“We are pleased to introduce the NAVIX™ Access Device, the first in a line of revolutionary products under development, based on Xlumena’s Advanced Translumenal Therapy™ technology,” said Michael Allen, President and CEO of Xlumena. “We believe this is an important first step in providing the interventional endoscopist with innovative tools that will enable a broader reach within the specialty and take interventional endoscopy to a new therapeutic level.”

Kenneth Binmoeller, M.D., Medical Director at the Interventional Endoscopy Center at California Pacific Medical Center in San Francisco, Calif. added: “Xlumena has accurately identified some of the technical challenges, the interventional endoscopists are struggling with, and is developing simple, elegant solutions with products such as the NAVIX™ Access Device.

Xlumena will initially make the NAVIX™ Access Device available to a select number of interventional endoscopy centers across the US. The clearance follows the Xlumena AXIOS™ translumenal gallbladder stent and delivery system receiving a humanitarian use designation by the FDA. FDA clearance for the AXIOS™ stent and delivery system is pending.

Xlumena will host a Tech Suite at the Digestive Diseases Week (DDW) meeting in New Orleans, LA on May 2-6, 2010 to showcase the NAVIX™ and other Advanced Translumenal Therapy™ platforms to invited partners and physicians.

About Xlumena, Inc. Based in Mountain View, Calif., Xlumena was founded in 2008 to develop, manufacture and market advanced, image-guided therapeutic endoscopy devices for the gastroenterologist/interventional endoscopist. Collaborating with top physicians in the field, Xlumena focuses on interventional innovation, the practice of listening to physicians, leveraging their expertise, and being inspired by their vision. That inspiration, along with Xlumena’s design capabilities and resources, guides the development of technology that advances therapy to the next level. These innovations may enable numerous translumenal therapeutic procedures, helping transform complex surgeries into outpatient events.

Source: Xlumena, Inc

So far, the following states have reported cases:

– California
– Connecticut
– Idaho
– Indiana
– Kentucky
– Maine
– Michigan
– Minnesota
– Nevada
– New Mexico
– New York
– Ohio
– Oregon
– Pennsylvania
– Utah, Virginia
– Washington
– Wisconsin
– Wyoming

The Food and Drug Administration (FDA) advises people not to eat fresh spinach or products which may contain fresh spinach. If you think you may have symptoms of E. coli poisoning after eating fresh spinach or products with fresh spinach in them you should seek medical advice, says the FDA.

Symptoms include:

– diarrhea, often with bloody stools
– can include abdominal pain
– fever (sometimes)

Most healthy adults will usually make a full recovery within about seven days. However, one of the complications, HUS, a type of kidney failure, can lead to serious kidney damage and death. Children and elderly people are the most vulnerable.

River Ranch of California, which received bulk spring mix containing spinach from Natural Selections, is recalling packages of spring mix containing spinach. The following brands include spring mix containing spinach:

– Farmers Market
– Hy Vee
– Fresh and Easy.
(The company stresses that its products which do not contain spinach are not being recalled.)

Natural Selection Foods, LLC, San Juan Bautista, California, is recalling all products containing spinach. Consumers are warned to look out for the following ‘best if used by dates’:

– All dates between August 17 2006 – October 1, 2006.

The following brands of Natural Selection Foods are included in the recall:

– Natural Selection Foods

– Pride of San Juan

– River Ranch

– Superior

– Earthbound Farm

– Bellissima

– Dole

– Ready Pac

– Jansal Valley

– Rave Spinach

– Emeril

– Sysco

– Cheney Brothers

– President’s Choice

– Cross Valley

– Coastline

– O Organic

– Fresh Point

– D’Arrigo Brothers

– Green Harvest

– Mann

– Snoboy

– The Farmer’s Market

– Mills Family Farm

– Premium Fresh

– Nature’s Basket

– Pro-Mark

– Tanimura & Antle

– Compliments

– Trader Joe’s

– Riverside Farms
These products are not only sold in the USA, but also in Canada and Mexico.

More information on the E. coli O157:H7 outbreak

Studies have shown elevated levels of the hormone progesterone
accompanied by increased intra-abdominal pressures from the enlarging
uterus, may lower esophageal sphincter (LES) pressure in pregnant women
contributing to heartburn symptoms, according to research highlighted in
the newly updated “Pregnancy in Gastrointestinal Disorders” monograph by
the American College of Gastroenterology (ACG).

