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Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has today announced its results for the first nine months of the 2022 fiscal year. On the Group level, reporting is performed in accordance with IFRS (International Financial Reporting Standards).

At the end of the third quarter, the Formycon Group’s financial figures were as expected. The turnover of the Group, which, alongside Formycon AG, comprises the fully consolidated subsidiary companies Formycon Project 201 GmbH, FYB202 Project GmbH, Formycon Project 203 GmbH, Bioeq GmbH as well as a 50% stake in Bioeq AG, which is consolidated at equity, totaled Euro 28.2 million in the first nine months of the year 2022 (prior-year period IFRS: Euro 27.4 million). Formycon is forecasting revenues at Group level of around Euro 40 million for the whole year.

The Formycon Group focuses on research and development for its own, or out-licensed biosimilars projects as well as its own COVID-19 drug (FYB207). A large part of the revenue results from the development services for the out-licensed (FYB203) and partnered project (FYB201).

In July 2022 the commercialization of FYB201 in Great Britain started, through the distribution partner Teva Pharmaceutical Industries Ltd. (“Teva”) and in October, in the US, through Coherus BioSciences Inc. Additionally, in November, FYB201 was introduced onto the market in Germany by Teva. The nine-month figures included the first commercialization revenues from Great Britain since the introduction of FYB201 onto the market at the start of July. For the full year 2022, sales and earnings contributions from the marketing revenues in the additional territories are expected.

The Group’s earnings before interest, tax, depreciation and amortization (EBITDA) stood at Euro -10.9 million (prior-year period IFRS: Euro -10.0 million), the operating result (EBIT) was Euro -12.1 million as of September 30, 2022, compared with -10.9 million in the prior-year period. The Group net period result amounted to Euro 61.1 million (prior-year period IFRS: Euro -11.1 million).

The period result is further affected by a one-off effect that influenced the result but not the liquidity. This resulted from the sale of the minority stake (24.9%) in FYB 202 in the course of the transaction with ATHOS KG (“ATHOS”). In the course of this, Formycon AG withdrew as a partner of FYB 202 GmbH & Co. KG. In parallel with this, the acquisition of 100% of the shares of FYB202 Project GmbH, in which the global assets and commercialization rights to FYB202 are located, took place.

After the acquisition of FYB202, as part of the transaction with ATHOS, the 50% stake ATHOS held in FYB201, a biosimilar for Lucentis®¹, was also taken over, among others. For both financial assets (FYB201 and FYB202) there is a conditional liability (conditional purchase price components) towards ATHOS, the amount of which depends on the project-specific and actual realization of proceeds. The compounding of this liability, which must be adapted periodically, also influences the result but not liquidity and runs counter to the previously described effect.

The Formycon Group’s stocks of liquid assets, which comprise cash, checks, bank deposits and securities, remained solid at Euro 12.1 million as of September 30, 2022. Including short-term receivables from deliveries and services, as well as other assets, the Formycon Group held liquid assets totaling Euro 22.6 million on the day of reporting (prior year: Euro 33.7 million).

In the first nine months of the year, Formycon AG, as the Group’s central development and operational unit, continues to report according to the regulations of the Handelsgesetzbuch (HGB – German Commercial Code) and achieved a turnover of Euro 21.8 million (prior-year period: Euro 20.4 million). The company’s nine-month result was Euro 73.7 million compared to Euro -10.7 million last year.

“The nine-month result reflects our expectations. The global introduction onto the market of FYB201 under the trade name Ongavia®² (UK) or Ranivisio®³ (EU) and Cimerli^TM4 (US) by our partners and the revenues anticipated due to this are an important milestone in our transformation to a commercial-stage company. At the same time, we continue our growth strategy with planned investments into our pipeline, in order to create sustainable value, explains Dr. Stefan Glombitza, CEO of Formycon AG.

¹Lucentis® is a registered trademark of Genentech 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) has today published preclinical in vivo results for the development of their COVID-19 drug FYB207.

In the course  of preclinical in vivo studies, data on the pharmacokinetics and efficacy of various constructs of the ACE2-Fc fusion protein were collected in two different models, in order to select the most appropriate candidate for the human clinical trial.

