Galapagos business update
15 November 2013 - 5:38PM
Galapagos NV (Euronext: GLPG) announced
today that third quarter 2013 results were in line with management expectations.
Management revised guidance for 2013 year end cash balance to €135 million (up
from €125 million). This increase is due to cash received from recent deals and
timing difference in spending on clinical development programs. The guidance
for 2013 Group revenues remains unchanged at €160 million.
"Galapagos made progress on its financial and operational goals in the third
quarter, announcing a major new collaboration with AbbVie to add power to our
cystic fibrosis research efforts, achievement of milestones in the alliances,
and the award of a sizeable grant from the Flemish IWT," said Onno van de
Stolpe, CEO of Galapagos. "We are focused on delivering the Phase 2B RA study
and the Phase 2 Crohn's study with GLPG0634, while also achieving our ambitious
clinical milestones on our proprietary and other partnered programs."
In the third quarter of 2013, Galapagos reported a major new alliance and
substantial progress in its R&D programs.
Galapagos and AbbVie entered into a global alliance to discover, develop and
commercialize novel potentiator and combination therapies in cystic fibrosis.
AbbVie and Galapagos are working collaboratively to contribute technologies and
resources in order to develop and commercialize oral drugs that address the main
mutations in CF patients, including F508del and G551D. Galapagos received a $45
million upfront payment and is eligible to receive up to $360 million in
milestones, plus double-digit royalties on sales of products arising from the
alliance.
On the clinical development side, Galapagos initiated a First-in-Human (FIH)
Phase 1 study with GLPG1205, which is being developed in the field of
Inflammatory Bowel Disease in alliance with Janssen Pharmaceutica. This
achievement triggered a €6.6 million milestone payment to Galapagos. The study
is expected to readout topline results by the end of this year.
In the osteoarthritis alliance with Servier, Galapagos delivered novel
molecules. This achievement involved a late stage discovery milestone for small
molecules against a novel target; this triggered a €3 million payment to
Galapagos. Work on the pre-clinical candidate in the Servier osteoarthritis
alliance was ended in the fourth quarter due to toxicity findings of the
molecule. The most advanced compound in this alliance is now in the lead
optimization stage.
The Flemish agency for Innovation by Science and Technology (IWT) awarded
Galapagos a TGO (transformational medical research) grant of €2.4 million for
psoriasis research and development. The goal of this 4-year project is to bring
a novel mode of action compound into the clinic that might lead to a safe and
effective treatment for patients suffering from psoriasis.
Galapagos now has 5 pre-clinical candidates, three partnered and two fully owned
by Galapagos. The Company remains on track to nominate an additional pre-
clinical candidate from the potentiator series in cystic fibrosis before year
end.
Galapagos appointed David Smith as CEO of the Service Division. Argenta
announced a drug discovery collaboration with Pcovery, and in the fourth quarter
BioFocus signed an agreement worth up to $31 million with Biogen Idec in
scleroderma.
About Galapagos
Galapagos (Euronext: GLPG; OTC: GLPYY) is specialized in novel modes-of-action,
with a large pipeline comprising of five Phase 2 studies (two led by GSK), one
Phase 1 study, five pre-clinical, and 20 discovery small-molecule and antibody
programs in cystic fibrosis, inflammation, antibiotics, metabolic disease, and
other indications.
AbbVie and Galapagos signed an agreement in CF where they work collaboratively
to develop and commercialize oral drugs that address two mutations in the CFTR
gene, the G551D and F508del mutation. In the field of inflammation, AbbVie and
Galapagos signed a worldwide license agreement whereby AbbVie will be
responsible for further development and commercialization of GLPG0634 after
Phase 2B. GLPG0634 is an orally-available, selective inhibitor of JAK1 for the
treatment of rheumatoid arthritis and potentially other inflammatory diseases,
currently in Phase 2B studies in RA and about to enter Phase 2 studies in
Crohn's disease. Galapagos has another selective JAK1 inhibitor in Phase 2 in
psoriasis and lupus, GSK2586184 (formerly GLPG0778, in-licensed by
GlaxoSmithKline in 2012). GLPG0974 is the first inhibitor of FFA2 to be
evaluated clinically for the treatment of IBD; this program is currently in a
Proof-of-Concept Phase 2 study. GLPG1205 is a first-in-class molecule that
targets inflammatory disorders and is currently in a First-in-Human Phase 1
study.
The Galapagos Group, including fee-for-service companies BioFocus, Argenta and
Fidelta, has around 800 employees and operates facilities in five countries,
with global headquarters in Mechelen, Belgium. Further information at:
www.glpg.com
Contact
Guillaume Jetten, CFO
Tel: +31 6 5230 3005
ir@glpg.com
Galapagos forward-looking statements
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, uncertainties and other
factors which might cause the actual results, financial condition, performance
or achievements of Galapagos, or industry results, to be materially different
from any historic or future results, financial conditions, performance or
achievements expressed or implied by such forward-looking statements. Given
these uncertainties, the reader is advised not to place any undue reliance on
such forward-looking statements. These forward-looking statements speak only as
of the date of publication of this document. Galapagos expressly 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
required by law or regulation.
Galapagos business update: http://hugin.info/133350/R/1743225/586310.pdf
[HUG#1743225]
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