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PDL BioPharma Announces Long-Term Nuvion Data Presented at 2007,Digestive Disease Week

Nuvion Antibody Led to a Sustained Response and Remission in Follow-up to Phase 1 and Phase 1/2 studies and Was Adequately Tolerated in Patients with IV Steroid-Refractory Ulcerative Colitis

FREMONT, Calif., May 22, 2007 /PRNewswire-FirstCall/ -- Data presented at the Digestive Disease Week (DDW) meeting this week in Washington D.C. by Dr. William Sandborn from the Mayo Clinic suggest that Nuvion (visilizumab), an antibody in development as a treatment for intravenous steroid-refractory ulcerative colitis (IVSR-UC), administered on day 1 and day 2, produced a sustained clinical response up to 310 days and was adequately tolerated. The results presented were from long-term follow up of 138 patients who had received Nuvion in a Phase 1 and Phase 1/2 study as a treatment for IVSR-UC, which contributes to the majority of an estimated 30,000 colectomy procedures performed in the U.S. each year. In addition, early data also will be presented at the meeting regarding the Nuvion antibody's potential as a treatment for Crohn's disease.

"The data presented by Professor Sandborn further support our decision to advance Nuvion into a Phase 3 program in patients with IV steroid-refractory ulcerative colitis," said Mark McCamish, M.D., Ph.D., PDL's senior vice president and chief medical officer. "Patients with severe ulcerative colitis face surgical intervention or colectomy, and positive results from our Phase 3 program would lead to a welcomed treatment for these difficult-to-treat patients who currently have very limited non-surgical options."

Nuvion is a humanized monoclonal antibody designed to target and modulate the action of T cells, the cells believed to cause inflammation leading to ulcerative colitis, with the aim of significantly reducing the symptoms of the disease and potentially delaying or avoiding the need for colectomy, or surgical removal of the colon. An estimated 60,000 colectomy procedures
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