The Managing Director of HUMAN BioPlazma,

Ákos Tóth, highlights the transformational growth that the business has experienced since becoming a part of Kedrion Biopharma in 2008, while pinpointing the strategic role that the subsidiary now plays in producing and distributing the company’s lifesaving biotherapies both inside and outside of Hungary.

Can you please provide some insight into the company’s presence within Hungary, and also describe how far the business has grown since Kedrion acquired HUMAN BioPlazma in 2008?

Our story actually dates back to 1954 when, through a ministry decree, the Hungarian State created HUMAN Serum Producer, a 100 percent State-owned company producing both plasma derivatives and vaccines. The company grew quite rapidly and eventually in 1966 moved to the current production site here in Gödöllő.

At the start of privatization in the early 1990s, Novopharm became the main owner of HUMAN, gradually acquiring 100 percent of the company’s shares from the State by 1999. Shortly after, the ownership of the company changed hands when Teva acquired Novopharm. At this point, the business had three primary pillars: plasma, vaccines, and generics. GSK eventually acquired the vaccine portfolio in 2005 and Kedrion acquired the plasma processing business towards the end of 2007, thus establishing HUMAN BioPlazma and writing a new chapter in our history under the umbrella of Kedrion Biopharma Kedrion immediately started an investment plan of 40 million Euro in total, eventually tripling the company’s original production capacity from 150,000 liters of plasma fractionation per year to 530,000 by 2012.

Kedrion was committed to revitalizing the company’s longstanding legacy and traditional portfolio with new investments and innovation. After more than 20 years of minimal R&D, we were proud to be able to introduce a new factor VIII product for patients suffering from hemophilia A in Hungary. Additionally, just last month, we launched the first liquid immunoglobulin preparation made entirely from Hungarian plasma.

Currently, we employ 300 people and generate an annual revenue of over EUR 40 million, a threefold increase since 2008. Additionally, given the relevant role of our operations in Hungary, we are extremely proud to have an active part in driving the growth and the ambitions of Kedrion Biopharma in the present and also for future development.

What key role does HUMAN BioPlazma play in Kedrion’s global supply chain?

We have two production lines, one of which is entirely dedicated to supplying the needs of the Hungarian market. We obtain plasma from both our own and the State’s collection centers. The plasma we collect from the State is recovered plasma derived from whole blood donations, as opposed to the source plasma that we collect in our centers through plasmapheresis. Through these two sources, we supply the Hungarian market with finished products. This has been the HUMAN’s fundamental mission ever since the 1950s. I am proud that even after various changes in ownership, this tradition has been kept alive.  Everyone has always understood the importance of maintaining the country’s self-sufficiency when it comes to blood plasma and plasma-derived products.3

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Last May we opened our fourth plasma collection center in Hungary. We’re the only plasma collectors in the country holding IQPP certification, essentially validating our efforts in meeting the highest quality standards of the Plasma Protein Therapeutics Association (PPTA).  Kedrion is fully committed to maintaining these high quality standards.

We’re now collecting 7 times more plasma in Hungary than we did in 2008. This goal has been achieved by optimizing and reshaping our plasma collection centers.

We’re also currently processing plasma coming from the whole Kedrion Biopharma global network. All the plasma that is fractionated here is then sent to Italy for the purification step and the finished products are then marketed under the Kedrion Biopharma brand.

Before Kedrion acquired the company, 2/3 of the business was based on finished products, where half of the production was sold locally in Hungary and the other half in markets across Europe and Asia. The remaining 1/3 of the business was attributed to contract manufacturing services, a necessary business brought in by Teva at the time.

Now, our business has changed, with less than 50 percent attributed to the sale and marketing of our own production and the rest of the portfolio comprised of contract manufacturing services for Kedrion Biopharma.

What strategic benefits do you see in maintaining domestic production capabilities in a country such as Hungary?

There are clear strategic advantages for companies that have established local production operations. It is interesting to see companies like Kedrion combining cutting-edge innovations with tradition. Kedrion Biopharma’s values blend in seamlessly with the local strategy. Compared to the other major players in this industry, Kedrion has strived to differentiate itself and create a unique value proposition by building productive partnerships, particularly with governments, to respond to the needs of the healthcare system and support the strategic goal in plasma-derived therapies for the treatment of rare and debilitating diseases.

The local subsidiary is building a bridge between donors and patients, people who are often in critical care. Our primary objective is to bring all key stakeholders together to ultimately benefit the patient, and we strive to have our efforts recognized by both government authorities and healthcare practitioners alike. Considering the importance of our lifesaving products, we continue to invest to work in line with the highest GMP standards.

On the notion of self-sufficiency in Hungary, how would you evaluate the demand for therapies when it comes to rare diseases, which normally only afflict a small portion of the population?

Together with the European Hemophilia Consortium, hemophilia patient associations have had a significant impact on the availability of treatment in Hungary; in the field of hemophilia, Hungary is among the top five countries in Europe in terms of patients treated and therapies available.

In the field of immunodeficiency, I still see a remarkable opportunity for growth. Our products are made using Hungarian plasma, for Hungarian patients. The level of diversity among our donors could help expand the breadth of therapies for immunodeficiency disorders. This is very important and can be a key factor in treating these diseases more effectively in the future. Kedrion Biopharma has understood the crucial role we play in promoting that agenda, especially in Hungary.

Having built much of your professional experiences outside this sector, what factors ultimately motivated you to enter and maintain a career in the pharmaceutical industry?

Our business here has a profound impact in improving the lives of Hungarian patients. We produce lifesaving products that are used in 40,000 to 50,000 cases a year in Hungary. This reason alone is enough to make me get out of bed in the morning. On top of that, my professional ambitions are center around understanding the nature of capital and driving the company to be successful in a way that is beneficial for all stakeholders – its owners, its employees, the patients and the donors.

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My personal role in the company focuses more on building the company, enabling it to seize opportunities and managing the challenges that come our way. I have certain ideas that could support our operations, whether this means attracting new investments from Kedrion Biopharma or employing more people. Ultimately it is all about evolving in a way that provides more value for the company, the country and its citizens, and definitely for our staff as well.

I come from a very diverse professional background and learned a lot about biochemistry in the past seven years. Having spent many years working in the manufacturing sector, I am not afraid of understanding a real process and implementing key initiatives for the process improvement. This is further enriched by incorporating new ways of thinking, while maintaining an open and collaborative working culture that fosters proactivity and innovation.

What objectives will you focus your efforts on achieving as managing director in the next 3-5 years?

Being local and being Hungarian is very important. This is a core focus: establishing strategic partnerships and collaborations with the government and all the stakeholders in healthcare system to further emphasize the importance of self-sufficiency when it comes to plasma and plasma-derived therapies in tackling rare diseases.

My last priority focuses on attracting more investments here in Hungary to expand the scale of our operations.