Archives Press Releases

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.

Munich – The biosimilars company Formycon from Martinsried near Munich has ended the 2016 financial year successfully and significantly advanced the development of its product candidates. The clinical phase III study of the most advanced biosimilar candidate FYB201 (ranibizumab), a follow-on drug to the successful ophthalmic agent Lucentis®*, is proceeding as planned. Formycon is therefore affirming its objective of marketing FYB201 as the first Lucentis® biosimilar under the responsibility of its licensing partner following the expiry of the Lucentis patent in the USA in 2020.

The development of FYB203 (aflibercept), a biosimilar candidate for Eylea®**, which is currently in its pre-clinical phase, is also advancing in line with expectations. With FYB201 and FYB203, Formycon’s development pipeline comprises the two most important and best-selling drugs for intraocular anti-VEGF treatments, one of the fastest-growing treatment sectors on the pharmaceutical market. Both projects are licensed out. Formycon is also working on the development of the two other biosimilar projects FYB202 and FYB205. The company will be releasing details of these products at a later date.

Formycon’s economic development also progressed as expected in 2016. The Group increased its turnover by more than 15 percent compared to the previous year to Euro 19.5 million (2015: 16.9 million). Sales were essentially generated from ongoing remunerations from licensing partners for the product development of FYB201 and FYB203.

In view of the expected higher expenditure on development caused by the on-plan project progress of the as yet un-licensed biosimilar developments, the Group’s earnings before interest, tax and depreciations (EBITDA) was Euro -3.37 million (2015: 1.47 million), with the net loss for the year being Euro -4.07 million (2015: 0.58 million). The Group’s equity ratio of 82.9 percent (2015: 91.6) is at an above-average level as in previous years. The company has no financial liabilities. Stocks of liquid assets, including securities, totaled Euro 14.0 million on the day of reporting. Including short-term receivables from deliveries and services worth Euro 5.2 million, Formycon held liquid assets of around Euro 19.2 million (2015: 23.1 million).

Formycon AG as the Group’s actual operational unit achieved a turnover of Euro 13.9 million (2015: 13.6 million) and had a net deficit of Euro -4.18 million (0.6) on a background of increased development expenditure.

The workforce has grown significantly from 53 to 70 over the past year. This reflects the increased demand for resources associated with the expansion and growing maturity of the product pipeline.

Dr. Nicolas Combé, Director and CFO of Formycon, believes that the company is on the right path: “By the year end, we anticipate that we will have achieved further major milestones in our development projects. These should include the clinical trial of our biosimilar candidate FYB201. We also expect news for FYB202, the marketing rights for which are still fully owned by Formycon. Given its solid financial foundations and ongoing revenue, Formycon is in excellent shape. For the 2017 financial year, we anticipate an annual turnover in the region of Euro 25 million.”

Dr. Stefan Glombitza, who has been responsible for operational business since October 2016 as the third member of the board, also believes the company is well positioned in relation to its operational divisions: “Over the last year we have significantly expanded Formycon’s development division and we will continue to do upgrades in accordance with our progress. Our significant scientific expertise, coupled with efficient processes in development will support our objective to gain on time marketing authorizations and achieve further important milestones while we are advancing our biosimilar product pipeline.”

The full annual report is available at www.formycon.com/investors/financial-reports. The English version will be published at the end of May.

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

Munich – The biosimilar company Formycon plans, with effect from March 1, 2017, to switch to Deutsche Börse AG’s new stock exchange segment “Scale” for small and medium-sized enterprises (SMEs). A corresponding request for inclusion in the SME segment has been lodged with Deutsche Börse AG. Formycon will be accompanied by its capital market partner Süddeutsche Aktienbank.

The new segment, which will be more strictly regulated in some areas both in terms of its inclusion and its follow-up requirements than the entry standard, will improve access to investors for small and medium-sized companies and place the emphasis on transparency and quality criteria. Deutsche Börse is therefore supporting the goals of the German government of sustaining innovation and growth in Germany and is keen, through this action, to make a contribution towards Germany’s sustainability as a business location.

“We welcome the new segment, and we anticipate further attention from investors and analysts as a result”, says Dr. Nicolas Combé, Chief Financial Officer at Formycon. “We also believe that the new SME segment represents a sensible further development of the entry standard. It should lead to more transparency on the market and could evolve into an indicator for small and medium-sized quality companies.”

