Galapagos NV and AbbVie Inc. announced 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 second quarter of 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 second quarter of 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 Inc. ratified the appointment of Ernst & Young LLP as auditors at its AGM held on May 6, 2013.

AbbVie Inc. reported unaudited consolidated earnings results for the first quarter ended March 31, 2013. For the quarter, the company reported net sales of $4,329 million compared to $4,173 million a year ago. Operating earnings were $1,305 million compared to $978 million a year ago. Earnings before income tax was $1,239 million compared to $1,006 million a year ago. Net earnings were $968 million or $0.60 per diluted share compared to $883 million or $0.56 per diluted share a year ago. As adjusted (non-GAAP) pre-tax earnings were $1,407 million, after-tax earnings were $1,095 million and diluted EPS was $0.68. The company is confirming its diluted earnings-per-share guidance for the full-year 2013 of $2.66 to $2.76 on a GAAP basis, or $3.03 to $3.13 on an adjusted basis. The company's 2013 adjusted diluted earnings-per-share guidance excludes $0.37 per share of intangible asset amortization expense and other specified items, primarily associated with certain separation-related costs and previous ongoing restructuring activities. The company will further refine the forecast for specified items, including separation-related costs, as the year progresses. The company expects approximately $6 billion of operating cash flow in 2013. For the second quarter, the company expects adjusted earnings per share of $0.78 to $0.80. This excludes roughly $0.12 of specified items and noncash amortization, resulting in a second quarter GAAP EPS of $0.66 to $0.68.