Pharmacists need a passport
Lilia Moskalenko, "Expert" No. 13-2011
Young innovative companies have become more active in the domestic pharmaceutical industry.
However, the absence of a detailed state policy may slow down their development.
Biological preparations are an excellent niche for the specialization of Russian drug manufacturers! In the field of chemical synthesis, competition from manufacturers from Asia and Eastern Europe is very strong, for us this is not the way of development, – Mikhail Kubylinsky, general director of the St. Petersburg pharmaceutical company "Biocad" is sure. "But in biotechnology, we can compete on an equal footing with foreign players."
His company, founded in the early 2000s, immediately focused not on the production of outdated medicines, as most domestic enterprises did then, but, like manufacturers from developed countries, on the production of high-tech, socially significant drugs.
"We began to develop cancer and multiple sclerosis therapies. These diseases contribute more than others to the growth of disability of the population, therefore, drugs for their treatment are in great demand," they say in Biocade. Then the company launched the production of analogues of Western biological products.
Today, Biocad creates not only analogues, but also original biological agents, including those based on pegylated proteins, which are used in the treatment of oncology and blood diseases, autoimmune, cardiovascular diseases, chronic viral infections. In 2012, the company intends to release its first original drug for the treatment of hepatitis C – it has already passed the first stage of clinical trials.
From generics to originalsThere are more and more companies like Biocad in Russia.
Domestic drug manufacturers have a surge in innovative activity. The innovators are not former large Soviet enterprises, but companies created in the early noughties: Microgen, Polisan, Moscow Pharm-Synthesis, St. Petersburg Pharmsintez, Himrar, the already mentioned Biocad, Binnopharm. Some of them belong to large Russian corporations, such as Binnopharm, which is part of AFK-Sistema; others are independent enterprises that grew out of research laboratories (Polisan and Pharm-Sintez); some companies, such as Microgen, are state-owned.
The emergence of a young innovative growth in the domestic pharmaceutical industry is a landmark event for the industry, where the lion's share of companies still produce cheap generic generic formulations that were developed more than half a century ago. The technological backwardness of the basic enterprises of the industry is one of the reasons that foreign companies have seized our pharmaceutical market: Berlin–Chemie, Teva, Novartis, Gedeon Rihter, Nycomed, etc. (see the table). In 2009, the share of foreign drugs was 80% in the Russian pharmacy market and over 90% in the public procurement market. In order to survive, some companies began to sell business: for example, Nizhpharm acquired the German concern Stada, Zio-Zdorovye acquired Actavis, again a German company. Others concentrated on narrow market niches – mainly on the production of dietary supplements or vitamins, as well as simple drugs like corvalol, valoserdin, the therapeutic effect of which is difficult to prove.
Young innovative Russian pharmaceutical companies started their business with the production of generics, which allowed them to earn money for their own developments. Today, such manufacturers have switched to more sophisticated technologies, including biotechnologies – based on small molecules, antibodies, recombined proteins.
Most of them work on their own substances. "Raw material independence allows us to make unique products," says Timofey Petrov, CEO of Pharm-Synthesis. The companies also have their own scientific laboratories, actively cooperate with research centers of the country: Zelenograd "Binnopharm", for example, conducts joint research with Lomonosov Moscow State University, St. Petersburg "Biocad" - with the St. Petersburg Chemical and Pharmaceutical Academy.
During the development of new drugs, companies faced the need to create their own pharmaceutical production – until recently, they were engaged only in research, and the "assembly" of drugs was outsourced. Pharmsintez, Pharm–Synthesis, and Biocad announced the construction of facilities according to Western GMP standards (good manufacturing practice). Industrialization is an important point: Russian companies have traditionally been strong with scientific ideas, but very few could implement them. Some players are planning to build full-cycle production complexes in the near future. Their infrastructure would allow for the entire technological process, from the development of new formulas to clinical trials. For example, Binnopharm in Zelenograd is currently engaged in this.
BioradiopreparationsWhat kind of innovations are Russian pharmaceutical companies offering today?
