UK STUDY SHOWS RIFAXIMIN-α SIGNIFICANTLY REDUCES HOSPITAL RESOURCE USE FOR PATIENTS WITH HEPATIC ENCEPHALOPATHY

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14 April 2016

CORPORATE PRESS RELEASE

 

 

LONDON, UK, Thursday 14 April, 07:00 BST. Norgine B.V. today presented new positive UK real word practice data from the IMPRESS retrospective observational study for
rifaximin-α at the International Liver Congress 2016, 13-16 April in Barcelona, Spain. These data showed that in UK clinical practice, treatment with rifaximin-α for hepatic encephalopathy:

·         is well tolerated

·         is associated with reductions in hospitalisation frequency, bed occupancy (including critical care) and emergency room visits – within six months of treatment initiation and sustained at 12 months.

The IMPRESS retrospective observational study included 11 specialist National Health Service (NHS) centres and 145 patients prescribed rifaximin-α for hepatic encephalopathy between July 2008 and May 2014.

Peter Martin, COO at Norgine said;” These positive real life use results for rifaximin-α prove that this treatment is not only well tolerated but also reduces hospital resource. By using rifaximin-α healthcare systems can make substantial savings as it reduces hospitalisations and bed occupancy within six months of treatment. Hepatic encephalopathy has a huge impact on the lives of patients – as often they are not able to care for themselves, their families, careers and health systems overall and rifaximin-α can help reduce this burden.”

Norgine currently holds marketing rights for XIFAXAN® 550mg (known as TARGAXAN®? 550 in the UK and some other markets) in Australia, Belgium, Denmark, Finland, Germany, Luxembourg, Netherlands, New Zealand, Norway, Republic of Ireland, Sweden, United Kingdom and Switzerland. Norgine and Alfa Wassermann co-promote the product under the TIXTAR® brand name in France.

The product is reimbursed in Australia, England, Germany, Ireland, Luxembourg, New Zealand, Norway, Scotland, Sweden, Switzerland and Wales.

 

Ends

 

Notes to Editors

 

About the impact of rifaximin-α on NHS hospital resource use in UK patients with hepatic encephalopathy: a retrospective observational study (IMPRESS)

A retrospective observational study in 11 specialist National Health Service (NHS) centres of 145 patients prescribed RFX (rifaximin-α) for HE between July 2008 and May 2014. Local clinical staff reviewed patients’ medical records for demographics, RFX prescribing and adverse drug reactions (ADRs) to RFX. Details of inpatient hospitalisations and hospital visits in the 12 months pre- and post-RFX initiation were extracted from NHS Trust electronic databases.

 

 

6 months (n=114)

12 months (n=102)

mean (SD)

n*

Pre-RFX

Post-RFX

P

n*

Pre-RFX

Post-RFX

P

Hospitalisations with overnight stay per patient

101

2.2

(1.9)

1.0

(1.3)

<0.001

99

2.7

(2.8)

1.7

(2.0)

0.002

Total bed days for all

101

2890

1206

–

99

3138

1621

–

Total bed days per inpatient

101

28.6

(31.4)

11.9

(23.2)

<0.001

99

31.7

(35.9)

16.4

(29.1)

<0.001

Critical care bed days per inpatient

19

7.9

(10.1)

2.0

(5.1)

0.046

18

11.3

(11.8)

2.4

(6.0)

0.017

Emergency room visits per patient

63

1.0

(2.3)

1.0

(1.0)

<0.001

65

2.4

(3.4)

1.8

(2.6)

0.099

*Paired analysis (patients with >1 of each attendance type in either [for both] periods)

 

 

About Hepatic Encephalopathy (HE)

HE is a serious and potentially life-threatening neuropsychiatric condition associated with liver cirrhosis.[1] Severe HE has been estimated to affect 30-45 per cent of people with cirrhosis and symptoms include disorientation, confusion, inappropriate behaviour and personality change.[2] Hepatic encephalopathy results from a damaged liver that is not able to detoxify the blood as efficiently as usual. Toxins build up in the bloodstream and eventually in the brain, which leads to neurological
disorders. 1, [3]

