NORGINE PRESENTS PROSPER STUDY – FIRST EVER REAL WORLD EVIDENCE STUDY IN HEPATIC ENCEPHALOPATHY PATIENTS TAKING RIFAXIMIN-α 550mg

NORGINE PRESENTS PROSPER STUDY – FIRST EVER REAL WORLD EVIDENCE STUDY IN HEPATIC ENCEPHALOPATHY PATIENTS TAKING RIFAXIMIN- α 550mg

London, Wednesday 22 April 2015. 07:00 GMT+1. Norgine B.V. today presented the study design of PROSPER, a real world outcomes study of hepatic encephalopathy patients’ experiences on rifaximin-α 550mg at the International Liver Congress (ILC) 2015. PROSPER is an observational, multicentre study among 550 patients in Europe and Australia. It has been designed to monitor the clinical effectiveness of rifaximin-α and its impact on health care resources utilisations.[1]

Hepatic encephalopathy places a significant burden on patients and their caregivers, with the burden increasing as the severity of the disease progresses.[2]^,[3] 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.[4]

It is anticipated that the findings of this study will provide important real world evidence, as well as potentially providing a better understanding of the burden and natural history of hepatic encephalopathy as well as the variability in disease management in individual units.

Donna McVey, Chief Development Officer, Norgine said: “The announcement of this study is a milestone in our journey in hepatology and demonstrates our commitment to patients with hepatic encephalopathy; helping to improve the understanding of the impact of rifaximin-α 550mg in the real world, beyond what we see in controlled clinical trials. This study will help us and healthcare decision-makers to improve the treatment of hepatic encephalopathy and ensure effective use of rifaximin-α 550mg to minimise the burden of this disease on patients, their carer and healthcare budgets.”

Hepatic encephalopathy is a serious and potentially life-threatening neuropsychiatric condition associated with advanced liver cirrhosis that affects around 248,000 people in Europe and Australia combined.[5]^{, [6], [7], [8]}

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NOTES TO EDITORS:

About Hepatic Encephalopathy (HE)

Hepatic encephalopathy is the term used to describe a complex and variable neuropsychiatric condition of patients with acute or chronic liver disease, more commonly associated with advanced cirrhosis. Patients with hepatic encephalopathy may experience symptoms ranging from subtle, clinically indiscernible neurological abnormalities, to severe neurological impairment.
 

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

XIFAXAN^® / TARGAXAN^®? 550mg is indicated for the reduction in recurrence of episodes of overt hepatic encephalopathy in patients ≥18 years of age. TARGAXAN^®?/ XIFAXAN^® 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 European specialist pharmaceutical company that has been established for over 100 years. In 2014, Norgine’s total revenue was €296 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 an 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 group with headquarters in Bologna, Italy with its own Research, Development and Manufacturing facilities. In 2014, Alfa Wassermann net sales were above €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 has been prescribed for 28 years, under the trade names of NORMIX^®, XIFAXAN^® and others, in 47 countries, including the USA where Salix Pharmaceuticals is the exclusive licensee. 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.

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April 2015. GL/MPR/0415/0036