AbbVie 2012 Annual Report Download - page 8

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. Its worldwide sales have grown to
approximately $9.3 billion in 2012, compared to $7.9 billion in 2011 and $6.5 billion in 2010. HUMIRA
accounted for approximately 50 percent of AbbVie’s total sales in 2012. The United States composition
of matter (that is, compound) patent covering adalimumab is expected to expire in December 2016, and
the equivalent European Union patent is expected to expire in the majority of EU countries in April
2018.
AbbVie continues to dedicate substantial research and development efforts to expanding
indications for HUMIRA, including in the fields of rheumatology (peripheral spondyloarthritis, axial
spondyloarthritis and 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 in the United States and the European Union; peripheral and axial spondyloarthritis in the
United States; peripheral spondyloarthritis in the European Union; and hidradenitis suppurativa in the
United States and the European Union.
Metabolics/Hormones products. Metabolic and hormone products target a number of conditions,
including exocrine pancreatic insufficiency, testosterone deficiency, and hypothyroidism, and generated
combined sales of $2.1 billion in 2012. These products include:
Synthroid. Synthroid is used in the treatment of hypothyroidism. AbbVie’s 2012 sales of
Synthroid totaled $551 million.
AndroGel. AndroGel is a daily testosterone replacement therapy that is available in two
strengths: 1 percent and 1.62 percent. AbbVie’s 2012 sales of AndroGel totaled $1.2 billion.
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’s 2012 sales of Creon totaled $353 million.
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. Worldwide sales of these products were $1.4 billion in 2012.
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
2