|By PR Newswire||
|December 7, 2012 02:02 AM EST||
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.
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) 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 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. Also, hepatic encephalopathy is associated with poorer employment and financial status, as well as increased burden on the caregiver.
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.
In common with most countries around the world, Europe has a serious problem with the increasing incidence of liver cirrhosis, 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.,
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 and improve the quality of life for sufferers and their caregivers.
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,
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
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
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.
Join us at Cloud Expo | @ThingsExpo 2016 – June 7-9 at the Javits Center in New York City and November 1-3 at the Santa Clara Convention Center in Santa Clara, CA – and deliver your unique message in a way that is striking and unforgettable by taking advantage of SYS-CON's unmatched high-impact, result-driven event / media packages.
May. 26, 2016 08:00 PM EDT Reads: 2,284
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, will provide an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life ...
May. 26, 2016 08:00 PM EDT Reads: 1,868
As cloud and storage projections continue to rise, the number of organizations moving to the cloud is escalating and it is clear cloud storage is here to stay. However, is it secure? Data is the lifeblood for government entities, countries, cloud service providers and enterprises alike and losing or exposing that data can have disastrous results. There are new concepts for data storage on the horizon that will deliver secure solutions for storing and moving sensitive data around the world. ...
May. 26, 2016 08:00 PM EDT Reads: 1,220
In the rush to compete in the digital age, a successful digital transformation is essential, but many organizations are setting themselves up for failure. There’s a common misconception that the process is just about technology, but it’s not. It’s about your business. It shouldn’t be treated as an isolated IT project; it should be driven by business needs with the committed involvement of a range of stakeholders.
May. 26, 2016 08:00 PM EDT Reads: 2,257
SYS-CON Events announced today that EastBanc Technologies will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. EastBanc Technologies has been working at the frontier of technology since 1999. Today, the firm provides full-lifecycle software development delivering flexible technology solutions that seamlessly integrate with existing systems – whether on premise or cloud. EastBanc Technologies partners with p...
May. 26, 2016 08:00 PM EDT Reads: 2,089
SYS-CON Events announced today that BMC Software has been named "Siver Sponsor" of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. BMC is a global leader in innovative software solutions that help businesses transform into digital enterprises for the ultimate competitive advantage. BMC Digital Enterprise Management is a set of innovative IT solutions designed to make digital business fast, seamless, and optimized from mainframe to mo...
May. 26, 2016 08:00 PM EDT Reads: 2,055
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York and Silicon Valley. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty ...
May. 26, 2016 07:45 PM EDT Reads: 2,506
SoftLayer operates a global cloud infrastructure platform built for Internet scale. With a global footprint of data centers and network points of presence, SoftLayer provides infrastructure as a service to leading-edge customers ranging from Web startups to global enterprises. SoftLayer's modular architecture, full-featured API, and sophisticated automation provide unparalleled performance and control. Its flexible unified platform seamlessly spans physical and virtual devices linked via a world...
May. 26, 2016 07:30 PM EDT Reads: 2,015
SYS-CON Events announced today that ContentMX, the marketing technology and services company with a singular mission to increase engagement and drive more conversations for enterprise, channel and SMB technology marketers, has been named “Sponsor & Exhibitor Lounge Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York City, New York. “CloudExpo is a great opportunity to start a conversation with new prospects, but what happens after the...
May. 26, 2016 07:15 PM EDT Reads: 989
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management...
May. 26, 2016 07:15 PM EDT Reads: 2,984
The essence of data analysis involves setting up data pipelines that consist of several operations that are chained together – starting from data collection, data quality checks, data integration, data analysis and data visualization (including the setting up of interaction paths in that visualization). In our opinion, the challenges stem from the technology diversity at each stage of the data pipeline as well as the lack of process around the analysis.
May. 26, 2016 07:00 PM EDT Reads: 1,334
The 19th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Containers, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportunity. Submit y...
May. 26, 2016 07:00 PM EDT Reads: 1,923
18th Cloud Expo, taking place June 7-9, 2016, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterprises are using some...
May. 26, 2016 06:45 PM EDT Reads: 3,059
SYS-CON Events announced today that Isomorphic Software will exhibit at SYS-CON's [email protected] at Cloud Expo New York, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Isomorphic Software provides the SmartClient HTML5/AJAX platform, the most advanced technology for building rich, high-productivity enterprise web applications for any device. SmartClient couples the industry’s broadest, deepest UI component set with a java server framework to deliver an end-...
May. 26, 2016 06:30 PM EDT Reads: 2,020
As organizations shift towards IT-as-a-service models, the need for managing and protecting data residing across physical, virtual, and now cloud environments grows with it. Commvault can ensure protection, access and E-Discovery of your data – whether in a private cloud, a Service Provider delivered public cloud, or a hybrid cloud environment – across the heterogeneous enterprise. In his general session at 18th Cloud Expo, Randy De Meno, Chief Technologist - Windows Products and Microsoft Part...
May. 26, 2016 06:15 PM EDT Reads: 371