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PRESS RELEASE: Formycon AG: Formycon announces Start of Phase I Clinical Trial with Ustekinumab Biosimilar Candidate FYB202

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DGAP-News: Formycon AG / Key word(s): Study/Miscellaneous
Formycon AG: Formycon announces Start of Phase I Clinical Trial with
Ustekinumab Biosimilar Candidate FYB202

2019-10-28 / 07:10
The issuer is solely responsible for the content of this announcement.

_Press release // October 28, 2019_

*Formycon announces Start of Phase I Clinical Trial with Ustekinumab
Biosimilar Candidate FYB202*

*- *Testing of comparable pharmacokinetics, safety, and tolerability of
FYB202 with
reference drug Stelara(R)*

- Dosing of study subjects started

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announced the
start of a Phase I clinical trial comparing the pharmacokinetics, safety,
and tolerability of FYB202 and the reference product Stelara(R) (USA / EU).
Dosing of study subjects started last week.

FYB202 is being developed in a joint venture by Aristo Pharma GmbH and
Formycon AG in which Aristo Pharma GmbH holds 75.1% and Formycon AG 24.9%.
Bioeq GmbH is the sponsor of the clinical trial and is also responsible for
the study design and clinical operation.

Provided successful completion of clinical Phase I and subsequent Phase III
testing and timely regulatory approval, FYB202 can be launched after patent
expiry of Stelara(R) (USA 09/2023; EU 07/2024).

_* Stelara_(R) _is a registered trademark of Johnson & Johnson._

*About Formycon:*
Formycon is a leading, independent developer of high-quality follow-on
products for biopharmaceutical medicines known as 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

*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 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. While the global market for biosimilars
is currently more than USD 5.0 billion, industry experts expect this figure
to grow up to USD 30 billion by the year 2025.

*Contact Formycon AG*
Sabrina Müller
Corporate Communications and Investor Relations
Fraunhoferstr. 15
82152 Martinsried/Planegg/Germany
phone +49 (0) 89 - 86 46 67 149
fax + 49 (0) 89 - 86 46 67 110
www.formycon.com [1]

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.

2019-10-28 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Archive at www.dgap.de
Language: English
Company: Formycon AG
Fraunhoferstraße 15
82152 Planegg-Martinsried
Phone: 089 864667 100
Fax: 089 864667 110
Internet: www.formycon.com
Indices: Scale 30
Listed: Regulated Unofficial Market in Berlin, Frankfurt (Scale),
Tradegate Exchange
EQS News ID: 897691

End of News DGAP News Service

897691 2019-10-28

1: https://link.cockpit.eqs.com/cgi-bin/fncls.ssp?fn=redirect&url=0216201e94844788516726bab0fb34a3&application_id=897691&site_id=vwd&application_name=news

(END) Dow Jones Newswires

October 28, 2019 02:10 ET ( 06:10 GMT)

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