Formycon shares have been listed in the curb segment entry standard since 2012. Formycon has already reported beyond the specified minimum standards that are imposed on corporate publicity in the past. The company communicates quarterly in German and English, for example, on the progress of its business and regularly updates investors and analysts. Formycon will continue to do so in the future.

Formycon develops follow-on versions of biopharmaceuticals, so-called biosimilars. Currently the company is working on four biosimilar projects, which are in different stages of pre-clinical and clinical development. Two of them have already been out-licensed.

Munich – The biosimilar company Formycon has been named “growth champion 2017” in the category “Chemistry and Pharma” by the news magazine Focus. Due to its significant growth in sales over recent years, Formycon was ranked first in this segment in a rating of the 500 companies in Germany with the largest growth in sales in the period from 2012 to 2015. In the overall ranking, Formycon took second place.

“We are very pleased with our excellent rankings in the Focus list,” said Dr. Carsten Brockmeyer, executive board member and CEO of Formycon. “They illustrate the rapid and successful achievements of our young company over the last few years with our biotechnological follow-on drugs and company growth. We owe this result to the great commitment of the entire Formycon team and the excellent support of our partners.”

Since the start of development activity in 2012, Formycon has continuously expanded its range of biosimilar projects, with four projects currently in the pipeline. In the current year, the company anticipates sales of EUR 20 million. In particular, Formycon expects a further substantial increase in revenues from the year 2020. From this point and given a successful development, it is planned to launch FYB201 – the first biosimilar developed by the company – on the market.

Biosimilars are follow-on products of biopharmaceutical drugs and are increasingly taking over the role of classical generics. In contrast to the latter, biosimilars are complex medical preparations whose development requires extensive know-how and considerable financial resources. Compared to original pharmaceutical products, which are usually expensive, biosimilars offer significant savings potential for healthcare systems and thus make a central contribution to the improvement of patient care in the form of highly effective, biopharmaceutical drugs.

Formycon’s most advanced development project (in partnership with Bioeq IP AG) is FYB201, a biosimilar candidate of the ophthalmic drug Lucentis®* (ranibizumab), for which patients have been enrolled in a global clinical phase III since the start of 2016. FYB201 is therefore the world’s only Lucentis® biosimilar to be in a phase III licensing study, the final stage of clinical development to gain marketing approval.

FYB203, which has been licensed out to Santo Holding Deutschland (GmbH), is a biosimilar candidate to Eylea®** (aflibercept) which, like Lucentis®, is used to treat neovascular, age-related macular degeneration (nAMD) and other serious eye conditions. Details of the FYB202 and FYB205 projects, which have not yet been partnered and the rights to which are still fully owned by Formycon, have so far not been published.

The Focus special “Growth Champions 2017” includes a list of the 500 German companies with the highest average percentage growth per year. Focus also subdivided the list into different industry sectors. The ranking was developed in cooperation with the statistical company Statista and takes into account both privately owned and listed companies. The prerequisites for inclusion were that the companies operate independently, are not subsidiaries, have their head office in Germany and generated at least EUR 100,000 in sales in 2012 and EUR 1.8 million or more in 2015.

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

Munich – In the first nine months of the 2016 financial year, the biosimilars company Formycon has further advanced the development of its drug candidates. Revenue from sales has primarily been generated through the development of the two partnered biosimilar product candidates FYB201 and FYB203. At the same time, Formycon has also invested heavily in both of its own development programs – FYB202 and FYB205 – thereby continuing its successful economic path as planned.

With a turnover of Euro 11.66 million, the Formycon Group achieved an overall performance of Euro 11.82 million after consideration of other operating income worth Euro 0.16 million. The nine-month earnings before interest, taxes, depreciation and amortizations (EBITDA) stood at Euro -2.06 million, with the operating result (EBIT) amounting to Euro -2.58 million. The result for the period totaled Euro -2.57 million.

As of September 30, 2016, the Formycon Group held liquid assets worth Euro 16 million. Including short-term receivables from deliveries and services worth around Euro 3 million, Formycon had liquid assets of around Euro 19 million at its disposal. As a result, the company continues to maintain a solid financial buffer which will enable it to advance the development of its biosimilar candidates.