The proprietary modifications of the molecular structure of the FYB207 lead candidate led to the desired effects and resulted in a significant extension of the half-life. By corresponding glyco optimizations and sequence modifications in the antibody part (Fc part), the lead candidate ACE2-IgG1-Fc (FYB207) achieved a half-life of more than 14 days, which is the order of magnitude of antibodies. As a result, FYB207 may not only have a broader application spectra for prophylaxis and treatment of COVID-19 but also in other indication areas.

Due to the high sialylation achieved within the context of glyco optimization, binding affinity to relevant receptors in the liver is reduced, which significantly slows down the elimination of the active substance and increases the bioavailability in the organism. In addition, sequence modifications have been introduced in the binding region of the antibody portion to the neonatal-receptor, enabling FYB207 to bind better to this receptor, thereby improving the recycling of the fusion protein in the body.

In the efficacy study, the in vivo preclinical models showed a significant reduction in viral load in the lungs, demonstrating the neutralizing effect of FYB207 also against the SARS-CoV-2 Delta variant in the organism. Thus, the FYB207 lead candidate, unlike vaccines and neutralizing antibodies, retains its full antiviral potential against SARS-CoV-2 variants of concern.

SARS-CoV-2 and other coronaviruses use the protein ACE2 on the surface of human cells as a portal of entry for respiratory infections. Biotechnologically produced ACE2 may compete for binding of the virus and thus prevent cell infection. Formycon has fused the human ACE2 protein to the constant part of human immunoglobulin G1 (IgG1) using computational structural design and thereby created FYB207, a highly effective SARS-CoV-2 blocker. By fusion with the optimized Fc part, ACE2 was stabilized and bioavailability significantly prolonged. ACE2 also has inherent enzymatic activity that may provide patients with additional protection for their lungs and cardiovascular system. In addition, FYB207 can potentially be used for all coronaviruses that use ACE2 as a port of entry.

The development strategy for an accelerated approval process has already been coordinated with the Paul Ehrlich Institute (“PEI”) and the FDA through Scientific Advices in 2021. In a follow-on Scientific Advice in May 2022, the PEI confirmed full support for the improved drug molecule for the accelerated development program. Another PEI meeting to align the clinical program is scheduled this year.

The GMP production of the study medication currently takes place for the start of the clinical trials. A toxicity study with the optimized molecular construct will be conducted at the beginning of next year. Entry into clinical trials is planned for 2023.

“The performed pre-clinical studies and the available data from the lead candidates form an important milestone in the development of our COVID-19 drug. The expanded in vivo study confirmed the intended objective – extending half-life – and showed that with FYB207 we are on track to develop a highly effective and long-lasting COVID-19 medication that is directed against all variants. In terms of efficacy, the study also showed the desired successes by demonstrating that viral load in the lungs of living organisms is significantly reduced,” explains Dr. Andreas Seidl, CSO of Formycon AG.

“The threat of viral mutations will continue in the future. With each successful mutation, SARS-CoV-2 evades vaccines and therapeutic antibodies a little bit more. Fusion proteins such as FYB207 can potentially make an important contribution here for the prevention and treatment of COVID-19,” adds Dr. Stefan Glombitza, CEO of Formycon AG.

Formycon will present the results of the completed in vivo preclinical studies at the Festival of Biologics in Basel (Switzerland) on November 4, 2022 and the Drug Discovery Summit in Madrid (Spain) on November 16/17, 2022.

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today published its half-year report 2022, confirming the preliminary operating figures for the first half of 2022 already announced on September 06, 2022. In addition to this, the figures published today include purchase price allocation effects from the transaction with ATHOS KG closed in May where Formycon AG acquired 100% of the rights to FYB202, a biosimilar candidate for Stelara®¹, the 50% stake of ATHOS KG in FYB201, a biosimilar for Lucentis®², and the operational development unit Bioeq GmbH.

On the day of reporting, June 30, 2022, the financial figures of the Formycon Group were in line with Formycon’s expectations. Turnover within the Group, which alongside Formycon AG also includes the fully consolidated subsidiaries Formycon Project 201 GmbH, FYB202 Project GmbH, Formycon Project 203 GmbH, Bioeq GmbH and the 50% stake in Bioeq AG, which is consolidated at equity, totaled in Euro 17.6 million in the first six months of 2022 (H1/2021 IFRS: Euro 20.2 million).

With the market launch of FYB201 in the United Kingdom (UK) and the United States of America, as well as the launch in the EU by the respective commercialization partners, the first revenue and earnings contributions from commercialization proceeds are expected in the second half of 2022. For the full year of 2022, Formycon continues to forecast revenues above last year’s level for the entire Group (2021 IFRS: Euro 36.6 million).

