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News Release

FOR IMMEDIATE RELEASE
September 28, 2016

AbbVie and Eisai Obtain Additional Approval for New Indication of Fully Human Anti-TNF-α Monoclonal Antibody HUMIRA® in the Treatment of non-infectious Uveitis
-The First Biologic Treatment Available for Non-Infectious Intermediate, Posterior and Panuveitis Regardless of Underlying Disease-

AbbVie GK
Eisai Co., Ltd.

AbbVie GK (Headquarters: Tokyo, President: James Feliciano, “AbbVie”) and Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) today announced the additional approval for a new indication of HUMIRA® (generic name: adalimumab [recombinant], “HUMIRA”), a fully human anti-TNF-α monoclonal antibody formulation, in the treatment of non-infectious intermediate, posterior and panuveitis. Through this approval, HUMIRA has become the first biologic treatment available for non-infectious intermediate, posterior and panuveitis regardless of underlying disease.

Non-infectious uveitis is a group of diseases characterized by inflammation of the uvea, the middle layer of the eye.1 It can lead to reduced vision or vision loss and is the third-leading cause of preventable blindness worldwide.1-5 However, non-infectious uveitis can be complicated to diagnose and treat6,7 and there are no universally accepted guidelines for the treatment of the condition.8,9 At this time, corticosteroids are the current mainstay of treatment in uveitis patients excluded infectious condition.10 However, they may not be effective in all patients, and can have serious ocular long-term side effects including glaucoma and cataracts.11,12 Some patients have underlying diseases that preclude the use of corticosteroids.

HUMIRA targets and helps block TNF-α, a specific source of inflammation that can have a role in uveitis.13,14 The approval is based on results from two pivotal Phase 3 studies VISUAL-I and VISUAL-II, and also extension study VISUAL-III, which demonstrated that patients with active and controlled non-infectious intermediate, posterior and panuveitis treated with HUMIRA had a significantly lower risk for treatment failure (a combination of uveitic flare and decrease in visual acuity), compared to placebo. No new safety risks were identified for patients with non-infectious uveitis treated with HUMIRA.15

In Japan, AbbVie is the marketing and manufacturing authorization holder for HUMIRA, while Eisai is responsible for distribution. In addition to the new indication of non-infectious uveitis, Abbvie and Eisai are co-promoting HUMIRA for the indications in rheumatoid arthritis, plaque psoriasis, arthropathic psoriasis, ankylosing spondylitis, and juvenile idiopathic arthritis. For the indications in the field of gastrointestinal disease such as ulcerative colitis, Crohn's disease, and intestinal Bechet's disease, AbbVie and EA Pharma, a subsidiary of Eisai, are co-promoting HUMIRA.

AbbVie and Eisai will continue to promote and provide information on the proper use of HUMIRA while making further contributions to improve the quality of life of patients with non-infectious uveitis.

