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FDA Approves Mircera: First Renal Anemia Treatment in the US withMonthly Maintenance Dosing

BASEL, Switzerland, 15 November 2007--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.

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.

"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´s leading regulatory authorities", said William M. Burns, CEO Roche Pharma.

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)1,2,3, up to six times longer than darbepoetin alfa and up to 20 times longer than epoetin.

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.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 countries6.
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 Mircera7. Patients maintained stable Hb levels (±1g/dL) when switched to once-monthly Mircera from a shorter-acting frequently administered ESA treatment regimen8,9,10,11,12. Mircera has a safety profile comparable to other erythropoietic agents.

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.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world’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’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. Trademarks used or mentioned in this release are protected by law.


References
1) Detail aide, p2: MIRCERA PI, p2/lines 45-48
2) ARANESP PI, p2/ 1
3) EPOGEN PI, p3/ 4
4) Detail aide, p4: DOF/ISE Corr, p116/figure 12
5) Detail aide, p4: DOF/CSR, p358, per data points 10.22-baseline 11.38 wk 6
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.
7) Detail aide, p4: MIRCERA PI, p3/lines 97-99
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.
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.
10) Ryckelynck, Jean-Philippe, Harris, Kevin, Selgas, Rafael, Stompor, Thomas, Ladányi, 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.
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.
12) Detail aide, p5: DOF/ISE Main, pp67

Posted: November 2007

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