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}\trowd \irow0\irowband0\ltrrow\ts11\trrh-856\trleft0\trkeep\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15 
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City}}{\*\xmlopen\xmlns2{\factoidname place}}Basel{\*\xmlclose}{\*\xmlclose}, }{\rtlch\fcs1 \af0\afs22 \ltrch\fcs0 \insrsid6974155 11 January 2010}{\rtlch\fcs1 \af0\afs22 \ltrch\fcs0 \insrsid6974155\charrsid4226948 
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\brdrs\brdrw15 \trftsWidth3\trwWidth9638\trftsWidthB3\trftsWidthA3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrnone \clbrdrl\brdrnone \clbrdrb\brdrnone \clbrdrr\brdrnone \cltxlrtb\clftsWidth3\clwWidth9638\clshdrawnil \cellx9638\pard \ltrpar
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\ab\af0\afs28 \ltrch\fcs0 \b\fs28\insrsid6974155\charrsid15480022 pproves ACTEMRA}{\rtlch\fcs1 \ab\af0\afs28 \ltrch\fcs0 \b\fs28\insrsid6974155  for the treatment of moderately to s}{\rtlch\fcs1 \ab\af0\afs28 \ltrch\fcs0 
\b\fs28\insrsid6974155\charrsid15480022 everely}{\rtlch\fcs1 \ab\af0\afs28 \ltrch\fcs0 \b\fs28\insrsid6974155  active rheumatoid a}{\rtlch\fcs1 \ab\af0\afs28 \ltrch\fcs0 \b\fs28\insrsid6974155\charrsid15480022 rthritis
\par }{\rtlch\fcs1 \af0\afs22 \ltrch\fcs0 \b\fs22\insrsid6974155\charrsid6974155 First-in-class biologic therapy, IL-6 receptor-inhibiting monoclonal antibody approved based on largest clinical development program in rheumatoid arthritis to date }{\rtlch\fcs1 
\af0\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 
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Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the United States (US) Food and Drug Administration (FDA) approved ACTEMRA (tocilizumab, RoACTEMRA in the European Union) for the treatment of adult patients with mod
erately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. ACTEMRA, the result of a research & development collaboration with Chugai, is the first interleukin-6
 (IL-6) receptor-inhibiting monoclonal antibody approved to treat RA, may be used alone or in combination with methotrexate or other disease modifying anti-rheumatic drugs (DMARDs). 
\par 
\par {\*\bkmkstart OLE_LINK5}{\*\bkmkstart OLE_LINK6}"The FDA approval of ACTEMRA marks a major step forward in the treatment of RA, providing a new option for patients with this very serious disease,\'94
 said Hal Barron, M.D., executive vice president, Global Development and chief medical officer, Roche and Genentech. \'93We are optimistic that working with the agency, we will be able to generate the additional data required }{\rtlch\fcs1 \ab\af0\afs22 
\ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 to support approval in earlier lines of RA therapy and are }{\rtlch\fcs1 \af0\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 
committed to comprehensively characterizing both the clinical benefit and the safety of ACTEMRA in earlier lines of therapy through our large\~pharmacovigilance\~program, including the risk management program, and ongoing clinical and post-marketing\~
studies globally."
\par {\*\bkmkend OLE_LINK5}{\*\bkmkend OLE_LINK6}
\par RA is a chronic, progressive inflammatory disease of the joints and surrounding tissues that is associated with intense pain, irreversible join
t destruction and systemic complications. There are several key cytokines, or proteins, involved in the inflammatory process, including IL-6. Research shows that IL-6 levels are elevated in patients with RA. ACTEMRA is the first medication designed to spe
cifically inhibit the biological activity of IL-6.
