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May 02, 2018, Munich/Zurich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its licensee Bioeq IP AG have today published an interim result for the clinical phase III trial for the biosimilar candidate FYB201. According to this, the primary endpoint has been achieved in the COLUMBUS-AMD trial, thus confirming comparable efficacy between FYB201 and the reference medicinal product Lucentis® in patients with neovascular age-related macular degeneration (nAMD). The clinical endpoint relates to efficacy of the investigational product and measures the change in the best corrected visual acuity after eight weeks. The confidence interval lies within the pre-defined equivalence limits and the study has so far progressed without any abnormalities with regard to the safety and immunogenicity of the product FYB201.

The last patient in the trial, in which patients are treated for a total of 48 weeks, is expected to complete treatment in the second quarter of 2018. The data from the phase III study will be part of the application for marketing approval with the US Food and Drug Administration FDA and the European Medicines Agency EMA.

Formycon’s development and distribution partner Bioeq is responsible for the clinical phase III study. Bioeq also holds the exclusive global marketing rights for the product FYB201.

Dr. Thiemo Schreiber from Bioeq comments: “As the sponsor and marketer of the FYB201 program, we are pleased about this positive study result and, on the basis of this important milestone, we will continue license negotiations with interested parties. Our aim is the approval and launch of FYB201 as the first biosimilar to Lucentis® in the United States of America in 2020 and in the countries of the European Economic Area in 2022. We thus want to offer a larger number of patients more affordable access to this important and highly effective treatment.”

Dr. Carsten Brockmeyer, CEO of Formycon, considers Formycon’s leading position as a developer of biosimilars in the promising biosimilar sector to have been confirmed: “We are delighted with the result. It confirms Formycon’s pioneering role in the development of biosimilars in ophthalmology and emphasizes our ability to successfully develop high-quality biosimilars. We will consistently drive forward our development pipeline of currently four biosimilars.”

Lucentis® is used in the treatment of neovascular age-related macular degeneration (wet AMD) 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. This leads to a progressive loss of vision and is one of the major causes of age-related blindness. Globally, it is estimated that up to 7.5 million people suffer from wet AMD. There are some 450,000 patients in Germany alone. The total market volume for treatments in this field amounted to over 9.3 billion dollars in 2017, and is continuing to rise sharply.

* Lucentis is a registered trademark of Genentech Inc.

Munich – The biosimilars company Formycon has ranked 7th in the FT1000 list compiled by the highly respected business newspaper the Financial Times and data provider Statista, making it the only biotech company to appear in the top ten. The rankings, which have now been compiled for the second time, list Europe’s 1,000 strongest-growing companies that have achieved the highest percentage sales growth between the financial years of 2013 and 2016.

This placement represents a further honor in recognition of Formycon’s dynamic growth: In 2016 and 2017, Formycon was crowned growth champion in the “Chemistry and Pharmaceuticals” category by the news magazine Focus. Formycon took 1st place in this segment out of 500 companies in Germany.

Dr. Nicolas Combé, board member and CFO of Formycon, said: “We are absolutely delighted by this award and see this as confirmation of our strategic focus. At this stage in the company’s life, the financing of our development activities is of central importance. Through existing licensing agreements, a joint venture and our solid liquidity, we are excellently placed and in a very promising position for a biotech company.”

Dr. Stefan Glombitza, board member and COO of Formycon, was also thrilled by the company’s top-ten placement on the FT1000 list: “The rewarded growth reflects the continuous progress of our biosimilar programs, which we are supporting by a structured organizational development. All these activities are consistently targeting a clear goal: to provide through our biosimilar developments as many patients as possible with access to high-quality therapies and sustainably relieve the financial burden from health systems.”

The complete FT1000 list is already available to view online. A special printed edition will appear on April 30, 2018 in the Financial Times.

The overall FT1000 rankings can be found here
More information about the rankings can be found here

Munich – Over the recent months of the 2017 financial year, the biosimilars company Formycon has again progressed well with the further development of its four biosimilars, which are in various stages of development.

FYB201 is the worldwide only biosimilar candidate for the ophthalmic agent Lucentis®* (ranibizumab) in a clinical phase III trial for the regulated markets. Alongside advanced clinical testing, Formycon is working intensively and in close consultation with the respective regulatory authorities on the preparation of the filing documents. On condition of a further successful development, market launch in the USA is planned for 2020. With the development of an innovative application system underpinned by the company’s own patent applications, Formycon has created additional tools for a highly promising positioning of FYB201 on the market.

