DGAP-News: Formycon AG / Key word(s): Miscellaneous 
Formycon receives positive Scientific Advice from Paul-Ehrlich-Institute for the COVID-19 Drug FYB207 and assures GMP 
Manufacturing Capacities 
2021-02-24 / 07:00 
The issuer is solely responsible for the content of this announcement. 
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Press Release // February 24, 2021 
Formycon receives positive Scientific Advice from Paul-Ehrlich-Institute for the COVID-19 Drug FYB207 and assures GMP 
Manufacturing Capacities 
- Process development, preclinical as well as concepts for clinical phase I and phase II aligned 
- Accelerated review of applications for clinical trials 
- Manufacturing capacities for FYB207 assured at experienced German GMP manufacturer 
- Scientific Advice Meeting with the U.S. Food and Drug Administration (FDA) in preparation 
Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has received the consent from the Paul-Ehrlich-Institute (PEI) 
regarding the proposed development concept for its innovative SARS-CoV-2 blocker FYB207. As result of the Scientific 
Advice, the Federal Institute for Vaccines and Biomedicines supports Formycon's approach in the further development of 
FYB207. In particular, analytics, process development, manufacturing (so-called CMC-part: Chemistry-Manufacturing and 
Control), the preclinical development as well as the clinical concept of phases I and II, including the associated 
bioanalytical strategy, have been aligned. The review of the applications for the clinical trials is expected to be 
conducted in an accelerated process. All preclinical activities as well as preparations for entering clinical trials 
with FYB207 are progressing according to plan. In addition, Formycon is preparing a Scientific Advice Meeting with the 
U.S. Food and Drug Administration (FDA) and has assured GMP manufacturing capacity for FYB207 with an experienced 
German manufacturer. 
With FYB207, Formycon, together with its academic partners Prof. Dr. Ulrike Protzer, Chair of Virology, and Prof. Dr. 
Johannes Buchner, Chair of Biotechnology at the Technical University of Munich, is developing an efficient antiviral 
SARS-CoV-2 blocker based on a long-acting ACE2-immunoglobulin fusion protein. SARS-CoV-2 and other corona viruses use 
ACE2 on the surface of human cells as an entry point for respiratory tract infections. Formycon has therefore fused the 
human ACE2 protein to the constant part of human Immunoglobulin G4 (IgG4) by using computer-aided structural design, 
creating a very effective SARS-CoV-2 blocker that completely prevents cell infection in vitro. 
The risk of infection enhancement by vaccines and antibodies described for corona viruses is minimized by using the 
IgG4 portion in the fusion. FYB207 also has a natural enzymatic activity that may provide additional protection for the 
lungs and cardiovascular system in symptomatic patients. Because ACE2 is the human receptor for the spike protein of 
SARS-CoV-2, FYB207 is protected against virus escape by mutation. In addition, FYB207 can potentially be used for all 
corona viruses that use ACE2 as an entry portal. 
"We are delighted about the positive feedback from the Paul-Ehrlich-Institute and feel confirmed in the development 
approach of FYB207. Especially in terms of virus mutations, an effective drug becomes an indispensable cornerstone in 
the fight against the corona pandemic. With FYB207, we are developing an important treatment option for COVID-19 
patients while also contributing to the prevention of outbreaks of future corona viruses", says Dr. Carsten Brockmeyer, 
CEO of Formycon AG. 
Dr. Stefan Glombitza, COO of Formycon AG adds: "The consultation with the Paul-Ehrlich-Institute has provided us with 
clarity for our approach in the development of FYB207. The speed with which we are advancing this program from initial 
laboratory studies to entry into clinical trials reflects the high level of commitment of all parties involved. People 
infected with SARS-CoV-2 and at risk of severe illness or even death urgently need effective medicines." 
About Formycon: 
Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. The 
company focuses on treatments in ophthalmology, immunology and on other key chronic diseases, covering the entire value 
chain from technical development to the clinical phase III as well as the preparation of dossiers for marketing 
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. Based on its 
extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of a 
COVID-19 fusion protein. 
Contact: 
Sabrina Müller 
Senior Manager Corporate Communications and Investor Relations 
Formycon AG 
Fraunhoferstr. 15 
82152 Martinsried/Planegg/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: 
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. Formycon AG assumes 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. This document and the information contained therein may not be distributed in or into the United 
States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would 
be prohibited. This document does not constitute an offer for the sale of securities in the United States. 
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2021-02-24 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. 
The issuer is solely responsible for the content of this announcement. 
The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. 
Archive at www.dgap.de 
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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:  1170518 
 
End of News   DGAP News Service 
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1170518 2021-02-24

(END) Dow Jones Newswires

February 24, 2021 01:02 ET (06:02 GMT)