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New Injectafer® (US brand name of Ferinject®) data to be presented at the American Society of Nephrology's Kidney Week 2011

(PresseBox) (Bern, ) In October 2011, Galenica announced that its US partner Luitpold Pharmaceuticals, Inc. had submitted a New Drug Application (NDA) with the US Food and Drug Administration (FDA) for Injectafer® for the treatment of iron deficiency anaemia. The NDA includes data from two large, multi-center, randomised, controlled clinical trials evaluating the efficacy and cardiovascular risk profile of Injectafer®. The data have been accepted for presentation at the American Society of Nephrology's (ASN) Kidney Week 2011 in Philadelphia (USA).

The first trial presented today (Abstract number FR-PO1394) compares Injectafer® (US brand name of Ferinject®, ferric carboxymaltose) to either oral or intravenous (i.v.) iron (standard of care therapy) in patients with iron deficiency anaemia of various etiologies. In this trial, Injectafer® raised hemoglobin more than oral iron or i.v. standard of care therapy, with a mean change in hemoglobin of 1.57 g/dL vs 0.80 g/dL when compared to oral iron and 2.90 g/dL vs 2.16 g/dL when compared with i.v. standard of care therapy. These increases were statistically significant (p=0.001). Further, cardiovascular safety was evaluated based on an adjudicated composite safety endpoint comprised of death, myocardial infarction, stroke, unstable angina, congestive heart failure, arrhythmias, hypertension and hypotension. Rates of the composite safety endpoint were 3.95% for Injectafer® vs 4.90% when compared to i.v. standard of care and at 2.85% for Injectafer® vs 1.58% when compared to oral iron. This study included approximately 1,000 patients half of whom received Injectafer®.

The second trial, the largest head-to-head study of i.v. iron in high risk patients with iron deficiency anaemia and chronic kidney disease, will be presented on 12 November in Saturday's Late Breaking Clinical Trials poster session and compares Injectafer® to Venofer® (iron sucrose injection).

American Society of Nephrology's Kidney Week

With more than 13,000 kidney professionals from around the globe the ASN Kidney Week is one of the most important congresses in nephrology. The congress is organised by the American Society of Nephrology and is currently taking place in Philadelphia (USA, Pennsylvania).

Injectafer®, the novel i.v. iron replacement therapy, is a non-dextran iron currently under review by the US FDA for treatment of patients with iron deficiency anemia. In 2007, registration of Ferinject® (brand name outside the US) was approved by the Swiss regulatory agency Swissmedic and by the UK Medicines & Healthcare products Regulatory Agency (MHRA). Thereby the MHRA, acting as a Reference country, has supported the subsequent approval of Ferinject® throughout the European Union. Ferinject® is currently registered for use in 37 countries worldwide.

Injectafer® is an innovative non-dextran intravenous iron (i.v.) replacement therapy discovered and developed by Vifor Pharma, a company of the Galenica Group. Ferric carboxymaltose is the active pharmaceutical ingredient of Injectafer®. To date, Ferinject® (brand name of Injectafer® outside the US) has gained marketing authorisation in 37 countries worldwide for the treatment of iron deficiency where oral iron is ineffective or cannot be used. In many countries, intravenous iron replacement products are primarily used to treat dialysis patients. However, iron deficiency is also a complication of many other illnesses. Vifor Pharma is evaluating new opportunities in the treatment of iron deficiency with Ferinject® in different therapeutic areas. Further trials with Ferinject® in chronic kidney disease (CKD), oncology (anaemia in cancer patients), cardiology (chronic heart failure), patient blood management and gynaecology are ongoing.

Galenica AG

Galenica is a diversified group active throughout the healthcare market which, among other things, develops, manufactures, markets and distributes pharmaceutical products, runs pharmacies, provides logistical and database services and sets up networks. In all of its business sectors - Pharma, Logistics and Retail - the Galenica Group enjoys a leading position. 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).

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