DGAP-News

Formycon publishes Update on Development Projects

DGAP-News: Formycon AG / Key word(s): Miscellaneous/Miscellaneous Formycon publishes Update on Development Projects 17.06.2022 / 07:30 The issuer is solely responsible for the content of this announcement.

Press Release // June 17, 2022

Formycon publishes Update on Development Projects

- FYB201/ONGAVIA¹ is expected to be the first biosimilar to Lucentis² 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.