AbbVie 2013 Annual Report Download - page 6

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HUMIRA. HUMIRA is a biologic therapy administered as a subcutaneous injection. It is
approved to treat the following autoimmune diseases in the United States, Canada, and Mexico
(collectively, North America), and in the European Union:
Condition Principal Markets
Rheumatoid arthritis (moderate to severe) North America, European Union
Psoriatic arthritis North America, European Union
Ankylosing spondylitis North America, European Union
Crohn’s disease (moderate to severe) North America, European Union
Plaque psoriasis (moderate to severe) North America, European Union
Juvenile idiopathic arthritis North America, European Union
Ulcerative colitis (moderate to severe) United States, European Union
Axial spondyloarthritis European Union
Pediatric Crohn’s disease (severe) European Union
HUMIRA is also approved in over 60 other markets, including Japan, Brazil, and Australia.
HUMIRA was introduced to the market in January 2003. HUMIRA accounted for approximately
57 percent of AbbVie’s total sales in 2013. The United States composition of matter (that is,
compound) patent covering adalimumab (which is sold under the trademark HUMIRA) is expected to
expire in December 2016, and the equivalent European Union patent is expected to expire in the
majority of European Union countries in April 2018.
AbbVie continues to dedicate substantial research and development efforts to expanding
indications for HUMIRA, including in the fields of rheumatology (pediatric enthesitis related arthritis),
gastroenterology (pediatric Crohn’s disease and pediatric ulcerative colitis), dermatology (pediatric
psoriasis and hidradenitis suppurativa), and ophthalmology (uveitis). Phase III trials are ongoing in
preparation for regulatory applications for uveitis and hidradenitis suppurativa in the United States and
the European Union. AbbVie continues to work on HUMIRA formulation and delivery enhancements
to improve convenience and the overall patient experience.
Metabolics/Hormones products. Metabolic and hormone products target a number of conditions,
including hypothyroidism, testosterone deficiency, and exocrine pancreatic insufficiency. These products
include:
Synthroid. Synthroid is used in the treatment of hypothyroidism.
AndroGel. AndroGel is a testosterone replacement therapy for males diagnosed with low
testosterone that is available in two strengths: 1 percent and 1.62 percent.
Creon. Creon is a pancreatic enzyme therapy for exocrine pancreatic insufficiency, a
condition that occurs in patients with cystic fibrosis, chronic pancreatitis, and several other
conditions.
AbbVie has the rights to sell Synthroid, AndroGel, and Creon only in the United States.
Virology products. AbbVie’s virology products include two products for the treatment of HIV
infection, Kaletra and Norvir.
Kaletra. Kaletra (also marketed as Aluvia in emerging markets) is a prescription anti-HIV-1
medicine that contains two protease inhibitors: lopinavir and ritonavir. Kaletra is used with other
anti-HIV-1 medications to increase the chance of treatment response in people with HIV-1.
Norvir. Norvir (ritonavir) is a protease inhibitor that is indicated in combination with other
antiretroviral agents for the treatment of HIV-1 infection.
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