AbbVie 2013 Annual Report Download - page 40

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AbbVie expects to continue to drive strong HUMIRA sales growth in several ways. AbbVie seeks to
expand the HUMIRA patient base by applying for regulatory approval of new indications for
HUMIRA, treating conditions such as uveitis, hidradenitis suppurativa and pediatric Crohn’s disease.
AbbVie will also seek to drive HUMIRA sales growth by expanding its market share and its presence
in underserved markets.
Research and development (R&D) efforts will continue to focus a significant portion of expenditures
on compounds for immunology, virology, oncology, renal disease, neurological diseases and women’s
health. AbbVie’s scientists work to advance a pipeline of specialty molecules that demonstrate strong
clinical performance for patients and economic value for patients and their healthcare systems. Current
R&D projects are described in the ‘‘Research and Development’’ section below.
AbbVie plans to continue making investments in key emerging markets, including Brazil, China, Mexico
and Russia. Continued penetration of HUMIRA and other leading products is expected to help drive
growth in these markets.
AbbVie will continue its investment in products with durable sales, while making adjustments as
necessary to increase the value of its product portfolio. AbbVie plans to achieve this objective in a
variety of ways depending on product and circumstances by, for example, identifying supply chain
efficiencies, pursuing additional indications, and optimizing residual value as products reach the end of
exclusivity. AbbVie believes that its approach will allow the company to maintain a strong operating
margin.
Research and Development
Research and innovation continues to be a key strategic priority for AbbVie. AbbVie’s long-term
success depends to a great extent on its ability to continue to discover and develop innovative
pharmaceutical products and acquire or collaborate on compounds currently in development at other
biotechnology or pharmaceutical companies.
AbbVie’s pipeline includes more than 20 compounds or indications in Phase II or III development
individually or under collaboration or license agreements. Of these programs, approximately 10 are in
Phase III development or in registration. AbbVie expects several Phase II programs to transition into
Phase III programs during 2014. R&D is focused on therapeutic areas that include immunology,
virology, oncology, renal disease, neurological diseases, and women’s health, among others.
Immunology
HUMIRA is currently approved for ten indications in major geographies, including nine indications in
Europe and seven in the United States. AbbVie continues to dedicate R&D efforts to expanding
indications for HUMIRA, including in the fields of gastroenterology, dermatology and ophthalmology.
Registration submissions and regulatory approvals for HUMIRA in 2013 included approval for two new
gastroenterology indications in Japan—intestinal Behcet’s and ulcerative colitis.
Phase III trials are ongoing in preparation for regulatory applications of HUMIRA for uveitis and
hidradenitis suppurativa in the United States and the European Union. The results of AbbVie’s two
fully-enrolled Phase III clinical trials to evaluate the safety and efficacy of HUMIRA for patients with
moderate to severe hidradenitis suppurativa in the United States are expected in 2014. The FDA issued
a Complete Response Letter to the company’s registration submission for axial spondyloarthritis, which
is currently under evaluation by the company.
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