PBAC Approves XIFAXAN(R) (Rifaxamin a) 550 mg Cost Effectiveness in Australia

AsiaNet 53154

LONDON, May 24 /PRN=KYODO JBN/ --

     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 disease.

    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 Peter

Martin.

    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(R) 550 mg /TARGAXAN(R) 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(R) and

TARGAXAN(R) 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 listing.

    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 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.

    About Norgine

    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 cEUR250

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 care.

    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 EUR360million 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(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)

VESSEL FLUXUM are registered trademarks of Alfa Wassermann group of companies.

    References

    i. Bass, N.M. et al. N Engl J Med, 2010: 362(12): 1071-81)

Source: Norgine