Formycon receives Euro 12.7 million grant for further development of COVID-19 drug FYB207 as part of the Bavarian Therapy Strategy to combat the COVID-19 pandemic
The funding will support the currently ongoing preclinical development, the production of the investigational product under GMP conditions, and the clinical testing of FYB207 in a phase I/IIa trial, which is scheduled to start in the fourth quarter of 2021.
FYB207 is a long-acting ACE2-immunoglobulin fusion protein. SARS-CoV-2 and other coronaviruses use the ACE2 protein on the surface of human cells as a portal of entry for respiratory infections. Formycon has therefore fused the human ACE2 protein to the constant part of human immunoglobulin G4 (IgG4) using computer-aided structural design and created FYB207, a very effective SARS-CoV-2 blocker that has shown in vitro to completely prevent cells from infection.
As part of the Bavarian Therapy Strategy to combat the COVID-19 pandemic, the Free State of Bavaria had created the opportunity to support development and innovation projects that aim to open up new therapy options for the treatment of the infectious disease induced by the SARS-CoV-2 coronavirus with the funding call "BayTherapie 2020" and the provision of a total of up to Euro 50 million.
Formycon Reports Financial Results for the First Quarter of 2021
- Sales and other earnings total EUR 9.4 million
- EBITDA is EUR -1.7 million
- EBIT and net result in line with expectations at around EUR -2.0 million each
Consolidated sales including other income increased by around EUR 2.2 million to a total of EUR 9.4 million as of March 31, 2021, compared with the same period of the previous year (EUR 7.2 million). Earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to EUR -1.7 million (Q1/previous year: EUR 0.4 million), the operating result (EBIT) amounted to EUR -1.9 million (Q1/previous year: EUR 0.2 million) and therefore was in line with expectations. The quarterly result totaled EUR -2.0 million (Q1/previous year: EUR 0.2 million). In line with its growth strategy, Formycon will continue to invest in the development of its own as-yet unpartnered pipeline programs in 2021 and, in addition to the COVID-19 drug FYB207, will also advance the as-yet unpublished biosimilar candidate FYB206 on the development side. The forecast Group sales for 2021 will be higher than in the previous year (EUR 34.2 million).
In the current phase of the company, Formycon is focusing on the research and development activities of its own and out-licensed biosimilar projects or projects developed in partnership, which are providing the current revenues. After successful approval of the biosimilar candidates, Formycon will also participate in the marketing revenues.
The liquidity ratios of the Formycon Group also developed as planned by the end of the first quarter: Stocks of liquid assets, which comprise cash, checks, bank deposits and securities, totaled EUR 35.3 million at the end of March. Including short-term receivables from deliveries and services, as well as other assets worth around EUR 10.7 million, the Formycon Group held liquid assets totaling EUR 46.0 million on the day of reporting (Q1/previous year: EUR 25.8 million).
In the first three months of the year, Formycon AG as the company's actual operational unit achieved a turnover of EUR 5.1 million (Q1/previous year: EUR 5.3 million). The company's three-month result was EUR -2.1 million (Q1/previous year: EUR 0.1 million).
Commenting on the first quarter, Chief Financial Officer Dr. Nicolas Combé said: "We are very pleased with the start to the new fiscal year. We are on track with our biosimilar candidates as communicated and the development of our COVID-19 drug (FYB207) is also progressing. Our strengthened liquidity base allows further investments in FYB207 beyond the currently ongoing preclinical phase and we also continue to advance the still unpartnered biosimilar project FYB206 according to our plans. For the full year 2021, we expect consolidated revenues to be above the prior year."
Formycon and Bioeq announce submission of the marketing authorization application for FYB201, a biosimilar candidate to Lucentis(R)1 (ranibizumab) to the European Medicines Agency (EMA)
Lucentis(R) is used in the treatment of neovascular (wet) macular degeneration and other serious eye diseases. It inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina.
The commercialization of FYB201 in Europe will be performed by Teva Pharmaceutical Industries Ltd., which has acquired the distribution rights under an exclusive strategic partnership from Bioeq AG.
1)Lucentis(R) is a registered trademark of Genentech Inc.
Teva Pharmaceutical Industries Ltd. becomes strategic partner for the commercialization of FYB201, Formycon's biosimilar candidate to Lucentis(R)1 (ranibizumab) in Europe, Canada, Israel and New Zealand
Teva Pharmaceutical Industries Ltd. is a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Teva maintains an established presence in generics and also conducts significant innovative research to support its growing portfolio of specialty and biopharmaceutical products.
