Formycon starts clinical development program for FYB206, a biosimilar candidate for immuno-oncology blockbuster drug Keytruda®

First patient entered Phase I clinical trial “Dahlia” to compare the pharmacokinetics (PK), safety and tolerability of FYB206 with the reference product Keytruda^®* (First Patient In).
“Dahlia” investigates the PK equivalence as part of a preventive therapy for patients who have had a malignant melanoma (black skin cancer) completely surgically removed.
In the parallel Phase III trial “Lotus”, the safety and efficacy of FYB206 will be compared with the reference drug Keytruda^® in patients with non-small cell lung cancer. Recruitment is expected to start very soon.
The start of clinical development of FYB206 underscores Formycon’s excellent position among the first three biosimilar companies announcing entry into the clinical development phase for the EU and US market.

Planegg-Martinsried – Formycon AG (FSE: FYB, “Formycon”) announced today that the clinical development program for FYB206, a biosimilar for Keytruda^®* / pembrolizumab, has started with the inclusion of the first patient.

Dr. Stefan Glombitza, Chief Executive Officer (CEO) of Formycon AG, commented: “With the start of the clinical development program and the first patient in, we have reached a major milestone. We are at the forefront of the development of a pembrolizumab biosimilar. Our FYB206 project not only has immense commercial potential, but above all offers exceptional therapeutic options. We are doing absolutely everything we can to ensure that more cancer patients worldwide can be treated with this drug in the future. After all, only biosimilars combine quality and efficacy with cost efficiency and thus improve healthcare.”

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 sales of USD 25 billion in 2023[i], Keytruda^® is currently the world’s best-selling drug. Due to the increasing number of cancers diagnoses around the world – the International Agency for Research on Cancer (IARC) predicts an increase of 77% by 2050[ii] – further growth in sales are forecasted for pembrolizumab over the coming years.

Formycon has started the clinical development program with a Phase I study to compare the pharmacokinetics (PK), safety and tolerability of FYB206 with the reference product Keytruda^®/ pembrolizumab in patients with malignant melanoma (black skin cancer). The first patient was included in the study. For melanoma patients, preventive monotherapy with pembrolizumab after complete surgical removal of the tumor aims to minimize the risk of recurrence. The study design of the “Dahlia” Phase I study was developed in close cooperation with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and anticipates a treatment period of one year for the patients in the trial.

Dr. Andreas Seidl, Chief Scientific Officer (CSO) at Formycon, added: “With our sophisticated study design, we excellently address both the complexity of the mode of action and the requirements of the regulatory authorities. To largely exclude disease-related influencing factors in the investigation of PK equivalence, we have chosen the study indication for the preventive treatment of patients after surgical removal of a melanoma. We are assuming that the influence of the tumor on the variability of the pharmacokinetic parameters is rather low. The fact that our team has successfully put together such a comprehensive clinical program fills me with great pride and once again demonstrates our leading role as a focused biosimilar specialist”.

In the parallel phase III study, the safety and efficacy of FYB206 will be compared with the reference product Keytruda^® in patients with non-small cell lung cancer. Patients will be treated with pembrolizumab and chemotherapy for 24 months as part of a combination therapy. Recruitment is expected to start also very soon.

Following the completion of clinical development and subject to approval by the regulatory authorities, Formycon currently expects the earliest market entry of its biosimilar candidate FYB206 after the expiry of the market exclusivity of the reference product in 2029 for the USA and 2030 for the EU.

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

[i] Merck Announces Fourth-Quarter and Full-Year 2023 Financial Results – https://www.merck.com/news/merck-announces-fourth-quarter-and-full-year-2023-financial-results/

[ii] Word Health Organization (WHO): Global cancer burden growing, amidst mounting need for services -https://www.who.int/news/item/01-02-2024-global-cancer-burden-growing–amidst-mounting-need-for-services

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 providers. 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.

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.

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