\par 
\par \'93For many RA patients, treatment with existing therapies does not resolve the painful and debilitating symptoms of the disease,\'94 said Mark Genovese, M.D., ACTEMRA study investigator and Professor of Medici
ne and Co-Chief of the Division of Immunology and Rheumatology at {\*\xmlopen\xmlns2{\factoidname place}}{\*\xmlopen\xmlns2{\factoidname PlaceName}}Stanford{\*\xmlclose} {\*\xmlopen\xmlns2{\factoidname PlaceType}}University{\*\xmlclose} 
{\*\xmlopen\xmlns2{\factoidname PlaceName}}Medical{\*\xmlclose} {\*\xmlopen\xmlns2{\factoidname PlaceType}}Center{\*\xmlclose}{\*\xmlclose}. \'93
Data from the clinical development program clearly establish ACTEMRA and its unique mechanism of action as an important new option for RA patients who experience continued disease symptoms despite treatment with existing therapies.\'94 
\par 
\par ACTEMRA has been studied in five multi-national Phase III studies, involving more than 4,000 patients, making it the largest clinical development program for an indication in RA to date. The studies showed that ACTEMRA \endash 
 alone or in combination with methotrexate or other DMARDs \endash  significantly reduced RA signs and symptoms, regardless of previous therapy, compared with DMARDs alone. 
\par 
\par ACTEMRA will be available in the {\*\xmlopen\xmlns2{\factoidname place}}{\*\xmlopen\xmlns2{\factoidname country-region}}US{\*\xmlclose}{\*\xmlclose} the week of January 18 2010.
\par 
\par The treatment is also approved for use in the European Union and a growing number of other countries including {\*\xmlopen\xmlns2{\factoidname country-region}}Mexico{\*\xmlclose}, {\*\xmlopen\xmlns2{\factoidname country-region}}India{\*\xmlclose}, 
{\*\xmlopen\xmlns2{\factoidname country-region}}Brazil{\*\xmlclose}, {\*\xmlopen\xmlns2{\factoidname country-region}}Switzerland{\*\xmlclose} and {\*\xmlopen\xmlns2{\factoidname place}}{\*\xmlopen\xmlns2{\factoidname country-region}}Australia{\*\xmlclose}
{\*\xmlclose}. 
\par 
\par }{\rtlch\fcs1 \af0\afs22 \ltrch\fcs0 \b\fs22\insrsid6974155\charrsid6974155 This approval is based on data from the following pivotal studies:
\par }\pard \ltrpar\ql \fi360\li-360\ri0\sl380\slmult0\nowidctlpar\wrapdefault\aspalpha\aspnum\faauto\nosnaplinegrid\adjustright\rin0\lin-360\itap0\pararsid6974155 {\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 RADIATE (}{\rtlch\fcs1 
\af1\afs22 \ltrch\fcs0 \b\fs22\ul\insrsid6974155\charrsid6974155 R}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 heum}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \b\fs22\ul\insrsid6974155\charrsid6974155 A}{\rtlch\fcs1 \af1\afs22 
\ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 toi}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \b\fs22\ul\insrsid6974155\charrsid6974155 D}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155  Arthrit}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 
\b\fs22\ul\insrsid6974155\charrsid6974155 I}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 s Study in }{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \b\fs22\ul\insrsid6974155\charrsid6974155 A}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 
\fs22\insrsid6974155\charrsid6974155 nti-}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \b\fs22\ul\insrsid6974155\charrsid6974155 T}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 NF Failur}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 
\b\fs22\ul\insrsid6974155\charrsid6974155 E}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 s) Trial:
\par {\listtext\pard\plain\ltrpar \rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \f3\fs22\lang1033\langfe1049\langfenp1049\insrsid6974155\charrsid6974155 \loch\af3\dbch\af0\hich\f3 \'b7\tab}}\pard \ltrpar\ql \fi-360\li360\ri0\sl380\slmult0\widctlpar