By the end of 2019, Bioeq had already entered into a license and development agreement with the US Biosimilar-specialist Coherus BioSciences, Inc., which will exclusively distribute FYB201 in the United States of America (US). With today's partnership between Bioeq and Teva, FYB201's distribution is now complemented by another strong partner. After successful approval by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), Formycon will participate in the marketing revenues.
"With the selection of the two commercialization partners Coherus BioSciences, Inc. and Teva Pharmaceutical Industries Ltd. by Bioeq AG we are optimistically looking forward to the marketing launch of FYB201, which is scheduled for the coming year. We are delighted that two powerful companies will commercialize our product in the territories of the US, Europe, Canada, Israel and New Zealand and are convinced of the quality and potential of our biosimilar candidate to Lucentis(R) (ranibizumab)" says Dr. Carsten Brockmeyer, CEO of Formycon AG.
1) Lucentis(R) is a registered trademark of Genentech Inc.
Formycon announces conclusion of exclusive commercialization agreement between Bioeq AG and Teva Pharmaceutical Industries Ltd. for FYB201 in Europe, Canada, Israel and New Zealand
Teva Pharmaceutical Industries Ltd. is a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area and one of the largest and most complex supply chains in the pharmaceutical industry.
The submission of the marketing authorization for FYB201 to the European Medicines Agency (EMA) is expected to take place contemporarily.
1)Lucentis(R) is a registered trademark of Genentech Inc.
Formycon Publishes Annual Financial Statements for the 2020 Financial Year
- Group turnover and other earnings total Euro 34.6 million
- Solid liquidity base totaling Euro 49.2 million
- Annual result shaped by scheduled investments in FYB206 and FYB207
On the day of reporting, December 31, 2020, the Formycon Group's commercial figures had developed as forecast. Consolidated group sales which, in addition to the AG, include the two subsidiaries Formycon 201 Project GmbH and Formycon 203 Project GmbH as well as the 24.9 percent share in the FYB 202 GmbH & Co. KG joint venture, amounted, as forecast, to a total of Euro 34.2 million (previous year: Euro 33.2 million).
Group earnings before interest, taxes and depreciation on fixed assets and intangible assets (EBITDA) amounted to Euro -4.8 million (previous year: Euro -1.4 million) on the day of reporting. The operating result (EBIT) totaled Euro -5.7 million (previous year: Euro -2.3 million). At Euro -5.9 million (previous year Euro -2.3 million), the result for the year was in line with expectations. In line with its growth strategy, Formycon had invested in the development of its own or young pipeline in the 2020 financial year, resulting in a slightly higher negative annual result compared to previous years. In addition to the COVID-19 drug (FYB207), the main development focus was on the as yet unpublished and unpartnered biosimilar candidate FYB206. Formycon was also able to recruit further qualified specialists last year in line with the needs of the development projects and employed 131 people at the end of the reporting period (+16% compared to the previous year).
Current assets consist largely of liquidity and near-liquid assets. As of December 31, 2020, the Formycon Group had a solid capital base, which, including the cash capital increase of around Euro 25.8 million completed in the fourth quarter of 2020, totaled Euro 42.2 million (previous year: Euro 22.4 million) in cash and cash equivalents (cash on hand, checks, bank balances, and securities). Including short-term receivables and other assets worth a further Euro 7.0 million, the Formycon Group holds liquid assets of Euro 49.2 million in total (previous year Euro 27.6 million) and therefore has flexible room for maneuver for the further development of its own or as yet unpartnered projects. In the current phase of the company, Formycon is focusing on the research and development activities of its own and out-licensed biosimilar projects, which are providing the current revenues. After successful approval of the biosimilar candidates, Formycon will also participate in the marketing revenues.
The Group's balance sheet total rose by 41% to around Euro 75.6 million (previous year: Euro 53.6 million) with an equity ratio of 90 percent, unchanged from the previous year. The company has no financial liabilities.
Formycon AG, as the Group's actual operational unit, achieved a turnover of Euro 25.1 million (previous year: Euro 21.0 million) and recorded an EBITDA of Euro -4.7 million (previous year: Euro -1.3 million). Accordingly, this resulted in an EBIT amounting to Euro -5.6 million (previous year: Euro -2.2 million) and an annual result of a rounded Euro -5.7 million (previous year: Euro -2.2 million).
Dr. Nicolas Combé, CFO of Formycon AG, looks back on the past financial year as follows: "Due to the prevailing Corona pandemic, 2020 was a year full of challenges. We are proud of what we have achieved and, in addition to our aspirational biosimilar projects, we have added another asset to the product pipeline with the development of our COVID-19 drug (FYB207). The good liquidity base allows us to operate from a stable position and, in addition to investments in FYB207, also enabled us to intensively further develop the early-stage and as yet unpartnered biosimilar candidate FYB206. Through our well-positioned development organization, we are able to develop up to five projects in parallel, creating further value for Formycon."
