Teva Announces Collaboration to Commercialize Formycon’s Biosimilar Candidate to Eylea® (aflibercept) in major parts of Europe and in Israel
Rhea-AI Summary
Teva Pharmaceuticals has announced a strategic collaboration with Klinge Biopharma and Formycon AG for the semi-exclusive commercialization of FYB203, a biosimilar candidate to Eylea® (aflibercept) in Europe (excluding Italy) and Israel. The product will be marketed under the brand name AHZANTIVE®, pending regulatory approval.
The collaboration leverages Teva's commercial experience in biosimilars and distribution network across Europe, combined with Formycon's expertise in biosimilar development. Under the agreement, Teva will lead commercialization efforts, while Klinge will receive milestone payments and revenue sharing.
The EMA's CHMP issued a positive recommendation for FYB203 in November 2024, with European Commission's decision expected in January 2025. The FDA has already approved the biosimilar in June 2024. Eylea®, used to treat neovascular age-related macular degeneration and other retinal diseases, generated global sales of approximately $9 billion in 2023, including $2.9 billion in the European market.
Positive
- FDA approval already secured for FYB203 in June 2024
- Positive CHMP recommendation received, indicating likely EU approval
- Target drug Eylea® has substantial market size ($2.9B in Europe)
- Builds on existing successful partnership with Formycon for ranibizumab biosimilar
- Expands Teva's biosimilar portfolio in line with growth strategy
Negative
- Semi-exclusive rights only, excluding Italian market
- Revenue sharing arrangement with Klinge may impact profit margins
News Market Reaction – TEVA
On the day this news was published, TEVA declined 2.39%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
- Klinge Biopharma GmbH (Klinge) holds the exclusive global commercialization rights for FYB203, Formycon's biosimilar candidate to Eylea®1
- Agreement builds on the proven and successful collaboration of commercialization of FYB201, Formycon's biosimilar to Lucentis®2 (ranibizumab) in Europe
- The partnership broadens Teva's biosimilars portfolio, in line with its Pivot to Growth strategy
TEL AVIV, Israel, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE: and TASE: TEVA) today announced that it has entered into a strategic collaboration with Klinge Biopharma GmbH (Klinge) and Formycon AG (FSE: FYB) for the semi-exclusive commercialization of FYB203, Formycon's biosimilar candidate to Eylea® (aflibercept) in Europe, excluding Italy, and in Israel.
This collaboration combines Teva’s deep commercial experience in biosimilars and its extensive distribution network and broad sales and marketing reach across Europe, with Formycon’s capabilities in the development of biosimilar medicines for highly regulated countries. Klinge has in-licensed the exclusive global commercialization rights to FYB203 from Formycon.
Under the terms of the agreement, Teva will lead the commercialization of FYB203 in the designated regions, to be marketed under the brand name AHZANTIVE®3, subject to regulatory approval. In return, Klinge will receive milestone payments and a portion from the product’s revenue.
Formycon is a leading, independent developer of high-quality biosimilars, focusing 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.
Richard Daniell, Executive Vice President, European Commercial at Teva said: "We are excited to extend our collaboration with Formycon, reinforcing the solid foundation that commenced with the commercialization of ranibizumab biosimilar (Ranivisio®4/Ongavia®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."
Commenting on the agreement, Nicola Mikulcik, CBO of Formycon, says, “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®/Ongavia®) 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.”
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, including USD 2.9 billion in the European market, further underscoring its status as the highest-revenue drug in the anti-VEGF therapy sector.
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 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/
1) Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.
2) Lucentis® is a registered trademark of Genentech Inc.
3) AHZANTIVE® is a registered trademark of Klinge Biopharma GmbH
4) Ranivisio® is a registered trademark of Bioeq AG
5) Ongavia® is a registered trademark of Teva Pharmaceutical Industries Ltd.
6) Baiama® is a registered trademark of Klinge Biopharma GmbH
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to commercialize Formycon’s biosimilar product candidate to Eylea® (aflibercept) under the strategic partnership with Klinge, once European regulatory approval is obtained; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to sustain and focus our portfolio of generic medicines; and other factors discussed in our Quarterly Report on Form 10-Q for the third quarter of 2024, and in our Annual Report on Form 10-K for the year ended December 31, 2023, including in the section captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
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FAQ
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