About XIFAXAN® / TARGAXAN®? / TIXTAR® 550mg film-coated tablets

XIFAXAN® / TARGAXAN®? / TIXTAR® 550mg is indicated for the reduction in recurrence of episodes of overt hepatic encephalopathy in patients ≥18 years of age. TARGAXAN®?/ XIFAXAN® / TIXTAR® 550mg is a broad spectrum antibiotic that targets commensal gut bacteria, acting on Gram-negative and Gram-positive aerobes and anaerobes, reducing the excess ammonia produced by the gut bacteria of patients with cirrhosis.

 

Product under licence from Alfa Wassermann S.p.A. XIFAXAN®, TARGAXAN® and TIXTAR® are registered trademarks of the Alfa Wassermann group of companies, licensed to the Norgine group of companies.

 

 

About Norgine

Norgine is a European specialist pharmaceutical company that has been established for over 100 years. In 2015, Norgine’s total revenue was EUR 320 million and the company employs over 1,000 people.

Norgine provides expertise and ‘know how’ in Europe to develop, manufacture and market products that offer real value to healthcare professionals, payers and patients.  Norgine’s approach and infrastructure is integrated and focused upon ensuring that Norgine wins partnership opportunities for growth.

Norgine is headquartered in the Netherlands and its global operations are based in Amsterdam and in Harefield, UK. Norgine owns a R&D site in Hengoed, Wales and two manufacturing sites, one in Hengoed, Wales and one in Dreux, France.

For more information, please visit www.norgine.com

In 2012, Norgine established a complementary business Norgine Ventures, supporting innovative healthcare companies through the provision of debt-like financing in Europe and the US. For more information, please visit www.norgineventures.com.

NORGINE and the sail logo are trademarks of the Norgine group of companies.

About Alfa Wassermann

Alfa Wassermann is a private pharmaceutical company wholly owned by and subject to the direction and coordination of Alfasigma S.p.A. Alfa Wassermann has its headquarters in Bologna, Italy with its own Research, Development and Manufacturing facilities. In 2014, Alfa Wassermann net sales were more than €430million and the company employs over 1,400 people. It has a growing number of affiliate companies in both Europe as well as in emerging markets such as Russia, China and Mexico. Its main product rifaximin-α is a gut-selective antibiotic which is prescribed under the trade names of NORMIX®, XIFAXAN® and others, in 47 countries, including the USA. Alfa Wassermann has also developed other important products: sulodexide (VESSEL®), a heparinoid for thromboembolic diseases, and parnaparin (FLUXUM®), a low molecular weight heparin for the treatment and prophylaxis of deep-vein thrombosis. For more information, please visit Alfa Wassermann’s website at www.alfawassermann.com

ALFA WASSERMANN®, the ALFA WASSERMANN logo, NORMIX®, XIFAXAN® and TARGAXAN® are registered trademarks of Alfa Wassermann group of companies.

Media Contacts:

Isabelle Jouin, T: +44 (0)1895 453643

Charlotte Andrews, T: +44 (0)1895 453607

Follow us @norgine

 

GL/XIF/0316/0139
April 2016

 

References

 


[1] Morgan M. Chapter 8: Hepatic Encephalopathy in Patients with Cirrhosis. In: Dooley JS, Lok A, Burroughs A, Heathcote J, editors. Sherlock’s Diseases of the Liver and Biliary System. 12th ed: Blackwell Publishing Ltd; 2011.

[2] Poordad F. Review article: the burden of hepatic encephalopathy, Aliment Pharmacol Ther 2006;25 (S1):3-9.

[3] Mullen KD. Review of the final report of the 1998 Working Party on definition, nomenclature and diagnosis of hepatic encephalopathy. Aliment Pharmacol Ther. 2007 Feb;25 Suppl 1:11-