Welcome!

News Feed Item

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.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
In his session at @ThingsExpo, Eric Lachapelle, CEO of the Professional Evaluation and Certification Board (PECB), will provide an overview of various initiatives to certifiy the security of connected devices and future trends in ensuring public trust of IoT. Eric Lachapelle is the Chief Executive Officer of the Professional Evaluation and Certification Board (PECB), an international certification body. His role is to help companies and individuals to achieve professional, accredited and worldw...
MongoDB Atlas leverages VPC peering for AWS, a service that allows multiple VPC networks to interact. This includes VPCs that belong to other AWS account holders. By performing cross account VPC peering, users ensure networks that host and communicate their data are secure. In his session at 20th Cloud Expo, Jay Gordon, a Developer Advocate at MongoDB, will explain how to properly architect your VPC using existing AWS tools and then peer with your MongoDB Atlas cluster. He'll discuss the secur...
SYS-CON Events announced today that Linux Academy, the foremost online Linux and cloud training platform and community, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Linux Academy was founded on the belief that providing high-quality, in-depth training should be available at an affordable price. Industry leaders in quality training, provided services, and student certification passes, its goal is to c...
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm. In his Day 3 Keynote at 20th Cloud Expo, Chris Brown, a Solutions Marketing Manager at Nutanix, will explore t...
In his session at Cloud Expo, Alan Winters, an entertainment executive/TV producer turned serial entrepreneur, will present a success story of an entrepreneur who has both suffered through and benefited from offshore development across multiple businesses: The smart choice, or how to select the right offshore development partner Warning signs, or how to minimize chances of making the wrong choice Collaboration, or how to establish the most effective work processes Budget control, or how to m...
Deep learning has been very successful in social sciences and specially areas where there is a lot of data. Trading is another field that can be viewed as social science with a lot of data. With the advent of Deep Learning and Big Data technologies for efficient computation, we are finally able to use the same methods in investment management as we would in face recognition or in making chat-bots. In his session at 20th Cloud Expo, Gaurav Chakravorty, co-founder and Head of Strategy Development ...
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
"delaPlex is a software development company. We do team-based outsourcing development," explained Mark Rivers, COO and Co-founder of delaPlex Software, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
SYS-CON Events announced today that Technologic Systems Inc., an embedded systems solutions company, will exhibit at SYS-CON's @ThingsExpo, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Technologic Systems is an embedded systems company with headquarters in Fountain Hills, Arizona. They have been in business for 32 years, helping more than 8,000 OEM customers and building over a hundred COTS products that have never been discontinued. Technologic Systems’ pr...
SYS-CON Events announced today that CA Technologies has been named “Platinum Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY, and the 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. CA Technologies helps customers succeed in a future where every business – from apparel to energy – is being rewritten by software. From ...
In his keynote at @ThingsExpo, Chris Matthieu, Director of IoT Engineering at Citrix and co-founder and CTO of Octoblu, focused on building an IoT platform and company. He provided a behind-the-scenes look at Octoblu’s platform, business, and pivots along the way (including the Citrix acquisition of Octoblu).
SYS-CON Events announced today that Auditwerx will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Auditwerx specializes in SOC 1, SOC 2, and SOC 3 attestation services throughout the U.S. and Canada. As a division of Carr, Riggs & Ingram (CRI), one of the top 20 largest CPA firms nationally, you can expect the resources, skills, and experience of a much larger firm combined with the accessibility and atten...
SYS-CON Events announced today that Loom Systems will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Founded in 2015, Loom Systems delivers an advanced AI solution to predict and prevent problems in the digital business. Loom stands alone in the industry as an AI analysis platform requiring no prior math knowledge from operators, leveraging the existing staff to succeed in the digital era. With offices in S...
What if you could build a web application that could support true web-scale traffic without having to ever provision or manage a single server? Sounds magical, and it is! In his session at 20th Cloud Expo, Chris Munns, Senior Developer Advocate for Serverless Applications at Amazon Web Services, will show how to build a serverless website that scales automatically using services like AWS Lambda, Amazon API Gateway, and Amazon S3. We will review several frameworks that can help you build serverle...
SYS-CON Events announced today that HTBase will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. HTBase (Gartner 2016 Cool Vendor) delivers a Composable IT infrastructure solution architected for agility and increased efficiency. It turns compute, storage, and fabric into fluid pools of resources that are easily composed and re-composed to meet each application’s needs. With HTBase, companies can quickly prov...