Click
here to access the live audio webcast R&D Update
presentation today at 13.00 CET/8 AM EST, call number +32 2290
1791
Mechelen, Belgium; 19
March 2010 – Galapagos NV (Euronext: GLPG) announced the
decision to pursue cystic fibrosis (CF) in its strategy to deliver
breakthrough medicines to patients with orphan diseases. Details
of Galapagos’ CF program and its pipeline of 4 clinical
and over 50 pre-clinical and discovery programs will be discussed
during the R&D Update presentation webcast later today.
Over the past years, Galapagos
has established a strong franchise in orphan diseases. Galapagos
has applied its proprietary target discovery platform in collaborations
with the CHDI (for Huntington’s disease), the Cystic Fibrosis
Foundation and the ALS Foundation. In addition, Galapagos is
evaluating its SARM candidate drug, GLPG0492, for the treatment
of Duchenne muscular dystrophy.
“Orphan diseases represent
significant unmet clinical needs. The lack of novel disease-modifying
therapies for these diseases presents significant opportunities
for a company capable of delivering new mode-of-action therapies.
Galapagos has made a strategic decision to pursue cystic fibrosis
as the first orphan disease in which we will discover, develop
and launch our own medicines. This decision is based on our
successful collaboration with the CF Foundation, through which
we have identified the first ever disease-modifying targets
for CF,” said Onno van de Stolpe, CEO of Galapagos. “With
this strategy, Galapagos expects to benefit from the accelerated
approval procedures and exclusive commercial rights granted
to developers of orphan drugs through US and European regulatory
agencies, to ultimately provide real medical benefit to this
sizeable population of patients.”
The CF Foundation and Galapagos
entered a target discovery collaboration in 2005, which resulted
in 19 novel disease-modifying targets that have been validated
in the standard pre-clinical model for this disease. Galapagos
has secured all rights to these targets and has started to develop
small molecule therapies against a select group of these targets.
Galapagos will retain intellectual property and commercial rights
on any compounds reaching the market. Galapagos medicines in
CF will be disease-modifying agents with clear efficacy benefits
relative to existing therapies, which only treat the symptoms
of the disease. A first pre-clinical candidate is scheduled
to be nominated by 2013.
“We are confident that
the strategic decision to enter CF drug discovery will provide
new treatment options for CF patients and thus create long term
value for our shareholders. In the first years, research expenses
for this new strategy will be limited and we anticipate that
the clinical trials to support approval can be financed by our
strengthening cashflow,” said Van de Stolpe.
Conference call and
webcast presentation
Galapagos will conduct a conference call open to the public
today at 13.00 Central European Time (CET), which will also
be webcast. To participate in the conference call, please call
+32 2290 1791 ten minutes prior to commencement. A question
and answer session will follow the presentation of the results.
Click
here to access the live audio webcast. The archived
webcast also will be available for replay shortly after the
close of the call.
About cystic fibrosis
Cystic fibrosis (CF) is a hereditary disease of the entire body
which leads to severe disability and early death in many cases.
Symptoms include frequent lung infections, sinus infections,
poor growth, and diarrhea. The cause is a defect in gene which
encodes for cystic fibrosis transmembrane conductance regulator
(CFTR), a protein which regulates components of sweat, mucus,
and digestive juices. CF affects approximately 70,000 people
worldwide. Patient symptoms are treated with antibiotics and
other medicines, with the global market expected to double from
just over $1 billion in 2010 to $2 billion by 2015. There currently
is no cure for the disease, and most patients die in their 30s
due to lung failure. More info at: www.cff.org/AboutCF
About Galapagos
Galapagos (Euronext: GLPG; OTC: GLPYY) is a mid-size biotechnology
company specialized in the discovery and development of small
molecule and antibody therapies with novel modes-of-action.
The Company is progressing one of the largest pipelines in biotech,
with four clinical and over 50 small molecule discovery/pre-clinical
programs. Through risk/reward-sharing alliances with GlaxoSmithKline,
Lilly, Janssen Pharmaceutica, Merck & Co. and Roche, Galapagos
is eligible to receive up to €3 billion in downstream milestones,
plus royalties. With the acquisition of Argenta, Galapagos now
has more than 670 employees and operates facilities in six countries,
with global headquarters in Mechelen, Belgium. More info at:
www.glpg.com
CONTACT
Galapagos NV
Onno van de Stolpe, CEO
Tel: +31 6 2909 8028
Elizabeth Goodwin, Director
Investor Relations
Tel: +31 6 2291 6240
ir@glpg.com
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