EQS-News: Formycon AG
/ Key word(s): Study results/Study
Press Release // April 25, 2023 Formycon announces successful results of Phase I clinical trial for ustekinumab biosimilar candidate FYB202 and concludes clinical development
Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announced the successful conclusion of the extended Phase I clinical study comparing the pharmacokinetics of FYB202 and the reference drug Stelara®. As early as August 2022, the primary endpoint was achieved in the randomized, double-blind, multicenter Phase III study (VESPUCCI), demonstrating the comparable efficacy of FYB202 and the reference drug in patients with moderate-to-severe psoriasis vulgaris (plaque psoriasis). The positive results of the Phase I pharmacokinetics study successfully conclude the clinical development program. FYB202 was bioequivalent to the reference drug Stelara® sourced in the EU as well as in the U.S. for all primary endpoint parameters. European and U.S. regulatory submissions are still planned for the third quarter of 2023. Provided successful approval by the respective health agencies, Fresenius Kabi will commercialize FYB202 in key global markets. The active ingredient ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23. Since 2009, the originator medicine has been used to treat various severe inflammatory conditions such as moderate-to-severe psoriasis as well as psoriatic arthritis. Its approved indications were expanded to chronic inflammatory bowel diseases like treatment of Crohn’s disease (2016) and ulcerative colitis (2019). Stelara® achieved a global sales volume of USD 9.7 billion in 2022. [1] Formycon CEO Dr. Stefan Glombitza comments: “The successful conclusion of the development phase of our ustekinumab biosimilar candidate marks a very important milestone for Formycon and highlights the significant progress in our biosimilar pipeline. We are confident that we will provide the authorities with a convincing data package this fall. With FYB202, we can contribute significantly to the treatment options in the growing market segment of inflammatory diseases.” * Stelara® is a registered Trademark of Johnson & Johnson About Biosimilars: Contact: Disclaimer: [1] Johnson & Johnson top pharmaceutical products by sales 2022 | Statista.
25.04.2023 CET/CEST Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group AG. |
Language: | English |
Company: | Formycon AG |
Fraunhoferstraße 15 | |
82152 Planegg-Martinsried | |
Germany | |
Phone: | 089 864667 100 |
Fax: | 089 864667 110 |
Internet: | www.formycon.com |
ISIN: | DE000A1EWVY8 |
WKN: | A1EWVY |
Indices: | Scale 30 |
Listed: | Regulated Unofficial Market in Berlin, Dusseldorf, Frankfurt (Scale), Hamburg, Munich, Stuttgart, Tradegate Exchange |
EQS News ID: | 1615653 |
End of News | EQS News Service |
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1615653 25.04.2023 CET/CEST
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