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

ZURICH and BERLIN, May 31, 2010 - Results of a subanalysis from the FAIR-HF (Ferinject(R) Assessment in
patients with IRon deficiency and Chronic Heart Failure) study demonstrate
that correcting iron deficiency with Ferinject(R) (ferric carboxymaltose) can
improve renal function in chronic heart failure patients. Ferinject(R) is an
intravenous (i.v.) iron product used to treat iron deficiency and iron
deficiency anaemia. These results were now presented at the Heart Failure
Association's Late Breaking Clinical 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) (ferric
carboxymaltose) on renal function in iron deficient, anaemic or non-anaemic
patients with chronic heart failure (CHF). Renal dysfunction commonly
complicates the natural course of CHF as it makes patients susceptible to
more severe symptoms and increases the risk of hospitalisation and death.
Current CHF therapies appear to have little or no beneficial effect on
declining renal function due to CHF.

"The results of the subanalysis are exciting findings for cardiologists
and nephrologists who treat these patients, and need to be investigated
further," said Dr. Piotr Ponikowski, Professor of Cardiology at the Medical
University in Wroclaw, Poland. "Many patients with CHF have renal dysfunction
which is strongly related to poor health outcomes. None of the therapies used
currently or recommended for CHF patients have a favourable effect on renal
function. Thus, there is great interest in treatments which may have
renoprotective properties."

In total, 459 patients with CHF and iron deficiency were studied in 75
sites 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 received
a placebo. Renal function was evaluated by assessing the estimated glomerular
filtration rate (eGFR) at baseline and throughout the study (at weeks 4, 12
and 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 patients
receiving Ferinject(R), compared to a small decrease in renal function in the
placebo group. At the end of the study, eGFR had increased by a mean of 3.2
ml/min/1.73m2 from baseline in Ferinject(R)-treated patients, whereas in the
placebo group, eGFR was reduced by 0.6 ml/min/1.73m2. The difference between
the Ferinject(R) and placebo groups was statistically significant (p = 0.017
at week 24). These improvements in eGFR were seen as early as week 4 of the
study. The response to Ferinject(R) was independent of the level of renal
function at the start of the study, age, sex, CHF severity, or the presence
of anaemia.

35% of patients treated with Ferinject(R) achieved an increase in eGFR of
more 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 than
5ml/min/1.73m2. Dr. Iain Macdougall, of King's College Hospital, London,
United Kingdom, commented: "There has been increasing interest and
collaboration among nephrologists and cardiologists in elucidating the causes
and improving the management of the cardio-renal anaemia syndrome. The
synergy between the heart and the kidney is now well-recognised, and any
impact on heart function appears to impact kidney function, and vice versa."
He added: "The data presented here continue on this theme and show that
intravenous iron therapy may be able to improve the function of both organs
simultaneously. 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 of
correcting iron deficiency with Ferinject(R) in symptomatic CHF patients
regardless of whether they had anaemia or not. FAIR-HF met both of its
primary endpoints: improvements in quality of life (measured using the
self-reported Patient Global Assessment [PGA]) and CHF symptoms (defined by
the New York Heart Association (NYHA) class) at the end of the study compared
with placebo. Both endpoints were statistically highly significant in favour
of Ferinject(R). The results were published in the New England Journal of
Medicine 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 and
longevity, through better prevention, diagnosis and treatment of heart
failure, including the establishment of networks for its management,
education and research." The Heart Failure Congress is the annual meeting of
the HFA, and is dedicated to all professionals interested in the broad
spectrum of problems relating to heart failure. Heart Failure Congress Late
Breaking Clinical Trials sessions are innovative and provide the latest
breakthroughs in clinical science. More information about the HFA can be
found under the following link:
www.escardio.org/communities/HFA/Pages/welcome.aspx

About Ferinject(R)

Ferinject(R) is an innovative intravenous iron replacement product
discovered and developed by Vifor Pharma. Ferric carboxymaltose, the active
pharmaceutical ingredient of Ferinject(R), overcomes the unmet clinical needs
of i.v. iron therapy as Ferinject(R) is not associated with dextran-induced
hypersensitivity reactions and has a low potential for iron toxicity.
Ferinject(R), in doses up to 1000 mg iron, can be administered in a 15 minute
drip infusion in patients with iron deficiency associated with a variety of
clinical conditions.

So far, Ferinject(R) gained marketing authorisation in 20 European
countries and Switzerland 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 part of many other illnesses representing a great
market potential for Vifor Pharma's iron product. Ongoing development of
scientific evidence supporting the use of Ferinject(R) outside of dialysis
therefore has top priority. Vifor Pharma is evaluating new opportunities in
the treatment of iron deficiency with Ferinject(R) in different therapeutic
areas. Trials with Ferinject(R) in chronic kidney disease (CKD), oncology
(anaemia in cancer patients), gastroenterology (inflammatory bowel
diseases),and gynaecology are ongoing or planned.

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

Additional information about Vifor Pharma can be found at
www.viforpharma.com

References

Ponikowski P. et al.

The impact of intravenous ferric carboxymaltose on renal function: An
analysis 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 heart
failure 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

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 at viforpharma.com