To: Harold Engstrom who wrote (983 ) 5/25/1999 4:50:00 PM From: Beltropolis Boy Respond to of 1686
how timely ... -----Biogen Announces That AMEVIVE(TM) Shows Excellent Dose Response With Positive Side-Effect Profile in Phase II Psoriasis Study May 25, 1999 04:01 PM CAMBRIDGE, Mass., May 25 /PRNewswire/ -- Biogen (BGEN) today announced that AMEVIVE(TM) (Recombinantly Engineered LFA-3/IgG1 Human Fusion Protein), its candidate for treatment of moderate-to-severe psoriasis, showed excellent dose response and side-effect profile in a Phase II clinical trial. The Company said it will proceed aggressively to begin Phase III registrational studies in North America and Europe after making further improvements in the commercial process. The study was a randomized, double-blind, multi-dose, placebo-controlled trial of AMEVIVE(TM) in patients with moderate-to-severe chronic plaque psoriasis. It involved 229 patients at 22 sites in the U.S. who were treated with AMEVIVE(TM) or placebo by intravenous bolus injection weekly for 12 weeks, followed by a 12-week observation period. Disease severity was measured by Physician Global Assessment and the Psoriasis Activity and Severity Index, which are the standard measures of severity in psoriasis. Quality of Life assessments were obtained using standard instruments. Jim Vincent, Biogen's Chairman and CEO, said, "We are very encouraged by these findings. Psoriasis is a serious disease that has a major impact on patients' lives. Existing therapies are not optimal, and often have long-lasting toxicities. We believe that biotechnology-based approaches to treating psoriasis are an important way to treat the fundamental, biologic basis of this disease and that AMEVIVE(TM) offers a novel approach to treating this underserved patient population." Psoriasis is an inflammatory disorder characterized by red, scaly, thick plaques that can cause considerable discomfort. AMEVIVE(TM) works by modulating the activation of the T cells that cause the disease. An estimated one percent of people in the U.S. and Europe have psoriasis and as many as one million have the moderate-to-severe form of the disease.