AMEVIVE® (alefacept)

What Are Biologic Medicines?
Biologics are a class of drugs derived from proteins produced by living cells. While pharmaceutical products are combinations of different chemicals, biologics are produced from human and animal proteins. In treating psoriasis, biologic medications work by specifically altering the interactions between cells to disrupt the processes that cause disease.

Because biologics are proteins, they would be digested if taken orally. As a result, these protein-derived medications must be injected into the skin, muscle or vein.

History of Biologics
Research into biologics originated in the mid-1970s, when scientist Herbert Boyer, Ph.D. at the University of Southern California used his knowledge of the amino acid sequence of insulin to manufacture a copy of the insulin gene. By manipulating the gene, he was able to produce man-made insulin, which was a revolutionary discovery for the treatment of diabetes. Since then, similar techniques have been used to produce man-made versions of other biologic substances.

Biologics in Psoriasis
Recently, scientists discovered that psoriasis is an autoimmune skin disease that involves T-cells. Using this knowledge, medical researchers searched for highly selective ways to disable these psoriasis-causing immune cells and the chemicals they release. This work has led to the development of biologic medications, which interrupt the underlying processes that drive psoriasis to halt the progression of the disease. AMEVIVE® (alefacept) is the first biologic to be approved by the FDA for the treatment of adults with moderate-to-severe psoriasis who are candidates for systemic therapy or phototherapy.

Another Treatment Option
Many people with psoriasis are frustrated by a lack of effective treatments. A survey by the National Psoriasis Foundation (NPF) found that one-third of people with moderate-to-severe disease are very unsatisfied with current therapies. Biologic medicines offer these patients a much-needed treatment option. In clinical trials, AMEVIVE appears to be generally well tolerated and may offer some patients a break from the side effects associated with some treatments.

Biologics may be safe because they are highly specific and target disease-causing cells, leaving healthy cells alone. They are like smart bombs designed to target the malfunctioning cell without compromising the body's ability to fight infection.

The Future for Psoriasis
The advent of biologic medicines that are effective and may have fewer side effects and safety issues offers potential hope for some psoriasis patients. For more information about biologics and psoriasis, visit www.Amevive.com (see full prescribing information visit www.Amevive.com).

Important Safety Information Commonly observed adverse events that occurred in clinical studies more frequently with AMEVIVE® (alefacept) included: sore throat, dizziness, increased cough, nausea, itching, muscle aches, chills, injection site pain, injection site inflammation, and accidental injury.

AMEVIVE must be administered under the supervision of a physician.

AMEVIVE reduces lymphocyte counts (also called T-cells). T-cell levels should be measured weekly during the 12-week dosing period.

AMEVIVE reduces immune cell counts, which could increase your chance of developing infection or malignancy, which you should discuss with your doctor. If you develop any signs of infection or malignancy while undergoing a course of treatment with AMEVIVE, you should notify your doctor.

AMEVIVE should not be taken if you are known to be allergic to AMEVIVE or any of its components. If you become pregnant while you are receiving AMEVIVE or within 8 weeks of finishing AMEVIVE, notify your doctor and consider enrolling in the Pregnancy Registry by calling 1-866-AMEVIVE.