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Formycon AG: Global strategic partners bioeq and Formycon initiate pivotal phase III clinical trial with their Lucentis(R) biosimilar

DGAP-News: Formycon AG / Key word(s): Study/Research Update
Formycon AG: Global strategic partners bioeq and Formycon initiate
pivotal phase III clinical trial with their Lucentis(R) biosimilar

07.10.2015 / 08:30

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Press Release // October 7, 2015

Global strategic partners bioeq and Formycon initiate pivotal phase III
clinical trial with their Lucentis(R) biosimilar
- Formycon and Bioeq initiate pivotal Phase III clinical trial for
FYB201, an investigational biosimilar ranibizumab (Lucentis(R))*

- Global program underscores Formycon's and bioeq's leadership in
ophthalmology biosimilars

- Both companies continue to advance biosimilar pipeline

Munich - Formycon AG, Munich, Germany, and bioeq GmbH, Holzkirchen,
Germany, today announced the initiation of a pivotal Phase III clinical
trial with FYB201, an investigational biosimilar ranibizumab (Lucentis(R)).
The global clinical trial is designed to confirm biosimilarity with regard
to safety, efficacy and immunogenicity of FYB201 versus Lucentis(R) in
patients with neovascular age-related macular degeneration (nAMD). The
study design was developed in consultation with the Food and Drug
Administration (FDA) in the United States and the European Medicines Agency
(EMA) and is expected to support the registration in both regions.

Top selling eye drug Lucentis(R) is the leading treatment for nAMD and
other eye diseases and had estimated sales of $4.1 billion in 2014. It
inhibits vascular endothelial growth factor (VEGF) which is responsible for
the excessive formation of blood vessels in the retina leading to
progressive loss of vision. The current total market size for intraocular
anti-VEGF therapy is about $6.9 billion.

Formycon had licensed FYB201 exclusively to Santo Holding GmbH,
Holzkirchen, Germany end of 2013. bioeq GmbH, an affiliate of Santo Holding
GmbH, acts as the sponsor of the Phase III study and will also be
responsible for the global commercialization and licensing of FYB201.

Carsten Brockmeyer, Ph.D., CEO Formycon AG: "We believe that we are the
first company initiating a pivotal phase III study for a biosimilar version
of ranibizumab. This underlines our mission to provide high quality
biologics to patients across the world. I am glad that Formycon and bioeq
will jointly drive the clinical development, regulatory filings and
commercialization of FYB201, which will help us to become a significant
player in the field of ophthalmological diseases, one of the most rapidly
growing therapeutic areas. We continue to advance our pipeline with two
other biosimilar candidates already in preclinical phase."