Accuray Incorporated (Nasdaq ARAY), a global leader in the field of radiosurgery, announced today that the company will showcase the treatment planning capabilities of the CyberKnife(R) Robotic Radiosurgery System at the 10th Biennial European Society for Therapeutic Radiology and Oncology (ESTRO) Conference on Physics and Radiation Technology for Clinical Radiotherapy in Maastricht, The Netherlands.

The latest generation of the MultiPlan(R) Treatment Planning System provides the most comprehensive set of tools available for highprecision radiosurgery treatment planning. The CyberKnife Systems planning capabilities also include Monte Carlo Dose Calculation, which produces results in minutes compared to what commonly requires hours or days with other systems.

“We strongly believe that these new capabilities will transform the treatment planning practice, specifically for the treatment of lung tumors,” said Frederic Sottilini, Senior Director, Marketing, Accuray EMEA.

Clinical findings will be presented during the conference, including the results of a study presented by Erasmus MCDaniel den Hoed Cancer Center that demonstrates the benefits of the dose calculations performed using the CyberKnife Systems Monte Carlo Dose Calculation in the treatment of NonSmall Cell Lung Cancer.

Additionally a Lunch Symposium will be held on Monday, August 31 at 100 p.m. CET in room 04/05, where conference attendees can learn more about the versatility and precision of the CyberKnife Systems treatment planning and delivery technologies.

“Medical physicists from renowned academic centers will contribute to the scientific quality of this symposium, which should gather physicists from all over Europe who are interested in learning more about the highlysophisticated treatment planning techniques that are available,” said Sottilini.

About the CyberKnife(R) Robotic Radiosurgery System

The CyberKnife Robotic Radiosurgery System is the worlds only robotic radiosurgery system designed to treat tumors anywhere in the body noninvasively. Using continual image guidance technology and computer controlled robotic mobility, the CyberKnife System automatically tracks, detects and corrects for tumor and patient movement in realtime throughout the treatment. This enables the CyberKnife System to deliver highdose radiation with pinpoint precision, which minimizes damage to surrounding healthy tissue and eliminates the need for invasive head or body stabilization frames.

About Accuray

Accuray Incorporated (Nasdaq ARAY), based in Sunnyvale, Calif., is a global leader in the field of radiosurgery dedicated to providing an improved quality of life and a nonsurgical treatment option for those diagnosed with cancer. Accuray develops and markets the CyberKnife Robotic Radiosurgery System, which extends the benefits of radiosurgery to include extracranial tumors, including those in the spine, lung, prostate, liver and pancreas. To date, the CyberKnife System has been used to treat more than 70,000 patients worldwide and currently 176 systems have been installed in leading hospitals in the Americas, Europe and Asia.

Safe Harbor Statement

The foregoing may contain certain forwardlooking statements that involve risks and uncertainties, including uncertainties associated with the medical device industry. Except for the historical information contained herein, the matters set forth in this press release, as to performance of products, clinical studies, and market acceptance are forwardlooking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forwardlooking statements speak only as of the date the statements are made and are based on information available at the time those statements are made and/or managements good faith belief as of that time with respect to future events. You should not put undue reliance on any forwardlooking statements. Important factors that could cause actual performance and results to differ materially from the forwardlooking statements we make include commercialization of products; market acceptance of products; competing products; and other risks detailed from time to time under the heading “Risk Factors” in our report on Form 10K for the 2008 fiscal year, as updated from time to time by our quarterly reports on Form 10Q and our other filings with the Securities and Exchange Commission. The Companys actual results of operations may differ significantly from those contemplated by such forwardlooking statements as a result of these and other factors. We assume no obligation to update forwardlooking statements to reflect actual performance or results, changes in assumptions or changes in other factors affecting forwardlooking information, except to the extent required by applicable securities laws.

The worlds foremost thought leaders in the science of aging will convene at Harvard in September to discuss the question that has perplexed people since Ponce de Leon first sought out the Fountain of Youth, “can we live longer and healthier lives?” For the first time the scientific consensus appears to be, “yes.”

Worldrenowned physicians, academic leaders and awardwinning researchers in what has been described as the hottest field in biology, are expected to attend the first ever Aging & Healthy Lifespan Conference on Sept. 23 at Harvard Medical School. They plan to present breakthrough scientific research and insights on social trends that may provide the key to unlock the secret to living longer and healthier lives. The groundbreaking research presented by these experts has been predicted to change healthcare as we know it by combating agerelated diseases like Alzheimers, type2 diabetes and cancer, ultimately extending the human lifespan altogether.

The conferences agenda features more than 20 experts, who have been described as mavericks and pioneers in the field of aging research, including Aubrey de Grey, Ph.D., Chairman and Chief Science Officer of the Methuselah Foundation, who developed an approach to identify all components that cause human aging and remedy each one to expedite a cure for aging;
David Ewing Duncan, awardwinning journalist and bestselling author of seven books, including The Experimental Man, a Chief Correspondent for public radios “Biotech Nation,” a longtime commentator for NPRs “Morning Edition,” and the Director of the Center for Life Science Policy and a Visiting Researcher at the Graduate School of Journalism at the University of California, Berkley.
Leonard Guarente, Ph.D., Novartis Professor of Biology at the Massachusetts Institute of Technology and researcher credited with the discovery of the biochemical activities of sirtuins that have the potential to combat diseases of aging;
Cynthia Kenyon, Ph.D., Director of Hillblom Center for the Biology of Aging, University of California, San Francisco, who first discovered that genetic dissection influences aging;
Michael F. Roizen, M.D., CoFounder of RealAge and awardwinning, #1 New York Times bestselling author and coauthor of five books in the RealAge series, including RealAge Are You as Young as You Can Be? and YOU The Owners Manual An Insiders Guide to the Body that Will Make You Healthier and Younger, coauthored with Dr. Mehmet Oz.
David Sinclair, Ph.D., Sirtris CoFounder, Scientific Advisory Board CoChair and Associate Professor of Pathology at Harvard Medical School and key contributor to the scientific understanding of aging;
Christoph Westphal, M.D., Ph.D., Chief Executive Officer, Sirtris, a GSK Company and Senior Vice President, Centre of Excellence for External Drug Discovery, GSK. Sirtris is focused on discovering and developing drugs to treat diseases of aging. Speakers at the Aging & Healthy Lifespan Conference will present emerging research into scientific and medical advances in aging, as well as lifestyle and demographic trends on two speaker tracks. One track will focus on new research and insights in the science of aging including updates on the science behind sirtuins and resveratrol, the key ingredient in red wine that researchers believe has the power to slow symptoms of aging. The second track will feature emerging social trends in lifestyles, behaviors and activities of the aging population.

The meeting of these experts is welltimed, as over the next 20 years, the population over age 65 is expected to double, and with it, healthcare spending expected to rise by 25 percent.

“We have understood the science behind aging for some time now, but now we are finally working towards making this research a pharmaceutical reality,” said Dr. Sinclair. “I think the highlight of the Aging & Health Lifespan Conference will be the examination of how this research can have a lifechanging effect on our aging population in the very near term.”

UroToday.com In the June issue of the Journal of Urology, Dr. Philipp Dahm and colleagues report that duplicate presentations commonly occur at the American Urological Association (AUA) and European Association of Urology (EAU) annual meetings.

