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

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.

“The successful approval of FYB201 in Saudi Arabia underlines the quality of our biosimilar and its importance as an affordable treatment option for DME, one of the most common causes of severe visual impairment and blindness in the middle east,” said Nicola Mikulcik, CBO of Formycon. “Our partner MS Pharma winning the important NUPCO tender in Saudi Arabia is an outstanding achievement, as it enables us to serve a significant part of the public healthcare sector in Saudi Arabia.”

Kalle Känd, CEO of MS Pharma, stated, “The approval of Ravegza® in Saudi Arabia represents a significant milestone in the company’s ongoing mission to improve patient health and expand our services providing high quality accessible medicines. Biosimilar and specialty medicines are integral to MS Pharma product portfolio and play a crucial role in advancing our growth objectives in the MENA region. We are very proud that we will be making a substantial contribution to public healthcare through the government tender awarded in Saudi Arabia. This approval supports the company’s commitment to the Saudi market and its broader strategic initiatives within the kingdom.”

About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities.

For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/Ranibizumab, Formycon already has a biosimilar on the market in Europe and the USA. Another five biosimilar candidates are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines.

Formycon AG is headquartered in Munich and is listed on the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. Further information can be found at: www.formycon.com/

About MS Pharma:
MS Pharma is a leading regional pharmaceutical company operating in the MENA region, well-positioned for fast business growth, with its headquarters in Amman, Jordan, and management offices in Zug, Switzerland.

Established in 1989, MS Pharma has a robust presence in over 20 countries, and a diverse portfolio encompassing a wide array of generic, value-added, and biosimilar medicines, covering over 300 international nonproprietary names (INNs) for various treatments and maintaining more than 2000 market authorizations. MS Pharma’s operations are supported by three research and development centers and four manufacturing sites and boasts significant B2C capabilities with expansive reach in the Middle East and Africa.

For further details, please visit our website: www.mspharma.com.

About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars.

Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures.

Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare providers. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.

Contact:
Sabrina Müller
Director Investor Relations and Corporate Communications
Formycon AG
Fraunhoferstr. 15
82152 Martinsried/Planegg
Germany

phone +49 (0) 89 – 86 46 67 149
fax + 49 (0) 89 – 86 46 67 110
Sabrina.Mueller@formycon.com

Disclaimer:
This press release may contain forward-looking statements and information which are based on Formycon’s current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.

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^[i] AlQahtani AS, Hazzazi MA, Waheeb SA, Semidey VA, Semidey VA, Elgendy HK, Alkhars WI, Abouammoh MA, Al-Dhibi H. Saudi Arabia Guidelines for diabetic macular edema: A consensus of the Saudi Retina Group. Saudi Med J. 2021 Feb;42(2):131-145. doi: 10.15537/smj.2021.2.25623. PMID: 33563731; PMCID: PMC7989293. https://pubmed.ncbi.nlm.nih.gov/33563731/