-- AclarusDx(TM) Alzheimer's test now available as a Research Use Only
product
-- Strong need for accurate patient characterization in Alzheimer clinical
trials
-- Clinical guidance from a world-class Alzheimer Scientific Advisory Board
PARIS--(BUSINESS WIRE)-- Regulatory News:
ExonHit Therapeutics (Paris: ALEHT) is pleased to announce that AclarusDx(TM) Alzheimer's test (formerly known as EHT Dx21), its blood-based test for the detection of Alzheimer's disease (AD), is now available as a Research Use Only (RUO) product for pharmaceutical companies and leading academic centers conducting clinical trials in Alzheimer's disease.
"Alzheimer's disease is a multi-factorial and a complex pathology. Currently, its diagnosis is mainly based on clinical criteria, i.e., relies on subjective measurements. Including subjects who are not properly characterized may easily increase the cost of a clinical study and potentially jeopardize its success," commented Loic Maurel, M.D., President of the Management Board of ExonHit Therapeutics. "The use of AclarusDx(TM) Alzheimer's test could be a tremendous asset for the pharmaceutical industry as it has the potential to identify populations of patients who might benefit the most from therapeutic advances in AD."
AclarusDx(TM) Alzheimer's test is a reproducible, objective, and non invasive test. A blood sample is all that is required from the patient, so it can be implemented at any recruiting site. Unlike brain imaging techniques or cerebrospinal fluid sampling, no special equipment or medical facilities are required and the ease of the procedure should enhance volunteers' willingness to participate in trials. It may also increase the recruitment speed and allow the clinical trial sponsor to include investigating centers other than the main hospitals. When used in combination with neuro-cognitive tests, AclarusDx(TM) Alzheimer's test could help pharmaceutical companies running clinical trials to include patients fulfilling clinical criteria for AD and who share a common transcriptional profile that has been correlated to AD. Hence, AclarusDx(TM) Alzheimer's test could lower the trial's "background noise" and potentially lead to a better study outcome by selecting a more homogeneous study population.
In 2008, 43 clinical trials involving approximately 10,700 patients were initiated to test new AD therapies. In 2009, 70 AD clinical studies involving around 14,000 patients were started (1).To recruit one Alzheimer patient, 3 to 4 individuals have to be screened (2).
The launch of AclarusDx(TM) Alzheimer's test as a RUO product is the first step in ExonHit's commercial strategy in which trial sponsors will send patient blood samples for analysis in ExonHit's GLP-compliant laboratories in the US. In parallel, the Company is preparing the launch of its product in the clinical in vitro diagnostics (IVD) market with partners. ExonHit is anticipating a CE marking in Q4 2010 for a European launch in Q1 of 2011. Regarding US marketing approval, discussions have been initiated with the FDA to define the exact regulatory path to meet IVD requirements.
ExonHit Therapeutics has a unique approach to Alzheimer's disease with both therapeutic (EHT 0202, its lead candidate in Phase II) and diagnostic programs (AclarusDx(TM) Alzheimer's test) in clinical development. For its research and development work in AD diagnostics and more recently therapeutics, ExonHit is counseled by experts from both sides of the Atlantic: Jeffrey Cummings, M.D., Serge Gauthier, M.D., Zaven Khachaturian, Ph.D., Peter Snyder, Ph.D. and Bruno Vellas, M.D..
About ExonHit's Alzheimer Scientific Advisory Board
The Board advises the Company on the development of novel therapies and the clinical development of molecular diagnostics for the research community, the pharmaceutical industry and the healthcare community at large with a particular emphasis on strategies for disease prevention.
Jeffrey Cummings, M.D., is the Augustus Rose Professor of Neurology, Director of the Mary S. Easton Center for Alzheimer's Disease Research, and Director of the Deane F. Johnson Center for Neurotherapeutics at the David Geffen School of Medicine at UCLA (Los Angeles, CA). He is the 2008 recipient of the National Alzheimer's Association's Ronald and Nancy Reagan Research Award. Professor Cummings has authored nearly 1,000 articles, chapters, and abstracts on Alzheimer's disease and other brain diseases.
Serge Gauthier, M.D., is a Professor within the Departments of Psychiatry, Neurology & Neurosurgery, and Medicine at McGill University (Montreal, Canada). He is also Director of the Alzheimer's Disease and Related Disorders Unit at the McGill Center for Studies in Aging, Douglas Mental Health University Institute. In 2006, he received the "Prix Ambassadeur" from the Montreal Palais des Congres and in 2007 was elected as one of the Best Doctors in North America(R).
