THE NATIONAL HEALTH AUTHORITY
BUNDESAMT FÜR GESUNDHEIT APPROVES REIMBURSEMENT OF XIFAXAN® 550 THE SWITZERLAND
LONDON, UK, Tuesday 1 September 2015, 12:00 GMT+1 – Norgine B.V. today announced that the National Health Authority in Switzerland, Bundesamt für Gesundheit, has approved the reimbursement of XIFAXAN® 550 (rifaximin-α 550mg) as an add-on therapy to non-absorbable disaccharides as it can reduce the recurrence of episodes of overt hepatic encephalopathy in patients aged 18 years or older with hepatic cirrhosis. Hepatic encephalopathy is a potentially life-threatening neuropsychiatric condition associated with liver disease. It is estimated that 740,000 people in Europe are affected by cirrhosis, of which hepatic encephalopathy is a common complication.[1], [2], [3], [4]
This positive decision acknowledges that XIFAXAN® 550 can reduce the relative risk of recurrent episodes of hepatic encephalopathy by 58%, with an associated 50% reduction of hospitalisations.[5] Furthermore, it supports the value of XIFAXAN® 550 (rifaximin-α 550mg) as a needed therapy when it is known there is currently no cure for hepatic encephalopathy apart from liver transplantation.
XIFAXAN® 550 is reimbursed in Australia, Finland, Germany, Ireland, Luxembourg, Norway, Scotland, Sweden and United Kingdom. Norgine and Alfa Wasermann are continuing to work with other Health Technology Assessment bodies across Europe to ensure patients have appropriate access to this important medicine.
Peter Martin, Chief Operating Officer Norgine, commented, “We are pleased that Bundesamt für Gesundheit has approved the reimbursement of XIFAXAN® 550, acknowledging the value that this medicine can bring to patients and their families. Hepatic encephalopathy has a huge impact on the lives of patients, their families and careers, XIFAXAN® 550 can help to reduce the burden that repeated hepatic encephalopathy episodes bring.”
Norgine currently holds marketing rights for XIFAXAN® 550 (known as TARGAXAN®▼ 550 in the UK and some other markets) in Australia, Belgium, Denmark, Finland, France, Germany, Luxembourg, MENA, Netherlands, New Zealand, Norway, Republic of Ireland, Sweden, Switzerland and United Kingdom.
Ends
GL/XIF/0815/0125
September 2015
Notes to Editors
About Bundesamt für Gesundheit (The Federal Office for Public Health)
The Federal Office of Public Health (FOPH) is part of the Federal Department of Home Affairs. Along with the cantons it is responsible for public health in Switzerland and for developing national health policy. As the national health authority, the FOPH also represents Switzerland’s interests in the field of health in international organisations and with respect to other countries.
About Hepatic Encephalopathy (HE)
HE is a serious and potentially life-threatening neuropsychiatric condition associated with liver cirrhosis.[6] 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.[7] 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. 2, [8]
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 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 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 Valeant / 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.
Media Contacts:
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Charlotte Andrews, T: +44 (0)1895 453607
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References
[1] Bundesamt für Gesundheit final decision for rifaxmin: http://www.spezialitätenliste.ch/ShowPreparations.aspx. Accessed online 1 September 2015.
[2] Blachier M, Leleu H, Peck-Radosavljevic M, et al. The burden of liver disease in Europe: a review of available epidemiological data. J Hepatol 2013; 58(3): 593-608
[3] Eurostat. World population 1960-2012. Available at: http://ec.europa.eu/eurostat/statistics–‐explained/index.php/File:World_population,_1960–‐2012.png (Accessed February 2015)
[4] Sheasgreen C et al, Pathophysiology, diagnosis and management of hepatic encephalopathy. Inflammopharmacol 2014;22(6): 319-326
[5] Bass NM et al. Rifaximin treatment in hepatic encephalopathy. New Eng J Med 2010; 362(12):1071-1081
[6] 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.