|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.
SYS-CON Events announced today that HPM Networks will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. For 20 years, HPM Networks has been integrating technology solutions that solve complex business challenges. HPM Networks has designed solutions for both SMB and enterprise customers throughout the San Francisco Bay Area.
Aug. 3, 2015 06:45 PM EDT Reads: 551
For IoT to grow as quickly as analyst firms’ project, a lot is going to fall on developers to quickly bring applications to market. But the lack of a standard development platform threatens to slow growth and make application development more time consuming and costly, much like we’ve seen in the mobile space. In his session at @ThingsExpo, Mike Weiner, Product Manager of the Omega DevCloud with KORE Telematics Inc., discussed the evolving requirements for developers as IoT matures and conducted a live demonstration of how quickly application development can happen when the need to comply wit...
Aug. 2, 2015 11:15 AM EDT Reads: 377
The Internet of Everything (IoE) brings together people, process, data and things to make networked connections more relevant and valuable than ever before – transforming information into knowledge and knowledge into wisdom. IoE creates new capabilities, richer experiences, and unprecedented opportunities to improve business and government operations, decision making and mission support capabilities.
Aug. 1, 2015 10:00 AM EDT Reads: 351
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at @ThingsExpo, James Kirkland, Red Hat's Chief Architect for the Internet of Things and Intelligent Systems, described how to revolutionize your archit...
Jul. 30, 2015 07:30 PM EDT Reads: 1,434
MuleSoft has announced the findings of its 2015 Connectivity Benchmark Report on the adoption and business impact of APIs. The findings suggest traditional businesses are quickly evolving into "composable enterprises" built out of hundreds of connected software services, applications and devices. Most are embracing the Internet of Things (IoT) and microservices technologies like Docker. A majority are integrating wearables, like smart watches, and more than half plan to generate revenue with APIs within the next year.
Jul. 30, 2015 02:30 PM EDT Reads: 162
Growth hacking is common for startups to make unheard-of progress in building their business. Career Hacks can help Geek Girls and those who support them (yes, that's you too, Dad!) to excel in this typically male-dominated world. Get ready to learn the facts: Is there a bias against women in the tech / developer communities? Why are women 50% of the workforce, but hold only 24% of the STEM or IT positions? Some beginnings of what to do about it! In her Opening Keynote at 16th Cloud Expo, Sandy Carter, IBM General Manager Cloud Ecosystem and Developers, and a Social Business Evangelist, d...
Jul. 30, 2015 12:00 PM EDT Reads: 2,093
In his keynote at 16th Cloud Expo, Rodney Rogers, CEO of Virtustream, discussed the evolution of the company from inception to its recent acquisition by EMC – including personal insights, lessons learned (and some WTF moments) along the way. Learn how Virtustream’s unique approach of combining the economics and elasticity of the consumer cloud model with proper performance, application automation and security into a platform became a breakout success with enterprise customers and a natural fit for the EMC Federation.
Jul. 30, 2015 09:00 AM EDT Reads: 2,182
The Internet of Things is not only adding billions of sensors and billions of terabytes to the Internet. It is also forcing a fundamental change in the way we envision Information Technology. For the first time, more data is being created by devices at the edge of the Internet rather than from centralized systems. What does this mean for today's IT professional? In this Power Panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists addressed this very serious issue of profound change in the industry.
Jul. 29, 2015 03:00 PM EDT Reads: 1,309
Discussions about cloud computing are evolving into discussions about enterprise IT in general. As enterprises increasingly migrate toward their own unique clouds, new issues such as the use of containers and microservices emerge to keep things interesting. In this Power Panel at 16th Cloud Expo, moderated by Conference Chair Roger Strukhoff, panelists addressed the state of cloud computing today, and what enterprise IT professionals need to know about how the latest topics and trends affect their organization.
Jul. 29, 2015 02:00 PM EDT Reads: 1,218
It is one thing to build single industrial IoT applications, but what will it take to build the Smart Cities and truly society-changing applications of the future? The technology won’t be the problem, it will be the number of parties that need to work together and be aligned in their motivation to succeed. In his session at @ThingsExpo, Jason Mondanaro, Director, Product Management at Metanga, discussed how you can plan to cooperate, partner, and form lasting all-star teams to change the world and it starts with business models and monetization strategies.
