In H117 Formycon (DE:FYB) disclosed that FYB202 is a proposed biosimilar of Stelara and it recently announced that it is in the process of entering into a co-investment agreement with Santo Holding to advance FYB202 through regulatory approval. The global Phase III study of Lucentis biosimilar FYB201 for neovascular age-related macular degeneration (nAMD) is progressing according to plan with US and EU launches slated for 2020 and 2022. Lastly, FYB203 (Eylea biosimilar) and FYB205 (undisclosed) are advancing in preclinical studies. Cash and equity at end H117 was €14.4m.
Stelara biosimilar disclosed and partnership close
Formycon disclosed that FYB202 is a proposed biosimilar candidate of Stelara (ustekinumab, 2016 sales $3.2bn). Stelara is indicated for plaque psoriasis, psoriatic arthritis and Crohn’s disease. EvaluatePharma’s consensus forecasts predict a market of $4.5bn in 2020. Stelara’s patent protection ends in 2023 in the US and 2024 in the EU. Executing on its strategy, Formycon is in the process of partnering FYB202 with Santo Holding; according to the signed term sheet, it will have a 30% participation in total costs and revenue.
Phase III of Lucentis biosimilar approaches milestone
Formycon and its partner Bioeq IP continue the global Phase III clinical trial of lead asset FYB201, a biosimilar of Lucentis (2016 revenues $3.2bn). Formycon expects to achieve an undisclosed key milestone in the near future. Total development, regulatory and commercial milestones could be over three-digit million euros. The companies’ aim is to launch in the US in mid-2020 and the EU in 2022 on Lucentis’ patent expiration. We continue to view FYB201 as a potential first-to-market mover, as competitors are behind.
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