The European Commission approves FYB201/Ranivisio®1 (Ranivisio

DGAP-News: Formycon AG / Tag(s): Regulatory Approval
The European Commission approves FYB201/Ranivisio®1 (Ranivisio – Ranibizumab), a biosimilar of Lucentis®2 (topical with additional functionalities)
29.08.2022 / 08:00 CET/CEST
The issuer is solely responsible for the content of this announcement.

Press release, August 29, 2022

The European Commission approves FYB201/Ranivisio®1 (Ranivisio – Ranibizumab), a biosimilar of Lucentis®2

Munich, Amsterdam, Zug – Formycon AG (“Formycon”), Polpharma Biologics Group BV (“Polpharma Biologics”) and Bioeq AG (“Bioeq”) jointly announce that the European Commission (“EC”) has granted marketing authorization on the market (“AMM”) for Ranivisio® (Ranivisio – Ranibizumab), a biosimilar of Lucentis® (ranibizumab-injection), for the treatment of several serious retinal diseases in the European Union (“EU”).[i]

The EC approval follows a positive opinion issued in June 2022 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and applies to the 27 Member States of the European Union plus l Iceland, Norway and Liechtenstein.

Ranivisio® is indicated for the treatment of neovascular (wet) age-related macular degeneration (nDMA), the treatment of visual impairment due to diabetic macular edema (DME) or choroidal neovascularization (CNV), the treatment of proliferative diabetic retinopathy (PDR), as well as the treatment of visual impairment due to macular edema secondary to retinal vein occlusion (branch OVR or central OVR).[i]

FYB201/Ranivisio® was developed by Bioeq, a joint venture between Formycon and Polpharma Biologics. Mid-2021, Teva Pharmaceutical Industries Ltd. (“Teva”) has entered into a strategic partnership for the exclusive commercialization of FYB201 in Europe and other selected countries. Commercial launches across Europe are planned over the coming year, and the treatment is already available in the UK under the trade name Ongavia®3, following its approval by the Medicines and Healthcare Products Regulatory Agency (MHRA) in May 2022.

EU approval is based on the totality of evidence, including analytical, non-clinical, clinical and manufacturing data. In a phase III randomized, double-blind, parallel-group, multicenter study (COLUMBUS-AMD), it was shown that Ranivisio® is very similar to the reference product Lucentis® in terms of comparable efficacy, safety, pharmacokinetics and immunogenicity in patients with neovascular (wet) age-related macular degeneration. I

AMD is caused by excessive growth of blood vessels in the retina. Ranibizumab inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of these blood vessels in the retina. In developed countries, AMD is the most common cause of severe visual impairment or blindness and it is estimated that up to 77 million Europeans will be affected by 2050.[ii] The consequences of AMD weigh heavily on healthcare systems and societies, as the increasing incidence of the disease is expected to absorb huge amounts of healthcare resources and funds across the EU.

“Due to demographic development, more and more people in Europe are affected by age-related macular degeneration and other serious retinal diseases. This is very often accompanied by a significant deterioration in the quality of life. We are therefore particularly pleased that FYB201/Ranivisio® – which we have developed in collaboration with Polpharma Biologics and Bioeq – can contribute to the treatment options of ophthalmologists and the best possible care for these patients,” says Dr. Stefan Glombitza, CEO of Formycon AG.

“With the European launches of Ranivisio®, Formycon is transitioning to a new commercial phase. We are very happy to have in Teva a very reputable and strong commercialization partner at our side for the EU and other markets”, adds Formycon CBO Nicola Mikulcik.

“We are extremely pleased with this recognition by European regulatory authorities of the biosimilar ranibizumab. The production of biosimilars is a process with high levels of scientific rigor and approval from Ranivisio® is the culmination of years of dedication by Polpharma Biologics and our partners to successfully engineer this medical breakthrough for people with severe retinal disorders,” said Michael Soldan, CEO of Polpharma Biologics. “We look forward to working with our strategic partners to rapidly deliver this very important treatment to the people across Europe who need it most.”

