Presidents of Russia Vladimir Putin and President of Kazakhstan Nursultan Nazarbaev visited the plant and scientific-research center BIOCAD Russian biotech company in the special economic zone “Neudorf” in St. Petersburg on December 25, 2016. During the visit, Director General of BIOCAD held a guided tour of the key laboratories and production, where the heads of states observed the stages of the medicines production and familiarized with the basic activities of the company.
The competitive domestic pharmaceutical is the key issue for the Russian Government today. By 2018, at least 90% of the products from the list of strategically important and vital ones shall be localized in the country. This refers to a full cycle of drug development from substances synthesis to the finished dosage form. The Russian pharmaceutical companies are marching with great strides in this direction, they have long been competitive.
In order to implement the proactive import substitution program, BIOCAD company established a scientific-research center, that is developing competence in molecular biology, bioinformatics, and genomics. Currently, more than 400 employees are involved in the processes of drug development. The average age of R&D staff of the company is 28 years. All stages of drug development are carried out by the company on its own in Russia.
Director General Dmitry Morozov BIOCAD Presidents held a tour of key scientific departments and laboratories. In particular, the departments of the antibodies and analytical development, the laboratory for biological research, bioanalytical laboratory, department of biotechnological processes development, as well as the department of advanced studies.
The revolutionary treatments for cancer are developed in these laboratories. A new class of drugs – monoclonal antibodies to the so-called checkpoint-inhibitors – allows you to trigger the answer of the patient’s immune system against the tumor cells. As a result, the long-term response to treatment and survival rates that were previously unimaginable can be achieved in 30-40% of patients with metastatic tumors of different localizations that are resistant to all regimes of chemotherapy. BIOCAD finalized its own original development of a monoclonal antibody against the PD-1 antigen, which is not inferior to the foreign analogs. Currently, first patients receive treatment with this drug in clinical trials.
In addition, BIOCAD currently holds phase 2 of clinical study of innovation preparation based on monoclonal antibodies against interleukin-17 for the treatment of autoimmune diseases, in particular, severe psoriasis. On a number of characteristics, the preparation is considerably superior to the first class Swiss drug that was registered in Russia only in 2016.
New research laboratory complex for the department of advanced studies was opened in June 2016. The new direction in modern medicine is the preparations of gene and cell therapy, which can cure the disease, previously not amenable to treatment. Among them are the last stages of cancer, hereditary and many other diseases. The purpose of the department is to provide opportunities for development of the medicine of the future in the country.
“Today, major changes occur in the country to provide people with domestic drugs. Supertechnical domestic preparation appeared in Russia with the support of the Ministry of Health, Ministry of the Industry and Trade, Ministry of Economic Development. Now we can safely compete with foreign counterparts. The quality and technology of our R&D and manufacturing facilities are not inferior to the western ones. And some of our labs provide opportunities for development of the medicine of future in our country. Russia – a country with a strong scientific heritage – simply has to be among the leading pharmaceutical states”, BIOCAD Director General Dmitry Morozov told us about the plans.
There are only a few companies in the world that have all the infrastructure and competencies needed for the development of the most advanced classes of drugs: from in silico modeling and genetic engineering to pre-clinical studies. Most companies prefer to outsource most of the studies to the specialized service companies or purchase the ready-made development work. There are no more than 10 fully integrated biotech companies in the world.
The product portfolio of the company consists of 39 drugs, more than 10 of them are biological. More than 40 products are in various stages of development. In 2016, the BIOCAD company began shipping products to foreign countries. According to the results of the year, the BIOCAD company’s export of drugs amounted to about 3 million US dollars in monetary terms.
BIOCAD have signed distribution agreements with partners in more than 40 countries in the Latin America, Southeast Asia, MENAT, including the major markets such as Argentina, Colombia, Venezuela, Thailand, Indonesia, Egypt, Algeria. The company also implemented a number of agreements on the transfer of medicines production technology, such as with partners from Kazakhstan and Morocco. The registration processes started in all countries, as a result of the completion of which the export of Russian products could reach more than $ 850 million over five years.
Photos: by the press service of the President of the Russian Federation and BIOCAD
In September 2016, the Russian biotech company BIOCAD localized the production of rituximab in Kazakhstan, the high-tech product based on monoclonal antibodies for the treatment of blood cancer. This was made possible thanks to the cooperation with the Karaganda pharmaceutical complex (Kazakhstan). Now the first stage of the localization – the secondary packaging – was implemented, when the production facilities of the Kazakh enterprises carries out packing of the finished substance from Russia. At the moment, a deeper localization is carried out. The Russian company transmits its knowledge and experience in this field to their colleagues. Rituximab by BIOCAD has been registered in Kazakhstan and should become more efficient and affordable alternative to imported analogs. Total investment in the project amounted to $ 3 million.