Five minutes at CPhI worldwide with …
Chemistry Today/Pharma Horizon: What projects are you focused on now?
Ivanov Roman: We were one of the first companies to produce mAB in Russia, that now make up most of our sales. Currently we are investing mostly on the development of next-in-classrugs based on mAB. In 2015 we started to develop mABs specific to clinically validated targets, but with some incremental advantage over the first-in-class molecules. We have a focus in oncology: for example, we are developing an anti-PD1 antibody that would be our first immuno-oncology drug. It is a checkpoint inhibitor, a class of molecules that caused a revolution in oncology. It has certain advantages compared to marketed mABs with similar mechanism of action and it is in registration clinical trials for melanoma and lung cancer. Right now we have 14 original mABs in non-clinical and clinical studies and many more in early-stage development.
CT/PH: What is the impact of your products?
IR: We offer biosimilars for rituximab, trastuzumab, bevacizumab. The rituximab biosimilar was launched in early 2014, the trastuzumab and bevacizumab in early 2016. Our products made a huge impact on the availability of biologicals in Russia. For trastuzumab and bevacizumab the prices dropped almost four times. As a result, the availability of these drugs increased: less than half of breast cancer patients in Russia could use trastuzumab, now all of them can. The volume doubled or even tripled.
CT/PH: What about autoimmune diseases?
IR: In oncology we are the number one in the Russian market, surpassing Roche or Novartis. We believe we will reach the same position for autoimmune diseases in a couple of years. Multiple sclerosis, psoriasis, rheumatoid arthritis are our key areas of interest. We have biosimilars and generics of all first-generation drugs for treatment of multiple sclerosis. We provide biosimilars of interferon-beta (1a and 1b) as well as glatiramer acetate generic. Right now we started clinical trials for next generation drugs – pegylated interferon-beta molecule as well as anti-CD20 antibody for treatment of multiple sclerosis. We have completed a large development program for the infliximab biosimilar, to be launched in Russia by the end of the year, and we are in the clinical development for the adalimumab biosimilar. We also have a broad portfolio of innovative products for rheumatology diseases. For example, our leading project, the antibody against IL-17, aims at creating a drug that would be superior to Cosentyx, which is the first-inclass anti-IL-17 product. Currently the project is in Phase III of clinical development and in Phase II it has already demonstrated great potential in terms of activity and safety in patients with psoriasis and ankylosing spondylitis.
CT/PH: Do you offer ADCs?
IR: Right now we develop different forms of antibodies: mono- or bi-specific antibodies, combinations of antibodies to different targets, but they are all conventional antibodies, not antibody-drug conjugates.
CT/PH: What kind of technologies do you use for production?
IR: For all new products we use our own in-house lines of CHO cells. Our facility in St.Petersburg has multiple single-use bioreactors that provide us with a manufacturing capacity that would be sufficient to cover 100% the Russian market, plus other markets. This is all GMP/cGMP certified, not only by local Russian authorities but also by other countries. Next year we will file for Phase II/Phase III clinical trials for our mABs and comply with GMP regulation in Europe.
CT/PH: So is Russia your core market?
IR: Yes, but we are currently registering our products in 50 markets worldwide. We already export drugs to Vietnam, India, Sri Lanka. In November we launch our antibodies in Marocco and other North Africa countries.
CT/PH: Is the current geopolitical situation making things harder?
IR: Actually I would say it is very beneficial to us. Our key partners in Middle East and North Africa, and in certain countries of South East Asia or Latin America are actually very keen to collaborate with Russian companies due to the geopolitical situation. Economic sanctions and the devaluation of Russian currency have greatly stimulated our growth. Thanks to the devaluation of currency we became even more competitive than Indian companies. The cost of development in Russia is now lower than in many Asian countries, in fact, while the quality of human resources in our opinion is much higher. As a manufacturing company we are in a unique situation. We have ambitions to launch our products in Europe as well, and I do not think the political situation will make any difference: affordable, high quality biologicals are needed by Europeans as by anyone else. We want to make biologicals affordable to all patients, wherever in the world they are.
CT/PH: And in general what is the situation of the pharma industry in Russia?
IR: Until ten to fifteen years ago there was virtually no pharmaceutical industry here, since pharmaceutical manufacturing in Soviet Union was localized in Warsaw Pact countries in Eastern Europe such as Hungary and Poland. After the collapse of Soviet Union, Russia lost almost all pharmaceutical industry. All of the current industry was born in the last ten to fifteen years. In 2010 the Russian government launched a program specifically aimed at the development of a competitive pharmaceutical industry, and within the last seven years several large companies appeared in Russia, investing lots of money in infrastructure and R&D. These companies, that we can call the “New Russian Pharma”, are using these funds to take utmost care of the quality of their products. We believe that this industry is competitive not only internally, but also worldwide, and we believe in the next three years they will be noticeable players internationally.
CT/PH: Does Biocad work in small molecule APIs as well?
IR: We established our own small molecule development facility, and currently we produce in house several oncology APIs such as docetaxel, paclitaxel, irinotecan and others. We are very price competitive even compared to Chinese and Indian manufacturers, and the quality is so good that we started investing to introduce these injectable generics on the European market.
CT/PH: What is your take on CPhI 2017?
IR: It is a great place to meet with your partners. We had already got contracts at previous CPhIs for almost every geographical region, so now it is mostly about follow-up, milestone discussion with existing partners. We also had some meetings about outlicensing our innovative molecules and inlicensing some innovative products from biotech companies. Frankfurt is in my opinion the best location, it is so convenient in terms of transportation. After one day it has been already a success for our company.