< Notes to editors >

1.  Summary of Product Charateristics
[Information being added is indicated by underlining]

1) Brand name:
HUMIRA® for Subcutaneous Injection 20 mg syringe 0.4 mL
HUMIRA® for Subcutaneous Injection 40 mg syringe 0.8 mL
HUMIRA® for Subcutaneous Injection 40 mg syringe 0.4 mL *
HUMIRA® for Subcutaneous Injection 80 mg syringe 0.8 mL *
* Prelaunched
2) Generic name:
Adalimumab (recombinant)
3) Indications:
HUMIRA for Subcutaneous Injection 20 mg syringe 0.4 mL
HUMIRA for Subcutaneous Injection 40 mg syringe 0.8 mL
HUMIRA for Subcutaneous Injection 40 mg syringe 0.4 mL
Patients who have had an inadequate response to conventional therapy for the following disease
Juvenile idiopathic arthritis with active polyarthritis
HUMIRA for Subcutaneous Injection 40 mg syringe 0.8 mL
HUMIRA for Subcutaneous Injection 40 mg syringe 0.4 mL
HUMIRA for Subcutaneous Injection 80 mg syringe 0.8 mL
Rheumatoid arthritis (including inhibition of the progression of structural damage)
Patients who have had an inadequate response to conventional therapy for the following diseases
Plaque psoriasis and Arthritic psoriasis
Ankylosing Spondylitis
Intestinal Behcet's disease
Non-infectious intermediate uveitis, posterior uveitis or panuveitis
Induction and maintenance therapy for moderate to severely active Crohn's disease (administer HUMIRA to patients who have had an inadequate response to conventional therapy.)
Treatment of moderate to severe ulcerative colitis (administer HUMIRA to patients who have had an inadequate response to conventional therapy)
4) Dosage and administration:
HUMIRA for Subcutaneous Injection 20 mg syringe 0.4 mL
HUMIRA for Subcutaneous Injection 40 mg syringe 0.8 mL
HUMIRA for Subcutaneous Injection 40 mg syringe 0.4 mL
Juvenile idiopathic arthritis with active polyarthritis
Normally, the dose of adalimumab (genetic recombination) for juvenile idiopathic arthritis patients who weigh over 15 kg but less than 30 kg is 20 mg administered every other week (eow) and for patients weighing 30 kg or more is 40 mg administered eow as subcutaneous injection.
HUMIRA for Subcutaneous Injection 40mg syringe 0.8 mL
HUMIRA for Subcutaneous Injection 40mg syringe 0.4 mL
HUMIRA for Subcutaneous Injection 80mg syringe 0.8 mL
Rheumatoid arthritis
Normally, the dose of adalimumab (genetic recombination) for adult patients is 40mg administered every other week (eow) as subcutaneous injection. The dose may be increased to 80mg administered eow when the effect of treatment with 40mg eow is insufficient.
Plaque psoriasis and Arthritic psoriasis
Normally, the dose of adalimumab (genetic recombination) for adult psoriasis patients is an initial dose of 80 mg followed by 40 mg given eow starting 2 week after the initial dose as subcutaneous injection. The dose may be increased to 80 mg eow when the effect of treatment with 40 mg eow is insufficient.
Ankylosing Spondylitis
Normally, the dose of adalimumab (genetic recombination) for adult patients is 40 mg administered eow as subcutaneous injection. The dose may be increased to 80 mg administered eow when the effect of treatment with 40 mg eow is insufficient.
Intestinal Behcet's disease
Normally, the initial dose of adalimumab (genetic recombination) for adult intestinal Behcet's disease patients is 160 mg as subcutaneous injection. The initial dose is followed by 80 mg two weeks later. Four weeks after the initial dose begin 40 mg eow.
Crohn's disease
Normally, the initial dose of adalimumab (genetic recombination) for adult Crohn's Disease patients is 160 mg as subcutaneous injection. The initial dose is followed by 80 mg two weeks later. Four weeks after the initial dose begin a maintenance dose of 40 mg eow. The dose may be increased to 80 mg administered eow when the effect of treatment with 40 mg eow is decreased.
Ulcerative colitis
Normally, the initial dose of adalimumab (genetic recombination) for adult ulcerative colitis patients is 160 mg as subcutaneous injection. The initial dose is followed by 80 mg two weeks later. Four weeks after the initial dose begin a maintenance dose of 40 mg eow.
Non-infectious intermediate uveitis, posterior uveitis or panuveitis
Normally, the initial dose of adalimumab (genetic recombination) for adult patients is 80 mg administered as subcutaneous injection. After a week of the initial dose, 40 mg is administered. From 3 weeks after the initial dose, 40 mg is administered once eow.
2. Summary of Safety Information

Contradictions
HUMIRA is contraindicated in patients with serious infection (sepsis etc.), active tuberculosis, a history of hypersensitivity to any of the ingredients of HUMIRA, a current or past history of demyelinating disorder (multiple sclerosis, etc.), and congestive heart failure.

Precautions for Use (The related part to non-infectious uveitis)
HUMIRA should be administered only when clinical symptoms clearly attributed to the disease remained in the previous treatments, despite the proper treatment with conventional therapies (cyclosporine and etc. in the case of uveitis secondary to Behcet's disease, or oral steroids and etc. in the case of other non-infectious uveitis).

