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
We all know that end users experience the internet primarily with mobile devices. From an app development perspective, we know that successfully responding to the needs of mobile customers depends on rapid DevOps – failing fast, in short, until the right solution evolves in your customers' relationship to your business. Whether you’re decomposing an SOA monolith, or developing a new application cloud natively, it’s not a question of using microservices - not doing so will be a path to eventual ...
DXWorldEXPO LLC announced today that ICC-USA, a computer systems integrator and server manufacturing company focused on developing products and product appliances, will exhibit at the 22nd International CloudEXPO | DXWorldEXPO. DXWordEXPO New York 2018, colocated with CloudEXPO New York 2018 will be held November 11-13, 2018, in New York City. ICC is a computer systems integrator and server manufacturing company focused on developing products and product appliances to meet a wide range of ...
Michael Maximilien, better known as max or Dr. Max, is a computer scientist with IBM. At IBM Research Triangle Park, he was a principal engineer for the worldwide industry point-of-sale standard: JavaPOS. At IBM Research, some highlights include pioneering research on semantic Web services, mashups, and cloud computing, and platform-as-a-service. He joined the IBM Cloud Labs in 2014 and works closely with Pivotal Inc., to help make the Cloud Found the best PaaS.
We all know that end users experience the Internet primarily with mobile devices. From an app development perspective, we know that successfully responding to the needs of mobile customers depends on rapid DevOps – failing fast, in short, until the right solution evolves in your customers' relationship to your business. Whether you’re decomposing an SOA monolith, or developing a new application cloud natively, it’s not a question of using microservices – not doing so will be a path to eventual b...
Sanjeev Sharma Joins November 11-13, 2018 @DevOpsSummit at @CloudEXPO New York Faculty. Sanjeev Sharma is an internationally known DevOps and Cloud Transformation thought leader, technology executive, and author. Sanjeev's industry experience includes tenures as CTO, Technical Sales leader, and Cloud Architect leader. As an IBM Distinguished Engineer, Sanjeev is recognized at the highest levels of IBM's core of technical leaders.
Headquartered in Plainsboro, NJ, Synametrics Technologies has provided IT professionals and computer systems developers since 1997. Based on the success of their initial product offerings (WinSQL and DeltaCopy), the company continues to create and hone innovative products that help its customers get more from their computer applications, databases and infrastructure. To date, over one million users around the world have chosen Synametrics solutions to help power their accelerated business or per...
Dion Hinchcliffe is an internationally recognized digital expert, bestselling book author, frequent keynote speaker, analyst, futurist, and transformation expert based in Washington, DC. He is currently Chief Strategy Officer at the industry-leading digital strategy and online community solutions firm, 7Summits.
In an era of historic innovation fueled by unprecedented access to data and technology, the low cost and risk of entering new markets has leveled the playing field for business. Today, any ambitious innovator can easily introduce a new application or product that can reinvent business models and transform the client experience. In their Day 2 Keynote at 19th Cloud Expo, Mercer Rowe, IBM Vice President of Strategic Alliances, and Raejeanne Skillern, Intel Vice President of Data Center Group and ...
Founded in 2000, Chetu Inc. is a global provider of customized software development solutions and IT staff augmentation services for software technology providers. By providing clients with unparalleled niche technology expertise and industry experience, Chetu has become the premiere long-term, back-end software development partner for start-ups, SMBs, and Fortune 500 companies. Chetu is headquartered in Plantation, Florida, with thirteen offices throughout the U.S. and abroad.
One of the biggest challenges with adopting a DevOps mentality is: new applications are easily adapted to cloud-native, microservice-based, or containerized architectures - they can be built for them - but old applications need complex refactoring. On the other hand, these new technologies can require relearning or adapting new, oftentimes more complex, methodologies and tools to be ready for production. In his general session at @DevOpsSummit at 20th Cloud Expo, Chris Brown, Solutions Marketi...
At the keynote this morning we spoke about the value proposition of Nutanix, of having a DevOps culture and a mindset, and the business outcomes of achieving agility and scale, which everybody here is trying to accomplish," noted Mark Lavi, DevOps Solution Architect at Nutanix, in this SYS-CON.tv interview at @DevOpsSummit at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
HyperConvergence came to market with the objective of being simple, flexible and to help drive down operating expenses. It reduced the footprint by bundling the compute/storage/network into one box. This brought a new set of challenges as the HyperConverged vendors are very focused on their own proprietary building blocks. If you want to scale in a certain way, let's say you identified a need for more storage and want to add a device that is not sold by the HyperConverged vendor, forget about it...
In his Opening Keynote at 21st Cloud Expo, John Considine, General Manager of IBM Cloud Infrastructure, led attendees through the exciting evolution of the cloud. He looked at this major disruption from the perspective of technology, business models, and what this means for enterprises of all sizes. John Considine is General Manager of Cloud Infrastructure Services at IBM. In that role he is responsible for leading IBM’s public cloud infrastructure including strategy, development, and offering m...
Historically, some banking activities such as trading have been relying heavily on analytics and cutting edge algorithmic tools. The coming of age of powerful data analytics solutions combined with the development of intelligent algorithms have created new opportunities for financial institutions. In his session at 20th Cloud Expo, Sebastien Meunier, Head of Digital for North America at Chappuis Halder & Co., discussed how these tools can be leveraged to develop a lasting competitive advantage ...
Most companies are adopting or evaluating container technology - Docker in particular - to speed up application deployment, drive down cost, ease management and make application delivery more flexible overall. As with most new architectures, this dream takes a lot of work to become a reality. Even when you do get your application componentized enough and packaged properly, there are still challenges for DevOps teams to making the shift to continuous delivery and achieving that reduction in cost ...