From the monograph, physician experts from ACG have compiled important
health tips on managing heartburn symptoms, and importantly, identifying
which heartburn medications are safe for use in pregnant women and those,
which should be avoided.

Strategies to Ease Heartburn Symptoms during Pregnancy

According to the ACG, pregnant women can treat and relieve their
heartburn symptoms through lifestyle and dietary changes. The following
tips can help reduce heartburn discomfort:

– Avoid eating late at night or before retiring to bed. Common
heartburn triggers include greasy or spicy food, chocolate, peppermint,
tomato sauces, caffeine, carbonated drinks, and citrus fruits.

– Wear loose-fitting clothes. Clothes that fit tightly around your
waist put pressure on your abdomen and the lower esophageal sphincter.

– Eat smaller meals. Overfilling the stomach can result in acid reflux
and heartburn.

– Don’t lie down after eating. Wait at least 3 hours after eating
before going to bed. When you lie down, it’s easier for stomach contents
(including acid) to back up into the esophagus, particularly when you go to
bed with a full stomach.

– Raise the head of the bed 4 to 6 inches. This can help reduce acid
reflux by decreasing the amount of gastric contents that reach the lower
esophagus.

– Avoid tobacco and alcohol. Abstinence from alcohol and smoking can
help reduce reflux symptoms and avoid fetal exposure to potentially harmful
substances.

The Do’s and Don’ts of Using Heartburn Drugs during Pregnancy

Pregnant women with mild reflux usually do well with simple lifestyle
changes. If lifestyle and dietary changes are not enough, you should
consult your doctor before taking any medication to relieve heartburn
symptoms.

According to ACG President Amy E. Foxx-Orenstein, DO, FACG, “Heartburn
medications to treat acid reflux during pregnancy should be balanced to
alleviate the mother’s symptoms of heartburn, while protecting the
developing fetus.”

Based on a review of published scientific clinical studies (in animals
and humans) on the safety of heartburn medications during pregnancy,
researchers conclude there are certain drugs that are considered safe for
use in pregnancy and those which should be avoided.

Antacids are one of the most common over-the-counter medications to
treat heartburn. As with any drug, antacids should be used cautiously
during pregnancy.

Antacids

– Antacids containing aluminum, calcium, or magnesium are considered
safe and effective in treating the heartburn of pregnancy.

– Magnesium-containing antacids should be avoided during the last
trimester of pregnancy because it could interfere with uterine contractions
during labor.

– Avoid antacids containing sodium bicarbonate. Sodium bicarbonate
could cause metabolic alkalosis and increase the potential of fluid
overload in both the fetus and mother.

Histamine-type II (H-2) Receptor Antagonists

While limited data exists in humans on the safety of histamine-type II
(H-2) receptor antagonists, ranitidine (Zantac(R)) is the only H-2
antagonist, which has been studied specifically during pregnancy.

In a double-blind, placebo controlled, triple crossover study,
ranitidine (Zantac(R)) taken once or twice daily in pregnant heartburn
patients not responding to antacids and lifestyle modification, was found
to be more effective than placebo in reducing the symptoms of heartburn and
acid regurgitation. No adverse effects on the fetus were reported. (Larson
JD, et al., “Double-blind placebo-controlled study of ranitidine for
gastroesophageal reflux symptoms during pregnancy.” Obstet Gynecol 1997;
90:83-7.)

A study on the safety of cimetidine (Tagamet(R)) and ranitidine
(Zantac(R)) suggests that pregnant women taking these drugs from the first
trimester through their entire pregnancy have delivered normal babies.
(Richter JE., “Gastroesophageal reflux disease during pregnancy.
Gastroenterol Clin N Am 2003; 32:235-61.)

Proton Pump Inhibitors

Proton pump inhibitors should be reserved for pregnant patients with
more severe heartburn symptoms and those not responding to antacids and
lifestyle and dietary changes. Lansoprazole (Prevacid(R)) is the preferred
PPI because of case reports of safety in pregnant women. Limited data
exists about human safety during pregnancy with the newer PPIs.

