REMICADE(R) Becomes First Anti-TNF Biologic Therapy to Treat One Million Patients...(nadequate response to methotrexat...)

methotrexate.

-- In June 2002, REMICADE became the first TNF-alpha inhibitor approved

by the FDA for maintenance therapy in patients with moderate to severe

Crohn's disease. And in April 2003, it became the first TNF-alpha

inhibitor approved for maintenance therapy of fistulising Crohn's

disease.

-- In May 2003, REMICADE became the first TNF-alpha inhibitor approved in

the EU for the treatment of ankylosing spondylitis in patients who

have severe axial symptoms, elevated serological markers of

inflammatory activity and who have responded inadequately to

conventional therapy.

-- In October 2004, REMICADE became the first TNF-alpha inhibitor

approved for the treatment of active and progressive psoriatic

arthritis in patients who have responded inadequately to disease

modifying anti-rheumatic drug therapy.

-- In September 2005, the FDA approved REMICADE as the first and only

biologic for reducing signs and symptoms, achieving clinical remission

and mucosal healing and eliminating corticosteroid use in adults with

moderately to severely active UC who have had an inadequate response

to conventional therapy. The FDA extended the indication to include

maintenance therapy for UC in October 2006.

-- In March 2006, REMICADE became the first biologic therapy approved to

treat moderately to severely active UC in the European Union (EU), in

patients with an inadequate response to conventional therapy,

including corticosteroids and 6-MP or AZA, or those intolerant to or

contraindicated for such therapies.

-- In May 2006, REMICADE became the first and only biologic indicated to

reduce signs and symptoms and induce and maintain clinical remission

in pediatric patients with moderately to
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