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Reactions 1260 - 11 Jul 2009 Tysabri update, 10 PML cases reported so far Until 26 June 2009, ten progressive multifocal leukoencephalopathy (PML) cases have been reported with Tysabri [natalizumab], according to an update issued by Biogen Idec. Since the reintroduction of Tysabri in July 2006, * 24 900 patients have received at least 1 year of Tysabri treatment, 14 400 patients have received at least 18 months of treatment and 6800 patients have received at least 24 months of treatment. Between July 2006 and 26 June 2009, ten patients developed PML; four cases were reported in 2008 and six cases were reported in 2009. All patients were treated for multiple sclerosis. Six patients developed PML after receiving Tysabri for 12–31 months, whereas the remaining four patients developed PML after receiving 14–35 doses of Tysabri. Only two of the ten cases were reported in the US. * see Reactions 1106 p 3; 801069048 Biogen Idec. Patients treated with TYSABRI as of the end of March 2009. Internet Document : [2 pages], 26 Jun 2009. Available from: URL: http:// www.investor.biogenidec.com 801075480 1 Reactions 11 Jul 2009 No. 1260 0114-9954/10/1260-0001/$14.95 © 2010 Adis Data Information BV. All rights reserved

Tysabri update, 10 PML cases reported so far

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Page 1: Tysabri update, 10 PML cases reported so far

Reactions 1260 - 11 Jul 2009

Tysabri update, 10 PML casesreported so far

Until 26 June 2009, ten progressive multifocalleukoencephalopathy (PML) cases have been reportedwith Tysabri [natalizumab], according to an updateissued by Biogen Idec.

Since the reintroduction of Tysabri in July 2006,*24 900 patients have received at least 1 year of Tysabritreatment, 14 400 patients have received at least18 months of treatment and 6800 patients have receivedat least 24 months of treatment. Between July 2006 and26 June 2009, ten patients developed PML; four caseswere reported in 2008 and six cases were reported in2009. All patients were treated for multiple sclerosis. Sixpatients developed PML after receiving Tysabri for12–31 months, whereas the remaining four patientsdeveloped PML after receiving 14–35 doses of Tysabri.Only two of the ten cases were reported in the US.* see Reactions 1106 p 3; 801069048

Biogen Idec. Patients treated with TYSABRI as of the end of March 2009. InternetDocument : [2 pages], 26 Jun 2009. Available from: URL: http://www.investor.biogenidec.com 801075480

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Reactions 11 Jul 2009 No. 12600114-9954/10/1260-0001/$14.95 © 2010 Adis Data Information BV. All rights reserved