DGAP-News: Formycon AG: Formycon and Bioeq Achieve Important Milestone: Biosimilar Ranibizumab Candidate FYB201 Shows Efficacy Comparable to the Reference Product in Phase III Study

Formycon and Bioeq Achieve Important Milestone: Biosimilar Ranibizumab Candidate FYB201 Shows Efficacy Comparable to the Reference Product in Phase III Study

- Interim top-line data of COLUMBUS-AMD trial show comparable efficacy between FYB201 and Lucentis^(R)* (ranibizumab)

- Primary endpoint of the global phase III study achieved

- Last patient expected to complete treatment in the second quarter of 2018

- Bioeq intensifies out-licensing discussions

May 02, 2018, Munich/Zurich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its licensee Bioeq IP AG have today published an interim result for the clinical phase III trial for the biosimilar candidate FYB201. According to this, the primary endpoint has been achieved in the COLUMBUS-AMD trial, thus confirming comparable efficacy between FYB201 and the reference medicinal product Lucentis^(R) in patients with neovascular age-related macular degeneration (nAMD). The clinical endpoint relates to efficacy of the investigational product and measures the change in the best corrected visual acuity after eight weeks. The confidence interval lies within the pre-defined equivalence limits and the study has so far progressed without any abnormalities with regard to the safety and immunogenicity of the product FYB201.

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. 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.

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

Dr. Thiemo Schreiber from Bioeq comments: "As the sponsor and marketer of the FYB201 program, we are pleased about this positive study result and, on the basis of this important milestone, we will continue license negotiations with interested parties. Our aim is the approval and launch of FYB201 as the first biosimilar to Lucentis^(R) in the United States of America in 2020 and in the countries of the European Economic Area in 2022. We thus want to offer a larger number of patients more affordable access to this important and highly effective treatment."

Dr. Carsten Brockmeyer, CEO of Formycon, considers Formycon's leading position as a developer of biosimilars in the promising biosimilar sector to have been confirmed: "We are delighted with the result. It confirms Formycon's pioneering role in the development of biosimilars in ophthalmology and emphasizes our ability to successfully develop high-quality biosimilars. We will consistently drive forward our development pipeline of currently four biosimilars."

Lucentis^(R) is used in the treatment of neovascular age-related macular degeneration (wet AMD) and other serious eye diseases. It inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina. This leads to a progressive loss of vision and is one of the major causes of age-related blindness. Globally, it is estimated that up to 7.5 million people suffer from wet AMD. There are some 450,000 patients in Germany alone. The total market volume for treatments in this field amounted to over 9.3 billion dollars in 2017, and is continuing to rise sharply.

* 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.

About Bioeq:
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.

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 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.

Contact Formycon:
Thorsten Schüller
Corporate Communications and Investor Relations
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried/Germany
phone +49 (0) 89 - 86 46 67 150
fax + 49 (0) 89 - 86 46 67 110
Thorsten.schueller@formycon.com // www.formycon.com

Contact Bioeq:
Dr. Thiemo Schreiber
Business Development
Bioeq IP AG
Waldmannstrasse 8
8001 Zurich/Switzerland
phone +41 (0) 44 533 41 00
fax +41 (0) 44 533 41 09
mobile +41 (0) 79 920 71 40
Thiemo.schreiber@bioeq.ch

Disclaimer:
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 and Bioeq IP AG do 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.
Formycon AG and Bioeq IP AG assume no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated.
This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended.
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