Łukasiewicz- Industrial Chemistry Institute has signed an agreement with the National Center for Research and Development (NCRD) launching the project “Development of innovative technology for the production of a medicinal product used in the treatment of multiple sclerosis.” The project, worth PLN 38.8 million, will be subsidized with funds from the European Union in the amount of PLN 20.4 million.
The scope of the project includes carrying out, a number of complementary research works, studies of drug formulation technology with process scaling and development of documentation required by pharmaceutical law confirming the quality, efficacy and safety of a generic oral tablet with cladribine API.
The development of the drug will be based on institute’s own proprietary solutions, and the overarching goal of the project is to register a new drug for the treatment of multiple sclerosis. One of the key research and technological challenges will be conducting a large pool of experiments with critical analysis of the results in order to obtain a stable formulation of the drug product under laboratory conditions, and later in the process of scaling up in a controlled area.
Łukasiewicz – IChI is the only Polish manufacturer of the active substance cladribine, obtained based on its own technology and know-how and produced in its own laboratories. This allows the entire process to be independent of the changing external environment (e.g., external manufacturers of active substances).
Currently, there is only one oral formulation of cladribine on the market, which is covered by patent protection in terms of drug form and dosage regimen. The lack of competition makes the price of this drug very high (up to several thousand zlotys per tablet), making the availability of the product to patients significantly limited.
It is estimated that there are 2.8 million people with multiple sclerosis worldwide. According to the Ministry of Health in Poland, in 2012 the number of patients reached 16.44/10,000 of the population, and in 2021 this number will almost double. Developments in medicine and increased access to treatment mean that the progression of the disease can be significantly slowed, and patients can lead almost fully normal and active lives.