The authors state that duplicate presentations of the same data at multiple meetings has disadvantages to include decreasing the opportunity for other presentations and decreasing the newsworthiness of the duplicate data. In this report, duplicate presentations at the AUA and EAU annual meetings in 2005, 2006, and 2007 were identified. The 2006 annual association meetings served as the reference meeting. The annual meeting online abstract databases were used to identify clinical research studies, and basic science was excluded. Only studies of identical design and objective were considered duplicates. The authors also determined the publication rate of duplicate abstracts using the science citation index.

At the 2006 EAU and AUA annual meetings, 282 and 312 prostate cancer related abstracts were identified, respectively. Similar characteristics were identified with regard to the number of authors, the country of authorship, and the study design. The median number of contributing authors was 6, and 81% of duplicate abstracts originated in a single country. Among the identified prostate cancer abstracts, 92.4% were observational studies and most commonly uncontrolled case series in 45.4%. At the AUA, abstracts originated from North America in 69.2%, Europe in 25.6% and other parts of the world in 5.1%. At the EAU, abstracts originated from North America in 12.1%, Europe in 79.1% and other parts of the world in 8.9%. In the AUA abstracts, study sample size was significantly higher with 50% including over 500 subjects compared with 29.4% at the EAU meeting. Overall duplicate rate of AUA abstracts at the 2006 annual meeting was 19.2% (60 of 312) and 48 of these 60 were presented at the EAU meeting the same year. Eight were presented at the EAU meeting the previous year (2005) and 4 presented the following year (2007). At the 2006 EAU meeting, the duplication rate of prostate cancer abstracts was 20.9% (59 of 282) with 48 of 59 presented at the 2006 AUA meeting, 3 the year before and 8 the year after.

Among the duplicated abstracts, 40.8% had a modified title and in 43.6% of studies the number of authors changed. Multivariate logistic regression analysis revealed that an outcome study design type and European abstract origin were the strongest predictors of duplicate presentation. With a followup of 30 months, 25 of 71 studies (35.1%) were published in journals indexed by the PubMed. Most commonly the journal was European Urology (32%). In summary one fifth of prostate cancer clinical research abstracts were presented at the AUA and EAU annual meetings in duplicate.

Pop GH, Fesperman SF, Ball DA, Yeung LL, Vieweg J, Dahm P
J Urol. 2009 Aug;182(2)6748
doi10.1016/j.juro.2009.04.024

Written by UroToday.com Contributing Editor Christopher P. Evans, MD, FACS

UroToday the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice. To access the latest urology news releases from UroToday, go tourotoday.com

Updates on the impact of sexually transmitted diseases, infection risk from animals in the home and public settings, seasonal and H1N1 influenza, and foodborne diseases were presented today at a news conference at the National Press Club in Washington, D.C. The news conference was sponsored by the National Foundation for Infectious Diseases (NFID).

“Each year we face new and reemerging infectious diseases threats,” said Susan J. Rehm, M.D., NFID medical director and vice chair, Department of Infectious Disease, at the Cleveland Clinic. “Our goal as medical professionals is to ensure that we identify these threats in a timely manner and educate the public to minimize the overall impact on society.”

Influenza is currently the leading cause of vaccinepreventable death in the United States. Seasonal influenza causes an estimated 36,000 deaths and 200,000 hospitalizations in the United States. Most of the deaths occur in the elderly, but the hospitalization rate for children 2 years of age and younger is comparable to the hospitalization rate of the elderly. As of June 30, 2009 the Centers for Disease Control and Prevention had received 89 reports of influenzaassociated pediatric deaths with 67 being attributed to seasonal influenza and 22 pandemic influenza cases.

“Unfortunately, seasonal influenza immunization has never been a health priority for Americans,” said Carol J. Baker, executive director of the Texas Childrens Hospital Center for Vaccine Awareness and Research and professor of pediatrics, molecular virology and microbiology at Baylor College of Medicine in Houston. “Influenza is not easy to recognize and is often confused with less severe respiratory viral infectious such as the common cold.”

Novel H1N1 influenza virus, which was recognized in late April 2009, has caused a million cases of influenza worldwide and the age groups most affected are the young rather than the elderly. Cases of the pandemic (novel H1N1) influenza are expected to rise during this fall and winter.

“Seasonal influenza vaccine should be available soon. We should start immunizing as soon as the vaccine is available to prevent the seasonal influenza. In addition to vaccines, we should remember hand hygiene, cough etiquette and social distancing also helps to prevent the spread of both types of influenza,” said Dr. Baker.

Additional topics discussed at the 14th Richard J. Duma/NFID Annual News Conference and Symposium on Infectious Diseases included

Sexually Transmitted Diseases Neither Gone Nor Forgotten David Martin, M.D., chief, section of Infectious Diseases and Harry E. Dascomb Professor of Medicine and Microbiology at Louisiana State University School of Medicine in New Orleans, discussed the most common reportable infectious diseases in the United States is Chlyamydia trachomatis. The number of reported cases is growing each year due to increased screening efforts. “Excellent C. trachomatis diagnostic tests are now available and can be performed on urine specimens. Treatment is inexpensive and safe. Therefore, theoretically, this common STD could be dramatically curtailed in the United States population if broadbased screening efforts were undertaken,” said Dr. Martin. Dr. Martin outlined the need to eliminate barriers associated with screening including lack of access to healthcare, health care provider reticence to address sexual health issues, limited budgets to support screening programs, insufficient treatment of exposed sex partners, and lack of knowledge on the part of young sexually active individuals about the true risk of unprotected sexual intercourse with multiple partners. Dr. Martin also provided updates on treatment options for gonorrhea, the increased incidence of syphilis and medical advances which lead to discoveries of new STDs.

Infection Risk from Animals in the Home and in Public Settings Larry K. Pickering, M.D., FAAP, senior advisor to the director of the National Center for Immunization and Respiratory Diseases of the Centers for Disease Control and Prevention, executive secretary of the Advisory Committee on Immunization Practices (ACIP) and professor of pediatrics in the department of pediatrics at Emory University School of Medicine outlined the risks associated with animal exposures to nontraditional pets in the home and to animals in public settings. “The majority of households in the United States own a pet, and exposure to animals in public settings (petting zoos, state fairs, pet stores, animal swap meets, carnivals, child care centers) results in millions of humananimal interaction each year. Many pet owners, people in the process of choosing a pet and people exposed to animals in public settings are not aware of the potential risk posed by certain animals, especially nontraditional pets such as rodents, reptiles and weasels,” stated Dr. Pickering. “Infections with organisms acquired from these animals can involve many organ systems including the gastrointestinal tract, skin, lungs, blood and central nervous system. Organisms which have been associated with outbreaks include Salmonella species, E. coli 0157H7, Campylobacter species, Cryptosporidum species, and lymphocytic choriomeningitis. Dr. Pickering discussed regulations and recommendations applicable to these exposures and defined measures which can minimize or prevent illness in children from exposure to these animals.

Foodborne Diseases The Continuing Challenges to Public Health Robert V. Tauxe, M.D., M.P.H., deputy director, Division of Foodborne Bacterial, and Mycotic Diseases at the Centers for Disease Control and Prevention (CDC) provided an overview on the prevention of foodborne diseases, how they can be prevented and the roles the CDC plays in detection and prevention. “Educating consumers and food handlers is important, but not sufficient,” said Dr. Tauxe. “Through studying various outbreaks we can learn how to prevent disease through targeted prevention strategies.”