As a rule, they are based on biotechnologies – the production of medicines using organic substances. In this way, for example, antibiotics, antifungal and antitumor agents are created. It is in this area that Russian scientists have had the most extensive developments since Soviet times. In addition, biotechnologies are the most advanced field of modern pharmacotherapy, they bring the greatest added value to companies.
In addition to biotechnologies, our pharmaceutical enterprises are now trying to master other types of high-tech drugs, in particular radioisotope. For example, the heads of the capital's Pharm-Sintez company are developing octreotide In 111 and resoxane Tc 99 – tools for early diagnosis and treatment of oncological diseases.
Some domestic innovations have already been recognized abroad. The most striking success is with the company "Pharmsintez" from St. Petersburg, which uses biocatalytic synthesis technologies: its orphan (the so–called vital means for the treatment of rare diseases) drug virexxa against endometrial cancer, insensitive to hormone therapy, made a splash in the USA.
It is known that all over the world, cancer of the uterine body is poorly treated: as a result of hormone therapy, tumor cells lose receptors sensitive to the action of drugs. Virexxa stimulates the appearance of new receptors, which allows you to continue effective hormone treatment. The drug has received a special status in the United States, which makes it possible to start selling it on the capacious American market. Pharmsintez does not stop there – in the near future the company will release two more drugs that have no analogues: muloXEN (for the treatment of multiple sclerosis) and pulmoXEN (against cystic fibrosis).
Other Russian players have also started exporting their drugs. In recent years, the Polisan research company has produced three original drugs in six dosage forms for the CIS and Southeast Asian markets.
Of course, the mass export of unique drugs is still a dream for the domestic pharmaceutical industry. Basically, our manufacturers focus on the domestic public procurement market. Until recently, the share of domestic companies in this market of mainly high–tech, effective drugs was minimal - about 10%. Meanwhile, working in this segment provides pharmaceutical manufacturers with guaranteed sales, and it takes the company itself to a completely different level.
Deliver directly to the liverCases when domestic pharmacists discover fundamentally new formulas, new directions of pharmacotherapy, let's be fair, are very rare.
As a rule, they discover previously unknown therapeutic properties of drugs or ways of delivering the active substance into the body. "A drug for the treatment of liver cancer, and then its metabolites, which are absorbed in the stomach, are usually found not only in the liver, but also in other organs and tissues, which is absolutely unnecessary for the patient," says Igor Varlamov, CEO of Binnopharm. "With the help of nanotechnologies developed and mastered by us, the medicine is delivered directly to the liver."
Many domestic companies lack resources for fundamental innovations. First of all, financial: the creation of a new drug formula costs at least $ 800 million, and there are no pharmaceutical companies in Russia today whose annual turnover was at least half of this amount. The cost of domestic developments, as a rule, is an order of magnitude lower. In addition, our manufacturers have not yet accumulated enough competence to break through in the market of unique drugs.
However, their success suggests the beginning of the formation of an innovative trend in our pharmaceutical industry.
Today, two out of seven drugs under the state program "7 nosologies", which provides for financing public procurement of drugs for the treatment of complex socially significant diseases, are Russian. And in their narrow segments, our innovative players compete with foreigners on an equal footing, and in some places they dominate. Thus, the Moscow company "Pharm-Synthesis" occupies almost half of the segment of antitumor drugs, leaving far behind the global giants Novartis and Roche.
Import substitution trendWhat contributed to the innovative growth of domestic pharmaceutical companies?
First of all, the political situation. Last year, the authorities seriously worried about the deplorable state of the domestic pharmaceutical industry: when the most important antibiotics and vaccines are supplied by foreigners, the national security of the country is under threat. Last year, by decree of Vladimir Putin, the Federal Target Program "Pharma 2020" was adopted, which implies import substitution and active development of drug production in Russia. Following this program, government spending on medicines for the hospital sector will increase by 2015. It is planned to allocate about 35 billion rubles for the 7 Nosologies program alone. Government spending on healthcare will grow in the coming years, and the market for public procurement of medicines should increase from 8-10 billion to 15-17 billion dollars in the next ten years.
