Pharmaceuticals

Peter Kahn · California
Years of pain from ankylosing spondylitis prevented Peter Kahn from participating in his favorite adventure sports. Following treatment with Humira, he’s able to resume his active, athletic lifestyle in Los Angeles.

 

Pharmaceuticals: building a balanced portfolio

In 2006, we achieved several important milestones in our pharmaceutical business, with several marketed products exceeding $1 billion in sales. Humira, our biologic therapy, surpassed the $2 billion annual sales mark with the launch of its third indication. Expanding our presence in the large and growing lipid management market, we acquired Kos Pharmaceuticals Inc. and announced a strategic collaboration with AstraZeneca PLC for the first statin and fenofibrate combination therapy.

Immunology: expanding treatment options

Humira is Abbott’s flagship biologic for the treatment of rheumatoid arthritis (RA), psoriatic arthritis, ankylosing spondylitis and Crohn’s disease — autoimmune disorders in which a human protein, tumor necrosis factor (TNF), plays a role in disease progression. Humira is a fully human monoclonal antibody that blocks TNF, reducing inflammation.

In 2007, we launched our fourth Humira indication — Crohn’s disease — in the United States and also plan to launch Humira for Crohn’s disease outside of the United States in 2007. Crohn’s disease, a chronic inflammatory disease of the intestines, is typically diagnosed before age 40. Humira can be self-administered at home — important for a young and active patient population. In addition, Humira is in development for ulcerative colitis, inflammation of the large intestine.

In 2006, we launched Humira for ankylosing spondylitis, an inflammation of the spine that can result in extreme physical limitation. Humira also treats RA, a painful joint disease that afflicts more than 5 million people worldwide, as well as psoriatic arthritis, which is characterized by arthritis and psoriatic skin disease. In the United States, we improved patient convenience with the launch of the Humira Pen, a one-touch, easy-to-grasp device that offers patients an easier way to self-administer Humira.

Immunology Pipeline: advancing multiple medical uses

We made significant advances in developing Humira to treat three additional indications — psoriasis, juvenile RA and ulcerative colitis. Moderate to severe psoriasis, characterized by very dry, cracked skin, afflicts 30 million people worldwide. In 2006, we presented data demonstrating the superiority of Humira to the current standard of care. We expect to submit a new drug application for psoriasis in 2007.

With a number of pipeline opportunities in a single well-established product, Humira will continue to bring relief to thousands of people worldwide over the next several years.

Brendan Devlin · Illinois
Brendan Devlin, pictured with Aidan, his 5-year-old son, has low HDL (good cholesterol) and elevated triglycerides. His doctor prescribed TriCor to improve his overall lipid profile.

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Immunology Pipeline: developing biologics beyond Humira

In our late-stage immunology pipeline, ABT-874 is an investigational biologic therapy designed to target and neutralize interleukin-12 (IL-12), a protein that regulates inflammatory response. Phase II outcomes in psoriasis have shown efficacy results that numerically exceed any Phase II data available for any other agents. We anticipate initiating our Phase III clinical program in psoriasis in 2007 and will continue Phase II development of ABT-874 for Crohn’s disease.

Cardiovascular: broadening Abbott’s presence in lipid management

Two strategic actions in 2006 allowed us to significantly expand our presence in the nearly $20 billion lipid management market. Our acquisition of Kos Pharmaceuticals added the primarily HDL-raising product Niaspan and several pipeline opportunities. We also initiated a collaboration with AstraZeneca to develop the first statin and fenofibrate single-pill combination product to manage lipids. We now have in-house expertise and access to products for the three major lipid parameters that contribute to cardiovascular disease: high triglycerides, low HDL (good cholesterol) and high LDL (bad cholesterol).

In our cardiovascular pipeline, we are building on the success of TriCor with ABT-335, our next-generation fenofibrate in late-stage trials. And, through our collaboration with AstraZeneca, we are codeveloping a single-pill, fixed-dose combination therapy of AstraZeneca’s Crestor and either TriCor or ABT-335. We will select one of the two programs in 2007 for development and commercialization. This combination therapy would target the treatment of all three blood lipids.

Kos Pharmaceuticals: complementing our cardiovascular portfolio and pipeline

The Kos Pharmaceuticals acquisition complements our existing commercial expertise, bringing Niaspan and Advicor to Abbott’s on-market product portfolio. Niaspan, an extended-release prescription niacin product, is especially effective in raising HDL. Advicor, a Niaspan and lovastatin combination therapy, is for multiple lipid disorders. A new caplet formulation of Niaspan is under U.S. FDA review, and Simcor, a fixed-dose combination of Niaspan and simvastatin, is also in late-stage development.

Kos also broadens our R&D capabilities and pipeline. This includes Flutiform, in Phase III development for asthma. The U.S. market for asthma drugs exceeds $10 billion. Kos also brought us an innovative inhaled insulin device in development, complementing our existing presence in the blood glucose monitoring market.

Virology: improving patient convenience

Kaletra remains the world’s leading protease inhibitor for HIV treatment. Today, HIV can be treated as a chronic disease, making long-term viral suppression, tolerability and convenience important for patient success.

In 2006, following a successful U.S. launch, we introduced Kaletra tablets in Europe. The new tablet formulation of Kaletra offers patients improved convenience with a reduced pill count, no refrigeration requirements and the option of being taken with or without food.

Abbott Science: growing promise for innovative therapies

We more than doubled our late-stage pipeline with the strategic actions we took this year with Kos Pharmaceuticals and our collaboration with AstraZeneca, as well as advanced a number of Humira indications. We also moved forward several innovative compounds in pain management, neurological diseases, oncology and infectious diseases.

Diana Irazabal · South America
Kaletra tablets offer improved convenience for patients with HIV, with a reduced pill count and no refrigeration requirements, which help Diana to keep her busy schedule as an HIV educator.

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More than 75 million Americans suffer from chronic or acute pain. Abbott is developing a more convenient controlled-release form of our pain brand, Vicodin, to provide a longer duration of pain relief for the management of moderate to moderately severe pain. We also have compounds in early-stage development for schizophrenia, Alzheimer’s disease, attention deficit hyperactivity disorder (ADHD) and pain. This includes compounds that target receptors in the brain called neuronal nicotinic receptors, which play a role in regulating pain, mood, memory and other neurological functions.

Abbott scientists are also researching a number of cutting-edge treatments to fight cancer. One, a Bcl-2 family inhibitor, is designed to restore apoptosis (the natural process of cell death often inhibited in cancer cells) and kill tumors, such as lymphomas and small cell lung carcinoma. Another compound, a multitargeted kinase inhibitor, is designed to disrupt blood flow to tumors, inhibiting the progression of cancer. Also in development are PARP (Poly (ADP-ribose) polymerase) inhibitors, which prevent DNA repair in cancer cells and stop the disease from progressing.

We are conducting early-stage research in infectious diseases, partnering with Enanta Pharmaceuticals Inc. to develop protease inhibitors for the treatment of hepatitis C, which affects more than 170 million people worldwide.

TAP, our joint venture with Takeda Pharmaceutical Company Ltd., is developing two compounds in its digestive disease pipeline: TAK-390MR, in Phase III for the treatment of acid-related disorders, and ilaprazole, an investigational proton pump inhibitor. TAP is continuing the development of febuxostat, a treatment for patients with high serum uric acid levels associated with gout, and is currently conducting an additional clinical trial.

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