Norgine: New Real World Study Shows Rifaximin-a Significantly Reduced Hospitalisation in Patients With Overt Hepatic Encephalopathy (HE) When Added to Lactulose

- Rifaximin-a in combination with lactulose, the standard of care
(SOC) treatment resulted in significant reductions (p<0.001) in
both HE related hospital admissions and length of hospital stay
- Rifaximin-a also showed good efficacy in the management of patients
with liver disease with the complication of HE based on real-world
data

Amsterdam (ots/PRNewswire) - Norgine B.V. today highlighted
results of a real world study showing significant reductions in the
number and length of hospitalisations when rifaximin-a is added to
lactulose, the SOC treatment for patients with overt hepatic
encephalopathy (HE).[1]

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The findings, borne out in real world evidence, come from an
independent, investigator initiated study, presented today at the
International Liver Congress (ILC) in Vienna. The study compared the
progress of 127 patients in their first six months of combination
treatment with rifaximin-a with the prior six months when treated
with lactulose alone.[1]

"Adding rifaximin-ato standard treatment was proven to
significantly reduce episodes of hepatic encephalopathy in liver
disease patients and keep patients out of hospital for longer,
compared to lactulose alone" said Dr. Rosalie C. Oey, Lead
Investigator of the study. "Preventing the recurrence of HE is
extremely important for patients' quality of life and the findings
highlight the prophylactic value of rifaximin-a in the long-term
management of the disease."

Marko Korenjak, President, European Liver Patients' Assosiation
(ELPA) commented, "Hepatic encephalopathy is a very serious and
frightening complication for both patients and their carers and
significantly impacts on people's quality of life. The European Liver
Patients' Assosiation welcomes research that may enhance the
availability of treatment options which potentially benefit patients
and reduce the burden on healthcare systems."

HE is a serious, potentially life-threatening chronic condition
associated with liver cirrhosis.[2] HE is a significant complication
of advanced chronic liver disease and occurs in up to 40% of patients
and often remains under-diagnosed and under-treated.[3],[4] HE is
debilitating and can significantly impact the life of patients and
their carers. People with liver disease who develop HE are
approximately twice as likely to die, when compared with liver
disease patients without the condition over the same time period. [5]

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Notes to Editors:

About the study

The study aimed to evaluate the efficacy and safety of rifaximin
treatment in a real-world pattern, five years after rifaximin-alpha
registration as secondary prophylaxis for overt hepatic
encephalopathy (HE) in the Netherlands. The study included 127
patients (71.7% male; median age 60.8 years (IQR 56.2-66.1); median
MELD score 15.0 (IQR 12.1-20.4)). When comparing the first 6 months
after rifaximin-alpha initiation to the prior 6 months, HE-related
hospital admissions reduced (0.86 to 0.41 admissions/patient;
p<0.001), as well as the mean length of stay (8.85 to 3.79 bed
days/admission; p<0.001). Non-serious adverse events were recorded in
2.4% of patients. The investigated-initiated study was sponsored by
the Foundation for Liver and Gastrointestinal Research Rotterdam
(SLO) and supported by an educational grant from Norgine B.V.,
Amsterdam, the Netherlands.

About Hepatic Encephalopathy (HE)

HE is a serious and potentially life-threatening neuropsychiatric
condition associated with liver cirrhosis.[2] Severe HE has been
estimated to affect 40% of people with cirrhosis and symptoms include
disorientation, confusion, inappropriate behaviour and personality
change.[3] 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.[3]

About Norgine

Norgine is a leading European specialist pharmaceutical company
with a direct commercial presence in all major European markets.
Norgine specialises in gastroenterology, hepatology, cancer and
supportive care. In 2017, Norgine's total net product sales were EUR
345 million, up 17 per cent.

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.

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.

References

[1] Oey, R.C. et al, The efficacy and safety of rifaximin-alpha:
a 2-year observational study of overt hepatic encephalopathy,
Presented at , International Liver Congress (ILC) 2019, Vienna
SAT-092

[2] 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

[3] Hepatic Encephalopathy in Chronic Liver Disease: 2014 Practice
Guideline by the European Association for the Study of the Liver and
the American Association for the Study of Liver Diseases. Journal of
Hepatology 2014; 61(3):642-659

[4] 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

[5] Morgan, C.LI et al, Mortality associated with hepatic
encephalopathy in patients with severe liver disease, Hepatology
2014; 60 (Abstract P452): S219

GL/COR/0419/0188, Date of preparation April 2019

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