Luxembourg National Health Fund Approves Reimbursement of XIFAXAN® 550

London, 14 February 2014. 13:00 GMT: Norgine today announced that Luxembourg’s National Health Fund, the Caisse Nationale de Santé (CNS), has approved the reimbursement of XIFAXAN^® 550 (rifaximin-α 550mg) for the prevention of the recurrence of hepatic encephalopathy (HE) in accordance with its officially-approved summary of product characteristics. Hepatic encephalopathy is a potentially life-threatening neuropsychiatric condition associated with liver disease.

The CNS’ final decision allows for reimbursement conditional only on the treating physician’s written confirmation that s/he has experience in treating patients with hepatic encephalopathy and the product was prescribed for this particular patient in line with XIFAXAN^® 550 ‘s local marketing authorisation.[i]

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

XIFAXAN^® 550 is reimbursed in Australia, Scotland and Germany.  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. Norgine expects a decision from NICE in the first half of 2014.

‘It’s critical that we deliver medicines which treat serious conditions and improve quality-of-life as well as alleviate the cost burden on healthcare systems caused by hospital admissions,” said Peter Martin, Norgine Chief Operating Officer. “XIFAXAN^® 550 provides healthcare professionals with a proven treatment optionⁱ for patients with hepatic encephalopathy, which is a recognised growing problem that may lead to premature death[ii].”

Norgine currently markets XIFAXAN^® 550 in Germany, the UK and Ireland, Netherlands, Belgium, France, Australia, Switzerland, Luxembourg, Finland, Norway, Sweden and Denmark. Future XIFAXAN® 550 launches will include New Zealand. XIFAXAN^® 550 is known in several European markets, including Luxembourg, as TARGAXAN^® 550.

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.

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Notes to editors

About the Caisse Nationale de Santé (CNS)

The Caisse Nationale de Santé (CNS) is Luxembourg’s National Health Fund, dealing with a wide range of health-related benefits for citizens including the reimbursement of prescription medicines.

The CNS’ letterⁱ to Norgine confirming reimbursement states that :

« le médicament TARGAXAN est inscrit sue la liste positive prévue à l’article 22 du Code de la sécurité sociale et est pris en charge par l’assurance maladie au taux préférentiel de 100% d’après les spécifications et conditions particulières figurant à l’annexe qui fait partie intégrante de la présente décision.»

« Demande de pris en charge de TARGAXAN. Je soussigné(e), docteur en médicine, ayant l’expérience de la prise en charge de patients atteints d’encéphalophathie hépatique, certifie que l’indication est posée pour un traitement par TARGAXAN de l’assuré(e) ci-dessus nommé(e), conformément au résumé des caractéristiques officiellement approuvé.»

About Hepatic Encephalopathy

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 cirrhosis. Patients with hepatic encephalopathy may experience symptoms ranging from subtle, clinically indiscernible neurological abnormalities, to severe neurological impairment.

XIFAXAN^® 550 Pivotal Clinical Trial

The pivotal clinical trial by Bass et al (2010)[iii], in which patients in remission from recurrent episodes of hepatic encephalopathy (HE) due to cirrhosis who were treated with XIFAXAN 550mg twice-daily (bd) with or without lactulose*, were compared with patients given placebo (bd) with or without lactulose over six months, demonstrated that:

• Daily XIFAXAN^® 550 treatment significantly reduced the relative risk of patients experiencing a breakthrough episode of hepatic encephalopathy by 58% vs. placebo (>90% were receiving concurrent lactulose in both treatment arms) [HR:0.42; 95% CI 0.28-0.64, p<0.001]. There was a 23.8% absolute reduction in risk for experiencing a recurrent episode of hepatic encephalopathy.
• Daily XIFAXAN^® 550 treatment significantly reduced the risk of hospitalisation involving hepatic encephalopathy by 50% vs. placebo (>90% were receiving concurrent lactulose in both treatment arms) [HR:0.50; 95% CI 0.29-0.87, p=0.01]. There was a 9% absolute reduction in risk for being hospitalised due to hepatic encephalopathy.

About Norgine

Norgine is a leading independent European specialty pharmaceutical company that has been established for over 100 years and has a presence in all major European markets. In 2013, Norgine’s net product sales were €267 million and the company employs over 1,000 people.

Norgine’s focus is the development and marketing of pharmaceutical products that address significant unmet clinical needs in therapeutic areas such as gastroenterology, hepatology , critical and supportive care. Norgine owns a manufacturing and development site in Hengoed, UK and a manufacturing site in Dreux, France.  For more information, please visit www.norgine.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^® and XIFAXAN^® and TARGAXAN^® are registered trademarks of Alfa Wassermann group of companies.

References

[1] Letter from CNS to Norgine dated 31^st January 2014 (public confirmation will be available online at www.cns.lu/prestataires/?m=14-0&p=45 from 1st March 2014)

[1] Jepsen P et al. Hepatology.2010;51:1675-82

[1] Bass NM, Mullen KD, Sanyal A, Poordad F, Neff G, Leevy CB, et al. Rifaximin treatment in hepatic encephalopathy. N Engl J Med. 2010 Mar 25;362(12):1071-81.