Archives Press Releases

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

[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

Munich, Germany – Formycon AG (FSE: FYB) and its commercialization partner Fresenius Kabi today announced the signing of a settlement agreement with Johnson & Johnson concerning the commercialization of FYB202, a biosimilar to Stelara^®1 (ustekinumab), in Europe and Canada. It was agreed to keep the terms of the agreement confidential.

Nicola Mikulcik, Chief Business Officer of Formycon AG, commented: “Achieving this settlement is testament to our strategic approach of ensuring we make early preparations to expand patient access to critical treatments. Our aim is to make a significant difference in patients’ lives by providing them with reliable, high-quality, and affordable treatment options. Following the settlement for the US, this is another important step that underlines the joint effort of Formycon and Fresenius Kabi, and it solidifies our position to make FYB202 accessible in key global markets.”

FYB202 is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin 23 and is used for the treatment of various severe immune-mediated disorders. Stelara^® is approved for the treatment of moderate-to-severe plaque psoriasis, Crohn’s disease, ulcerative colitis as well as active psoriatic arthritis. The marketing authorization application for FYB202 was accepted for review by the European Medicines Agency (EMA) in September 2023 and by the U.S. Food and Drug Administration (FDA) in November 2023. In February 2023, Formycon and Fresenius Kabi had entered into a global license agreement for the ustekinumab biosimilar candidate FYB202, under which FYB202 will be marketed by Fresenius Kabi in key global markets following successful approval.

¹⁾Stelara^® is a registered trademark of Johnson & Johnson.

Munich, Germany/Amman, Jordan – Formycon AG (FSE: FYB) and MS Pharma announced today that FYB201, a biosimilar to Lucentis^® (Ranibizumab), has received marketing authorization from the Saudi Food & Drug Authority. Following the successful market launch in Jordan last year and with winning the NUPCO tender in Saudi Arabia, FYB201 is expected to be available in another country in the MENA region from the second quarter of 2024. In addition, further market launches are planned in Algeria and other Gulf Cooperation Council (GCC) markets over the course of 2024. In Saudi Arabia, MS Pharma will market the biosimilar under the trade name Ravegza^®.

FYB201/Ravegza^® 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.

At the end of 2021, the company entered into an exclusive partnership with MS Pharma for the commercialization of FYB201 in the Middle East and North Africa (MENA) region. This strategic collaboration aims to improve access to ophthalmic treatments in the MENA region.

Ravegza^® is approved in Saudi Arabia for the treatment of patients with age-related neovascular (wet) macular degeneration (nAMD) and other serious eye diseases including retinopathies secondary to diabetes. In Saudi Arabia, millions of individuals grapple with Diabetes Mellitus (DM) and its complications. The prevalence of diabetic retinopathies (DR) is approximately 19.7%[i], resulting from damage to blood vessels in the retina due to prolonged high blood sugar levels. Additionally, Diabetic Macular Oedema (DME) affects 5.7% of the population, leading to fluid accumulation in the macula, vision impairment and even blindness. By inhibiting vascular endothelial growth factor (VEGF), Ravegza® is indicated to treat nAMD and DME effective and cost-efficient.

“The successful approval of FYB201 in Saudi Arabia underlines the quality of our biosimilar and its importance as an affordable treatment option for DME, one of the most common causes of severe visual impairment and blindness in the middle east,” said Nicola Mikulcik, CBO of Formycon. “Our partner MS Pharma winning the important NUPCO tender in Saudi Arabia is an outstanding achievement, as it enables us to serve a significant part of the public healthcare sector in Saudi Arabia.”

Kalle Känd, CEO of MS Pharma, stated, “The approval of Ravegza® in Saudi Arabia represents a significant milestone in the company’s ongoing mission to improve patient health and expand our services providing high quality accessible medicines. Biosimilar and specialty medicines are integral to MS Pharma product portfolio and play a crucial role in advancing our growth objectives in the MENA region. We are very proud that we will be making a substantial contribution to public healthcare through the government tender awarded in Saudi Arabia. This approval supports the company’s commitment to the Saudi market and its broader strategic initiatives within the kingdom.”

[i] AlQahtani AS, Hazzazi MA, Waheeb SA, Semidey VA, Semidey VA, Elgendy HK, Alkhars WI, Abouammoh MA, Al-Dhibi H. Saudi Arabia Guidelines for diabetic macular edema: A consensus of the Saudi Retina Group. Saudi Med J. 2021 Feb;42(2):131-145. doi: 10.15537/smj.2021.2.25623. PMID: 33563731; PMCID: PMC7989293. https://pubmed.ncbi.nlm.nih.gov/33563731/

Munich, Germany/Budapest, Hungary – Formycon AG (FWB: FYB) (“Formycon”) today announced that Hungary based specialty pharmaceutical company Gedeon Richter Plc. (“Gedeon Richter“) becomes strategic investor via cash capital increase from authorized capital in the amount of 9.08% of Formycon’s share capital.

Both companies are convinced of the huge potential of biosimilars and share the strategic proximity as well as the respective expertise in their fields of activity.

