Press release

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

Monday, 14 November 2011

Data from two large, multi-center, randomised, controlled clinical trials of Injectafer® (US brand name of Ferinject®, ferric carboxymaltose) were presented at the American Society of Nephrology’s (ASN) Kidney Week 2011. These trials were sponsored by Galenica’s US partner Luitpold Pharmaceuticals, Inc. and included endpoints to evaluate the efficacy and cardiovascular risk profile of Injectafer®. Both trials met their efficacy and safety endpoints. The mean change in hemoglobin was statistically higher for Injectafer® in both trials. The rates of the composite cardiovascular safety endpoint was statistically similar for Injectafer® versus oral iron or i.v. standard of care.

In total, the studies included more than 3,500 patients of which approximately 1,800 were treated with Injectafer®, bringing the total number of patients treated with Injectafer® and analysed in a clinical trial setting to nearly 5,800.

_The first trial (abstract number FR-PO1394) compared Injectafer® 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 (Latebreaker poster number LB-PO3155), the largest head-to-head study of i.v. iron in high risk patients with iron deficiency anaemia and chronic kidney disease, was presented at the Late Breaking Clinical Trials poster session and compared Injectafer® to Venofer® (iron sucrose injection). The study included 2,561 patients, approximately half of whom received Injectafer®. In these high risk patients, two 750 mg doses of Injectafer® raised hemoglobin more than five 200 mg doses of Venofer®, with a change in hemoglobin of 1.13 g/dL for Injectafer® vs 0.92 for Venofer®. These increases were statistically significant (treatment difference [95% CI] = 0.21 [0.13, 0.28]). Rates of the adjudicated composite safety endpoint comprised of death, myocardial infarction, stroke, unstable angina, congestive heart failure, arrhythmias, hypertension and hypotension were statistically similar at 13.71% for Injectafer® vs 12.14% for Venofer® (treatment difference [95% CI] = 1.57% [-1.10%, 4.25%]). Rates of a composite of death, myocardial infarction and stroke were 1.88% for Injectafer® vs 2.72% for Venofer®.

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).

_The data from the clinical trials were included as part of the NDA filed with the US Food and Drug Administration of Injectafer® for the treatment of patients with iron deficiency anaemia by Luitpold Pharmaceuticals, Inc., the US partner of Galenica.

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).

_Galenica is listed on the Swiss Stock Exchange (SIX Swiss Exchange, GALN, security number 1,553,646).

_Iron Deficiency Anemia (IDA) is a state in which iron stores are inadequate for normal blood formation, as the iron requirements exceed the supply. In severe cases red cells in a patient with IDA are both microcytic (small) and hypochromic (pale), and values for mean corpuscular volume (MCV) and mean corpuscular Hb concentration (MCHC) are characteristically reduced. According to the World Health Organization (WHO) it is estimated that about 700 million people have iron deficiency anaemia (IDA). [Source: World Health Organization. Preventing and controlling Iron Deficiency Anaemia through primary health care. Available at: http://www.who.int/nutrition/publications/micronutrients/anaemia_iron_deficiency/ida_preventng_control_primary_healthcare.pdf]

_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.

COntaCt

Christina Hertig

Christina Hertig

Head of Corporate Communications


Galenica Ltd.

Corp. Communications
Untermattweg 8
CH-3027 Bern

Phone:
+41 58 852 85 17
Fax:
+41 58 852 85 58

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