Zaven Khachaturian, Ph.D., is a Senior Associate of Khachaturian and Associates (Potomac, MD). He was formerly President and CEO of the Lou Ruvo Brain Institute (Las Vegas, NV) which is dedicated to finding cures for memory, mood and movement disorders associated with dementia diseases (including Alzheimer's). Also, for nearly two decades, Dr. Khachaturian led the Alzheimer's disease research department at the U.S National Institutes of Health. In 1984, Dr. Khachaturian posited a unifying theory of brain aging, which is now referred to as the "Calcium Hypothesis of Brain Aging". Zaven Khachaturian is a former member of the FDA's Peripheral and Central Nervous System Advisory Committee and remains as ad hoc consultant.
Peter Snyder, Ph.D., is Vice President for Research for the Lifespan Hospital System (including Rhode Island Hospital) and Professor of Neurology at the Alpert Medical School of Brown University (Providence, RI). Earlier in his career, Dr. Snyder was an Early Clinical Leader and Director at Pfizer Pharmaceutical's Global Research & Development laboratories in Groton (Connecticut, USA). In 2008, he was honored as a Fulton-Cushing Lecturer in the Department of Neurosurgery at the Yale University School of Medicine. Dr. Snyder is the Associate Editor of Brain and Cognition, and he maintains an active research program in Alzheimer's disease.
Bruno Vellas, M.D., is a Professor of Internal Medicine & Geriatrics and heads the Alzheimer's Disease Clinical Research Center and the Gerontopole at Toulouse University Medical Center (Toulouse, France). He is a Principal investigator within the European Alzheimer's Disease Consortium and co-leads the Epidemiology and Sociology of Aging research group at Inserm Unit 558.
About Alzheimer's disease
Alzheimer's disease is a progressive neurodegenerative condition that is the most frequent cause of dementia in the elderly. Worldwide, an estimated 26.6 million people had Alzheimer's disease in 2006. This number is set to quadruple by 2050 to more than 100 million; 1 in 85 people worldwide will be living with the disease (3). In France alone, 800,000 people, or 18% of the population over-75, have Alzheimer's disease (4).
Note: AclarusDx(TM) Alzheimer's test is available as a Research Use Only product. It is a research tool and should not be used to diagnose patients in a clinical diagnostic setting until its registration as an IVD product in Europe and in the US
About ExonHit Therapeutics
ExonHit Therapeutics (Alternext: ALEHT) is a fast-emerging healthcare player active in both therapeutics and diagnostics. The company is applying its proprietary technology, based on the analysis of alternative RNA splicing, to develop innovative molecular diagnostic tests and therapeutics for neurodegenerative and cancer indications. ExonHit has a balanced investment strategy with internal development programs and strategic collaborations, in particular with bioMerieux and Allergan.
ExonHit is headquartered in Paris, France and has U.S. offices in Gaithersburg, Maryland. The company is listed on Alternext of NYSE Euronext Paris. For more information, please visit http://www.exonhit.com.
Disclaimer
This press release contains elements that are not historical facts including, without limitation, certain statements on future expectations and other forward-looking statements. Such statements are based on management's current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those anticipated.
In addition, ExonHit Therapeutics, its shareholders, and its affiliates, directors, officers, advisors and employees have not verified the accuracy of, and make no representations or warranties in relation to, statistical data or predictions contained in this press release that were taken or derived from third party sources or industry publications, and such statistical data and predictions are used in this press release for information purposes only.
Lastly, this press release may be drafted in the French and English languages. In an event of differences between the texts, the French language version shall prevail.
References
(2) CRO Market Surveillance report - IMS Health Global, March 2006 (Pharmaceutical/Biotech Market and Clinical Development)
(3) Brookmeyer R, Johnson E, Ziegler-Graham K, MH Arrighi (July 2007). "Forecasting the global burden of Alzheimer's disease". Alzheimer's and Dementia 3 (3): 186-91
(4) Plan Maladie d'Alzheimer 2004-2007- Ministere des solidarites, de la sante et de la famille
Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6112197&lang=en
Source: ExonHit Therapeutics
Nearly Half of State Residents Postponed Making Major Purchases;
34
Percent Have Taken Money Out of Savings or Investments To Help Pay
Expenses;
One-Third Working Longer Hours To Make Ends Meet
SIOUX FALLS, S.D.--(BUSINESS WIRE)-- A new survey released today by Citi revealed that South Dakotans are more positive about the economy in their area and employment opportunities for people like them than across the nation as a whole. In response to current economic concerns, however, South Dakota residents continue to make dramatic changes in their personal behavior and financial planning, including 46% who have postponed the purchase of a major item such as an automobile, 34% who have taken money out of savings or investments to help pay expenses, one third of South Dakotans (33%) are working longer hours to make ends meet and 13% are pursuing additional education in order to increase their opportunities.
