DGAP-News: Formycon AG: Formycon Announces Details of Further Pipeline Product: FYB202 is a Biosimilar Candidate for Stelara(R) (ustekinumab)

Press Release // May 10, 2017

Formycon Announces Details of Further Pipeline Product: FYB202 is a Biosimilar Candidate for Stelara (ustekinumab)

- Development pipeline now comprises three of the highest-selling reference products from the third wave of biosimilars

- Munich-based biosimilar company targets another multi-billion dollar market alongside ophthalmology

- Ustekinumab addresses major patient potential and offers significant opportunities for growth

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.

About Formycon:
Formycon is a leading, independent developer of high-quality follow-on products for biopharmaceutical medicines known as biosimilars. The company focuses on ophthalmology treatments and on other key chronic diseases, covering the entire added value chain from technical development to the clinical phase III and 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, two of which have already been licensed out.
 

About biosimilars:
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.

Contact:
Thorsten Schüller
Corporate Communications and Investor Relations
Formycon AG
Fraunhoferstr. 15
82152 Martinsried/Planegg/Germany
phone +49 (0) 89 - 86 46 67 150
fax + 49 (0) 89 - 86 46 67 110
[email protected] // www.formycon.com

Disclaimer:
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.
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