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{\pard\sa900\fs50\f0\i Media Release\par}
Basel, 15 November 2007\line \line {\b FDA approves Mircera: 
first renal anemia treatment in the US with monthly maintenance dosing}  \line \line Roche 
announced today that the U.S. Food and Drug Administration (FDA) has approved Mircera (methoxy polyethylene 
glycol-epoetin beta) for the treatment of anaemia associated with chronic kidney disease (CKD) in patients 
on dialysis and patients not on dialysis. Mircera is the only FDA-approved ESA to provide correction 
of anemia with once-every-two-week dosing. Mircera is also the only FDA-approved ESA to maintain stable 
hemoglobin levels with once-monthly or once-every-two-week dosing in all CKD patients. Mircera offers 
the added convenience of storage at room temperature for extended time periods when necessary. \line \line The 
outcome of an ongoing patent case will determine when patients can gain access to Mircera in the United 
States. Following approval by the European Agency for the Evaluation of Medicinal Products (EMEA), Mircera 
has already been launched in Austria, Sweden, Germany, the UK and Norway and will continue its international 
roll-out. \line \line \u8220?The FDA approval for our innovative anaemia treatment Mircera 
is another significant milestone for Roche, Mircera has now been reviewed and approved by both the FDA 
and the EMEA, two of the world\u180?s leading regulatory authorities\u8221?, said William M. Burns, CEO Roche Pharma. 
\line \line In contrast to erythropoietin, Mircera is an erythropoietin receptor 
activator with greater activity in vivo as well as increased half-life. Mircera has the longest half-life 
of all FDA-approved erythropoiesis stimulating agents (ESAs){\super 1,2,3} , up to 
six times longer than darbepoetin alfa and up to 20 times longer than epoetin.\line \line The 
Phase III data supporting the FDA approval for Mircera consisted of two correction and four maintenance 
studies exploring intravenous (IV) and subcutaneous (SC) Mircera at extended administration intervals.{\super 2,3,4,5,9,10,11}  
The initial registration clinical program for Mircera consisted of 10 global studies involving more 
than 2,700 patients from 29 countries{\super 6} . \line In clinical trials, 
Mircera was as effective as commercially available agents in correcting renal anemia in patients with 
CRF on dialysis and not on dialysis. Up to 97.5 percent of patients who were not currently receiving 
an ESA achieved target Hb levels (>=11g/dL) with once-every two week dosing of Mircera{\super 7} . 
Patients maintained stable Hb levels (\u177?1g/dL) when switched to once-monthly Mircera from a shorter-acting 
frequently administered ESA treatment regimen{\super 8,9,10,11,12} . Mircera has a 
safety profile comparable to other erythropoietic agents.\line \line In the European 
Union (EU), Mircera is the first ESA approved to directly convert all CKD patient types previously treated 
with any ESA to once-monthly maintenance dosing. It is also the first ESA in the EU that offers a convenient 
dosing schedule of once every two weeks to correct anaemia in all CKD patient types not previously treated. 