American College of Gastroenterology
acg.gi

View drug information on Cimetidine Hydrochloride Oral Solution; Ranitidine Capsules.

A coincidence? Or the harbinger of a brewing epidemic, potentially
threatening a larger swath of the Garden State?

Fortunately, the onslaught of patients was actually part of a disaster
drill conducted by the medical facility that also involved the Hudson
Regional Health Commission, the public health agency serving parts of
Northern New Jersey. The purported scenario was an E. coli outbreak at a
local restaurant, and the patients were actually volunteers from a nearby
high school pretending to be ill.

One goal of the emergency preparedness exercise was to give the medical
facility and the regional public health agency experience using
EpiCenter(TM), a community health surveillance system recently introduced
by health data management specialists Health Monitoring Systems
(hmsinc) and adopted by the Hudson Regional Health
Commission and other public health agencies across the country. The
EpiCenter system collects electronic data in real time from
healthcare-providing organizations, such as hospital emergency department
registrations, and then processes the information through advanced
analytical techniques to identify unusual patterns emerging.

That early warning of developing threats to public health can give
public health professionals a valuable head start in recognizing and
managing disease spread and epidemic outbreaks, as well as possible
bioterrorism, a surge in criminal assaults and even tainted street drugs.

In the North Bergen emergency preparedness exercise, EpiCenter’s
built-in statistical tools were able to detect an unusual pattern of
gastrointestinal cases developing. The system issued notifications of a
possible E. coli outbreak to the appropriate regional public health
watchdogs, who in turn contacted the medical center.

“Drills are an important part of our ability to be prepared for a range
of emergencies that might come up,” said Carrie Nawrocki, Hudson Regional
Health Commission epidemiologist. “It is crucial that we are alerted
quickly when unusual events occur so we can take the right steps to manage
the outbreak, including working with local health departments and notifying
other hospitals in the region.”

Added Nawrocki, “Some hospitals might have difficulty recognizing
patterns of incoming patient complaints. That’s quite understandable given
the activity level in emergency departments, especially on a very busy day
like our drill. We need a reliable tool to see emerging problems, and
that’s why EpiCenter is so critical to us. We were delighted with how
EpiCenter performed — exactly as desired.”

The actual processing of the test data was handled on a parallel
version of EpiCenter set up specifically for the drill by Health Monitoring
Systems.

Doreen McSharry, Palisades Medical Center’s safety and infection
control director, and Howard Wassinger from the Center’s IT department,
planned the drill.

McSharry noted that the “exercise not only tested our ability to
recognize a potential outbreak, but also our capability to manage an
unusually large influx of potentially infectious patients. Exercises of
this nature are performed every year at hospitals and medical facilities
throughout the country in accordance with Joint Commission standards. We
were pleased to work with Health Monitoring Systems on this year’s drill.”

Steve DeFrancesco, Health Monitoring chief information officer, added
that as the open source EpiCenter is being used by increasing numbers of
public health agencies, Health Monitoring Systems stands ready to assist in
other disaster drills. “Seeing the results of EpiCenter’s sophisticated,
accurate and fast data analysis can be reassuring to epidemiologists and
others in public health and the healthcare professionals in their regions.
We’re eager to build additional partnerships in the public health arena.”

Health Monitoring Systems
hmsinc

The researchers observed that adult GF mice were more active and engaged in more “risky” behavior than mice raised with normal microorganisms. When GF mice were exposed to normal microorganisms very early in life, as adults they developed the behavioral characteristics of those exposed to microorganisms from birth. In contrast, colonizing adult GF mice with bacteria did not influence their behavior.

Subsequent gene profiling in the brain identified genes and signaling pathways involved in learning, memory and motor control that were affected by the absence of gut bacetria, highlighting the profound changes in the mice that developed in the absence of microorganisms. This suggests that, over the course of evolution, colonization of gut by microorganisms in early infancy became integrated into early brain development.

“These studies are the results from a systematic genomic approach to understand host microbe interactions that was initiated several years ago and supported by the GIS and its director, Edison Liu. It is an illustration of how this data-driven approach can generate unexpected results and lead you to new directions, with very novel findings,” said Dr Pettersson, co-ordinator of this international study, and Dr Hibberd.

