Since 1996, more than 48 thousand positive samples for viral hepatitis C have been detected in our country. However, experts do not exclude that the real number of patients can be much larger: hepatitis is asymptomatic for a long time. The cost of treatment is very high. Part of the inhabitants of our country are forced to purchase drugs from "gray" suppliers.
Recently, the Belarusian-Dutch company "Pharmland" has created and registered sophosbuvir - an analogue of an innovative drug for the treatment of hepatitis C. This can be one of the solutions for patients. Vadim Senchuk, Deputy Director General for Science and Innovation, tells about how the development was carried out and what is happening today on the world market for the development of drugs for this serious disease, what will happen to the sales of the Belarusian drug.
Why we started developing a medicine
"The last five years in the world have appeared very effective tools for the complete cure of virtually all types of hepatitis C. These are two drugs - sophosbuvir and daklatasvir, which give the best effect in combination with each other. Before their invention, the disease was considered incurable. Therefore, their appearance as a result of years of research of large foreign corporations is a revolutionary event.
Deputy Director General for Scientific and Innovative Work, Candidate of Biological Sciences
Unfortunately, today, a monstrously high price has been formed on drugs for the treatment of hepatitis. In 2013, when they entered the market, a three-month course of treatment with two drugs cost 80-90 thousand dollars. Then the price fell, but in Europe and the US it is still measured in tens of thousands of dollars.
The drugs are under patent protection, which inhibits the emergence of more affordable counterparts. Both the high price and the long operation of the patent are due to significant investments in the development of innovative medicines. The creation of a new molecule usually takes ten years. In order to justify its investments in the development, the originators tend to keep the drugs under patent for as long as possible protection: during this period they, based on their interests, decide who to give a license for production.
Originator sophosbuvira is the largest American biotechnology company Gilead. Largely due to this development, its capitalization today amounts to tens of billions of dollars.
Photos from CNBC.com
The company granted a license for the production of this drug in India, which belongs to poor countries. For such regions, there are special WHO recommendations. In addition, Gilead feared that in the absence of a license, Indian companies would create "gray" analogs and start exporting them around the world. While the license allows you to limit sales markets.
Belarus companies-originators do not want to give a license for production or register drugs here. We are not a poor country and do not represent much interest as a market.
So, the residents of our country until recently had no choice but to search the Internet for "gray" suppliers of drugs from hepatitis. And to buy medicines that were not registered, which means they did not pass the test. When infectious diseases are very dangerous, when a person buys a low-quality medication: he can consider himself cured and at the same time continue to be a source of infection. This presents a danger both for himself and for others.
To stop the growth of hepatitis C, it is important to scale the use of medications: the more carriers of the virus in the population receive treatment, the better.
Therefore, we decided to develop the drug on our own. Several years ago we came up with an initiative to develop sophosbuvira in Belarus to the Ministry of Health. Our development was included in the state program for the development of the pharmaceutical industry.
What we are developing
I repeat that the ideal for the treatment of hepatitis C today is a combination of two drugs - sophosbuvira and daklatasvira. As a result of their use in India and Iran, the cure of patients with chronic form of hepatitis C was 100%. Sofosbuvir can work with other drugs that are selected by virologists depending on the form of the disease. But in combination with daklatasvir it is effective for almost all types of hepatitis C. These drugs are sold separately, because they are created by two different companies.
Due to the fact that sophosbuvir is a prodrug, that is, it turns into a final medicinal product already in the human body, its patent protection in many countries is in doubt.
Daklataswir is under strict patent protection until 2024.
We developed the development of sophosbuvir about two years ago, and not so long ago we registered this medicine. We also note that we consider with great interest the possibility of developing daklataswir as a continuation of this project. Unlike sophosbuvira, this molecule is strictly patented - under the patent there are both the composition of the pharmaceutical composition and the application. However, patent law does not prohibit us from engaging in development. Therefore, like most companies in the world, we prepare generics during the patent protection period for original drugs, in order to be the first when the patent expires.
People often believe that making a copy is not so difficult: I read the composition in the instructions, bought the ingredients, and did it. Nothing like that. We know what we are looking for, we know the molecule that interests us. But in order to give it the necessary therapeutic properties, it is necessary to conduct a large study of the correct pharmaceutical composition with the desired properties.
The full composition of the original drug for us - closed information, the file on the drug, we do not see. In recent years, global companies have been following the path of creating closed technologies that can not be determined based on the composition of the drug.
For example, very many drugs include starch. But the starch is of different structure. It can be in the form of a so-called dendrimer, which looks like a tree with a branching structure. We can "twist" these twigs, put the right drug between them, and then "collapse" them. This starch will slowly give the drug to the solution. And if you simply mix starch with the substance, there will be a completely different picture, although the inscription on the composition on the package will be the same.
"Pharmland". Photo: Lana Krasikova
An important part of our work was aimed at achieving the same solubility in our generic product as the original preparation. The test is conducted in three environments - acid, alkaline and neutral, which mimic different environments in the human body. We needed to ensure that the solubility curves coincided with those obtained with the original preparation.
Registration and testing. The entire process, from the first steps to registration, took two years, including a clinical study, in which 28 people took part.
If we produced an innovative drug from scratch and checked its therapeutic effect, then we would need much more time and volunteers for testing. But we experienced a generic. It was only necessary to check the biological equivalence of our drug to the original, the level of the drug in the blood plasma. We obtained a good result: our drug is absorbed into the human body at the same rate and creates the same concentration in the blood as the original. By the way, in many countries clinical trials not carried out, only chemical identity is checked.
We managed to make the development faster than planned in the framework of the state program. Today, such an urgent situation with hepatitis C, that we threw almost all the forces of our scientific and pharmaceutical laboratory, concentrated our entire resource to try to do it quickly. Twelve of our specialists participated in the development - chemists, technologists for development and production, registrars for conducting clinical trials.
We financed research only at our own expense. To date, spent about 100 thousand dollars to develop before registration, without taking into account marketing costs.
"Pharmland". Photo: Lana Krasikova
Now we are proceeding to industrial production at our plant for the production of generic drugs in Nesvizh. Hiring new specialists and supplying additional equipment for this will not be required. There are enough operating capacities. And we plan to start deliveries this year.
The volume and dynamics of these supplies are now being discussed with the Ministry of Health. We expect that part of the products will go through state orders, some of them will be delivered through pharmacies, and also through clinical institutions, so that they provide a paid medical service for patients with hepatitis C. It is very important that the drug is taken under the supervision of specialists. Necessary diagnosis, the appointment of virologists and infectious diseases, which correctly select for each patient therapeutic complex.
"Pharmland". Photo: Lana Krasikova
We will offer a very comfortable price compared to the original price. Perhaps it is high - compared with simple aspirin. But in determining the price, much determines the cost of the substance in the world market. The cost of a course of treatment from three packages will not exceed $ 1 thousand. In this we plan to provide patients free of charge and the second necessary drug - daklataswir - within the framework of clinical trials.