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Munich – On July 25, 2023, Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) held its regular Annual General Meeting in person in Munich.

The represented shareholders followed the proposals of the management board and the supervisory board and voted in favor of all administration’s resolution proposals with large majorities. Both the members of the management board and the supervisory board received votes of confidence with majorities of 95 percent each.

Wolfgang Essler was elected with a large majority as a new member of the supervisory board after Dr. Thomas Strüngmann had resigned his supervisory board mandate at the end of the Annual General Meeting.

In its presentation, the management board provided detailed information to the shareholders about the company development and addressed all questions. Additionally, Dr. Andreas Seidl, who was appointed to the position of Chief Scientific Officer (CSO) in the board on July 1, 2022, and Enno Spillner, who was appointed to the position of Chief Financial Officer (CFO) in the board on April 1, 2023, introduced themselves to the shareholders.

At the time of the vote, approximately 9,636,657 million shares were represented, which corresponded to 60,08 percent of the share capital. Detailed voting results and further information about the 2023 Annual General Meeting can be found at Annual General Meeting – Formycon AG.

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Klinge Biopharma GmbH (“Klinge“) announce that the biologics license application (BLA) for FYB203, a biosimilar candidate for Eylea®¹ (Active ingredient: Aflibercept) has been submitted to the U.S. Food and Drug Administration („FDA“) in line with the initial schedule. Within 60 days after submission, FDA is expected to decide on whether to accept and to further review the BLA (“file acceptance”).

Eylea® is used in the treatment of neovascular age-related macular degeneration (“nAMD”) and other severe retinal diseases. It inhibits vascular endothelial growth factor (“VEGF”), which is responsible for the excessive formation of blood vessels in the retina. With global sales of around US$ 9.6 billion[i] Eylea® is currently the top-selling drug in this therapeutic area.

“We are very delighted to bring our second biosimilar candidate in ophthalmology on formal track for approval in the U.S. I would like to thank our licensing partner Klinge for their continuous support as well as the entire Formycon Team for their great efforts. With FYB203 we are going to address an important as well as growing market for the treatment of severe retinal diseases and contribute to alternative and cost-effective therapeutic options,” says Formycon CEO Dr. Stefan Glombitza.

“The submission of the BLA for FYB203 is proceeding according to our initial planning and we have once again demonstrated the agility and expertise of our development organization. FYB203 is an excellent complement to our ophthalmic portfolio and in addition to our already approved ranibizumab biosimilar (FYB201), we are fully committed in making another highly effective treatment option available,” comments Formycon CSO Dr. Andreas Seidl.

Eylea^® is a registered Trademark of Regeneron Pharmaceuticals Inc.

[i]Regeneron Reports Fourth Quarter and Full Year 2022 Financial and Operating Results | Regeneron Pharmaceuticals Inc.0

From June 07 to 08, 2023, the “Jefferies Global Healthcare Conference 2023” will be held in New York City, attended by members of the Formycon Management Board.

On Thursday, June 08, 2023 at 14:30 (CET) you can join us live via video webcast when Dr. Stefan Glombitza (CEO) and Enno Spillner (CFO) present Formycon AG.

Following the presentation, the webcast recording will be available for another 90 days via the webcast link.

Our next Events:

June 29 – 30, 2023
Stifel European Healthcare Summit 2023
Bordeaux

July 25, 2023
Annual General Meeting of Formycon AG
Haus der Bayerischen Wirtschaft, Munich

August 23 – 24, 2023
HIT – Hamburger Investorentag 2023
Hamburg

Please find our current Events at:
https://www.formycon.com/en/investor-relations/calendar/

Munich/Martinsried – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today published the unaudited results for the first quarter of the fiscal year 2023. Reporting on Group level is published in accordance with IFRS (International Financial Reporting Standards).

Significant milestone payment from FYB202 project and revenue contributions from FYB201 commercialization reflected in revenues

Formycon Group’s revenues increased to a total of Euro 21.5. million in the first quarter of 2023 (Q1/2022: Euro 8.1 million).

A significant part of revenues resulted from a first milestone payment as part of the commercialization partnership from project FYB202 signed in Q1/2023. A further milestone payment is expected in the course of 2023. The revenue and net-earnings contributions from the commercialization of FYB201, which are partly reflected in the revenues and partly in the at-equity result[1], are around the same level as in the previous quarter (Q4/2022). With the recent granting of the permanent reimbursement code (Q-code) in the United States and the associated simplification of the reimbursement process for treating physicians and their staff, a significant increase in sales of CIMERLI™^* in the United States can be expected from the second quarter of 2023 onwards.

