• 2006
revenues in the €33-35 million range, a three-fold
increase over 2005
• Cash position per 31 December 2006 of €51.5
million
• First milestone in osteoarthritis alliance with
GSK
• Proof of Principle in osteoarthritis program
• Rheumatoid arthritis program on track to enter the
clinic in 2008
• Rudi Pauwels joins Board of Directors, Wilson Totten
and David Stone step down
Mechelen, Belgium; 12
January 2007 - Galapagos NV (Euronext & LSE: GLPG) announces
today that consolidated 2006 revenues will be in the range
of €33-35 million, with a year-end cash balance of
€51.5 million. Detailed financial results will be reported
on 2 March 2007. In an update of its R&D programs, the
Company reports that it has achieved significant progress
in the advancement of its drug discovery pipeline in bone
and joint diseases. In the osteoarthritis (OA) program,
it obtained its first milestone in the alliance with GSK;
furthermore, Galapagos achieved Proof of Principle in a
relevant OA animal model. Compounds from several projects
protected against the destruction of cartilage, the aim
of OA-therapy. In the rheumatoid arthritis (RA) program,
the Company developed compounds in lead optimization that
show very promising results in animal models. The composition
of the Galapagos Board has changed with two Non-Executive
Directors stepping down and the appointment of a new independent
Non-Executive Director.
Drug discovery
program advancements
Osteoarthritis
In the OA program, Galapagos achieved a first milestone
of €400,000 in the turn-key drug discovery alliance
with GlaxoSmithKline (LSE & NYSE: GSK). GSK and Galapagos
collaborate to deliver disease-modifying drugs with clinical
Proof of Concept in clinical research Phase IIA to GSK’s
global research and development organization. The alliance
is worth up to €137 million in upfront, milestone,
and equity payments to Galapagos, plus up to double-digit
royalties on global product sales.
Galapagos also achieved
Proof of Principle in a relevant OA animal model, showing
ex vivo protection of bovine cartilage explants treated
with compounds developed against Galapagos’ OA targets.
Galapagos has several series of proprietary compounds in
hit-to-lead and lead optimization that have potential to
deliver a novel therapeutic for the treatment of OA. Next
to RA, this is the second Proof of Principle for compounds
targeting proteins identified in Galapagos’ SilenceSelect
discovery platform and this further validates the target
discovery technology as well as the pipeline in bone and
joint diseases.
Rheumatoid arthritis
In its RA program, Galapagos already reported the achievement
of reduction in disease-causing cytokines and reduced paw
swelling in a therapeutic mouse RA model. Today the Company
reports that these lead compounds also show substantial
protection against bone loss in the industry standard RA
animal model. Furthermore, the program has achieved relevant
potencies and pharmacokinetic profiles for compounds in
lead optimization. These compounds target a proprietary
kinase protein that was identified using the Galapagos’
SilenceSelect discovery platform. Based on these important
results, Galapagos anticipates initiation of preclinical
studies in 2007, with a candidate drug expected to enter
clinical phase I in 2008.
ProSkelia
With the acquisition of ProSkelia (Romainville, France)
on 22 December 2006, Galapagos enhanced its product portfolio
with the addition of three preclinical products in bone
diseases (osteoporosis and bone metastasis), and one preclinical
product in cachexia (muscle atrophy and weight loss). The
combined product development portfolio will contribute to
Galapagos’ goal of having multiple clinical programs
in bone and joint diseases in 2008. The transaction with
ProSkelia also included an exclusive option and license
to oestradiol glucoside, a product for treatment of menopausal
symptoms (‘hot flashes’). Galapagos has started
the preparations to initiate a phase IIb clinical trial
for this compound in Q4 of 2007. The ProSkelia capabilities
and facilities will be used to accelerate the development
of all optimized leads in bone and joint diseases.
Galapagos board
changes
The board and management
are delighted to announce the addition of Dr Rudi Pauwels
as an independent, Non-Executive Board Member with effect
as of 1 January 2007, as Rudi brings substantial experience
in drug development. “I am very pleased to have Galapagos
co-founder Rudi Pauwels return as a member of the Board
of Directors”, said Onno van de Stolpe, CEO of Galapagos.
“As a pioneer of Belgian biotech, Rudi brings with
him expertise in the discovery and development of new drugs,
and Galapagos will benefit from his experience in bringing
new drugs to the market.” “Rudi’s addition
to the board highlights Galapagos’ move into drug
development,” added Raj Parekh, Chairman of the Galapagos
board.
Dr Pauwels (46), in
addition to being a co-founder of Galapagos, was also co-founder
of Tibotec (now a J&J company), a leading player in
the field of anti-HIV drug development, and Virco, a company
involved in molecular diagnostic tools for HIV resistance
testing. Dr Pauwels is a pharmaceutical scientist who received
several awards for his scientific work and his achievements
as a biotech entrepreneur.
The appointment of Dr
Pauwels will be submitted for approval at the next shareholders’
meeting. There are no further details to be disclosed under
Schedule 2(g) and Rule 17 of the AIM rules.
Dr Wilson Totten decided
to step down as a Board Member effective 23 December 2006.
He served as an independent Non-Executive Director on the
Galapagos board since October 2004. Dr David Stone decided
to step down as a Board Member effective 31 December 2006.
Dr Stone joined the Galapagos Board as a dependent Non-Executive
Director after the acquisition by Galapagos of BioFocus
Ltd. in October 2005. “Both Wilson and David have
significantly contributed to the transition of Galapagos
from a target discovery company to a full fledge drug discovery
entity,” commented Raj Parekh, Chairman. “On
behalf of the Galapagos board, I want to thank them for
this accomplishment.”
About Galapagos
Galapagos (Euronext
Brussels, GLPG; Euronext Amsterdam, GLPGA; London AiM: GLPG)
is a drug discovery company with clinical and pre-clinical
programs in bone and joint diseases, cachexia, and menopausal
hot flashes. Its division BioFocus DPI offers a full suite
of target-to-drug discovery products and services to pharmaceutical
and biotech companies, encompassing target discovery and
validation, screening and drug discovery through to delivery
of pre-clinical candidates. BioFocus DPI also provides adenoviral
reagents for rapid identification and validation of novel
drug targets, compound libraries for drug screening as well
as chemogenomics and ADMET database products to select targets
and compounds. Galapagos currently employs 450 people and
operates facilities in eight countries, with global headquarters
in Mechelen, Belgium. More information about Galapagos and
BioFocus DPI can be found at www.glpg.com.
CONTACT
Galapagos NV
Onno van de Stolpe, CEO
Tel: +31 6 2909 8028
ir@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, 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
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is a registered trademark of Galapagos NV and/or its affiliates.