The full 2020 annual financial statements / annual report can be found on our website at https://www.formycon.com/en/investor-relations/financial-reports/.
Formycon receives approval for early action for COVID-19 drug FYB207 as part of a grant from the Bavarian Ministry of Economic Affairs, Regional Development and Energy (StMWi)
- Consideration of FYB207 in the funding call “BayTherapie2020”
- Funded project includes development activities of FYB207 through to completion of Phase IIa clinical trials
- Requested funding amount of approximately Euro 11 million
The early start of the project enables Formycon to implement the preclinical development activities as planned and to manufacture the test product under GMP conditions before the final approval is granted. FYB207 is expected to move into Phase I/IIa clinical testing in the fourth quarter of 2021.
As part of the Bavarian therapy strategy to combat the COVID-19 pandemic, the Free State of Bavaria has created the conditions for funding development and innovation projects aimed at opening up new therapy options for treating the infectious disease induced by the SARS-CoV-2 coronavirus with the funding call "BayTherapie 2020" and the provision of a total of up to Euro 50 million.
SARS-CoV-2 and other coronaviruses use the protein ACE2 on the surface of human cells as a portal of entry for respiratory infections. Formycon has therefore fused the human ACE2 protein to the constant part of human immunoglobulin G4 (IgG4) using computational structural design and created FYB207, a highly effective SARS-CoV-2 blocker that completely prevents cell infection in vitro.
Compared to vaccines and therapeutic antibodies, the ACE2-IgG4-Fc fusion protein is maximally protected against viral escape by mutation. The risk of infection amplification by vaccines and IgG1 antibodies described for coronaviruses is minimized by using the IgG4 portion in the fusion. FYB207 also has inherent enzymatic activity that may provide patients with additional lung and cardiovascular protection. In addition, FYB207 can potentially be used for all coronaviruses that use ACE2 as a port of entry.
Recently, Formycon AG, together with its academic partners Prof. Ulrike Protzer, Chair of Virology, and Prof. Johannes Buchner, Chair of Biotechnology at the Technical University of Munich, published new results on the in vitro neutralization of SARS-CoV-2 variants by Formycon's COVID-19 drug FYB207. These showed that FYB207 had an even stronger effect against the B.1.1.7 mutant of the virus, which is considered particularly infectious, than against earlier variants.
"We are pleased that the Bavarian State Ministry of Economic Affairs, Regional Development and Energy has granted an early start to our funding application. Our project prevailed in a highly competitive process and, in addition to the associated scientific and technological recognition of our development approach by renowned reviewers, the support of public funding is a key component of project financing. We want FYB207 to be an important treatment option for COVID-19 patients that saves lives. At the same time, we also want to contribute to the prevention of outbreaks of new coronaviruses in the future," comments Formycon CFO Dr. Nicolas Combé.
Formycon's COVID-19 Drug FYB207 even more efficient against SARS-CoV-2 Mutant B.1.1.7
The study, which builds on previous published data (BioRxiv Preprint: https://doi.org/10.1101/2020.12.06.413443) will be presented today at the "30th Annual Meeting of the Society for Virology" and is titled "Singular ACE2-IgG4-Fc fusion protein efficiently inhibits SARS-CoV-2 entry". The presentation will be available soon on our website https://www.formycon.com/en/pipeline/fyb207/.
In the current study, a series of SARS-CoV-2 variants with increasing infectivity were tested: (I) SARS-CoV-2-Jan, isolated from a COVID-19 patient from the earliest documented COVID-19 outbreak in Germany in January 2020, which was directly related to the first outbreak in Wuhan, China, (II) SARS-CoV-2-April, which was isolated when the virus first spread massively in Europe in April 2020, and (III) SARS-CoV-2 variant B.1.1.7, which was first detected in the United Kingdom in September 2020, is associated with increased infectivity and mortality, and soon became the predominant SARS-CoV-2 variant in Europe.
The FYB207 concentration required for 50% inhibition in vitro (IC50 value) is in the low nanomolar range and decreased with each variant: (I) 4.7 nM, (II) 1.3 nM, (III) 0.6 nM, clearly showing that the neutralizing activity of FYB207 increased the more infectious and harmful the SARS-CoV-2 variant was. The IC50 values for FYB207 suggest a high neutralizing activity against SARS-CoV-2 B.1.1.7. The in vitro neutralization assay is considered a surrogate for potential therapeutic efficacy in SARS-CoV-2 infected patients.