Since 1996 the CDC has utilized a national surveillance network which allows for sharing of DNA fingerprint patterns, permitting rapid detection of clusters of strains from ill persons that have matching patterns. This system facilitates the detection and investigation of dispersed common sources of outbreaks. Each year 50,000 strains are reported to the surveillance system. In recent years the system has detected multistate outbreaks including E. coli, Salmonella, and Botulism.

About the News Conference and Symposium

The 14th Richard J. Duma/NFID Annual News Conference and Symposium on Infectious Diseases was supported, in part, by unrestricted educational grants to NFID from Cubist Pharmaceuticals, Inc.; Merck & Co., Inc; Roche; and Wyeth Pharmaceuticals.

This event is named for former NFID president and executive director Richard J. Duma, M.D, Ph.D., currently director of infectious diseases at Halifax Medical Center in Daytona Beach, Florida.

About the National Foundation for Infectious Diseases

The National Foundation for Infectious Diseases (NFID) is a nonprofit, taxexempt 501(c)(3) organization founded in 1973 and dedicated to educating the public and healthcare professionals about the causes, treatment and prevention of infectious diseases

American Psychological Association 117th Annual Convention in Toronto, Canada, Aug. 69, 2009

Thursday, Aug. 6, Friday, Aug. 7, Saturday Aug.8, 800 am 500 pm
Sunday, Aug. 9, 800 am 12 noon

Program and Papers

The program will be available online in early July. Programs will also be available on site.

APA Annual Convention Highlights

Thursday, Aug. 6 Opening Session New Developments in Genetics Research Pros and Cons of Personalized Medicine, Francis Collins, MD, PhD, National Institute of Health, Bethesda, Md.

Paper Session The Internet Networks, Connections and Addictions, Kimberly Young, PsyD, St. Bonaventure University, Katherine Loufus, MA, University of Dallas, Dana Klisanin, PhD, N.Y., and Gilbert J. Garza, PhD, University of Dallas

Symposium PTSD and the Return From War Treatment, Recovery and Reintegration, Walter E. Penk, PhD, Cental Texas VA Health Care System, College Station, Texas

Invited Address Loneliness Human Nature and the Need for Social Connections, John T. Cacioppo, PhD, University of Chicago

Symposium New Happenings in Trauma Research, Patricia A. Frazier, PhD, University of MinnesotaTwin Cities

Paper Session Less Materialism Consumer Spending During Recession, Lilia Boujbel, PhD, Montreal, Canada, Seraphine ShenMiller, MA, University of Oregon and Joel Saegert, PhD, University of Texas, San Antonio Friday, Aug. 7 Symposium Using Virtual Environments to Treat Mental Disorders, Richard W. Wexler, PhD, Personnel Systems Inc., Pomona, N.Y., and Stephane Bouchard, PhD, University of Quebec at Ooutaouais, Hull, Quebec City, Canada

Invited Address Helping Employees Adapt to Downsizings, Acquisitions and Other Workplace Transitions, Mitchell Lee Marks, PhD, San Francisco State University and JoiningForces.org

Invited Address Understanding How Different Races Interact, Jennifer A. Richeson, PhD, Northwestern University

Invited Address Geographic and Psychological Profiling Does it Work? Kim Rossmo, PhD, Texas State University

Invited Address Resiliency and Mental Health Of Gay Minority Teenagers, Ritch C. SavinWilliams, PhD, Cornell University

Invited Address Why Are We Angry? Raymond DiGiuseppe, PhD, St. Johns University

Invited Address Recovering From Economic Crisis Preparing Employees for Opportunities and Challenges, Mitchell Lee Marks, PhD, San Francisco State University

Roundtable Discussion Rise in Trafficking Women in Africa, Asia and the United States, Thema S. BryantDavis, PhD, Pepperdine University

Symposium Issues and Challenges of GayStraight Relationships, Mark S. Kiselica, PhD, College of New Jersey

Invited Address Myths and Realities of Workplace Aggression and Violence, Julian Barling, PhD, Queens University at Kingston, Ontario, Canada Saturday, Aug. 8 Invited Address How Dogs Think, Stanley Coren, PhD, University of British Columbia, Canada

Invited Address Happiness in Turbulent Times, Ed Diener, PhD, University of Illinois at UrbanaChampaign

Invited Address Aging Well in the 21st Century, Laura L. Carstensen, PhD, Stanford University

Plenary Session Genetic Risk for Mental Disorders New Ways for Prevention, Ahmad Hariri, PhD, University of Pittsburgh

Invited Address Stress, Inflammation and Multiple Sclerosis, Mary W. Meagher, PhD, Texas A&M University

Paper Session Current Research on Autism, Anna J. Esbensen, PhD, University of WisconsinMadison

Symposium Managing Menopause With Hypnotherapy, Gary Evans, PhD, Baylor University

Symposium Underlying Connections of Drug Addiction and Learning, Paul Schnur, PhD, and David Shurtleff, PhD, National Institute on Drug Abuse, Bethesda, Md.

Presidential Address Promises of Obama Lessons of Leadership in Times of Crisis and Change, Greg Pennington, PhD, Hay Group Inc., Atlanta

Invited Address How Social Experiences (Re)Program the Brain, Michael Meaney, PhD, Douglas Institute, Montreal, Canada Sunday, Aug. 9 Symposium Challenges of Eliminating Racism The U.S. Election and Moving Forward, Shara Sand, PsyD, LaGuardia Community College

Symposium Human Factors in Sports, Robert Gray, PhD, Arizona State University

Symposium Preventing College Drinking and Drug Use, William H. Zywiak, PhD, Pacific Institute for Research and Evaluation, Pawtucket, R.I.

Symposium Military Substance Use, Mental Health and Deployment Issues, Robert M. Bray, PhD, RTI International, Research Triangle Park, N.C.

Invited Address Physical Inactivity Biggest Public Health Problem of 21st Century, Steven N. Blair, PhD, University of South CarolinaColumbia

Paper Session Personality Characteristics, Intelligence and Humor Styles of StandUp Comedians, Gil Greengross, MS, University of New Mexico

Invited Address Brain Studies of Chemical Sense Cues Reveal Alcoholism Risk, David Kareken, PhD, Indiana UniversityPurdue University at Indianapolis Other Program Highlights Trends in Retirement

Eating Disorders Around the World

Sex Differences in Recovery from Knee Surgery

Autisms Effect on Siblings

Do Nutritional and Herbal Supplements Work for Depression?

Creativity Over the Lifespan

How Emotional Intelligence Affects Pilots and Athletes Focus

Predictors of Adolescent Obesity

What Protects Soldiers Deployed to Iraq From Developing PTSD?

Culture and Suicide Rates

How Interaction with Animals Can Alleviate Test Anxiety in College Students

Traits of Oldest Old in LongTerm Care

Healing Powers of Animals

Sports Fans Experience

Omega3 Treatment of Psychiatric Disorders in Children and Adolescents

Age Differences in ProEnvironmental Behavior

Rates of Suicide and Homicides in the United States

Best and Worst Movie Portrayals of Mental Illness and its Treatment

Pros and Cons of Text Messaging Among College Students

Effect of Video Games on Academic Achievement Source
Pam Willenz

Researchers are proposing a new system that would warn of an impending pandemic before the first case of disease emerged in a given population by detecting subtle signals in human behavior.

“The goal is a public information and awareness system for pandemic with the same level of credibility, timeliness and visibility as stormwarning icons presented on television screens,” said Barrett Caldwell, a Purdue University associate professor of industrial engineering.

