Early preventions regarding COVID-19 ensure operating schedule
Liquidity situation not affected and still solid
FDA-Resubmission of FYB201 planned for the second half of the year
FYB202 and FYB203: Clinical trial strategy unchanged
Pipeline candidate FYB206 in preclinical phase
Munich - In consideration of the current developments of the corona pandemic, Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announces news on its development portfolio.
An early reaction and the implementation of appropriate organizational decentralization measures enabled Formycon to adapt well to the current situation, so that the impact of the pandemic on the company's operational development activities has been minimal so far. This also applies to the company's liquidity situation, which is unaffected and remains very solid.
Formycon continues to work with license partner Bioeq AG and its manufacturing partner on the resubmission of the Biologics License Application (BLA) for the FYB201 project, a biosimilar candidate for Lucentis(R)* (Ranibizumab), despite the situation regarding COVID-19. Together, Formycon and its partners are interacting with the U.S. Food and Drug Administration (FDA) and are currently focused on supporting the effort to generate the additional manufacturing data requested by the FDA for resubmission. Based on the manufacturing dates, completion of these efforts, and certain regulatory interactions for FYB201, a resubmission of the BLA is expected in the course of the second half of 2020 by license partner Bioeq AG.
The development project FYB202, a biosimilar candidate for Stelara(R)** (Ustekinumab), has been in phase I clinical trial since October 2019, which is at an advanced stage. Preparations for the start of the phase III clinical trial, which is scheduled for the third quarter of 2020, are continuing as planned. FYB202 is being developed in a joint venture by Aristo Pharma GmbH and Formycon AG in which Aristo Pharma GmbH holds 75.1% and Formycon AG 24.9%. Bioeq GmbH is the sponsor of the clinical trials and is also responsible for the study design and clinical operations.
Initiating work on the planned phase III clinical trial with FYB203, Formycon's biosimilar candidate for Eylea(R)*** (Aflibercept), is also proceeding as expected. The first regulatory approvals have been granted for the randomized, double-blind, multicenter phase III study comparing the efficacy and safety of Aflibercept FYB203 biosimilar with the reference drug Eylea(R) in patients with neovascular age-related macular degeneration. The start of the phase III clinical trial is planned for mid-2020. The worldwide marketing rights for FYB203 have since been transferred from Santo Holding (Deutschland) GmbH within the Santo Group to Klinge Biopharma GmbH.
In addition, Formycon continues to expand its biosimilar pipeline. The development of the biosimilar candidate FYB206, for example, is currently in the preclinical phase and relevant intellectual property (IP) has already been established by filing a corresponding patent application. There have been no details on the other pipeline candidates (FYB20x) announced yet. The rights to these projects are held by Formycon.
"Formycon took early extensive measures to protect employees from infection during the corona pandemic, while at the same time ensuring the operating schedule. In addition, we are in close contact with our external partners, which have also taken intensive arrangements within the framework of the current situation to minimize the effects as far as possible," explains Dr. Stefan Glombitza, COO of Formycon.
CEO Dr. Carsten Brockmeyer adds: "The current crisis will also impact the healthcare systems financially. The access to affordable high-quality medicines will become even more important and the need towards the use of biosimilar medicinal products is therefore expected to increase in the future."
* Lucentis(R) is a registered trademark of Genentech Inc.** Stelara(R) is a registered trademark Johnson & Johnson*** Eylea(R) is a registered trademark of Regeneron Pharmaceuticals Inc.
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 antibody-based COVID-19 compounds.
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 approximately 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.
Press & IR Contact Sabrina Müller Corporate Communications and Investor Relations T + 49 89 86 46 67 149 F + 49 89 86 46 67 110 firstname.lastname@example.org
Formycon AG Fraunhoferstr. 15 82152 Planegg/Martinsried Germany 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.