DGAP-News

Formycon AG: Formycon Reports First Half 2016 Financial and Operating Results

DGAP-News: Formycon AG / Key word(s): Quarter Results/Interim Report
Formycon AG: Formycon Reports First Half 2016 Financial and Operating
Results

20.09.2016 / 07:30
The issuer is solely responsible for the content of this announcement.

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Press Release // September 20, 2016


Formycon Reports First Half 2016 Financial and Operating Results

- Biosimilar projects continue to develop successfully over the first six
months

- Half-yearly figures on track

- Santo Holding (Deutschland) GmbH transfers project rights to Bioeq IP
AG joint venture company

Munich - The development of Formycon's biosimilar candidates has progressed
well during the first half of 2016. Biosimilar developer Formycon AG
announced this update today as it unveiled its 2016 half-year figures.

Formycon is currently working on four biosimilar development projects
(FYB201, FYB202, FYB203, FYB205) at different stages of preclinical and
clinical development.

The furthest-advanced is FYB201, a biosimilar candidate of the ophthalmic
drug Lucentis(R)* (ranibizumab), for which patients have been enrolled in a
global clinical phase III since the start of 2016 in collaboration with
bioeq GmbH. FYB201 is therefore the world's only Lucentis(R) biosimilar to
be in a phase III study, the final step in clinical development to gain
marketing approval. Formycon is pursuing the goal of marketing FYB201 via
its licensing partner as the first Lucentis(R) biosimilar following the
expiry of the drug's patent in the USA and Europe.

Further important milestones were reached during the first six months of
2016 on the development projects FYB202 and FYB203, which are in the pre-
clinical phase, including agreements with renowned biopharmaceutical
contract manufacturers. For FYB205, the company's latest biosimilar
project, which has been started in Q1 2016, a cell line development
agreement has been signed with a prestigious partner.

FYB203, which is partnered to Santo Holding (Deutschland) GmbH, is a
biosimilar candidate for Eylea(R)** (aflibercept) which, like Lucentis(R),
is used to treat neovascular, age-related macular degeneration (nAMD) and
other serious eye conditions. For FYB202 and FYB205, which both are not
partnered and fully owned by Formycon, the reference products have not been
disclosed so far.

With effect from April 1, 2016 Santo Holding (Deutschland) GmbH has, with
Formycon's approval, transferred the global commercialization rights for
FYB201 to the Swiss company Bioeq IP AG. Bioeq IP AG is a joint venture