For 2023, Formycon continues to forecast a significant increase in revenues at Group level compared to the previous fiscal year (2022: Euro 42.5 million), resulting from revenue contributions related to Lucentis®^** Biosimilars (FYB201) Ranivisio®^***/ Ongavia®^**** /CIMERLI™, anticipated milestone payments for project FYB202 and development services for the out-licensed (FYB203) and partnered project (FYB201).

EBITDA and EBIT in Q1 clearly positive due to milestone payment

As a result of the significant milestone payment on the revenue side, both EBITDA at Euro 4.5 million (Q1/2022: Euro -4.0 million) and EBIT at Euro 4.1 million (Q1/2022: Euro -4.4 million) are clearly positive compared to the prior-year quarters. However, as Formycon continues to remain in investment and development mode, EBITDA for the year is forecasted to be approximately at the level of the previous year (2022: Euro -15.9 million).

Net result for Q1 affected by at-equity consolidation and contingent liability to ATHOS KG

The Group’s net result for the period remains impacted by the following effects, which are recognized in earnings but not in cash: Due to the at-equity consolidation of the 50% share in Bioeq AG and the resulting pro-rata loss of Euro -6.5 million, as well as the fair value valuation of the contingent liability (contingent purchase price component) to ATHOS KG for the acquired assets (FYB201 and FYB202) in the amount of Euro -8.0 million, the consolidated net result for the first quarter of 2023 stood at Euro -13.5 million (Q1/2022: Euro -4.5 million). For 2023, Formycon group continues to expect a net result approximately in the amount of the previous year’s net result excluding the non-recurring gain from Formycons former investment participation in the FYB 202 GmbH & Co. KG partnership (2022: Euro -54.0 million).

The Group’s financial position at the reporting date of March 31, 2023 was strengthened as follows: Cash and cash equivalents totaled around Euro 54.8 million compared to Euro 9.8 million at December 31, 2022. At the beginning of 2023 Formycon was able to place a capital increase against contributions in cash in the amount of approximately Euro 70.1 million (gross proceeds), making partial use of the authorized capital and excluding shareholders’ subscription rights.

In addition, as part of the ATHOS transaction, the company was provided with an on-demand credit-line amounting up to Euro 68.0 million, of which Euro 20.0 million remained drawn as of March 31, 2023 after an initial repayment of Euro 20.0 million.

„In terms of key figures, the first quarter of 2023 was characterized by various positive special effects. In addition to the milestone payment as part of the global commercialization partnership for our FYB202 Stelara®***** biosimilar candidate, we also expect revenue and net-earnings contributions from the commercialization of FYB201 to increase significantly in the upcoming months, due to the recently issued reimbursement code in the United States. In addition, we will continue to invest significantly in the expansion of our pipeline to generate sustainable value. We continue to confirm our guidance for 2023″, commented Enno Spillner, CFO of Formycon AG.

[1] Due to the at-equity valuation of the 50% share in Bioeq AG, Formycon realizes a negative investment result in the amount of 50% of Bioeq AG’s net income for the period in addition to the direct license income from product sales.

*             Cimerli^TM is a Trademark of Coherus BioSciences, Inc.
**            Lucentis® is a registered Trademark of Genentech Inc.
***          Ranivisio® is a registered Trademark of Bioeq AG
****         Ongavia® is a registered Trademark of Teva Pharmaceutical Industries Ltd.
*****       Stelara® is a registered Trademark of Johnson & Johnson

Munich/Martinsried – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announced that members of the Management Board will present at the following investor conferences in the second quarter of 2023:

Equity Forum – Spring Conference 2023

• May 16 – 17, 2023
• Frankfurt/Main, Germany
• Presentation and 1×1 Meetings (Enno Spillner, CFO)

Hauck Aufhäuser – Stockpicker Summit 2023

• May 30 – June 01, 2023
• Mallorca, Spain
• 1×1 Meetings (Dr. Stefan Glombitza, CEO & Enno Spillner, CFO)

Jefferies Global Healthcare Conference 2023

• June 07 – 08, 2023
• New York City, USA
• Presentation and 1×1 Meetings (Dr. Stefan Glombitza, CEO & Enno Spillner, CFO)

Stifel European Healthcare Summit 2023

• June 29 – 30, 2023
• Bordeaux, France
• 1×1 Meetings (Enno Spillner, CFO)

For further information please visit the Formycon Website at Calendar – Formycon AG.

