NEW ANALYSIS OF UK STUDY SHOWS RIFAXIMIN-α SIGNIFICANTLY REDUCES NUMBER OF EMERGENCY DEPARTMENT ATTENDANCES FOR PATIENTS WITH HEPATIC ENCEPHALOPATHY

CORPORATE PRESS RELEASE

NEW ANALYSIS OF UK STUDY SHOWS RIFAXIMIN-α SIGNIFICANTLY REDUCES NUMBER OF EMERGENCY DEPARTMENT ATTENDANCES FOR PATIENTS WITH HEPATIC ENCEPHALOPATHY

LONDON, UK, Friday 21 April 2017, 07:00 GMT. Norgine B.V. today presented a new analysis from the UK real world study IMPRESS, that show treatment with rifaximin-α for hepatic encephalopathy could significantly reduce the number of emergency department attendances, with or without admission per patient, at six months of treatment initiation. This effect was sustained at 12 months.^[1]

These data were sponsored by Norgine and presented at The International Liver Congress on 19-23 April 2017, the Netherlands.

IMPRESS is a retrospective observational study that included 11 specialist National Health Service (NHS) centres with 145 patients prescribed rifaximin-α for hepatic encephalopathy. In the study, treatment with rifaximin-α for hepatic encephalopathy was well tolerated.^[2]

Hepatic encephalopathy is a potentially life-threatening neuropsychiatric condition associated with liver disease.^[3] Hepatic encephalopathy affects around 10,000 patients in the UK.^[4]

Peter Martin, Chief Operating Officer at Norgine said; “The IMPRESS study continues to reinforce the value of rifaximin-α in reducing the recurrence of episodes of hepatic encephalopathy. By recognising hepatic encephalopathy patients and treating them as early as possible with rifaximin-α, healthcare systems will make significant savings.”

XIFAXAN^® 550mg / TARGAXAN^® 550mg / TIXTELLER^® 550mg (rifaximin-α) is reimbursed through healthcare systems in Australia, England and Wales, Germany, Ireland, Italy, Luxembourg, Netherlands, New Zealand, Norway, Scotland, Sweden and Switzerland.

Norgine currently holds marketing rights for XIFAXAN^® 550mg (known as TARGAXAN^® 550mg in the UK and Belgium) in Australia, Belgium, Denmark, Finland, Germany, Luxembourg, Netherlands, New Zealand, Norway, Republic of Ireland, Sweden and United Kingdom.

Ends

Notes to Editors 

Rifaximin-α is associated with reductions in emergency department resource use in UK patients with hepatic encephalopathy: real world evidence from the IMPRESS study

In clinical trials rifaximin-α has been shown to reduce recurrence of episodes of overt hepatic encephalopathy and hepatic encephalopathy-related hospitalisations. UK real world data confirmed reductions in hospital admissions and length of stay with rifaximin-α use, however data on use of emergency department resources are still scarce. This study assessed the impact of rifaximin-α on utilisation of emergency department resources.

All cause emergency department attendances, with and without admission pre- and post-rifaximin-α initiation periods are shown in the table below.¹

About Hepatic Encephalopathy (HE)

HE is a serious and potentially life-threatening neuropsychiatric condition associated with liver cirrhosis.^[5] 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.^[6] 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, [7]}

About XIFAXAN^® / TARGAXAN^® / TIXTELLER^® 550mg film-coated tablets

XIFAXAN^® / TARGAXAN^® / TIXTELLER^® 550mg is indicated for the reduction in recurrence of episodes of overt hepatic encephalopathy in patients ≥18 years of age. TARGAXAN^®/ XIFAXAN^® / TIXTELLER^® 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^® and TARGAXAN^® are registered trademarks of the Alfa Wassermann group of companies, licensed to the Norgine group of companies.

About Norgine

Norgine is a leading European specialist pharmaceutical company with a direct commercial presence in all major European markets. In 2016, Norgine’s total revenue was EUR 368 million. Norgine employs over 1,000 people across its commercial, development and manufacturing operations and manages all aspects of product development, production, marketing, sale and supply.

Norgine specialises in gastroenterology, hepatology, cancer and supportive care.

Norgine is headquartered in the Netherlands. Norgine owns a R&D site in Hengoed, Wales and two manufacturing sites in Hengoed, Wales and 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 2015, Alfa Wassermann net sales were €429 million and the company employed over 1,500 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^®, TARGAXAN^®, TIXTAR^® and TIXTELLER^® 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/0317/0163
April 2017

References

^[1] Hudson. M. et al. Rifaximin-α is associated with reductions in emergency department resource use in UK patients with hepatic encephalopathy: real world evidence from the IMPRESS study. Abstract ILC2017-RS-1526. The International Liver Congress, 19-23 April 2017; Amsterdam, The Netherlands.

^[2] Aspinall R. et al. The impact of rifaximin-alpha on NHS hospital resource use in UK patients with hepatic encephalopathy: a retrospective observational study (IMPRESS). Abstract ILC2016-RS-1132. The International Liver Congress, 13-17 April 2016

^[3] Patidar KR. et al. Covert hepatic encephalopathy is independently associated with poor survival and increased risk of hospitalization. Am J Gastroenterol. 2014. 109. 1757-63.

^[4] Fleming K M. et al. Incidence and prevalence of cirrhosis in the United Kingdom, 1992-2001: A general population-based study. Journal of Hepatology 49 (2008) 732-738.

^[5] 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.

^[6] Poordad F. Review article: the burden of hepatic encephalopathy, Aliment Pharmacol Ther 2006;25 (S1):3-9.

^[7] 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 1:11-6.