The data suggests that there is a critical period early in life when gut microorganisms affect the brain and change the behavior in later life”, said Dr Diaz-Heijtz. Added Dr Pettersson, “Not only are signal substances like serotonin and dopamine subject to regulation by bacteria, synapse function also appears to be regulated by colonizing bacteria. Our findings, presented today, are a result of a long-standing and ongoing collaboration between KI and the GIS in Singapore, aimed at exploring host-microbe interactions in a systematic manner.”

Dr Hibberd said, “This work builds upon our understanding of how our genome interacts with the microbial world, leading to a new and exciting understanding of how humans might benefit from our interaction with microbes. We hope to continue our collaboration with KI and the Stockholm Brain Institute to explore this new frontier of scientific knowledge.”

Notes

Research publication:

The research findings described in the press release can be found in the 31 January, 2011 advance online issue of Proc Nat. Acad Sci USA under the title “Normal gut microbiota modulates brain development and behavior”.

Authors:

Rochellys Diaz Heijtza,b,1, Shugui Wangc, Farhana Anuard, Yu Qiana,b, Britta Bj?¶rkholmd, Annika Samuelssond, Martin L. Hibberdc, Hans Forssbergb,e, and Sven Petterssonc,d,1

Departments of aNeuroscience, and dMicrobiology, Cell and Tumor Biology, bStockholm Brain Institute, Karolinska Institutet, 171 77 Stockholm, Sweden ;

cGenome Institute of Singapore, 02-01 Genome 138672, Singapore ;

eDepartment of Women’s and Children’s Health, Karolinska Institutet, 171 76
Stockholm, Sweden

Source:

Genome Institute of Singapore

Karolinska Institute

Agency for Science, Technology and Research (A*STAR)

Typhoid used to be endemic in many currently developed nations some centuries ago. In fact, scientists have for several years debated the cause of the Plague of Athens. Analysis carried out by Manolis Papagrigorakis and colleagues using DNA collected from teeth from an ancient Greek burial pit points to typhoid fever as the disease responsible for this devastating epidemic.
Who gets typhoid fever?
The World Health Organization (WHO) has deemed typhoid fever a serious problem in endemic areas (India, Southeast Asia, Africa, Central and South America) where there are between 16 and 33 million cases each year that result in over half a million deaths.

Interesting related article

What is gastroenteritis? What is food poisoning?

What are antibiotics? How do antibiotics work?

What is a fever? Symptoms and causes of fever

However, some industrial nationals are experiencing worrying rises in typhoid fevers; mainly among people who visited parts of the world where it is endemic. In 2006 there were almost 500 cases (497) of enteric fever reported in England , Wales , and Northern Ireland – the highest level for 10 years; the Health Protection Agency, UK, says UK travellers visiting friends and relatives on the Indian sub-continent are carrying an unnecessary burden of typhoid and paratyphoid. Paratyphoid fever is increasing across Asia, a study revealed.

Though children are more likely than adults to get typhoid, adults tend to have worse symptoms. Risk factors for typhoid include working in or traveling to areas where the illness is endemic, having close contact with another person infected with typhoid, having a weakened immune system due to medication or disease, and drinking water that has been contaminated with the bacteria that cause typhoid.
What causes typhoid fever?
Typhoid fever ultimately is caused by the Salmonella typhi bacteria, and it is most commonly transmitted through the fecal-oral route. That is, patients with typhoid can contaminate the water supply with their stool, where the bacteria flourish. The food supply can become contaminated by infected stool, poor sanitation, or someone who fails to wash his hands after using the bathroom. When another person consumes tainted food or water, he can pick up the typhoid bacteria and become infected.

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Gastrointestinal / Gastroenterology News

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Some people, known as chronic carriers, still harbor typhoid bacteria (and can still contaminate food and water supplies) even after receiving antibiotic treatment and proving to be free of symptoms.
What are the symptoms of typhoid fever?
Typhoid sufferers often have fevers that run as high as 103 or 104 degrees (39 to 40 Celsius). Additional initial signs of the condition include:

Headaches
Poor appetite
Generalized aches and pains
Lethargy, weakness, and fatigue
Diarrhea
Rash (rose-colored sports on the lower chest and upper abdomen)

If untreated, a second stage of typhoid may result with a continuation of a high fever, severe constipation or diarrhea that resembles pea soup, extreme weight loss, and an uncomfortable, distended abdomen.

