing an original Hungarian active pharmaceutical ingredient, in the framework of applied research and experimental development studies, which will provide directly applicable new technical, scientific drug development results.
Two institutes of Semmelweis University, the Institute of Pharmacology and the Department of Neurology, are participating in the project as consortium partners to carry out the basic research studies.
Non-reimbursable grant: HUF 1.082.561.031
Supporting organisation: NRDI Office
Source: NRDI Fund
APPLICATION SUMMARY:
The September 2022 Research Council meeting of the MEDITOP Pharmaceuticals Ltd. and Semmelweis University consortium proposal 2018-1.3.1-VKE-2018-00030 - 2022 summarized the results of the proposal so far
According to the information from the CRO company, 197 patients have been enrolled so far in the human Phase III clinical trial under the tender sponsored by MEDITOP Pharmaceuticals Ltd, which means that the number of patients in the study protocol can be met by mid-2023.
SOTE Institute of Pharmacology
The results obtained from the studies conducted in the framework of this call have been published in the International Journal of Molecular Sciences, Lakatos et al. 2022;23(17):9564. doi: 10.3390/ijms23179564.
Semmelweis University, Department of Neurology
The enrolment of patients suffering from acute low back pain in the clinical trial started in 2019 at the Neurological Clinic of Semmelweis University in collaboration with the Institute of Pharmacology is ongoing, and the planned trial is expected to be successfully completed in 2023.
DRUG DEVELOPMENT
Project ID no:
2020-1.1.2-PIACI-KFI-2021-00288
"Expansion of the product portfolio of MEDITOP Pharmaceuticals Ltd. with new and renewed generic products"
Within the framework of the project, we aim to produce two products:
One of the main objectives is to develop a new advanced generic formulation belonging to the anticoagulant activity group with two strengths. The other major objective of the project is to develop a new pharmaceutical formulation of a generic product belonging to the smooth muscle antispasmodic group. Physical completion of the application: 31 August 2024.
Non-repayable grant: HUF 399.403.815
Sponsor: NRDI Office
Source: NRDI Fund
DEVELOPMENT OF A CLINICAL MODEL
Project ID no:
2020-2.1.1-ED-2020-00007
Project title:
"Favipiravir development"
Within the framework of the project, the development, production, packaging, qualification and stability testing of the clinical trial formulation of Favipiravir will be carried out at MEDITOP Pharmaceuticals Ltd. in collaboration with the Natural Science Research Centre, Richter Gedeon Chemical Factory NyRt. and First Chemical Industry ZRt.
Project completion date: 30.06.2021.
The final financial statement has been submitted.
Sponsor: Ministry of Innovation and Technology
Source: ITM
DEVELOPMENT OF A CLINICAL SAMPLE
Project ID:
NVKP_16-1-2016-0037
Project title:
"Screening for mutations predisposing to poor prognosis childhood solid tumors and identification of biomarkers to optimize their individualized treatment"
Within the framework of the project, in collaboration with Semmelweis University and the Natural Sciences Research Centre of the Hungarian Academy of Sciences, MEDITOP Pharmaceuticals Ltd. will produce clinical samples aimed at improving the clinical prospects of patients with the worst prognosis of childhood solid tumours.
Sponsor: NRDI Office
Source: NRDI Fund
PROCUREMENT OF EQUIPMENT
Name of beneficiary:
MEDITOP Pharmaceutical Ltd.
Project title:
Purchase of equipment at MEDITOP Pharmaceutical Ltd.
Amount of the contracted grant:
HUF 139.500.000
Rate of aid (%): 68,71%
Description of the project content:
MEDITOP Pharmaceutical Ltd. was affected by the negative impact of the unexpected COVID-19 epidemic, which during the epidemic situation continuously strived to maintain production volume and capacity and to keep jobs. Overall, the equipment to be purchased under the tender will result in capacity and efficiency gains in the packaging of products in the company's current portfolio that will allow us to build production capacity for new products in our development pipeline and for products under registration in export markets. By bringing this equipment into production, we expect an efficiency gain of 30-40%. Greater efficiency can provide greater flexibility for production and we can also expect an increase in the number of products we can offer.
Project completion date: 27.11.2021.
The final financial statement has been submitted.
Project identification number: VEKOP-1.2.6-20-2020-00226
PRODUCT DEVELOPMENT
New Innovative Medicines Development Launched at MEDITOP Ltd!
MEDITOP Pharmaceutical Ltd. as a Beneficiary has been awarded a HUF 450.40 million non-refundable grant from the European Union in July 2017 within the framework of the Széchenyi 2020 programme. The grant intensity is 54.01%, which will be used for the research and development of new medicines, together with the company's own resources. As a result of the project, new drugs will be registered, which will greatly increase the competitiveness of the company on both the domestic and international markets. The pharmaceutical technology development of the new products will be carried out at the MEDITOP Pharmaceuticals Ltd. site in Pilisborosjenő. The project started on 14 September 2017 and is scheduled to be completed two years later, on 13 September 2019. The investment will create jobs for 5 highly qualified new researchers.
VEKOP-2.1.1.1.- 15-2016- 00057.
The application successfully completed the industrial research needed to develop new products.
The samples for clinical trials have been produced and the procurement process for the new devices was completed on time. The bioequivalence studies necessary for the registration of new products have been carried out as planned for several products. However, for two new products, the approvals by the Ethics Committee took significantly longer and the original deadline for the application was extended.
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Unfortunately, due to the extension, these trials coincided with the COVID-19 epidemic and as a consequence, the universities were not able to complete these trials in time, thus another extension was necessary to complete the application.
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The project was completed on 14 September 2021 with the successful drug technology development of new formulations and the creation of 5 jobs for highly qualified new researchers.
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Project title: Pharmaceutical R&D development at MEDITOP Ltd.
Project ID: VEKOP-2.1.1.- 15-2016- 00057.
SITE DEVELOPMENT
Name of the promoter: Ministry of National Economy.
Source of aid: targeted financial budgetary support for the implementation of the Pest County Regional Development Concept 2014-2030 and the Pest County Regional Development Programme 2014-2020 from the Pest County Development appropriation.
Name of the beneficiary: MEDITOP Pharmaceutical Ltd.
Aid contract number: PM_KKV-2016/107.
Aid amount: HUF 51,05 million.
Title of the aided activity: Development of the premises of MEDITOP Kft. in Pest county.
Content of the project: The basic objective of the investment is to extend the warehouse complex, which provides the logistical background for the business expansion completed a few years ago and ensures the smooth operation of production. The investment is expected to triple the wholesale and cold storage capacity (from 32 EU pallets to 88 pallets). A separate psychotropic warehouse with a capacity of 10 EU pallets will be built on the same site. In the High Storage area, the existing cold storage space will be converted into a cold storage area (32 EU pallets capacity). A separate hazardous waste storage area will also be constructed without the need for a building permit, with a net surface area of 35.62 m2. The wholesale warehouse will be equipped with a shelving system in order to increase the efficient storage capacity.
Project completion date: 15.07.2018.
Project Closing Press Release can be downloaded here in MS WORD format.
The APPLICATION FORM in MS Word format can be downloaded here.
The APPLICATION FORM in MS Word format can be downloaded here.