For the full year, Formycon continues to anticipate group revenues in the range of Euro 20 million.

In the first three quarters of 2016, Formycon AG as the actual operational unit achieved sales of Euro 8.72 million, while the overall performance amounted to Euro 8.87 million. The EBITDA stood at Euro -2.30 million, the EBIT at Euro -2.82 million and earnings at Euro -2.81 million. On the day of review, Formycon employed 68 people.

Dr. Nicolas Combé, Director and CFO of Formycon, believes these results confirm that the company remains on the right path: “With the planned investments in our biosimilar projects, we are building up a valuable pipeline and positioning ourselves as a leading independent developer for biosimilars. Together with our licensing partners Santo Holding and Bioeq IP AG, our goal is to be the first to offer high-quality follow-on drugs after the expiry of patents on reference products. The progress this year shows us that we are on the right track.”

Formycon currently has four biosimilar projects in clinical and pre-clinical development. The furthest-advanced is FYB201, a biosimilar candidate of the ophthalmic drug Lucentis®* (ranibizumab), for which patients have been enrolling in a global clinical phase III since the start of 2016 in collaboration with Bioeq IP AG. FYB201 is therefore the world’s only Lucentis® biosimilar to be in the phase III licensing study, the final stage of clinical development to gain marketing approval.

FYB203, which has been licensed out to Santo Holding (Deutschland) GmbH, 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. Details of the FYB202 and FYB205 projects, which have not yet been partnered and the rights to which are still fully owned by Formycon, have so far not been published.

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

Research Seal awarded in recognition of particular dedication to biosimilar development

Munich – The biosimilar company Formycon has been awarded the Research Seal by the Stifterverband in recognition of its innovative research and development work. With this award, the organization is acknowledging the Munich company’s dedication to the development of biopharmaceutical follow-on drugs, known as biosimilars. According to the organization, the “Innovative Through Research” Seal is also intended to highlight the special responsibility that researching companies take on through their work on behalf of the state and society.

The Stifterverband points out that, although there are 3.5 million companies in Germany, less than one percent of them actually carries out research. This is an extremely important group. Only by researching can new things be discovered and innovation and growth created, says the organization.

Formycon is currently working on four biosimilar development projects (FYB201, FYB202, FYB203, FYB205), which are in various stages of pre-clinical and clinical development.

The most advanced development project is FYB201, a biosimilar candidate of the ophthalmic drug Lucentis®* (ranibizumab). It is the world’s only Lucentis® biosimilar to be in a phase III approval study. Formycon is pursuing the goal of marketing FYB201 via its licensing partner Bioeq IP AG as the first Lucentis® biosimilar following the expiry of the drug’s patent in the USA and Europe.

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. The project is licensed to Santo Holding Deutschland (GmbH).

Details of the biosimilar projects FYB202 and FYB205 have not yet been made public.

Dr. Carsten Brockmeyer, CEO of Formycon, is delighted by the award from the Stifterverband: “The award of the Research Seal is a major legitimation for us. It highlights the efforts that the entire Formycon team has been making for years in research and development to develop high-quality biosimilars. We will continue to work hard to ensure that as many patients as possible are able to receive high-quality medicines at affordable prices.”

The Stifterverband, a joint initiative between companies and foundations, is one of Germany’s largest private sponsors of science. Alongside its commitment to academic growth, first-class universities and cutting-edge research, the Stifterverband also regularly examines and evaluates the German research and innovation system on behalf of the German Ministry of Education and Research.

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

Munich – The development of Formycon’s biosimilar candidates has progressed well during the first half of 2016. Biosimilar developer Formycon AG announced this update today as it unveiled its 2016 half-year figures.

Formycon is currently working on four biosimilar development projects (FYB201, FYB202, FYB203, FYB205) at different stages of preclinical and clinical development.

The furthest-advanced is FYB201, a biosimilar candidate of the ophthalmic drug Lucentis®* (ranibizumab), for which patients have been enrolled in a global clinical phase III since the start of 2016 in collaboration with bioeq GmbH. FYB201 is therefore the world’s only Lucentis® biosimilar to be in a phase III study, the final step in clinical development to gain marketing approval. Formycon is pursuing the goal of marketing FYB201 via its licensing partner as the first Lucentis® biosimilar following the expiry of the drug’s patent in the USA and Europe.

