September 26, 2016

AbbVie Showcases Commitment to Research and Innovation in Dermatology at the 25th European Academy of Dermatology and Venereology Congress

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- New Phase 2 open-label extension data to be presented on investigational biologic compound risankizumab, an anti-IL-23 monoclonal antibody, currently under investigation for moderate to severe chronic plaque psoriasis
- AbbVie to present 22 abstracts including long term safety and efficacy data on HUMIRA (adalimumab) in moderate to severe chronic plaque psoriasis and moderate to severe hidradenitis suppurativa (HS) and real-world data on the impact of HS on people living with the disease

NORTH CHICAGO, Ill., Sept. 26, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that new data on HUMIRA® (adalimumab) and investigational medicine risankizumab (formerly BI 655066), an IL-23 inhibitor, will be presented at the 25th European Academy of Dermatology and Venereology Congress (EADV), September 28 - October 2, in Vienna, Austria. These presentations build upon AbbVie's continued scientific leadership in serious dermatological conditions including psoriasis, psoriatic arthritis and hidradenitis suppurativa.

"AbbVie's presence at EADV 2016 highlights the latest scientific research in difficult-to-treat skin conditions, including data underscoring the considerable impact these diseases can have on a person's physical, social and emotional wellbeing and the need for quality care," said Shao-Lee Lin, Vice President Therapeutic Areas and International Development, AbbVie. "Additionally, building on our deep experience over more than 18 years in immunology with HUMIRA, we are excited to present the latest results of data evaluating investigational compound risankizumab, an IL-23 biologic for patients living with moderate to severe chronic plaque psoriasis."

New data from studies evaluating investigational IL-23 monoclonal biologic antibody, risankizumab, will be presented from the Phase 2 open-label extension study in moderate to severe chronic plaque psoriasis.

AbbVie will also present HUMIRA two-year safety and efficacy results for the treatment of moderate to severe HS, as well as multiple health economics outcomes research studies revealing the real-world burden of HS on patients and demonstrating AbbVie's commitment to the underserved HS community. Further, new seven year interim results from the ESPRIT 10-year post-marketing surveillance safety registry of HUMIRA will report safety and effectiveness of HUMIRA treatment for moderate to severe chronic plaque psoriasis.

Abstracts of Interest

Investigational Medicines Abstracts
Psoriasis

  • Clinical Response Following Re-Treatment with a Selective IL-23p19 Inhibitor Risankizumab (BI 655066) or Switching from Ustekinumab to Risankizumab in Patients with Moderate-to-Severe Chronic Plaque Psoriasis; Papp K, et al. (FC03.04; Oral Session; Thursday, September 29, 2016; 1:45-1:55 p.m. CET).
  • IL-23 Pathway Inhibition by Risankizumab Differentially Modulates the Molecular and Histopathological Profile in Psoriatic Skin Compared with Ustekinumab; Visvanathan S, et al. (FC04.04; Oral Session; Thursday, September 29, 2016; 4:00-4:10 p.m. CET).

HUMIRA (Abbvie-Sponsored) Abstracts
Psoriasis

  • Efficacy and Safety of Adalimumab in Nail-Psoriasis Patients with and Without Psoriatic Arthritis from the First 26 Weeks of a Phase-3, Randomized, Placebo-Controlled Trial; Elewski B, et al. (P2061; E-Poster).
  • Seven Year Interim Results from the ESPRIT 10 Year Post-marketing Surveillance Registry of Adalimumab for Moderate to Severe Psoriasis; Francisco K, et al. (P2037; E-Poster).
  • Development of a Novel Medication Adherence Prediction Model for Patients with Plaque Psoriasis Based on Results from the Global ALIGN Study; Mrowietz U, et al. (P2033; E-Poster).
  • Cost Per Responder Analysis of Treatments for Moderate-to-Severe Psoriasis in the United Kingdom; Li J, et al. (P2100; E-Poster).
  • Healthcare Resource Use and Costs of Adalimumab-Treated Adults with Psoriasis Who Dose Escalated Versus Switched to Another Biologic Agent; Papp K, et al. (P2066; E-Poster).
  • Cost-Effectiveness of Adalimumab and Secukinumab as First-line Treatments of Moderate-to-Severe Psoriasis and Active Psoriatic Arthritis; Langley R, et al. (P1997; E-Poster).
  • Patients' Willingness to Pay for a Subcutaneous Injection Device That Reduces Injection Site Pain in the Treatment of Psoriasis; Cividino A, et al. (P2039; E-Poster).