FYB203 is a biosimilar candidate for Eylea®** (aflibercept) which, like Lucentis®, is used to treat neovascular, age-related macular degeneration (nAMD) and other serious eye conditions. In this project Formycon is completing its final measures to establish a highly efficient biosimilar manufacturing process. Formycon has submitted various patent applications for the pharmaceutical formulation of this product, and therefore believes that FYB203 is also in a highly promising position for its market launch following the expiry of the reference product’s legal protection in the USA in 2023.

Project activities for FYB202, a biosimilar candidate for Stelara®*** (ustekinumab), are currently focusing on the optimization of a suitable manufacturing process. As already announced in July 2017, a term sheet was signed for the joint development of FYB202 with Santo Holding (Deutschland) GmbH. Under the terms of the agreement, Formycon will bear up to 30 percent of the development costs for FYB202 and in return will receive up to a 30 percent share of the global marketing proceeds.

On the FYB205 project, for which Formycon has so far not published any details, work has been stepped up on the development of a suitable cell line.

The business figures of the Formycon Group, which alongside the joint stock company also comprises the two sub-holdings Formycon Project 201 GmbH and Formycon Project 203 GmbH, continue to be impacted by project activities. As in the past, income resulted primarily from the development of the two licensed-out biosimilar candidates. The planned expenditure on un-licensed projects in particular has had an impact on the earnings side. As a result, turnover at the Formycon Group during the first nine months rose by just under 3.5 million to Euro 15.12 million compared to the same period last year, while earnings before interest, taxes, depreciation and amortization on tangible and intangible assets (EBITDA) was Euro -4.25 million. The operating result (EBIT) was Euro -4.84 million, while the net earnings were Euro -4.89 million.

As of September 30, 2017, the Formycon Group held liquid assets worth Euro 19.04 million. Short-term receivables from deliveries and services totaled Euro 4.67 million.

For the year as a whole and under the assumption that the planned agreement with Santo Holding on FYB202 will be implemented within 2017, Formycon continues to anticipate group turnover in the region of Euro 25 million.

In the first three quarters of 2017, Formycon AG as the actual operational unit achieved a turnover of Euro 7.41 million. The EBITDA stood at Euro -4.48 million, the operating result at Euro -5.07 million, and net earnings at Euro -5.11 million. On the day of review at the end of September, Formycon employed 75 people.

Dr. Carsten Brockmeyer, board member and CEO of Formycon AG explains: “Over the past nine months, Formycon has made significant advances. Together with our partners, we have progressed very well in the clinical testing of FYB201. We are working closely with the authorities on this. We have also pushed ahead rapidly with our other biosimilar programs. We are delighted by the interest in our biosimilars, which is also expressed in the term sheet for FYB202. We are confident that we will be able to report on more specific outcomes of our work in the near future.”

Dr. Nicolas Combé, board member and CFO of Formycon AG, comments: “The investments in our biosimilar projects mean we are continuously increasing the value of our pipeline. The company’s economic development over the first nine months of 2017 shows that we remain in a very solid financial position. With the implementation of the term sheet signed with Santo for FYB202, we also anticipate a significant improvement in our results. The potential market launch of FYB201 should then bring us the first product marketing revenue from 2020 onwards, which is expected to build up considerably with the step-by-step market expansion and potential market launch of our other product candidates over time.”

Dr. Stefan Glombitza, board member and COO of Formycon AG, adds: “To be ideally prepared for the forthcoming challenges arising from the projects, it is important to work continuously on developing our business processes and organization further. In the first nine months, in parallel to our operational project activities, we have also successfully implemented targeted measures that create the framework for an efficient and scalable organization. By the end of this year, we will have increased our workforce to 83 and we are also planning additional expansions in capacity for 2018.”

* Lucentis is a registered trademark of Genentech Inc.
**Eylea is a registered trademark of Regeneron Pharmaceuticals Inc.
*** Stelara is registered trademark of Johnson & Johnson

Munich – The Supervisory Board of the biosimilar company Formycon AG has extended the appointments of Dr. Carsten Brockmeyer, board member and CEO, and Dr. Nicolas Combé, board member and CFO, until June 30, 2022. With these contract extensions, the control committee is honoring the successful work carried out by the Formycon management team over recent years, and providing the continuity needed at the executive level of the company to allow further sustainable and successful development.