The final stage of symptoms, known as the typhoid state, leaves a person delirious and lying motionless with her eyes half-closed. During the fourth week of illness, improvement slowly begins to come and the fever is likely to decrease gradually over ten days.
How is typhoid fever diagnosed?
If a physician suspects typhoid based on the physical symptoms mentioned above, she will order a stool culture and/or blood culture to specifically identify the Salmonella typhi bacteria. A doctor will also conduct a detailed medical and travel history to assess your exposure to the bacteria. Additional tests used to diagnose typhoid fever include enzyme-linked immunosorbent assay (ELISA) and fluorescent antibody test.
How is typhoid fever treated?
The Salmonella bacteria that causes typhoid can be killed by antibiotics such as ciprofloxacin or ceftriaxone. However, some strains become resistant to antibiotics after long-term use, and antibiotics have known side-effects.

Additional treatments for typhoid include drinking fluid to prevent dehydration and eating a healthy diet to ensure the absorption of nutrients.
How can typhoid fever be prevented?
Typhoid fever can be prevented through proper sanitation and hygiene. Since the disease spreads in places where human feces come into to contact with food and drinking water, prevention relies on careful food preparation and persistent hand washing. To prevent typhoid, people in endemic areas should avoid drinking untreated water, avoid raw fruits and vegetables, choose to consume hot foods where bacteria cannot survive, adequately clean household items, and avoid handling food if there is a risk of spreading the disease.

There are two vaccines that are recommended by the World Health Organization. They are usually only given to those who are traveling to typhoid endemic areas and they are from 50 to 80% effective in preventing typhoid.

Peter Crosta M.A.

Pankaj J. Pasricha, M.D., Ph.D., Professor and Chief, Division of
Gastroenterology & Hepatology at Stanford University School of Medicine,
and colleagues; Dr. Prince VS Jeyabal, Dr. Raj Kumar, Dr. Pandu RR Gangula,
Dr. Mary-Adelaide Micci; from the University of Texas Medical Branch
authored the paper, which was published in the October 2007 issue of
Neurogastroenterology and Motility. Dr. Pasricha is also Chairman of the
NIH-funded Diabetic Gastroparesis Consortium, which has a mandate to better
characterize the underlying biology and develop therapeutic interventions
for patients with diabetic gastroparesis.

In this study, Dr. Pasricha examined the expression of duodenal nNOS
and the role of AGE and RAGE (receptor for AGEs) signaling in an in vivo
model of diabetes. He used two drugs aminoguanidine, a well characterized
inhibitor of AGE formation, and alagebrium, a novel compound that acts as
an AGE-crosslink breaker. The study showed that diabetes resulted in an
accumulation of serum AGEs and that there was a 50% reduction in myenteric
nNOS expression which was reversible by either aminoguanidine or
alagebrium. This is the first reported evidence for the potential
importance of AGE signaling in the pathogenesis of enteric neuropathy. In
this study, late administration of alagebrium reduced serum AGEs to control
levels and also restored nNOS levels. Further studies will be needed to
understand the mode of action of alagebrium, however, the results of the
study suggest that countering the AGE-RAGE signaling pathway may be a major
target for diabetes related gastrointestinal complications, particularly
those that arise from reduction of nNOS expression.

“I am quite enthused by the observation that alagebrium may preserve
nNOS activity, which would allow it to advance as a leading candidate for
clinical development in the fight against this challenging disease,” said
Dr. Pasricha.

Patients with diabetes commonly experience gastric and intestinal
dysfunction, however, the mechanism of how this happens is not well
understood. The term diabetic enteropathy is often used to explain the
disturbance in bowel function such as chronic diarrhea which occurs in 15%
or more diabetics. A role for decreased nNOS expression has been suggested
as a possible cause for the diarrhea however how diabetes causes such
changes in nNOS expression levels is unknown. Dr. Raj Kumar will continue
to work on how glycation of nNOS affects its structure and function.

