• FYB201/ONGAVIA®1 is expected to be the first biosimilar to Lucentis®2 to be commercialized in Europe
  • EMA and FDA approvals for Lucentis® biosimilar FYB201 anticipated in Q3/2022
  • FYB202: Treatment of all patients in phase III clinical trial completed (last-patient-out) primary efficacy endpoint data expected by end of July 2022
  • Additional phase I study initiated
  • FYB203: Enrollment in phase III clinical trial completed (last-patient-in) primary efficacy endpoint data expected by end of 2022
  • FYB207: Neutralization of the omicron variant proven in vitro
  • Improved molecular structure increases in vivo half-life and efficacy
  • Paul Ehrlich Institute confirms full support for accelerated development program
  • Clinical trial in preparation

Munich – Formycon AG (ISIN: DE000A1EWVY8 / WKN: A1EWVY) („Formycon“) today announced an update on their development projects.

FYB201, Formycons biosimilar to Lucentis® (ranibizumab), was recently approved by the British Medicines Agency MHRA (Medicines and Healthcare products Regulatory Agency) in the United Kingdom. The Commercialization partner Teva Pharmaceutical Industries Ltd. („Teva“) expects to launch FYB201 under the trade name ONGAVIA® in the UK later this year. ONGAVIA® will become available to patients in the UK suffering from age-related neovascular (wet) macular degeneration and other serious eye diseases. Thereby FYB201/ONGAVIA® is expected to be the first biosimilar to Lucentis® to be marketed in Europe.

Approval processes for FYB201 with the European Medicines Agency („EMA“) and the U.S. Food and Drug Administration („FDA“) continue to proceed as planned. The opinion of the Committee for Medicinal Products for Human Use ("CHMP") of the EMA is expected shortly. The subsequent decision of the European Commission and the associated EU approval of FYB201 is expected this summer. In addition, the submission of marketing authorization applications for FYB201 in further attractive markets is planned or has already occurred.

In the U.S., a biologics license application seeking approval of FYB201 for all Lucentis® indications including neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization is under review by the FDA with a target action date of August 2, 2022. If approved by the FDA on August 2, 2022, U.S. partner Coherus BioSciences, Inc. plans to launch FYB201 under the trade name CIMERLI™3 in the second half of 2022. Earlier in 2022, the FDA’s pre-license inspections (“PLI”) in Europe for FYB201 were completed. As part of the PLI, Formycons premises in Martinsried/Planegg (Germany) were inspected by the FDA in March. The inspection went without any complaint, no form 4834 was issued.

Nicola Mikulcik, CBO of Formycon, explains: “We are delighted that FYB201 under the brand name ONGAVIA® is expected to be the first available biosimilar to Lucentis® in the United Kingdom and can be used in the treatment of age-related neovascular (wet) macular degeneration and other serious eye diseases. This will provide access to this highly effective drug to more patients."

In the FYB202 project, a biosimilar candidate for Stelara®5 (ustekinumab), the treatment of the last patient in the phase III clinical trial (VESPUCCI study) was successfully completed (last-patient-out) despite the current challenging environment for conducting clinical trials. The aim of the randomized, double-blind, multi-center phase III study is to demonstrate the similarity of FYB202 and the reference product Stelara® in terms of safety, efficacy and immunogenicity in patients with moderate to severe psoriasis vulgaris. Results on the primary efficacy endpoint are expected in July.

In parallel to the ongoing phase III trial, additional Scientific Advice Meetings were held with the FDA and the EMA to discuss the development strategy of FYB202 in detail and in which additional extensive analytical data packages for the similarity of FYB202 with the reference product Stelara® on a commercial production scale were presented. Both authorities support Formycon's similarity testing strategy. In addition, a comparative phase I pharmacokinetics study of FYB202 with the reference product Stelara® was discussed, in which the confidence interval for one of the required parameters was narrowly missed. Based on the findings, the study concept was adapted accordingly and the changes have already been coordinated with the authorities. The study start of the extended scope pharmacokinetics study is planned in the next weeks. European and U.S. regulatory submissions for FYB202 are planned for the third quarter of 2023 following the availability of these additional pharmacokinetic data.