Further important milestones were reached during the first six months of 2016 on the development projects FYB202 and FYB203, which are in the pre-clinical phase, including agreements with renowned biopharmaceutical contract manufacturers. For FYB205, the company’s latest biosimilar project, which has been started in Q1 2016, a cell line development agreement has been signed with a prestigious partner.

FYB203, which is partnered to Santo Holding (Deutschland) GmbH, 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. For FYB202 and FYB205, which both are not partnered and fully owned by Formycon, the reference products have not been disclosed so far.

With effect from April 1, 2016 Santo Holding (Deutschland) GmbH has, with Formycon’s approval, transferred the global commercialization rights for FYB201 to the Swiss company Bioeq IP AG. Bioeq IP AG is a joint venture company, the shares of which are held equally by Santo Holding AG and Swiss Pharma International AG, a company of the Polpharma Group. Nothing will change in relation to Formycon’s forecast future licensing income as a result of this transfer.

Through the expansion and progress of biosimilar projects, Formycon has adapted its structures and in the process also further increased its workforce, as it has done in previous years. At the half-year stage, the company employed 65 people compared to 53 at the start of 2016. As reported, from October 1, 2016, the experienced pharmaceutical manager Dr. Stefan Glombitza will join the management board, which currently comprises two members. Together with Dr. Carsten Brockmeyer (CEO) and Dr. Nicolas Combé (CFO), Dr. Glombitza will take on the role of Chief Operating Officer (COO) with special responsibility for the company’s operational development activities.

In economic terms, Formycon has concluded the first half of 2016 on schedule. The Formycon Group’s turnover was Euro 8.76 million, compared to Euro 9.82 million in the same period the previous year. Formycon received income from the development of its partnered biosimilar product candidates FYB201 and FYB203. As planned, Formycon has invested further in its biosimilar assets FYB202 and FYB205. As a consequence of this increased research and development expenditure, the operating result stood at Euro -1.17 million compared to Euro 1.5 million during the same period last year.

The company’s financial position remains consistently solid: Formycon holds liquid assets of around Euro 17.8 million. Including short-term receivables from deliveries and services worth Euro 2.95 million, Formycon’s liquid assets total around Euro 20.7 million (2015: 23.1 million). The Group’s equity ratio is over 93 percent. Based on income from its partnered projects, the company continues to anticipate a rise in turnover to over Euro 20 million for the current year. The annual result is greatly dependent on whether the FYB202 project will be partnered in 2016.

Formycon AG, as the company’s central development and operational unit, achieved a turnover of Euro 7.1 million (previous year: 7.1 million) during the first six months, with the result from the first half-year being Euro -1.2 (1.7) million. The full half-year report is available on the Formycon Website.

Dr. Brockmeyer says: “Following last year’s excellent results, we have been able to continue our path to success during the first six months of 2016, enroll numerous patients in the phase III study with our leading biosimilar candidate FYB201, achieve important milestones in FYB202 and FYB203, and expand our product pipeline with the new biosimilar candidate FYB205. The role of biosimilars in medical care is growing increasingly on a global scale, and the demand for affordable biopharmaceuticals is rising. This convinces us that we are on the right path with our biosimilar projects.”

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

Munich – The biosimilar company Formycon AG has today announced that Dr. Stefan Glombitza will join the company on October 1, 2016 and add his strengths to the Management Board. In addition to the existing Board Members Dr. Carsten Brockmeyer and Dr. Nicolas Combé, Dr. Glombitza will in future act as Chief Operating Officer (COO), focusing especially on the company’s operational development activities, while CEO Dr. Brockmeyer will focus more on the areas of strategy, synergies and developing the business further. Dr. Combé will continue to be in charge of Formycon’s finances.

Dr. Glombitza, 51, has more than twenty years of extensive experience in the pharmaceutical industry and has particular expertise in the generics sector. After studying pharmacy at the University of Regensburg and subsequently gaining his doctorate, he began his professional career in 1995 as Medical Affairs Manager at Hexal AG. As Head of the Medicines Department, he advanced the introduction of international project management in Hexal AG’s development department to a crucial point and ultimately was appointed to the Management Board of Hexal Pharmaforschung as Head of Project Management.

