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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.

Munich – The biosimilars company Formycon, Martinsried near Munich, has ended the 2015 financial year with both operational and financial success. In the last year, Formycon has made great strides with the initiation of the clinical Phase III study involving the biosimilar candidate FYB201 (ranibizumab) in particular. FYB201 is a follow-on drug to the successful ophthalmic agent Lucentis®*, which achieved global sales worth around 3.5 billion dollars in 2015. With the Phase III, managed by licensing partner Santo Holding, the widespread use on patients is intended to demonstrate that FYB201 is comparable with the reference product in terms of efficacy and safety.

At the same time, Formycon was able to license out a further biosimilar project – FYB203 (aflibercept) – from its pipeline to Santo Holding GmbH in 2015. FYB203 is a biosimilar candidate for Eylea®**. Consequently, Formycon’s development pipeline comprises the two most important and best-selling drugs for intraocular anti-VEGF treatments, one of the fastest-growing therapeutic sectors on the pharmaceutical market.

Operational advances have been underpinned by the company’s strong financial development. Formycon was therefore able to successfully raise capital in the spring of 2015, bringing in Euro 11.1 million for the company’s further development. As a result of the out-licensing, the company has also once again earned significant sales that were considerably higher than 2014.

The Formycon Group increased its turnover in 2015 by 34 percent compared to the previous year, from Euro 12.58 million to Euro 16.9 million. The EBITDA was Euro 1.47 million (2014: 1.94 million), while the annual net profit stood at Euro 0.57 million (2014: 0.86 million). The Group’s equity ratio had risen during the period under review from 77.6 percent to 91.5 percent, representing an above-average level. The company has no financial liabilities. Stocks of liquid assets, which comprise cash, checks, bank deposits and securities, totaled Euro 20.3 million on the day of reporting. Including short-term receivables from deliveries and services worth Euro 2.76 million, Formycon held liquid assets of around Euro 23.1 million (2014: 12.48 million).

Formycon AG achieved a turnover of Euro 13.6 million (2014: 10.53 million) and had an annual net profit of Euro 0.6 million (0.87 million).

The number of employees has grown from 40 at the start of the year to 53 at the end of December 2015. For 2016, Formycon is planning a further moderate increase in its workforce.

The focus of the next few years will be on the further consistent implementation of the company’s strategy, ongoing expansion of the pipeline and further out-licensings of biosimilar candidates. The aim is to continue combining business development with healthy financial results.

Dr. Nicolas Combé, Director and CFO of Formycon, also anticipates positive development in 2016: “Thanks to our two out-licensed biosimilar projects FYB201 and FYB203, we expect the 2016 financial year to bring a further increase in group turnover compared to 2015 to over Euro 20 million. The 2016 annual results will depend greatly on a potential partnership for the FYB202 project. We will also continue to invest a considerable share of our resources in the development of our biosimilars and the expansion of our pipeline in order that we can guarantee the long-term economic success of our company.”

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

Munich – Formycon AG today has announced details on the second biosimilar product which is jointly developed with Santo Holding GmbH. FYB203 is a biosimilar candidate for Eylea® (aflibercept). This comprises the common development pipeline with the two most important and best-selling medications in the field of ophthalmology, FYB201 (biosimilar candidate for Lucentis®**) and FYB203.

Eylea® and Lucentis® are used for the treatment of neovascular age-related macular degeneration (neovascular AMD) and other serious eye conditions. Lucentis® generated revenues of approximately USD 3.5 billion in 2015, while Eylea® achieved an estimated market volume of more than USD 4 billion. Together, both products represent almost the entire global market volume for intraocular anti-VEGF treatments, one of the fastest growing therapeutic areas on the pharmaceutical market.

Formycon out-licensed FYB203 exclusively to Santo Holding GmbH in Holzkirchen in May 2015. Bioeq GmbH, a subsidiary of Santo Holding GmbH, will be responsible for the clinical development, the approval and the global marketing and licensing of FYB203. Both development programs will be developed in close coordination with the US Food and Drug Administration (FDA), as well as the European Medicines Agency (EMA), and are striving towards approval in both regions.

Dr. Carsten Brockmeyer, CEO of Formycon AG: “The development of biosimilars for Lucentis® and Eylea® has made us pioneers in the area of opthalmology biosimilars with the two most important products in this field. We believe we are the only company with a Lucentis® biosimilar already in the pivotal Phase III clinical study. Our strong position is also underlined by the number of formulation and application patents we have already filed which gives us a further competitive advantage. It is our goal to launch our biosimilars on the market at day one after the patent on the reference product expires.”

