approval for ms drug on the horizon

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RESEARCH" DEVELOPMENT Approval for MS drug on the horizon Word is out on the street - Betaseron® could soon be approved for treating multiple sclerosis (MS). The synthetic interferon jointly developed by Chiron and Berlex, is to be reviewed by a US FDA advisory panel this month, reports the Wall Street Journal 14 Mar}. Although the companies have not published study data, Wall Street analysts believe that clinical trials of Betaseron® have shown a one-third reduction in the relapse rate in patients with relapsing/remitting MS. The analysts also expect study data to show that recipients had a decline in brain lesions, as determined by magnetic resonance imaging. This decline in brain lesions may indicate a slowing of the disorder. Until now it has been widely held that, regardless of the relapse rate, MS progresses at a relentless pace. Today this dogma is being questioned. Whether fewer relapses and brain lesions indicate a slowing or halting of MS is just one factor for the panel to consider in its review of Betaseron®. 800181183 Stage of Company Product cleve nt PrereglStrBbOn ChJronIBeOex Betaseron (interferon Phase III TeYs Copotymer· ' (m . basic pr n) Phase 111111 psen-Beaufour Ginkgolide B BIogen Interferon Elan EL970 Phase I Centocor Centara ( nti.cD4 1Mb') Xoma T -all receptor proI8ln Pradincal Alhefla Monoclonal N8UIOIICIIIIlC* an Centooor erleron y 1Mb' ICOS 23F2G (Ieuc:? mAb) Immune Peptide vacane RespclfW8 MS 6()4.4 (i muno- mocIu Teel Monogen TM21 Sciences ( TCR'IMb') Pepbgen TP12 (TCR peptide) 1Mb' - monoclonal TCR' - T-all ISSN 015&-270319310313-00111$1.00C AdI8 In_nation. Ud 11

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Page 1: Approval for MS drug on the horizon

RESEARCH" DEVELOPMENT

Approval for MS drug on the horizon Word is out on the street - Betaseron® could soon

be approved for treating multiple sclerosis (MS). The synthetic interferon ~, jointly developed by Chiron and Berlex, is to be reviewed by a US FDA advisory panel this month, reports the Wall Street Journal 14 Mar}.

Although the companies have not published study data, Wall Street analysts believe that clinical trials of Betaseron® have shown a one-third reduction in the relapse rate in patients with relapsing/remitting MS. The analysts also expect study data to show that recipients had a decline in brain lesions, as determined by magnetic resonance imaging. This decline in brain lesions may indicate a slowing of the disorder.

Until now it has been widely held that, regardless of the relapse rate, MS progresses at a relentless pace. Today this dogma is being questioned. Whether fewer relapses and brain lesions indicate a slowing or halting of MS is just one factor for the panel to consider in its review of Betaseron®.

800181183

Stage of Company Product cleve nt PrereglStrBbOn ChJronIBeOex Betaseron

(interferon ~)

Phase III TeYs Copotymer· ' (m . basic pr n)

Phase 111111 psen-Beaufour Ginkgolide B

BIogen Interferon ~

Elan EL970

Phase I Centocor Centara ( nti.cD4 1Mb')

Xoma T -all receptor proI8ln

Pradincal Alhefla Monoclonal N8UIOIICIIIIlC* an Centooor erleron y 1Mb'

ICOS 23F2G (Ieuc:? mAb)

Immune Peptide vacane RespclfW8

MS 6()4.4 (i muno-mocIu

Teel Monogen TM21 Sciences ( TCR'IMb')

Pepbgen TP12 (TCR peptide)

1Mb' - monoclonal

TCR' - T-all

ISSN 015&-270319310313-00111$1.00C AdI8 In_nation. Ud

11