MECHELEN, BELGIUM--(Marketwire - Nov 16, 2012) - Galapagos NV (EURONEXT BRUSSELS: GLPG)
announces
today that third quarter 2012 operational and financial results were in
line
with management expectations. Management confirms the 2012 financial
guidance
given earlier this year:group revenues of EUR150 million, sustained
operational
and net profitability, and a year-end cash position of at least EUR130
million by
the end of 2012.
GLPG0634 Phase 2a results
Galapagos announced that a second Phase 2A clinical trial with GLPG0634
repeated
the excellent safety of the drug, as well as the significant
clinical
improvements to rheumatoid arthritis (RA) patients within 4
weeks.
Statistically significant improvements were seen for DAS28, HAQ-DI, ACR
and CRP
for the 300mg dose. The results enable Galapagos to move rapidly into
Phase 2B
clinical studies in early 2013. GLPG0634 is the first selective JAK1
inhibitor
to potentially treat multiple autoimmune diseases, such as RA. In
February
2012, Galapagos and Abbott announced a global collaboration for
GLPG0634 to
treat RA and other autoimmune diseases.
Tax ruling on Abbott collaboration
Galapagos received a positive ruling from the Belgian tax authorities
on the
collaboration agreement with Abbott. Galapagos may exempt 80% of
qualifying
income, based on the Galapagos patents covering JAK1 inhibitor GLPG0634,
from
Belgian corporate income tax. This will result in an effective income tax
rate
of under 5% for Galapagos for this income.
Initiation of Phase I study with GLPG0974
In October, Galapagos started its second Phase I clinical study with
GLPG0974, a
GPR43 inhibitor being developed to treat chronic neutrophil-driven
inflammatory
conditions such as inflammatory bowel disease (IBD). In this clinical
study,
the safety and tolerability of GLPG0974 will be evaluated for 2 weeks
in 32
healthy volunteers. Aim of the study is also to confirm the strong
biomarker
signal and the once-daily (QD) dosing of the compound after 14 days.
Results of
the study are expected to be reported early next year.
Shareholder notifications
The Capital Group Companies gave notification of a holding of
1,554,436
Galapagos shares, which represents 5.8% of Galapagos' shares outstanding
today.
Johnson & Johnson notified that it indirectly held 2,350,061 Galapagos
shares
through Tibotec-Virco and Crucell, which represents 8.8% of Galapagos'
shares
outstanding today. .
Outlook
Management reiterates the full-year 2012 guidance given earlier in the
year: The
service operations are expected to increase further their cash and
profit
contribution in 2012. Management guides for at least EUR150 million in
revenues,
sustained operational and net profitability, and a year-end cash position
of at
least EUR130 million by the end of 2012.
About Galapagos
Galapagos (EURONEXT BRUSSELS: GLPG) (PINKSHEETS: GLPYY) is a mid-size
clinical stage
biotechnology company specialized in the discovery and development of
small
molecule and antibody therapies with novel modes-of-action. The
Company is
progressing its JAK1 inhibitor GLPG0634, as well as one of the largest
pipelines
in biotech, with four programs in development and over 30 discovery
programs.
The Galapagos Group has over 800 employees and operates facilities
in six
countries, with global headquarters in Mechelen, Belgium. More
info at:
www.glpg.com
This release may contain forward-looking statements, including,
without
limitation, statements containing the words "believes,"
"anticipates,"
"expects," "intends," "plans," "seeks," "estimates," "may," "will,"
"could,"
"stands to," and "continues," as well as similar expressions. Such
forward-looking statements may involve known and unknown risks,
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factors which might cause the actual results, financial condition,
performance
or achievements of Galapagos, or industry results, to be materially
different
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performance or
achievements expressed or implied by such forward-looking statements.
Given
these uncertainties, the reader is advised not to place any undue
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only as
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disclaims any
obligation to update any such forward-looking statements in this
document to
reflect any change in its expectations with regard thereto or any
change in
events, conditions or circumstances on which any such statement is based,
unless
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Source: Galapagos NV via Thomson Reuters ONE
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