Formycon AG

Biosimilar Candidate FYB201 Shows Efficacy Comparable to the Reference Product in Phase III Study

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Planegg-Martinsried (pta006/02.05.2018/07:00) - Publication of insider information in accordance with Article 17 of the Regulation (EU) No 596/2014
Ad-hoc announcement // May 02, 2018, 07:00 CET

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-Interim top-line data of COLUMBUS-AMD trial show comparable efficacy of FYB201 to Lucentis®* (ranibizumab)
-Primary endpoint of the phase III study achieved

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announced that, according to an interim result, the primary endpoint has been achieved in the COLUMBUS-AMD phase III trial, which is intended to demonstrate the efficacy, safety and immunogenicity of FYB201 and the reference medicinal product Lucentis® in patients with neovascular age-related macular degeneration (nAMD). The primary endpoint relates to efficacy and measures the comparable change in best corrected visual acuity after eight weeks. The confidence interval lies within the pre-defined equivalence limits and demonstrates the comparable efficacy of FYB201 and Lucentis®.

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. Formycon's development and distribution partner Bioeq IP AG is responsible for the clinical phase III study. Bioeq also holds the exclusive global marketing rights for FYB201.

With the achievement of the primary endpoint in the comparative phase III trial, a further important milestone has been achieved in the development of FYB201. 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.

* Lucentis is a registered trademark of Genentech Inc.

About Formycon:
Formycon is a leading, independent developer of high-quality follow-on products for biopharmaceutical medicines known as biosimilars. The company focuses on treatments in ophthalmology, immunology and on other key chronic diseases, covering the entire added value chain from technical development to the clinical phase III and 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.