Dr. Stefan Glombitza, COO of Formycon AG, adds: "We are confident that we will be able to provide a compelling data package for submission next year. There is strong interest in our FYB202 development and we aim to make a decision on a suitable commercialization partner in the second half of 2022."

In the development of FYB203, Formycon's biosimilar candidate for Eylea®6 (aflibercept), the last patient in the ongoing phase III clinical trial (MAGELLAN-AMD study) was enrolled in April (last-patient-in). The aim of the randomized, double-blind, multi-center phase III study is to demonstrate the similarity of FYB203 and the reference product Eylea® in terms of efficacy, safety and immunogenicity in patients with neovascular (wet) age-related macular degeneration. Data on the primary efficacy endpoint are expected by the end of this year.

The FYB206 biosimilar project continues to progress according to plan. Following convincing results from the extensive analytical characterization of the developed molecule as well as significant progress in the development of the manufacturing process, a comprehensive data package is currently being compiled in order to closely coordinate further program steps in Scientific Advice Meetings with the EMA and FDA in the second half of the year. Scaling up of the manufacturing process to commercial scale is planned for the end of 2022. Formycon plans to announce details of the reference molecule later this year.

FYB207 is a promising antiviral drug candidate against SARS-CoV-2 and its variants. This is a fusion protein of the human protein ACE2 (Angiotensin Converting Enzyme II) and the constant part of a human antibody. Since ACE2 is the entry point for cell infection, the virus cannot evade a drug based precisely on this protein. Previously published laboratory studies have shown that FYB207 retained its full antiviral potential against the SARS-CoV-2 alpha, beta and delta variants. New laboratory data demonstrate that the omicron variant now prevalent is neutralized by FYB207 with consistently high efficacy as well. In contrast, vaccines and therapeutic antibodies against SARS-CoV-2 variants have already lost efficacy.

Based on preclinical studies conducted in 2021, Formycon was able to make defined proprietary modifications to the FYB207 molecular structure that resulted in significant improvements in half-life and efficacy. The development strategy for an accelerated approval process has already been coordinated with the Paul Ehrlich Institute ("PEI") and the FDA through Scientific Advices in 2021. In a follow-on Scientific Advice in May 2022, the PEI confirmed full support for the improved drug molecule for the accelerated development program. On this basis, preclinical studies are expected to be completed, the manufacturing process will be adapted to the optimized molecule, and the production of test material for stability studies and clinical trials will be carried out in 2022. Entry into clinical trials is planned for 2023.

Formycon has extensive know-how and numerous patent applications in the field of fusion proteins against viral diseases, an increasingly important therapeutic area. Together with its academic partners Prof. Dr. Ulrike Protzer, Chair of Virology, and Prof. Dr. Johannes Buchner, Chair of Biotechnology at the Technical University of Munich ("TUM"), Formycon has built a great scientific reputation, which is reflected for FYB207, in addition to the Pharma Trend Image & Innovation Award "The Most Innovative Product®" in the category of Leap Innovations, also in the granting of extensive funding. Formycon is therefore evaluating various strategic options for fully exploiting the commercial potential of this platform technology. In this context, discussions are also underway with SCG Cell Therapy Ltd. to regain the exclusive license to develop, manufacture and commercialize FYB207 for the Asia-Pacific region (excluding Japan). Collaboration with academic partners will continue intensively as FYB207 development continues.

Dr. Carsten Brockmeyer, CEO of Formycon AG, says: "With each successful mutation, SARS-CoV-2 escapes vaccines and therapeutic antibodies a little bit more. In particular, older people, whose vaccination protection declines more rapidly than in younger ages, and people who have to take immunosuppressive drugs continue to have a high risk of becoming more severely ill or even dying from COVID-19. The threat of viral mutations is likely to increase even further in the future worldwide due to social and environmental developments. Fusion proteins such as FYB207 can potentially make an important contribution here for the prevention and treatment of COVID-19, but also aid global pandemic preparedness in general."

1) ONGAVIA® is a registered trademark of Teva Pharmaceutical Industries Ltd.2) Lucentis® is a registered trademark of Genentech Inc.3) CIMERLI™ is a trademark of Coherus BioSciences, Inc.4) Form 483 is used by FDA to document and comment on concerns, identified during the inspection.5) Stelara® is a registered trademark of Johnson & Johnson6) Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.