AbbVie and Galapagos extend GLPG0634 collaboration to include Crohn's disease
(Thomson Reuters ONE) -
* First selective JAK1 inhibitor to enter Phase 2 studies in Crohn's disease
* Galapagos to fund and complete Phase 2 study; AbbVie to pay Galapagos $50
million upon successful completion, expected in 2015
North Chicago, USA and Mechelen, Belgium; 17 May 2013 - 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 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. Driven by
new therapies in development, Decision Resources estimates that the market for
Crohn's disease treatment will grow from $3.8 Billion in 2011 to $5.6 Billion in
2021.
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 (at)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.
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
Contact
AbbVie
Media
Adelle Infante
847-938-8745
Investors
Liz Shea
847-935-2211
Galapagos NV
Onno van de Stolpe, Chief Executive Officer
Tel. +31 6 2909 8028
Elizabeth Goodwin, Director Investor Relations
Tel: +31 6 2291 6240
ir(at)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.
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.
AbbVie and Galapagos extend GLPG0634 collaboration:
http://hugin.info/133350/R/1702694/562714.pdf
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Source: Galapagos NV via Thomson Reuters ONE
[HUG#1702694]
Unternehmensinformation / Kurzprofil:
Datum: 17.05.2013 - 07:16 Uhr
Sprache: Deutsch
News-ID 261159
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contact information:
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