First new treatment for 30 years for life-threatening condition linked to liver disease
LONDON, Thursday 19 February 2015. TARGAXAN®▼ 550 (rifaximin-α 550mg), an innovative treatment for hepatic encephalopathy (HE), will be available to patients in England and Wales following its approval by the National Institute for Health and Care Excellence (NICE).[1] Hepatic encephalopathy is a serious and potentially life-threatening neuropsychiatric condition associated with advanced liver disease that affects around 10,000 patients in the UK.[2], [3], [4] Norgine markets this innovative treatment which is licensed for the reduction in recurrence of episodes of overt hepatic encephalopathy in patients of 18 years of age and over.[5]
Peter Martin, Chief Operating Officer, Norgine said: “Norgine is very pleased that the true value of TARGAXAN®▼ 550 has been recognised. It is a reflection of the value this medicine brings to patients, carers and the healthcare system, as demonstrated in the real world data that was submitted. It is critical to have additional treatment options for hepatic encephalopathy as liver disease is increasing and there is currently no cure for HE apart from liver transplantation.”
Richard Hall, co-founder, Liver4Life, said: “As someone with personal experience of caring for a close relative with this devastating condition, I am delighted with NICE’s decision to approve this vitally important treatment. Treatment options are extremely limited for patients with HE with no other new options being made available since lactulose was launched in 1969.Clinicians are now able to offer a treatment that actually makes a tremendous difference to the quality of life for patients and their families.”
Andrew Langford, Chief Executive, British Liver Trust, said: “In my opinion, rifaximin offers an invaluable treatment for people with HE and significantly improves both their and their carers’ quality of life. As a charity that works with many people affected by HE, the British Liver Trust is very pleased with NICE’s decision.”
Norgine currently holds marketing rights for XIFAXAN® 550mg (known as TARGAXAN®? 550 in the UK and some other markets) in Australia, Belgium, Denmark, Finland, France, Germany, Luxembourg, Netherlands, New Zealand, Norway, Republic of Ireland, Sweden, United Kingdom and Switzerland. The product is reimbursed in Australia, Germany, Ireland, Luxembourg, New Zealand, Norway, Scotland and Sweden.
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 reduction in risk of overt hepatic encephalopathy recurrence 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 leading independent European specialty pharmaceutical company that has been established for over 100 years and has a presence in all major European markets. 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. 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.norgine.com
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.
Media contacts:
Caroline Ashe, Norgine Corporate Communications
Mob : +44 (0)7714 061 327, email : cashe@norgine.com
Charlotte Andrews, Norgine Corporate Communications
Mob: +44 (0)7714 061 485, email: candrews2@norgine.com
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References
[1] NICE, Final Appraisal Determination, ‘Rifaximin for preventing episodes of overt hepatic encephalopathy’, published 19 February 2014 and available online at www.nice.org.uk
[2] Gitlin N, Lewis DC, Hinkley L. The diagnosis and prevalence of subclinical hepatic encephalopathy in apparently healthy, ambulant, non-shunted patients with cirrhosis. J Hepatol. 1986;3(1):75-82.
[3] Gilberstadt SJ, Gilberstadt H, Zieve L, Buegel B, Collier RO, Jr., McClain CJ. Psychomotor performance defects in cirrhotic patients without overt encephalopathy. Arch Intern Med. Apr 1980;140(4):519-521
[4] Das A, Dhiman RK, Saraswat VA, Verma M, Naik SR. Prevalence and natural history of subclinical hepatic encephalopathy in cirrhosis. J Gastroenterol Hepatol. May 2001;16(5):531-535.
[5] TARGAXAN® 550? Summary of Product Characteristics, www.medicines.org.uk/emc/medicine/27427/SPC/TARGAXAN+550+mg+film-coated+tablets/
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