Consolidated earnings before interest, taxes, depreciation and amortization (EBITDA) stood at Euro -7.6 million (H1/2021 IFRS: Euro -9.7 million), while the operating result (EBIT) was around Euro -8.5 million as of June 30, 2022, compared with Euro -10.5 million in the prior-year period. The consolidated result for the period recorded a significant increase and amounted to Euro 80.0 million (H1/2021 IFRS: Euro -10.6 million).

Due to the sale of the minority stake (24.9%) in FYB 202 GmbH & Co. KG to Aristo Pharma GmbH as part of the transaction with ATHOS KG, the result for the period was dominated by an extraordinary effect, which had no impact on earnings or liquidity. In this context Formycon AG ceased to be a shareholder of FYB 202 GmbH & Co. KG. In parallel, the acquisition of 100% of the shares in FYB202 Project GmbH, in which the global assets and commercialization rights to FYB202 are located, was realized.

Extract of the Formycon Group balance sheet (IFRS, as of June 30, 2022)

The increases in non-current assets, equity and non-current liabilities resulted mainly from the transaction with ATHOS KG and the subsequent purchase price allocation. Deferred tax liabilities reflect the tax effect of the intangible assets acquired and recorded. The liabilities from the conditional purchase price payment represent the component of the purchase price that is contingent on project-specific and factual revenue recognition in the acquired projects (FYB201 and FYB202). This purchase price component can assume values between 0 and the amount stated here.

The Group’s financial position continues to be solid: Stocks of liquid assets, which comprise cash, checks, bank deposits and securities, totaled around Euro 18.2 million on the day of reporting, compared to Euro 25.0 million as of December 31, 2021. In addition, as part of the ATHOS transaction, the company was provided with an on-demand line of credit amounting to Euro 50 million, of which Euro 40.0 million have not been utilized and could still be drawn down as of the reporting date.

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). Formycon AG achieved a turnover (HGB) of Euro 12.5 million in the first half of 2022 (H1/2021 HGB: Euro 12.4 million). The result (HGB) for this period amounted to Euro 82.6 million (H1/2021 HGB: Euro -10.0 million) which is also caused by the extraordinary effect described above.

“We look back on a successful half-year, which culminated in the transaction with ATHOS KG and the first approval of FYB201. The launch of FYB201, which has now taken place in the U.K. as well as in the US and is expected in the EU shortly, is another important milestone in our transformation into a company generating income from product commercialization,“ commented Dr. Stefan Glombitza, CEO of Formycon AG.

The full half-year report can be found at
https://www.formycon.com/en/investor-relations/financial-reports/

¹⁾ Stelara® is a registered trademark of Johnson & Johnson
²⁾ Lucentis® is a registered trademark of Genentech Inc.

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announced details of a previously undisclosed project in its development pipeline. FYB206 is a biosimilar candidate for Keytruda^® (pembrolizumab) and the development is at an advanced preclinical stage. In addition to biosimilars in the field of ophthalmology (FYB201/FYB203), immunology (FYB202) and two further yet unpublished biosimilar candidates (FYB208/FYB209), Formycon is expanding its therapeutic range with FYB206 to the rapidly growing field of immuno-oncology.

The active ingredient pembrolizumab is a humanized monoclonal antibody that belongs to the group of immune checkpoint inhibitors and is established in the treatment of a variety of tumors. Pembrolizumab binds to the PD-1 receptor and specifically blocks the interaction between PD-1 and its ligand PD-L1. This helps the immune system activate the body’s own cellular anti-tumor immune response and kill e.g. melanoma cells.

Since 2015, Keytruda^® has been established for the treatment of advanced melanoma, lung and other types of carcinoma. In 2021, the reference market for Keytruda^® was reported at a size of more than USD 17 billion worldwide.[i] Expert analyses predict that Keytruda^® will become the world’s top-selling drug in 2023, with annual revenue potential expected to be well over USD 20 billion as early as 2025.[ii]

The development and commercialization rights for FYB206 are fully owned by Formycon. Important IP has already been created and patent applications have been filed, with data from the development of alternative formulations. Following convincing results from the extensive analytical protein characterization as well as significant progress in the development of the manufacturing process, a comprehensive data package is currently being compiled in order to closely align further program steps in Scientific Advice Meetings with the EMA and FDA in the second half of the year. Adjusting the manufacturing process to commercial scale is planned for the end of 2022. For this purpose, Formycon has already secured GMP manufacturing capacities at a renowned contract manufacturer.

