Munich – Formycon AG, with its head office in Martinsried near Munich, ended the financial year 2013 very successfully and has thus created a comfortable starting position for further positive business development. In December 2013, much earlier than planned, Formycon successfully licensed out the first development project. In addition, Dr. Carsten Brockmeyer, one of the world’s leading biosimilar experts, joined the board of directors. In November 2013, Formycon also appointed Dr. Gerhard Schaefer, former Head of Global Product and Business Development at Sandoz International, and Simon Sturge, previously Corporate Senior Vice President at Boehringer Ingelheim, to the advisory board. The company can thus count on further expertise and many years of experience.
Formycon is specialised in the development of biosimilars, the more cost-effective follow-on products of complex, biotechnologically manufactured medicines. Because ever more biotechnologically manufactured medicinal products are being authorised (+ 12-15 % per annum), the market for biosimilars is also increasing: according to estimates, the total volume in the year 2020 will be over 15 billion USD. The large pharmaceutical companies are showing a correspondingly great interest in these products. However, in contrast to the generic preparations of standard, chemically synthesised active substances, the development of biosimilars is very complex and expensive, demanding high requirements from the know-how and experience of the teams.
Concentration on the third wave of biosimilars
Formycon AG is one of the few companies in the world that have the expertise for developing biosimilars – also for highly regulated markets such as Europe, the USA and Japan – and has taken on a clear pioneering role in this innovative and demanding market. “We are concentrating specifically on the so-called third wave of biosimilars, i.e. products whose patents expire as of the year 2020,” explains Dr. Nicolas Combé, Director and CFO of Formycon AG.
Partner successfully found for the first project – further licensing out and extension of the pipeline planned
Formycon currently has two projects in development. The company successfully licensed out one of them to Santo Holding GmbH in December 2013, ahead of plan. On behalf of Santo and its partners Andreas and Thomas Strüngmann, founders and former owners of the generics manufacturer HEXAL, Formycon will bring the first development project to market maturity. From this contract, Formycon is reckoning with success-based payments in the mid thousand million range, which will make it possible to realise the further development of the pipeline earlier than planned. Thanks to this contract and to a very solid investor structure, Formycon is one of the few independent companies operating in this promising market of the biosimilars. “We achieved more than expected in 2013,” said Combé. We also reached the milestones for the second development project: after conclusion of the analysis phase, we started with the development of the cell line, so that the second Formycon project is also going according to schedule. The licence options for the second Biosimilar of Formycon’s pipeline are already to be examined in the second half of the year 2014.
On the basis of the unique expertise of the scientists and management as well as the integrated development processes, Formycon is a preferred partner for large pharmaceutical companies in biosimilar development.
Biosimilars are on the advance throughout the world.
Twenty biosimilars have been granted marketing authorisation in the EU to date. Also in other parts of the world (e.g. Switzerland, Turkey, Malaysia, Australia, Japan, Mexico, Taiwan, Korea) several biosimilars are already on the market. In the US, new guidelines for the marketing authorisation of biosimilars are currently being formulated (FDA Draft Guidances on Biosimilars). This will further open up this large market for high-quality biosimilars, as developed by Formycon.
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.