The import substitution program focuses not only on the production of generics, but also on the production of original drugs. To do this, in the coming years, pharmacological clusters with a full technological cycle will be formed in some regions – from the production of substances to ready-made dosage forms. Several Russian regions have already announced the formation of pharmaceutical clusters and special economic zones – these are St. Petersburg, Moscow, Yaroslavl and Kaluga regions - which naturally stimulates Russian pharmaceutical manufacturers. "Our company is a resident of the special economic zone "Saint Petersburg, site "Noirdoff"". As part of the project, we have been provided with preferential tax conditions, ready–made land plots with connected communications," says Mikhail Kubylinsky, CEO of the Biocad company. – This greatly facilitates the conditions for business development. For example, we are starting to build additional capacities of the plant for the production of new biological drugs in the near future."
Need a morbidity passportSo far, young innovative companies occupy a negligible share in the market.
If the favorable conditions for their growth continue, then in five years it will be possible to say that the pharmaceutical industry has moved to a fundamentally new level. "By this time, the R&D expenses of domestic companies will grow to $ 200-300 million, and they will be able to increase their market share," Igor Varlamov from Binnopharm is confident.
However, alas, there are also enough factors that can freeze the innovative trend in the domestic pharmaceutical industry. And almost all of them, paradoxically, are connected with legislative initiatives designed to stimulate the production of medicines within the country. Last autumn, the law "On the Circulation of Medicines" was adopted, which, among other things, changed the rules for registration and clinical trials – for a more rapid introduction of medicines to the market. However, instead, additional bureaucratic difficulties arose, and the release dates of new drugs only lengthened. "The Ministry of Health has a real "traffic jam" of applications submitted for registration, officials simply can't cope. In 2010, we were supposed to bring to the market several technological preparations – biosimilars and original ones, but we could not do it. Some domestic medicines enter the market later than scheduled for a quarter or even six months," says a representative of a Russian innovative company who wished to remain anonymous. – Manufacturers suffer losses, but that's not even the main thing. Any delay of a domestic drug means that an existing imported drug, which is often an order of magnitude more expensive, will be put up for state trade. The delay of a domestic drug on the market can cost the state $ 150 million a year – we had such a case."
Without the state, first of all, without a detailed state order for years to come, the pharmaceutical industry will not reach the modern level of development: the consumer market is not capable of being a driver of pharmaceutical innovations. High-tech drugs, especially original ones, are expensive, and therefore the state is their main consumer all over the world. "In developed countries, the state determines the structure of diseases of the population, identifies those that cause the greatest damage to the economy, and based on these studies draws up a list of drugs that will be needed by the population over the next ten years," says Igor Varlamov. – If such a program existed in Russia, we would have much more new developments from different fields of pharmacotherapy. Today, there is no point in increasing them – we do not know what drugs the state will need in two or three years, and we do not want to take risks. Research costs a lot of money. According to world statistics, at each stage of project selection, out of ten drugs, only one goes to the next level of testing. Only guaranteed demand from the state can remove these risks."
Despite the increased interest of the state in the pharmaceutical industry, there is no drug consumption program in Russia, as there is no modern passport of morbidity in the country, taking into account the peculiarities of the regions – officials are guided by data collected in Soviet times, and statistics of developed countries, which is not applicable to Russia. Last year, such a passport was compiled by Western global companies, revealing a large discrepancy between the state list and the existing structure of morbidity in Russia. In particular, one of the first lines of the Western rating is occupied by mental disorders that are not included in the state register at all. It is obvious that the ratings of diseases of citizens need to be compiled every few years and based on them to form a plan for the consumption of medicines. So far, instead of this detailed work, there are only general arguments that, as stated in the Federal Target Program, "domestic drug manufacturers should occupy half of the market by 2016," the Russian pharmaceutical industry is unlikely to reach a fundamentally new level.
Portal "Eternal youth" http://vechnayamolodost.ru08.04.2011