Munich/Martinsried – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today published its financial results and business development for the fiscal year 2022. The annual report at Group level is published for the first time in accordance with IFRS (International Financial Reporting Standards).

Strong corporate development due to progressing product pipeline, ATHOS transaction as well as market approvals and commercial launches of the first biosimilar FYB201

Formycon reflects on a transformative and successful financial year, which, in addition to significant progress in the development projects, was primarily driven by the transaction with ATHOS KG (“ATHOS“) in spring 2022 as well as by the approvals and market launches of the first biosimilar in the second half of the year.

The successful progress of the development projects forms the basis for Formycon’s long-term and sustainable growth. The late-stage biosimilar candidates FYB202 (ustekinumab) and FYB203 (aflibercept) have meanwhile successfully completed the clinical development phases and FYB206 (pembrolizumab) is in an advanced preclinical development stage. Formycon will continue to invest in the expansion of its biosimilar pipeline and has started the development of two new biosimilar candidates (FYB208 & FYB209) in the past fiscal year, substantially expanding the product portfolio. The final construct with a significantly longer half-life and improved efficacy was selected for the innovative COVID-19 drug FYB207 and GMP production has been started. Furthermore, a toxicity study has been initiated, which results are a prerequisite for entering the clinical development phase.

As part of the ATHOS transaction, 50% of the formerly out-licensed Lucentis®¹ biosimilar FYB201 and 100% of the Stelara®² biosimilar candidate FYB202, previously developed in a joint venture, were reacquired. The step-up in ownership of both projects has significantly increased the share in the initial and future commercialization revenues of the two products. The acquisition and integration of the long-standing partner Bioeq GmbH complemented and sustainably strengthened the development organization with extensive competencies.

Following approvals of FYB201 in the United Kingdom, the United States of America and Europe of FYB201 and market launches by the respective commercialization partners in the second half of 2022, Formycon expects significant revenue contributions from product commercialization starting in 2023.

Financial figures underline advancing development

On December 31, 2022, the Formycon Group’s financial figures had developed as follows: Group revenues, which in addition to Formycon AG also include the fully consolidated subsidiaries Formycon Project 201 GmbH, FYB202 Project GmbH, Formycon Project 203 GmbH, Bioeq GmbH and the 50% stake in Bioeq AG increased to a total of Euro 42.5 million (2021 IFRS: Euro 36.6 million) in the fiscal year 2022.

Consolidated earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to Euro -15.9 million (2021 IFRS: Euro -12.6 million), while the operating result (EBIT) was around Euro -17.7 million as of December 31, 2022, compared to Euro -14.0 million in the prior-year, primarily reflecting investments in the company’s own pipeline projects.

The net result for the period amounted to approximately Euro 36.0 million (2021 IFRS: Euro -13.3 million) and was mainly driven by a one-off effect affecting earnings but not liquidity in the amount of approximately Euro 89.7 million, which resulted from the ATHOS transaction. In addition, a non-cash financial expense of approximately Euro 22.8 million from the fair value valuation of the contingent purchase price payments associated with the transaction and the pro rata loss of Bioeq AG of Euro 12.8 million were included in the financial result.

The Group’s financial position remained stable as of the reporting date: Liquidity totaled around Euro 9.8 million on the reporting date, compared to Euro 25.0 million in the previous year. In addition, as part of the ATHOS transaction, the company was provided with an on-demand credit-line amounting to Euro 68.0 million, of which Euro 40.0 million had been drawn down as of the reporting date.

At the beginning of 2023 (after period end), Formycon was able to place a capital increase against contributions in cash in the amount of approximately Euro 70.1 million (gross proceeds), making partial use of the authorized capital and excluding shareholders’ subscription rights.

The net proceeds from the capital increase will primarily be used to accelerate the ongoing development projects (FYB202, FYB206, FYB208, FYB209) towards regulatory approval, as well as to expand the biosimilar pipeline and support the organic growth strategy. In addition, Formycon is considering integrating further assets along the value chain into the Company in order to accelerate its development into a highly specialized and globally active company in the biosimilars market segment. The capital measure also serves to strengthen the balance sheet, including the repayment of the drawn amount under the loan facility granted by ATHOS and Active Ownership as part of the ATHOS transaction.

