) and biotech company, Galapagos NV, recently extended their
agreement for the development of autoimmune disease candidate,
GLP0634. The original agreement, announced in Feb 2012, related
to the worldwide development and commercialization of the oral,
next-generation JAK1 inhibitor for multiple autoimmune diseases.
The initial focus was on the development of GLP0634 for
However, now with the extension of the agreement, AbbVie and
Galapagos will evaluate GLP0634 for Crohn's disease as well. The
companies said that the Crohn's disease phase II program will be
funded and completed by Galapagos. A 20-week, phase IIa/b study
in Crohn's disease patients will commence by early 2014. The
study will evaluate induction of disease remission and early
maintenance of beneficial effects with top-line results due in
the second quarter of 2015. This study will be conducted along
with a phase IIb rheumatoid arthritis study.
The successful completion of the Crohn's disease phase II
study will trigger a $50 million payment from AbbVie. Once phase
II development is completed, AbbVie will be responsible for
funding and developing the candidate and also for its approval
and commercialization. Other financial details of the original
agreement remain unchanged.
We note that AbbVie already has a strong presence in the
market for autoimmune diseases thanks to its blockbuster drug,
Meanwhile, earlier this month, AbbVie signed a deal with
Alvine Pharmaceuticals, for the global development of a novel
oral treatment for patients with celiac disease, an autoimmune
disease. The candidate, ALV003, is currently in phase II
Under this deal, AbbVie will make an upfront payment of $70
million and will gain an exclusive option to either acquire
ALV003-related assets or the equity of the company. AbbVie may
exercise its option once Alvine completes a phase IIb study.
AbbVie will be liable to make a milestone payment on the
commencement of phase III development.
AbbVie currently carries a Zacks Rank #3 (Hold). Companies
that currently look well-positioned include
Salix Pharmaceuticals, Ltd.
). All three are Zacks Rank #1 (Strong Buy) stocks.
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