XIFAXAN® 550mg (rifaximin-?) Registered for Reduction of Recurrence of Episodes of Overt Hepatic Encephalopathy in the EU*

Bologna, Italy And Amsterdam (ots/PRNewswire) -

Alfa Wassermann and Norgine are pleased to announce that they have
received European Marketing Authorisation for XIFAXAN(R) 550mg
(rifaximin-alpha) / REFERO(R) / TARGAXAN(R) / TIXTELLER(R) in the
reduction of recurrence of episodes of overt hepatic encephalopathy
(HE) in patients greater than or equal to 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-alpha, 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(R) 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(R) 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(R) 550mg in
Australia in May 2012 for the prevention of the recurrence of hepatic
encephalopathy where other treatments have failed or are
contraindicated. XIFAXAN(R) 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 EUR330million 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-alpha is a gut-selective antibiotic which has been
prescribed for 24 years, under the Trade Names of NORMIX(R),
XIFAXAN(R) 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(R)), a
heparinoid for thromboembolic diseases, and Parnaparin (FLUXUM(R)), 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(R), the ALFA WASSERMANN logo, NORMIX(R) and
XIFAXAN(R) 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 EUR250 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(R) for the treatment of
constipation and faecal impaction, MOVIPREP(R) a bowel cleansing
preparation, Klean-Prep(R) for large bowel preparation prior to
colonoscopy or surgery, XIFAXAN(R) for the treatment of traveller's
diarrhoea and hepatic encephalopathy and ORAMORPH(R) 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(R) 550mg / REFERO(R) / TARGAXAN(R) / TIXTELLER(R)
(rifaximin-alpha) are trademarks of Alfa Wassermann group of
companies. Product under licence from Alfa Wassermann.

MOVIPREP(R) and MOVICOL(R) are registered trademarks of the
Norgine(R) group of companies.

KLEAN-PREP(R) is a registered trademark.

ORAMORPH(R) is a registered trademark.

ORIGINAL APA-OTS TEXT - THE INFORMATION CONTAINED IN THIS PRESS RELEASE IS SUBJECT TO THE EXCLUSIVE RESPONSIBILITY OF THE ISSUER | PRN

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