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Galenica Ltd.. (5/28/15). "Press Release: Galenica and Roche Enter into Exclusive License Agreement for the Commercialisation of Mircera in the US".
|Region||United States (USA)|
|Today||Galenica Holding AG|
|Organisation 2||Roche Pharma (Group Division)|
|Index term||Galenica–Roche: erythropoietin stimulating agent, 201505– license €na excl commercialisation of Mircera in US by Galenica + supply by Roche|
|Person||O'Day, Daniel (Roche Molecular Diagnositcs –200708–)|
|Person 2||Jornod, Etienne (Galenica 201505 Executive Chairman)|
Galenica and Roche have entered into an exclusive license agreement for the commercialisation of Roche’s drug Mircera® 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® (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 Erythropoietin Stimulating Agent (ESA) for bi-weekly or monthly treatment. It works like the human protein called 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 license 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.
Galenica management confirms the target of achieving the same level of profit in 2015 as in the previous year, both before and after deduction of minority interests and calculated on a comparable exchange rate basis to 2014 and considering all current projects.
1 J Am Soc Nephrol 23: 1631 – 1634, 2012
For further information, please contact:
Christina Hertig, Head Corporate Communications
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Galenica is a diversified Group active throughout the healthcare market which, among other activities, develops, manufactures and markets pharmaceutical products, runs pharmacies, provides logistical and database services and sets up networks. With its two Business units Vifor Pharma and Galenica Santé, the Galenica Group enjoys a leading position in all its core business activities. A large part of the Group’s income is generated by international operations. Galenica is listed on the Swiss Stock Exchange (SIX Swiss Exchange, GALN, security number 1,553,646).
For more information, please visit the company’s website at www.galenica.com.
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.
Record changed: 2017-04-02
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