Formycon AG (DE:FYB) has reported FY16 financial results that highlight the progress of its biosimilars pipeline. During 2016 partner Bioeq IP AG started a global Phase III study of Lucentis biosimilar FYB201 for neovascular age-related macular degeneration (nAMD); US and EU launches are planned for 2020 and 2022. Formycon disclosed that FYB203 is a proposed biosimilar of Eylea in preclinical studies. It targets all biologics in the nAMD market, which had revenues of $8.2bn in 2016. The company recently disclosed that FYB202 is a biosimilar of Stelara. Cash at end 2016 was €14m.
Global Phase III trial of Lucentis biosimilar underway
Formycon and its partner Bioeq IP AG are running a global Phase III clinical trial of lead asset FYB201, a biosimilar of Lucentis (2016 revenues $3.2bn). Development, regulatory and commercial milestones could be over three-digit million euros. The company aims for US launch in 2020 and the EU in 2022 on patent expiries. We view FYB201 as a potential first-to-market mover, as competitors are behind.
Biosimilar candidate for Eylea’s growing market
In February 2016 Formycon disclosed FYB203 is a proposed biosimilar of Eylea for nAMD (2016 sales $5bn). It is in preclinical studies and partnered with Santo Holding in a deal that involves an upfront payment of single-digit million euros (received) and ongoing payments for its product development activities up to regulatory approval; sales revenue may reach double digits. Eylea patents expire in 2023 in the US and 2025 in the EU. With no other known competitors, we believe that Formycon is uniquely positioned in the growing Eylea market.
FYB202 disclosed as a biosimilar of Stelara
Formycon has disclosed that FYB202 is a biosimilar candidate of Stelara (ustekinumab, 2016 sales $3.2bn) in pre-clinical stage. Stelara is indicated for psoriasis and Crohn’s disease. Consensus forecasts predict a market of $4.5bn in 2020 (EvaluatePharma). Patent protection ends in 2023 in the US and 2024 in the EU. Additionally, Formycon has an undisclosed biosimilar FYB205. It plans to partner both FYB205 and FYB202 in the future.
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