Put companies on watchlist
Formycon AG
ISIN: DE000A1EWVY8
WKN: A1EWVY
About
Company Snapshot
New: Enable Investor Alerts
Be informed about new publications
New: AI Factsheet

Corporate News meets AI! 
Content analysis and summary

EN GIF 300X250

Formycon AG · ISIN: DE000A1EWVY8 · EQS - Company News (157 News)
Country: Germany · Primary market: Germany · EQS NID: 2008887
16 October 2024 06:50AM

Formycon published results of analytical similarity study of biosimilar candidate FYB206 and Keytruda® in peer-reviewed journal Drugs in R&D


EQS-News: Formycon AG / Key word(s): Scientific publication/Study results
Formycon published results of analytical similarity study of biosimilar candidate FYB206 and Keytruda® in peer-reviewed journal Drugs in R&D

16.10.2024 / 06:50 CET/CEST
The issuer is solely responsible for the content of this announcement.


Press Release // October 16, 2024
 

Formycon published results of analytical similarity study of biosimilar candidate FYB206 and Keytruda® in peer-reviewed journal Drugs in R&D
 

  • The comparative analytical evaluation results indicate that the proposed Keytruda®-biosimilar FYB206 is structurally and functionally highly similar to the reference product
  • Strong analytical results provide a solid foundation for the ongoing clinical trials with FYB206 and underline Formycon's excellent position in the leading group of pembrolizumab biosimilar developers
     

Planegg-Martinsried, Germany Formycon AG (FSE: FYB, “Formycon”) announced today that the results of the comparative analytical evaluation of the proposed pembrolizumab biosimilar FYB206 and the immuno-oncology blockbuster drug Keytruda®1 were published in Drugs in R&D, an international, peer-reviewed journal owned by Springer. The paper indicates that FYB206 is structurally and functionally highly similar to the reference product, thereby supporting the testing of the proposed pembrolizumab biosimilar in clinical trials to confirm the similarity between the two products.

To determine FYB206’s suitability to enter clinical trials, a comprehensive comparative analytical assessment was designed to demonstrate analytical similarity in clinically relevant quality attributes between the reference product and the corresponding biosimilar candidate. The analytical panel to evaluate similarity in the current study was designed on the basis of available information on pembrolizumab and knowledge gained during initial analyses of the reference product. The wide battery of qualified and fit for purpose analytical and functional tests was assigned to categories such as structural characterization, product-related variants, glycosylation, general properties, and biological function. All tested functional attributes with a potential impact on clinical performance (PD-1 binding, neutralization of PD-1, FcRn binding) of FYB206 were found to be highly similar to the reference product.

In summary, the results of the extensive data package from all assessments covering structure, purity, protein variants, binding and potency confirm the high similarity between FYB206 and Keytruda®.

Dr. Andreas Seidl, Chief Scientific Officer (CSO) at Formycon, commented: “The remarkable results of this comparative analytical evaluation suggest that FYB206 has the characteristics to be a safe and efficacious alternative to Keytruda®. With this solid foundation, obtained prior to the start of the pharmacokinetic equivalence and confirmatory efficacy and safety trials with FYB206 in June and July 2024, we are committed to continuously initiate new clinical centres and to work closely with the investigators to expand access for patients with high unmet medical needs.”

The full paper entitled “Comparative Analytical Evaluation of the Proposed Biosimilar FYB206 and its Reference Medicinal Product Keytruda®” can be found here.

The active ingredient pembrolizumab is a humanized monoclonal antibody that belongs to the group of immune checkpoint inhibitors and is used to treat a variety of tumors. Pembrolizumab binds to the PD-1 receptor and specifically blocks the interaction between PD-1 and its ligand PD-L1. This helps the immune system to activate the body's own cellular anti-tumor immune response and kill cancer cells. With its broad range of indications in oncology and the continuing high global demand, sales of this currently best-selling drug worldwide could rise to USD 30 billion by 2026.2

FYB206/pembrolizumab is currently being tested in the pharmacokinetic equivalence trial “Dahlia” to compare the pharmacokinetics (PK), safety and tolerability of FYB206 with the reference product Keytruda® in patients receiving adjuvant treatment for malignant melanoma (black skin cancer). The parallel “Lotus” trial compares the efficacy and safety of FYB206 with Keytruda® in combination with chemotherapy in patients with non-small cell lung cancer (NSCLC).

---------------

1 Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA

2. https://www.reuters.com/business/healthcare-pharmaceuticals/merck-raises-2024-profit-forecast-strong-cancer-hpv-drugs-sales-2024-04-25/

 

About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/Ranibizumab, Formycon already has a biosimilar on the market in Europe and the USA. Two further biosimilars, FYB202/ustekinumab and FYB203/aflibercept, received FDA approval; FYB202 is also approved in Europe. Another three biosimilar candidates are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines.

Formycon AG is headquartered in Munich and is listed on the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. Further information can be found at: https://www.formycon.com


About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare systems. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.

 

Contact:
Sabrina Müller,
Director Investor Relations & Corporate Communications,
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany
Tel.: +49 (0) 89 - 86 46 67 149
Fax: + 49 (0) 89 - 86 46 67 110
Sabrina.Mueller@formycon.com

 

Disclaimer:
This press release may contain forward-looking statements and information which are based on Formycon’s 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.



16.10.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com


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: 2008887

 
End of News EQS News Service

2008887  16.10.2024 CET/CEST

fncls.ssp?fn=show_t_gif&application_id=2008887&application_name=news&site_id=boersengefluester~~~ace3d64b-2049-452a-8d18-fbc8044c4b5f
Visual performance / price development - Formycon AG
Smart analysis and research tools can be found here.

This publication was provided by our content partner EQS3.

EQS Newswire
via EQS - Newsfeed
EQS Group AG ©2024
(DGAP)
Contact:
Karlstraße 47 D-80333 München
+49 (0) 89 444 430-000

 

SMART * AD
EN GIF 970X250

P R O D U C T   S U G G E S T I O N S

The information presented here has been provided by our content partner EQS-Group. The originator of the news is the respective issuer, the company relating to the news, a publication service provider (press or information agency) which uses the distribution service of EQS to transmit company news to shareholders, investors, investors or interested parties. The original publications and other company-relevant information can be found at eqs-news.com.


The information you can access does not constitute investment advice. The presentation of our cooperation partners, where the implementation of investment decisions would be possible depending on the individual risk profile, is solely at the discretion of the person using the service. We only present companies of which we are convinced that the range of services and customer service will satisfy discerning investors.

If you are considering leverage products, familiarise yourself with the typical characteristics of the financial instruments beforehand. Take the time to determine the risk content of the planned investment before making an investment decision. Bear in mind that a total loss cannot be ruled out with leverage products.

For newcomers to the subject, we offer various options in both the training and the tools section, through which you can train theoretical knowledge and practical experience and thus improve your skills. The offer ranges from participation in webinars to personal mentoring. The range is continuously being expanded.


1 Lab features are usually functionalities that emerge from the think tank of the investor community. In the early stages, these are experimental functionalities whose development process is largely determined by use and the resulting feedback from the community. When integrating external services or functionalities, the functionality can only be guaranteed to the extent that the individual process elements, such as interfaces, interact with each other.