\jclisttab\tx360\wrapdefault\aspalpha\aspnum\faauto\ls3\nosnaplinegrid\adjustright\rin0\lin360\itap0\pararsid6974155 {\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 
50% and 30% of patients who received ACTEMRA 8 mg/kg or 4 mg/kg plus methotrexate, respectively, achieved ACR20 at week 24, compared with 10% of patients who received placebo plus methotrexate}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 
\cs33\fs22\super\insrsid6974155\charrsid6974155 \chftn {\footnote\ftnalt \ltrpar \pard\plain \ltrpar\s31\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6974155 \rtlch\fcs1 \af0\afs20\alang1025 \ltrch\fcs0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0 \f38\fs18\insrsid6974155\charrsid6974155 \chftn 
 Emery P. et al. IL-6 Receptor Inhibition with Tocilizumab Improves Treatment Outcomes in Patients with Rheumatoid Arthritis Refractory to Anti-TNF Biologics: The RADIATE Study. }{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0 
\i\f38\fs18\insrsid6974155\charrsid6974155 Annals of the Rheumatic Diseases.}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0 \f38\fs18\insrsid6974155\charrsid6974155  2008;67:1516-1523.}}}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 

\par }\pard \ltrpar\ql \fi360\li-360\ri0\sl380\slmult0\nowidctlpar\wrapdefault\aspalpha\aspnum\faauto\nosnaplinegrid\adjustright\rin0\lin-360\itap0\pararsid6974155 {\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 OPTION (T}{\rtlch\fcs1 
\af1\afs22 \ltrch\fcs0 \b\fs22\ul\insrsid6974155\charrsid6974155 O}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 cilizumab }{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \b\fs22\ul\insrsid6974155\charrsid6974155 P}{\rtlch\fcs1 \af1\afs22 
\ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 ivotal }{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \b\fs22\ul\insrsid6974155\charrsid6974155 T}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 rial in Methotrexate }{\rtlch\fcs1 
\af1\afs22 \ltrch\fcs0 \b\fs22\insrsid6974155\charrsid6974155 I}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 nadequate resp}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \b\fs22\ul\insrsid6974155\charrsid6974155 ON}{\rtlch\fcs1 
\af1\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 ders) Trial:
\par {\listtext\pard\plain\ltrpar \rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \f3\fs22\lang1033\langfe1049\langfenp1049\insrsid6974155\charrsid6974155 \loch\af3\dbch\af0\hich\f3 \'b7\tab}}\pard \ltrpar\ql \fi-360\li360\ri0\sl380\slmult0\widctlpar
\jclisttab\tx360\wrapdefault\aspalpha\aspnum\faauto\ls3\nosnaplinegrid\adjustright\rin0\lin360\itap0\pararsid6974155 {\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 
59% and 48% of patients who received ACTEMRA 8 mg/kg and 4 mg/kg plus methotrexate, respectively, achieved ACR20 at week 24, compared with 27% of patients who received placebo plus methotrexate}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 
\cs33\fs22\super\insrsid6974155\charrsid6974155 \chftn {\footnote\ftnalt \ltrpar \pard\plain \ltrpar\s31\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6974155 \rtlch\fcs1 \af0\afs20\alang1025 \ltrch\fcs0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0 \f38\fs18\insrsid6974155\charrsid6974155 \chftn  Smolen 
J. et al. Effect of Interleukin-6 Receptor Inhibition with Tocilizumab in Patients with Rheumatoid Arthritis (OPTION Study): a Double-Blind, Placebo-Controlled, Randomised Trial. }{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0 
\i\f38\fs18\insrsid6974155\charrsid6974155 The Lancet}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0 \f38\fs18\insrsid6974155\charrsid6974155 . 2008;371,9617:987-997.}}}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 
