^* Klinge Biopharma GmbH (Klinge) owns the exclusive worldwide
Marketing rights for FYB203, Formycon’s biosimilar candidate for Eylea(®1)
* The agreement is based on proven and successful cooperation
in the marketing of FYB201, Formycon’s biosimilar to Lucentis(®2)
(ranibizumab), in Europe
* The partnership expands Teva’s biosimilar portfolio in line with the
“Pivot to Growth” strategy
TEL AVIV, Israel, Jan. 14, 2025 (GLOBE NEWSWIRE) — Teva Pharmaceuticals
International GmbH, a subsidiary of Teva Pharmaceutical Industries
Ltd. (NYSE: and TASE: TEVA) announced today for the semi-exclusive
Commercialization of FYB203, Formycon’s biosimilar candidate for Eylea(®) (aflibercept)
in Europe (with the exception of Italy) and in Israel a strategic one
Collaboration with Klinge Biopharma GmbH (Klinge) and Formycon AG (FSE: FYB)
to have entered.
This collaboration leverages Teva’s extensive commercial experience
in the field of biosimilars, its extensive distribution network and its breadth
Sales and marketing reach across Europe with the capabilities of
Formycon in the development of biosimilar medicines for countries with strict
regulations together. Klinge has exclusive worldwide marketing rights
Licensed for FYB203 from Formycon.
Under the terms of the agreement, Teva will continue to commercialize FYB203 in
the designated regions. Subject to regulatory approval
The product is marketed under the brand name AHZANTIVE(®3). In return
Klinge receives milestone payments and a share of product sales.
Formycon is a leading, independent developer of high-quality biosimilars
Focus on therapies in ophthalmology, immunology, immuno-oncology and
other important disease areas and covers almost the entire
Value chain from technical development to clinical studies
to approval by the authorities.
Richard Daniell, Executive Vice President, European Commercial at Teva, said:
?We are pleased to expand our collaboration with Formycon and with it
to strengthen the solid foundation that comes with the commercialization of ranibizumab
Biosimilars (Ranivisio(®4)/Ongavia(®5)) were launched in Europe. The
Collaboration expands and underlines Teva’s broad biosimilar portfolio
once again our firm commitment to providing access to high quality, innovative
Medicines for the benefit of patients and those we care for
to improve health systems.”
Commenting on the agreement, Nicola Mikulcik, CBO of Formycon, said:?With
Teva, we are gaining a strong and proven partner for FYB203 on a large scale
Parts of Europe and Israel. Teva markets its ranibizumab biosimilar FYB201
(Ranivisio(®)/Ongavia(®)) already in Europe and can be an existing one
commercial infrastructure and well-established sales channels in the area of
Using ophthalmology synergistically. We look forward to this trustworthy relationship
and build successful collaboration. What is particularly noteworthy is that
For the first time, Formycon covers the entire commercial supply chain of the end product
takes responsibility.”
In June 2024, the US Food and Drug Administration (FDA) approved
the aflibercept biosimilar FYB203. In November 2024, the Committee for
Medicines for Human Use (CHMP) of the European Medicines Agency (EMA).
positive recommendation for market approval of FYB203 under the brand names
AHZANTIVE(®) / Baiama(®6). The European approval decision
Commission is expected in the second half of January 2025.
Eylea(®) (aflibercept) is used to treat neovascular age-related diseases
Macular degeneration (nAMD) and other serious retinal diseases are used.
The active ingredient inhibits vascular endothelial growth factor (VEGF), which is responsible for
the excessive formation of blood vessels in the retina is responsible. In the
In 2023, Eylea(®) achieved global sales of around USD 9 billion,
of which 2.9 billion USD on the European market, underpinning this
its status as the top-selling drug in the field of anti-VEGF therapy.
About Teva:
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a worldwide
leading pharmaceutical company leveraging its generics expertise and innovations
promotes the discovery, deployment and further development of modern
advance medicines. For over 120 years, Teva has maintained its commitment to
never gave up on improving health. Today this enables global
The company’s network of around 37,000 employees in 58 markets
To expand boundaries of scientific innovation and high-quality medicines
to deliver that improves the health of millions of people every day
patients contribute. Learn more about how Teva is committed to one
for better health can be found at www.tevapharm.com.
About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality
Biosimilars, follow-up products to biopharmaceutical drugs. The company
focuses on therapies in the areas of ophthalmology, immunology,
Immuno-oncology and other important disease areas and covers almost all of them
entire value chain from technical development to clinical
studies through to approval by the authorities. For marketing his
Formycon relies on strong, trustworthy and long-term biosimilars worldwide
Partnerships. With FYB201/Ranibizumab, Formycon already has a biosimilar
Europe and the USA on the market. Two other biosimilars, FYB202/Ustekinumab
and FYB203/aflibercept, received FDA approval; FYB202 is also in Europe
approved. Another four biosimilar candidates are currently in the pipeline
Development. With its biosimilars, Formycon makes an important contribution
giving as many patients as possible access to highly effective and affordable medicines
to enable medicines.
Formycon shares are listed in the Frankfurt Prime Standard
Stock exchange: FYB/ISIN: DE000A1EWVY8/WKN: A1EWVY and is part of the
Selection indices 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
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that are personal
Securities Litigation Reform Act of 1995, based on current assessments
and expectations of management and significant known and
are subject to unknown risks and uncertainties that may result in
our future results, performance or achievements may differ significantly from those in
results expressed or implied by these forward-looking statements,
achievements or successes differ. Forward-looking statements can be identified by the
Using words like?should”,?expect”,?anticipate”,?estimate”,
“goal”, “can”, “predict”, “guidance”, “intend”, “plan”,
“believe” and other similar terms or expressions in connection with a
Discussion of future operating or financial performance identified
become. Important factors that cause or contribute to such deviations
may contribute are risks relating to: our ability to formycons
Biosimilar product candidates to Eylea(®) (aflibercept) as part of the
strategic partnership with Klinge to market as soon as the European
official approval is available; our ability to be successful in the market
compete, including our ability to provide additional pharmaceutical
develop and market products; our ability to our?pivot to
Successfully implementing our “Growth” strategy. This includes expanding our
Pipeline of innovative and biosimilar drugs and the profitable
Marketing the innovative drug and biosimilar portfolio, be it
organically or through business development, as well as maintaining and
Focusing our generics portfolio; other factors that are 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
are discussed, among other things, in the “Risk Factors” section. Forward-looking
Statements only apply at the time they are made. Therefore
We assume no obligation to make any forward-looking statements or otherwise herein
information contained as a result of new information, future events
or to update or revise for any other reason. You will
You are cautioned not to place undue reliance on these forward-looking statements
to leave.
Media inquiries to Teva
(mailto:[email protected])
Inquiries to Teva Investor Relations
[email protected] (mailto:[email protected])
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