“Cancer, in its various forms, is still one of the most common and serious diseases of our time. The cost of effective cancer treatments has become a major challenge for healthcare systems around the globe. With the development of a Keytruda^® biosimilar, we are pursuing the goal of facilitating access to this important medication for patients worldwide, while at the same time providing urgently needed savings for the healthcare systems,” says Dr. Stefan Glombitza, CEO of Formycon AG.

Formycon’s CSO, Dr. Andreas Seidl, adds: “With FYB206, we have a promising biosimilar candidate in the fast-growing field of immuno-oncology in our development portfolio. Keytruda^® is a highly effective drug being successfully used as a breakthrough therapy for several types of cancer, including skin, lung and colorectal cancer.”

^*Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA.

[i] Statista Revenue of Keytruda from 2014 to 2021 Keytruda revenue 2014-2021 | Statista. Retrieved September 2022

[ii] Best-selling drugs of the next 5 years  The best-selling drugs of the next 5 years – Pharma Excipients; Merck, BMS, AbbVie blockbusters will rule pharma sales in 2025: report | Fierce Pharma. Retrieved September 2022

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announced its preliminary and unaudited financial figures for the first half of 2022. Reporting at Group level is performed for the first time in accordance with IFRS (International Financial Reporting Standards).

The preliminary figures do not yet include purchase price allocation effects from the ATHOS transaction closed in May where Formycon AG acquired 100% of the rights to FYB202, a biosimilar candidate for Stelara®¹, the 50% stake of ATHOS KG in FYB201, a biosimilar for Lucentis®², and the operational development unit Bioeq GmbH. The publication of the final figures respectively the half-year report is scheduled for October 28, 2022.

On the day of reporting, June 30, 2022, the preliminary key financial figures of the Formycon Group were in line with Formycon’s expectations. Turnover within the Group, which alongside Formycon AG also includes the fully consolidated subsidiaries Formycon Project 201 GmbH, FYB202 Project GmbH, Formycon Project 203 GmbH, Bioeq GmbH and the 50% stake in Bioeq AG, which is consolidated at equity, totaled in Euro 17.6 million in the first six months of 2022 (H1/2021 IFRS: Euro 20.2 million). For the full year of 2022, Formycon continues to forecast revenues above last year’s level for the entire Group (2021 IFRS: Euro 37 million).

Preliminary consolidated earnings before interest, taxes, depreciation and amortization (EBITDA) stood at Euro -7.6 million (H1/2021 IFRS: Euro -9.7 million), while the preliminary operating result (EBIT) was around Euro -8.5 million as of June 30, 2022, compared with Euro -10.6 million in the prior-year period. The preliminary consolidated result for the period recorded a significant increase and amounted to Euro 80.0 million (H1/2021 IFRS: Euro -10.6 million).

The preliminary result for the period was dominated by an extraordinary effect, which had no impact on earnings or liquidity and resulted from the sale of the minority stake (24.9%) in FYB 202 GmbH & Co. KG to Aristo Pharma GmbH, following which Formycon AG ceased to be a shareholder of FYB 202 GmbH & Co. KG. In parallel, the acquisition of 100% of the shares in FYB202 Project GmbH, in which the global assets and commercialization rights to FYB202 are located, was realized.

The Group’s financial position continues to be solid: Stocks of liquid assets, which comprise cash, checks, bank deposits and securities, totaled around Euro 18.2 million on the day of reporting, compared to Euro 25.0 million as of December 31, 2021. In addition, as part of the ATHOS transaction, the company was provided with an on-demand line of credit amounting to Euro 50 million, of which Euro 40.0 million have not been utilized and could still be drawn down as of the reporting date.

Currently, Formycon Group is focusing on research and development activities for its fully-owned and out-licensed biosimilar projects, as well as its fully-owned COVID-19 drug (FYB207). The current revenues also result from the development services for the out-licensed or partnered projects. Following the approval of these products, Formycon will also take a share of subsequent commercialization revenues. With the market launch of FYB201 in the United Kingdom (UK) and the briefly upcoming market launch in the United States of America and – following the recently announced approval by the European Commission in late August – in the EU through the respective commercialization partners, Formycon expects first revenues and earnings contributions from the commercialization revenues in the second half of 2022.

