Projects co-financed from the state budget or state special-purpose funds

The achievement of the specified project goal will be realized through conducting planned industrial research and development works, divided into 4 tasks.

1. Conducting pre-formulation studies and literature review.
2. Developing the composition, manufacturing technology for the prototype, and analytical methods for the medicinal product.
3. Validation and transfer of analytical methods, scale-up, and manufacturing of registration batches.
4. Conducting the bioequivalence study.

Total project value: PLN 2,348,881.09
Value of co-financing: PLN 1,322,585.84

The strategic goal of the project is the development and introduction onto the EU market, in late 2027/early 2028, of a medicinal product with the active substance dapagliflozin – a generic drug for type 2 diabetes for use in the treatment of adults with insufficiently controlled diabetes, in the form of 5 mg and 10 mg film-coated tablets. The project addresses a highly significant therapeutic area, as diabetes is one of the most common chronic diseases and represents a huge health and economic problem for many countries. It is referred to as the world’s first non-communicable epidemic. It is estimated that 422 million people worldwide suffer from diabetes, of which 179 million are people whose disease has not yet been diagnosed. It is estimated that by 2035, the number of people worldwide suffering from diabetes will be approximately 592 million.

1. Conducting pre-formulation studies and literature review.
2. Developing analytical methods for the medicinal product.
3. Validation and transfer of analytical methods, scale-up, and manufacturing of clinical trial batches.
4. Conducting the bioavailability study.
5. Manufacturing of pilot batches.

Total project value: PLN 7,651,817.25
Value of co-financing: PLN 4,369,830.84

The project aims to develop a new pharmaceutical form of a medicinal product based on active substances authorized for marketing, containing the antibiotic colistimethate sodium (CMS), powder for solution for injection, infusion, and inhalation, used in the treatment of severe infections caused by Gram-negative bacteria in patients with limited treatment options, within the therapeutic areas of:

• respiratory diseases,
• rare diseases (primary ciliary dyskinesia),
• infectious diseases (including COVID-19),
• paediatric diseases (cystic fibrosis, one of the most common rare diseases in Poland and worldwide).

The achievement of the specified project goal will be realized through conducting planned industrial research and development works, divided into 4 tasks:

1. Conducting pre-formulation studies and literature review.
2. Developing the composition, manufacturing technology for the prototype, and analytical methods for the medicinal product.
3. Validation and transfer of analytical methods, scale-up, and manufacturing of registration batches.
4. Conducting the bioequivalence study.

Commercialization of the project results will take place through launching production by TZF “Polfa” S.A. and introducing the product to the market at the end of the second quarter of 2029, when the patent protection and market exclusivity of the original drug JARDIANCE will have expired.

Total project value: PLN 2,910,092.80
Value of co-financing: PLN 1,691,526.67

The strategic goal of the project is the development and introduction to the Polish and EU markets in 2029 of a medicinal product with the active substance empagliflozin – a generic drug for type 2 diabetes in the form of 10 mg and 25 mg film-coated tablets, with a planned volume of 3.1 million packages in the period from 2029 to 2033.

The achievement of this defined strategic project goal will result in an increase in the share of domestic medicines in both the Polish and European pharmaceutical markets, which is a vital element in ensuring pharmaceutical security.

Diabetes is one of the most common chronic diseases and represents a huge health and economic problem for many countries. It is referred to as the world’s first non-communicable epidemic. It is estimated that 422 million people worldwide suffer from diabetes, of which 179 million are people whose disease has not yet been diagnosed. It is estimated that by 2035, the number of people worldwide suffering from diabetes will be approximately 592 million. The development of a single-active-ingredient generic medicinal product containing empagliflozin significantly addresses the product gap in the European and global markets.

Reprivatisation Fund

Building, installations, and equipment for a new lyophilisation department, manufacturing of highly potent drugs (HPDs) with an R&D laboratory, product development (R&D) concerning the manufacturing of highly potent drugs, and modernisation of the energy infrastructure.

Total project value: PLN 625,883,846.93
Value of co-financing: PLN 200,000,018.55

The investment covers the construction of a manufacturing and laboratory building, including its equipment, and research and development (R&D) work on highly potent products.

This will be a multi-storey building with designated functional zones:

• manufacturing,
• laboratory
• technical and logistics support
• office.

The manufacturing area will feature a line for dispensing HP products in the form of lyophilisates and solutions in vials and pre-filled syringes. This will be a new segment for the Company, with target production capacity of 6 million pre-filled syringes annually. This will enable contract manufacturing, in addition to production for the Company’s own needs.

The building will also house the production of lyophilised drugs on a COMBO line with powder filling capability, which will manufacture antibiotics, antifungal agents, anaesthetic and cardiological preparations (a line for dispensing products in liquid and powder form).

The laboratory zone will provide modern facilities for research and development departments, enabling the fast and effective execution of work related to the development of proprietary products, including highly potent products.

The building will also contain offices for the employees of the manufacturing units and laboratories.

Date of signing the co-financing agreement: December 2019