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Formycon and Bioeq announce Launch of Phase III Study of FYB202, a Biosimilar Candidate for Stelara(R)* (Ustekinumab)

DGAP-News: Formycon AG / Key word(s): Study/Miscellaneous Formycon and Bioeq announce Launch of Phase III Study of FYB202, a Biosimilar Candidate for Stelara(R)* (Ustekinumab) 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.