Investor Update

Basel, 28 May 2015

Roche enters into exclusive license agreement with Galenica for the commercialisation of Mircera in the United States

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has entered into an exclusive licence agreement with Galenica for the commercialisation of Roche’s drug Mircera (methoxy polyethylene glycol-epoetin beta) in the US and Puerto Rico. Mircera is a prescription medicine used to treat symptomatic anaemia associated with chronic kidney disease (CKD) in adult patients and represents an ideal complement to the existing product portfolio of Galenica for patients with CKD and iron deficiency.

Mircera is approved in the US by the Food and Drug Administration and in the European Union by the European Medicines Agency for the treatment of anaemia associated with CKD in adult patients on dialysis as well as those not on dialysis. Anaemia in CKD is associated with reduced quality of life and increased cardiovascular disease, hospitalisations, cognitive impairment and mortality1. Mircera is a long-acting erythropoietin stimulating agent (ESA) for biweekly or monthly treatment. It works like the human protein erythropoietin to help the body make more red blood cells and is used to reduce or avoid the need for red blood cell transfusion.

“We are very pleased that Mircera will be available to anaemia patients in the US, providing an important additional treatment option for people with chronic kidney disease,” said Daniel O’Day, Chief Operating Officer, Roche Pharmaceuticals Division.

Etienne Jornod, Executive Chairman of the Galenica Group, commented, “This agreement follows the logic of our strategy of bringing complementary partners together. It is a great opportunity for us to collaborate with one of the world’s largest and most innovative pharma companies.”

Mircera is currently marketed by Roche in the European Union and rest of the world, and by Chugai in Japan. Under this licence agreement, Galenica has the exclusive right to commercialise Mircera in the US and Puerto Rico. Roche will manufacture and supply Mircera to Galenica.

Roche will receive upfront and milestone payments, supply reimbursements, as well as tiered royalties on Mircera sales in the US and Puerto Rico. The financial details of the agreement were not disclosed.

In addition, Galenica has entered into a supply agreement with Fresenius Medical Care North America (FMCNA) under which Galenica will supply Mircera for FMCNA’s use solely within its dialysis facilities.

About Mircera

Mircera (methoxy polyethylene glycol-epoetin beta) is an erythropoietin stimulating agent used for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adult patients. Outside the US, Mircera is currently marketed worldwide by Roche, except for Japan, where it is marketed by Chugai.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-eight medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.

In 2014, the Roche Group employed 88,500 people worldwide, invested 8.9 billion Swiss francs in R&D and posted sales of 47.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit

All trademarks used or mentioned in this release are protected by law.

1. J Am Soc Nephrol 23: 1631 – 1634, 2012