EQS-News: Teva becomes strategic commercialization partner for Formycon’s biosimilar candidate FYB203 (Eylea®/ aflibercept) in major parts of Europe and Israel

Presse Release // January 13, 2025
 

Teva becomes strategic commercialization partner for Formycon’s biosimilar candidate FYB203 (Eylea®/ aflibercept) in major parts of Europe and Israel

Planegg-Martinsried, Germany – Klinge Biopharma GmbH (Klinge), the licensee and exclusive global commercialization rights holder for FYB203, Formycon’s biosimilar candidate to Eylea^®1 (Aflibercept), informed Formycon AG (FSE: FYB) about the signing of a licensing agreement with Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (Teva) for the semi-exclusive commercialization of FYB203 in major parts of Europe and Israel. In parallel Formycon has signed an agreement with Teva under which Formycon will supply the finished product.

The collaboration combines Formycon’s capabilities in the development of biosimilar medicines for highly regulated countries with Teva’s deep commercial experience in biosimilars and its extensive distribution network and -broad sales and marketing reach across Europe.

Teva is a global pharmaceutical leader harnessing its generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine.

Under the licensing agreement, Teva will obtain semi-exclusive commercialization rights for major parts of Europe, excluding Italy, as well as for Israel for FYB203, Formycon’s biosimilar candidate to Eylea^®, to be marketed under the brand name AHZANTIVE^®2 subject to regulatory approval. In return, Klinge will receive milestone payments and royalties on net sales.

Formycon will participate in the mid-single-digit to low-double-digit percentage range in all payment streams to Klinge resulting from this agreement. Furthermore, Formycon will receive payments for organizing the commercial market supply of AHZANTIVE^® on behalf of Klinge.

“With Teva, we are gaining a strong and proven partner for FYB203 in the major parts of Europe and Israel. Teva is already marketing our FYB201 ranibizumab biosimilar (Ranivisio^®3/ Ongavia^®4) in Europe and can synergistically leverage an existing commercial infrastructure and well-established distribution channels in the ophthalmology field. We are pleased to build on this trusted and successful collaboration. Particularly noteworthy is Formycon’s first-time responsibility for managing the entire commercial supply chain of the finished product,” commented Nicola Mikulcik, CBO of Formycon AG.

Commenting on the agreement, Richard Daniell, Executive Vice President European Commercial of Teva, says: “We are excited to extend our collaboration with Formycon, reinforcing the solid foundation that commenced with the commercialization of ranibizumab biosimilar (Ranivisio^®3 / Ongavia^®4) for Lucentis^®5 in Europe. The collaboration expands Teva’s broad biosimilar portfolio and again demonstrates our firm commitment to creating greater access to quality innovative medicines to the benefit of patients and the healthcare systems we serve."

In June 2024, the U.S. Food and Drug Administration (FDA) approved the aflibercept biosimilar FYB203. In November 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for the marketing authorization of FYB203 under the brand names AHZANTIVE^® / Baiama^®6. The European Commission's decision on approval is expected in the second half of January 2025.

Eylea^® (Aflibercept) is used to treat neovascular age-related macular degeneration (nAMD) and other severe retinal diseases. The active ingredient inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina. In 2023, Eylea^® achieved global sales of approximately USD 9 billion[i], including USD 2.9 billion[ii] in the European market, further underscoring its status as the highest-revenue drug in the anti-VEGF therapy sector.
 

1. Eylea^® is a registered trademark of Regeneron Pharmaceuticals Inc.
2. AHZANTIVE^® is a registered trademark of Klinge Biopharma GmbH
3. Ranivisio^® is a registered trademark of Bioeq AG
4. Ongavia^® is a registered trademark of Teva Pharmaceutical Industries Ltd.
5. Lucentis^® is a registered trademark of Genentech Inc.
6. Baiama^® is a registered trademark of Klinge Biopharma GmbH

1. https://investor.regeneron.com/news-releases/news-release-details/regeneron-reports-fourth-quarter-and-full-year-2023-financial/
2. IQVIA sales data

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 shares are listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and are part of the selection index SDAX and TecDAX. Further information can be found at: https://www.formycon.com/

About Teva:
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader, harnessing its 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 58 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
Mail: 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.