Food Allergies An American Obsession?

Food allergies are increasingly top-of-mind for many Americans. In fact, one out of every three people in this country claim to have a food allergy of one kind or another.* But the science doesn’t support these fears. Government and medical association estimates put the actual incident rate at only between one in 25 and one in 70.

Parents are one of the groups most concerned about food allergies, especially as kids go back to school and eat more meals away from home. In many cases, they’re also ill-informed about the differences between allergies and intolerances, and the proper course of treatment for each. A new survey conducted among California parents last month reveals that many are self-diagnosing food allergies and eliminating nutrient-rich foods from their child’s diet without seeing a doctor first.

“Medical self-diagnosis is risky business,” says Dr. Stuart Epstein, Beverly Hills Allergist, Associate Clinical Professor David Geffen UCLA School of Medicine and Cedars-Sinai Medical Center Attending Allergist. “Without professional advice, suffering is almost always extended and important foods eliminated unnecessarily.”

And milk is often the “fall guy.” In fact, nearly two-thirds (63%) of parents surveyed in this recent Omnibus Poll admitted to eliminating — or limiting their children’s intake — of milk at the first sign of problems, believing dairy products to be at least partially responsible for their symptoms.

“Parents are sometimes quick to point the finger at cow’s milk when their child comes down with unexplained symptoms like intestinal problems or allergic reactions,” stresses Dr. Epstein. “Eliminating milk from your diet, especially a child’s diet, without talking to your doctor first, is not a smart idea.”

In fact, the American Academy of Pediatrics issued a statement last week urging parents not to eliminate dairy foods from their children’s diet for lactose intolerance reasons. Dairy foods like milk are an important source of calcium and other nutrients that facilitate growth during a critical bone building time.

Americans often confuse food allergies with food sensitivities or intolerances. An allergy is a specific condition that involves immune response, where as an intolerance — like lactose intolerance — is very rare among young people. Medical experts like Dr. Epstein recommend seeking medical attention at the first sign of a problem.

From August 14th to 22nd Market Tools surveyed 551 California parents online to gauge food allergy and lactose intolerance awareness and milk allergies as a health concern for their children.

Key Findings:

– Sixty-three percent (63%) of California parents eliminate milk from their child’s diet at the first sign of a food-related health issue.

– Forty percent (40%) of parents do not consult a doctor before eliminating foods from their child’s diet.

About the CMPB

The California Milk Processor Board was established in 1993 to make milk more competitive and increase milk consumption in California. Awareness of GOT MILK? is over 90% nationally and it is considered one of the most important and successful campaigns in history. GOT MILK? is a federally registered trademark that has been licensed by the national dairy boards since 1995. GOT MILK? gifts and recipes can be viewed at http://www.gotmilk.com. The CMPB is funded by all California milk processors and administered by the California Department of Food and Agriculture.

— National Institute of Health, Food Allergy Citation & Incidence Rates, pp 1-2, http://www.nih.org.

— Paajanen L et al. Cow milk not responsible for most gastrointestinal immune-like syndromes — evidence from a population-based study. American Journal of Clinical Nutrition. 2005; 82:1327-1235.

— Heyman, Melvin B., M.D., M.P.H., FAAP, Lactose Intolerance in Infants, Children and Adolescents (Pediatrics, 2006;118:1279-1286).

The California Milk Processor Board
http://www.gotmilk.com

GMOs And Allergies: Tests May Help Answer Questions

The potential of genetically engineered foods to cause allergic reactions in humans is a big reason for opposition to such crops. Although protocols are in place to ask questions about the allergy-causing possibilities, there has been no test that offers definitive answers.

But all of that could change as a Michigan State University researcher has developed the first animal model to test whether genetically engineered foods could cause human allergic reactions. Venu Gangur, MSU assistant professor of food science and human nutrition, has received a $447,000 grant from the Environmental Protection Agency to validate the test.

Genetically engineered crops are created by inserting a protein from a different organism into the original crop’s genome. This is usually done to create a plant that is more resistant to insects or diseases.

The Food and Agriculture Organization within the World Health Organization has a structured approach to determining whether genetically engineered foods cause allergies, according to Gangur, who also is a faculty member in the National Food Safety and Toxicology Center. “But it has a major flaw. A critical question in that process asks, ‘Does the protein cause an allergic reaction in animals?’ The problem is that there has been no good animal model available to test this.”

Gangur and students in his lab have developed a mouse model – the first of its kind – to test the allergy-causing potential of genetically engineered foods. He’ll use the EPA grant to examine whether the model works on a variety of proteins. If successfully validated, the testing could be available commercially in about five years.

Perhaps the best known case of a genetically engineered crop potentially causing allergies was StarLink corn. Created by Aventis in 1996, StarLink contained the cry9C protein from a common soil bacterium, a strain of Bacillus thuringiensis. The cry9C protein protected the corn from several types of corn borers and black cutworms. StarLink was approved by the EPA for use in animal feed and nonfood products in 1998. But in 2000, fragments of cry9C DNA were detected in taco shells and other food products.

“Many people believed that StarLink was responsible for their asthma attacks and other allergic reactions,” Gangur said. “The Centers for Disease Control took samples and tried to figure out if StarLink was the cause, but the data were inconclusive. There was really no good method to determine if StarLink caused allergic reactions. This is why our model will be such a valuable tool. We’ll be able to determine the allergenic potential of genetically engineered crops before they’re released into the human or animal food chain.”

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Robert Tempelman, MSU professor of animal science and statistics and probability, is the project’s co-investigator.

Gale Strasburg, chairperson of the MSU Department of Food Science and Human Nutrition; and Jim Pestka and Maurice Bennink, MSU professors of food science and human nutrition, also are participating in the project.