Formycon AG, as the Group’s parent company and central development and operating unit, will continue to report in accordance with the rules of the German Commercial Code (HGB / German GAAP). Formycon AG achieved revenues (HGB) of Euro 28.3 million in the financial year 2022 (2021 HGB: Euro 26.5 million). The result (HGB) for this period amounted to Euro 65.8 million (2021 HGB: Euro -13.3 million) which is also caused by the extraordinary effect described above.

“We look back to a successful financial year with many positive events. The approvals and launches of our first biosimilar FYB201 as well as the ATHOS transaction have provided important growth impulses for our company. It is a great source of pride for us and the entire team that we were able to make an initial contribution to providing patients worldwide with expanded access to modern therapeutic options in ophthalmology. We will continue to invest in our development pipeline and focus on the successful advancement of our biosimilar candidates to sustainably increase the value creation of our company,” said Dr. Stefan Glombitza, CEO of Formycon AG.

 Formycon Group outlook for 2023

In 2023, Formycon Group expects a significant increase of revenues compared to fiscal 2022, resulting from revenue and earnings contributions from the commercialization of the Lucentis® biosimilar (FYB201) Ranivisio®³/ Ongavia®⁴ /CIMERLI™⁵ as well as anticipated milestone payments for the FYB202 project.

Due to the Group still continuing in a growth phase committing to intensive investment and product development, EBITDA is expected to remain at roughly prior-year level. No significant change is likewise expected to consolidated net result excluding the non-recurring gain from Formycon’s former investment participation in the FYB 202 GmbH & Co. KG partnership.

From a development perspective, regulatory submissions for Stelara® biosimilar candidate FYB202 and Eylea®⁶ biosimilar candidate FYB203 to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are expected in 2023.

The full Annual Report can be found at Financial Reports – Formycon AG

¹⁾ Stelara® is a registered Trademark of Johnson & Johnson 

²⁾ Lucentis® is a registered Trademark of Genentech Inc.

³⁾ Ranivisio® is a registered Trademark of Bioeq AG

⁴⁾ Ongavia® is a registered Trademark of Teva Pharmaceutical Industries Ltd.

⁵⁾ CIMERLI^TM is a Trademark of Coherus BioSciences, Inc.

⁶⁾ Eylea ® is a registered Trademark of Regeneron Pharmaceuticals Inc.

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announced the successful conclusion of the extended Phase I clinical study comparing the pharmacokinetics of FYB202 and the reference drug Stelara®.

As early as August 2022, the primary endpoint was achieved in the randomized, double-blind, multicenter Phase III study (VESPUCCI), demonstrating the comparable efficacy of FYB202 and the reference drug in patients with moderate-to-severe psoriasis vulgaris (plaque psoriasis). The positive results of the Phase I pharmacokinetics study successfully conclude the clinical development program. FYB202 was bioequivalent to the reference drug Stelara® sourced in the EU as well as in the U.S. for all primary endpoint parameters.

European and U.S. regulatory submissions are still planned for the third quarter of 2023. Provided successful approval by the respective health agencies, Fresenius Kabi will commercialize FYB202 in key global markets.

The active ingredient ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23. Since 2009, the originator medicine has been used to treat various severe inflammatory conditions such as moderate-to-severe psoriasis as well as psoriatic arthritis. Its approved indications were expanded to chronic inflammatory bowel diseases like treatment of Crohn’s disease (2016) and ulcerative colitis (2019). Stelara® achieved a global sales volume of USD 9.7 billion in 2022.[1]

Formycon CEO Dr. Stefan Glombitza comments: “The successful conclusion of the development phase of our ustekinumab biosimilar candidate marks a very important milestone for Formycon and highlights the significant progress in our biosimilar pipeline. We are confident that we will provide the authorities with a convincing data package this fall. With FYB202, we can contribute significantly to the treatment options in the growing market segment of inflammatory diseases.”

^* Stelara® is a registered Trademark of Johnson & Johnson

[1] Johnson & Johnson top pharmaceutical products by sales 2022 | Statista.

Munich, Germany – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announced that the Company’s Supervisory Board has appointed Mr. Enno Spillner to the Company’s Executive Board as Chief Financial Officer (CFO) effective April 1, 2023.