\par }\pard \ltrpar\ql \fi360\li-360\ri0\sl380\slmult0\nowidctlpar\wrapdefault\aspalpha\aspnum\faauto\nosnaplinegrid\adjustright\rin0\lin-360\itap0\pararsid6974155 {\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 TOWARD (}{\rtlch\fcs1 
\af1\afs22 \ltrch\fcs0 \b\fs22\ul\insrsid6974155\charrsid6974155 T}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 ocilizumab in c}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \b\fs22\ul\insrsid6974155\charrsid6974155 O}{\rtlch\fcs1 
\af1\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 mbination }{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \b\fs22\ul\insrsid6974155\charrsid6974155 W}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 ith traditional DM}{
\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \b\fs22\ul\insrsid6974155\charrsid6974155 ARD}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155  therapy) Trial:
\par {\listtext\pard\plain\ltrpar \rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \f3\fs22\lang1033\langfe1049\langfenp1049\insrsid6974155\charrsid6974155 \loch\af3\dbch\af0\hich\f3 \'b7\tab}}\pard \ltrpar\ql \fi-360\li360\ri0\sl380\slmult0\widctlpar
\jclisttab\tx360\wrapdefault\aspalpha\aspnum\faauto\ls3\nosnaplinegrid\adjustright\rin0\lin360\itap0\pararsid6974155 {\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 
61% of patients who received ACTEMRA 8mg/kg plus DMARD(s) achieved ACR20 at 24 weeks, compared with 25% of patients treated with DMARDs plus placebo}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \cs33\fs22\super\insrsid6974155\charrsid6974155 \chftn 
{\footnote\ftnalt \ltrpar \pard\plain \ltrpar\s31\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6974155 \rtlch\fcs1 \af0\afs20\alang1025 \ltrch\fcs0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\rtlch\fcs1 \af1\afs18 \ltrch\fcs0 \cs33\f38\fs18\super\insrsid6974155\charrsid6974155 \chftn }{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0 \f38\fs18\insrsid6974155\charrsid6974155  Genovese M., et al. Interleukin-6 Recept
or Inhibition with Tocilizumab Reduces Disease Activity in Rheumatoid Arthritis with Inadequate Response to Disease-Modifying Antirheumatic Drugs. }{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0 \i\f38\fs18\insrsid6974155\charrsid6974155 Arthritis & Rheumatism}{
\rtlch\fcs1 \af1\afs18 \ltrch\fcs0 \f38\fs18\insrsid6974155\charrsid6974155 . 2008;58(10):2968-2980.}}}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 
\par }\pard \ltrpar\ql \li0\ri0\sl380\slmult0\nowidctlpar\wrapdefault\aspalpha\aspnum\faauto\nosnaplinegrid\adjustright\rin0\lin0\itap0\pararsid6974155 {\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 AMBITION (}{\rtlch\fcs1 \af1\afs22 
\ltrch\fcs0 \b\fs22\ul\insrsid6974155\charrsid6974155 A}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 ctemra versus }{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \b\fs22\ul\insrsid6974155\charrsid6974155 M}{\rtlch\fcs1 \af1\afs22 
\ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 ethotrexate double-}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \b\fs22\ul\insrsid6974155\charrsid6974155 B}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 lind }{\rtlch\fcs1 \af1\afs22 
\ltrch\fcs0 \b\fs22\ul\insrsid6974155\charrsid6974155 I}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 nvestigative }{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \b\fs22\ul\insrsid6974155\charrsid6974155 T}{\rtlch\fcs1 \af1\afs22 
\ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 rial }{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \b\fs22\ul\insrsid6974155\charrsid6974155 I}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 n m}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 
