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Last updated September 27, 2007

ABOUT ARANESP

WHAT IS ARANESP?

Aranesp (darbepoetin alfa) is a drug used to treat certain types of anemia. It belongs to a class of medications called ESAs (erythropoiesis-stimulating agents). ESAs are genetically engineered versions of a natural protein, erythropoietin, which increases the number of red blood cells in the body. ESAs stimulate the bone marrow to make more red blood cells. This increases the hemoglobin, which is the oxygen-carrying component of blood. Aranesp is given by IV or in the form of a shot usually administered 1 - 3 times a week.

Procrit, Epogen, and Aranesp are the most commonly prescribed ESAs sold in the United States. Epogen and Procrit are the same generic drug (epoetin alfa) just marketed under different brand names. Aranesp is a newer, longer-acting drug.

ABOUT ANEMIA

Anemia is a condition which occurs when there aren't enough healthy red blood cells in the body. Red blood cells contain hemoglobin which carries oxygen from the lungs to the rest of the body. Anemia can make you feel weak, cold, dizzy, irritable and fatigued. There are many different types of anemia, each with a different cause. The most common anemia is due to iron or vitamin deficiency. Dialysis patients have a higher risk of anemia because their kidneys can't create enough hormones to make red blood cells and they lose iron in the process of dialysis. Some cancer treatments, i.e., chemotherapy and radiation, damage the body's ability to make red blood cells, which leads to aplastic anemia. This type of anemia can also be caused by some medications, like those used to treat HIV and rheumatoid arthritis.

FDA-APPROVED USES

Aranesp was originally approved by the FDA on September 17, 2001 to treat anemia in chronic kidney failure patients. On July 19, 2002, Aranesp was approved to treat cancer patients whose anemia is caused by chemotherapy. It was approved for pediatric use on December 15, 2005.

Aranesp is not approved to treat the symptoms of anemia, including fatigue, tiredness, low energy, poor quality of life, shortness of breath, and dizziness.

Physicians may still prescribe Aranesp for "off-label" uses such as these, but the pharmaceutical companies are strictly prohibited from promoting or marketing drugs for any uses not approved by the FDA. Be that as it may, pharmaceutical companies are often caught promoting the off label use of their drugs. This can lead to serious sanctions and other regulatory actions by the FDA.

Some athletes abuse Aranesp and other ESAs because they believe that with more red blood cells, more oxygen will get to their muscles, enabling them to perform better.

THE DRUG COMPANY

Aranesp, Epogen, and Procrit are all manufactured by Amgen, a biotechnology firm with headquarters in Thousand Oaks, California and locations throughout the United States, Canada, Europe, Asia, and Australia. Founded in 1980, Amgen (Applied Molecular Genetics) is now a Fortune 500 company and is the largest biotechnology company in the world. Amgen's total revenue for 2006 was $14.3 billion dollars.

Aranesp and Epogen are also marketed and distributed by Amgen. Whereas, Procrit is marketed and distributed by Ortho Biotech Products, L.P., a subsidiary of Johnson & Johnson.

ARANESP SALES

ESAs are the best selling drugs ever created by biotechnology. Nearly one million Americans, including 500,000 kidney patients, receive ESAs every year.

Aranesp is Amgen's biggest-selling product, bringing in billions of dollars every year.

Total Aranesp sales: 2006 $4.12 billion dollars ($2.8 billion U.S. / $1.3 billion international)
2005 $3.27 billion dollars
2004 $2.47 billion dollars
2003 $1.54 billion dollars
2002 $416 million dollars

Aranesp and Epogen together accounted for 47% of Amgen's revenue in 2006. With sales growing at least 68% per year, anemia drugs have been referred to as the "largest and most lucrative market in biotechnology".