Press Release // November 20, 2018
 

Formycon Releases Updates on Development Programs and Milestones
 

- FYB201 with positive 48-week data after completion of Phase III study

- Pre-submission meetings with FDA and EMA in preparation

- Development of FYB202 and FYB203 significantly advanced
 

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today published an update on development programs and key milestones.
 

For FYB201, new data from the recently completed COLUMBUS-AMD phase III trial in patients with neovascular age-related macular degeneration (nAMD) are available. The last patient in the trial, in which patients were investigated for a total of 48 weeks, has completed the study on June 06, 2018. In addition to the achievement of the primary efficacy endpoint reported in May 2018, the study showed comparable results with regard to efficacy, safety and immunogenicity between the investigational medicinal product FYB201 and the reference medicinal product Lucentis(R)* (ranibizumab). The final study report will be available in December 2018.
 

Formycon's partner Bioeq IP AG, who is responsible for the COLUMBUS-AMD study and holds the exclusive global marketing rights for the product FYB201, has filed a request for a Type IV pre-submission meeting with the US Food and Drug Administration FDA to be held in December 2018. In addition to the data package for the technical and clinical development, the implementation of the commercial supply chain will be discussed. The filing of the Biologics License Application (BLA) under the 351 (k) pathway to the FDA is planned for the first half of 2019. A respective pre-submission meeting with the European Medicines Agency EMA is planned for the first quarter 2019.
 

FYB202 is a biosimilar candidate for Stelara(R)** (ustekinumab). The drug substance process development and manufacturing scale-up are at an advanced stage. A preclinical pharmacokinetic study has concluded the in-life phase and sample analysis is ongoing. Scientific advice briefing books have been sent to the US FDA for a Type II meeting and to the EMA for a scientific advice meeting. The advices are expected for November (EMA) and early 2019 (FDA). The initiation of the clinical testing of FYB202 is planned for mid-2019.
 

Significant progress has also been made in the development of FYB203, which is a biosimilar candidate for Eylea(R)*** (aflibercept). Similar to FYB202 drug substance process development and scale-up are at an advanced level. In preclinical development the in-life phase for a pharmacokinetic study has been completed and sample analysis is ongoing. Currently scientific advice briefing books are being prepared in order to align on the future development strategy with both regulatory authorities (FDA and EMA).
 

FYB205, for which Formycon has so far not published any details, is an early stage biosimilar project that has been progressed up to the initial cell line screening.
 

In addition, Formycon is exploring other biosimilar targets with the goal of optimizing the full potential of the development pipeline.
 

Dr. Carsten Brockmeyer, CEO of Formycon: "We believe FYB201 is the only Lucentis(R) biosimilar that has successfully completed phase III testing for the global market. The positive outcome of the FYB201 phase III study and the robust progress we have made in our partnered FYB202 and FYB203 programs underlines Formycon's pioneering role in the development of global quality biosimilars in ophthalmology and immunology. I would like to thank the Formycon team and our licensing and cooperation partners for their great commitment and cooperation."
 

Dr. Stefan Glombitza, COO of Formycon, completes: "Our teams are combining strong scientific skills with tremendous passion. This is a very powerful enabler to drive such complex development programs forward and the cross-functional teams can be proud of the achievements that have been made across all programs. We have expanded our organization by further skilled talents with focus on late stage experience and this will help us thrive our programs into further advanced stages."
 

* Lucentis(R) is a registered trademark of Genentech Inc.
** Stelara(R) is a registered trademark of Johnson & Johnson
*** Eylea(R) is a registered trademark of Regeneron Pharmaceuticals 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 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.


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 5.0 billion, industry experts expect this figure to grow up to USD 30 billion by the year 2025.


Contact:
Sabrina Müller
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
[email protected] // 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.
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