\b\fs22\ul\insrsid6974155\charrsid6974155 ON}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 otherapy) Trial:
\par {\listtext\pard\plain\ltrpar \rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \f3\fs22\lang1033\langfe1049\langfenp1049\insrsid6974155\charrsid6974155 \loch\af3\dbch\af0\hich\f3 \'b7\tab}}\pard \ltrpar\ql \fi-360\li360\ri0\sl380\slmult0\widctlpar
\jclisttab\tx360\wrapdefault\aspalpha\aspnum\faauto\ls3\nosnaplinegrid\adjustright\rin0\lin360\itap0\pararsid6974155 {\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 
70% of patients who received ACTEMRA 8 mg/kg achieved ACR20 at week 24, compared with 53% of patients receiving methotrexate alone}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \cs33\fs22\super\insrsid6974155\charrsid6974155 \chftn {\footnote\ftnalt \ltrpar 
\pard\plain \ltrpar\s31\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6974155 \rtlch\fcs1 \af0\afs20\alang1025 \ltrch\fcs0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\rtlch\fcs1 \af1\afs18 
\ltrch\fcs0 \f38\fs18\insrsid6974155\charrsid6974155 \chftn  Jones. G. Abstract 1210. The AMBITION Study: Superiority of Tociluzumab (TCZ) vs Methotrexate (MTX) Monotherapy in Patients with Rheumatoid Arthritis (RA). Data presented at the 
{\*\xmlopen\xmlns2{\factoidname place}}{\*\xmlopen\xmlns2{\factoidname PlaceName}}American{\*\xmlclose} {\*\xmlopen\xmlns2{\factoidname PlaceType}}College{\*\xmlclose}{\*\xmlclose} of Rheumatology (ACR) Annual Scientific Meeting 2008.}}}{\rtlch\fcs1 
\af1\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 
\par }\pard \ltrpar\ql \fi360\li-360\ri0\sl380\slmult0\nowidctlpar\wrapdefault\aspalpha\aspnum\faauto\nosnaplinegrid\adjustright\rin0\lin-360\itap0\pararsid6974155 {\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 LITHE (Toci}{
\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \b\fs22\ul\insrsid6974155\charrsid6974155 LI}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 zumab Safety and }{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \b\fs22\ul\insrsid6974155\charrsid6974155 THE}{
\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155  Prevention of Structural Joint Damage) Trial:
\par {\listtext\pard\plain\ltrpar \rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \f3\fs22\lang1033\langfe1049\langfenp1049\insrsid6974155\charrsid6974155 \loch\af3\dbch\af0\hich\f3 \'b7\tab}}\pard \ltrpar\ql \fi-360\li360\ri0\sl380\slmult0\widctlpar
\jclisttab\tx360\wrapdefault\aspalpha\aspnum\faauto\ls3\nosnaplinegrid\adjustright\rin0\lin360\itap0\pararsid6974155 {\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 
56% and 51% of patients who received ACTEMRA 8 mg/kg or 4 mg/kg plus methotrexate, respectively, achieved ACR20 at Week 24 compared with 27% of patients who received placebo plus methotrexate}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 
\cs33\fs22\super\insrsid6974155\charrsid6974155 {\*\bkmkstart _Ref246473516}\chftn {\footnote\ftnalt \ltrpar \pard\plain \ltrpar\s31\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6974155 \rtlch\fcs1 
\af0\afs20\alang1025 \ltrch\fcs0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0 \f38\fs18\insrsid6974155\charrsid6974155 \chftn  Fleischmann R., Abstract 637. LITHE: Tocilizumab Inhibits Radiogr
aphic Progression and Improves Physical Function in Rheumatoid Arthritis (RA) Patients (Pts) at 2 Yrs with Increasing Clinical Efficacy Over Time. Data presented at ACR 2008.}}}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \fs22\insrsid6974155 
{\*\bkmkend _Ref246473516}
