NORTH CHICAGO, Ill. and
MECHELEN, Belgium, May 17, 2013 /PRNewswire/ -- Galapagos NV
(Euronext: GLPG) and AbbVie (NYSE: ABBV) announced today an
extension of their GLPG0634 clinical development collaboration to
include Crohn's disease. Galapagos will fund and complete a
Phase 2 program in Crohn's disease, which is designed to facilitate
rapid progression into Phase 3. Upon successful completion of
the study, expected in Q2 2015, AbbVie will pay Galapagos
$50 million. The terms of the
collaboration extension are in addition to previously agreed upon
financial terms. AbbVie will be responsible for funding and
performing clinical development beyond Phase 2, and completing
regulatory and commercialization activities.
Galapagos will start an innovative 20-week, Phase 2A/B study
with GLPG0634 in 180 patients suffering from Crohn's disease by
early 2014. The study will measure both induction of disease
remission and early maintenance of its beneficial effects in
Crohn's disease, and is expected to read out topline results in Q2
2015. This Phase 2 study in Crohn's disease will be performed
in parallel with the Phase 2B study in rheumatoid arthritis
(RA).
Crohn's disease is a serious chronic, inflammatory autoimmune
disease of the gastrointestinal (GI) tract that affects millions of
people worldwide, including more than one million people in
Europe and more than 500,000
people in the U.S. The Janus kinases (JAK) are a family of
enzymes that play a key role in the signaling mechanism used by a
number of cytokines that are involved in autoimmune diseases.
JAK inhibitors, with their immune-modulating effects, have
the potential to become an effective treatment option for this
disease. By inhibiting JAK1, GLPG0634 blocks signaling for
several key pro-inflammatory cytokines such as interleukin 6
(IL-6). Its selective JAK1 inhibition profile avoids
inhibition of JAK2 which offers a unique advantage in Crohn's
disease. Inhibition of JAK2 has shown anemia and reduced
formation of blood cells in clinical studies with other JAK
inhibitors, which is a particular concern in patients with
inflammatory bowel disease, as blood loss through gastrointestinal
bleeding often already causes anemia in these patients.
Therefore, GLPG0634 may potentially support a better safety profile
than other JAK inhibitors.
"AbbVie supports the start of this innovative study in Crohn's
disease with GLPG0634. Our experience within
gastroenterology, combined with a novel alternative treatment for
this disease may provide a greater benefit to patients in the
future," said Scott Brun, M.D., vice
president, pharmaceutical development, AbbVie.
"Galapagos and AbbVie are moving forward with GLPG0634,
expanding the scope of the development program into inflammatory
bowel disease. The innovative Phase 2 program in Crohn's
disease is designed to move rapidly into Phase 3 when successful,"
said Onno van de Stolpe, CEO of
Galapagos. "Galapagos is in a strong financial position to
fund the Crohn's program, in addition to the Phase 2b program with
GLPG0634 in RA and our other proprietary clinical and pre-clinical
programs. Our pipeline continues to mature in stage and
scope, now that we have three Phase 2 molecules in five
inflammatory indications, all with readouts by mid 2015 or
earlier."
About candidate drug GLPG0634
GLPG0634 is an
orally-available, novel Janus kinase (JAK) inhibitor with
selectivity for JAK1 developed by Galapagos. JAKs are
critical components of signalling mechanisms utilized by a number
of cytokines and growth factors, including those that are elevated
in rheumatoid arthritis patients. JAK inhibitors have shown
long-term efficacy in rheumatoid arthritis studies with an early
onset of action. GLPG0634 differentiates from other JAK
inhibitors in development by specifically targeting JAK1, a
strategy which could result in a better efficacy and safety
profile. GLPG0634 is a fully proprietary program. Upon
successful completion of the Phase 2b studies in RA, AbbVie will
license the program and will assume sole responsibility for Phase 3
clinical development and global manufacturing.
About Crohn's disease
Crohn's disease is a type of
inflammatory bowel disease in which the well-controlled balance of
the intestinal immune system is disturbed. The disease causes
ulcerations of the small and large intestines in particular, but
may affect any part of the digestive system from mouth to
anus. The cause of the disease is unknown, with onset usually
between the ages of 15 and 35. Patients suffer from abdominal
pain, diarrhea (often bloody), vomiting, fever, and weight
loss. There is no cure for Crohn's disease; treatment options
today are restricted to controlling symptoms, maintaining
remission, and preventing relapse by the use of drugs that suppress
the inflammation or the immune system, antibiotics, and eventually
surgical removal of the inflamed bowels.
About AbbVie
AbbVie is a global, research-based
biopharmaceutical company formed in 2013 following separation from
Abbott. The company's mission is to use its expertise,
dedicated people and unique approach to innovation to develop and
market advanced therapies that address some of the world's most
complex and serious diseases. In 2013, AbbVie employs
approximately 21,000 people worldwide and markets medicines in more
than 170 countries. For further information on the company
and its people, portfolio and commitments, please visit
www.abbvie.com. Follow @abbvie on Twitter or view careers on
our Facebook or LinkedIn page.
About Galapagos
Galapagos (Euronext: GLPG; OTC:
GLPYY) is specialized in novel modes-of-action, with a large
pipeline of four clinical, seven 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 in RA and
Phase 2 studies in Crohn's disease. AbbVie and Galapagos
signed a worldwide license agreement whereby AbbVie will be
responsible for further development and commercialization after
Phase 2b in RA. 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 is currently in a Proof of Concept Phase 2 study.
The Galapagos Group, including fee-for-service companies
BioFocus, Argenta and Fidelta, has
800 employees and operates facilities in five countries, with
global headquarters in Mechelen,
Belgium. Further information at: www.glpg.com
Galapagos forward-looking statements
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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
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reader is advised not to place any undue reliance on such
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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.
AbbVie forward-looking statements
Some
statements in this news release may be forward-looking statements
for purposes of the Private Securities Litigation Reform Act of
1995. The words "believe," "expect," "anticipate," "project"
and similar expressions, among others, generally identify
forward-looking statements. AbbVie cautions that these
forward-looking statements are subject to risks and uncertainties
that may cause actual results to differ materially from those
indicated in the forward-looking statements. Such risks and
uncertainties include, but are not limited to, challenges to
intellectual property, competition from other products,
difficulties inherent in the research and development process,
adverse litigation or government action, and changes to laws and
regulations applicable to our industry. Additional
information about the economic, competitive, governmental,
technological and other factors that may affect AbbVie's operations
is set forth in Item 1A, "Risk Factors," in our 2012 Annual Report
on Form 10-K/A, which has been filed with the Securities and
Exchange Commission. AbbVie undertakes no obligation to
release publicly any revisions to forward-looking statements as a
result of subsequent events or developments, except as required by
law.
SOURCE AbbVie