Gail M. Zimmerman President and CEO National Psoriasis Foundation Portland, Ore. www.psoriasis.org

1
Gail M. ZimmermanPresident and CEONational
Psoriasis FoundationPortland,
Ore.www.psoriasis.org
Testimony to the FDA Dermatologic and Ophthalmic
Drugs Advisory Committee
May 23, 2002
2
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.

3
Financial disclosure information FY2001 and
FY2002

• Corporate members in general support of the NPFs
  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

4
Physically disabling and emotionally devastating
Moderate to severe psoriasis
5
Moderate to severe psoriasis
6
Moderate to severe psoriasis significantly
impacts the most common, intimate aspects of
day-to-day life
Psoriasis rarely kills people, but it is murder
to live with

• Sleep
• Covering up with clothes shame, embarrassment
• Hours of treatment a day

• Work
• Children
• Relationships
• Suicide

7
People with psoriasis need new options

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

• 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

8
Moderate to severe psoriasis

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

• 33 percent are very unsatisfied with todays
  available treatments

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

9
Moderate to severe psoriasis

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

• What are their options?

10
Risk/benefit considerations

• What we know vs. what we dont 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 

11
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