The system works by monitoring “event phases” of human behavior leading up to a pandemic, such as an increase in people purchasing flurelated medications or “foraging” on the Internet for certain types of information related to the flu.

Understanding these phases might be a way to overcome a fundamental hurdle in controlling pandemic Conventional approaches require publichealth officials to know when certain events leading to pandemic begin, Caldwell said.

“The problem with this requirement is that by the time you know an event has happened, its often too late to do much about it,” he said.

Caldwell and former Purdue industrial engineering doctoral student Sandra K. Garrett have proposed a new approach to warn the public of an impending pandemic.

“If you can recognize the triggers, the signals suggesting an event is likely to occur, you can start responding to it, gathering resources, preparing and mobilizing people,” said Garrett, an assistant professor of industrial engineering at Clemson University. “Our basic research idea could be used for any pandemic, or even other types of disasters.”

Garrett and Caldwell detailed the findings in a paper that will be presented June 2 at the Industrial Engineering Research Conference in Miami.

The paper shows how prepandemic events are separated into four categories of “human factors,” or social behavior a period during which it is first possible to detect signals of an emerging pandemic; a time when it is possible to begin early efforts to prevent or mitigate spread; a time when it is critical to implement such measures; and a period when it is time to complete mitigation steps.

The method is an elaboration of “signaldetection theory,” conceived decades ago.

“Normally, when psychologists study signal detection, they are looking at very rapid changes, like whether a tone changes, whether a light changes color or turns on and off,” Caldwell said.

The new approach proposes to make signal detection sensitive to more gradual events that are slower to develop.

“This is important because a pandemic is not a single point in time but a scenario that may take place in several waves over a period of months,” he said. “One of the challenges is that the way influenza spreads, you dont know that someones sick until several days later, and by then they have had the opportunity to infect other people. At that point you have to project backward to see where people have first been sick and where certain flurelated events have happened. You are reactive, rather than proactive.”

The researchers envision a system that uses icons similar to those used to alert the public about an impending blizzard, hurricane or tornado. The new approach would enable public health officials to properly manage “event deadlines,” or respond to a problem before its too late.

“For example, by now we have many cases in the United States, so the event deadline for closing travel boarders with Mexico has already passed,” Caldwell said.

The method also would enable officials to recognize a critical “trigger” that marks when people are prompted to act in certain ways based on a mental preview of what they think may happen in the near future.

“This trigger could be that something has already happened or you think that something is going to happen so you are doing something to prepare yourself,” Caldwell said. “There are no swine flu cases yet, but you think there might be cases near where you live. You go out and buy cans of food and extra juice, and so on.”

A need for such a warning system can be seen in the World Health Organizations unexpectedly rapid response to swine flu, Caldwell said.

“Health officials were very surprised that the World Health Organization went from a phase 3 pandemic alert to phase 5 in 48 hours,” he said. “The pandemic preparation materials produced a few years ago stated that these sorts of decisions could be expected to evolve over several days to maybe two weeks, but not two days. So the events have unfolded much faster than people were expecting.”

The research was funded by a grant from the Indiana State Department of Health through Purdues Healthcare Technical Assistance Program, based at Purdues Discovery Park, which strives to improve healthcare performance and delivery.

In related work, the researchers have collaborated with health officials and hospitals in Indiana to determine an “alternative care system” that may need to be activated once a pandemic reaches the local area.

“A pandemic flu alternative care system is designed to respond to concerns that the existing hospital structures may not have the capacity to respond to the number of flu cases,” Caldwell said. “One of the problems that we uncovered in research was that a really complex alternative care system requires even more advance planning and even more coordination of signals to know when and how to activate. Something that starts out with just a fluinformation telephone number isnt bad, but we had looked at systems all the way up to temporary satellite hospitals that just handled incoming flu patients.”

Previous research emphasized that counties should recognize when and what type of alternative care system would be required based on the signals officials received, determining when to activate the system based on where cases were being reported.

Writer
Emil Venere

Source
Emil Venere
Purdue University See our Map Of H1N1 OutbreaksSee our Mexico Swine Flu Blog

Science is largely a collaborative enterprise. Frequently researchers from various disciplines but with some common interests pool their efforts and exchange ideas, to devise new avenues of investigation. When unraveling complex conditions such as those known as autism spectrum disorders, researchers from different centers also benefit by drawing on diverse populations of patients, finding a broader pool of information than even a large facility can provide.

Such collaboration is the rationale for the MidAtlantic Research Consortium (MAC) of the federally sponsored Intellectual and Developmental Disabilities Research Centers (IDDRC). The consortium met on April 27 to focus on autism studies. The Childrens Hospital of Philadelphia hosted the fullday research symposium, which brought together scientists from centers in Philadelphia, Baltimore and Washington.

The research centers have a history of cooperation with one another going back 25 to 30 years, said the symposiums moderator, Marc Yudkoff, M.D., director of the IDDRC at Childrens Hospital, and a faculty member of the University of Pennsylvania School of Medicine.

CHOP and Penn, along with Childrens National Medical Center in Washington, D.C., and the Kennedy Krieger Institute of Johns Hopkins University in Baltimore, comprise the MidAtlantic Research Consortium. All four institutions have centers created and funded by the National Institutes of Health, committed to researching causes and treatments of developmental disabilities and mental retardation. “The goal of all our centers, both at CHOP and throughout the country, is to improve both diagnoses and outcomes for people with developmental disabilities,” said Yudkoff, who is chief of Child Development, Rehabilitation and Metabolic Disease at Childrens Hospital.

The consortium made autism spectrum disorders the centerpiece of their meeting, said Yudkoff, acknowledging multifaceted research being pursued by the participating centers, using genetics, neurobiology and imaging studies to investigate the intricate puzzle of autism.

“The last 20 years of research have made it clear that autism is not a single disease, but a continuum of multiple disorders thats why we refer to the autism spectrum,” said Michael Robinson, Ph.D., associate director of the IDDRC at Childrens Hospital. “Researchers ultimately must subclassify patients based on genetics and behavior, then focus on subgroups of ASDs in animal models. Scientists will then translate those findings into therapies personalized to a childs specific subtype of autistic disorder.”

Gene studies took the stage in a presentation by Hakon Hakonarson, M.D., Ph.D., director of the Center for Applied Genomics at CHOP. Hakonarson described the first study to find a common gene involved in autism spectrum disorders (ASDs), research that attracted substantial press attention when it was published the day after the symposium. That study and another study by Hakonarsons team found two major gene pathways involved in autism, both of which play important roles in early brain development.

Several researchers presented the results of brain imaging studies. Lauren Kenworthy, Ph.D., of Childrens National Medical Center, showed how brains respond when children are asked to complete tasks that involve memory and organization. Different brain regions were active in children with highfunctioning autism, in contrast to brain activity in “neurotypical” children those without autism or other neurological disorders. Robert Schultz, Ph.D., director of the Center for Autism Research at CHOP, used magnetic resonance imaging (MRI) and other imaging tools to study the “social brain,” showing how children with ASDs and neurotypical children have contrasting patterns of brain activity when recognizing peoples faces.

In a third broad area, basic science studies, Mary Blue, Ph.D., of Kennedy Krieger Institute, presented the results of animal studies that shed light on how autism operates in humans. By altering the flow of serotonin, a neurotransmitter in the brain, Blue showed that mice behaved less socially, had impairments in fine motor functions and increased repetitive behaviors. The changed animal behaviors, said Blue, shared similarities with some behaviors seen in children with ASDs, and greater knowledge of the relationship between brain chemicals and behavior might suggest future treatments for children.