With the takeover by Novartis in 2005, Dr. Glombitza’s remit expanded to cover leadership of global project and portfolio management within Sandoz’s generics division, a global network of eight international development centers. After four successful years in this role came the new challenge of establishing a central shared-service organization for the Regulatory Affairs, Medicine, Pharmacovigilance and Quality Assurance divisions of all of the brands within the German business sector. Dr. Glombitza developed and implemented this new organizational concept and headed up the Pharmaceutical Affairs division until 2013, when he returned to global development. From October 2013, he was in charge of the global development center at the Austrian sites of Kundl and Schaftenau. This development center, with its international project portfolio, represents an important pillar of Sandoz’s development.

“With Dr. Glombitza we have successfully brought on board a renowned expert and experienced pharmaceutical manager. We are very much looking forward to working with him,” said Dr. Olaf Stiller, Chairman of the Formycon Supervisory Board. “Formycon’s encouraging development and the associated company growth means that the tasks and challenges within the business have grown too. We firmly believe that Dr. Glombitza will, with his expertise, be able to help us take Formycon forward on its journey into the future.”

“I’m absolutely delighted to be playing my part in the future development of Formycon in this key role,” added Dr. Glombitza. “The company has impressed me with its tremendous development expertise and strong strategic positioning. I’m very proud to be contributing my experience from my previous professional roles to the company’s future and I am convinced that we will complement each other very well on the Management Board. From October, I will be showing my unwavering commitment to taking Formycon further forward on its path to growth.”

Munich – Dr. Carsten Brockmeyer, CEO of the biosimilar company Formycon AG, has again been chosen as one of the world’s top 100 most influential people in the pharmaceutical sector by the trade magazine “The Medicine Maker”. Brockmeyer was also included in the “Medicine Maker Power List” last year. Dr. Brockmeyer is joined on the list by other highly decorated people from the worlds of industry and science, including Nobel Prize winners, CEOs and a host of outstanding scientists from the pharmaceutical sector.

“I’m delighted to once again have been included in this group of outstanding people in the medicines industry. It shows that biosimilars are constantly growing in importance in the world of medicine. This further accolade also bears testimony to the services that the entire Formycon team has been contributing for years,” said Dr. Carsten Brockmeyer.

The Medicine Maker is a trade magazine published in the United Kingdom and which read all over the world. The list is compiled from readers’ nominations and assistance from experts and is based exclusively on services rendered to medicines development. The rankings are determined in three steps. First, the magazine’s readers are asked which people from the pharmaceutical industry they would include on the list. Out of these nominees, the jurors each select their 100 most influential people. These lists are then consolidated into the final document. The list can be viewed here.

Munich – The first quarter of 2016 has been successful for the biosimilars company Formycon both in operational and financial terms. On the furthest-progressed development project FYB201, a biosimilar candidate for Lucentis®*, the first patient was enrolled in February of this year in the phase III study which is intended to support market approval in Europe and the USA. The study is being financed by and carried out under the responsibility of Formycon’s licensing partner Santo Holding/bioeq, as is all of the further development and subsequent marketing. Work has also begun on the development of a further biosimilar candidate. The program has now been given an official project status with the code FYB205.

At group level, sales revenues and other earnings totaled Euro 6.34 million, which represents an increase of Euro 3.34 million (previous year: Euro 3.0 million). From January to March, the EBITDA was Euro -0.02 million (Euro -0.3 million) based on a quarterly result of Euro -0.19 million (Euro -0.57 million). Stocks of liquid assets, which comprise cash, checks, bank deposits and securities, totaled Euro 15.29 million at the end of March. Including short-term receivables from deliveries and services worth Euro 7.48 million, Formycon held liquid assets of Euro 22.76 million on the day of reporting.

Revenues from sales and other earnings at Formycon AG totaled Euro 4.99 million. The quarterly result stood at Euro -0.33 million. Chief Financial Officer Dr. Nicolas Combé commented on the quarterly figures with these words: “We are very happy with how the first quarter has progressed and we have achieved further important milestones on our various projects. The financial results lay entirely within our forecasts. As already communicated, we anticipate a growth in sales to over Euro 20 million for the whole year at group level. The annual result will depend greatly on the time at which we partner our FYB202 project. We are already in negotiations with potential partners for this, however there is still a possibility that we will continue to manage the project on our own for a certain period.”

* Lucentis is a registered trademark of Genentech Inc.