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
NOT FOR DISTRIBUTION, PUBLICATION OR FORWARDING IN THE UNITED STATES, CANADA, JAPAN AND AUSTRALIA
-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.
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.
The Swiss company Bioeq IP AG based in Zürich is a biopharmaceutical joint venture between the leading Polish pharmaceutical company Polpharma and the Strüngmann family's investment company.
Bioeq licenses, develops and commercializes biological successor products of successful biopharmaceuticals, called biosimilars. FYB201 is currently the most advanced biosimilar program of Bioeq. The clinical studies and registration are conducted by a subsidiary, Bioeq GmbH based in Holzkirchen, Germany, on behalf of Bioeq IP AG.
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 more than 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. While the global market for biosimilars is currently more than USD 3.0 billion, industry experts expect this figure to grow tenfold by the year 2025.
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This press release may contain forward-looking statements and information which are based on our current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here.
Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful.
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