“The anticipated significant market growth in ophthalmology means that the provision of safe and high quality medications in this area poses a significant challenge for the global health care systems. Through our biosimilars, we are striving to make a considerable contribution to the supply of as many patients as possible worldwide with these important pharmaceutical products”, added Dr. Nicolas Combé, CFO of Formycon AG.

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

Munich – Formycon AG, Munich, and bioeq GmbH, Holzkirchen, today announced that they have enrolled the first patient in their clinical Phase III study involving FYB201, Formycon’s biosimilar version of Lucentis®. The objective of the study is to demonstrate the comparability of FYB201 and Lucentis® in terms of safety, effectiveness, and immunogenicity in patients with neovascular age-related macular degeneration (nAMD). This condition, known as wet AMD, is one of the primary causes of loss of vision in people over the age of 60 in developed countries. It is estimated that as many as 7.5 million people worldwide suffer from wet AMD. Germany alone has around 450,000 patients with the condition.

Lucentis® is a leading drug for the treatment of neovascular age-related macular degeneration. It inhibits the vascular endothelial growth factor (VEGF) responsible for the excessive formation of blood vessels in the retina, which leads to a progressive loss of vision. The total market volume for intraocular anti-VEGF treatments in 2015 was around US$ 7.5 billion, and is growing rapidly.

Dr. Björn Capsius, Director Clinical Development at Formycon, said: “We are delighted that, after intensive preparations, our study has now started to enroll its first patient. It is a major step forward in the development of our biosimilar and we will gain important data supporting the regulatory approval in the EU and US.”

Dr. Joachim Kiefer, Head of Clinical Development at bioeq, added: “The active ingredient ranibizumab is an effective and proven therapy for the treatment of age-related macular degeneration. By developing a high-quality and cost-effective biosimilar, we want to give as many patients as possible the opportunity to access this treatment option. This not only helps improve patient care, but also helps to reduce healthcare costs.”

At the end of 2013, Formycon licensed FYB201 exclusively to Santo Holding GmbH, Holzkirchen. bioeq GmbH, a subsidiary of Santo Holding GmbH, is the sponsor of the Phase III study and is also responsible for the global marketing and licensing of FYB201.

* Lucentis is a registered trademark of Genentech Inc.

Munich – Formycon, the biosimilars company, has announced a significant increase in its revenue for the first nine months of this year, thus continuing on its path of profitable growth. With the signing of its second out-licensing deal in May of this year with Santo Holding GmbH, financing is now fully in place to proceed with the development of its first two biosimilar product candidates, FYB201 and FYB203, all the way through to regulatory approval and market launch. In close partnership with bioeq GmbH, Formycon recently initiated a phase III clinical trial, pivotal for gaining market approval in Europe and the U.S., for FYB201, a biosimilar version of Lucentis®*. The first patient is to be accepted into the testing program over the coming weeks. Furthermore, Formycon is planning to begin development work on three additional biosimilar candidates from next year on, thereby further expanding its existing product pipeline and setting the foundations for continued growth.

Total consolidated revenue and other income for the period was EUR 14.71 million, an increase of EUR 5.73 million compared to the prior-year period (8.98m). EBITDA for the period from January to September was EUR 2.22 million (2.64m), while nine-month net income was EUR 1.51 million (1.81m). As of the end of September, the company’s holdings of cash, cash equivalents and marketable securities were EUR 17.12 million. Including also short-term receivables in the amount of EUR 5.7 million, Formycon thus has liquid assets of well over EUR 20 million at its disposal, roughly the twice the level at the end of the prior nine-month period (EUR 10,44 million).

Total revenue and other income for parent company Formycon AG alone, on an unconsolidated basis, was EUR 11.45 million, with nine-month net income of EUR 1.28 million. Dr. Nicolas Combé, CEO of Formycon, had this to say on the nine-month results: “We are putting our growth strategy into action deliberately and consistently, underscoring our company’s commitment as a leading independent developer of biosimilar drugs. Moreover, we see enormous demand on the market for these products, and thus we are now planning to expand our pipeline by three additional molecules. With these actions, we are putting the foundations into place to generate significant further value for our company and its shareholders. This path of profitable growth is a testimony to the superb work by our team, with which we are extremely satisfied.”

Formycon continues to anticipate a full-year profit, thereby confirming its existing guidance.

* Lucentis is a registered trademark of Genentech Inc.