\par }\pard \ltrpar\ql \li0\ri0\sl380\slmult0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\nosnaplinegrid\adjustright\rin0\lin0\itap0\pararsid1919860 {\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 \fs22\insrsid1919860\charrsid6974155 
\par }\pard \ltrpar\ql \li0\ri0\sl380\slmult0\nowidctlpar\wrapdefault\aspalpha\aspnum\faauto\outlinelevel0\adjustright\rin0\lin0\itap0\pararsid6974155 {\rtlch\fcs1 \af0\afs22 \ltrch\fcs0 \b\fs22\insrsid6974155 
\par }{\rtlch\fcs1 \af0\afs22 \ltrch\fcs0 \b\fs22\insrsid6974155\charrsid6974155 About ACTEMRA
\par }\pard \ltrpar\ql \li0\ri0\sl380\slmult0\nowidctlpar\wrapdefault\faauto\rin0\lin0\itap0\pararsid6974155 {\rtlch\fcs1 \af0\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 ACTEMRA i
s the first humanised IL-6 receptor-inhibiting monoclonal antibody. An extensive clinical development programme of five Phase III trials was designed to evaluate clinical findings of ACTEMRA, all of which met their primary endpoints. ACTEMRA was first app
roved in {\*\xmlopen\xmlns2{\factoidname country-region}}Japan{\*\xmlclose}
, and launched by Chugai in June 2005 as a therapy for Castleman's disease; in April 2008, additional indications for RA, juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis were also approved in {\*\xmlopen\xmlns2{\factoidname 
place}}{\*\xmlopen\xmlns2{\factoidname country-region}}Japan{\*\xmlclose}{\*\xmlclose}. ACTEMRA was a
pproved in the European Union in January 2009 for the treatment of RA in patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more DMARDs or TNF inhibitors. It is also approved for use in several othe
r countries, including {\*\xmlopen\xmlns2{\factoidname country-region}}Mexico{\*\xmlclose}, {\*\xmlopen\xmlns2{\factoidname country-region}}India{\*\xmlclose}, {\*\xmlopen\xmlns2{\factoidname country-region}}Brazil{\*\xmlclose}, 
{\*\xmlopen\xmlns2{\factoidname country-region}}Switzerland{\*\xmlclose} and {\*\xmlopen\xmlns2{\factoidname place}}{\*\xmlopen\xmlns2{\factoidname country-region}}Australia{\*\xmlclose}{\*\xmlclose}. 
\par 
\par The overall safety profile of ACTEMRA is consistent across all global clinical studies. 
\par }{\rtlch\fcs1 \af4\afs22 \ltrch\fcs0 \fs22\lang1033\langfe1033\langfenp1033\insrsid6974155\charrsid6974155 Serious side effects associated with ACTEMRA include serious infections that may lead to hosp
italization or death, gastrointestinal perforations (a hole in the stomach or intestines), and hypersensitivity reactions including anaphylaxis.}{\rtlch\fcs1 \ai\af4\afs22 \ltrch\fcs0 \fs22\lang1033\langfe1033\langfenp1033\insrsid6974155\charrsid6974155 
\~}{\rtlch\fcs1 \af4\afs22 \ltrch\fcs0 \fs22\lang1033\langfe1033\langfenp1033\insrsid6974155\charrsid6974155 The most common AEs reported in clinical studies were upper respiratory tract infection, nasopharyngitis (infla
mmation of the nose and throat), headache, high blood pressure and increased liver enzymes. The increases in liver enzymes that were seen in patients were generally mild and reversible and\~}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0 
\fs22\lang1033\langfe1033\langfenp1033\insrsid6974155\charrsid6974155 did not result in apparent permanent or clinically evident\~hepatic injury}{\rtlch\fcs1 \af4\afs22 \ltrch\fcs0 \fs22\lang1033\langfe1033\langfenp1033\insrsid6974155\charrsid6974155 .}{
\rtlch\fcs1 \ai\af4\afs22 \ltrch\fcs0 \fs22\lang1033\langfe1033\langfenp1033\insrsid6974155\charrsid6974155 \~}{\rtlch\fcs1 \af4\afs22 \ltrch\fcs0 \fs22\lang1033\langfe1033\langfenp1033\insrsid6974155\charrsid6974155 
Laboratory changes, including increases in total cholesterol, the amount of fat circulating in the blood, and decreases in neutrophils (one of the cell types that helps fight infections) and platelets, were seen.}{\rtlch\fcs1 \ai\af4\afs22 \ltrch\fcs0 
