Good morning!
This will be a favorable year for us in many respects. Thanks to the achievement of last year’s goals, we are maintaining strong momentum toward the commercialization of innovative therapies for animals. “Consistency” is also a key word for 2025, as we have scheduled breakthrough events in the Bioceltix calendar. We are also supported by forecasts from international analysts. In the latest issue, we write, among other things, about the Bloomberg Intelligence’s Global Pet Economy 2024 report, which outlines prospects for the veterinary industry through 2030. Thanks to the growing population of four-legged companions and their progressing humanization, the value of the pet-related market could soar to USD 500 billion over the next five years. The biggest beneficiary of these trends is the United States. This is also the direction for Bioceltix. But first – the EMA registration process for our first drug, construction of a second manufacturing facility, and international networking among the most important industry players.
We invite you to a New Year’s review of events from the life of our Company and from the veterinary industry.
This was breaking news in the world of Polish biotechnology. In December, the media were filled with the headline: “Bioceltix announces success of a clinical trial of a product for arthritis in horses.” With joy and pride, we published the results of the BCX-EM study, which unequivocally confirmed the effectiveness and safety of our product. We achieved all study objectives at both the primary and secondary endpoints. The results confirmed a statistically significant effect of the drug in horses and the persistence of the therapeutic effect long after administration – after three months, approximately 90% of our patients returned to physical activity. We are already preparing to initiate the registration procedure for BCX-EM at the European Medicines Agency. More about the course of the study and the equine market in the article: Bioceltix published full results of the clinical trial of a product for arthritis in horses
Work related to the construction of our new stem cell manufacturing facility is also progressing at a good pace. We have entered into an agreement for design works with Bionexen. Its scope includes, among other things, the development of the final conceptual design of the facility based on the previously prepared functional and utility design. Bionexen is also obliged to engage, as a subcontractor, the Lithuanian team of Biotecha UAB. Increasing production capacity thanks to the new facility will provide us with the expected scale of drug manufacturing. We believe that the comprehensive nature of our activities will contribute to achieving a strong market position in the future. BIOCELTIX S.A.: Conclusion of an agreement for design works related to the construction of a pharmaceutical stem cell manufacturing facility.
On the road toward this goal, we have planned several important international stops. We will be in London on 10 February, where, as an event partner, we will take part in the three-day Animal Health, Nutrition & Technology Innovation conference. In addition to a dedicated Bioceltix zone, where we will be able to meet and talk with key industry players, we have been invited to deliver a presentation entitled “Veterinary Innovation: Cutting-Edge Stem Cell-Based Therapies.” The anniversary edition of one of the most important events dedicated to the animal health sector promises to be highly substantive: Partnering | Kisaco Research
📰 The report of the Central Statistical Office (GUS) on the state of Polish biotechnology resonated widely across the industry. Over the past five years, the number of companies engaged in drug discovery in Poland has increased by approximately 8%. Expenditure on biotechnology has grown significantly, by as much as 22%. Is this enough to speak of a spectacular success of the “made in Poland” biotechnology sector?
In the pre-holiday episode of the BioOpen Talk podcast, Dr Eng. Paweł Wielgus confronted GUS data with business reality. The holidays are over, but the challenges remain, as discussed in a conversation with editor Adam Zalewski: BioOpen Talk #5 – Current overview of the Polish biotechnology market | Dr Eng. Paweł Wielgus – YouTube
We are setting sail for international waters:
The U.S. Food and Drug Administration (FDA) has, for the first time in history, approved a medicinal product using allogeneic mesenchymal stem cells for marketing. The product is Ryoncil – an intravenously administered pediatric drug intended to treat a condition known as steroid-refractory acute graft-versus-host disease (SR-aGVHD). Due to the innovative nature of therapies using mesenchymal stem cells, this is a major event in the world of human medicine. Approval of the first MSC-based drug is an important signal from the U.S. pharmaceutical regulator. We believe this will also have a positive impact on the future registration of such drugs for animals. It is worth emphasizing that the mechanism of action of Ryoncil is based on the immunomodulatory properties of mesenchymal stem cells, similarly to the products being developed by Bioceltix. More information: FDA Approves First Mesenchymal Stromal Cell Therapy to Treat Steroid-refractory Acute Graft-versus-host Disease | FDA
We remain in the U.S. The FDA has issued a notice regarding the medicinal product Librela® – a monoclonal antibody used in dogs for the treatment of joint pain associated with osteoarthritis. The pharmaceutical regulator points out that adverse reactions may occur following administration of the drug, such as ataxia (movement coordination disorders resulting from problems in the functioning of the brain, especially the cerebellum, spinal cord or peripheral nerves), anorexia, lethargy, excessive thirst, and in some cases, as a result of these disorders, even death of patients. The manufacturer emphasizes that the post-marketing adverse event evaluation process is proceeding in a standard manner and that it has full confidence in the safety and efficacy of Librela®. To date, the drug has been sold worldwide in more than 21 million doses. Dear Veterinarian Letter notifying veterinarians about adverse events reported in dogs treated with Librela (bedinvetmab injection) | FDA
Business is increasingly looking toward the equine market, which is a very good sign for us. An example? The Australian company Randlab, which has equine products in its portfolio, was acquired by Animalcare Group. With company revenues of PLN 60 million and EBITDA of PLN 29 million, the value of the transaction amounted to approximately PLN 320 million – almost as much as Bioceltix’s entire market capitalization. This acquisition highlights the prospects and opportunities inherent in the equine market. “This transaction further stimulates my imagination when it comes to the potential behind Bioceltix,” comments Dr Eng. Paweł Wielgus. Animalcare completes purchase of Aussie equine vet firm Randlab – Sharecast.com
The Bloomberg Intelligence (BI) Global Pet Economy 2024 report shows that the most important growth driver for the veterinary industry will be the healthcare sector. By 2030, the value of medicines for companion animals could exceed USD 24 billion. Growing demand for modern therapies is driven, among other things, by the increasing lifespan of our pets, leading to a higher incidence of age-related diseases. These conditions can, however, be effectively treated thanks to modern medicines. Advanced therapies are gaining increasing social acceptance. This is driving companies to develop innovative drugs in such complex therapeutic areas as oncology or osteoarthritis: GlobalPETS – PETS International Magazine November 2024 – Page 30–31
Not only social trends, but also the letter of the law is now working in favor of Mexican four-legged companions. Animal welfare has been enshrined in the Constitution of Mexico. The new regulations are intended to strengthen the country’s commitment to protecting animals from neglect and abuse. This is a response to the growing problem of cruelty toward animals in the country. Although approximately 80 million companion animals live in Mexico, according to a 2021 report by the INEGI agency, the country ranks a dismal third on the international map of animal abuse. The reform explicitly prohibits cruelty and recommends educational measures for society. This is a step in the right direction: Mexico passed unprecedented animal rights reforms. What happens next? | Vox
Wishing you all the best for 2025, we thank you for being with us! We encourage you to follow the Bioceltix profile on LinkedIn, where we share industry news and updates on the progress of our work.
If you have suggestions regarding the newsletter content, please contact us by email at: newsletter@bioceltix.com.
With kind regards,
The Bioceltix Team