Hidradenitis Suppurativa

  • Adalimumab Efficacy in Hidradenitis Suppurativa Patients is Sustained at Least Two Years with Weekly Dosing: Results from a Phase 3 Open-Label Extension Study (PIONEER); Zouboulis C, et al. (P0067; E-Poster).
  • Patient Subgroups; Pooled Analysis from the Phase 3, PIONEER Studies of Adalimumab Treatment in Patients with Moderate to Severe Hidradenitis Suppurativa; Jemec G, et al. (P0103; E-Poster).
  • Baseline Characteristics from UNITE; an Observational, International, Multicenter Registry to Evaluate Clinical Practice with Hidradenitis Suppurativa; Prens E, et al. (P0091; E-Poster).
  • Utilizing Patient Reported Data to Assess Hidradenitis Suppurativa Severity; Papp K, et al. (P0086; E-Poster).
  • Salary Growth and Risk of Leaving the Workforce Among Patients With Hidradenitis Suppurativa in the United States; Tzellos T, et al. (P0109; E-Poster).
  • Impact of Hidradenitis Suppurativa on Work Loss, Indirect Costs and Patients' Salary; Tzellos T, et al. (P0094; E-Poster).

About HUMIRA
Since first gaining approval 13 years ago, HUMIRA has been approved in more than 90 countries across 14 globally approved indications, and is currently being used to treat more than a million patients worldwide.1-3

About Risankizumab (ABBV-066; formerly BI 655066) 
Risankizumab selectively blocks IL-23 by binding to its p19 subunit. IL-23, a key cytokine involved in inflammatory processes, has been linked to a number of chronic immune-mediated diseases. Risankizumab is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading future development and commercialization of risankizumab globally. The therapeutic potential of risankizumab is being evaluated in immunological disorders, including Crohn's disease, psoriasis, psoriatic arthritis and asthma.

Risankizumab is not approved by regulatory authorities, and its safety and efficacy are being investigated.

About HUMIRA in the European Union3

HUMIRA EU Therapeutic Indications
HUMIRA is approved for use in adults with moderate to severe active rheumatoid arthritis, severe active ankylosing spondylitis (AS), severe axial spondyloarthritis without radiographic evidence of AS, moderate to severe chronic plaque psoriasis, active and progressive psoriatic arthritis, moderately to severely active Crohn's disease, moderately to severely active ulcerative colitis, active moderate to severe hidradenitis suppurativa and non-infectious intermediate, posterior and panuveitis in adults. HUMIRA is approved for use in pediatric patients with active enthesitis-related arthritis, severe chronic plaque psoriasis, moderately to severely active Crohn's disease, and active polyarticular juvenile idiopathic arthritis. See Summary of Product Characteristics (SmPC) for full indication.

Important EU Safety Information3
HUMIRA is contraindicated in patients with active tuberculosis or other severe infections such as sepsis, and opportunistic infections and in patients with moderate to severe heart failure (NYHA class III/IV). It is also contraindicated in patients hypersensitive to the active substance or to any of the excipients. The use of HUMIRA increases the risk of developing serious infections which may, in rare cases, be life-threatening. Rare cases of lymphoma and leukemia have been reported in patients treated with HUMIRA. On rare occasions, a severe type of cancer called hepatosplenic T-cell lymphoma has been observed and often results in death. A risk for the development of malignancies in patients treated with TNF-antagonists cannot be excluded. The most frequently reported adverse events across all indications included respiratory infections, injection site reactions, headache and musculoskeletal pain.

(See SmPC for full details)

Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

Forward-Looking Statements
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2015 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

References:

  1. AbbVie Data on File.
  2. Pharmaceutical and Medical Devices Agency (PMDA). New Drugs Approved in FY 2013. Available at: http://www.pmda.go.jp/files/000153463.pdf#page=1. Accessed September 2, 2016.
  3. HUMIRA [Summary of Product Characteristics]. AbbVie Ltd. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000481/human_med_000822.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d124. Last updated June, 2016. Accessed September 2, 2016.
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SOURCE AbbVie

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