\fs22\lang1033\langfe1033\langfenp1033\insrsid6974155\charrsid6974155 \~}{\rtlch\fcs1 \af4\afs22 \ltrch\fcs0 \fs22\lang1033\langfe1033\langfenp1033\insrsid6974155\charrsid6974155 Treatments that suppress the immune
 system, such as ACTEMRA, may cause an increase in the risk of cancer.}{\rtlch\fcs1 \af0\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 
\par }{\rtlch\fcs1 \ai\af0\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155  }{\rtlch\fcs1 \af0\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 
\par }\pard \ltrpar\ql \li0\ri0\sl380\slmult0\nowidctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6974155 {\rtlch\fcs1 \af0\afs22 \ltrch\fcs0 \b\fs22\insrsid6974155\charrsid6974155 About Roche
\par }\pard \ltrpar\ql \li0\ri0\sl380\slmult0\nowidctlpar\wrapdefault\faauto\rin0\lin0\itap0\pararsid6974155 {\rtlch\fcs1 \af0\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 Headquartered in {\*\xmlopen\xmlns2{\factoidname place}}
{\*\xmlopen\xmlns2{\factoidname City}}Basel{\*\xmlclose}, {\*\xmlopen\xmlns2{\factoidname country-region}}Switzerland{\*\xmlclose}{\*\xmlclose}
, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world\rquote s larg
est biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and central nervous system (CNS). Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes man
agement. Roche\rquote 
s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2008, Roche had over 80,000 employees worldwide and invested alm
ost 9 billion Swiss francs in R&D. The Roche Group posted sales of 45.6 billion Swiss francs. {\*\xmlopen\xmlns2{\factoidname place}}{\*\xmlopen\xmlns2{\factoidname City}}Genentech{\*\xmlclose}, {\*\xmlopen\xmlns2{\factoidname country-region}}
United States{\*\xmlclose}{\*\xmlclose}, is a wholly owned member of the Group. Roche has a majority stake in {\*\xmlopen\xmlns2{\factoidname place}}{\*\xmlopen\xmlns2{\factoidname City}}Chugai Pharmaceutical{\*\xmlclose}, {\*\xmlopen\xmlns2{\factoidname 
country-region}}Japan{\*\xmlclose}{\*\xmlclose}. For more information: }{\field\flddirty{\*\fldinst {\rtlch\fcs1 \af0\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 HYPERLINK "http://www.roche.com" }{\rtlch\fcs1 \af0\afs22 \ltrch\fcs0 
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\af0\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 www.roche.com}}}\sectd \psz9\linex0\headery737\footery510\endnhere\titlepg\sectlinegrid326\sectdefaultcl\sftnbj {\rtlch\fcs1 \af0\afs22 \ltrch\fcs0 \fs22\insrsid6974155\charrsid6974155 .
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\par }{\rtlch\fcs1 \af0\afs18 \ltrch\fcs0 \fs18\insrsid6974155\charrsid3736049 All trademarks used or mentioned in this release are protected by law.
\par }\pard \ltrpar\ql \li0\ri0\sl360\slmult1\nowidctlpar\wrapdefault\aspalpha\aspnum\faauto\outlinelevel0\adjustright\rin0\lin0\itap0\pararsid6974155 {\rtlch\fcs1 \af0\afs22 \ltrch\fcs0 \insrsid6974155\charrsid4226948 
\par }\pard \ltrpar\ql \li0\ri0\sl380\slmult0\nowidctlpar\wrapdefault\aspalpha\aspnum\faauto\outlinelevel0\adjustright\rin0\lin0\itap0\pararsid6974155 {\rtlch\fcs1 \af0\afs22 \ltrch\fcs0 \b\insrsid6974155\charrsid4601016 Further information
\par {\listtext\pard\plain\ltrpar \rtlch\fcs1 \af0\afs22 \ltrch\fcs0 \lang1033\langfe1049\loch\af38\hich\af38\dbch\af11\langfenp1049\insrsid6974155\charrsid4226948 \hich\af38\dbch\af11\loch\f38 -\tab}}\pard \ltrpar\ql \fi-360\li360\ri0\sl380\slmult0
\nowidctlpar\jclisttab\tx360\wrapdefault\aspalpha\aspnum\faauto\ls2\adjustright\rin0\lin360\itap0\pararsid6974155 {\rtlch\fcs1 \af0\afs22 \ltrch\fcs0 \insrsid6974155\charrsid4226948 Roche & Autoimmune diseases:
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