“Dr. Pasricha’s ground breaking work may be the first step in providing
treatment for gastrointestinal disorders resulting from diabetes,” said
Noah Berkowitz, M.D., Ph. D. President and Chief Executive Officer of
Synvista. “We look forward to future research efforts to further elucidate
the role of AGEs in gastrointestinal complications including diabetic
intestinal dysfunction, diabetic enteropathy and diabetic gastroparesis and
the role that alagebrium may play in those disease.”

About Synvista Therapeutics

Synvista Therapeutics is a biopharmaceutical company developing small
molecule drugs to treat and prevent cardiovascular disease and to treat
nephropathy in people with diabetes. The Company has identified several
product candidates that it believes represent novel approaches to some of
the largest pharmaceutical markets. The Company’s portfolio includes orally
bioavailable, organoselenium mimics of glutathione peroxidase. These
compounds metabolize lipid peroxides and have the potential to limit
myocardial damage subsequent to a myocardial infarction. The Company is
developing a clinical diagnostic test, based on cardiovascular risk
assessment, using Haptoglobin characterization, to identify patients at
high risk for cardiovascular complications of diabetes.

Synvista Therapeutics also is developing alagebrium, a proposed breaker
of AGEs for the treatment of diastolic heart failure. This disease
represents a rapidly growing market of unmet medical need, particularly
common among diabetic patients. Alagebrium has demonstrated relevant
clinical activity in two Phase 2 clinical trials in heart failure, as well
as in animal models of heart failure and nephropathy, among others.
Alagebrium has been tested in approximately 1,000 patients in multiple
Phase 1 and Phase 2 clinical trials, allowing Synvista Therapeutics to
assemble a sizeable human safety database. For more information, please
visit the Company’s website at synvista.

Any statements contained in this press release that relate to future
plans, events or performance are forward-looking statements that involve
risks and uncertainties including, but not limited to, the risks associated
with the events described in this press release, future clinical
development of Synvista Therapeutics’ product candidates, and other risks
identified in Synvista Therapeutics’ filings with the Securities and
Exchange Commission. Further information on risks faced by Synvista are
detailed under the caption “Risk Factors” in Synvista Therapeutics’ Annual
Report on Form 10-K for the year ended December 31, 2006. These filings are
available on a website maintained by the Securities and Exchange Commission
at sec. The information contained in this press release is
accurate as of the date indicated. Actual results, events or performance
may differ materially. Synvista Therapeutics undertakes no obligation to
publicly release the result of any revision to these forward- looking
statements that may be made to reflect events or circumstances after the
date hereof or to reflect the occurrence of unanticipated events.

(1) Nature Clinical Practice Gastroenterology & Hepatology 4, 336 – 346
(01 Jun 2007) Review, Pankaj J. Pasricha, M.D., Ph.D., Professor of
Neuroscience & Cell Biology and Biomedical Engineering at the University of
Texas Medical Branch

Synvista Therapeutics, Inc.
alteon

Orphan drug status is granted by the FDA to promote the development
of drugs for diseases that affect fewer than 200,000 patients.
Products granted orphan drug status are allowed seven years of market
exclusivity in the U.S. upon FDA approval.

“We are pleased with the FDA’s decision, and we believe EUR-1073 has
the potential to address key unmet medical needs of pediatric patients
with ulcerative colitis,” said Gearoid Faherty, Chairman and Chief
Executive Officer. “The development of EUR-1073 is part of our
strategy to develop a pipeline of gastroenterology products to be
marketed by our own sales force, and we believe it would be
complementary to EUR-1008, currently under review by the FDA as a
treatment for exocrine pancreatic insufficiency, a digestive
disease.”

In April 2008, Eurand acquired from Chiesi Pharmaceutici SpA the
exclusive U.S. and Canadian rights to market EUR-1073, an
enteric-coated, controlled-release formulation of beclomethasone
diproprionate, which Chiesi markets as CLIPPER(TM) in several
European countries for use in the treatment of ulcerative colitis.

About Ulcerative Colitis

Ulcerative colitis is a type of inflammatory bowel disease that
produces inflammation and ulcers along the inside of the large
intestine. The inflammation can interfere with the normal function of
the colon, often causing cramping, bloating, diarrhea, bleeding,
fatigue, weight loss and frequent bowel movements which seriously
affect quality of life. Ulcerative colitis is a chronic
relapsing/remitting illness for which there is no known cure:
however, patients can manage their symptoms. A known issue that
arises with ulcerative colitis patients is medication compliance and
excessive pill burden: many currently available ulcerative colitis
treatments require multiple, large pills to be taken several times
daily, and inconvenient means of administration are often involved.

