Promomed Group produced the first batch of nilotinib substance
The first industrial batch of the active pharmaceutical substance nilotinib for antitumor medicine was produced at the Biokhimik plant of Promomed Group. Nilotinib APS has become a breakthrough unique development achieved by specialists of the company.
The drug product based on nilotinib substance is used to treat blood cancer when the body makes too many abnormal white blood cells. The drug suppresses their production. The original drug is rather expensive, moreover, due to the policy of the originator company, it is not supplied to new regions of Russia. The originator company has a patent for the nilotinib molecule in the form of a long list of salts. This version of the patentmakes it impossible to produce generic versions of the drug.
To increase the availability of such targeted therapy for patients with blood cancer, experts of the R&D Center of Promomed Group modified the active substance, while maintaining its pharmacological activity.
The synthesis of own nilotinib substance was developed in the laboratory and successfully implemented at the new site for the production of anticancer substances at the Biokhimik plant. The pharmacological activity of the newly developed substance produced in the workshop has been proven in bioequivalence studies.
Thus, Promomed Group is ready to launch an effective antitumor drug on the market, without violating of the foreign company's exclusive rights. The drug product will be available in 150 and 200 mg capsules convinient for approved dosing schedules. Nilotinib is included in the List of Vital and Essential Drugs (VED list).
"Localization of synthesis of nilotinib substance on our production site is a key element of import independence. We will be able to make life easier for thousands of fellow citizens by offering them a high-quality and at the same time more affordable medicine. I would also like to mention the well-coordinated work of the staff of R&D laboratory and production divisions, who took an active part in this process," commented Alexander Rudko, the Chief Operating Officer of the Biokhimik plant.
