Galapagos reports 2006 financial update, drug discovery advancements and changes to Board of Directors
January 12 2007 - 1:01AM
UK Regulatory
* 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[1]
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 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.
SilenceSelect� is a registered trademark of Galapagos NV and/or its
affiliates.
[1] ADMET is the acronym for Absorption, Distribution, Metabolism,
Excretion and Toxicity; meeting parameters against these five
criteria is critical to the success of a pharmaceutical compound as a
drug
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