DGAP-News: Formycon AG
/ Key word(s): Study/Miscellaneous
09.11.2020 / 07:30
The issuer is solely responsible for the content of this announcement.
Press Release // November 9, 2020
Formycon and Bioeq announce Launch of Phase III Study of FYB202, a Biosimilar Candidate for Stelara(R)* (Ustekinumab)
- Vespucci study examines comparable efficacy, safety and immunogenicity of FYB202 and the reference product Stelara(R) in patients with moderate to severe psoriasis vulgaris (plaque psoriasis)
- Successful transfer of the third (late-stage) biosimilar candidate into a Phase III clinical trial
Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and Bioeq GmbH announced the dosage of the first patient in the Phase III clinical trial (first-patient-in). The aim of the randomized, double-blind, multi-center Phase III study is to demonstrate the comparability of FYB202 and the reference product Stelara(R) in terms of efficacy, safety and immunogenicity in patients with moderate to severe psoriasis vulgaris. This is the most common form of psoriasis, accounting for 80 to 90 percent of its occurrence, and is also known as plaque psoriasis. Due to this systemic disease affecting the entire body or organism, affected patients also have an increased risk of developing psoriatic arthritis and chronic inflammatory bowel diseases such as Crohn's disease or ulcerative colitis.
The active ingredient ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23. Since 2009, Stelara(R) has been used to treat various severe inflammatory conditions such as moderate to severe psoriasis. In 2016, its indications were expanded to treat Crohn's disease and in 2019 it was also approved for the treatment of ulcerative colitis. Both of these conditions are chronic inflammatory bowel diseases. The drug is also used to treat psoriatic arthritis. In 2019, the reference market for Stelara(R) was over USD 6 billion worldwide.
FYB202 is being developed as part of a joint venture between Aristo Pharma GmbH and Formycon AG, as well as in cooperation with bioeq GmbH. Bioeq is responsible for the clinical studies which were developed in close cooperation with the US Food and Drug Administration (FDA) and the European regulatory authority (EMA).
Formycon's COO Dr. Stefan Glombitza is pleased: "With the start of what is now our third clinical Phase III study, we have reached another milestone in the development of our (late-stage) biosimilar candidates. With FYB202 we have a promising biosimilar candidate and are addressing an important and growing market in the inflammatory diseases segment. We would also like to thank our partners for their constructive cooperation and look forward to further joint steps towards the approval of our high-quality Stelara(R) biosimilar."
* Stelara(R) is a registered Trademark of Johnson & Johnson
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.
Bioeq was founded in 2014 and is a leading service provider in the development of biopharmaceutical follow-on products, known as biosimilars. Working with various partners, Bioeq develops third-wave biosimilars and specializes in ophthalmic agents. The development programs meet the standards for highly regulated markets such as Europe, the USA, Canada, or Japan, and are therefore suitable for global licensing. Bioeq's expertise lies primarily in comprehensive project management, clinical development, the drafting of licensing strategies in dialog with the authorities, the development of application systems for administering the products, the drawing-up of patent strategies, and in license management. Bioeq is currently working on five different biosimilar projects.
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. In 2019, global sales of biosimilars exceeded USD12 billion. Analysts estimate that this figure could rise to around USD 69 billion by 2025.
Senior Manager Corporate Communications and Investor Relations
phone +49 (0) 89 - 86 46 67 149
fax + 49 (0) 89 - 86 46 67 110
Sabrina.Mueller@formycon.com // www.formycon.com
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.
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