AbbVie (ABBV) 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 rheumatoid arthritis.
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, Humira.
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 development.
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. (SLXP), Jazz Pharmaceuticals (JAZZ) and Santarus, Inc. (SNTS). All three are Zacks Rank #1 (Strong Buy) stocks.
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