Compared to national survey data released by Citi in September 2009, key findings from Citi's South Dakota survey illustrate:
-- While 50% of South Dakota residents believe that the country's economic
conditions have a ways to go before hitting bottom, this assessment is
not nearly as bleak as the 63% reported at the national level.
-- Nearly three in five (58%) South Dakotans expect that business
conditions in the area will become much or somewhat better over the next
12 months, a figure nearly identical to the 57% of national survey
participants who believe business conditions will get better in their
area.
-- This optimism resonates even more strongly at the personal level, with
67% of survey participants optimistic that their own financial situation
will improve over the next year, a finding closely aligned with the 65%
reported nationally.
Over one-third (37%) of South Dakotans cite the cost of health care as the element of America's economy that worries them most today, with 27% expressing greater concern over the amount of money they pay for daily necessities such as food and gasoline. By nearly two to one (30% to 17%), South Dakotans believe that they are worse off financially than they were a year ago, with 53% reporting their financial situations are about the same as before. While South Dakotans have a somewhat negative view of current economic conditions in their area, with 53% rating it only fair or poor, these attitudes are significantly more positive than figures reported from the national survey, which had 78% of participants reporting the economy in their area as fair or poor.
"The trend toward postponing major non-essential purchases is encouraging because it illustrates that South Dakota consumers are willing to make the tough choices necessary to stabilize and strengthen their personal finances during challenging times," said Kendall Stork, President and CEO of Citibank South Dakota. "Although the impact of the economic downturn on South Dakota residents cannot be underestimated, it is encouraging that more consumers are beginning to feel renewed confidence and that the worst might be behind us."
Signs of Optimism
Looking specifically at the housing market, South Dakotans are somewhat more likely to say that homes will increase in value rather than go down, with one in five (21%) believing home values in their area will go up over the next year and 62% suspecting the value of their homes will stay the same. Similarly, by a margin of 59% to 14% South Dakotan homeowners believe that if they put their homes on the market today, they would be able to sell their home for more than they paid for it.
South Dakotans are optimistic that circumstances will improve over the next 12 months and report that they will be looking to the performance of the stock market and personal investments, costs of daily necessities and quality of jobs in their area as signs that the economy is getting better.
"Surveys like these are valuable tools in helping us gain a deeper understanding of our customers' needs and aspirations," continued Stork. "Citi remains committed to providing the tools, services and expertise necessary to enable our customers to better manage their money and make that brighter economic future a reality."
Survey Methodology
Hart Research Associates conducted the telephone survey of 401 adults in South Dakota from September 14 to 16, 2009. The Random Digit Dialed (RDD) survey has an overall statistical margin of sampling error of plus or minus 4.9 percentage points and is higher among subgroups. Hart conducted the national survey of 2,005 adults nationally from September 1-5, 2009. It has a sampling error of plus or minus 2.2 percentage points. The survey also included a sample of respondents who use only a mobile telephone.
About Citi
Citi, the leading global financial services company, has approximately 200 million customer accounts and does business in more than 140 countries. Through Citicorp and Citi Holdings, Citi provides consumers, corporations, governments and institutions with a broad range of financial products and services, including consumer banking and credit, corporate and investment banking, securities brokerage, and wealth management. Additional information may be found at www.citigroup.com or www.citi.com.
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Source: Citi
BENTONVILLE, Ark., Dec. 3 /PRNewswire-FirstCall/ -- Wal-Mart Stores, Inc. (NYSE: WMT) announced today that it will collaborate with FIFA's exclusive worldwide master licensee, Global Brands Group (GBG), to operate 2010 FIFA World Cup(TM) Official Event Stores in nearly all of its retail markets around the world. Walmart will feature FIFA event branded shops inside select stores that will offer exclusive FIFA World Cup(TM) official licensed products and host special events leading up to the games.
"We want soccer fans around the world to participate in the world's most spectacular sporting event by giving them access to exclusive FIFA World Cup merchandise at a great price," said John Aden, senior vice president, Walmart International. ''This is a unique opportunity for us to leverage our global scale, bringing the 2010 FIFA World Cup South Africa(TM) experience to Walmart stores for our local customers."
The FIFA World Cup(TM) will begin June 11, 2010 and finish July 11, 2010. More than 26 billion cumulative viewers watched the 64 matches of the 2006 FIFA World Cup(TM). Soccer is by far the biggest sport in Europe, South America, Africa and the majority of markets in Asia.