"Health authorities around the world are increasingly concerned that neutralizing antibodies or vaccines may lose their activity against emerging SARS-CoV-2 mutants. While studies with neutralizing antibodies and sera from vaccinated individuals in vitro have indicated a reduction in neutralizing activity against B.1.1.7 and further SARS-CoV-2 mutants, our new in vitro data show that FYB207 neutralizes SARS-CoV-2 mutant B.1.1.7 even more. These results support our strategy to develop FYB207 as a treatment option for COVID-19 patients, but also to contribute to the preparedness for the outbreak of new coronavirus mutants", says Dr. Carsten Brockmeyer, CEO of Formycon AG.
SARS-CoV-2 and other coronaviruses use the ACE2 protein on the surface of human cells as a portal of entry for respiratory tract infections. Formycon has therefore fused the human ACE2 protein to the constant part of human immunoglobulin G4 (IgG4) using computational structural design, creating a very effective SARS-CoV-2 blocker that completely prevents cell infection in vitro.
Compared to vaccines and therapeutic antibodies, the ACE2-IgG4-Fc fusion protein is maximally protected against escape of the virus by mutation. The risk of infection amplification by vaccines and IgG1 antibodies, described for coronaviruses, is minimized by using the IgG4 portion in the fusion. FYB207 also has inherent enzymatic activity that may provide patients with additional pulmonary and cardiovascular protection. In addition, FYB207 can potentially be used with all coronaviruses that use ACE2 as a portal of entry.
The preclinical activities as well as the preparations for the entry into clinical trials with FYB207 are proceeding according to plan. In addition, Formycon had a successful Scientific Advice Meeting with the Paul-Ehrlich-Institute and has already secured GMP manufacturing capacity for FYB207.
Formycon, together with its academic research partners, is receiving funding from the Bavarian Research Foundation for the initial development steps of this project.
Formycon and Leukocare cooperate in the development of high-quality biopharmaceuticals
- Companies combine leading development expertise in high-quality biopharmaceuticals with profound knowhow in biopharmaceutical formulation development
- Master Service Agreement stipulates potential development of stable Leukocare formulations for additional Formycon projects in upcoming years
- First project covers formulation development for a biosimilar of a blockbuster therapeutic antibody
Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and Leukocare AG today announced a collaboration in the area of high-quality biopharmaceuticals. Under the terms of this agreement, Leukocare will apply its formulation development technologies combining state-of-the art protein analytics, bioinformatics and artificial intelligence to develop stable formulations potentially for several candidates in Formycon´s product pipeline. The first project has been started and covers the formulation development for a biosimilar of a blockbuster therapeutic antibody.
By applying Leukocare’s formulation and bioinformatics expertise to Formycon’s comprehensive development knowhow, the partners want to achieve superior stability profiles overall leading to additional value propositions for development projects.
Stefan Glombitza, Chief Operating Officer at Formycon, stated, “Suitable Drug Product formulations are an essential success factor in the development of biopharmaceutical drugs and are getting increasingly important in the competitive IP landscape. We are convinced that Leukocare’s technology platform can successfully complement our development expertise and look very much forward to our collaboration.”
“Michael Scholl, Chief Executive Officer at Leukocare, commented, “We are very proud of this partnership with Formycon, a world-leading developer of high-quality biosimilars and biopharmaceuticals. This collaboration is a perfect fit for both companies to drive the development of high-quality products.”
“Andreas Seidl, Chief Operating Officer of Leukocare, added, “Our algorithm-based formulation development expertise will allow Formycon to make use of a large formulation design space, thereby gaining manifold options for freedom to operate in a competitive environment. This will strongly support Formycon in providing high-quality medicines to as many patients as possible.”
Formycon confirms BLA-Submission Strategy and Timeline for its Lucentis(R)* Biosimilar-Candidate FYB201 following consultation with the FDA
- Pre-BLA-interaction with U.S. Food and Drug Administration (FDA) confirms planned resubmission in first half of 2021
- Submission of the marketing authorization to the European Medicines Agency (EMA) in immediate consequence
- Submission for other highly regulated territories in preparation
As announced in November 2020, the initial submission strategy of the Lucentis(R) biosimilar candidate FYB201 has been adjusted as part of a simplification of the approval procedure. With the optimization of the commercial supply chain, the approval for FYB201 will directly occur in a large commercial scale. In the context of the interaction with the FDA, the data requested by the authorities have been reviewed and the further procedure has been aligned. The BLA-submission is expected to be filed with the U.S. Food and Drug Administration on schedule during the first half of 2021. Submission to the European Medicines Agency (EMA) is expected to follow-up.
In addition to the approval in the United States of America and the countries of the European Union, Formycon and Bioeq are seeking approval of the biosimilar candidate to Lucentis(R) (ranibizumab) in other highly regulated territories such as Canada, Australia, the United Kingdom and Switzerland.
* Lucentis(R) is a registered Trademark of Genentech Inc.
