Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and Leukocare AG today announced a collaboration in the area of high-quality biopharmaceuticals. Under the terms of this agreement, Leukocare will apply its formulation development technologies combining state-of-the art protein analytics, bioinformatics and artificial intelligence to develop stable formulations potentially for several candidates in Formycon´s product pipeline. The first project has been started and covers the formulation development for a biosimilar of a blockbuster therapeutic antibody.
By applying Leukocare’s formulation and bioinformatics expertise to Formycon’s comprehensive development knowhow, the partners want to achieve superior stability profiles overall leading to additional value propositions for development projects.
Stefan Glombitza, Chief Operating Officer at Formycon, stated, “Suitable Drug Product formulations are an essential success factor in the development of biopharmaceutical drugs and are getting increasingly important in the competitive IP landscape. We are convinced that Leukocare’s technology platform can successfully complement our development expertise and look very much forward to our collaboration.”
“Michael Scholl, Chief Executive Officer at Leukocare, commented, “We are very proud of this partnership with Formycon, a world-leading developer of high-quality biosimilars and biopharmaceuticals. This collaboration is a perfect fit for both companies to drive the development of high-quality products.”
“Andreas Seidl, Chief Operating Officer of Leukocare, added, “Our algorithm-based formulation development expertise will allow Formycon to make use of a large formulation design space, thereby gaining manifold options for freedom to operate in a competitive environment. This will strongly support Formycon in providing high-quality medicines to as many patients as possible.”
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.