Launch of Rienso® ▼ (Ferumoxytol) Offers Adult Patients with Chronic Kidney Disease a New Option for the Treatment of Iron

 Launch of Rienso® ▼ (Ferumoxytol) Offers Adult Patients with Chronic Kidney
      Disease a New Option for the Treatment of Iron Deficiency Anaemia

  PR Newswire

  ZURICH, November 1, 2012

ZURICH, November 1, 2012 /PRNewswire/ --

Today, Takeda Pharmaceuticals International GmbH (Takeda) announced the launch
of Rienso ^® (ferumoxytol) in the UK, a new intravenous ( IV ) iron therapy to
treat iron deficiency anaemia (IDA) in adult patients with chronic kidney
disease (CKD). This follows marketing authorisation granted by the European
Commission (EC) in June 2012.

Clinical studies demonstrated that Rienso significantly increases haemoglobin
levels as compared to oral iron across the spectrum of CKD. ^[ ^1 ^] ^, ^[ ^2
^] ^, ^[ ^3 ^] Moreover, Rienso was well tolerated by CKD patients with IDA
and had an overall treatment-related adverse event rate similar to oral iron
treatment based on data from three pivotal Phase III studies involving 1,726
subjects. ^[ ^1 ^] ^, ^[ ^2 ^] ^, ^[ ^3 ^] These outcomes were further
supported by additional retrospective observational data from three large
haemodialysis studies conducted in the United States involving more than 8,600
patients and more than 33,300 administered doses of Rienso. ^[ ^4 ^] ^, ^[ ^5
^]

"While treatments for iron deficiency anaemia have been widely available for
many years, this condition continues to place a significant burden on the
everyday life of CKD patients worldwide, and its management should be tailored
to appropriately address the clinical consequences of this debilitating
disorder" says Professor Iain Macdougall, Consultant Nephrologist and
Professor of Clinical Nephrology, King's College London. "Rienso is an
effective treatment option for the management of anaemia, and news of its
availability in the UK will be warmly received by the renal community."

In Europe, incidence rate of end-stage renal disease stands around 135 per
1,000,000 population with anaemia being the most frequent complication. ^[ ^6
^] CKD is a progressive and incapacitating condition that profoundly affects
the lives of patients who suffer from it. One of the reasons for its
development is iron deficiency, and the prevalence and severity of anaemia
worsens steadily as CKD advances. ^[ ^7 ^] ^, ^[ ^8 ^] The treatment of
anaemia in CKD has been shown to reduce hospitalisation and mortality rates,
and improve exercise capacity and quality of life. ^[ ^9]

"This new treatment option for IDA in CKD marks Takeda's commitment to the
development of renal anaemia management. It adds to treatment choice by
providing patients with an alternative solution for receiving IV iron therapy"
says Trevor Smith, Takeda's Head of Commercial Operations, Europe & Canada.

About Rienso ^®  (ferumoxytol) 

Rienso is an IV iron therapy with an approved indication for the treatment of
IDA in adult patients with CKD. The maximum total dose of ferumoxytol is 1.02g
and is administered as an initial 510mg intravenous injection, followed by a
second 510mg intravenous injection 2-8 days later. The treatment course for
most adults is two injections of 510mg intravenous iron. Ferumoxytol
significantly increases Hb levels in CKD patients with IDA, both on dialysis
and in patients not on dialysis compared with oral iron. Clinical trials have
also highlighted that ferumoxytol is well tolerated.

Ferumoxytol was developed by AMAG Pharmaceuticals, Inc (AMAG). It received
marketing approval as Feraheme from the US Food and Drug Administration on
June 30, 2009 and was commercially launched by AMAG in the US shortly
thereafter. Ferumoxytol received marketing approval in Canada in December
2011, in the European Union in June 2012 and in Switzerland in August 2012,
where it will be marketed by Takeda as Rienso ^® .

A Summary of Product Characteristics is available on the European Medicines
Agency website ( http://www.ema.europa.eu ).

About iron deficiency anaemia (IDA)

Iron deficiency is a common cause of anaemia often seen in the later stages of
CKD, as renal function deteriorates and erythropoiesis (red blood cell
production) declines. IDA can have a profound impact on patients' lives,
causing fatigue, shortness of breath and an increase in the risk of
cardiovascular (CV) complications including congestive heart failure. ^[ ^9 ^]
^, ^[ ^10 ^]

About Takeda Pharmaceuticals International GmbH

Takeda Pharmaceuticals International GmbH, headquartered in Zurich, is a
wholly owned subsidiary of Takeda Pharmaceutical Company Limited. As the
largest pharmaceutical company in Japan and a leader in the global industry,
Takeda's mission is to strive toward better health for patients worldwide
through leading innovation in medicine. It has a commercial presence covering
around 70 countries, with particular strength in Asia, North America, Europe
and fast-growing emerging markets including Latin America, Russia-CIS and
China. Takeda is ranked 12th by global Rx sales, 14th in the BRIC countries
and 18th in Europe. Areas of focus include cardiovascular and metabolic
diseases, immunology and respiratory diseases, oncology and central nervous
system diseases, among others. Through the integration of Millennium
Pharmaceuticals and Nycomed, Takeda has been transforming itself, broadening
its therapeutic expertise and geographic outreach.

Additional information about Takeda is available through its corporate
website, http://www.takeda.com .

About Takeda UK Ltd

Takeda UK Ltd, based in High Wycombe in Buckinghamshire, is the UK subsidiary
of Takeda Pharmaceutical Company and is responsible for sales and marketing of
the Company's products in the UK.

Further information about Takeda UK Ltd is available at
http://www.takeda.co.uk 

References

1.Spinowitz BS, Kausz AT, Baptista J, et al . Ferumoxytol for treating iron
    deficiency anemia in CKD. J Am Soc Nephrol 2008; 19: 1599-1605.
2.AMAG Pharmaceuticals. Data on file.
3.Provenzano R, Schiller B, Rao M, et al . Ferumoxytol as an intravenous
    iron replacement therapy in hemodialysis patients. Clin J Am Soc Nephrol
    2009; 4: 386-393. 
4.Schiller B, Bhat P, Sharma A, et al. Safety of Feraheme ^® (Ferumoxytol)
    in hemodialysis patients at 3 dialysis chains over a 1-year period. J Am
    Soc Nephrol 2011; 22: 477A-478A. Abstr FR-PO1573.
5.Sharma A, Bhat P, Schiller B, et al. Efficacy of Feraheme ^® (Ferumoxytol)
    administration on target hemoglobin levels and other iron parameters
    across 3 dialysis chains. J Am Soc Nephrol 2011; 22: 485A. Abstr
    FR-PO1603.
6.Meguid El Nahas A, Bello AK. Chronic kidney disease: the global challenge.
    Lancet 2005; 365: 331-340.
7.Qunibi WY. The efficacy and safety of current intravenous iron
    preparations for the management of iron-deficiency anaemia: a review.
    Arzneimittelforschung 2010; 60: 399-412.
8.Schmidt RJ, Dalton CL. Treating anemia of chronic kidney disease in the
    primary care setting: cardiovascular outcomes and management
    recommendations. Osteopath Med Prim Care 2007; 1: 14.
9.O'Mara NB. Anemia in patients with chronic kidney disease. Diabetes
    Spectrum 2008; 21: 12-19.
10.National Kidney Foundation. KDOQI clinical practice guidelines and
    clinical practice recommendations for anemia in chronic kidney disease. Am
    J Kidney Dis 2006; 47:S11-15.

Contact: For Media Enquiries: Danny Stepto, Takeda: +41-79-609-9452,
danny.stepto@takeda.com.
 
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