EQS-News

FYB201/Ranibizumab keeps gaining momentum with approvals and launches in the MENA region

EQS-News: Formycon AG / Key word(s): Regulatory Approval/Market Launch FYB201/Ranibizumab keeps gaining momentum with approvals and launches in the MENA region 11.03.2024 / 07:30 CET/CEST The issuer is solely responsible for the content of this announcement. Press release // March 11, 2024

 

FYB201/Ranibizumab keeps gaining momentum with approvals and launches in the MENA region

• Commercialization partner MS Pharma wins government tender for Ranibizumab in Saudi Arabia
• Commercial launch of FYB201/Ravegza planned for second quarter of 2024
• Further launches planned throughout 2024 to improve access to ophthalmic treatments in the MENA region

Munich, Germany / Amman, Jordan – Formycon AG (FSE: FYB) and MS Pharma announced today that FYB201, a biosimilar to Lucentis (Ranibizumab), has received marketing authorization from the Saudi Food & Drug Authority. Following the successful market launch in Jordan last year and with winning the NUPCO tender in Saudi Arabia, FYB201 is expected to be available in another country in the MENA region from the second quarter of 2024. In addition, further market launches are planned in Algeria and other Gulf Cooperation Council (GCC) markets over the course of 2024. In Saudi Arabia, MS Pharma will market the biosimilar under the trade name Ravegza.

FYB201/Ravegza was developed by Bioeq AG, a joint venture between Formycon AG and Polpharma Biologics Group BV. As a biosimilar to Lucentis, FYB201 has already proven to be an important, cost-effective treatment option for patients with severe retinal diseases in the USA and large parts of Europe.

At the end of 2021, the company entered into an exclusive partnership with MS Pharma for the commercialization of FYB201 in the Middle East and North Africa (MENA) region. This strategic collaboration aims to improve access to ophthalmic treatments in the MENA region.

Ravegza is approved in Saudi Arabia for the treatment of patients with age-related neovascular (wet) macular degeneration (nAMD) and other serious eye diseases including retinopathies secondary to diabetes. In Saudi Arabia, millions of individuals grapple with Diabetes Mellitus (DM) and its complications. The prevalence of diabetic retinopathies (DR) is approximately 19.7%[i], resulting from damage to blood vessels in the retina due to prolonged high blood sugar levels. Additionally, Diabetic Macular Oedema (DME) affects 5.7% of the population, leading to fluid accumulation in the macula, vision impairment and even blindness. By inhibiting vascular endothelial growth factor (VEGF), Ravegza is indicated to treat nAMD and DME effective and cost-efficient.