As in the previous year, the preliminary operating key figures (EBITDA and EBIT) continue to be mainly attributable to investments in the company’s own pipeline. In the FYB202 project, the extended scope pharmacokinetics Phase I study is currently ongoing, following the completion of which the regulatory submission in Europe and the US is planned for the third quarter of 2023. In project FYB203, a biosimilar candidate for Eylea®³, which has been out-licensed to Klinge Biopharma GmbH (an ATHOS company), recruitment for the ongoing Phase III clinical trial was successfully completed in April 2022. Data on the primary efficacy endpoint are expected by the end of this year.

The FYB206 biosimilar project continues to progress according to plan. Scientific advice meetings with EMA and FDA and scale-up of the manufacturing process to commercial scale are planned for the second half of the year. In the innovative development project FYB207, a promising antiviral drug candidate against SARS-CoV-2 and its variants, preclinical studies are expected to be completed in 2022, the manufacturing process will be adapted to the optimized molecule, and the production of test material for stability studies and clinical trials will be carried out. Entry into clinical trials is planned for 2023. In addition, the development pipeline was expanded by the two new biosimilar projects FYB208 and FYB209.

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). Formycon AG achieved a turnover (HGB) of approximately Euro 12.5 million in the first half of 2022 (H1/2021 HGB: Euro 12.4 million). The preliminary result (HGB) for this period amounted to Euro 82.6 million (H1/2021 HGB: Euro -10.0 million) which is also caused by the extraordinary effect described above.

Dr. Stefan Glombitza, CEO of Formycon AG, comments on the preliminary half-year results as follows: “We are extremely satisfied with the performance in the first half of 2022. The successfully realized transaction with ATHOS KG and the first market approval of FYB201 were certainly outstanding events. We also made very pleasing progress in all other development projects and also initiated two new biosimilar projects with FYB208 and FYB209. The international launch of FYB201, which has already started in the UK and will soon continue in US and EU, marks another important milestone for our company. Based on the expected cash flows in combination with a broad and valuable pipeline as well as a strong development organization, we believe we are very well positioned for the continued consistent execution of our growth strategy.”

¹⁾ Stelara® is a registered trademark of Johnson & Johnson
²⁾ Lucentis® is a registered trademark of Genentech Inc.
³⁾ Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.

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 (“MA”) for Ranivisio^® (Ranivisio – Ranibizumab), a biosimilar to Lucentis^® (ranibizumab-injection), for the treatment for several serious retinal diseases in the European Union (“EU”).[i]

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 is applicable to all 27 European Union member states plus Iceland, Norway and Liechtenstein.

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

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

The EU-approval is based on the totality of evidence including analytical, nonclinical, clinical and manufacturing data. In a randomized, double-masked, parallel group, multicenter phase III study (COLUMBUS-AMD) it was shown that Ranivisio^® is highly similar to the reference product Lucentis^® in terms of comparable efficacy, safety, pharmacokinetics and immunogenicity in patients with age-related neovascular (wet) 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 carry a significant burden for healthcare systems and societies as the increasing incidence of the condition  is expected to absorb considerable amounts of healthcare resources and funds across the EU.

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

“With the European launches of Ranivisio^®, Formycon is in transition to a new business phase. We are very happy that in Teva we have a highly reputable and strong commercialization partner on our side for the EU and other markets”, adds Formycon CBO Nicola Mikulcik.

“We are immensely pleased with this recognition by the European regulatory authorities of biosimilar ranibizumab. The production of biosimilars is a process with high levels of scientific rigor and the approval of Ranivisio^® is the culmination of years of dedication by Polpharma Biologics, and our partners, to successfully engineer this medical advancement for those with severe retinal impairments,” says Michael Soldan, CEO of Polpharma Biologics. “We look forward to working with our strategic partners to rapidly get 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.

[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.

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today reported positive preliminary efficacy and safety data from VESPUCCI Phase III clinical trial for FYB202, its proposed biosimilar version of Stelara^®(Ustekinumab).

The multi-center, randomized, double-blinded, comparative clinical study met the primary efficacy endpoint, demonstrating comparable efficacy between FYB202 and the reference medicine Stelara^® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis). This is the most common form of psoriasis, accounting for 80 to 90 percent of all cases.

