MUNICH, Germany I July 12, 2021 I Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) announced today that it has received the final notification for a grant from the Bavarian Ministry of Economic Affairs, Regional Development and Energy in the amount of Euro 12.7 million to support the further development of the COVID-19 drug FYB207.
The funding will support the currently ongoing preclinical development, the production of the investigational product under GMP conditions, and the clinical testing of FYB207 in a phase I/IIa trial, which is scheduled to start in the fourth quarter of 2021.
FYB207 is a long-acting ACE2-immunoglobulin fusion protein. SARS-CoV-2 and other coronaviruses use the ACE2 protein on the surface of human cells as a portal of entry for respiratory infections. Formycon has therefore fused the human ACE2 protein to the constant part of human immunoglobulin G4 (IgG4) using computer-aided structural design and created FYB207, a very effective SARS-CoV-2 blocker that has shown in vitro to completely prevent cells from infection.
As part of the Bavarian Therapy Strategy to combat the COVID-19 pandemic, the Free State of Bavaria had created the opportunity to support development and innovation projects that aim to open up new therapy options for the treatment of the infectious disease induced by the SARS-CoV-2 coronavirus with the funding call “BayTherapie 2020” and the provision of a total of up to Euro 50 million.
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 four 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 fusion protein.
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 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. In 2019, global sales of biosimilars exceeded USD12 billion. Analysts estimate that this figure could rise to around USD 69 billion by 2025.
SOURCE: Formycon
Post Views: 297
MUNICH, Germany I July 12, 2021 I Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) announced today that it has received the final notification for a grant from the Bavarian Ministry of Economic Affairs, Regional Development and Energy in the amount of Euro 12.7 million to support the further development of the COVID-19 drug FYB207.
The funding will support the currently ongoing preclinical development, the production of the investigational product under GMP conditions, and the clinical testing of FYB207 in a phase I/IIa trial, which is scheduled to start in the fourth quarter of 2021.
FYB207 is a long-acting ACE2-immunoglobulin fusion protein. SARS-CoV-2 and other coronaviruses use the ACE2 protein on the surface of human cells as a portal of entry for respiratory infections. Formycon has therefore fused the human ACE2 protein to the constant part of human immunoglobulin G4 (IgG4) using computer-aided structural design and created FYB207, a very effective SARS-CoV-2 blocker that has shown in vitro to completely prevent cells from infection.
As part of the Bavarian Therapy Strategy to combat the COVID-19 pandemic, the Free State of Bavaria had created the opportunity to support development and innovation projects that aim to open up new therapy options for the treatment of the infectious disease induced by the SARS-CoV-2 coronavirus with the funding call “BayTherapie 2020” and the provision of a total of up to Euro 50 million.
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 four 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 fusion protein.
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 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. In 2019, global sales of biosimilars exceeded USD12 billion. Analysts estimate that this figure could rise to around USD 69 billion by 2025.
SOURCE: Formycon
Post Views: 297
