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This excerpt taken from the ELN 6-K filed Apr 11, 2005. Current Focus of Operations We are now focused clearly on three core therapeutic areas: neurodegenerative diseases, autoimmune diseases and severe pain. Due to the number of product and business divestments since the beginning of 2002, our financial performance in historical years is of limited comparable relevance to an understanding of our future prospects. Near term, we are focusing our development, sales and marketing resources on Tysabri for MS and Crohn’s disease, and Prialt, for severe pain. In November and December 2004, the FDA approved Tysabri for MS treatment and Prialt for severe pain treatment, respectively. In February 2005, the European Commission granted marketing approval for Prialt for the treatment of severe, chronic pain in patients who require intrathecal analgesia. In addition, we are continuing our research of neurodegenerative diseases, including MS, rheumatoid arthritis, Alzheimer’s disease and Parkinson’s disease. On 28 February 2005, we and Biogen Idec announced the voluntary suspension of marketing and clinical dosing of Tysabri. On 30 March 2005, we and Biogen Idec announced that our ongoing safety evaluation of Tysabri led to a previously
diagnosed case of malignant astrocytoma being reassessed as PML in a patient in an open label Crohn’s disease clinical trial. The patient had received doses of Tysabri over an 18 month period. The patient died in December 2003. We are working with leading experts, regulatory agencies and the clinical investigators to investigate these serious adverse events and to determine the appropriate path forward. |
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