THE DUTCH MINISTRY OF HEALTH MINISTERIE VAN VOLKSGEZONDHEID WELZIJN EN SPORT APPROVES REIMBURSEMENT OF XIFAXAN 550

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THE DUTCH MINISTRY OF HEALTH (MINISTERIE VAN VOLKSGEZONDHEID, WELZIJN EN SPORT) APPROVES REIMBURSEMENT OF XIFAXAN^® 550

LONDON, UK, Thursday 16 June 2016, 07:00 BST – Norgine B.V. today announced that the Ministry of Health in the Netherlands, Ministry van Volksgezondheid, Welzijn en Sport, has approved the reimbursement of XIFAXAN^® 550 (rifaximin-α 550mg) when added to lactulose, for prophylaxis of the 3rd and following episodes of overt hepatic encephalopathy in patients ≥ 18 years. The reimbursement approval is effective from 1 July 2016.[1] Hepatic encephalopathy is a potentially life-threatening neuropsychiatric condition associated with chronic liver disease.

There is currently no cure for hepatic encephalopathy apart from liver transplantation.

Peter Martin, Chief Operating Officer, Norgine said: “We know that hepatic encephalopathy has a huge impact on the lives of patients, their families and carers and healthcare  systems. This decision further demonstrates the value of XIFAXAN^® 550 by reducing the recurrence of episodes of hepatic encephalopathy which ultimately can help decrease the cost of care for these patients.”

XIFAXAN^® 550 is reimbursed in Australia, England, Finland, Germany, Ireland, Luxembourg, New Zealand, Norway, Scotland, Sweden, Switzerland and Wales.

It is estimated that 500,000 people in Europe are living with advanced chronic liver disease, of which 40% will go on to develop hepatic encephalopathy. [2]^{, [3]}

Norgine currently holds marketing rights for XIFAXAN^® 550mg (known as TARGAXAN^®? 550 in the UK and some other markets) in Australia, Belgium, Denmark, Finland, Germany, Luxembourg, Netherlands, New Zealand, Norway, Republic of Ireland, Sweden, United Kingdom and Switzerland. Norgine and Alfa Wassermann co-promote the product under the TIXTAR^® brand name in France.

Ends

GL/XIF/0616/0146
June 2016

Notes to Editors

About Ministry van Volksgezondheid, Welzijn en Sport (The Ministry of Health, Welfare and Sport)

The Netherlands healthy and well. This is the motto of the Ministry of Health, Welfare and Sport (VWS). The ambition of the Ministry of VWS is to keep everyone healthy as long as possible and to restore the sick to health as quickly as possible. The ministry also seeks to support people with a physical or mental limitation and promote social participation.

https://www.government.nl/ministries/ministry-of-health-welfare-and-sport

About Hepatic Encephalopathy (HE)

HE is a serious and potentially life-threatening neuropsychiatric condition associated with liver cirrhosis.[4] 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.[5] 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, [6]

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

XIFAXAN^® / TARGAXAN^®? / TIXTAR^® 550mg is indicated for the reduction in recurrence of episodes of overt hepatic encephalopathy in patients ≥18 years of age. TARGAXAN^®?/ XIFAXAN^® / TIXTAR^® 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^® and TIXTAR^® 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 2015, Norgine’s total revenue was EUR 320 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 company wholly owned by and subject to the direction and coordination of Alfasigma S.p.A. Alfa Wassermann has its headquarters in Bologna, Italy with its own Research, Development and Manufacturing facilities. In 2015, Alfa Wassermann net sales were €429 million and the company employs over 1,500 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.. 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^® ,  TARGAXAN^® and TIXTAR^® are registered trademarks of Alfa Wassermann group of companies.

Media Contacts:

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

Charlotte Andrews, T: +44 (0)1895 453607

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