About Eurand

Eurand is a specialty pharmaceutical company that develops,
manufactures and commercializes enhanced pharmaceutical and
biopharmaceutical products based on its proprietary drug formulation
technologies. Eurand has had four products approved by the FDA since
2001 and has a pipeline of product candidates in development for
itself and its collaboration partners. Its technology platforms
include bioavailability enhancement of poorly soluble drugs, custom
release profiles, taste-masking orally disintegrating tablet (ODT)
formulations, and drug conjugation.

Forward-Looking Statement

This release, and oral statements made with respect to information
contained in this release, constitutes forward-looking statements.
Such forward-looking statements include those which express plan,
anticipation, intent, contingency, goals, targets or future
development and/or otherwise are not statements of historical fact
including, but not limited to the future and status of the Company’s
regulatory filings for EUR-1008, anticipated product launches,
enrollment and future plans for its clinical trials, progress of and
reports of results from clinical studies, clinical development plans
and product development activities. The words “potentially,”
“anticipates,” “could,” “calls for” and similar expressions also
identify forward-looking statements. These statements are based upon
management’s current expectations and are subject to risks and
uncertainties, known and unknown, which could cause actual results
and developments to differ materially from those expressed or implied
in such statements. Factors that could affect actual results include
risks associated with the possibility that the FDA does not approve
the Company’s NDA relating to EUR-1008; the outcome of any
discussions with the FDA; and unexpected delays or additional
requirements in preparation of materials for submission to the FDA as
a part of the Company’s NDA filing, including those relating to
Eurand’s raw material supplier. Investors are advised to refer to the
Company’s Risk Factors set forth in its Annual Report on Form-20-F as
filed with the U.S. Securities and Exchange Commission.
Forward-looking statements contained in this press release are made
as of this date, and the Company undertakes no obligation to publicly
update any forward-looking statement, whether as a result of new
information, future events or otherwise. Actual events could differ
materially from those anticipated in the forward-looking statements.

Source
Eurand N.V.

The authors report that patients reported relief from IBS symptoms for up to 10 weeks after completing rifaximin treatment. They specifically reported considerable reductions in abdominal pain, bloating, and better stool consistency.

The authors explain that the idea that bacteria play a major role in IBS has been disputed over the last ten years. These latest findings confirm that intestinal bacteria, also known as the gut microbiome, are closely involved in IBS symptoms.

Irritable bowel syndrome, also known as spastic colitis, nervous colon syndrome, or IBS is a chronic (long-term) gastrointestinal disorder that causes bloating, mucous in stools, irregular bowel habits (diarrhea and constipation), and abdominal pain. In the majority of cases patients have periods during their lives when the symptoms wax and wane. Although IBS can be extremely unpleasant, it does not usually lead to serious complications. However, it can cause absenteeism (from work), serious fatigue and make the patient’s life a misery. Fortunately, the majority of patients do not have severe symptoms.

Approximately 30 million Americans are known to be affected by IBS. This latest therapy was developed at Cedars-Sinai Medical Center.

Lead author, Mark Pimentel, M.D., GI Motility Program director and principal investigator of the clinical trials at Cedars-Sinai, said that their findings demostrate that targeted antibiotics are both safe and effective for long-lasting IBS relief.

William D. Chey, M.D., professor in the Department of Internal Medicine at the University of Michigan, said:

“This represents a big change in the way we think about and treat IBS.”

Chey added that currently available treatments, such as fiber supplements or dietary changes do not provide satisfactory relief for a significant number of patients – as soon as treatment stops, symptoms tend to come rushing back. With this new treatment, however, even when they have stopped taking the meidcation, patients continue feeling better.

The study involved 660 patients in two double-blind trials. All the IBS participants with mild to moderate diarrhea and bloating were randomly selected to receive a three times daily dose of 550milligrams of rifaximin or a placebo (dummy drug) for a period of two weeks. They were then monitored for a further ten weeks.

