Soon multiple sclerosis patients will have access to cheaper and more effective drugs. The technology developed in Poland for the production of cladribine tablets will bring a real breakthrough to the market, increasing access to effective treatment.
Łukasiewicz – Industrial Chemistry Institute signed an agreement with the National Centre for Research and Development (NCBR), initiating 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 co-financed with EU funds to the tune of PLN 20.4 million.
– ‘We want effective treatment for multiple sclerosis to be available to every patient,’ says Ewa Śmigiera, PhD Eng., Director of Łukasiewicz – ICI. – A new, cheaper, effective drug will be created in our laboratories. We will create it from scratch; from the synthesis of the active ingredient, through the development of the technology for producing the drug, we will carry out the entire scale-up process until we have a product ready for sale in pharmacies. In doing so, we will break the current market monopoly responsible for such high treatment costs.
The scope of the project includes conducting a number of complementary research works in the field of chemistry, physico-chemistry, analytical studies, studies of drug formulation technology with process scaling and development of documentation required by pharmaceutical law to confirm the quality, efficacy and safety of a generic oral tablet with cladribine API. The development of the drug will be based on the company’s own proprietary solutions, and the overarching goal of the project is to register a new multiple sclerosis treatment drug. One of the key research and technological problems will be to conduct a large pool of experiments with critical analysis of the results in order to obtain a stable formulation of the medicinal product under laboratory conditions and later in the process of scale-up in a controlled area.
– Our advantage is that we have many years of experience in the synthesis of active substances, including the production of cladribine. Our skills, backed by decades of experience, have been successfully applied in the development of further technologies for the manufacture of pharmaceutical products, including the production of Biodribin®, a drug successfully used in cancer therapy – emphasises Wojciech Maszewski, Director of the Łukasiewicz Pharmaceutical Products Department – ICI. – The same active substance can be used in tablets for the treatment of the highly active form of multiple sclerosis. This is the aim of our activities in the project.
Łukasiewicz – ICI is the only Polish manufacturer of the active substance cladribine, which is obtained on the basis of its own technology and know-how and produced in its own laboratories. This makes the whole process independent of the changing external environment (e.g. external manufacturers of active substances).
Currently, there is only one oral formulation of cladribine available on the market, which is covered by patent protection in terms of the drug form and dosage regimen. The lack of competition causes the price of this drug to be very high (even several thousand zlotys for one tablet), which significantly limits the availability of the product to patients. The launch of the medicinal product developed under the project carried out by Łukasiewicz – ICI, used in the treatment of multiple sclerosis, will significantly influence the shape of this market segment.
It is estimated that there are 2.8 million multiple sclerosis patients worldwide. According to the Ministry of Health, the number of patients in Poland in 2012 was 16.44/10,000 of the population, and in 2021 it will already be almost double that number. Developments in medicine and increased access to treatment have meant that the progression of the disease can be significantly slowed and patients can lead almost fully normal and active lives.
Multiple sclerosis (MS) is a chronic, incurable disease of the central nervous system. Its direct cause is still unknown, but an autoimmune basis is widely accepted. It involves multifocal damage to the brain and spinal cord. The activity of the disease and the rate of disability progression vary from patient to patient, but the neurological condition deteriorates steadily. It is a debilitating disease both physically and psychologically. One of the most effective inhibitors of the disease is cladribine.
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