04 November 2014



LONDON, UK, Tuesday 4 November 2014, 07.00 GMT – Norgine B.V. today announced that Sweden’s National Health Fund, The Dental and Pharmaceutical Benefits Agency (TLV) has approved the reimbursement of XIFAXAN® 550 (rifaximin-α) for the reduction in recurrence of episodes of manifest (overt) hepatic encephalopathy in patients aged 18 and above. Hepatic encephalopathy is a potentially life-threatening neuropsychiatric condition associated with liver disease.[1]

The approval further stated that treatment with XIFAXAN® 550 (rifaximin-α) leads to lower care costs, mainly because in the manifest phase there is an increased cost for hospitalisation.1

This positive decision further reinforces the value of XIFAXAN® 550 as a needed therapy when we know there is currently no cure for hepatic encephalopathy apart from liver transplantation.

XIFAXAN® 550 is reimbursed in Scotland, Ireland, Australia, Germany and Luxembourg. Norgine is working closely with other Health Technology Assessment bodies across Europe, including the National Institute for Health and Care Excellence (NICE) in the UK, to ensure patients have appropriate access to this important medicine.

Peter Martin, Chief Operating Officer, Norgine commented, “This positive decision is acknowledgement of the value that XIFAXAN® 550 can bring to patients who have not had any new licensed treatment options for over 30 years. Hepatic encephalopathy has a huge impact on the lives of patients and their careers for which XIFAXAN® 550 can help to reduce the recurrence of repeat episodes.” [2]

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, United Kingdom and Switzerland.



Notes to Editors

Charlotte Andrews: Tel: +44 (0)1895 453669, Mob: +44 (0)7714 061485
Peter Martin: Tel: +44 (0)1895 453744, Mob: +44 (0)7799 078744
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About The Dental and Pharmaceutical Benefits Agency (TLV)
The Dental and Pharmaceutical Benefits Agency, TLV, is a central government agency whose remit is to determine whether a pharmaceutical product or dental care procedure shall be subsidized by the state.

The TLV reimbursement approval states that:
XIFAXAN® contains the active substance rifaximin and is a preparation intended to reduce the recurrence of episodes of manifest (overt) hepatic encephalopathy in patients aged 18 and above. XIFAXAN® is a tablet that is to be taken twice daily. 1

About hepatic encephalopathy
HE is a serious and potentially life-threatening neuropsychiatric condition associated with liver cirrhosis.[3] 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.[4] 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, [5]

About XIFAXAN® 550
XIFAXAN® 550 mg is indicated for reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients ≥18 years of age.  XIFAXAN® 550 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 2013, Norgine’s total revenue was €274 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 2013, Alfa Wassermann net sales were above €390million 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 24 years, under the trade names of NORMIX®, XIFAXAN® and others, in 33 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.



[1] TLV final decision for rifaximin: http://www.tlv.se/beslut/beslut-lakemedel/generell-subvention/Xifaxan-ingar-i-hogkostnadsskyddet/. Accessed online 28 October 2014.

[3] 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.

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

[5] 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