Melissa Parisi, M.D., Ph.D., of the Eunice Kennedy Shriver National Institute of Child Health and Development, provided a federal government perspective on the research findings. Parisi, who heads up the NIH branch that supports the various IDDRC programs, noted that all the centers are multidisciplinary, with an emphasis on quickly translating scientific discoveries into clinical treatments. Referring specifically to autism research within NIH, Parisi added, the overall plan “addresses overarching questions for families, such as what treatments work, and what does the future hold?”

About The Childrens Hospital of Philadelphia The Childrens Hospital of Philadelphia was founded in 1855 as the nations first pediatric hospital. Through its longstanding commitment to providing exceptional patient care, training new generations of pediatric healthcare professionals and pioneering major research initiatives, Childrens Hospital has fostered many discoveries that have benefited children worldwide. Its pediatric research program is among the largest in the country, ranking second in National Institutes of Health funding. In addition, its unique familycentered care and public service programs have brought the 430bed hospital recognition as a leading advocate for children and adolescents.

New results released demonstrate that the enlargement of Zometa(R) (zoledronic acid) injection to garden variety chemotherapy before breast cancer surgery reduces the size of breast tumors more effectively than chemotherapy alone in women with earlystage disease.

These neoadjuvant subset results from the retrospective exploratory analysis of the ecumenical AZURE (Adjuvant Zoledronic acid to redUce REcurrence) trial are the first to spectacle the direct effect of Zometa in combination with chemotherapy to support shrink cancerous breast tumors, potentially resulting in deficient radical surgery for some women. The poop sheet were presented at the 31st Annual CTRCAACR San Antonio Breast Cancer Symposium.

“These results support a abeyant antitumor benefit of combining Zometa with chemotherapy in the neoadjuvant treatment of breast cancer,” said Matthew Winter, MBChB MSc, Clinical Research Fellow, University of Sheffield, UK, a head investigator of that subset analysis. “Adding Zometa to chemotherapy prior to surgery increased tumor shrinkage in that analysis. When breast cancer treatment is habituated prior to surgery, the goal is to reduce the size of the tumor and in doing so potentially improve breast conservation relations and longerterm outcomes.”

In the analysis, pre and postmenopausal women who received Zometa in adding to chemotherapy before surgery (neoadjuvant use) experienced a significant 33% reduction in the size of their primary tumor (14.1 mm reduction in tumor size) compared with patients who received chemotherapy alone (P=0.002)(1). The proportion of patients requiring mastectomy was higher (77.9%) in the chemotherapyalone group than in the Zometa group (65.3%).

“Clinical evidence continues to demonstrate that Zometa may play a role in protecting patients from the return and spread of earlystage breast cancer,” said David Epstein, President and CEO, Novartis Oncology. “We are encouraged by these latest results, which parade Zometa may avail some women abstain mastectomies, and we conscious committed to further exploring the benefit of Zometa as an anticancer treatment.”

Zometa is the apples leading treatment to reduce or delay bone complications in patients with progressive cancer that has spread to the bones over a broad range of solid tumors, including breast cancer.

The plausible anticancer properties of Zometa were previously observed in premenopausal women with earlystage breast cancer from the Austrian Breast & Colorectal Cancer Study Group12 (ABCSG12) study, which was presented at the American Society of Clinical Oncology annual meeting (ASCO) earlier that year. Final results from the AZURE trial are expected in the next two to three years.

Novartis is further exploring the anticancer effect of Zometa in a broad clinical program in breast, lung and prostate cancers with the results expected habituated in the next two to three years. Laboratory research has suggested that Zometa may assist protect patients with earlystage breast cancer from the return or spread of the cancer to other parts of the body (distant metastatic sites) through several unequal pathways, including inhibiting angiogenesis (formation of blood vessels that grow and dine cancer cells), stimulating cancerfighting Tcells, inducing tumor cell apoptosis (programmed cell un) and summation the activity of anticancer agents that target tumor cell metastases(2).

Study details

AZURE is a randomized, openlabel, multicenter, parallel group trial with a fiveyear treatment phase and a subsequent fiveyear followup phase designed to determine whether Zometa, added to usual therapy (chemotherapy and/or hormonal therapy) before (neoadjuvant) or after (adjuvant) surgery, is superior to each therapy alone in improving diseasefree survival in pre and postmenopausal women with earlystage breast cancer. The trial includes 3,360 patients from 174 centers in seven countries and is coordinated by the Cancer Research Centre, Weston Park Hospital, Sheffield, England with support from Novartis(1).

The neoadjuvant subset in the doing analysis included 205 participants who received either chemotherapy alone or in combination with Zometa once occasionally so often three to four weeks for six months prior to breast cancer surgery. Following adjustment for other prognostic factors, the adjusted mean tumor size after treatment was 28.2 millimeters in the Zometa group and 42.4 millimeters in the chemotherapy group, a significant reduction of 33%(1). The pathologic complete response rate (no evidence of residual cancer in the breast or lymph nodes) increased to 10.9% in the Zometa group from 5.8% in the chemotherapy group (P=0.033). The proportion of women needing a mastectomy was reduced by 16% in patients taking Zometa (65.3% in the Zometa group versus 77.9% in the chemotherapyalone group)(1).

About Zometa

Zometa is indicated for patients with multiple myeloma and documented bone metastases from solid tumors in conjunction with regulation antineoplastic therapy; prostate cancer should have progressed after treatment with at least one hormonal therapy.

weighty safety material

Zometa is contraindicated in patients with hypersensitivity to zoledronic acid or other bisphosphonates, or any of the excipients in the formulation of Zometa. Hypersensitivity reactions, including rare cases of urticaria and angioedema and very rare cases of anaphylactic reaction/shock, have antediluvian reported.

Due to the risk of clinically significant deterioration in renal objective, which may progress to renal downfall, singular doses of Zometa should not exceed 4 mg, and the duration of infusion should be no diminished than 15 minutes. Risk factors for the deterioration of renal use combine impaired baseline renal work and multiple cycles of bisphosphonate treatment.

Zometa is not recommended in patients with bone metastases with severe renal impairment. In patients with mild to moderate renal impairment at baseline, lower doses of Zometa are recommended based on calculated creatinine clearance. Before each Zometa dose, serum creatinine should be measured and treatment should be withheld for renal deterioration until serum creatinine has returned to within 10% of the baseline value.

Zometa should not be used pending pregnancy. Women of childbearing hidden should be advised to shake off becoming pregnant. If the patient becomes pregnant while taking that drug, the patient should be apprised of the imaginable harm to the fetus.

Osteonecrosis of the jaw (ONJ) has oldfashioned reported predominantly in cancer patients treated with intravenous bisphosphonates, including Zometa. profuse of these patients were stable with receiving chemotherapy and corticosteroids, which may be risk factors for ONJ. Postmarketing patience and the literature suggest a greater density of reports of ONJ based on tumor lot (far out breast cancer, multiple myeloma) and dental status (dental extraction, periodontal disease, legendary trauma, including poorly fitting dentures). alive with reports of ONJ involved patients with signs of limited infection, including osteomyelitis. Cancer patients should maintain appreciated oral hygiene and should have a dental examination with preventive dentistry prior to treatment with bisphosphonates. While on treatment, these patients should shuffle off invasive dental procedures, if conceivable. No whole relation are available as to whether discontinuation of bisphosphonate therapy reduces the risk of ONJ in patients requiring dental procedures. A causal relationship halfway bisphosphonate use and ONJ has not olden established. Clinical judgment of the treating physician should guide the management plan of each patient based on characteristic benefit/risk assessment.

