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2017-09-27 06:56 CEST
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VIFOR PHARMA EXPANDS EXCLUSIVE LICENSE AGREEMENT FOR THE COMMERCIALISATION OF MIRCERA® IN THE US

  • Additional Mircera® volume will provide Vifor Pharma with more flexibility to expand its US ESA business

IN 2015 VIFOR PHARMA (FORMERLY A COMPANY OF GALENICA GROUP) ENTERED INTO AN EXCLUSIVE LICENSE AGREEMENT WITH ROCHE FOR THE COMMERCIALISATION OF ITS MEDICINE MIRCERA® in the US. MIRCERA® IS A LONG-ACTING ESA INDICATED FOR THE TREATMENT OF ANAEMIA ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD) IN ADULT PATIENTS.

Mircera® (methoxy polyethylene glycol-epoetin beta) is approved in the US by the Food and Drug Administration (FDA) and in the European Union by the European Medicines Agency (EMA) 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 erythropoiesis stimulating agent (ESA) for bi-weekly 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.

Following a successful rollout of Mircera® at Fresenius Kidney Care clinics, there are currently more than 140,000 patients in the United States under treatment with Mircera®.

In order to provide Vifor Pharma more flexibility to meet the ESA requirements of the US nephrology market, Vifor Pharma and Roche have now completed an agreement giving Vifor Pharma access to additional volume for Mircera® for the US market in order to optimally meet the needs of new and existing partners.

FURTHER INFORMATION

Media Relations   Investor Relations
Beatrix Benz   Julien Vignot
Head of Global Communications & Public Affairs   Head of Investor Relations
Tel.: +41 58 851 80 16   Tel.: +41 58 851 66 90
E-mail: media@viforpharma.com   E-mail: investors@viforpharma.com
     

Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is the partner of choice for specialty pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, a joint company with Fresenius Medical Care; Relypsa; and OM Pharma. Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348). For more information, please visit www.viforpharma.com.

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 in Japan, where it is marketed by Chugai.

References

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

PRESS RELEASE
Sep 27, 2017

HUG#2137111