iVFarma

Contributing to Demography

The iVFarma biotechnological company, based in the Moscow technopark Slava is developing infertility treatment medicines with the entire production cycle, from creating a pharmaceutical substance to producing a ready-made dosage form, carried out exclusively in Russia. OOO iVFarma General Director Mikhail Polzikov, candidate of chemical sciences, was interviewed by Investportal and told us about his company helping Russian families to become happy parents.

- Mikhail, how old is iVFarma?

- Our company was founded in 2012; it has recently celebrated its 6th anniversary. On the one hand, this is not a long time for a pharmaceutical start-up, but on the other hand, we managed to use this time very efficiently and we are proud of our achievements. The company’s name in Russian is the transliteration of the English “IVFarma”, where IVF stands for “in vitro fertilization”. This is exactly why IVFarma was created. Its purpose was the development of complex biotechnological preparations required in Russia, for in vitro fertilization and improvement of women's health. I will briefly explain why we have chosen this field of work. This year, Louise Brown, who had been the first human being to be born as a result of IVF, celebrated her 40th birthday. To date, this technology has helped more than 5 million long-awaited children to be born all over the world. In Russia, assisted reproductive technologies are also in high demand, and the number of specialized clinics and IVF cycles is growing year by year.

Today, the company’s staff is 20 people. All of them have experience working in research institutes, both in Russia and abroad, in IVF clinics, as well as in global pharmaceutical companies. Our colleagues working on the same mission and our contracting manufacturers are the N. F. Gamalei National Research Center for Epidemiology and Microbiology   at the Russian Ministry of Health and the Urals Medsintez plant that employs highly qualified professionals ready to join us in solving complex production and biotechnology scaling issues.

- What medicines do you manufacture?

- Our first medicine Primapur® is a recombinant human follicle-stimulating hormone, used in IVF programs as a stimulant for ovocyte formation in the woman's body. The preparation is obtained through genetic engineering from Chinese hamster cells in a special bioreactor. The creation of such producer cells was a serious scientific and technical challenge that we faced together with our colleagues from the Federal Research Center of the Russian Academy of Sciences Biotechnology Institute headed by the outstanding scientist Ivan Vorobyov.

Primapur® is a biosimilar drug, i. e. a complex human protein with various modifications necessary to ensure its biological activity in the human body. In comparison with conventional generic drugs, biosimilar drugs require more complex pharmaceutical development and comparative preclinical and clinical studies, and therefore they are referred to a separate category of drugs.

Primapur® has successfully passed comparative preclinical and physical&chemical tests, as well as a study involving female volunteers, the so-called bioequivalence study or Phase I. Recently, we have also completed the most extensive IVF program ovary stimulation study registered by the Russian Ministry of Health. Our goal was to statistically prove the therapeutic equivalence of our drug and the Western analogue that is well-known at the market. The study involved 3 IVF clinics in Moscow and the Moscow Region, as well as 110 couples receiving infertility therapy with IVF methods. Last year, in November, the first participating couple had a child thanks to our Primapur® that was used for stimulation. It should be noted that all the studies were conducted in accordance with European and Russian requirements for the development of such kind of drugs, in cooperation with both Russian scientists and foreign organizations based in 4 countries. At the beginning of the next year, we are planning to obtain permission for Primapur® to be marketed in the Russian Federation, to launch the first domestic recombinant human follicle-stimulating hormone, fully developed and manufactured in Russia, in a convenient injection pen.

- Mikhail, have you developed the injection pen too?

- Yes, another, equally important, research area is creating a convenient injector, or a pen, to be used by patients for self-injection. Since the IVF programs stimulation procedure on average takes 10 days, we had to make such daily injections easier for patients excluding the necessity to prepare and dissolve the drug, and to ensure the highest possible level of convenience and simplicity. Together with our colleagues from the Medsintez plant, we have created a unique injection pen for follicle-stimulating hormone injections with a minimum dosage increment of 5 international hormone activity units based on the insulin injection pen. The minimum dosage increment allows the reproductive physician to more accurately select and adjust the required daily dose for each individual patient. Of course, our production technology, the drug composition, and the injection pen are protected in Russia by patents of invention, along with the trade names.

It is a fair assumption to say that since the day our company was created we have developed from scratch a technology that can be used to obtain both the substance and the ready-made follicle-stimulating hormone preparation, and we have also created a modern injection means that can be applied by patients.  Foreign developments of this kind are known to take from 8 to 10 years, so we are proud to have passed this way much faster in Russia.

- Tell us about the main markets where the company's products are sold.

- Our main consumers are in vitro fertilization clinics. To date, Russia has about 200 specialized clinics, both private and public. The need for IVF programs in Russia has not been covered yet, and the market is growing. According to European experience, it is necessary to carry out 1,500 IVF programs per 1 million people a year, to satisfy the demand for such procedures, on the one hand, and to contribute to the country's demography through IVF programs, on the other hand. Today, this parameter in Russia is twice lower than the recommended value, but there is a successfully developing government program that allows to grant more and more IVF program quotas to those who need IVF.

Our European and Chinese colleagues are also interested in our developments, but for now we are focused only on the Russian market, since our main goal is to help Russian couples and to reduce the IVF program costs at least through lowering the cost of the stimulation drug.

- How come that IVFarma is located in the Slava technopark?

- We learned about the Slava technopark and met the technopark director Viktor Shkredov at the time the company was created. We liked the technopark atmosphere at once. Although there was much more to be done, the team was very enthusiastic, and we got captured by their energy. Obviously, this unflagging energy has not been exhausted yet. On the contrary, the technopark team seems to have more and more of it over the years. We try to keep up both improving our results and extending our space. Our company occupies three premises already, and we expect to open our own quality control and product development laboratory on the technopark territory in the near future. We are also going to apply for the anchor residency in the Slava technopark.

It is worth noting that the Slava technopark unites many biomedical enterprises, with which we successfully cooperate and can simply exchange opinions over a cup of coffee. It is great when you can get expert advice right on the job. On the other hand, the non-medical resident companies of the technopark can quickly provide quality business services (for example, printing services), which saves us a lot of time and energy.

- Does your company participate in major industry events?

- Of course, we take part in specialized congresses and exhibitions. Our exhibition activity is focused on medical congresses in the field of reproductive and women's health. For example, in September we will participate in the Russian Association of Human Reproduction XXVIII international conference "Reproductive technologies today and tomorrow” to be held in Ufa. At the conference, we will present the results of the clinical therapeutic equivalence study of our first drug Primapur®, in comparison with the Western analogue. In November, we plan to present our injection pen in London at the 26th World Congress Controversies in Obstetrics, Gynecology and Infertility (COGI).

- What new drugs and studies are you currently working on?

- Of course, we never intended to stop after one drug, even though it is as hard to obtain as a follicle-stimulating hormone, and we are already developing other biotechnological preparations in cooperation with scientists from the organizations of the Russian Academy of Sciences and the Ministry of Health. We hope that they will find use in the human reproduction field. Also, we cooperate with scientists from the St. Petersburg Institute of the Russian Academy of Sciences to explore a completely new and promising molecule for female and male infertility treatment, but this exciting path of research and development has just been started. We are optimistic about our work and believe that we will be able to help more couples to become happy parents.