In postmarketing understanding, severe and occasionally incapacitating bone, joint and/or muscle pain has disused reported infrequently in patients taking bisphosphonates.

The largest common adverse events (greater than or equal to 15%) in bone metastases clinical trials, regardless of causality, with Zometa 4 mg (n=1031) were as succeeds bone pain (55%), nausea (46%), fatigue (39%), anemia (33%), pyrexia (32%), vomiting (32%), constipation (31%), dyspnea (27%), diarrhea (24%), weakness (24%), myalgia (23%), anorexia (22%), cough (22%), arthralgia (21%), lowerlimb edema (21%), malignant neoplasm aggravated (20%), headache (19%), dizziness (excluding vertigo) (18%), insomnia (16%), decreased weight (16%), back pain (15%) and paresthesia (15%).

Caution is advised when bisphosphonates are administered with aminoglycosides, loop diuretics and potentially nephrotoxic drugs.

Zometa contains the aforementioned active ingredient as inaugurate in Reclast(R) (zoledronic acid). Patients being treated with Zometa should not be treated with Reclast.

Patients should be administered an oral calcium supplement of 500 mg and a multiple vitamin containing 400 IU of vitamin D daily.

Please see full Prescribing dossier.

Disclaimer

The foregoing release contains forwardappearing statements that can be identified by terminology such as “imaginable,” “potentially,” “may,” “encouraged,” “committed,” “exploring,” “expected,” “suggested,” “risk,” “should,” “suggest,” or similar expressions, or by express or implied discussions regarding budding new indications or labelling for Zometa or regarding inclined future revenues from Zometa. You should not lay undue reliance on these statements. Such forwardappearing statements reflect the common knowledge views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Zometa to be materially peculiar from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Zometa will be submitted or approved for any additional indications or labeling in any dime store. Nor can there be any guarantee that Zometa will achieve any particular levels of take in the future. In particular, managements expectations regarding Zometa could be affected by, among other details, unexpected clinical trial results, including unexpected new clinical picture and unexpected additional analysis of existing clinical dossier; unexpected regulatory happenings or delays or government regulation largely; the concourses ability to obtain or maintain patent or other proprietary intellectual goods protection; competition in general; government, industry and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Novartis Groups assets and liabilities as recorded in the Groups consolidated balance sheet, and other risks and factors referred to in Novartis AGs circulating embodiment 20F on repository with the US Securities and transposition Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the tidings in that press release as of that duration and does not undertake any obligation to update any forwardappearing statements selfsupporting in that press release as a development of new inside romance, future events or otherwise.

About Novartis Pharmaceuticals Corporation

Novartis Pharmaceuticals Corporation researches, develops, manufactures and trucks leading innovative prescription drugs used to treat a fraction of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous totality, dermatological, GI and respiratory areas. The congregations mission is to improve dynastys lives by pioneering novel healthcare solutions.

Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an branch of Novartis AG (NYSE NVS), which provides healthcare solutions that address the evolving requirements of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to tough meet these requirements innovative medicines, costsaving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer lustiness outputs. Novartis is the only zoo with leading positions in these areas. In 2007, the Groups continuing operations (excluding divestments in 2007) achieved net sales of USD 38.1 billion and net income of USD 6.5 billion. Approximately USD 6.4 billion was invested in R&D activities in many details the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 97,000 fullepoch associates and operate in ancient history 140 countries circumference the star. For more report, please browse novartis.com.

For more tidings

Additional tip regarding Zometa and Novartis Oncology can be initiate on the websites novartisoncologyvpo.com/zometa, us.zometa.com and us.novartisoncology.com.

References

1. Winter, M.C., et al. The inclusion of Zoledronic Acid to Neoadjuvant Chemotherapy May Influence Pathological Response Exploratory Evidence for Direct Antitumor Activity in Breast Cancer. Presented at the 31 Annual Meeting of the CTRCAACR San Antonio Breast Cancer Symposium (SABCS), 1014 December 2008. Abstract No. 5101.

2. Gnant, M. et al. Efficacy of Zoledronic Acid in Premenopausal Women With Breast Cancer Receiving Adjuvant Endocrine Therapy The ABCSG12 trial. Presented at the 44th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Ill., 31 May 2 June, 2008. Abstract LBA4.

Novartis Pharmaceuticals Corporation
novartis.com

UCB announced findings from new studies of the oncedaily antiepileptic drug (AED) Keppra XR(TM) (levetiracetam) extendedrelease tablets comparing tolerability versus levetiracetam immediate release (IR) and reporting on additional dosing schedules. The evidence were among five studies that were presented at the 62nd annual meeting of the American Epilepsy Society (AES) in Seattle.

Keppra XR was approved by the U.S. Food and Drug Administration in September 2008 for use as adjunctive treatment for inhabitants with partialonset seizures who are 16 years of age and older.

“In that new metaanalysis, patients taking Keppra XR experienced fewer nervous conformity side effects than those taking the lookalike dose of twice daily levetiracetam,” said James Zackheim, Medical Director, CNS, UCB. “Keppra XR is the only oncedaily, extendedrelease formulation of levetiracetam, and there is no generic alternative available.”

Summary of Keppra XR goods Presented at 2008 AES Annual Meeting

Safety Profile of Levetiracetam Extended Release Compared to Immediate Release An Indirect Comparison Using a MetaAnalytic Approach

Researchers conducted a metaanalysis of Phase III poop sheet to determine whether Keppra XR is associated with any tolerability advantages versus the double daily dose of levetiracetam IR. According to the metaanalysis, patients taking Keppra XR oncedaily had lower weights of some adverse events versus levetiracetam IR twicedaily.

In terms of overall tolerability, 52.8% of Keppra XR patients reported any adverse event, compared with 79% of patients taking levetiracetam IR.

While adverse events associated with levetiracetam IR were more observed with Keppra XR, patients treated with Keppra XR oncedaily experienced statistically significantly lower weights of adverse events enmeshed to nervous totality disorders (i.e., headache, somnolence and dizziness) versus levetiracetam IR twicedaily.

Keppra XRtreated patients reported numerically lower quotas of psychiatric disorders (i.e., nervousness, anxiety and depression) and nutrition/metabolism disorders.

No other differences in weights of adverse events were statistically significant.

Poster Session 3, Monday, December 8, 800 am 130 pm(Abstract 3.243)

Florent Richy, MPH, PhD, Soutrik Banerjee, MD, PhD, Christophe Gervasoni, MS, Patricia Grossman, PharmD, MBA, Sandra Helmers, MD

UCB Pharma, Inc.; University of Liege, Belgium; Joseph Fourier University, France; Stendhal University, France; Emory University Hospital, USA

original Dose Bioequivalence bounded by Levetiracetam 2 x 750 mg XR Tablets and 3 x 500 mg XR Tablets and Food Effect on 2 x 750 mg XR Tablets in Healthy Subjects

that study demonstrated that an investigational 750 mg tablet strength of Keppra XR is bioequivalent to the approved 500 mg tablet when these are each combined to achieve a 1,500 mg dose. Results Showboat that a rare dose of 2 x 750 mg Keppra XR tablets was bioequivalent to a 3 x 500 mg undivided dose of Keppra XR in healthy adults, and that food intake did not significantly modify Keppra XR 2 x 750 mg disposition.

