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Last updated: September 25, 2007

ABOUT EPOGEN

WHAT IS EPOGEN?

Epogen (epoetin alfa) is a drug used to treat certain types of anemia and to reduce blood transfusions during some surgeries. 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. Epogen is given by IV or in the form of a shot usually administered 1-3 times a week.

Procrit, Aranesp, and Epogen 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.

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

Epogen (epoetin alfa) was originally approved by the FDA on June 1, 1989. It was approved for pediatric use on July 26, 1999.

The FDA has approved Epogen for the treatment of anemia in chronic kidney failure patients, in cancer patients whose anemia is caused by chemotherapy, in HIV patients whose anemia is caused by AZT (zidovudine), and to reduce the number of transfusions in patients scheduled for major surgery (except heart surgery).

Epogen 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 Epogen 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 Epogen 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

Epogen, Aranesp, 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.

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

EPOGEN SALES

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

Total Epogen Sales: 2006 $2.51 billion dollars
2005 $2.45 billion dollars
2004 $2.60 billion dollars
2003 $2.43 billion dollars
2002 $2.26 billion dollars

Epogen and Aranesp together accounted for 47% of Amgen's revenue in 2006. With sales growing at least 6 - 8% per year, anemia drugs have been referred to as the "largest and most lucrative market in biotechnology".