• FYB286 expands Formycon’s biosimilar pipeline with a promising development project in an attractive niche indication
  • Combining Formycon’s development excellence with the manufacturing expertise of South American specialty pharma company Biocelys enables a highly competitive cost structure
  • Upfront financing by Santo Biosimilar GmbH, a company of the ATHOS Group, reflects its continued commitment to biosimilars and strong confidence in the capabilities of both collaboration partners

Planegg-Martinsried, Germany / Montevideo, Uruguay – Formycon AG (FSE: FYB, Prime Standard, “Formycon“) and Biocelys S.A. (“Biocelys”), a company of the ATHOS Group, today announced the launch of a collaboration to develop the biosimilar candidate FYB286. The partnership combines Formycon’s proven expertise in biosimilar development with Biocelys’ state-of-the-art manufacturing infrastructure. The project is being financed upfront by Santo Biosimilar GmbH (“Santo”), an affiliated company of ATHOS KG (“ATHOS”). ATHOS is Formycon’s largest anchor shareholder and indirectly controls both Santo Biosimilar GmbH and Biocelys S.A.

Under the agreement with Santo, Formycon will receive arm’s-length compensation for its development services and will participate in future revenues of Santo with a low double-digit percentage share. The technologically demanding development program targets a niche indication with attractive growth potential, making FYB286 a strategically compelling addition to Formycon’s value-focused biosimilar portfolio.

Dr. Stefan Glombitza, CEO of Formycon AG, commented: “Biosimilars for niche-busters1 combine two key elements: they meet the strong demand for high-quality biologic therapies for relatively rare conditions while creating an attractive market opportunity. For FYB286, we expect demand to increase substantially, particularly in emerging markets. Together with Biocelys, we can achieve both objectives: help patients with rare diseases and tap into a new market. Biocelys and Formycon complement each other perfectly by combining state-of-the-art manufacturing capabilities with our extensive expertise and operational excellence in biosimilar development. With Biocelys as part of our network of strategic manufacturing partners, we are strengthening our supply capabilities well beyond the FYB286 project and setting another important cornerstone in our FYB4Growth strategy.”

With FYB4Growth, Formycon is pursuing a growth strategy based on four strategic pillars focused on sustainable value creation: An intelligent portfolio strategy, geographic diversification of target markets, outstanding scientific excellence, and consistent cost efficiency form the foundation of Formycon’s robust and growth-oriented business model.

“In line with our vision to produce high-quality pharmaceuticals from Latin America for patients around the world, our collaboration with Formycon on the FYB286 project marks an important milestone. Our Montevideo site not only features state-of-the-art manufacturing facilities but also the expertise required to manufacture complex biologic molecules. Together with Formycon as our project partner, we will improve access to a much-needed therapy, particularly in regions where patient needs remain largely unmet,” said Adive Carrasco, Managing Director of Biocelys S.A.

“As long-term investors, we support FYB286 as a collaboration model that brings together the complementary strengths of our portfolio companies. The combination of scientific development excellence and modern biopharmaceutical manufacturing provides a solid foundation for executing projects of this kind efficiently and with clear focus on value creation. By providing the upfront financing, we are creating the framework that enables Formycon and Biocelys to implement the project independently and in partnership,” added ATHOS KG.

1We define a “niche-buster” as a drug for a niche indication with global annual sales in the low- to mid-single-digit billion-dollar range

About Formycon:
Formycon AG is a listed, independent developer of biosimilars based in Planegg-Martinsried, one of the leading life science locations in Europe, just outside Munich, Germany. Its 200 employees from 27 countries cover the entire development chain, from laboratory analysis through manufacturing and clinical testing to the documents for approval. Three Formycon biosimilars are approved in ophthalmology and immunology and are marketed worldwide through commercialization partners. Four further candidates are in development, among them biosimilars to two of the best-selling biologic medicines in the world. With its products, Formycon makes highly effective therapies affordable for more people.

Formycon AG is listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. Further information can be found at: https://www.formycon.com/en/

About #FYB4Growth:
With FYB4Growth, Formycon is pursuing a growth strategy based on four strategic pillars aimed at creating sustainable value. First, geographic diversification: in addition to Europe and the U.S., Formycon is strategically expanding into high growth regions such as MENA, APAC and Latin America through strong regional partners. Second, a smart portfolio strategy: Formycon relies on an intelligent portfolio strategy that specifically combines blockbuster molecules with selected niche products and creates the foundation for sustainable value generation through efficient regulatory development pathways. Third, excellence and innovation: Formycon positions itself as a technological and regulatory development powerhouse, creating clear competitive differentiation through innovative product solutions and new regulatory approaches. Fourth, consistent cost efficiency: streamlined processes, optimized development structures and the increased use of digital technologies are designed to enhance the scalability of the business model and strengthen Formycon’s competitiveness over the long term. Find out more at: https://www.fyb4growth.com

About Biocelys:
Biocelys S.A. (“Biocelys”), based at Parque de las Ciencias in Canelones, Uruguay, is a biopharmaceutical company for the development and manufacture of biotechnological drug substances. Its focus is on monoclonal antibodies and related recombinant proteins from mammalian cell culture, covering the process from cell bank through cell culture and purification to the released drug substance. The facility is newly built to current technical standards and designed for manufacturing in line with international GMP standards.

Biocelys is a company of the ATHOS Group. The company pursues the vision of making high-quality biopharmaceuticals available from Latin America to patients worldwide. Alongside its own process development, Biocelys performs technology transfers for partners and supports projects from process transfer through validation to commercial supply. Adive Carrasco is Managing Director of Biocelys S.A.

About Biosimilars:
Biosimilars are successor products to biologic medicines. They are not copies; each one is developed from the ground up and must demonstrate to the health authorities that it has no clinically meaningful differences from the reference product in terms of safety and efficacy. According to the IQVIA Institute, 118 biologic medicines with sales of USD 232 billion will lose their exclusivity in the US alone by 2034, and for only twelve of them is a biosimilar in development. In Europe, biosimilars have saved EUR 75 billion and made more than seven billion days of treatment possible.

Disclaimer:
This press release may contain forward-looking statements and information which are based on Formycon’s current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.