Mr. Spillner has more than 23 years of experience and outstanding expertise in the biotechnology industry. In his latest position he has been serving from 2016 to 2023 as CFO and member of the Management Board of Evotec SE, an international science company for the discovery, development and production of highly effective medicines.

In his role as CFO at Evotec SE, which is listed on MDAX, TecDAX as well as NASDAQ, the 52-year-old business graduate was responsible, inter alia, for the company’s successful capital market positioning and various successful financial and M&A transactions, and led the company to the US technology exchange NASDAQ in 2021. Most importantly, he helped ensure Evotec SE’s very dynamic international growth. Previously, Mr. Spillner worked for more than ten years (2005-2016) at the publicly listed 4SC AG, an innovative biopharmaceutical company, where he held the position as Chief Financial Officer and later additionally as Chief Executive Officer. Prior to that, Mr. Spillner had worked at Bioᴹ AG since 1999, initially as Head of Finance & Controlling. Later on, he gained additional responsibility for significant parts of the Bioᴹ investment business and in 2021 also took over the management of the BioM VC Fund as a partner. In this context, he held interim positions as CFO or CEO in portfolio companies.

Mr. Spillner currently holds supervisory board mandates at Nanobiotix SA, Paris and Leon-Nanodrugs GmbH, Munich.

In his role as Formycon CFO, he will be operationally responsible for the areas Finance/Controlling, Communications & Investor Relations, Human Resources, Legal/Compliance and IT and will, together with his colleagues on the Executive Board Dr. Stefan Glombitza (CEO), Nicola Mikulcik (CBO) and Dr. Andreas Seidl (CSO), drive the company’s further development into a globally operating and fully integrated pharmaceutical company with a focus on biosimilars.

Enno Spillner succeeds Dr. Nicolas Combé, whose appointment ended as scheduled on June 30, 2022. Since then, the co-founder of Formycon AG accompanied the company in an advisory capacity as interim CFO.

“I am very much looking forward to my new role of supporting Formycon with full verve in implementing its further growth strategy. The company has established a very promising position as a developer of high-quality biosimilars with a substantial portfolio. Formycon has extraordinary potential and I will work intensively with my new colleagues and the entire team to develop Formycon into one of the leading players in one of the large growth segments in the pharmaceutical industry. In particular, my wide-ranging experiences from the years at Evotec as well as my network can help to consistently implement the upcoming organizational and strategic steps. I would like to thank the Supervisory Board for the trust they have placed in me,” said Enno Spillner.

“With Enno Spillner, we are gaining an experienced and outstanding manager who has worked extremely successfully for many years as Chief Financial Officer at internationally operating listed biotechnology companies. We are convinced that he will shape the company with his expertise and help to continue Formycon’s success story.

I would like to express my special thanks to Dr. Combé, who, as founder and CFO, was jointly responsible for the establishment and development of our company for more than ten years and played a decisive role in driving it forward. On behalf of the entire Supervisory Board, we wish Nicolas all the best and are pleased that he will remain closely associated with the company,” commented Dr. Olaf Stiller, Chairman of the Supervisory Board of Formycon AG.

“Building Formycon from a start-up to a publicly listed company has been a fantastic and intense experience with many great moments. I have been very fortunate to be able to contribute to this success story, and I am very grateful for the support of so many special people over the years. In particular, I would like to thank my employees for their exceptional commitment, loyalty and willingness to perform, as well as my colleagues and the Supervisory Board for their ever-trusting cooperation and high personal appreciation. I am convinced that Enno Spillner as the new CFO is the ideal solution for Formycon and wish him and the entire Formycon family only the best for the future,” adds Dr. Nicolas Combé.

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today published positive preliminary efficacy and safety data from MAGELLAN-AMD Phase III clinical trial for FYB203, its proposed biosimilar to Eylea^®.

The FDA-specific interim analysis of the randomized, double-blind, multi-center phase III study met the primary efficacy endpoint, demonstrating comparable efficacy between FYB203 and the reference medicine Eylea^® in patients with neovascular age-related macular degeneration (nAMD).

The primary endpoint of the comparative global Phase III trial measures the change in best corrected visual acuity after eight weeks from baseline. The values obtained for FYB203 and the reference product are within the relevant equivalence limits. In addition, to date, the study was conducted without any clinically relevant differences in terms of safety and immunogenicity.

