XIFAXAN® 550mg (rifaximin-α) Registered for Reduction of Recurrence
of Episodes of Overt Hepatic Encephalopathy in the EU*
BOLOGNA, Italy and AMSTERDAM, December 7,
2012 /PRNewswire/ --
Alfa Wassermann and Norgine are pleased to announce that they
have received European Marketing Authorisation for
XIFAXAN® 550mg (rifaximin-α) / REFERO® /
TARGAXAN® / TIXTELLER® in the reduction of
recurrence of episodes of overt hepatic encephalopathy (HE) in
patients ≥ 18 years of age, in a number of EU territories*. HE is a
potentially life-threatening neuropsychiatric condition associated
with liver cirrhosis[1].
First launches in Europe are
expected in the first half of 2013.
Rifaximin-α, developed by Alfa Wassermann, is currently marketed
in many countries worldwide, including the US in a number of
indications.
A pivotal trial by Bass and colleagues
(2010)[2] demonstrated the
efficacy of twice-daily (bid) treatment with XIFAXAN®
550mg in patients with HE.
Hepatic encephalopathy results from increased serum toxic
substances such as ammonia arising from gut bacteria, which is not
efficiently removed by the damaged
liver[1] and then enters the
brain causing a spectrum of neuropsychiatric disorders ranging from
mild intellectual impairment, changes in mental state, confusion,
to personality changes, depressed level of consciousness and even
coma[3]. Also, hepatic
encephalopathy is associated with poorer employment and financial
status, as well as increased burden on the
caregiver.[4]
XIFAXAN® 550mg is a gut specific antibiotic which
targets Gram +ve and Gram -ve ammonia producing aerobes and
anaerobes to reduce the plasma ammonia load that is associated with
the development of hepatic
encephalopathy[5].
In common with most countries around the world, Europe has a serious problem with the
increasing incidence of liver
cirrhosis[6], hepatic
encephalopathy and the associated cost of treatment. Hepatic
encephalopathy was estimated to be responsible for 55,000
hospitalisations at a total cost of $1.2
billion per year in the USA
in
2007.[7],[8]
The European countries specified in the approval will be amongst
some of the first markets via which Alfa Wassermann and Norgine
enter the hepatic encephalopathy therapy area, with a medicine that
has the potential to make a significant impact on treatment
outcome[2] and improve the quality
of life for sufferers and their
caregivers.[9]
The EU licence follows the registration of XIFAXAN®
550mg in Australia in May 2012 for the prevention of the recurrence of
hepatic encephalopathy where other treatments have failed or are
contraindicated. XIFAXAN® 550mg received marketing
approval in the U.S. in March 2010
for the reduction in risk of overt hepatic encephalopathy (HE)
recurrence in patients 18 years of age or older.
* Approved status granted via DCP in
the following countries: Austria,
Belgium, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden,
United
Kingdom
About Alfa Wassermann
Alfa Wassermann is a private pharmaceutical group with Head
Quarters in Bologna, Italy with
its own Research, Development and Manufacturing facilities.
In 2011, Alfa Wassermann net sales were above €330million and
the company employs over 1400 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 web site at http://www.alfawassermann.it
ALFA WASSERMANN®, the ALFA WASSERMANN logo,
NORMIX® and XIFAXAN® are registered
trademarks of Alfa Wassermann group of companies
About Norgine
Norgine is an independent, successful European specialty
pharmaceutical company that has been established for over 100 years
and has a presence in all major European markets. In 2011,
Norgine's net product sales were €250 million and the company
employs over 1000 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 and
supportive care.
The Company currently markets a range of products in various
markets in its key therapeutic areas e.g. MOVICOL® for the
treatment of constipation and faecal impaction, MOVIPREP® a bowel
cleansing preparation, Klean-Prep® for large bowel preparation
prior to colonoscopy or surgery, XIFAXAN® for the treatment of
traveller's diarrhoea and hepatic encephalopathy and ORAMORPH® for
the treatment of moderate to severe pain associated with
cancer.
Norgine is active in research and development and currently has
products in various stages of clinical development. Norgine
manufactures most of its own products in Hengoed, UK and Dreux,
France.
For more information: http://www.norgine.com
References
1. Prakash, R. and K.D. Mullen,
Mechanisms, diagnosis and management of hepatic
encephalopathy. Nat Rev Gastroenterol Hepatol, 2010;
7(9): 515-25.
2. Bass, N.M., et al., Rifaximin treatment in hepatic
encephalopathy. N Engl J Med, 2010; 362(12):
1071-81.
3. Bajaj, J.S., Review article: the modern management of
hepatic encephalopathy. Aliment Pharmacol Ther, 2010;
31(5): 537-47.
4. Bajaj, J.S., et al., The multi-dimensional burden of
cirrhosis and hepatic encephalopathy on patients and
caregivers. Am J Gastroenterol, 2011; 106(9):
1646-53.
5. XIFAXAN Summary of Product Characteristics, 2012.
6. The Australian Liver Foundation. Facts on liver disease.
Available
at: http://www.liver.org.au/liver_diseases.htm Accessed
March 2012.
7. Huang, E., E. Esrailian, and B.M.
Spiegel, The cost-effectiveness and budget impact of
competing therapies in hepatic encephalopathy - a decision
analysis. Aliment Pharmacol Ther, 2007; 26(8):
1147-61.
8. Leise, M.D. and W.R. Kim,
Rifaximin in hepatic encephalopathy: is an ounce of prevention
worth a pretty penny? Gastroenterology, 2010; 139(4):
1416-8.
9. Sanyal, A., et al., Randomised clinical trial: rifaximin
improves health-related quality of life in cirrhotic patients with
hepatic encephalopathy - a double-blind placebo-controlled
study. Aliment Pharmacol Ther, 2011; 34(8): 853-61.
XIFAXAN® 550mg / REFERO® /
TARGAXAN® / TIXTELLER® (rifaximin-α) are
trademarks of Alfa Wassermann group of companies. Product under
licence from Alfa Wassermann.
MOVIPREP® and MOVICOL® are registered
trademarks of the Norgine® group of companies.
KLEAN-PREP® is a registered trademark.
ORAMORPH® is a registered trademark.