Konstantin Matentzoglu for Puls Biznesu

We are expanding our research portfolio - that's what you'll read about in Puls Biznesu. Editor Marcel Zatoński spoke with a member of our supervisory board, Dr. Konstantin Matentzoglu, among other topics, about the completion of the first stage of clinical trials for PB0016, our proposed biosimilar medicine to Entyvio®* (vedolizumab), reference drug developed by Takeda.

Polpharma Biologics' research portfolio is expanding

Jerzy Starak's portfolio company, heavily involved in biosimilars development, could be selling rights to their third program this year. The drug that their product mimics, generates more than USD 6 billion in sales annually

Translation from Polish.

Original article published in Puls Biznesu on 11.03.2024

NR 50 (6555) INDEKS 349 127 WYD. A+B 

Link to original article: https://www.pb.pl/polpharmie-biologics-puchnie-badawczy-portfel-1210452

[in brackets: additions by Polpharma Biologics]

IT'S THE VISION THAT BROUGHT ME ON BOARD:

Dr. Konstantin Matentzoglu is the former CEO of Celonic, a company active in the field of contract development and manufacturing of novel drugs. He started when the company employed less than 30 people and left leaving behind a team of more than 550. Since 2021, he has been advising Jerzy Starak as part of the supervisory board of Polpharma Biologics. Since October last year, he has taken a leadership role in operational activities of this entity. He stresses that what convinced him to come and work in Poland was the top-tier research teams, who were fueled by the investor's vision, which  "puts money on the table, thinking not only of ROI, but also about growing the industry."

The first biosimilar drug [biosimilar ranibizumab] which was developed and manufactured in Poland, made its debut in the US at the end of 2022 and is already generating tens of millions of dollars in quarterly sales. The second biosimilar [natalizumab] was marketed towards the end of last year in Norway, followed by Finland and Germany. Polpharma Biologics, a company from Jerzy Starak's portfolio, is responsible for both these drugs [development and manufacturing].

The company [Polpharma Biologics], which focuses solely on biosimilars, is already thinking about commercializing its third medicine – a proposed biosimilar to Entyvio (vedolizumab), which is –a drug developed by the Japanese company Takeda.

- “We have completed a pharmacokinetics & pharmacodynamics clinical study, which achieved all the pre-defined endpoints. In its essence, it showed that the effect of Entyvio in the body is no different to that of our proposed biosimilar. We are currently deep in the process of an extensive efficacy & safety study, which we will complete later this year. We also believe that this year we will sign a distribution contract with a potential partner and/or partners, granted that we decide to divide the rights between the US market and other markets. We already have a short-list of potential partners and talks are at an advanced stage”, reveals Dr. Konstantin Matentzoglu, a Member of the Polpharma Biologics Supervisory Board delegated to the company’s management board.

Race to the drug

Entyvio is a so-called blockbuster – it is the number 1 prescribed drug for inflammatory bowel diseases in the US and has been the preferred form of therapy for several years. With limited direct competition, Takeda expects its annual sales to reach USD 8 billion in the coming years.

“Vedolizumab is a drug used in the treatment of inflammatory bowel diseases, including the most common ones, namely Crohn's disease and ulcerative colitis. Globally, between USD 10 billion and USD 30 billion are allocated annually to medicines for patients with such conditions. There are several therapies with different mechanisms of action available in the market, but the Takeda drug [Entyvio] is currently the most popular and is seeing rapid sales growth. We believe that our medicine will be the first biosimilar in the market to compete with Takeda's drug - we have at least a year's advantage over our competitors”, says Konstantin Matentzoglu.

Current competitors include the Icelandic company, Alvotech and the Indian company, Intas. According to the currently available information, neither of these companies have started clinical trials yet. However, they may still have ample time to pursue such attempts, as Takeda’s drug is still protected by patents. In some cases (in the US market), the patents expire only in 2032. In Takeda’s presentations to investors, the Japanese company expressed the belief that Entyvio would not have to face any market competition at least until the end of this decade, taking into account the time needed to test and register biosimilars and challenge patents in court.

“We understand Takeda's position, but we do not share it. We are aware of Takeda's attempts to prolong the patent protection for their drug and we have prepared detailed IP analysis which we have presented to our potential commercial partners”, says the Polpharma Biologics Supervisory Board Member.

Multi-million investments

The company does not disclose how much money they have allocated to working on vedolizumab and clinical trials. In comparable projects, the cost of bringing a biosimilar drug to the commercialization stage is as much as USD 180–250 million.

“Developing biosimilars is extremely costly and time-consuming. On the one hand, market regulators declare that they expect such medicines be marketed in a cost-effective way, but on the other hand, they require extensive research to prove that the biosimilar is fully comparable to the reference drug. In the case of our proposed vedolizumab biosimilar, there is currently a big efficacy and safety clinical study underway where subjects are now being recruited in various countries, including Poland”, explains Konstantin Matentzoglu.

Polpharma Biologics assumes that the vedolizumab biosimilar will be submitted for approval to EMA and FDA (regulators of the European and US market) in 2027, making our medicine available to patients soon thereafter.

