abbvie inc (ABBV) Key Developments
AbbVie Announces Phase 2 Study of Venetoclax in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia with 17p Deletion Meets Primary Endpoint
Aug 12 15
AbbVie announced that a Phase 2 trial of its investigational medicine venetoclax met its primary endpoint of achieving overall response rates in patients with relapsed/refractory or previously untreated chronic lymphocytic leukemia (CLL) with 17p deletion, according to an independent review analysis. The open-label study evaluated the efficacy and safety of venetoclax, an inhibitor of the B-cell lymphoma-2 (BCL-2) protein that is being developed in partnership with Genentech and Roche. Data from this study will be presented at an upcoming medical conference and will serve as the pivotal registration data for applications to the FDA, EMA and other health authorities. The safety profile was similar to previous studies and no unexpected safety signals were reported for venetoclax. In 2015, the FDA granted Breakthrough Therapy Designation to venetoclax for the evaluation of treatment of CLL in previously treated (relapsed/refractory) patients with the 17p deletion genetic mutation.
European Commission Approves AbbVie's HUMIRA® (Adalimumab) for Moderate to Severe Hidradenitis Suppurativa (HS)
Jul 30 15
AbbVie announced that HUMIRA® (adalimumab) is approved for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS treatment. HUMIRA is now the first and only medication approved for HS in the European Union. HS, sometimes referred to as "acne inversa" by dermatologists, is a painful, chronic inflammatory skin disease. It is estimated to impact 1% of the adult population worldwide, but prevalence numbers vary across countries. It is characterized by recurrent, painful abscesses and nodules on the skin - typically around the armpits and groin, on the buttocks and under the breasts. HS can have considerable impact on patients' daily lives, their work ability, physical activities and emotional state. HS can be progressive in some people, and surgery may be considered to remove skin affected by the disease in advanced stages. Therefore, diagnosing and managing the disease early is important. This can be difficult, and many people with HS experience a lengthy delay in diagnosis and treatment. It's important for HS patients and people who think they may have HS to see a dermatologist who is trained to recognize and manage the disease.
Abbvie Inc. Reports Unaudited Consolidated Earnings Results for the Second Quarter and Six Months Ended June 30, 2015; Provides Earnings Guidance for the Year of 2015
Jul 24 15
AbbVie Inc. reported unaudited consolidated earnings results for the second quarter and six months ended June 30, 2015. For the quarter, the company reported net revenues of $5,475 million against $4,926 million a year ago. Operating earnings were $1,852 million compared to $1,515 million a year ago. Earnings before income tax expense was $1,678 million compared to $1,433 million a year ago. Net earnings were $1,366 million against $1,098 million a year ago. Diluted earnings per share were $0.83 compared to $0.68 a year ago. Non-GAAP pre-tax earnings were $2,275 million compared to $1,710 million a year ago. Non-GAAP after tax earnings were $1,776 million or $1.08 per diluted share compared to $1,330 million or $0.82 per diluted share a year ago. Second-quarter sales growth was driven by the continued strength of HUMIRA and other promoted products.
For the six months period, the company reported net revenues of $10,515 million against $9,489 million a year ago. Operating earnings were $3,539 million compared to $2,866 million a year ago. Earnings before income tax expense was $3,074 million compared to $2,719 million a year ago. Net earnings were $2,388 million against $2,078 million a year ago. Diluted earnings per share were $1.47 compared to $1.29 a year ago. Non-GAAP pre-tax earnings were $4,235 million compared to $3,190 million a year ago. Non-GAAP after tax earnings were $3,300 million or $2.03 per diluted share compared to $2,480 million or $1.53 per diluted share a year ago.
The company is confirming its adjusted diluted earnings-per-share guidance for the full-year 2015 of $4.10 to $4.30. The company’s 2015 adjusted diluted earnings-per-share guidance excludes $0.84 per share of intangible asset amortization expense, deal costs, integration, and other specified items, and includes $0.20 of dilution related to the Pharmacyclics acquisition. The company’s diluted earnings-per-share guidance is $3.26 to $3.46 on a GAAP basis.
C2N and AbbVie Announce FDA Orphan Drug Designation of C2N-8E12 (ABBV-8E12) for the Treatment of Progressive Supranuclear Palsy
Jul 17 15
C2N Diagnostics and AbbVie announced that the U.S. Food and Drug Administration (FDA) has granted their investigational recombinant humanized anti-tau antibody, C2N-8E12 (ABBV-8E12), an orphan drug designation for the treatment of progressive supranuclear palsy (PSP). The companies also have begun a Phase 1 clinical study of C2N-8E12 in patients with PSP. C2N-8E12 is a humanized antibody targeting the tau protein found in neurofibrillary tangles in the brain of patients with tauopathies such as PSP and Alzheimer's disease (AD). The Phase 1 study is a randomized, double-blind, placebo-controlled, single ascending dose, multicenter study that will evaluate the safety, tolerability and pharmacokinetics of C2N-8E12 in an estimated 32 subjects with PSP.
Biotest Announces Termination of Tregalizumab Collaboration with AbbVie
Jul 2 15
Biotest AG and AbbVie Inc. have terminated their collaboration for the development and commercialization of Tregalizumab, which is intended for treatment of rheumatoid arthritis, or RA. AbbVie has exercised its rights to opt-out of the worldwide license, development and commercialisation agreement signed in June 2011. Upon the effective date of termination, AbbVie will return all rights granted under the agreement at no cost to Biotest. Tregalizumab is an investigational humanised anti-CD4 monoclonal antibody, inducing selective activation of regulatory T-cells. As announced on April 24, 2015, the Phase IIb study (TREAT 2b) of Tregalizumab (BT-061) in patients with moderate to severe rheumatoid arthritis (RA) did not meet its primary endpoint.