2013-02-05 17:47:24 -
Mechelen, Belgium; 5 February 2013 - Galapagos NV (Euronext: GLPG) announced
today that GlaxoSmithKline plan to initiate Phase 2 studies with GSK2586184
(formerly GLPG0778) in systemic lupus erythematosus (SLE) and chronic plaque
psoriasis. GSK2586184 is the second selective JAK1 molecule discovered by
Galapagos to enter Phase 2 studies.
GSK2586184 is a selective JAK1 inhibitor which was discovered and developed
within Galapagos' osteoarthritis alliance with GSK. GSK in-licensed the
molecule in February 2012, gaining worldwide rights to further development and
commercialization. Galapagos is eligible, without further financial investment
from Galapagos, to receive from
GSK €34M in additional milestones plus up to
double-digit royalties on global commercial sales of all therapeutic indications
of GSK2586184.
"Inhibition of JAK1 is considered a promising new therapeutic route to treat
inflammatory diseases. Galapagos is leading the field with two JAK1 inhibition
molecules being tested in patients," said Onno van de Stolpe, CEO of Galapagos.
"With two of our JAK1 molecules in Phase 2, we hope that this will deliver a new
class of medicines to patients with inflammatory diseases."
GSK plans to initiate a 12 week, multi-center, dose-ranging, placebo-controlled
Phase 2 study investigating safety and efficacy of various doses of GSK2586184
in SLE patients. Furthermore, GSK will also initiate a 12 week multi-center,
dose-ranging, placebo-controlled Phase 2 study investigating the efficacy and
safety of GSK2586184 in chronic plaque psoriasis.
About Systemic lupus erythematosus
Systemic Lupus Erythematosus (SLE) is an autoimmune disease characterized by
inflammation of many parts of the body. This inflammation is caused by the
immune system that mistakenly attacks healthy cells, leading to tissue damage.
The cause remains unknown, but SLE occurs more often in women, especially at
childbearing age. SLE is more common in those of non-European descent, with
prevalence ranges of 20 to 150 cases per 100.000 persons. Joint pain, muscle
pain, fever, fatigue and malaise are the most common symptoms, and these can
come and go unpredictably. Because these complaints are often observed with
other diseases, diagnosis of SLE is difficult. Currently there is no cure for
SLE, but the symptoms can be controlled by medicines, the most common of which
are non-steroidal anti-inflammatory drugs (NSAID) and anti-malarial medicines.
Those with more serious illness may require corticosteroids,
immunosuppressants, but these have side-effects and are not always effective.
About Psoriasis
Psoriasis is an immune-mediated disease that affects the skin. It is caused by
the immune system being mistakenly triggered, resulting in overproduction of new
skin cells. The cause is not fully understood, but it is believed to have a
genetic component and certain medications and infections are well-known risk
factors. Psoriasis affects approximately 3% of people globally and it can occur
at any age, although it most commonly appears for the first time between the
ages of 15 and 25 years. There are five types of psoriasis with the most common
form being plaque psoriasis, characterized by red patches covered by a silvery
white scale appearing on the top first layer of the skin. Psoriasis can also
cause inflammation of the joints, which is known as psoriatic arthritis,
affecting between 10-30% of all people with psoriasis. Psoriasis is typically a
lifelong condition and there is currently no cure, but various treatments can
help to control the symptoms. Treating moderate to severe psoriasis usually
involves a combination of treatment strategies: topical treatments, light
therapy and/or systemic medications, including biologic drugs.
About Galapagos
Galapagos (Euronext: GLPG; OTC: GLPYY) is specialized in novel modes-of-action,
with a large pipeline of four clinical, six pre-clinical, and 30 discovery
small-molecule and antibody programs in cystic fibrosis, inflammation,
antibiotics, metabolic disease, and other indications.
GLPG0634 is an orally-available, selective inhibitor of JAK1 for the treatment
of rheumatoid arthritis and potentially other inflammatory diseases, about to
enter Phase 2b studies. AbbVie and Galapagos signed a worldwide license
agreement whereby AbbVie will be responsible for further development and
commercialization after Phase 2b. Galapagos has another selective JAK1
inhibitor in Phase 2 in lupus and psoriasis, GSK2586184 (formerly GLPG0778, in-
licensed by GlaxoSmithKline in 2012). GLPG0187 is a novel integrin receptor
antagonist currently in a Phase 1b patient study in metastasis. GLPG0974 is the
first inhibitor of GPR43 to be evaluated clinically for the treatment of IBD;
this program will start a Proof of Concept Phase 2 study in Q2 2013.
The Galapagos Group, including fee-for-service companies BioFocus, Argenta and
Fidelta, has over 800 employees and operates facilities in five countries, with
global headquarters in Mechelen, Belgium. Further information 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
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 announces GSK2586184 progresses to Phase 2 studies:
hugin.info/133350/R/1675695/545894.pdf
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Source: Galapagos NV via Thomson Reuters ONE
[HUG#1675695]
