LONDON, May 24, 2013 /CNW/ - Norgine today announced that the Australian
assessment body the Pharmaceutical Benefits Advisory Committee (PBAC)
has recommended the use of XIFAXAN 550 mg in the prevention of the
recurrence of hepatic encephalopathy (HE) where other treatments have
failed or are contraindicated; a potentially life-threatening
neuropsychiatric condition associated with liver disease.
XIFAXAN 550 mg is the only treatment that has demonstrated a reduction
in the recurrence of episodes of overt HE and hospitalisation due to HE
compared with placebo in a 6-month randomised, double blind,
placebo-controlled study[i] in which ~91% patients were taking concomitant lactulose in both arms,
in patients who were in remission from HE, resulting from chronic liver
The PBAC announced its final decision as follows:
The PBAC recommended listing of rifaximin on the basis of high clinical
need, improved clinical benefit over the existing treatments and
acceptable cost effectiveness.
On the basis of the information available to it at the April 2013
meeting, the PBAC considered that there was no longer a requirement for
a managed entry scheme approach.
This outcome represents the first acceptance for use made by a health
technology assessment (HTA) process for XIFAXAN 550 mg in their
healthcare system based on cost effectiveness review. Norgine and Alfa
Wassermann are working closely with other HTA bodies across Europe
including the National Institute for Health and Care Excellence (NICE)
and The Scottish Medicines Consortium (SMC) to ensure patients have
appropriate access to this important medicine. The review processes are
currently underway and Norgine expects these bodies to make their
decision in the second half of 2013.
'It's critical that we deliver medicines that 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 mg provides healthcare professionals with a world-leading
treatment option for patients with hepatic encephalopathy, which is a
recognised growing problem that may lead to premature death," added
Norgine currently holds marketing rights for XIFAXAN 550* in: Australia,
Belgium, Denmark, Egypt, Finland, France, Germany, Ireland, Luxembourg,
the Netherlands, New Zealand, Norway, Switzerland, Sweden and the UK.
In Europe, XIFAXAN® 550 mg /TARGAXAN® 550 mg is already available in
Denmark, Germany and in the UK for healthcare professionals to
prescribe in accordance with local guidance.
* 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.
Notes to editors
About the PBAC
The PBAC is the independent, expert advisory body comprising doctors,
other health professionals and a consumer representative, which makes
recommendations to the Australian Government about Pharmaceutical
Benefits Scheme (PBS) listings. The Government cannot list a medicine
on the PBS unless the PBAC makes a recommendation in favour of its
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
XIFAXAN 550 mg Pivotal Clinical Trial
The pivotal clinical trial by Bass et al (2010) , in which patients in
remission from recurrent episodes of hepatic encephalopathy 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 6 months, demonstrated:
• A 58% relative reduction in the risk of breakthrough episodes of overt
hepatic encephalopathy over 6 months (Hazard ratio 0.42; p<0.001). Thus
the numbers needed to treat (NNT) = 4
• A 50% relative reduction in the risk of hospitalisations caused by HE
over 6 months (Hazard ratio 0.50; p=0.01). Thus the numbers needed to
treat (NNT) = 9
*91% of patients in both groups were taking lactulose.
Norgine is a successful, independent European specialty pharmaceutical
company that has been established for over 100 years and has a presence
in all major European markets. In 2012, Norgine's net product sales
were c€250 million and the company employs over a 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
Norgine manufactures most of its own products in Hengoed, UK and Dreux,
France. For more information: http://www.norgine.com.
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 Alfa Wassermann
Alfa Wassermann is a private pharmaceutical group with Head Quarters in
Bologna, Italy with its own Research, Development and Manufacturing
facilities. In 2012, Alfa Wassermann net sales were above €360million
and the company employs over 1300 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®, 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® VESSEL FLUXUM are registered trademarks of Alfa Wassermann group of
i. Bass, N.M. et al. N Engl J Med, 2010: 362(12): 1071-81)
For further information:
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