Formycon announces commercial launch of FYB201 (Ranibizumab) in Canada (RanoptoTM) and Switzerland (Ranivisio®)

Press release // April 11, 2024

Formycon announces commercial launch of FYB201 (Ranibizumab) in Canada (Ranopto^TM) and Switzerland (Ranivisio^®)
 

• Commercial launch opens up additional key markets in Europe and North America, making FYB201 available in a total of 17 countries worldwide
• Lucentis^® biosimilar FYB201 is an effective and cost-efficient treatment option for patients with serious retinal diseases
• Commercialization partner Teva markets FYB201 in Canada under the trademark Ranopto^TM and in Switzerland under the trademark Ranivisio^®
   

Munich, Germany – Formycon AG (FSE: FYB) and Bioeq AG announce the commercial launch of FYB201, a biosimilar to Lucentis^®1(Ranibizumab), in Canada and Switzerland. The launch follows the marketing authorization granted by Health Canada under the trademark Ranopto^TM2and Swissmedic under the trademark Ranivisio^®3.

"Due to demographic developments, more and more people are affected by age-related macular degeneration and other retinal diseases, especially in industrialized nations. These diseases are often accompanied by a severe impairment in the quality of life. FYB201 is a new high-quality, effective and yet affordable treatment option for patients affected by such debilitating conditions. Teva is a strong commercialization partner with a proven track record in successfully launching FYB201 across major European markets and - like us - is convinced of the great potential of our biosimilar," commented Nicola Mikulcik, CBO of Formycon AG.

FYB201 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. In mid-2021, Bioeq and Teva entered into a strategic partnership for the exclusive commercialization of FYB201 in Canada, Europe and other territories. In Canada and Switzerland, FYB201 has been approved for the treatment of age-related neovascular (wet) macular degeneration (nAMD) and other serious retinal diseases.

The wet form of AMD is caused by excessive growth of blood vessels in the retina. The active ingredient ranibizumab inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of these blood vessels. In many developed countries, AMD is the leading cause of severe visual impairment or blindness. The risk of developing AMD increases with age. It is estimated that around 67 million people in Europe are currently affected[i], while around 2.5 million people in Canada suffer from AMD[ii]. The numbers are expected to continue to rise in the coming years.
 

¹ Lucentis^® is a registered trademark of Genentech Inc.
² Ranopto^TM is a trademark of Teva Canada Limited
³ Ranivisio^® is a registered trademark of Bioeq AG

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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: https://www.formycon.com/

About Bioeq:
Bioeq is a Swiss biopharmaceutical joint venture between the Polpharma Biologics Group BV and Formycon AG. Bioeq develops, licenses and commercializes biosimilars. Bioeq is marketing authorization holder of Ranivisio® in Switzerland. www.bioeq.ch

About Teva Pharmaceuticals:
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader with a category-defying portfolio, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery and expanded development of modern medicine. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its 37,000 employees across 60 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit www.tevapharm.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] Li JQ, Welchowski T, Schmid M, et al. Prevalence and incidence of age-related macular degeneration in Europe: a systematic review and meta-analysis British Journal of Ophthalmology 2020;104:1077-1084.: https://bjo.bmj.com/content/104/8/1077.

^[ii] Larissa Moniz, Chad Andrews, Jennifer Pereira: „Canadian patient experience with age-related macular degeneration“ in ARVO Annual Meeting Abstract, June 2022
https://iovs.arvojournals.org/article.aspx?articleid=2781783