29.02.2016
Formycon AG DE000A1EWVY8
DGAP-News: Formycon AG: Formycon discloses details on second pipeline product - FYB203 is a biosimilar for Eylea (aflibercept)
DGAP-News: Formycon AG / Key word(s): Research Update/Study
Formycon AG: Formycon discloses details on second pipeline product - FYB203
is a biosimilar for Eylea (aflibercept)
29.02.2016 / 08:00
The issuer is solely responsible for the content of this announcement.
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Press release // February 29, 2016
Formycon discloses details on second pipeline product - FYB203 is a
biosimilar for Eylea (aflibercept)
1. With its Eylea* biosimilar Formycon is solidifying its leading
position in ophthalmologic follow-on products
2. Global development programs for biosimilars aflibercept (FYB203) and
ranibizumab (FYB201)
3. Development pipeline covers the two most important and best-selling
medications in the field of ophthalmology
Munich - Formycon AG today has announced details on the second biosimilar
product which is jointly developed with Santo Holding GmbH. FYB203 is a
biosimilar candidate for Eylea (aflibercept). This comprises the common
development pipeline with the two most important and best-selling
medications in the field of ophthalmology, FYB201 (biosimilar candidate for
Lucentis**) and FYB203.
Eylea and Lucentis are used for the treatment of neovascular
age-related macular degeneration (neovascular AMD) and other serious eye
conditions. Lucentis generated revenues of approximately USD 3.5 billion
in 2015, while Eylea achieved an estimated market volume of more than
USD 4 billion. Together, both products represent almost the entire global
market volume for intraocular anti-VEGF treatments, one of the fastest
growing therapeutic areas on the pharmaceutical market.
Formycon out-licensed FYB203 exclusively to Santo Holding GmbH in
Holzkirchen in May 2015. Bioeq GmbH, a subsidiary of Santo Holding GmbH,
will be responsible for the clinical development, the approval and the
global marketing and licensing of FYB203. Both development programs will be
developed in close coordination with the US Food and Drug Administration
(FDA), as well as the European Medicines Agency (EMA), and are striving
towards approval in both regions.
Dr. Carsten Brockmeyer, CEO of Formycon AG: "The development of biosimilars
for Lucentis and Eylea has made us pioneers in the area of
opthalmology biosimilars with the two most important products in this
field. We believe we are the only company with a Lucentis biosimilar
already in the pivotal Phase III clinical study. Our strong position is
also underlined by the number of formulation and application patents we
have already filed which gives us a further competitive advantage. It is
our goal to launch our biosimilars on the market at day one after the
patent on the reference product expires."
"The anticipated significant market growth in ophthalmology means that the
provision of safe and high quality medications in this area poses a
significant challenge for the global health care systems. Through our
biosimilars, we are striving to make a considerable contribution to the
supply of as many patients as possible worldwide with these important
pharmaceutical products", added Dr. Nicolas Combé, CFO of Formycon AG.
* Eylea is a registered trademark of Regeneron Pharmaceuticals Inc.
** 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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29.02.2016 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.
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 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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