\line \line {\b About Roche} \line Headquartered in Basel, 
Switzerland, Roche is one of the world\u8217?s leading research-focused healthcare groups in the fields of 
pharmaceuticals and diagnostics. As the world\u8217?s biggest biotech company and an innovator of products 
and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes 
on a broad range of fronts to improving people\u8217?s health and quality of life. Roche is the world leader 
in in-vitro diagnostics and drugs for cancer and transplantation, a market leader in virology and active 
in other major therapeutic areas such as autoimmune diseases, inflammation, metabolism and central nervous 
system. In 2006 sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics 
Division posted sales of 8.7 billion Swiss francs. Roche employs roughly 75,000 worldwide and has R&D 
agreements and strategic alliances with numerous partners, including majority ownership interests in 
Genentech and Chugai. Additional information about the Roche Group is available on the Internet at www.roche.com (http://www.roche.com).\line \line For 
video content from Roche related to anaemia please log on to www.thenewsmarket.com/roche (http://www.thenewsmarket.com/roche), 
where you can order broadcast-standard video to be received digitally or by tape. Registration and video 
is free to the media.\line \line Additional information about renal anaemia is available 
on the Internet at www.AnaemiaWorld.com (http://www.anaemiaworld.com)\line \line {\pard\f0\li0\ri0\sa360\sl360\fs18 All 
trademarks used or mentioned in this release are protected by law.\par}\line \line \line {\pard\f0\li0\ri0\sa360\sl360\fs18 References\line 1) 
Detail aide, p2: MIRCERA PI, p2/lines 45-48\line 2) ARANESP PI, p2/ \u182?1\line 3) EPOGEN 
PI, p3/ \u182?4\line 4) Detail aide, p4: DOF/ISE Corr, p116/figure 12\line 5) Detail 
aide, p4: DOF/CSR, p358, per data points 10.22-baseline 11.38 wk 6\line 6) Dutka, Paula, Dalton, 
Cheryl, Beswick, Richard, Essig, Juliane, Vogel, Susan. Oral Presentation Abstract to be Presented at 
ANNA. Safety and tolerability of C.E.R.A. (continuous erythropoietin receptor activator) in patients 
with chronic kidney disease (CKD): pooled data from the phase II-III trials, 2007, Dallas, Texas. \line 7) 
Detail aide, p4: MIRCERA PI, p3/lines 97-99\line 8) Locatelli F, Sulowicz W, Harris K, Selgas 
R, Kaufman J, Klinger M, Malberti F, Dougherty F. Poster Presented at ASN. SC C.E.R.A. (Continuous Erythropoietin 
Receptor Activator) Once Every 2 Weeks or Once Monthly Maintains Stable Hb Levels after Converting Directly 
from SC Epoetin 1-3 Times per Week in Patients with CKD on Dialysis (PROTOS), 2006, San Diego, California.\line 9) 
Fishbane S, Levin N, Mann J, Lewis J, Bernardo M, Lunde N, Dougherty F. Poster Presented at ASN. IV 
C.E.R.A. (Continuous Erythropoietin Receptor Activator) Once Every 2 Weeks or Once Monthly Maintains 
Stable Hb Levels after Converting Directly from IV Epoetin 1-3 Times per Week in Patients with CKD on 
Dialysis (MAXIMA), 2006, San Diego, California.\line 10) Ryckelynck, Jean-Philippe, Harris, 
Kevin, Selgas, Rafael, Stompor, Thomas, Lad\u225?nyi, Erzsebet, Opatrna, Sylvie, Dougherty Frank C. Poster 
Presented at ASN. SC C.E.R.A. (Continuous Erythropoietin Receptor Activator) Administered up to Once 
Monthly in Patients with CKD on Dialysis Maintains Adequate Hb Levels Regardless of Age, Gender or Diabetic 
Status (PROTOS), 2006, San Diego, California.\line 11) Levin, Nathan W., Imbasciati, Enrico, 
Combe, Christian, Rocco, Michael V., Lok, Charmaine E., Donnelly, Sandra M., Dougherty, Frank C. Poster 
Presented at ASN. Adequate Hb Levels are Maintained with IV C.E.R.A (Continuous Erythropoietin Receptor 
Activator) Administered up to Once Monthly in Dialysis Patients Irrespective of Age, Gender or Diabetic 
Status (MAXIMA), 2006, San Diego, California.\line 12) Detail aide, p5: DOF/ISE Main, pp67\par}\line 
{\pard \par}
{\pard\sb180\f1\fs22 {\b F. Hoffmann-La Roche Ltd}\line 4070 Basel\line Switzerland \par}
{\pard\sb180\f1\fs22 Corporate Communications\line Roche Group Media Relations \par}
{\pard\sb180\f1\fs22 Tel. +41 61 688 88 88\line Fax +41 61 688 27 75\line www.roche.com \par}
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