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{\pard\sa900\fs50\f0\i Media Release\par}
Basel, 21 May 2007\line \line {\b Roche receives approvable 
letter for Mircera in the United States} \line Label to be finalized after FDA\u8217?s class 
review of renal anaemia agents \line \line \line Roche announced today 
that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for Mircera for the 
treatment of anemia associated with chronic renal failure including patients on dialysis and patients 
not on dialysis. \line \line Roche has received a draft label for Mircera from the 
FDA and expects the label to be finalized after the Cardiovascular and Renal Drugs Advisory Committee 
(CRDAC)* has issued its recommendations on the entire class of erythropoiesis stimulating agents (ESAs). 
As announced earlier, the FDA will convene the meeting to consider class topics related to ESAs in the 
renal setting. Roche and all other sponsors of ESAs in the United States have been informed of the upcoming 
CRDAC in the autumn and it is understood that recommendations from this meeting could impact the entire 
class labelling for all ESAs.\line \line "Today\u8217?s announcement is good news 
for us as it confirms our confidence in Mircera. We expect no further clinical trials being required 
prior to approval," said William M. Burns, CEO of the Pharmaceutical Division at Roche. "We 
see the upcoming class review as an opportunity to launch Mircera powerfully into a, by then, clarified 
market. We believe it is much better for Roche to enter the US when physicians and patients have assurance 
about the proper use of these drugs," he added. Roche will work with the FDA following this meeting 
in order to expedite the conclusion of the review process.\line \line {\b About 
Mircera} \line Mircera is the first of a new class of long-acting chemically synthesized 
erythropoiesis-stimulating agents (ESAs) developed for the treatment of anaemia in chronic kidney disease 
(CKD) patients. Mircera has a longer half-life than any commercially available ESA.\line \line The 
filing for Mircera is based on the largest Phase II-III program ever conducted for a drug treating anaemia 
associated with chronic kidney disease comprising 10 global studies involving more than 2,700 patients 
from 29 countries. The phase III program consisted of six pivotal studies that explored the use of Mircera 
to correct anaemia in untreated patients and to maintain haemoglobin after conversion from treatment 
regimens using existing agents. This program consisted of two correction and four maintenance studies 
of both intravenous and subcutaneous Mircera given at longer dosing intervals of up to once every four 
weeks.\line \line Mircera is the only anaemia treatment originally designed to correct 
anaemia in CKD patients with dosing once every two weeks and maintain CKD patients with dosing intervals 
up to once a month. It is also the only anaemia therapy to have compared itself in clinical trials against 
epoetin alfa, beta and darbepoetin alfa.\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 \line {\pard\f0\li0\ri0\sa360\sl360\fs18 *The 
Committee reviews and evaluates available data concerning the safety and effectiveness of marketed and 
investigational human drug products for use in the treatment of cardiovascular and renal disorders and 
makes appropriate recommendations to the Commissioner of Food and Drugs.\line \line All 
trademarks used or mentioned in this release are protected by law.\par}\line \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}
}