The primary endpoint of the comparative global Phase III study measures the percent improvement of the Psoriasis Area and Severity Index (PASI) at 12 weeks from baseline. The values obtained for FYB202 and reference product are within the relevant equivalence limits. In addition, to date, no clinically meaningful differences in safety and immunogenicity have been observed.

The extended Phase I pharmacokinetics study has commenced. Recruitment is evolving according to plan and a substantial number of subjects has already been enrolled in the study.

The active ingredient ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23. Since 2009, Stelara^® 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 over USD 9 billion in 2021.

As a result of the transaction with ATHOS KG, which was successfully concluded in the first half of 2022, the global commercialization rights to FYB202 are held in full by Formycon AG (prior to the transaction 24.9% co-ownership share).

Formycon’s CEO Dr. Stefan Glombitza is pleased with the results: “With FYB202 we have a promising biosimilar candidate and are addressing an important and growing market in the inflammatory diseases segment. The positive interim phase III study results mark an important milestone and underline our expertise in the development of high-quality biosimilars.”

* Stelara® is a registered trademark of Johnson & Johnson

Munich, Amsterdam, Zug – Formycon AG (“Formycon”), Polpharma Biologics Group BV (“Polpharma Biologics”) and Bioeq AG (“Bioeq”) jointly announce, that the U.S. Food and Drug Administration (“FDA”) has approved CIMERLI™ (ranibizumab-eqrn), a biosimilar product interchangeable with Lucentis® (ranibizumab injection).

FYB201 was developed by Bioeq, a Joint Venture between Formycon and Polpharma Biologics. End of the year 2019, Coherus BioSciences, Inc. (“Coherus”) entered into a license agreement for the exclusive commercialization of FYB201 under the brand name CIMERLI™ in the United States of America (“U.S.”).

CIMERLI™ obtained approval from FDA for the treatment of Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), Macular Edema following Retinal Vein Occlusion (RVO) and Myopic Choroidal Neovascularization (mCNV). CIMERLI™ is the first and only interchangeable biosimilar with an exclusivity of 12 month after market launch that is indicated for the treatment of all five Lucentis® indications and as such is a new medical option for patients with serious retinal diseases. [i]

FDA-approval and interchangeability designation are based on a totality of evidence including analytical, nonclinical, clinical and manufacturing data. Efficacy, safety, pharmacokinetics and immunogenicity of CIMERLI™ were found to be comparable to the reference drug Lucentis® in patients with Age-Related Neovascular (wet) Macular Degeneration (nAMD). Clinical readouts from the randomized, double-masked, parallel group, multicenter phase III study (COLUMBUS AMD) have been published in the peer-reviewed journal Ophthalmology. [ii]

CIMERLI™ belongs to the anti-VEGF therapy class of biologics that have been revolutionary in helping retinal patients in maintaining or regaining vision. It inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina. The U.S. market for ophthalmic drugs in anti-VEGF therapy is around $7 billion per year and, according to analysts, will continue to grow further. The commercial launch of CIMERLI™, in both 0.3mg and 0.5mg dosages, in the U.S. by Coherus, is planned for early October.

“We are very delighted about the full label approval as it will allow to offer this highly effective treatment option to an increasing number of patients with retinal diseases. At the same time, we would like to thank our partners Bioeq and Polpharma Biologics for the excellent joint development work and are pleased that Coherus acts as commercialization partner for the U.S.,” explained Dr. Stefan Glombitza, CEO of Formycon AG.

“As the impact of serious retinal diseases continues to rise in the U.S., it is critical that treatment options are both efficacious and affordable. Advanced biosimilars to Lucentis® can change patients’ lives, while also minimizing the financial impact of the cost of treatment on healthcare systems,” said Michael Soldan, CEO of Polpharma Biologics Group. “Polpharma Biologics is proud to have collaborated with Formycon and Bioeq on the development of ranibizumab biosimilar and we are excited about our contribution to this valuable treatment option that we expect to positively impact many patients lives.”

1) CIMERLI™ is a trademark of Coherus BioSciences, Inc.
2) Lucentis® is a registered trademark of Genentech Inc.

[i] U.S. Food and Drug Administration (FDA) website. Available from: https://www.fda.gov/
[ii] Holz FG, Oleksy P, Ricci F, et al. Efficacy and Safety of Biosimilar FYB201 Compared with Ranibizumab in Neovascular Age-Related Macular Degeneration. Ophthalmology. 2022; 129 (1): 54-63