The clear focus of Formycon as a leading dedicated and independent developer of biosimilars and the operating radius of Gedeon Richter as a major multinational company with core competences in research and manufacturing, combine complementary strengths under the same vision as both companies are highly driven to improve patient’s access to important biologic therapies.

Based on the resolutions of Formycon’s Management Board and Supervisory Board, Gedeon Richter subscribed a cash capital increase of 9.08% in a private placement. The Company’s registered share capital will be increased by partially utilizing the authorized capital from currently EUR 16,053,025.00 by EUR 1,603,877.00 to EUR 17,656,902.00 by issuing 1,603,877 new no par-value bearer shares, each with a nominal value of EUR 1.00 of the share capital, against cash contribution. The placement price per new share is EUR 51.65 and represents the mean average value between today’s XETRA closing price and the volume-weighted average price of the shares over the last thirty trading days. Shareholders’ subscription rights for the new shares were excluded in accordance with § 4 (3) of the Articles of Association. Gedeon Richter will be subject to a customary lock-up obligation of 180 days.

The total inflow of funds amounts to EUR 82.84 million and will be used primarily for the further development of Formycon‘s existing biosimilar pipeline, especially FYB206, FYB208 and FYB209. In addition, the start of FYB210, a new biosimilar candidate, is planned for second half of this year.

“Robust supply and cost-competitive manufacturing are becoming increasingly important as a key component of the biosimilar value chain. Over the past few years, we have established a very trustful and successful operational cooperation with Gedeon Richter by utilizing their state-of-the-art manufacturing capabilities and I am very happy that we can enrich this partnership now even further. This transaction has the potential to generate strong momentum as it enables both parties to jointly leverage strategic long-term opportunities,” comments Dr. Stefan Glombitza, CEO of Formycon AG.

“From a financing perspective the cash funding secures the undamped simultaneous development of our competitive biosimilar candidates while adding a renowned collaboration partner as anchor investor who is clearly welcomed by our supervisory board and management board,” adds Enno Spillner, CFO of Formycon AG.

“The capital increase announced today serves to reinforce our strategic partnership with Formycon, with the aim of broadening patient access to biological therapies globally. Joining forces in this way will provide scale benefits and new business opportunities for both parties, while ensuring mission critical knowledge and experience transfer in a fast-evolving industry,” adds Gábor Orbán, CEO of Gedeon Richter Plc.

Munich, Germany – Formycon AG (FWB: FYB) today announced that its commercialization partner, Coherus BioSciences, Inc. has released new sales figures for CIMERLI^®1 (Ranibizumab-eqrn) in the US.  Accordingly, the number of CIMERLI^® doses sold since its commercial launch in the US in October 2022 has increased to around 190,000 by the end of 2023. In October 2023, the number of doses sold was reported at 100,000. Thus, the amount almost doubled in the fourth quarter of 2023. According to Coherus, cumulative sales of CIMERLI^® in the US totaled USD 125 million, exceeding original expectations by around 25%.² Formycon benefits from net sales in the low double-digit million range, which are reflected partly in sales and partly in the at-equity result of the 50% participation in Bioeq AG.

CIMERLI^® is the first FDA-approved Lucentis^®3-biosimilar for both strengths. In December 2023, CIMERLI^® achieved a market share of 38% by volume in the US Ranibizumab market⁴ and thereby continues to be the most successful biosimilar in this segment.

„We are extremely pleased with the successful uptake of our Lucentis^® biosimilar in the US, which has continued to gain momentum from quarter to quarter. The figures are similarly positive in the UK, where FYB201 (trade name: Ongavia^®5) achieved a market share of 69% in November 2023.⁶ This is confirmation of the outstanding quality of our biosimilar and the strong performance of our commercialization partners. With recent approvals in Canada, among others, and subsequent expected approvals and launches in Latin America, the Middle East and North Africa, we see how this highly important treatment option in the field of ophthalmology reaches more and more markets and can contribute to the best possible care for patients,“ commented Dr. Stefan Glombitza, CEO of Formycon AG.

¹⁾CIMERLI^® is a registered Trademark of Coherus BioSciences, Inc.
²⁾Preliminary, unreviewed and unaudited financial information of Coherus BioSciences, Inc.
³⁾ Lucentis^® is a registered Trademark of Genentech Inc
⁴⁾ IQVIA WSP & NSP
⁵⁾Ongavia^® is a registered trademark of Teva Pharmaceutical Industries Ltd.
⁶⁾IQVIA Monthly Data

Munich, Germany – Formycon AG (FSE: FYB), a leading, independent developer of high-quality biosimilars, today announced that Formycon CEO Dr. Stefan Glombitza will present at the upcoming 42^nd Annual J.P. Morgan Healthcare Conference on Tuesday, January 09, 2024, at 8:15 a.m. PT (5:15 p.m. CET).

Investors, analysts, members of the media and the general public are invited to listen to the live audio webcast of the presentation and Q&A session via this weblink. Subsequently, the webcast will also be available as a replay for 30 days on the Formycon homepage in the Investor Webcast Section.

Members of the Formycon Management Team will be hosting one-on-one investor meetings in San Francisco during the JP Morgan week and participate in Meru Advisor’s corporate access event. We welcome the opportunity to connect in person. To request a meeting, please contact the Meru Advisors via this link.