May 02, 2018, Munich/Zurich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its licensee Bioeq IP AG have today published an interim result for the clinical phase III trial for the biosimilar candidate FYB201. According to this, the primary endpoint has been achieved in the COLUMBUS-AMD trial, thus confirming comparable efficacy between FYB201 and the reference medicinal product Lucentis® in patients with neovascular age-related macular degeneration (nAMD). The clinical endpoint relates to efficacy of the investigational product and measures the change in the best corrected visual acuity after eight weeks. The confidence interval lies within the pre-defined equivalence limits and the study has so far progressed without any abnormalities with regard to the safety and immunogenicity of the product FYB201.
The last patient in the trial, in which patients are treated for a total of 48 weeks, is expected to complete treatment in the second quarter of 2018. The data from the phase III study will be part of the application for marketing approval with the US Food and Drug Administration FDA and the European Medicines Agency EMA.
Formycon’s development and distribution partner Bioeq is responsible for the clinical phase III study. Bioeq also holds the exclusive global marketing rights for the product FYB201.
Dr. Thiemo Schreiber from Bioeq comments: “As the sponsor and marketer of the FYB201 program, we are pleased about this positive study result and, on the basis of this important milestone, we will continue license negotiations with interested parties. Our aim is the approval and launch of FYB201 as the first biosimilar to Lucentis® in the United States of America in 2020 and in the countries of the European Economic Area in 2022. We thus want to offer a larger number of patients more affordable access to this important and highly effective treatment.”
Dr. Carsten Brockmeyer, CEO of Formycon, considers Formycon’s leading position as a developer of biosimilars in the promising biosimilar sector to have been confirmed: “We are delighted with the result. It confirms Formycon’s pioneering role in the development of biosimilars in ophthalmology and emphasizes our ability to successfully develop high-quality biosimilars. We will consistently drive forward our development pipeline of currently four biosimilars.”
Lucentis® is used in the treatment of neovascular age-related macular degeneration (wet AMD) and other serious eye diseases. It inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina. This leads to a progressive loss of vision and is one of the major causes of age-related blindness. Globally, it is estimated that up to 7.5 million people suffer from wet AMD. There are some 450,000 patients in Germany alone. The total market volume for treatments in this field amounted to over 9.3 billion dollars in 2017, and is continuing to rise sharply.
* Lucentis is a registered trademark of Genentech Inc.
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 four biosimilars in development. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of an innovative COVID-19 drug FYB207.
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 2020, 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.