Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Bioeq AG (“Bioeq”) announce, that today the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization (MA) in the United Kingdom (“UK”) for FYB201, a biosimilar to Lucentis® (ranibizumab). Teva Pharmaceutical Industries Ltd. (“Teva”) will serve as the exclusive commercial partner and will market the biosimilar under the brand name ONGAVIA® throughout the UK.

Lucentis® is used in the treatment of age-related neovascular (wet) macular degeneration (nAMD) and other serious eye diseases like visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) and visual impairment due to choroidal neovascularization (CNV). It inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina.

The MHRA approval is based on a totality of evidence including analytical, clinical and manufacturing data. In a randomized, double-masked, parallel group, multicenter phase III study, the efficacy, safety, pharmacokinetics and immunogenicity of FYB201/ONGAVIA® was proven comparable to the reference drug Lucentis® (ranibizumab) in patients with age-related neovascular (wet) macular degeneration (nAMD).

Dr. Stefan Glombitza, COO of Formycon comments: “Retinal diseases are an increasing burden for patients worldwide. We are pleased to announce the approval of our Lucentis® biosimilar in UK, creating a treatment option for some of the most common and serious retinal diseases.”

The commercial launch of FYB201/ONGAVIA® in the UK by Teva Pharmaceutical Industries Ltd. (“Teva”), which has licensed the distribution rights from Bioeq under an exclusive strategic partnership, is expected to follow as soon as possible and targets to be the first available Biosimilar for Lucentis® in Europe.

1)Lucentis® is a registered trademark of Genentech Inc.