Norgine announces publication of the PROSPER study design in the hepatology, medicine and policy journal

CORPORATE MEDIA RELEASE

NORGINE ANNOUNCES PUBLICATION OF THE PROSPER STUDY DESIGN IN THE HEPATOLOGY, MEDICINE AND POLICY JOURNAL[i]

• PROSPER is the first Norgine funded European and Australian real world evidence study of patients’ experience with hepatic encephalopathy taking rifaximin-α 550mg

AMSTERDAM, THE NETHERANDS. Monday 29 January 2018. 08:00 AM CET. Norgine B.V. today announced the publication of the study design of PROSPER (The Prospective Real-world Outcomes Study of Hepatic Encephalopathy Patients’ Experience on Rifaximin-α) in the journal Hepatology Medicine and Policy. The study has been designed to monitor the clinical effectiveness of rifaximin-α and its impact on health care resources utilisations. PROSPER is an observational, multicentre study among 550 patients in Europe and Australia.

Hepatic encephalopathy places a significant burden on patients and their caregivers, with the burden increasing as the severity of the disease progresses.[ii]^,[iii] Furthermore patients with hepatic encephalopathy have significantly more hospitalisations, emergency hospital admissions, and primary care contacts compared with patients with severe liver disease without hepatic encephalopathy.[iv]

PROSPER will provide valuable real-world information on the effectiveness of rifaximin-α 550 mg in reducing the recurrence of hepatic encephalopathy, and its impact on the quality of life (QoL) and work productivity of patients and their caregivers. By providing data on both the direct costs (e.g., hospitalisation rate, duration of hospitalisation) and indirect costs (such as work productivity) of hepatic encephalopathy. PROSPER study findings are anticipated to report in 2018.

Dr Alastair Benbow, Chief Development and Medical Officer at Norgine said: “It is anticipated that the PROSPER study will continue to reinforce the value of rifaximin-α 550mg for all European and Australian patients and their health care systems. This will continue to emphasize that rifaximin-α 550mg can significantly reduce the number of emergency department attendances, with or without admission and lower the use of hospital resources and bed occupancy.” 

Hepatic encephalopathy is a debilitating condition that affects up to 40% of patients across Europe who suffer from advanced chronic liver disease.[v]

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.

GL/XIF/0118/0181

Notes to Editors:

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.

XIFAXAN and TARGAXAN are under license from Alfasigma S.p.A.
XIFAXAN and TARGAXAN are registered trademarks of the Alfasigma group of companies, licensed to the Norgine group of companies.

Media Contacts:

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

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References

[i] Krag et al.  Design of  the prospective Real World Outcomes Study of Hepatic Encephalopathy Patients’ Experience on Rifaximin-α (PROSPER). Medicine and Policy (2018) 3:4 DOI10.1186/s41124-017-0029-9.

[ii] Bajaj JS, et al. Am J Gastroenterol 2011; 106(9): 1646-1653.

[iii] Montagnese S, et al. Metab Brain Dis 2012; 27: 567-572.

[iv] Orr J, et al. J Hepatol 2014; 60:S215-359 Abstract 478.

[v] American Association for the Study of Liver Diseases; European Association for the Study of the Liver. 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..J Hepatol. 2014;61(3):642-59.