Adverse Reactions
Major adverse reactions included nasopharyngitis (30.0%), injection site erythema (9.7%), injection site reaction (8.6%), rash (7.6%), upper respiratory tract infection (6.4%).

3. About VISUAL-I, II, III

VISUAL-I and II investigated active and controlled non-infectious intermediate, posterior and panuveitis. These two trials were double-blind, randomized and placebo-controlled. VISUAL-I and VISUAL-II clinical trials were randomized 1:1 and patients treated with HUMIRA received an 80 mg baseline loading dose followed by 40 mg given by subcutaneous injection at week 1, followed by 40 mg every other week for up to 80 weeks. The primary endpoint in the VISUAL-I and VISUAL-II studies was time to treatment failure (TF), defined as having one or more of the following components present in at least one eye: increase in anterior chamber cells or vitreous haze, new chorioretinal or vascular lesions, or decrease in visual acuity. The VISUAL-III is open-label extention study with 40 mg every other week until approval for the subjects who had TF or completion without TF in VISUAL I and VISUAL II. The VISUAL-III study is currently in progress.

The VISUAL-I study found that, compared to placebo, patients on HUMIRA were significantly less likely to experience TF (hazard ratio=0.56; 95 % CI, 0.40-0.76; P<0.001). Median time to TF was prolonged from 3.0 months for placebo to 4.8 months for HUMIRA.15 The VISUAL-II study also found that, compared to placebo, patients on HUMIRA were significantly less likely to experience TF (hazard ratio=0.52; 95 % CI, 0.37-0.74; P<0.001). The median time to TF was 5.6 months for placebo and not estimable (>18 months) for HUMIRA, as more than half of the HUMIRA-treated patients did not experience TF (hazard ratio=0.52; 95 % Cl, 0.37-0.74; P=0.001).15

4. About non-infectious Uveitis

Uveitis refers to inflammation in the uveal tract of the eye, which includes the iris, ciliary body, and choroid.16 Uveitis is an acknowledged serious and debilitating disease with symptoms of severe inflammation, vision impairment and pain. Uveitis can be categorized by the etiology of the inflammatory process - infectious or non-infectious. Non-infectious uveitis can be further classified as subjects who diagnosed to sarcoidosis, Vogt-Koyanagi-Harada disease, Behçet's disease, ankylosing spondylitis, juvenile idiopathic arthritis, arthropathic psoriasis, rheumatoid arthritis etc. or subjects who have no characteristic disease pattern, or systemic involvement that indicates a specific diagnosis, are often labeled as having “idiopathic” uveitis. Uveitis can also be classified according to the primary anatomical location of the inflammation - anterior uveitis, intermediate uveitis, posterior uveitis, or panuveitis (affecting all 3 areas).17 The disability associated with uveitis-related visual impairment can be prolonged and negatively affects patients' mental and physical health, ability to work, and overall quality of life.18-23 Thus, non-infectious intermediate uveitis, posterior uveitis, and panuveitis are serious diseases with both substantial impact on day-to-day functioning and a likelihood of progression if left untreated.

5. 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.

AbbVie GK was established in Japan in 2013. The company employs approximately 1,000 people, dedicated to developing and delivering treatments in our therapeutic areas focused on immunology, neonatology, liver disease and neuroscience, where we believe we can make a remarkable impact on the lives of patients. For further information, please visit www.abbvie.co.jp.

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.

6. About Eisai

Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as “giving first thought to patients and their families and to increasing the benefits health care provides,” which we call our human health care (hhc) philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to address unmet medical needs, with a particular focus in our strategic areas of Oncology and Neurology. For further information on Eisai Co., Ltd., please visit www.eisai.com.

Media Inquiries
Public Affairs
AbbVie GK
Tel: +81-(0)3-4577-1112
Public Relations Department
Eisai Co., Ltd.
Tel: +81-(0)3-3817-5120

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