Formycon AG / DE000A1EWVY8
15.11.2024 - 18:18:17Aflibercept-Biosimilar FYB203 / AHZANTIVE®/ Baiama® receives positive CHMP Opinion from EMA
| EQS-Ad-hoc: Formycon AG / Key word(s): Statement/Regulatory Admission 15-Nov-2024 / 18:18 CET/CEST Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by EQS News - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. Disclosure of inside information according to Article 17 of the Regulation (EU) No 596/2014 Planegg-Martinsried, Germany, November 15, 2024 – Formycon (FSE: FYB, "Formycon“) announces that the European Medicines Agency (EMA) published today that the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for market approval for FYB203/ AHZANTIVE®1/ Baiama®2, a biosimilar candidate to Eylea®3 (Aflibercept). FYB203 has thus been recommended for approval in the European Union (EU) for the treatment of adult patients with Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Oedema (DME), visual impairment due to Myopic Choroidal Neovascularisation (CNV) and Macular Oedema following Retinal Vein Occlusion (RVO). The CHMP's scientific assessment report forms the basis for the European Commission's decision to grant a central marketing authorization, which is expected in the second half of January 2025. The CHMP recommendation for FYB203 / AHZANTIVE®/ Baiama® is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. FYB203 / AHZANTIVE®/ Baiama® demonstrated comparable quality, efficacy, safety and immunogenicity to the reference drug Eylea® in patients with Age-Related Neovascular (wet) Macular Degeneration (nAMD). 1) AHZANTIVE® is a registered Trademark of Klinge Biopharma GmbH 2) Baiama® is a registered Trademark of Klinge Biopharma GmbH 3) Eylea® is a registered Trademark of Regeneron Pharmaceuticals Inc. Contact: Sabrina Müller Director Investor Relations and Corporate Communications Formycon AG Fraunhoferstr. 15 82152 Planegg-Martinsried Germany phone +49 (0) 89 – 86 46 67 149 fax + 49 (0) 89 – 86 46 67 110 Sabrina.Mueller@formycon.com www.formycon.com Disclaimer Certain statements contained in this release may constitute "forward-looking statements" that involve a number of risks and uncertainties. Forward-looking statements can generally be identified by the use of the words "may," "will," "should," "plan," "expect," "anticipate," "estimate," "believe," "intend," "project," or "aim," or the negative of these words or other variations of these words or comparable terminology. Forward-looking statements are based on assumptions, forecasts, estimates, projections, opinions or plans that, by their nature, are subject to significant risks and uncertainties and contingencies that are subject to change. Formycon does not and will not give any assurance that any forward-looking statement will be achieved or prove to be accurate. Actual future business, financial condition, results of operations and prospects may differ materially from those projected or anticipated in the forward-looking statements. Subject to applicable legal requirements, neither Formycon nor any other person intends to update, review, revise or revise any forward-looking statements in this release to reflect actual events or developments, whether as a result of new information becoming available, new developments occurring in the future or otherwise, nor does it undertake any such obligation. End of Inside Information 15-Nov-2024 CET/CEST The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Archive at www.eqs-news.com |
| 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 Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange |
| EQS News ID: | 2031537 |
| End of Announcement | EQS News Service |
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2031537 15-Nov-2024 CET/CEST
