Access to therapy is part of the protection of the constitutional order: Peter Bely spoke at the SPIEF session on intellectual property
20.06.2024
20.06.2024
The ACE-based drug Nilotinib is used to treat blood cancer, in which the body produces an excessive number of abnormal white blood cells. The drug prevents their production. The original drug has a high cost, in addition, due to the policy of the originator company, it is not supplied to new regions of Russia. The originator company holds a patent for the Nilotinib molecule in the form of a long list of salts. This patent option makes it impossible to produce generic versions of the drug.
To increase the availability of such targeted therapy for blood cancer patients, the specialists of the Promomed Group R&D Center modified the active substance, while maintaining its pharmacological activity.
The technology for the synthesis of Nilotinib's own substance was developed in the laboratory, and then successfully implemented at the new site for the production of oncological substances at the Biochemik plant. The pharmacological activity of the newly developed and synthesized substance in the workshop has been proven in bioequivalence studies.
Thus, Promomed is ready to launch an effective antitumor drug on the market without violating the exclusive rights of a foreign company. The drug will be available in the form of capsules with dosages of 150 mg and 200 mg, which corresponds to the required intake regimens. Nilotinib is included in the list of VED.
"Localization of the synthesis of the Nilotinib substance at our own production site is a key element of import independence. We will be able to make life easier for thousands of our fellow citizens by offering them high-quality and at the same time more affordable medicines. I would also like to mention the well–coordinated work of the R&D and production laboratory staff, who took an active part in this process," said Alexander Rudko, Chief Operating Officer of Biochemist JSC.
The formation of a portfolio of drugs aimed at the treatment of socially significant, including oncological, diseases is one of the most important tasks for Promomed Group. The company offers its patients effective and safe medicines due to the high quality of their substances, adaptability of production processes, and the highest quality control standards.
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