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Genentech Considers Xanelim Chronic Psoriasis Therapy Indication

Executive Summary

Genentech hopes to position Xanelim for use as a chronic therapy for moderate to severe plaque psoriasis based on six-month data.

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Xanelim BLA filing

Genentech and Xoma will conduct an additional pharmacokinetics study to confirm equivalence between Xanelim (efalizumab) material used for clinical testing and commercial lots. The trial will delay the estimated BLA filing date until summer 2002. Genentech had planned to file a BLA in the first quarter of 2002 (1"The Pink Sheet" Aug. 6, p. 20)

Xanelim BLA filing

Genentech and Xoma will conduct an additional pharmacokinetics study to confirm equivalence between Xanelim (efalizumab) material used for clinical testing and commercial lots. The trial will delay the estimated BLA filing date until summer 2002. Genentech had planned to file a BLA in the first quarter of 2002 (1"The Pink Sheet" Aug. 6, p. 20)

Biogen Amevive NDA Filing For Psoriasis Expected In Second Half Of 2001

Biogen plans to file an NDA for the T-cell modulator Amevive for psoriasis in the second half of 2001, VP-Medical Research Burt Adelman, MD, said during the company's first quarter conference call April 12.

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