Corporate | 22 July 2015 07:55
Formycon AG / Key word(s): Miscellaneous
22.07.2015 07:55
Dissemination of a Corporate News, transmitted by DGAP - a service of EQS
Group AG.
The issuer / publisher is solely responsible for the content of this announcement.
---------------------------------------------------------------------------
Formycon AG receives favorable scientific advice from U.S. Food and Drug
Administration for its partnered biosimilar candidate FYB201
Munich - Formycon AG, a leading independent developer of biosimilar drugs,
has received a scientific advice letter from the U.S. Food and Drug
Administration (FDA) regarding the preclinical and clinical development
program for FYB201, the first biosimilar product candidate to emerge from
its development pipeline, following the receipt of similarly favorable
scientific advice from the European Medicines Agency (EMA) in December
2014. In its letter, the FDA, like the EMA, expresses its support for the
company's proposed approach to proceed with FYB201 directly to the pivotal
phase III clinical trial. Based upon the scientific advices received from
the EMA and FDA, Formycon and its license partner Bioeq GmbH are now in a
position to carry forward with a clinical study design for a global phase
III trial which will enable them to apply simultaneously for regulatory
approval in both the U.S. and European Union. All preclinical activities
and the preparations for the phase III trial for FYB201 are moving forward
according to plan.
The market launch of FYB201 in the highly regulated markets, particularly
the U.S. and European Union, is planned to begin starting from 2020.
Background: What are biosimilars?
Since their introduction in the 1980s, biopharmaceuticals have
revolutionized the treatment of diseases such as cancer, diabetes,
rheumatoid arthritis and multiple sclerosis. In the coming years, many of
the patents for these biotech drugs will expire - and by the year 2020,
medications with revenues of more than USD 100 billion will lose their
patent protection. In this way, it will become possible to launch new
competing drugs, known as "biosimilars". While the global market for these
new-generation drugs is currently some USD 2.5 billion, industry experts
expect this figure to grow tenfold by the year 2020. In contrast to
traditional generic drugs, the development and production of biosimilars is
highly complex and requires specialized expertise.
About Formycon:
Formycon AG is a leading independent developer of biosimilars for global
marketing and has become a recognized innovator in the field. The team of
the company has extensive experience in the development of complex
molecules. Its specialist expertise allows the company to develop
high-quality biosimilars that meet the strict requirements of the
regulatory authorities in highly regulated countries and regions such as
Europe and the USA. Formycon currently has three products under
development, of which the first two biosimilar candidates have already been
licensed out to Santo Holding GmbH, with further product development
projects in the pipeline. Its aim is to be the first company in the world
to present clinical data for each respective product candidate and on this
basis to license these products out to major pharmaceutical and generics
companies for further development. Alternatively, Formycon offers further
development of its biosimilars all the way through to marketing
authorization, as well as commercial production on behalf of its licensees.
Contact:
Formycon AG
Fraunhoferstr. 15
82152 Martinsried/Planegg
Germany
phone +49 (0) 89 - 86 46 67 100
fax + 49 (0) 89 - 86 46 67 110
ir@formycon.com // www.formycon.com
Disclaimer:
This release may contain forward-looking statements and information which
may be identified by formulations using terms such as "expects", "aims",
"anticipates", "intends", "plans", "believes", "seeks", "estimates" or
"will". Such forward-looking statements are based on our current
expectations and certain assumptions which may be subject to variety of
risks and uncertainties. The results actually achieved by Formycon AG may
substantially differ from these forward-looking statements. Formycon AG
assumes no obligation to update these forward-looking statements or to
correct them in case of developments which differ from those anticipated.
22.07.2015 The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------------
Language: English
Company: Formycon AG
Fraunhoferstraße 145
82152 Planegg-Martinsried
Germany
Phone: 089 864667 100
Fax: 089 864667 110
E-mail:
Internet: www.formycon.com
ISIN: DE000A1EWVY8
WKN: A1EWVY
Listed: Regulated Unofficial Market in Berlin; Open Market (Entry
Standard) in Frankfurt
End of Announcement DGAP News-Service
---------------------------------------------------------------------------