The median instance to peak plasma concentration was approximately 4 to 5 hours for each dose.

Each dose resulted in a similar halflife (the epoch imperious for half the quantity of a drug in the body to be metabolized or eliminated), apparent total clearance (the rate at which a drug in the body is metabolized or eliminated), and apparent total distribution (the amount of fluid that would be cryed for to dissolve the total amount of drug needed to achieve the carbon counterpart concentration as that construct in the blood).

When the 2 x 750 mg Keppra XR dose was taken with food, the tour to peak concentration was increased by 2 hours relative to fasted intake, while Cmax (the peak concentration of a drug in the body) remained within bioequivalence limits.

For all three Keppra XR dosing schedules (3 x 500 mg, 2 x 750 fasted and 2 x 750 fed), tolerability was privileged and the amounts of treatmentemergent adverse events were similar opposite all associations; in adjoining, adverse events were virtually all mild, and all resolved by the end of the study.

Poster Session 3, Monday, December 8, 800 am 130 pm(Abstract 3.239)

Christian Otoul, Elisabeth Rouits, Ingrid Burton, Evelyne Guenole, Mona Troenaru, Ans Valgaeren, Pierre Boulanger, Maria Laura SargentiniMaier

UCB Pharma SA, BraineLAlleud, Belgium; quarter of Pharmacokinetics, SGS Life information Services, Wavre, Belgium; Therapharm Recherches, Caen, France

Additional Keppra XR measurements Presented at 2008 AES Annual Meeting

Population Pharmacokinetics of Levetiracetam ExtendedRelease 500 mg Tablets

Poster Session 3, Monday, December 8, 800 am 130 pm(Abstract 3.247)

Elisabeth Rouits, M. Lovern, Maria Laura SargentiniMaier and Armel Stockis

UCB Pharma, BraineLAlleud, Belgium

Population DoseResponse Modeling of Levetiracetam Extended and ImmediateRelease Formulations in Adults with PartialOnset Seizures

Poster Session 3, Monday, December 8, 800 am 130 pm(Abstract 3.25)

Rik Schoemaker, Eric Snoeck, Armel Stockis, Christian Otoul, Maria Laura SargentiniMaier

ExprimoNV, Mechelen, Belgium; Pharmacometrics precinct, UCB Pharma SA, BraineLAlleud, Belgium

DoseProportionality of Levetiracetam 500 mg ExtendedRelease Tablets from 1 g to 3 g Once Daily

Poster Session 3, Monday, December 8, 800 am 130 (Abstract 3.263)

Ans Valgaeren, Nathalie Toublanc, Ingrid Burton, Sandrine GeluMantoulet, Mona Troenaru, Christian Otoul, Maria Laura SargentiniMaier, Armel Stockis

UCB Pharma SA, BraineLAlleud, Belgium; territory of Pharmacokinetics, SGS Life discipline Services, Wavre, Belgium; Therapharm Recherches, Caen, France

Keppra XR cannot be substituted with any IR levetiracetam or any other antiepileptic medication at the pharmacy counter outdoors a physicians approval.

serious Safety leak

Keppra XR(TM) extendedrelease tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in patients 16 years of age and older with epilepsy.

Keppra XR(TM) causes somnolence, dizziness, and behavioral abnormalities. The highest common adverse reactions observed with Keppra XR(TM) in combination with other AEDs were somnolence and irritability.

The adverse reactions that may be seen in patients receiving Keppra XR(TM) are expected to be similar to those seen in patients receiving immediaterelease Keppra(R) tablets.

Keppra(R) immediaterelease tablets cause somnolence and fatigue, coordination difficulties, and behavioral abnormalities (e.g., psychotic symptoms, suicidal ideation, and other abnormalities), as well as hematological abnormalities. In adults experiencing partial onset seizures, the utmost common adverse reactions observed with Keppra(R) in combination with other AEDs were somnolence, asthenia, infection and dizziness.

Keppra XR(TM) should be gradually withdrawn to minimize the probable of increased seizure iteration.

Dosing must be individualized according to the patients renal affair status. In patients with endstage renal disease on dialysis, it is recommended that immediaterelease Keppra(R) be used instead of Keppra XR(TM).

For full prescribing leak, please see KeppraXR.com.

In organization to ensure patient access to that respected medication in the U.S., UCB is initiating a copay support program. For more whole record, contact U.S.

About Epilepsy

Epilepsy is a chronic neurological disorder affecting approximately three million public in the U.S. making it more common than multiple sclerosis and Parkinsons disease combined. It is caused by abnormal, excessive electrical discharges of the nerve cells, or neurons, in the brain. Epilepsy is characterized by a tendency to have recurrent seizures and defined by two or more unprovoked seizures. There are frequent contrary seizure types and epileptic syndromes. Forty percent of patients taking only one AED linger to struggle seizures, and approximately 30% of patients taking adjunctive therapy maintain to actuality seizures. that highlights the ongoing hurting for for the development of new AEDs. For more learning about epilepsy, explore epilepsyfoundation.org, epilepsy.com, or epilepsyadvocate.com.

About UCB

UCB is a global leader in the biopharmaceutical industry dedicated to the research, development and commercialization of innovative medicines with a concenter on the fields of central nervous combination and immunology disorders. Employing approximately 12,000 community in more than 40 countries, UCB achieved wages of 3.6 billion euro in 2007. UCB is listed on NYSE Euronext (symbol UCB). Worldwide headquarters is located in Brussels, Belgium; U.S. headquarters is located in Atlanta, Georgia. For more break about UCB, see ucbgroup.com.

Forward appearing statement

that press release contains forwardseeing statements based on prevalent plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially distinctive from those that may be implied by such forwardseeing statements selfsupporting in that press release. pressing factors that could outcropping in such differences inject changes in general economic, occupation and competitive conditions, effects of future judicial decisions, changes in regulation, interrelation rate fluctuations and hiring and retention of its employees.

UCB
ucbgroup.com

UCB announced findings from new studies of the oncedaily antiepileptic drug (AED) Keppra XR(TM) (levetiracetam) extendedrelease tablets comparing tolerability versus levetiracetam immediate release (IR) and reporting on additional dosing schedules. The brass tacks were among five studies that were presented at the 62nd annual meeting of the American Epilepsy Society (AES) in Seattle.

Keppra XR was approved by the U.S. Food and Drug Administration in September 2008 for use as adjunctive treatment for common society with partialonset seizures who are 16 years of age and older.

“In that new metaanalysis, patients taking Keppra XR experienced fewer nervous setup side effects than those taking the ringer dose of twice daily levetiracetam,” said James Zackheim, Medical Director, CNS, UCB. “Keppra XR is the only oncedaily, extendedrelease formulation of levetiracetam, and there is no generic alternative available.”

Summary of Keppra XR testimony Presented at 2008 AES Annual Meeting

Safety Profile of Levetiracetam Extended Release Compared to Immediate Release An Indirect Comparison Using a MetaAnalytic Approach

Researchers conducted a metaanalysis of Phase III dope to determine whether Keppra XR is associated with any tolerability advantages versus the indistinguishable daily dose of levetiracetam IR. According to the metaanalysis, patients taking Keppra XR oncedaily had lower quotas of some adverse events versus levetiracetam IR twicedaily.

In terms of overall tolerability, 52.8% of Keppra XR patients reported any adverse event, compared with 79% of patients taking levetiracetam IR.

