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FAIR-HF Subanalysis Shows That Ferinject(R) Improves Kidney Function in Iron-Deficient Patients With Chronic Heart Failure

Monday, May 31, 2010 Heart Disease News J E 4
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ZURICH and BERLIN, May 31, 2010 Results of a subanalysisfrom the FAIR-HF (Ferinject(R) Assessment in patients with IRon deficiencyand Chronic Heart Failure) study demonstrate that correcting iron deficiencywith Ferinject(R) (ferric carboxymaltose) can improve renal function inchronic heart failure patients. Ferinject(R) is an intravenous (i.v.) ironproduct used to treat iron deficiency and iron deficiency anaemia. Theseresults were now presented at the Heart Failure Association's Late BreakingClinical Trials Session in Berlin, Germany, by Dr. Piotr Ponikowski,Professor of Cardiology from Wroclaw, Poland.

The authors of the FAIR-HF studied the effects of Ferinject(R) (ferriccarboxymaltose) on renal function in iron deficient, anaemic or non-anaemicpatients with chronic heart failure (CHF). Renal dysfunction commonlycomplicates the natural course of CHF as it makes patients susceptible tomore severe symptoms and increases the risk of hospitalisation and death.Current CHF therapies appear to have little or no beneficial effect ondeclining renal function due to CHF.

"The results of the subanalysis are exciting findings for cardiologistsand nephrologists who treat these patients, and need to be investigatedfurther," said Dr. Piotr Ponikowski, Professor of Cardiology at the MedicalUniversity in Wroclaw, Poland. "Many patients with CHF have renal dysfunctionwhich is strongly related to poor health outcomes. None of the therapies usedcurrently or recommended for CHF patients have a favourable effect on renalfunction. Thus, there is great interest in treatments which may haverenoprotective properties."

In total, 459 patients with CHF and iron deficiency were studied in 75sites around the world. Two-thirds of the patients received Ferinject(R)weekly until the iron deficiency was reversed, with monthly treatment(maintenance phase) thereafter until week 24. The remaining patients receiveda placebo. Renal function was evaluated by assessing the estimated glomerularfiltration rate (eGFR) at baseline and throughout the study (at weeks 4, 12and 24). Increased eGFR corresponds to increased renal function, i.e.improvement.

At study weeks 4, 12 and 24, eGFR was found to be increased in patientsreceiving Ferinject(R), compared to a small decrease in renal function in theplacebo group. At the end of the study, eGFR had increased by a mean of 3.2ml/min/1.73m2 from baseline in Ferinject(R)-treated patients, whereas in theplacebo group, eGFR was reduced by 0.6 ml/min/1.73m2. The difference betweenthe Ferinject(R) and placebo groups was statistically significant (p = 0.017at week 24). These improvements in eGFR were seen as early as week 4 of thestudy. The response to Ferinject(R) was independent of the level of renalfunction at the start of the study, age, sex, CHF severity, or the presenceof anaemia.

35% of patients treated with Ferinject(R) achieved an increase in eGFR ofmore than 5 ml/min/1.73m2, which is considered to be clinically meaningful,whilst 32% of patients on placebo showed a decline in eGFR of more than5ml/min/1.73m2. Dr. Iain Macdougall, of King's College Hospital, London,United Kingdom, commented: "There has been increasing interest andcollaboration among nephrologists and cardiologists in elucidating the causesand improving the management of the cardio-renal anaemia syndrome. Thesynergy between the heart and the kidney is now well-recognised, and anyimpact on heart function appears to impact kidney function, and vice versa."He added: "The data presented here continue on this theme and show thatintravenous iron therapy may be able to improve the function of both organssimultaneously. Further elucidation of the mechanisms involved are required."

About FAIR-HF

FAIR-HF is a large, multi-centre, randomised, double-blind,placebo-controlled, phase III study of patients with CHF and iron deficiency(with or without anaemia). It was designed to test the potential benefits ofcorrecting iron deficiency with Ferinject(R) in symptomatic CHF patientsregardless of whether they had anaemia or not. FAIR-HF met both of itsprimary endpoints: improvements in quality of life (measured using theself-reported Patient Global Assessment [PGA]) and CHF symptoms (defined bythe New York Heart Association (NYHA) class) at the end of the study comparedwith placebo. Both endpoints were statistically highly significant in favourof Ferinject(R). The results were published in the New England Journal ofMedicine in November 2009.

About the Heart Failure Association (HFA):

The HFA is the section of the European Society of Cardiology (ESC)dedicated to heart failure. Its mission is to "improve quality of life andlongevity, through better prevention, diagnosis and treatment of heartfailure, including the establishment of networks for its management,education and research." The Heart Failure Congress is the annual meeting ofthe HFA, and is dedicated to all professionals interested in the broadspectrum of problems relating to heart failure. Heart Failure Congress LateBreaking Clinical Trials sessions are innovative and provide the latestbreakthroughs in clinical science. More information about the HFA can befound under the following link:http://www.escardio.org/communities/HFA/Pages/welcome.aspx

About Ferinject(R)

Ferinject(R) is an innovative intravenous iron replacement productdiscovered and developed by Vifor Pharma. Ferric carboxymaltose, the activepharmaceutical ingredient of Ferinject(R), overcomes the unmet clinical needsof i.v. iron therapy as Ferinject(R) is not associated with dextran-inducedhypersensitivity reactions and has a low potential for iron toxicity.Ferinject(R), in doses up to 1000 mg iron, can be administered in a 15 minutedrip infusion in patients with iron deficiency associated with a variety ofclinical conditions.

So far, Ferinject(R) gained marketing authorisation in 20 Europeancountries and Switzerland for the treatment of iron deficiency where oraliron is ineffective or cannot be used. In many countries, intravenous ironreplacement products are primarily used to treat dialysis patients. However,iron deficiency is also part of many other illnesses representing a greatmarket potential for Vifor Pharma's iron product. Ongoing development ofscientific evidence supporting the use of Ferinject(R) outside of dialysistherefore has top priority. Vifor Pharma is evaluating new opportunities inthe treatment of iron deficiency with Ferinject(R) in different therapeuticareas. Trials with Ferinject(R) in chronic kidney disease (CKD), oncology(anaemia in cancer patients), gastroenterology (inflammatory boweldiseases),and gynaecology are ongoing or planned.

Vifor Pharma, the Pharma business sector of the Galenica Group,researches, develops, manufactures and markets pharmaceutical products, withfocus on the treatment of iron deficiency, where Vifor Pharma is one of theleading companies. It also conducts clinical studies for the application ofmedications for the treatment of various autoimmune diseases. Furthermore,Vifor Pharma manufactures prescription and over-the-counter (OTC) productsdeveloped within the company or produced or sold under license, and marketsthem on international markets. Vifor Pharma is headquartered in Switzerland(Zurich).

Additional information about Vifor Pharma can be found athttp://www.viforpharma.com

References

Ponikowski P. et al.

The impact of intravenous ferric carboxymaltose on renal function: Ananalysis of the FAIR-HF study.

Abstract presented at Late Breaking Trial Session, HFA 2010

Anker SD, Colet JC, Filippatos G,. et al.

Ferric Carboxymaltose in the treatment of iron deficient chronic heartfailure patients with our without anaemia.N Engl J of Med 2009; 361:2436-48 Ferinject(R) Summary of Product Characteristics For further information please contact: Media Relations: Harriet Sihn, Director External & Internal Communication, Vifor Pharma Tel. +41-58-851-80-26 E-mail: harriet.sihn@viforpharma.com

SOURCE Vifor Pharma
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