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EQS-News: Formycon AG
/ Key word(s): Conference
Formycon will present clinical data on its ustekinumab biosimilar candidate FYB202 at the EADV Congress in Amsterdam and the UEG Week in Vienna
17.09.2024 / 06:50 CET/CEST
The issuer is solely responsible for the content of this announcement.
Press Release // September 17, 2024
Formycon will present clinical data on its ustekinumab biosimilar candidate FYB202 at the EADV Congress in Amsterdam and the UEG Week in Vienna
Planegg-Martinsried – Formycon AG (FWB: FYB) will present clinical study data of its ustekinumab biosimilar candidate FYB202 at this year's European Academy of Dermatology & Venerology (EADV) congress, taking place in Amsterdam from September 25 to 28, 2024. The randomized, double-blind, multicenter VESPUCCI Phase III study met the primary endpoint, demonstrating similar efficacy of FYB202 and the reference drug Stelara® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis). The ePoster presentation shows details of the study design as well as the primary and secondary endpoints.
In addition, Formycon will present study data focusing on the pharmacokinetics of the ustekinumab biosimilar candidate FYB202 at the United European Gastroenterology (UEG) Week from October 12 to 15, 2024 in Vienna. In the Phase I pharmacokinetics study FYB202 showed bioequivalence to the reference drug for all primary endpoints.
Both posters were designed in cooperation with Fresenius Kabi, Formycon's commercialization partner for FYB202.
Presentation details:
EADV Congress
- Session: ePoster
- Poster-ID: P0984
- Title: A randomised, double-blind trial to compare the efficacy, safety, and immunogenicity of the proposed biosimilar ustekinumab (FYB202) with reference ustekinumab in patients with moderate-to-severe plaque psoriasis
- Room: Poster Area
- Date: September 25 – 28, 2024
UEG Week
- Session: ePoster incl. audio/video presentation on demand
- Poster-ID: PP0593
- Title: Proposed ustekinumab Biosimilar FYB202: Pharmacokinetic equivalence demonstrated in a randomised, double-blind, parallel-group, single-dose trial in healthy subjects (RUSTIC)
- Speaker: Sigrid Balser, Vice President Clinical Development & Operations, Formycon AG
- Room: Poster Area
- Date: October 13 – 15, 2024
FYB202 is an interleukin inhibitor that can be used both in dermatology for the treatment of psoriasis and in gastroenterology for the treatment of chronic inflammatory bowel disease. The biosimilar candidate is currently in the final phase of the approval process for the US and the European Union. The decision of the European Commission on the approval is expected in early Q4, while the decision of the FDA is anticipated by the end of September 2024.
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1 Stelara® is a registered trademark of Johnson & Johnson
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. FYB203/aflibercept, received FDA approval. Another four 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.
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