While adverse events associated with levetiracetam IR were as well observed with Keppra XR, patients treated with Keppra XR oncedaily experienced statistically significantly lower proportions of adverse events dependent to nervous structure disorders (i.e., headache, somnolence and dizziness) versus levetiracetam IR twicedaily.

Keppra XRtreated patients reported numerically lower comparisons of psychiatric disorders (i.e., nervousness, anxiety and depression) and nutrition/metabolism disorders.

No other differences in relations of adverse events were statistically significant.

Poster Session 3, Monday, December 8, 800 am 130 pm(Abstract 3.243)

Florent Richy, MPH, PhD, Soutrik Banerjee, MD, PhD, Christophe Gervasoni, MS, Patricia Grossman, PharmD, MBA, Sandra Helmers, MD

UCB Pharma, Inc.; University of Liege, Belgium; Joseph Fourier University, France; Stendhal University, France; Emory University Hospital, USA

strange Dose Bioequivalence bounded by Levetiracetam 2 x 750 mg XR Tablets and 3 x 500 mg XR Tablets and Food Effect on 2 x 750 mg XR Tablets in Healthy Subjects

that study demonstrated that an investigational 750 mg tablet strength of Keppra XR is bioequivalent to the approved 500 mg tablet when these are each combined to achieve a 1,500 mg dose. Results appearance that a singledout dose of 2 x 750 mg Keppra XR tablets was bioequivalent to a 3 x 500 mg unambiguous dose of Keppra XR in healthy adults, and that food intake did not significantly modify Keppra XR 2 x 750 mg disposition.

The median while to peak plasma concentration was approximately 4 to 5 hours for each dose.

Each dose resulted in a similar halflife (the stretch rightful for half the quantity of a drug in the body to be metabolized or eliminated), apparent total clearance (the rate at which a drug in the body is metabolized or eliminated), and apparent total distribution (the amount of fluid that would be requisite to dissolve the total amount of drug needed to achieve the twin concentration as that endow in the blood).

When the 2 x 750 mg Keppra XR dose was taken with food, the future to peak concentration was increased by 2 hours relative to fasted intake, while Cmax (the peak concentration of a drug in the body) remained within bioequivalence limits.

For all three Keppra XR dosing schedules (3 x 500 mg, 2 x 750 fasted and 2 x 750 fed), tolerability was honorable and the degrees of treatmentemergent adverse events were similar crossed all crowds; in annexation, adverse events were virtually all mild, and all resolved by the end of the study.

Poster Session 3, Monday, December 8, 800 am 130 pm(Abstract 3.239)

Christian Otoul, Elisabeth Rouits, Ingrid Burton, Evelyne Guenole, Mona Troenaru, Ans Valgaeren, Pierre Boulanger, Maria Laura SargentiniMaier

UCB Pharma SA, BraineLAlleud, Belgium; territory of Pharmacokinetics, SGS Life technique Services, Wavre, Belgium; Therapharm Recherches, Caen, France

Additional Keppra XR whole record Presented at 2008 AES Annual Meeting

Population Pharmacokinetics of Levetiracetam ExtendedRelease 500 mg Tablets

Poster Session 3, Monday, December 8, 800 am 130 pm(Abstract 3.247)

Elisabeth Rouits, M. Lovern, Maria Laura SargentiniMaier and Armel Stockis

UCB Pharma, BraineLAlleud, Belgium

Population DoseResponse Modeling of Levetiracetam Extended and ImmediateRelease Formulations in Adults with PartialOnset Seizures

Poster Session 3, Monday, December 8, 800 am 130 pm(Abstract 3.25)

Rik Schoemaker, Eric Snoeck, Armel Stockis, Christian Otoul, Maria Laura SargentiniMaier

ExprimoNV, Mechelen, Belgium; Pharmacometrics station, UCB Pharma SA, BraineLAlleud, Belgium

DoseProportionality of Levetiracetam 500 mg ExtendedRelease Tablets from 1 g to 3 g Once Daily

Poster Session 3, Monday, December 8, 800 am 130 (Abstract 3.263)

Ans Valgaeren, Nathalie Toublanc, Ingrid Burton, Sandrine GeluMantoulet, Mona Troenaru, Christian Otoul, Maria Laura SargentiniMaier, Armel Stockis

UCB Pharma SA, BraineLAlleud, Belgium; branch of Pharmacokinetics, SGS Life system Services, Wavre, Belgium; Therapharm Recherches, Caen, France

Keppra XR cannot be substituted with any IR levetiracetam or any other antiepileptic medication at the pharmacy counter outwardly a physicians approval.

of substance Safety inside yarn

Keppra XR(TM) extendedrelease tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in patients 16 years of age and older with epilepsy.

Keppra XR(TM) causes somnolence, dizziness, and behavioral abnormalities. The greater common adverse reactions observed with Keppra XR(TM) in combination with other AEDs were somnolence and irritability.

The adverse reactions that may be seen in patients receiving Keppra XR(TM) are expected to be similar to those seen in patients receiving immediaterelease Keppra(R) tablets.

Keppra(R) immediaterelease tablets cause somnolence and fatigue, coordination difficulties, and behavioral abnormalities (e.g., psychotic symptoms, suicidal ideation, and other abnormalities), as well as hematological abnormalities. In adults experiencing partial onset seizures, the lions share common adverse reactions observed with Keppra(R) in combination with other AEDs were somnolence, asthenia, infection and dizziness.

Keppra XR(TM) should be gradually withdrawn to minimize the quiescent of increased seizure recurrence.

Dosing must be individualized according to the patients renal business status. In patients with endstage renal disease on dialysis, it is recommended that immediaterelease Keppra(R) be used instead of Keppra XR(TM).

For full prescribing dossier, please see KeppraXR.com.

In placement to ensure patient access to that relevant medication in the U.S., UCB is initiating a copay support program. For more advice, contact U.S.

About Epilepsy

Epilepsy is a chronic neurological disorder affecting approximately three million society in the U.S. making it more common than multiple sclerosis and Parkinsons disease combined. It is caused by abnormal, excessive electrical discharges of the nerve cells, or neurons, in the brain. Epilepsy is characterized by a tendency to have recurrent seizures and defined by two or more unprovoked seizures. There are prevalent contrastive seizure types and epileptic syndromes. Forty percent of patients taking only one AED draw out to patience seizures, and approximately 30% of patients taking adjunctive therapy conscious on to maturity seizures. that highlights the ongoing suffer privation for the development of new AEDs. For more the latest about epilepsy, have a look at epilepsyfoundation.org, epilepsy.com, or epilepsyadvocate.com.

About UCB

UCB is a global leader in the biopharmaceutical industry dedicated to the research, development and commercialization of innovative medicines with a concentrate on the fields of central nervous philosophy and immunology disorders. Employing approximately 12,000 common folk in more than 40 countries, UCB achieved credit of 3.6 billion euro in 2007. UCB is listed on NYSE Euronext (symbol UCB). Worldwide headquarters is located in Brussels, Belgium; U.S. headquarters is located in Atlanta, Georgia. For more poop about UCB, surf ucbgroup.com.

Forward seeing statement

that press release contains forwardseeing statements based on in vogue plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially divergent from those that may be implied by such forwardseeing statements selfsupporting in that press release. primary factors that could emanation in such differences implicate changes in general economic, livelihood and competitive conditions, effects of future judicial decisions, changes in regulation, deal rate fluctuations and hiring and retention of its employees.

UCB
ucbgroup.com