1) Ranivisio® is a registered trademark of Bioeq AG.
2) Lucentis® is a registered trademark of Genentech Inc.
3) ongavia® is a registered trademark of Teva Pharmaceutical Industries Ltd.

About Formycon:
Formycon is a leading independent developer of high quality biopharmaceutical drugs, especially biosimilars. The company focuses on treatments in ophthalmology, immunology and other key chronic diseases, covering the entire value chain from technical development to clinical phase III as well as the preparation of MA dossiers. With its biosimilars, Formycon makes a major contribution to the access of the greatest number of patients to vital and affordable medicines. Formycon currently has six biosimilars in development. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of a COVID-19 drug FYB207. www.formycon.com

About Bioeq:
Bioeq is a Swiss biopharmaceutical joint venture between Polpharma Biologics Group and Formycon AG. Bioeq develops, licenses and markets biosimilars. www.bioeq.ch

About Polpharma Biologics:
Polpharma Biologics is an international biotechnology company with integrated operations in the European Union (EU), developing and manufacturing biosimilar medicines. Polpharma Biologics develops biosimilar products to treat a range of conditions in major therapeutic areas. Polpharma Biologics programs begin with cell line development and transition from technical and clinical development to commercial scale production, preparing drugs for future commercial partnerships with global pharmaceutical organizations. The company’s pipeline contains more than six biosimilars in various stages of development, including PB006 (biosimilar natalizumab) recently accepted for review by the EMA and FDA. www.polpharmabiologics.com

About Teva:
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic, biosimilar and specialty medicines with a portfolio of over 3,500 products in nearly every therapeutic area. Approximately 200 million people worldwide take a Teva medicine every day and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations that support our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com.

About biosimilars:
Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis, multiple sclerosis and eye diseases. In the years to come, many of these biotech drugs will lose their patent protection – and by 2020, drugs generating around $100 billion in revenue will no longer be patented. Biosimilars are follow-up versions of biopharmaceuticals, the exclusivity of which has expired. They are approved through strict regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar to the biopharmaceutical reference product of origin. Global sales of biosimilars are estimated to exceed $15 billion by 2020. By 2030, analysts estimate that figure could reach over $60 billion.

Contact:
Sabrina Müller
Senior Director of Corporate Communications and Investor Relations
Formycon AG
Fraunhoferstr. 15
82152 Martinsried/Planegg/Germany
telephone +49 (0) 89 – 86 46 67 149
fax + 49 (0) 89 – 86 46 67 110
[email protected] // www.formycon.com

Disclaimer:
This press release may contain forward-looking statements and information based on our current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could cause actual future results, financial condition, business performance, product development and the estimates presented herein to differ materially. These known and unknown risks and uncertainties include, but are not limited to, research and development, regulatory approval process, timing of actions by regulators and other governmental authorities, clinical outcomes, changes in laws and regulations , product quality, patient safety, patent litigation, contractual risks and dependencies on third parties. With respect to pipeline products, Formycon AG makes no representations, warranties, or other warranties that the products will receive the necessary regulatory approvals or that they will prove commercially operable and/or successful. Formycon AG undertakes no obligation to update these forward-looking statements or to correct them if developments differ from those anticipated. This document does not constitute an offer to sell or 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 and no public offering is planned. This document and the information herein may not be distributed in the United States of America, Canada, Australia, Japan or any other jurisdiction where such offer or solicitation is prohibited. This document does not constitute an offer of securities for sale in the United States.

References

[i] Ranivisio® (Ranivisio – Ranibizumab). EU Summary of Product Characteristics August 2021. Available at: https://www.ema.europa.eu/en. Last accessed August 2022.

[ii] 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. Available at: https://bjo.bmj.com/content/104/8/1077. Last accessed August 2022.

Additional Features:

File: Please also see Teva Pharmaceutical Industries Ltd press release.

29.08.2022 CET/CEST Dissemination of a Corporate News, transmitted by the DGAP – a service of EQS Group AG.
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Aurora J. William