02.05.2018
Formycon AG DE000A1EWVY8
DGAP-News: Formycon AG: Formycon and Bioeq Achieve Important Milestone: Biosimilar Ranibizumab Candidate FYB201 Shows Efficacy Comparable to the Reference Product in Phase III Study
DGAP-News: Formycon AG / Key word(s): Research Update/Study results
Formycon AG: Formycon and Bioeq Achieve Important Milestone: Biosimilar
Ranibizumab Candidate FYB201 Shows Efficacy Comparable to the Reference
Product in Phase III Study
02.05.2018 / 08:00
The issuer is solely responsible for the content of this announcement.
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Formycon and Bioeq Achieve Important Milestone: Biosimilar Ranibizumab
Candidate FYB201 Shows Efficacy Comparable to the Reference Product in Phase
III Study
- Interim top-line data of COLUMBUS-AMD trial show comparable efficacy
between FYB201 and Lucentis(R)* (ranibizumab)
- Primary endpoint of the global phase III study achieved
- Last patient expected to complete treatment in the second quarter of 2018
- Bioeq intensifies out-licensing discussions
May 02, 2018, Munich/Zurich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY)
and its licensee Bioeq IP AG have today published an interim result for the
clinical phase III trial for the biosimilar candidate FYB201. According to
this, the primary endpoint has been achieved in the COLUMBUS-AMD trial, thus
confirming comparable efficacy between FYB201 and the reference medicinal
product Lucentis(R) in patients with neovascular age-related macular
degeneration (nAMD). The clinical endpoint relates to efficacy of the
investigational product and measures the change in the best corrected visual
acuity after eight weeks. The confidence interval lies within the
pre-defined equivalence limits and the study has so far progressed without
any abnormalities with regard to the safety and immunogenicity of the
product FYB201.
The last patient in the trial, in which patients are treated for a total of
48 weeks, is expected to complete treatment in the second quarter of 2018.
The data from the phase III study will be part of the application for
marketing approval with the US Food and Drug Administration FDA and the
European Medicines Agency EMA.
Formycon's development and distribution partner Bioeq is responsible for the
clinical phase III study. Bioeq also holds the exclusive global marketing
rights for the product FYB201.
Dr. Thiemo Schreiber from Bioeq comments: "As the sponsor and marketer of
the FYB201 program, we are pleased about this positive study result and, on
the basis of this important milestone, we will continue license negotiations
with interested parties. Our aim is the approval and launch of FYB201 as the
first biosimilar to Lucentis(R) in the United States of America in 2020 and
in the countries of the European Economic Area in 2022. We thus want to
offer a larger number of patients more affordable access to this important
and highly effective treatment."
Dr. Carsten Brockmeyer, CEO of Formycon, considers Formycon's leading
position as a developer of biosimilars in the promising biosimilar sector to
have been confirmed: "We are delighted with the result. It confirms
Formycon's pioneering role in the development of biosimilars in
ophthalmology and emphasizes our ability to successfully develop
high-quality biosimilars. We will consistently drive forward our development
pipeline of currently four biosimilars."
Lucentis(R) is used in the treatment of neovascular age-related macular
degeneration (wet AMD) and other serious eye diseases. It inhibits vascular
endothelial growth factor (VEGF), which is responsible for the excessive
formation of blood vessels in the retina. This leads to a progressive loss
of vision and is one of the major causes of age-related blindness. Globally,
it is estimated that up to 7.5 million people suffer from wet AMD. There are
some 450,000 patients in Germany alone. The total market volume for
treatments in this field amounted to over 9.3 billion dollars in 2017, and
is continuing to rise sharply.
* Lucentis is a registered trademark of Genentech Inc.
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 added value chain from technical development
to the clinical phase III and 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 development.
About Bioeq:
The Swiss company Bioeq IP AG based in Zürich is a biopharmaceutical joint
venture between the leading Polish pharmaceutical company Polpharma and the
Strüngmann family's investment company.
Bioeq licenses, develops and commercializes biological successor products of
successful biopharmaceuticals, called biosimilars. FYB201 is currently the
most advanced biosimilar program of Bioeq. The clinical studies and
registration are conducted by a subsidiary, Bioeq GmbH based in Holzkirchen,
Germany, on behalf of Bioeq IP AG.
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 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 more
than USD 3.0 billion, industry experts expect this figure to grow tenfold by
the year 2025.
Contact Formycon:
Thorsten Schüller
Corporate Communications and Investor Relations
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried/Germany
phone +49 (0) 89 - 86 46 67 150
fax + 49 (0) 89 - 86 46 67 110
[email protected] // www.formycon.com
Contact Bioeq:
Dr. Thiemo Schreiber
Business Development
Bioeq IP AG
Waldmannstrasse 8
8001 Zurich/Switzerland
phone +41 (0) 44 533 41 00
fax +41 (0) 44 533 41 09
mobile +41 (0) 79 920 71 40
[email protected]
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,
patent litigation, contractual risks and dependencies from third parties.
With respect to pipeline products, Formycon AG and Bioeq IP AG do 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 and Bioeq IP AG assume 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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02.05.2018 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
Indices: Scale 30
Listed: Regulated Unofficial Market in Berlin, Frankfurt (Scale),
Tradegate Exchange
End of News DGAP News Service
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