Gail M. ZimmermanPresident and CEO

National Psoriasis Foundation

Portland, Ore.www.psoriasis.org

Testimony to the FDA Dermatologic and Ophthalmic Drugs Advisory Committee

May 23, 2002

National Psoriasis Foundation

Our mission is to improve the quality of life of people who have psoriasis and psoriatic arthritis. Through education and advocacy, we promote awareness and understanding, ensure access to treatment and support research that will lead to effective management and, ultimately, a cure.

Corporate members in general support of the NPF’s mission:

Abgenix Connetics Genentech MedImmune

Allergan Corixa ICN Novartis

Alva-Amco Daavlin ISIS Protein Design Labs

Biogen Fujisawa Immunex Corp./Wyeth

Centocor Galderma Medicis Roche

Unrestricted educational grants in support of programs and services:

Allergan Fujisawa ICN Roche

Biogen Genentech Immunex Corp./Wyeth

Bristol-Myers Squibb Protein Design Labs Schering

Financial disclosure information: FY2001 and FY2002

Physically disabling and emotionally devastating

Moderate to severe psoriasis

Moderate to severe psoriasis

Moderate to severe psoriasis significantly impacts the most common, intimate aspects of day-to-day life:

• Sleep

• Covering up with clothes – shame, embarrassment

• Hours of treatment a day

• Work

• Children

• Relationships

• Suicide

“Psoriasis rarely kills people, but it is murder to live with”

People with psoriasis need new options

• New medications will have unknown risks, but the list of KNOWN long-term risks of currently available therapies includes liver and kidney toxicities and birth defects

• There are 1.5 million people in this country with moderate to severe psoriasis

• 33 percent are very unsatisfied with today’s available treatments

• 78 percent are not using available therapies (phototherapy or systemic medications), primarily due to side effects and lack of effectiveness

Moderate to severe psoriasis

• Long-term, all existing medications for moderate to severe psoriasis are seriously limited by either efficacy or toxicity

• These 1.5 million people will likely require DECADES of treatment for their psoriasis

Moderate to severe psoriasis

• What are their options?

Risk/benefit considerations

What we know vs. what we don’t know

• Existing systemic treatments for psoriasis have serious known long-term risks, or are limited in efficacy

• Many patients and physicians are willing to accept unknown long-term risks of biologic therapy 

NPF position: approve Amevive

• Psoriasis severely affects quality of life

• People with psoriasis need and deserve adequate treatment options to clear or improve their disease

• Access to new treatment options like Amevive is needed