Olena Saliy: “The key goal is to create a hub in Ukraine that is engaged in the development, production and supply of veterinary drugs to the world”
35 years ago, a team of young scientists from Kyiv began developing vaccines for animals. Having started its business with several products, the BIOTESTLAB company today has a solid portfolio of 130 veterinary immunobiological and chemical-pharmaceutical products tested by production practice, among which some drugs have no analogues. Along with the portfolio, the trust of partners in Ukraine and the world also grew. This prompted the company to adopt a new strategy, involving business transformation from a local manufacturer to an international brand. At what stage is the implementation of this strategy and how this process is affected by russia's full-scale invasion of Ukraine, Elena Saliy, General Director of BIOTESTLAB LLC, told in an interview with the Pharmaceutical Industry magazine.
What key successes in the company's development can you highlight in recent years?
The decision to change the direction of development to create an international brand was made more than 10 years ago. It was preceded by a rebranding with a change in the name “Bio-Test-Laboratory” to “BIOTESTLAB” and renaming of the vaccine lines. The new long-term strategy provided for step-by-step reorganization procedures, expansion and technological re-equipment of the research and production base, GMP certification, and the launch of an export program. In 2015, we supplied vaccines to Egypt for the first time. In 2021, the share of exports in the company's sales structure increased to 35% in monetary terms, and the geography expanded to 20 countries.
But most importantly, by implementing our plan, we laid the foundation for further scaling the business and attracting investment in development. The key goal is to create a hub in Ukraine engaged in the development, production and supply of vaccines, medicines and disinfectants for veterinary use, eliminate most of the existing restrictions on the range of products, open new countries and continents, competing with world-famous manufacturers.
How has Russia's full-scale invasion of Ukraine affected business?
Let me start with the fact that the BIOTESTLAB Company has 35 years of experience in organizing work, particularly in crisis management. We have successfully gone through several periods of rapid national currency devaluation, two revolutions, and the outbreak of hostilities in eastern Ukraine. Therefore, we faced the big war as the most united, professional team in the company's entire history.
We are lucky that our production and logistics facilities are located in the capital of Ukraine, Kyiv, and its suburbs. This is 600 kilometers from the combat zone. Kyiv today is the most protected city in Europe. Key infrastructure, industrial, research, and production facilities are protected by modern air defense systems. The city is visited monthly by delegations led by presidents and prime ministers of many countries around the world; meetings, international conferences, and summits are held here. Ukrainians have withstood the aggressor's blow, the economy continues to operate, and the entire civilized world is now with us.
As for our company, firstly, we retained the management team, did not lose key specialists, and took care of safety. We developed plans for the continuous operation of the business. We have worked out actions in case of accidents, as well as outages of water, electricity, and heat at production and warehouse facilities. We purchased industrial generators and stocked up on fuel. Secondly, we have provided our production with strategic raw materials. We are grateful to our European and Asian partners who did not refuse cooperation; they trusted us and sent SPF eggs and active ingredients on time. We worked on import routes, reorienting from the port of Odesa to the port in Gdansk (Poland). We export products through the airport of Budapest, the capital of Hungary. The management decisions made in March 2022, which often required unconventional action, yielded results. In April, production operated steadily, producing more than half of the assortment. We shipped products to livestock and poultry farms, distributors, and supplied vaccines under government tenders. In addition, in March we received new orders from foreign partners. By the way, we have not failed a single export contract; we fulfill all our obligations on time and in full.
What is the company's focus now?
One of the priorities is product development. We have strengthened our R&D, marketing, information and drug registration departments.
In 2012, the product range consisted of 52 items; ten years later, in 2022, their number reached 130. These are primarily vaccines (commercial and autogenous) for poultry, pigs, and rabbits. In 2018, the first vaccine for cattle was released (BOVIMUN 4, a combined 4-valent vaccine against the respiratory-reproductive complex of diseases in cattle). At the moment we have developed four vaccines for cattle. We began developing vaccines for small livestock in response to requests from potential customers in African countries.
All this is happening in parallel with developing another important area for us – chemical and pharmaceutical products for farm and domestic animals. The decision-making on drugs for dogs and cats was facilitated by the successful launch in 2017-2019 of the first propofol-based anesthetic in Ukraine (RELAX), as well as a complex drug for the treatment of otitis media of various etiologies (OTOFLOX).
