Corporate | 18 November 2014 07:36
Formycon AG / Key word(s): Study
18.11.2014 07:36
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.
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Munich - Formycon AG, the biosimilar drug development company, is planning
to begin the pivotal phase III study of clinical testing for its first
biosimilar product (FYB201) already in the third quarter of 2015. The
company has brought its schedule forward on the basis of preliminary
guidance received from the European Medicines Agency (EMA) in London, with
which Formycon is working closely to define the regulatory approval pathway
and design of phase III clinical studies for FYB201. The company expects to
receive the EMA's final position as to its scientific advice in December.
This is a service through which the EMA provides consultation and
recommendations to drug developers on study design and clinical trials
reflecting the consensus of the EMA's scientific experts, in order to
facilitate subsequent regulatory approval.
For Formycon AG, the favorable response to its proposed plan for clinical
studies means a significant shortening of its development and approval
schedule. "This puts us almost exactly one year ahead. The opportunity to
jump directly to phase III serves as further confirmation of the high
quality of our work," says Dr. Carsten Brockmeyer, CEO of Formycon AG.
Following the company's successful capital raising and its partnership deal
for its first biosimilar drug signed with Santo Holding in 2013, this marks
yet another key milestone for Formycon. Marketing launch for FYB201 in the
USA and European Union is planned starting in 2020 - and in certain
selected countries should be possible starting already in 2018. The two
other biosimilar drugs currently in Formycon's development pipeline
continue to move forward according to plan and remain the subject of
discussions with various pharmaceutical and generic companies.
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 which has today become Formycon AG has extensive experience in
the development of complex molecules. The company has already successfully
licensed two protein-based product portfolios out to major pharmaceutical
companies - in 2008 and 2011. 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 biosimilar candidates
under development, the first of which has 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.
18.11.2014 The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
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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: Freiverkehr in Berlin; Frankfurt in Open Market (Entry
Standard)
End of Announcement DGAP News-Service
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