Pharmaceuticals

Pharmaceuticals

Key franchises

Abbott medicines are used to treat some of the world’s most serious and prevalent diseases, including rheumatoid arthritis, psoriasis, Crohn’s disease, lipid disorders, kidney disease and HIV. We also continue to pursue new therapeutic indications for existing medications that offer patients and physicians important treatment options.

Pharmaceuticals - Year in Review

In 2008, we achieved several important milestones in our pharmaceuticals business. We successfully launched our Humira biologic for the treatment of moderate to severe chronic plaque psoriasis, building on its strong performance in Crohn’s disease and rheumatoid arthritis (RA). Humira is now approved in 77 countries and currently treats approximately 340,000 patients worldwide.

We also enhanced our growing lipid franchise with two new therapies, Trilipix and Simcor, and continued development of our fixed-dose combination of Trilipix and AstraZeneca’s statin therapy, Crestor.

Immunology: continued expansion of Humira
Humira is Abbott’s biologic for the treatment of RA, chronic plaque psoriasis, Crohn’s disease, psoriatic arthritis, ankylosing spondylitis and polyarticular juvenile idiopathic arthritis (JIA) — autoimmune disorders in which a human protein, tumor necrosis factor (TNF), plays a role in disease activity. Humira is a fully human recombinant monoclonal antibody that blocks the body’s production of TNF, reducing the inflammation and some of the complications associated with these diseases.

In 2008, we launched Humira for the treatment of two new
diseases — chronic plaque psoriasis and JIA. Psoriasis symptoms are often painful and characterized by very dry, scaly areas of skin. Psoriasis affects an estimated 125 million people worldwide. The severity of the disease varies from person to person, with approximately 25 percent of people with psoriasis experiencing moderate to severe disease. Humira is also used to treat RA and JIA, painful diseases that can lead to damage of the joints and hinder a patient’s ability to perform daily activities; Crohn’s disease, characterized by inflammation in the gastrointestinal tract; psoriatic arthritis, characterized by both arthritis and psoriatic skin disease; and ankylosing spondylitis, an inflammation of the spine that can result in episodes of acute pain and physical limitation.

In Japan, we launched Humira for RA and submitted a regulatory application for chronic plaque psoriasis.

Humira is also in development for ulcerative colitis (inflammation of the large intestine) and pediatric Crohn’s disease.

With approvals in multiple autoimmune diseases in a single, well-established product, Humira should continue to be used to treat hundreds of thousands of patients for years to come.

Lipid management: building market leadership
Abbott’s lipid management product portfolio addresses the three lipid parameters that contribute to cardiovascular disease: high triglycerides, low HDL (good cholesterol) and high LDL (bad cholesterol). Over the past several years, we’ve taken a number of strategic steps to establish Abbott as a significant player in the lipid market with a portfolio uniquely positioned to address the growing need for add-on or combination therapies.

Of the more than 100 million Americans with lipid disorders, only an estimated 35 million are treated with lipid therapies. Of those 35 million treated, fewer than one in three report that they’ve reached their treatment goals. The majority of patients are taking single therapies, primarily focused on reducing LDL. Many patients may benefit from a combination treatment approach to help manage all three of their lipid levels.

In 2008, Abbott received U.S. Food and Drug Administration (FDA) approval for Trilipix, a fenofibrate for the reduction of triglycerides. It’s the first and only fenofibrate with an FDA-approved indication for combination use with statins. Supported by the largest clinical program of its kind, Trilipix demonstrated safety and efficacy when used alone or in combination with the three most commonly prescribed statins — Crestor, Lipitor and Zocor. Studies showed that Trilipix in combination with a statin was safe and effective, improving HDL, LDL and triglyceride levels.

Also in 2008, we received U.S. FDA approval for Simcor, a fixed-dose combination of Niaspan and simvastatin (generic Zocor) that addresses both HDL and LDL. In a single pill, Simcor combines the HDL-raising benefits of Niaspan with the LDL-lowering effects of a statin.

In our cardiovascular pipeline, development continues on a single-pill, fixed-dose combination therapy of Trilipix and AstraZeneca’s Crestor, which targets all three blood lipids. We plan to submit a new drug application to the FDA in 2009.

By 2010, Abbott’s growing cholesterol franchise has the potential to include many patient therapies — TriCor, Trilipix and a fixed-dose combination of Trilipix and Crestor, as well as Niaspan and Simcor.

Virology: continued leadership in HIV
Kaletra, our protease inhibitor, remains a leader for the treatment of HIV. Today, HIV is considered a chronic disease. As a result, long-term viral suppression, tolerability and convenience are important for patient success. Kaletra has robust resistance data. This is important because resistance — when the virus is no longer sensitive to a drug — is a leading cause of HIV treatment failure. In 2008, in Europe, Abbott launched a new, lower-strength Kaletra tablet, the first and only coformulated protease inhibitor tablet approved for use in children with HIV.

Also in 2008, Abbott submitted U.S. and European regulatory applications for a new heat-stable tablet formulation of Norvir, another leading protease inhibitor for treating HIV. This new formulation does not require refrigeration, which is particularly important in developing countries.

Abbott science: innovative therapies to advance
patient care
In addition to advancing a number of Humira indications and cholesterol compounds in our late-stage pipeline, we continued development work on several innovative earlier-stage therapies in oncology, neuroscience and pain management, immunology, infectious diseases and asthma. Many of the compounds in our pharmaceutical pipeline represent truly novel science and, if successful, would result in significant advances in treatment for patients.

We continue early work on several Abbott-discovered oncology compounds, with breakthrough research focused on unique, less-toxic treatments. In neuroscience, we are researching potential treatments for Alzheimer’s disease, schizophrenia and pain. In immunology, our anti-IL-12/23 biologic, ABT-874, has demonstrated promising results in psoriasis and is also being studied in Crohn’s disease. In infectious diseases, we’re conducting early-stage research to develop treatments for hepatitis C. We continue late-stage development of Flutiform, an investigational combination asthma treatment, with our partner SkyePharma.