Presse Release // May 15, 2024
 

MS Pharma becomes Partner for the Commercialization of FYB203, Formycon’s Biosimilar Candidate to Eylea^® (Aflibercept), in the MENA Region
 

Planegg-Martinsried – Klinge Biopharma GmbH ("Klinge"), licensee and exclusive holder of the worldwide commercialization rights for FYB203, Formycon's biosimilar candidate to Eylea®¹ (Aflibercept), has entered into an exclusive licensing and supply agreement with MS Pharma for the commercialization of FYB203 in the Middle East and North Africa (“MENA region”).

MS Pharma is a leading regional pharmaceutical company in the MENA region and specializes in the distribution of biotechnological as well as generic drugs. The company will have exclusive rights to license, commercialize and produce FYB203 locally at its new Biosimilars site in Saudi Arabia for the countries covered by the agreement. Commercialization rights for all other territories remain with Klinge. Formycon is entitled to participate in all Klinge income from the agreement with MS Pharma in the mid-single to low-double-digit-percentage range.

MS Pharma is also marketing Formycon’s ophthalmic Lucentis^®2 biosimilar FYB201 in the MENA region and can therefore leverage on established sales channels and an existing commercial infrastructure in the ophthalmic space.

In June 2023, Formycon announced that the biologics license application (“BLA”) for FYB203, has been submitted to the U.S. Food and Drug Administration (“FDA“). The agency assigned a target action date of June 2024. Moreover, FYB203 has been submitted end of 2023 to the European Medicines Agency (“EMA”), expecting regulatory approval beginning of 2025. MS Pharma plans to submit for regulatory approval in MENA countries at the earliest opportunity.

Eylea® (Aflibercept) is used in the treatment of neovascular age-related macular degeneration (“nAMD”) and other severe retinal diseases. It inhibits the vascular endothelial growth factor (“VEGF”), which is responsible for the excessive formation of blood vessels in the retina. In 2023, Eylea^® reached global sales of around US$ 9 billion[i], underlining its status as the currently best-selling drug in the field of anti-VEGF therapies.

“We are delighted that our licensee Klinge Biopharma chose a strong, experienced, and renowned partner for the MENA region. MS Pharma has vast experience in the field of ophthalmology, as we have already learned from our collaboration in the commercialization of our other biosimilar FYB201. Both ophthalmic biosimilars address an important and growing market for the treatment of severe retinal diseases and contribute to alternative and cost-effective therapeutic options in the whole region”, said Nicola Mikulcik, CBO of Formycon AG.

"Our partnership with Klinge Biopharma and the addition of an Aflibercept biosimilar to our product line is a milestone in MS Pharma's journey to enhance healthcare accessibility in the MENA region," said Kalle Kand, CEO of MS Pharma. "This agreement not only strengthens our biosimilar portfolio but also reinforces our capability to support local production, ultimately contributing to the regional economy and healthcare system."
 

Alira Health has acted as the exclusive financial and strategic and the lawyers of honert Munich as legal advisors to Klinge Biopharma. 

About Formycon:
Formycon AG (FSE: FYB) is a globally operating, independent pure-play developer of 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: https://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 & Corporate Communications,
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany
Tel.: +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.

^[i] Regeneron Reports Fourth Quarter and Full Year 2023 Financial and Operating Results | Regeneron Pharmaceuticals Inc.