Jerome Valcke, FIFA Secretary General, said, "This is an important milestone in our goal to connect with fans around the world. Given Walmart's global leadership position in the retail industry, it is the ideal platform to showcase the world-class merchandise we have been developing specifically for the 2010 FIFA World Cup(TM)."
Mark Matheny, CEO and Co-Chairman of Global Brands Group, said, "We are delighted to work with Walmart for the 2010 FIFA World Cup(TM). In the 105 year history of the association, this is the first time that such a coordinated retail presence with one retailer has been achieved."
All 2010 FIFA World Cup(TM) branded merchandise will be customized for the country where it will be sold. With everything from hats and bags, to soccer balls and T-shirts, fans who visit the shops will be able to support their team like never before. Walmart stores in Argentina, Brazil, Canada, Chile, China, Costa Rica, El Salvador, Guatemala, Honduras, Japan, Mexico, Nicaragua, Puerto Rico, United Kingdom and the United States are anticipated to participate.
About FIFA
For more than 100 years, the Federation Internationale de Football Association, founded on 21 May 1904 in Paris and better known as FIFA, has continued to provide the essential leadership role to the international football family. The eighth FIFA President, Joseph S. Blatter (Switzerland), guides the organization today with a commitment to the evolution of FIFA as a modern and dynamic association. For more information on FIFA and its competitions, especially on the 2010 FIFA World Cup South Africa(TM), visit the official website at www.fifa.com
About Global Brands Group
Global Brands Group is the world's leading independent, international brand management, retail and licensing company. Global Brands Group's passion for managing brands is tied to its desire to build sustainable equity and create new branding opportunities through geographic expansion, category extension and retail innovation. With corporate headquarters located in Singapore, Global Brands Group has a network of 14 offices in major cities around the world including London, Dubai, Tokyo, Hong Kong, Sydney, Buenos Aires and Johannesburg. www.globalbrandsgroup.com
About Wal-Mart Stores, Inc.
Wal-Mart Stores, Inc. (NYSE: WMT), or "Walmart," serves customers and members more than 200 million times per week at more than 8,000 retail units under 53 different banners in 15 countries. With fiscal year 2009 sales of $401 billion, Walmart employs more than 2.1 million associates worldwide. A leader in sustainability, corporate philanthropy and employment opportunity, Walmart ranked first among retailers in Fortune Magazine's 2009 Most Admired Companies survey. Additional information about Walmart can be found by visiting www.walmartstores.com. Online merchandise sales are available at www.walmart.com and www.samsclub.com.
SOURCE Wal-Mart Stores, Inc.
GLASGOW, UNITED KINGDOM -- (MARKET WIRE) -- 12/03/09 -- Easyspace, one of the leading providers of domain names and web hosting services in the UK, has this week launched its 2009 Christmas specials by offering discounts across its entire range of popular Gift Voucher products.
Launched in the last 2 months, the Gift Voucher range has already grown to be a popular addition to the existing products and services offered by Easyspace. Now, with Christmas just around the corner, Easyspace has discounted all 5 voucher values by 10%, allowing customers to buy at reduced cost as a gift for friends, family or colleagues, or as a way to buy their own new domains and hosting at a reduced cost.
Five values of Gift Voucher are available from Easyspace (Pounds Sterling 10, Pounds Sterling 25, Pounds Sterling 50, Pounds Sterling 75 and Pounds Sterling 100) and each can now be bought for 10% less (Pounds Sterling 9, Pounds Sterling 22.50, Pounds Sterling 45, Pounds Sterling 67.50 and Pounds Sterling 90), while continuing to hold its original value when it is used towards the purchase of a new product or service. What's more, Gift Vouchers can be used to purchase any product on Easyspace, from Domain Names to Web Hosting.
"We launched our Gift Voucher range just a couple of months ago in anticipation of the holiday season and, as planned, our 2009 offer for the festive period revolves around that new voucher range. Rather than discounting specific products, we've chosen to discount our vouchers, allowing customers to then pass the 10% saving on to any other purchase they make from Easyspace." comments Errol Vanderhorst, Managing Director at Easyspace.
"So, whether people are buying as a gift for friends, family or colleagues, or as a way to give themselves a saving on domain names, web hosting or any other product available at Easyspace, they can save a few pounds this Christmas, which is an opportunity most people are looking for given the financial year the country has had."
This discount pricing comes off the back of a quite a few product and service improvements at Easyspace, most notably the introduction of unlimited bandwidth and Wordpress compatibility with new shared web hosting packages and the One-Click install SaaS products now available with its range of Virtual Servers.
Errol continued, "It's been a busy and productive year at Easyspace with product and service improvements, including the launch of our popular Gift Vouchers, and we've quite a few upgrades and improvements ready to go live early in the next year."