40% of patients on rifaximin experienced relief immediately from abdominal pain, loose/watery stools and bloating. The majority of them had symptom relief that continued for several weeks after completing their antibiotic treatment.

Because IBS causes have been unclear, doctors have tended to focus on treatments which either slow down or speed up the digestive process, depending on whether their IBS provokes more diarrhea or constipation.

A previous study had found an association between bloating and bacterial fermentation in the intestine related to small intestine bacterial overgrowth (SIBO). Other studies have suggested that the bacteria which exist within the small and large intestines of individuals with IBS are not the same as those within the intestines of other people.

Rifaximin, which is marketed by Salix Pharmaceuticals Inc., is currently approved by the FDA to treat hepatic encephalopathy and traveler’s diarrhea.

“Rifaximin Therapy for Patients with Irritable Bowel Syndrome without Constipation”
Mark Pimentel, M.D., Anthony Lembo, M.D., William D. Chey, M.D., Salam Zakko, M.D., Yehuda Ringel, M.D., Jing Yu, Ph.D., Shadreck M. Mareya, Ph.D., Audrey L. Shaw, Ph.D., Enoch Bortey, Ph.D., and William P. Forbes, Pharm.D. for the TARGET Study Group
N Engl J Med 2011; 364:22-32January 6, 2011

NYU Medical Center is one of three sites currently approved by the FDA to study the efficacy of the gastric band in adolescent patients. To date, NYU physicians have the most experience with gastric banding procedures in adolescent patients in the United States.

Lap band surgery was performed on 53 morbidly obese adolescents between the ages of 13 and 17, according to the study. Most of the patients were girls. People are considered morbidly obese when their body mass index is at 40 or above, usually about 100 pounds overweight.

The patients in the study had a history of obesity for at least 5 years and many had conditions commonly found in obese adults such as high blood pressure, diabetes, and sleep apnea. They had also tried unsuccessfully to lose weight on numerous diet and exercise regimens, including medically supervised weight loss, according to the study. All of the adolescents were screened by a psychologist to ensure that they would comply with the study protocol.

“This study suggests that the lap band provides a safer and equally effective weight loss strategy compared to the gastric bypass,” said Evan Nadler, M.D., Director of Pediatric Minimally Invasive Surgery and Assistant Professor of Surgery at New York University School of Medicine, who is the lead author of the study. “This is good news for parents contemplating obesity surgery for their adolescent children. The bypass has serious risks and side effects associated with it and our study shows that the band provides similar weight loss benefits without the same risks.” Intestinal leakage and bleeding, blockage of the intestines, and severe nutritional deficiency are some of the side effects associated with the bypass procedure.

The gastric banding procedure places an inflatable silicon ring around the upper portion of the stomach, creating a smaller stomach, which helps patients feel full and limits the amount of food they eat. The ring is connected to a port that is placed underneath the skin at the time of surgery. At regular monthly visits, the ring can be made tighter or looser by injecting saline into the port. This minimally invasive procedure is usually performed in under an hour. It is reversible, adjustable, and requires no cutting or rerouting of the gastrointestinal tract.

By comparison, during the gastric bypass procedure the surgeon divides the stomach and reshapes it into a small pouch. It is then connected directly to the middle portion of the small intestine, bypassing the rest of the stomach and the upper portion of the small intestine.

According to the study, twelve and eighteen months following their surgery, the average weight loss for each patient was about 50 percent of excess weight, a figure comparable to weight loss following a gastric bypass procedure. None of the patients regained any lost weight, which has occurred after gastric bypass procedures, said Dr. Nadler.

Complications were found to be significantly less severe with the band procedure as well. None of the gastric band patients in the study had complications that required readmission to the hospital. Two patients experienced slippage of the band, two patients developed hiatal hernias, and one patient had a wound infection. All of these conditions were treated by outpatient procedures. According to the study, a few patients also experienced mild hair loss and iron deficiency which were treated with nutritional counseling and vitamin supplementation.

The authors of the paper are Dr. Nadler, and Heekoung A. Youn, Howard B. Ginsburg, Christine J. Ren, and George A. Fielding. This study was partially funded by the Harris Family Foundation.

Contact: Jennifer Choi

New York University Medical Center and School of Medicine