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.
Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. The company focuses on treatments in ophthalmology, immunology and on other key chronic diseases, covering the entire value chain from technical development to the clinical phase III as well as the preparation of dossiers for marketing approval. With its biosimilars, Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines. Formycon currently has four biosimilars in development. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of an innovative COVID-19 drug FYB207.
Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis, multiple sclerosis and eye diseases. In the coming years, many of these biotech drugs will lose their patent protection – and by 2020, medications with revenues of approximately USD 100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. Global sales of biosimilars are estimated to exceed $15 billion by 2020. By 2030, analysts estimate that this figure could rise to over $60 billion.