Ranibizumab biosimilar (Midas Pharma GmbH)

TEL AVIV, Israel I January 13, 2025 I Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE: and TASE: TEVA) today announced that it has entered into a strategic collaboration with Klinge Biopharma GmbH (Klinge) and Formycon AG (FSE: FYB) for the semi-exclusive commercialization of FYB203, Formycon’s biosimilar candidate to Eylea ® (aflibercept) in Europe, excluding Italy, and in Israel. This collaboration combines Teva’s deep commercial experience in biosimilars and its extensive distribution network and broad sales and marketing reach across Europe, with Formycon’s capabilities in the development of biosimilar medicines for highly regulated countries. Klinge has in-licensed the exclusive global commercialization rights to FYB203 from Formycon. Under the terms of the agreement, Teva will lead the commercialization of FYB203 in the designated regions, to be marketed under the brand name AHZANTIVE ®3 , subject to regulatory approval. In return, Klinge will receive milestone payments and a portion from the product’s revenue. Formycon is a leading, independent developer of high-quality biosimilars, focusing on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. Richard Daniell, Executive Vice President, European Commercial at Teva said: “We are excited to extend our collaboration with Formycon, reinforcing the solid foundation that commenced with the commercialization of ranibizumab biosimilar (Ranivisio ®4 /Ongavia ®5 ) in Europe. The collaboration expands Teva’s broad biosimilar portfolio and again demonstrates our firm commitment to creating greater access to quality innovative medicines to the benefit of patients and the healthcare systems we serve.” Commenting on the agreement, Nicola Mikulcik, CBO of Formycon, says, “With Teva, we are gaining a strong and proven partner for FYB203 in the major parts of Europe and Israel. Teva is already marketing our FYB201 ranibizumab biosimilar (Ranivisio ® /Ongavia ® ) in Europe and can synergistically leverage an existing commercial infrastructure and well-established distribution channels in the ophthalmology field. We are pleased to build on this trusted and successful collaboration. Particularly noteworthy is Formycon’s first-time responsibility for managing the entire commercial supply chain of the finished product.” In June 2024, the U.S. Food and Drug Administration (FDA) approved the aflibercept biosimilar FYB203. In November 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for the marketing authorization of FYB203 under the brand names AHZANTIVE ® / Baiama ®6 . The European Commission’s decision on approval is expected in the second half of January 2025. Eylea ® (Aflibercept) is used to treat neovascular age-related macular degeneration (nAMD) and other severe retinal diseases. The active ingredient inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina. In 2023, Eylea ® achieved global sales of approximately USD 9 billion, including USD 2.9 billion in the European market, further underscoring its status as the highest-revenue drug in the anti-VEGF therapy sector. About Teva: Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader, harnessing its generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine. For over 120 years, Teva’s commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its ~37,000 employees across 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit www.tevapharm.com. About Formycon: Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/Ranibizumab, Formycon already has a biosimilar on the market in Europe and the USA. Two further biosimilars, FYB202/ustekinumab and FYB203/aflibercept, received FDA approval; FYB202 is also approved in Europe. Another four biosimilar candidates are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines. Formycon shares are listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and are part of the selection index SDAX and TecDAX. Further information can be found at: https://www.formycon.com/ 1) Eylea ® is a registered trademark of Regeneron Pharmaceuticals Inc. 2) Lucentis ® is a registered trademark of Genentech Inc. 3) AHZANTIVE ® is a registered trademark of Klinge Biopharma GmbH 4) Ranivisio ® is a registered trademark of Bioeq AG 5) Ongavia ® is a registered trademark of Teva Pharmaceutical Industries Ltd. 6) Baiama ® is a registered trademark of Klinge Biopharma GmbH SOURCE: Teva Pharmaceutical Co

MUNICH, Germany I February 06, 2023 I Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today published positive preliminary efficacy and safety data from MAGELLAN-AMD Phase III clinical trial for FYB203, its proposed biosimilar to Eylea ® . The FDA-specific interim analysis of the randomized, double-blind, multi-center phase III study met the primary efficacy endpoint, demonstrating comparable efficacy between FYB203 and the reference medicine Eylea ® in patients with neovascular age-related macular degeneration (nAMD). The primary endpoint of the comparative global Phase III trial measures the change in best corrected visual acuity after eight weeks from baseline. The values obtained for FYB203 and the reference product are within the relevant equivalence limits. In addition, to date, the study was conducted without any clinically relevant differences in terms of safety and immunogenicity. Following the approval and market launch of the ophthalmological biosimilar for Lucentis® (FYB201 marketed as Ongavia® 2 (UK), Ranivisio® 3 (EU), and Cimerli TM4 (US)), Formycon is now announcing, with FYB203, another successful development in the field of ophthalmology, thereby highlighting its strong position in this area. Neovascular age-related macular degeneration (nAMD) is caused by the excessive growth of blood vessels in the retina. The active ingredient aflibercept inhibits the vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina, which leads to a progressive loss of vision. In industrialized countries, AMD is the most common cause of severe visual impairment or blindness. According to estimates, up to 77 million Europeans will be affected by 2050. [i] Eylea® is currently the top-selling drug in the field of age-related eye disease and in 2021 achieved revenues of around US$ 9 billion. Recently, Klinge Biopharma GmbH, licensee and exclusive holder of the worldwide commercialization rights of FYB203, had entered into a binding term sheet for the exclusive commercialization of FYB203 in the United States of America with Coherus BioSciences, Inc. Formycon’s CSO, Dr. Andreas Seidl, comments on the successful phase III study as follows: “We are delighted that our second project in the field of ophthalmology was able to impress in the clinical phase III MAGELLAN-AMD study. Given the extensive experience from FYB201, we are confident that we will also be able to make a high-quality and cost-effective biosimilar available with FYB203, thereby further expanding our strong position in the field of biosimilar development.” [i] Li JQ, Welchowski T, Schmid M, et al. Prevalence and incidence of age-related macular degeneration in Europe: a systematic review and meta-analysis British Journal of Ophthalmology 2020;104:1077-1084.: https://bjo.bmj.com/content/104/8/1077 . Last accessed in January 2023. 1 Eylea ® is a registered trademark of Regeneron Pharmaceuticals Inc. 2 Ongavia® is a registered trademark of Teva Pharmaceutical Industries Ltd. 3 Ranivisio® is a registered trademark of Bioeq AG 4 Cimerli TM is a trademark of Coherus BioSciences, Inc About Formycon: Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. The company focuses on treatments in ophthalmology, immunology and on other key chronic diseases, covering the entire value chain from technical development to the clinical phase III as well as the preparation of dossiers for marketing approval. With its biosimilars, Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines. Formycon currently has six biosimilars in development. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of a COVID-19 drug FYB207. About Biosimilars: Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis, multiple sclerosis and eye diseases. In the coming years, many of these biotech drugs will lose their patent protection – and by 2025, medications with revenues of approximately USD 100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. Global sales of biosimilars are estimated to exceed $15 billion by 2020. By 2030, analysts estimate that this figure could rise to over $60 billion. SOURCE: Formycon