Key Events from the Second Quarter
* Recently completed enrollment in all registrational studies in AbbVie's Phase
3 genotype 1 hepatitis C virus (HCV) program. Received Breakthrough Therapy
designation from the U.S. Food and Drug Administration (FDA) for AbbVie's
investigational direct-acting antiviral combination with and without ribavirin.
We expect our Phase 3 studies to begin to read out later this year and into
* Announced preliminary results from a Phase 1 study of ABT-199, AbbVie's
first-in-class BcL-2 inhibitor in development in partnership with
Roche/Genentech, in patients with high-risk relapsed/refractory chronic
lymphocytic leukemia (CLL), and in patients with relapsed/refractory
non-Hodgkin's lymphoma (NHL). We recently initiated a potentially registrational
Phase 2 single-agent, single-arm study in relapsed/refractory CLL patients with
the 17P chromosome deletion. We also expect to begin a Phase 3 comparative,
combination study in relapsed/refractory CLL in the next six to nine months.
* Initiated a Phase 3 study to assess the effects of the investigational
compound atrasentan, when added to standard of care, on progression of kidney
disease in patients with stage 2 to 4 chronic kidney disease and type 2
diabetes. The initiation of the Phase 3 study follows results from Phase 2b
studies, which were recently presented at the 2013 European Renal
Association-European Dialysis and Transplant Association (ERA-EDTA) Congress.
* AbbVie and Galapagos 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. Additionally, safety and efficacy data from a
Phase 2a study of GLPG0634 in rheumatoid arthritis was recently presented at
the European League Against Rheumatism (EULAR) Annual Congress.
* HUMIRA received approval in Japan for two additional gastroenterology
indications, including ulcerative colitis and intestinal BehÇet's disease.
HUMIRA is the first and only biologic treatment available for BehÇet's in the
* AbbVie and Alvine Pharmaceuticals announced a global collaboration to develop
a novel oral treatment for patients with celiac disease, currently in Phase 2
development. This collaboration builds on AbbVie's expertise and leadership in
the field of gastroenterology.
* Along with partner Bristol-Myers Squibb, AbbVie announced updated efficacy
and safety data from a randomized Phase 2, open-label study in patients with
previously-treated multiple myeloma. Results demonstrated median
progression-free survival of 33 months and an objective response rate of 92
percent among patients treated with the investigational monoclonal antibody
elotuzumab (10 mg/kg) in combination with lenalidomide and low-dose
* On June 20, the board of directors of AbbVie declared a quarterly cash
dividend of $0.40 per share, payable Aug. 15, 2013 to stockholders of record at
the close of business on July 15, 2013. AbbVie was named to the S&P 500
Dividend Aristocrats Index.