“We assume that biosimilar`s marketing authorization will be granted in 2028, one year after the planned submission of registration applications. We are already in the process of preparations for commercial manufacturing at our plant in Duchnice near Warsaw. Currently, works are underway there on a new production line”, says Konstantin Matentzoglu.

Commercialization progress

So far, two biosimilars developed by Polpharma Biologics are currently marketed.

The first is ranibizumab, a biosimilar to Lucentis from Novartis, used to treat conditions that include wet macular degeneration of the eye. The Polish company [Polpharma Biologics] developed it as part of a joint-venture under Bioeq, along with the German company Formycon.

Coherus BioSciences began selling the drug in the US at the end of 2022 under the brand name Cimerli. At the beginning of March this year, the Coherus division responsible for distributing this drug was bought by Sandoz for USD 170 million. Polpharma Biologics is responsible for drug manufacturing and receives royalties from its sales, although this amount is not publicly known. Teva is the current distributor in the UK and they plan to gradually introduce the biosimilar into more countries.

“Coherus recorded excellent sales of our ranibizumab biosimilar, quickly reaching a 40% share of the American market, which brings us very close to the market share achieved by the reference drug, Lucentis. Other biosimilar medicines have a single-digit share”, says Konstantin Matentzoglu.

In the case of ranibizumab, the market value is negatively affected not only by the introduction of Lucentis substitutes, but also by a cheaper alternative therapy Avastin manufactured by Roche, as well as  the new generation drug, Vabysmo, also developed by Roche.

"In our view, the price that Sandoz paid for Cimerli is beneficial, considering the fact that the drug generated USD 125 million in sales during its first year of availability in the market. Generally, biosimilars may continue to grow for a long time, as their lower price means that treatment becomes available to a wider audience. In the case of Cimerli, the dynamics may take a different course, as a lower-priced drug, Avastin, is already available in the marked for the price-sensitive patients. However, by bringing Vabysmo into the market, Roche introduced a next-generation treatment that is dynamically growing its market share.

Several Lucentis biosimilars have already hit the market in Europe, while in the US Byooviz, developed by Samsung Bioepis and Biogen, is also available", explains Stefan Schneider from the Swiss Vontobel investment house, which closely follows the business of Sandoz.The second biosimilar drug developed by Polpharma Biologics, is natalizumab, which is a biosimilar to Biogen's Tysabri, and faces less competition.

Global commercialization rights for this drug, which is used in the treatment of multiple sclerosis, were obtained by Sandoz in 2019. Last summer, this drug received market approval from the regulators in Europe and the US, Sandoz currently markets it under the brand name Tyruko in several European countries.

"Today the drug is available in selected European countries and Sandoz is planning to introduce it into other European countries over the coming months. It is important to ensure that this high-quality alternative medicine reaches US patients promptly. Its introduction into the US market is planned for the first half of this year", says Konstantin Matentzoglu.

Similar expectations, when it comes to the commercialization of Tyruko, are expressed by the Vontobel analyst.

"Roche was the first to introduce a novel therapy in the form of CD20 antibodies for the treatment of multiple sclerosis, and Novartis followed suit with Kesimpta. We do not expect additional Tysabri biosimilars to be introduced into the market. Tyruko received market approval in Norway in Q4 of last year, while in Q1 of this year it was also approved in Germany and Finland. We expect it to be gradually introduced into other European markets over the coming months, with the US following around mid-year", says Stefan Schneider.

Pharmaceutical giant

Jerzy Starak introduced large consumer brands into Poland back in the 1990s, then entered the pharmaceutical business with a bang in 2000 by buying a PLN 220 million share package in Polpharma from the Polish state. Already at the time, the company, which mainly relied on the manufacturing of an extensive portfolio of primary drugs at a large manufacturing plant in Starogard Gdański, was the country's biggest manufacturer of generics and henceforth grew rapidly through acquisitions. In 2005, Polpharma bought Medana from Sieradz, followed by the acquisition of the Russian company Akrikhin in 2007, then Chimpharm in Kazakhstan in 2011, and finally Polfa Warszawa in 2012, which, at the time, was valued at almost PLN 1 billion. As of 2020, the Russian entity is no longer a part of the group that is registered in Poland, however it remains under the same owner – Polpharma Group, registered in the Netherlands. According to the most recent figures reported to the Polish National Court Register for 2022, the Polpharma Group generated PLN 4.31 billion in consolidated revenues and PLN 775 million in net profits. A year before their net profit amounted to PLN 637.5 million. The company reports that every eighth  drug package in Polish pharmacies and every third one in Polish hospitals are sourced from their plants. Their portfolio covers approximately 800 products and they employ almost 4.5 thousand employees in Poland. Apart from Polpharma and Polpharma Biologics, Jerzy Starak is also a shareholder, among others, in Herbapol Lublin. Another family business, blossoming in silence, is JJP Biologics, a biotech on a quest for novel drugs. Until now, the company has not completed  any clinical trials, however one of their projects, concerning an immunological drug, already has a candidate and is in pre-clinical trials. In the last wealthiest Poles list compiled by "Forbes", Jerzy Starak took third place. His assets are valued at almost PLN 19.5 billion.

Full article: https://www.pb.pl/polpharmie-biologics-puchnie-badawczy-portfel-1210452

*Entyvio® is a trademark of Takeda Pharmaceutical Company Limited.