Following the approval and market launch of the ophthalmological biosimilar for Lucentis® (FYB201 marketed as Ongavia®² (UK), Ranivisio®³ (EU), and Cimerli^TM4 (US)), Formycon is now announcing, with FYB203, another successful development in the field of ophthalmology, thereby highlighting its strong position in this area.

Neovascular age-related macular degeneration (nAMD) is caused by the excessive growth of blood vessels in the retina. The active ingredient aflibercept inhibits the vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina, which leads to a progressive loss of vision. In industrialized countries, AMD is the most common cause of severe visual impairment or blindness. According to estimates, up to 77 million Europeans will be affected by 2050.[i]

Eylea® is currently the top-selling drug in the field of age-related eye disease and in 2021 achieved revenues of around US$ 9 billion. Recently, Klinge Biopharma GmbH, licensee and exclusive holder of the worldwide commercialization rights of FYB203, had entered into a binding term sheet for the exclusive commercialization of FYB203 in the United States of America with Coherus BioSciences, Inc.

Formycon’s CSO, Dr. Andreas Seidl, comments on the successful phase III study as follows: “We are delighted that our second project in the field of ophthalmology was able to impress in the clinical phase III MAGELLAN-AMD study. Given the extensive experience from FYB201, we are confident that we will also be able to make a high-quality and cost-effective biosimilar available with FYB203, thereby further expanding our strong position in the field of biosimilar development.”

[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. Last accessed in January 2023.

¹Eylea^® is a registered trademark of Regeneron Pharmaceuticals Inc.
²Ongavia® is a registered trademark of Teva Pharmaceutical Industries Ltd.
³Ranivisio® is a registered trademark of Bioeq AG
⁴Cimerli^TM is a trademark of Coherus BioSciences, Inc

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY), as the exclusive owner of the global commercial rights to FYB202, a biosimilar candidate to Stelara^® (ustekinumab), announced the conclusion of a global license agreement with Fresenius Kabi AG (“Fresenius Kabi”). Provided successful approval by the respective health agencies, Fresenius Kabi will commercialize FYB202 in key global markets.

Upon conclusion of the agreement Formycon receives an upfront payment as well as milestone payments contingent on the successful achievement of certain regulatory events which are expected to total in the mid double digit million Euro range. Post-commercialization value will be shared approximately equally by both companies. Semi-exclusive commercialization rights for Germany as well as rights for parts of the MENA2 region and Latin America remain with Formycon.

Fresenius Kabi is a global healthcare company that specializes in pharmaceuticals, medical technologies, and nutrition products for critical and chronic conditions. In the field of biosimilars, Fresenius Kabi focuses on the development and marketing of biosimilars in the area of autoimmune diseases and oncology.

In August 2022, Formycon published positive interim results for efficacy for FYB202 from the clinical phase III study VESPUCCI. The randomized, double-blind multi-centric phase III study achieved the primary endpoint, demonstrating comparable efficacy of FYB202 and the reference medicine Stelara^® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis).

In the extended phase I pharmacokinetics study, the recruitment of study subjects was successfully completed in October 2022. European and U.S. regulatory submissions for FYB202 are planned for the third quarter of 2023.

FYB202 is a proposed biosimilar referencing Johnson & Johnson’s Stelara®, a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin 23 for treatment of immune-mediated disorders. Stelara® is approved for treatment of moderate-to-severe plaque psoriasis, Crohn’s disease, ulcerative colitis as well as active psoriatic arthritis with a global sales volume of more than USD 9.5 billion in 2022.

“We are delighted about the conclusion of the agreement and are looking forward to a successful commercialization of our Ustekinumab biosimilar after approval. The combination of Formycon’s development expertise and Fresenius Kabi’s global commercial competence offers an excellent basis for providing access to our highly efficacious product to many patients,” says Nicola Mikulcik, Chief Business Officer at Formycon AG.

“We welcome the potential of this agreement to build on the strengths of our companies across the value chain from development to commercialization. With the commercialization of the Ustekinumab biosimilar we are expanding our product portfolio with another autoimmune disease treatment option. In line with our Vision 2026, this is yet another key milestone for Fresenius Kabi in delivering on our strategic priority of providing access to biosimilars for patients worldwide,” says Dr. Michael Schönhofen, Fresenius Kabi’s Chief Operating Officer and Member of the Fresenius Kabi Management Board.

¹⁾ Stelara^® is a registered trademark of Johnson & Johnson
²⁾ Middle East and North Africa