Recent press releases
30. November 2016
Focus magazine lists Formycon as growth champion 2017
- Biosimilar developer ranked first in the “Chemicals and Pharma” category
- Ranked second among the top 500 companies in Germany by growth
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 current 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.
Formycon is a leading independent pure play developer of biosimilars and has become a recognized innovator in this field. The company has extensive experience in the development of complex biological molecules. Formycon’s specialist expertise allows the company to develop high-quality biosimilars that meet the strict regulatory requirements of highly regulated markets such as Europe and the United States. Formycon currently has four biosimilars under development, of which two have been licensed out.
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 more than 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. While the global market for biosimilars is currently more than USD 3.0 billion, industry experts expect this figure to grow tenfold by the year 2025. In contrast to traditional generic drugs, the development and production of biosimilars is highly complex and requires specialized expertise.
This press release may contain forward-looking statements and information which are based on our current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here.
Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful.
Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated.
This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended.
This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.