During the full-scale war, the company did not change its pipeline for releasing new products – four drugs were launched on the market. These are two vaccines for poultry: live vaccine POLIMUN IB VAR 2 against infectious bronchitis of chickens from the VAR2/V2 strain (common in the Middle East, recently it has been increasingly found in Ukraine and neighboring countries of Eastern Europe), and polyvalent inactivated vaccine POLIMUN ND EDS IB MAX against Newcastle disease, egg drop syndrome and infectious bronchitis of chickens. The uniqueness of the latter is that it contains three strains of the IBV virus, which provides cross-protection against classical and variant pathogens of the disease.
Two more new products are KETAFUR, a combination of NSAIDs + antibiotic based on ketoprofen and ceftiofur for cattle, and HEPAX, an injectable hepatoprotector based on ademetionine in dosages specially selected for use in dogs and cats with different body weights.
TULAXAN – an injectable antibiotic with the active substance tulathromycin for use in livestock and pig farming – we have submitted for registration. In total, more than 25 vaccines and drugs for veterinary use are at various stages of development.
Another direction of our activity is the implementation of investment projects aimed at technical and technological re-equipment. The company adheres to high-quality standards and also works to increase the level of automation of production processes, productivity, and the development of new technologies. We purchased a new line for powder drug production, a new line for sterile drug production, and new bioreactors for vaccines. In addition, we are digitalizing management processes. Last year, we were recertified for compliance with GMP standards, and at the beginning of 2024 – for compliance of the quality management system with the requirements of the ISO 9001:2015 standard.
How do you see the future of the company? In what markets?
Ukraine remains and will be a priority, but we see growth in export markets. We work in three directions. The first is the opening of new countries for BIOTESTLAB products. The MENA (Middle East and North Africa) and ASEAN (Southeast Asia Nations) regions remain priorities, in addition to Sub-Saharan Africa. Today, the company's products are represented in 20 countries. Registration procedures in the UAE were completed last year, and we are now launching five drugs for pets to the market. We are also studying work prospects in Latin American countries. This is an attractive and interesting region for its market potential, albeit with complex logistics. The second direction is expanding our offer in markets where our products are already represented. An example of a successful case is Vietnam, where we have been supplying poultry vaccines since 2021. We proposed to the distributor to expand the range of products with vaccines for pigs and conducted training for the sales staff. In the summer of 2023, the first batch of vaccines against classical swine fever was shipped.
The third direction is participation in tenders held by international and governmental organizations in different countries. In particular, we are actively working to promote a vaccine against bovine lumpy skin disease, a highly contagious infectious disease common in large regions of Africa and Asia. In 2022, we won a tender to supply more than a million doses of this vaccine to Azerbaijan.
Last year, another area of work for us was the EU countries. Unlike the Asian and African markets, where we have focused on vaccines, the European market primarily needs chemical pharmaceuticals in sterile forms. We work with European EU-GMP consultants; we held meetings in Poland, the Czech Republic, Romania, Portugal, and Spain.
We decide which country we will move through next. We understand that the process is complex and lengthy, but this is important in terms of sales volume and company development, self-improvement, and deepening Ukraine’s integration into the EU, so this year we want to take the first steps on this path.
We are looking for managers with experience in export sales, and agents to open new opportunities abroad. We have strengthened marketing: we have never had such budgets as in 2023, and 2024, we have deepened market analytics, and we actively participate in exhibitions.
Last year, the company was represented with separate stands at the largest industry event in Southeast Asia, VIV Asia-2023 in Thailand, at exhibitions in Saudi Arabia and Qatar, and at forums in Ethiopia and Nigeria.
Participation in at least five international events is planned for 2024. Plans are underway to open representative offices in key export markets. As for the types of cooperation, in addition to B2B and B2G, we are considering options for supplying products in bulk, technology transfer, joint development, and transfer of dossiers.
Please share your plans for 2024. What projects will be your priority?
Our strategy remains the same. We will continue to transform our business into an international brand. We focus on stimulating investment in research, developing new technologies, and opening export markets, despite all possible risks. After all, our growth means new opportunities for us and our partners from Ukraine and abroad.
Published: Pharmaceutical Industry Review, #1 (100) / March 2024