“Since its strategic focus on the development of biosimilars in 2013, Formycon’s development has been exceptionally pleasing. The extension of the executive board members’ contracts reflects not only the achievements of the entire Formycon team, but is also an expression of continuity within the company and the trusting cooperation between the Supervisory Board and Management Board”, says Dr. Olaf Stiller, Chairman of the Supervisory Board of Formycon AG. “We are delighted to be continuing this exceptional collaboration with our management.”

Dr. Brockmeyer has been with Formycon since 2013 and, as a renowned biosimilars expert, is responsible for the company’s corporate and development strategy. Dr. Combé was one of the co-founders of the present-day Formycon, starting out with the company back in 2008, and is responsible for the Finance, Controlling, Legal and HR departments. Dr. Stefan Glombitza joined the Formycon Management Board in October 2016 being in charge of Formycon’s operational development. His position on the Management Board continues until September 30, 2021.

Under the leadership of the current management team, Formycon has established itself as an internationally renowned developer of biosimilars. Since 2013, the company has launched four biosimilar projects, of which one is already in the advanced stages of a phase III clinical trial.

Munich – The biosimilars company Formycon AG has accomplished a successful first half year in 2017. Phase III of the clinical trial involving the furthest-advanced biosimilar candidate FYB201 is continuing to progress as planned. FYB201 is a biosimilar candidate for the ophthalmic agent Lucentis®* (ranibizumab) and is scheduled to be marketed in the US from mid-2020 under the responsibility of the licensing partner following successful approval and expiry of the reference product’s legal protection.

The development of FYB202, a biosimilar candidate for Stelara®** (ustekinumab), has also been pleasing during the first six months of 2017 and is set to continue in future as part of a development cooperation agreement. To this effect, a term sheet has since been signed for the joint development of FYB202 with Santo Holding (Deutschland) GmbH. The aim is to develop FYB202 through to market authorization. As already announced, under the terms of the co-investment agreement, Formycon will bear up to 30 percent of the development costs for FYB202 and in return will receive a share of up to 30 percent of the future global market revenues.

The development of FYB203, a biosimilar project for Eylea®*** (aflibercept), which is also already being licensed out, as well as of FYB205, is progressing in accordance with the project schedule.

Formycon’s economic results during the first half-year have been shaped considerably by the development expenses associated with FYB202. The group which, alongside the joint stock company also comprises the two sub-holdings Formycon Project 201 GmbH and Formycon Project 203 GmbH, therefore had a turnover of Euro 8.01 million (1st half year of 2016: 8.76 million). As in the past, the main source of income was the development of the two licensed-out biosimilar candidates FYB201 and FYB203. The group period result at the end of June 2017 stood at Euro -2.91 million compared to Euro -1.18 million during the same period last year.

The company’s financial resources remain solid, regardless of the increase in expenditure on development: On the day of reporting, Formycon held liquid assets of around Euro 14.4 million. Including short-term receivables from deliveries and services worth Euro 1.33 million, Formycon’s liquid assets totaled around Euro 15.7 million (20.7). The equity ratio has risen by 1.7 percentage points to 84.6 percent compared to the same period last year. The turnover forecast for the year as a whole remains unchanged at Euro 25 million.

The implementation of the term sheet for FYB202 in the intended contractual and company law structure is anticipated during the second half of the year and should make a significant contribution to improving the Formycon Group’s results for the 2017 financial year. The cash inflow from the capital increase worth around Euro 6 million at the start of the third quarter is not included in the figures stated.

Formycon AG, as the company’s central development and operational unit, achieved a turnover of Euro 4.80 million (previous year: 7.05 million) during the first six months, with the result from the first half-year being Euro -2.88 (-1.23) million. This change in turnover is essentially due to the shift of development activities to the respective project companies.

Dr. Nicolas Combé, Chief Financial Officer of Formycon, is satisfied with developments over the first six months: “The agreements on FYB202 will lead to an extremely valid development financing for this project too. Together with the licensing agreements for FYB201 and FYB203, development financing for our three main projects should therefore be assured. This puts us in a highly promising position for keeping the company on a healthy course for growth and being able to leverage the economic potential that will arise from our share of future product marketing revenue in particular.”

Dr. Carsten Brockmeyer, CEO of Formycon, says: “In the first half year of 2017, Formycon achieved significant progress on all of its projects. The global provision to patients of safe and effective biological medicines at affordable prices is a major commitment of ours. We are well on the way to achieving this objective.”

You will find the full half-year report on the Internet at https://www.formycon.com/en/investors/financial-reports/.

* Lucentis is a registered trademark of Genentech Inc.
** Stelara is a registered trademark of Johnson & Johnson
*** Eylea is a registered trademark of Regeneron Pharmaceuticals Inc.