For more information please see http://blog.easyspace.com/2009/12/02/easyspace-launches-christmas-discount-with-10-off-gift-vouchers/ .
Contacts: Easyspace Ltd Lister Pavilion, Kelvin Campus West of Scotland Science Park Glasgow G20 0SP UK +44 (0) 870 755 5088 +44 (0) 870 753 2332 (FAX) press@easyspace.com
BERLIN--(BUSINESS WIRE)-- At the KMIS meeting (Klinisch-Mikrobiologisch-Infektiologisches Symposium) on Dec. 3-5, 2009 in Berlin, Bruker Daltonics announces a framework agreement with Synlab (www.synlab.de) concerning molecular microbial identification based on MALDI-TOF mass spectrometry. Synlab is a European private diagnostic laboratory association, and Bruker Daltonics is the worldwide leading provider of mass spectrometry-based microorganism identification solutions. Synlab currently has more than 70 diagnostic laboratories in Germany and other European countries.
Synlab and Bruker have concluded a long-term partnership agreement in order to equip the laboratories of the Synlab association exclusively with the MALDI Biotyper system for fast and reliable molecular microbial identification. The MALDI Biotyper is currently already in routine use in Synlab's clinical microbiology centers in Trier, Weiden and Dachau in Germany. Moreover, Bruker and Synlab intend to further enlarge and refine the MALDI Biotyper reference library using well defined clinical isolates from the daily microbiology routine work of the Synlab laboratories.
The MALDI Biotyper is integrated into the Synlab laboratories' microbiology workflow, combining fast molecular identification with conventional antibiotic susceptibility testing (AST). The MALDI Biotyper reports the identification results into the existing laboratory information systems (LIS). Integration with LIS MCS (www.mcs-ag.com), Medat (www.medat.de) and Vision4health (www.vision4health.com) has already been established for Synlab, while integration with other LIS providers is also possible.
Dr. Ulrich Knipp, Technical Head of Microbiology at Synlab in Trier, commented: "After evaluating the MALDI Biotyper very thoroughly within the Synlab group, we are convinced that Bruker Daltonics is the most reliable partner for microbial identification based on mass spectrometry, and is providing outstanding microbiological service and support. Bruker Daltonics is fully established in the clinical microbiology market, and the MALDI Biotyper fulfils our requirements for reliability and robustness. The MALDI Biotyper represents a clear milestone substantiating our high quality molecular microbiology diagnostics."
Dr. Guido Mix, Director of Microbiology at Bruker Daltonics, added: "We are very pleased that our MALDI Biotyper fulfils the high demands of leading clinical laboratories like Synlab. Our framework contract with Synlab validates our efforts to provide comprehensive service and applications support to our customers by our dedicated microbiologists, fully developed technicians network and dedicated IT specialists for integration into various laboratory information systems (LIS)."
About the Bruker MALDI Biotyper
Bruker's dedicated MALDI Biotyper solution (www.bdal.com/maldibiotyper) enables molecular identification, and taxonomical classification or dereplication of microorganisms like bacteria, yeasts and fungi. Classification and identification of microorganisms is achieved reliably and quickly using proteomic fingerprinting by high-throughput MALDI-TOF mass spectrometry. Applications include clinical routine microbial identification, environmental and pharmaceutical analysis, taxonomical research, food and consumer product safety and quality control, as well as marine microbiology. Bruker's robust MALDI Biotyper method requires minimal sample preparation efforts and offers low consumables cost per sample. The MALDI Biotyper is available in a research-use-only version, as well as in an IVD-CE version according to EU directive EC/98/79 in certain European countries.
ABOUT BRUKER CORPORATION (NASDAQ: BRKR)
Bruker is a leading provider of high-performance scientific instruments and solutions for molecular and materials research, as well as for industrial and applied analysis. For more information: www.bruker.com
CAUTIONARY STATEMENT
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations, but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to adverse changes in conditions in the global economy and volatility in the capital markets, the integration of businesses we have acquired or may acquire in the future, changing technologies, product development and market acceptance of our products, the cost and pricing of our products, manufacturing, competition, dependence on collaborative partners and key suppliers, capital spending and government funding policies, changes in governmental regulations, intellectual property rights, litigation, and exposure to foreign currency fluctuations. These and other factors are identified and described in more detail in our filings with the SEC, including, without limitation, our annual report on Form 10-K for the year ended December 31, 2008, our most recent quarterly reports on Form 10-Q and our current reports on Form 8-K. We disclaim any intent or obligation to update these forward-looking statements other than as required by law.
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Source: Bruker Daltonics
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