23.02.2016
Formycon AG DE000A1EWVY8
DGAP-News: Formycon AG: Formycon and bioeq enroll first patient in pivotal phase III study with biosimilar ranibizumab (FYB201)
DGAP-News: Formycon AG / Key word(s): Research Update/Study
Formycon AG: Formycon and bioeq enroll first patient in pivotal phase III
study with biosimilar ranibizumab (FYB201)
23.02.2016 / 08:00
The issuer is solely responsible for the content of this announcement.
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Press release // February 23, 2016
Formycon and bioeq enroll first patient in pivotal phase III study with
biosimilar ranibizumab (FYB201)
- COLUMBUS-AMD study investigates the comparability of FYB201, an
investigational biosimilar ranibizumab, and Lucentis(R)* in patients
with neovascular age-related macular degeneration (nAMD)
- Study involves 650 participants in around 80 clinical centers worldwide
- Partners Formycon and bioeq significantly advance in the development of
FYB201
Munich - Formycon AG, Munich, and bioeq GmbH, Holzkirchen, today announced
that they have enrolled the first patient in their clinical Phase III study
involving FYB201, Formycon's biosimilar version of Lucentis(R). The
objective of the study is to demonstrate the comparability of FYB201 and
Lucentis(R) in terms of safety, effectiveness, and immunogenicity in
patients with neovascular age-related macular degeneration (nAMD). This
condition, known as wet AMD, is one of the primary causes of loss of vision
in people over the age of 60 in developed countries. It is estimated that
as many as 7.5 million people worldwide suffer from wet AMD. Germany alone
has around 450,000 patients with the condition.
Lucentis* is a leading drug for the treatment of neovascular age-related
macular degeneration. It inhibits the vascular endothelial growth factor
(VEGF) responsible for the excessive formation of blood vessels in the
retina, which leads to a progressive loss of vision. The total market
volume for intraocular anti-VEGF treatments in 2015 was around US$ 7.5
billion, and is growing rapidly.
Dr. Björn Capsius, Director Clinical Development at Formycon, said: "We are
delighted that, after intensive preparations, our study has now started to
enroll its first patient. It is a major step forward in the development of
our biosimilar and we will gain important data supporting the regulatory
approval in the EU and US."
Dr. Joachim Kiefer, Head of Clinical Development at bioeq, added: "The
active ingredient ranibizumab is an effective and proven therapy for the
treatment of age-related macular degeneration. By developing a high-quality
and cost-effective biosimilar, we want to give as many patients as possible
the opportunity to access this treatment option. This not only helps
improve patient care, but also helps to reduce healthcare costs."
At the end of 2013, Formycon licensed FYB201 exclusively to Santo Holding
GmbH, Holzkirchen. bioeq GmbH, a subsidiary of Santo Holding GmbH, is the
sponsor of the Phase III study and is also responsible for the global
marketing and licensing of FYB201.
* Lucentis is a registered trademark of Genentech Inc.
About Formycon:
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 three
biosimilars under development, with further product candidates already
identified. Two biosimilar candidates have been licensed out to Santo
Holding GmbH.
About bioeq:
bioeq GmbH was established in March 2014 and is funded by the Strüngmann
Group (Santo Holding) and by Polpharma, a leading Polish pharmaceutical
company. bioeq is active in the development of biosimilars in compliance
with standards required for approval and distribution in the EU, US and
other highly regulated markets.
Starting from early stage development projects licensed from
internationally renowned partners or cell lines stemming from affiliated
companies, bioeq conducts development programs up to clinical development
and registration. bioeq's pipeline comprises several of the so-called
"third wave" biosimilars, for which patent protection is due to expire
within the next decade.
bioeq's management team combines expert scientists and senior management
with a skill set spanning from early stage development through to
commercialization of complex molecules and biosimilars.
About biosimilars:
Since their introduction in the 1980s, biopharmaceuticals have
revolutionized the treatment of serious diseases such as cancer, diabetes,
rheumatoid arthritis and multiple sclerosis. 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 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.
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 and patent litigation. 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.
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23.02.2016 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.
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Language: English
Company: Formycon AG
Fraunhoferstraße 15
82152 Planegg-Martinsried
Germany
Phone: 089 864667 100
Fax: 089 864667 110
Internet: www.formycon.com
ISIN: DE000A1EWVY8
WKN: A1EWVY
Listed: Regulated Unofficial Market in Berlin; Open Market (Entry
Standard) in Frankfurt
End of News DGAP News Service
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