Munich – The commercial performance of the biosimilars company Formycon has again advanced as planned in the first quarter of 2017. The development of its four biosimilar projects has progressed as expected and the company’s financial key performance indicators have developed as anticipated.

At group level, sales revenues and other earnings totaled Euro 3.38 million (previous year: Euro 6.34 million). During this phase of the company’s growth, sales revenues are directly linked to development expenditure in licensed projects, so this deviation is primarily a result of the reporting date. For the total year the company confirms the expected sales volume of around Euro 25 million. From January to March, the EBITDA was Euro -0.51 million (Euro -0.02 million) based on a quarterly result of Euro -0.71 million (Euro -0.19 million). Stocks of liquid assets, which comprise cash, checks, bank deposits and securities, totaled Euro 13.21 million at the end of March. Including short-term receivables from deliveries and services worth Euro 3.11 million, Formycon held liquid assets of Euro 16.32 million on the day of reporting.

Revenues from sales and other earnings at Formycon AG totaled Euro 2.16 million. The quarterly result stood at Euro -0.77 million.

Chief Financial Officer Dr. Nicolas Combé commented on the figures with these words: “The first quarter has again progressed in line with our expectations, and development costs are on budget, as outlined in our forecasts. What matters most here is that we have again made significant advances in our biosimilar projects. With the recently announced news that FYB202 is a biosimilar candidate for Stelara®*, we have once again highlighted the intrinsic value of our pipeline. We anticipate that we will reach further important milestones in our projects over the course of the year.”

* Stelara is registered trademark of Johnson & Johnson

Munich – The biosimilars company Formycon has today announced details of a further product from its development pipeline. FYB202 is a biosimilar candidate for Stelara®* (ustekinumab) which is currently in the pre-clinical testing phase. This means that Formycon’s development pipeline comprises FYB201 (biosimilar candidate for Lucentis®**), FYB203 (biosimilar candidate for Eylea®***) and FYB202 (biosimilar candidate for Stelara®), three of the highest-selling drugs from the third wave of biosimilars which addresses reference products set to lose their legal protection after 2020.

Stelara® (ustekinumab) is a human monoclonal antibody that targets the cytokines interleukin-12 and Interleukin-23. Since 2009, the drug has been used to treat various severe inflammatory conditions such as moderate to severe psoriasis. In 2016, its indications were extended, allowing Stelara® to also be used for the treatment of Crohn’s disease, a chronic inflammatory condition of the bowel.

In recent years, Stelara® has brought growing revenues and in 2016 achieved global sales of around US$ 3.2 billion. Further sales growth is also anticipated for the future. According to information from the US National Center for Biotechnology Information (NCBI) and the World Health Organization (WHO), the psoriasis market is set to increase by an average of 7.3 percent per year, reaching a volume of US$ 13.3 billion by 2024. For Crohn’s disease, an expansion of the market from its current level of US$ 3.5 billion to US$ 4.4 billion is expected over the same period. There may also be further potential for sales through the possible approval of Stelara® for additional indications, for example the treatment of other serious gastrointestinal conditions. Marketing of a biosimilar for Stelara® should become possible towards the end of 2023 in the USA and from the middle of 2024 in Europe once the legal protections expire.

Dr. Carsten Brockmeyer, board member and CEO of Formycon, regards the biosimilar candidate for Stelara® as a further important milestone on Formycon AG’s journey towards becoming a leading company in the promising biosimilar industry: “The costs of treating chronic conditions such as psoriasis and Crohn’s disease have become a major challenge for healthcare systems around the world. With the development of the Stelara® biosimilar, we are pursuing the goal of offering this treatment to doctors and patients at an affordable price, thereby increasing access to this important drug and at the same time allowing urgently needed savings to be made in healthcare systems.”

Dr. Stefan Glombitza, board member and COO of Formycon, adds: “For the sophisticated development of the biosimilar product FYB202, we will build on our first-class scientific expertise, strict development standards and efficient cooperation with renowned third-party manufacturers in order to achieve our milestones with the final goal of getting biosimilar approval from international authorities. Our team is highly motivated by the fact that through our product development we will be able to create broader access to high-quality medication for the many patients with psoriasis and Crohn’s disease.”

* Stelara is registered trademark of Johnson & Johnson
** Lucentis is a registered trademark of Genentech Inc.
*** Eylea is a registered trademark of Regeneron Pharmaceuticals Inc.