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Companies: Formycon AG
Edison
Formycon progressed all key projects in H121. FYB201 (partnered with Bioeq) is a Lucentis biosimilar to treat neovascular age-related macular degeneration (nAMD). The US FDA is reviewing the BLA with an August 2022 decision due; the European EMA review should complete in mid-2021. FYB201 will be marketed by Teva in Europe and by Coherus in the US. FYB202 (a Stelara biosimilar in a joint venture with Aristo Pharma) is waiting for its Phase III readout in psoriasis. FYB203 (an Eylea biosimilar par
Formycon progressed all key projects in 2020. FYB201 (partnered with Bioeq) is a Lucentis biosimilar to treat neovascular age-related macular degeneration (nAMD). After scaling up manufacturing in 2020, Bioeq aims to resubmit a BLA to the FDA in H121 with a subsequent EMA filing. FYB202 (a Stelara biosimilar) in a joint venture with Aristo Pharma started its Phase III for psoriasis. FYB203 (an Eylea biosimilar partnered with Klinge) is in Phase III. FYB207 is a novel COVID-19 therapy that neutra
Formycon continues to progress three core biosimilar projects. In H220, it is preparing the FYB201 (Lucentis biosimilar) EMA approval submission and helping in the resubmission of FYB201 to the FDA. FYB203 (Eylea biosimilar) entered Phase III in August. FYB202 (Stelara biosimilar, autoimmunity) is due to enter Phase III imminently. Development income from partners was €16.5m in H120, giving a loss of €1.4m and a cash outflow of €2.1m. Cash was €20.3m on 30 June.
Formycon ended 2019 with a strong €22.4m cash position and three main projects. A new project to manufacture antibodies against SARS-CoV-2 is underway to treat COVID-19. Formycon’s lead project, Lucentis biosimilar FYB201, treats neovascular age-related macular degeneration (nAMD) and is partnered with Bioeq AG (Bioeq). Bioeq aims to resubmit the BLA to the FDA in H220. FYB202 (a Stelara biosimilar) is in a joint venture with Aristo Pharma and is slated to enter Phase III in Q320. FYB203 (an Eyl
Formycon's partner Bioeq IP plans to file FYB201, a Lucentis biosimilar candidate, to treat neovascular age-related macular degeneration (nAMD) with the FDA imminently in Q419. The US launch could be in 2021 and the EU in 2022. H119 revenues were €17.2m from partners for product development services. There are three main projects. Bioeq is the partner on FYB201, Santo on FYB203 (an Eylea biosimilar candidate) and there isa a joint venture with Aristo Pharma on FYB202 (a Stelara biosimilar candid
Formycon's partner Bioeq IP (Bioeq) plans to file FYB201, a Lucentis biosimilar candidate, to treat neovascular age-related macular degeneration (nAMD) with the FDA imminently in Q419. The US launch could be in 2021 and the EU in 2022. H119 revenues were €17.2m from partners for product development services. There are three main projects. Bioeq is the partner on FYB201, Santo on FYB203 (an Eylea biosimilar candidate) and a joint venture with Aristo Pharma on FYB202 (a Stelara biosimilar candidat
Formycon's partner Bioeq IP AG (Bioeq) plans to file FYB201, its Lucentis biosimilar, to treat neovascular age-related macular degeneration (nAMD) with the FDA in early Q419. The Phase III met its key primary endpoint. The US launch could be in 2021 and the EU in 2022. FY18 revenues were €43m, which includes €34.5m in payments from partnered projects. Bioeq is the partner on FYB201, Santo on FYB203 (an Eylea biosimilar) and there is a joint venture with Aristo Pharma on FYB202 (a Stelara biosimi
Formycon has reported record H118 revenues, boosted by the one-off transfer of FYB202 into a joint venture with Aristo Pharma and payments stemming from the out-licensed assets FYB201 and FYB203. We believe that Formycon biosimilars FYB201 (Lucentis) and FYB203 (Eylea) are set to enter neovascular age-related macular degeneration (nAMD) market post-2020. Cash and equivalents at end-H118 were €11.8m and should give a cash runaway until 2020 based on H118 cash burn. Formycon guides for FY18 revenu
Formycon has announced that its Lucentis biosimilar FYB201 showed comparable efficacy with branded Lucentis in a global Phase III study in nAMD. With positive data in hand, the launch of FYB201 remains on track for 2020 (US) and 2022 (EU), ahead of most competitors. Formycon has also signed a JV (24.9% stake) with Aristo to develop its Stelara biosimilar FYB202 for approval. Lastly, Eylea biosimilar FYB203 and undisclosed FYB205 are advancing in preclinical studies. End-2017 cash was €15.5m.
In H117 Formycon 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 advan
Formycon 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 dis
Formycon is a pure-play biosimilar company focused on third-wave biosimilars (those coming off patent after 2020), an overlooked opportunity for most biosimilar developers. The company has four compounds, two of which are partnered. FYB201 is a biosimilar of Lucentis for neovascular age-related macular degeneration (nAMD) undergoing a global Phase III study; the company is aiming for US and EU launch in 2020 and 2022, respectively, upon patent expiries. FYB203 is a proposed biosimilar of Eylea,
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