Jul. 28, 2015 04:30 PM EDT Reads: 1,781
Converging digital disruptions is creating a major sea change - Cisco calls this the Internet of Everything (IoE). IoE is the network connection of People, Process, Data and Things, fueled by Cloud, Mobile, Social, Analytics and Security, and it represents a $19Trillion value-at-stake over the next 10 years. In her keynote at @ThingsExpo, Manjula Talreja, VP of Cisco Consulting Services, discussed IoE and the enormous opportunities it provides to public and private firms alike. She will share what businesses must do to thrive in the IoE economy, citing examples from several industry sectors.
Jul. 28, 2015 11:00 AM EDT Reads: 2,056
There will be 150 billion connected devices by 2020. New digital businesses have already disrupted value chains across every industry. APIs are at the center of the digital business. You need to understand what assets you have that can be exposed digitally, what their digital value chain is, and how to create an effective business model around that value chain to compete in this economy. No enterprise can be complacent and not engage in the digital economy. Learn how to be the disruptor and not the disruptee.
Jul. 27, 2015 10:00 AM EDT Reads: 2,057
Akana has released Envision, an enhanced API analytics platform that helps enterprises mine critical insights across their digital eco-systems, understand their customers and partners and offer value-added personalized services. “In today’s digital economy, data-driven insights are proving to be a key differentiator for businesses. Understanding the data that is being tunneled through their APIs and how it can be used to optimize their business and operations is of paramount importance,” said Alistair Farquharson, CTO of Akana.
Jul. 27, 2015 09:00 AM EDT Reads: 340
Business as usual for IT is evolving into a "Make or Buy" decision on a service-by-service conversation with input from the LOBs. How does your organization move forward with cloud? In his general session at 16th Cloud Expo, Paul Maravei, Regional Sales Manager, Hybrid Cloud and Managed Services at Cisco, discusses how Cisco and its partners offer a market-leading portfolio and ecosystem of cloud infrastructure and application services that allow you to uniquely and securely combine cloud business applications and services across multiple cloud delivery models.
Jul. 27, 2015 08:00 AM EDT Reads: 1,915
The enterprise market will drive IoT device adoption over the next five years. In his session at @ThingsExpo, John Greenough, an analyst at BI Intelligence, division of Business Insider, analyzed how companies will adopt IoT products and the associated cost of adopting those products. John Greenough is the lead analyst covering the Internet of Things for BI Intelligence- Business Insider’s paid research service. Numerous IoT companies have cited his analysis of the IoT. Prior to joining BI Intelligence, he worked analyzing bank technology for Corporate Insight and The Clearing House Payment...
Jul. 26, 2015 09:00 PM EDT Reads: 1,597
"Optimal Design is a technology integration and product development firm that specializes in connecting devices to the cloud," stated Joe Wascow, Co-Founder & CMO of Optimal Design, in this SYS-CON.tv interview at @ThingsExpo, held June 9-11, 2015, at the Javits Center in New York City.
Jul. 25, 2015 02:00 PM EDT Reads: 408
SYS-CON Events announced today that CommVault has been named “Bronze Sponsor” of SYS-CON's 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. A singular vision – a belief in a better way to address current and future data management needs – guides CommVault in the development of Singular Information Management® solutions for high-performance data protection, universal availability and simplified management of data on complex storage networks. CommVault's exclusive single-platform architecture gives companies unp...
Jul. 25, 2015 01:00 PM EDT Reads: 1,982
Electric Cloud and Arynga have announced a product integration partnership that will bring Continuous Delivery solutions to the automotive Internet-of-Things (IoT) market. The joint solution will help automotive manufacturers, OEMs and system integrators adopt DevOps automation and Continuous Delivery practices that reduce software build and release cycle times within the complex and specific parameters of embedded and IoT software systems.
Jul. 25, 2015 12:15 PM EDT Reads: 491
"ciqada is a combined platform of hardware modules and server products that lets people take their existing devices or new devices and lets them be accessible over the Internet for their users," noted Geoff Engelstein of ciqada, a division of Mars International, in this SYS-CON.tv interview at @ThingsExpo, held June 9-11, 2015, at the Javits Center in New York City.
Jul. 25, 2015 12:00 PM EDT Reads: 1,566
Internet of Things is moving from being a hype to a reality. Experts estimate that internet connected cars will grow to 152 million, while over 100 million internet connected wireless light bulbs and lamps will be operational by 2020. These and many other intriguing statistics highlight the importance of Internet powered devices and how market penetration is going to multiply many times over in the next few years.
Jul. 25, 2015 09:00 AM EDT Reads: 1,510