Presse Release // December 09, 2024
 

MS Pharma becomes Partner for the Commercialization of FYB202 / ustekinumab in the MENA Region

Planegg-Martinsried, Germany / Amman, Jodan – Formycon AG (FSE: FYB, Prime Standard) and MS Pharma jointly announce that they have entered into a licensing and supply agreement for the commercialization of FYB202, Formycon’s Biosimilar to Stelara^®1 (ustekinumab), 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 rights to license, commercialize and produce FYB202 locally at its new Biosimilars site in Saudi Arabia for the Gulf Cooperation Council (GCC) countries as well as further countries of the MENA region. In February 2023, Formycon entered into a license agreement with Fresenius Kabi for the commercialization of FYB202 in key global markets. As part of this agreement, Formycon retained the rights to separately out-license FYB202 for commercialization in specific countries of the MENA region.

“Since the launch of our Lucentis^®2 biosimilar FYB201 in the MENA region, we have established a very successful partnership with MS Pharma which was recently strengthened by adding the second ophthalmic biosimilar FYB203 (aflibercept) to this collaboration. It is our great pleasure to announce that we have now signed a further license and supply agreement with MS Pharma and added our FYB202 / ustekinumab biosimilar to this alliance. We are convinced that MS Pharma’s strong presence in the MENA region will support a good up-take of FYB202 as an effective, safe and cost-efficient treatment option for the numerous patients suffering from severe, chronic inflammatory diseases in the Middle East and North Africa. Formycon will receive an upfront payment as well as royalty payments from sales according to the agreement”, said Nicola Mikulcik, CBO of Formycon AG.

"Expanding our biosimilar pipeline with ustekinumab enables us to address additional therapeutic areas within our specialty business, enhancing patient access to these vital treatments across the MENA region. Our successful collaboration with Formycon continues to grow stronger, and the addition of new products fortifies our pipeline further. Crucially, all our biosimilar products will be manufactured locally at our state-of-the-art facility in Saudi Arabia, ensuring a reliable local supply and aligning with the Kingdom’s ambitious biotech strategy." said Kalle Känd, CEO of MS Pharma.

In September 2024, both the U.S. Food and Drug Administration (FDA) and the European Commission granted approval for the ustekinumab biosimilar FYB202. MS Pharma plans to submit for regulatory approval in MENA countries at the earliest opportunity.

Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 and is used in the treatment of severe inflammatory diseases in the fields of gastroenterology, dermatology, and rheumatology.

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1. Stelara^® is a registered trademark of Johnson & Johnson.
2. Lucentis^® is a registered trademark of Genentech Inc.

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. Two further biosimilars, FYB202/ustekinumab and FYB203/aflibercept, received FDA approval; FYB202 is also approved in Europe. Another four 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 in the Prime Standard of 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: https://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.