A cheaper for multiple sclerosis drug containing cladribine will be developed thanks to the work of Polish scientists from Łukasiewicz - Industrial Chemistry Institute, the institution reports.
In an interview with PAP, the director of the Department of Pharmaceutical Products at Łukasiewicz - Industrial Chemistry Institute, Wojciech Maszewski, reminds that currently only one drug for multiple sclerosis (MS) containing cladribine is available. It is used in the treatment of relapsing forms of multiple sclerosis with high activity. The drug is patented and manufactured by a foreign company. Due to the lack of competition, the price of the drug is very high (several thousand zlotys for one tablet), which significantly limits its availability to patients.
'We want to create a new drug based on cladribine, which will be cheaper and therefore more accessible to patients', the expert emphasises.
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.
Maszewski emphasises that Łukasiewicz - Industrial Chemistry Institute is currently the only Polish manufacturer of the active substance - cladribine. 'We manufacture it using our own technology, and on the basis of this cladribine we also manufacture a drug used in haematooncology, in the treatment of hairy cell leukaemia', Maszewski reminds.
In his opinion, the fact that Łukasiewicz - Industrial Chemistry Institute manufactures cladribine, the active substance of the MS drug, is a huge advantage. 'Thanks to this, we will control the entire process of manufacturing the drug, from the synthesis of the active substance to the formulation of the drug', he explains. He adds that the project work will consist of developing tablet formulation technology. 'In haematology, the drug is used in the form of intravenous injections. We have to develop a tablet so that the release profile of cladribine from it is safe and effective for patients', Maszewski explains.
He adds that developing a generic drug is not an easy task. 'When it comes to the chemical side and formulation, it is basically making the drug from scratch. The company that manufactures the original drug obviously does not share its technologies. In fact, developing a generic drug differs from developing an original drug mainly in terms of the requirements for clinical trials', the expert emphasises.
In the case of a generic drug, clinical trials are significantly simplified, because the goal is to show that the generic drug is bioequivalent to the original, i.e. that it works the same way. 'There is no need to conduct extensive clinical trials, because the manufacturer of the original drug has already tested that a given active substance works in patients', Maszewski explains.
The project will involve a number of research tasks in the areas of chemistry, physicochemistry, analytical studies, technology studies of the drug form with process scaling, and the development of documentation required by pharmaceutical law confirming the quality, efficacy, and safety of an oral generic tablet with cladribine.
'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', says Ewa Śmigiera, PhD, Director of Łukasiewicz - ICI, quoted in a press release sent to PAP.
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.
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. (PAP)
jjj/ agt/