The research of Gangur, Tempelman, Pestka and Bennink is supported by the Michigan Agricultural Experiment Station.

url: http://newsroom.msu.edu/site/indexer/2864/content.htm

Contact: Sue Nichols
American Society for Biochemistry and Molecular Biology

Food Allergies Could Be Fought With Friendly Bacteria In Alcoholic Milkshake

Feeding babies alcoholic milk may help to protect against some food allergies. Kefir, a traditional fermented drink, is consumed in Eastern Europe as a health food, and is often used to wean babies, as it is easily digested. Food allergy prevalence is especially high in children under the age of three, with around 5-8% of infants at risk. Currently the only treatment is avoidance of the problematic food.

“Friendly” bacteria in kefir may play a role in blocking the pathway involved in allergic responses, Lisa Richards reports in Chemistry & Industry, SCI’s fortnightly magazine. Research published 16 October 2006(DOI 10.1002/jsfa2469) in the SCI’s Journal of the Science of Food and Agriculture has shown that the milk drink inhibits the allergen specific antibody Immunoglobulin E (IgE). IgE is involved in immune responses to inactivate organisms that might cause disease. However, in the presence of allergens it can also activate cells responsible for the release of histamine, a chemical which stimulates allergic responses, such as inflammation and constriction of airways.

Ji-Ruei Liu’s team of scientists at the National Formosa University, Yunlin, Taiwan, fed mice the milky drink, and found that after 3 weeks, the amount of ovalbumin (OVA) specific IgE was reduced three-fold. Ovalbumin is an allergenic protein found in egg whites, which cause most allergies in young children. Kefir is also reported to prevent food antigens from passing through the intestinal wall.

Liu believes that the milky drink could be a promising tool in the prevention of allergies. “In the future, maybe we can screen out the certain components (bacterial strains or bioactive peptides) from kefir and utilize them in medicine,” he said.

Also in this weeks Chemistry & Industry, UK firm Rigest are looking for backers to develop an air sanitizing system using an enzyme found naturally in human tears. Lactoperoxidase can attack and kill microbes such as ‘flu viruses and the bacteria responsible for MRSA. The system could be used to sanitize the air in airplanes and hospital sick bays.

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Chemistry & Industrybr> Please acknowledge Chemistry & Industry as the source of these items. If publishing online, please include a hyperlink to http://www.chemind.org/ Please note Chemistry & Industry uses ‘&’ in its title, please do not correct to ‘and’.

About Chemistry & Industry
Chemistry & Industry magazine from SCI delivers news and comment from the interface between science and business. As well as covering industry and science, it focuses on developments that will be of significant commercial interest in five- to ten-years time. Published twice-monthly and free to SCI Members, it also carries authoritative features and reviews. Opinion-formers worldwide respect Chemistry & Industry for its independent insight.

Journal of the Science of Food and Agriculture
About the Journal of the Science of Food and Agriculture The Journal of the Science of Food and Agriculture (JSFA) publishes peer-reviewed original research and critical reviews in these areas, with particular emphasis on interdisciplinary studies at the agriculture/food interface. This international journal covers fundamental and applied research.

JSFA is an SCI journal, published by John Wiley & Sons, on behalf of the Society of Chemical Industry, and is available in print (ISSN: 0022-5142) and online (ISSN: 1097-0010) via Wiley InterScience http://www.interscience.wiley.com/ For further information about the journal go to http://interscience.wiley.com/jsfa

About SCI
SCI is a unique international forum where science meets business on independent, impartial ground. Anyone can join, and the Society offers a chance to share information between sectors as diverse as food and agriculture, pharmaceuticals, biotechnology, environmental science and safety. As well as publishing new research and running events, SCI has a growing database of member specialists who can give background information on a wide range of scientific issues. Originally established in 1881, SCI is a registered charity with members in over 70 countries.

About Wiley
John Wiley & Sons, Ltd., based in Chichester, England, is the largest subsidiary of John Wiley & Sons, Inc. Founded in 1807, John Wiley & Sons, Inc., provides must-have content and services to customers worldwide. Their core businesses include scientific, technical, and medical journals, encyclopedias, books, and online products and services; professional and consumer books and subscription services; and educational materials for undergraduate and graduate students and lifelong learners. Wiley has publishing, marketing, and distribution centres in the United States, Canada, Europe, Asia, and Australia. The company is listed on the New York Stock Exchange under the symbols JWa and JWb. Wiley’s recently re-launched Internet site can be accessed at http://www.wileyeurope.com/

Contact: SCI Press Office
Society of Chemical Industry

FDA Approves Allegra(R) (fexofenadine Hydrochloride) Oral Suspension For Treatment Of Seasonal Allergy Symptoms And Chronic Idiopathic Urticaria

Sanofi-aventis U.S. (EURONEXT: SAN and NYSE: SNY) announced today that the U.S. Food and Drug Administration (FDA) has approved Allegra(R) (fexofenadine hydrochloride) Oral Suspension for the twice-daily treatment of symptoms associated with seasonal allergies in pediatric patients, 2 to 11 years of age, and for the treatment of chronic idiopathic urticaria in children 6 months to 11 years of age. This approval makes available a safe and effective seasonal allergy treatment option that is non-impairing to pediatric populations as young as 2 years old.

“Until now, parents had few seasonal antihistamine treatment options that were not associated with cognitively impairing adverse side effects,” says Eli Meltzer, M.D., of the Allergy and Asthma Medical Group and Research Center in San Diego. “However, with Allegra Oral Suspension, which does not cause sedation at any dose and is well-established for its antihistamine activity, a medication is now available in a good tasting, easy-to-swallow formulation that can help reduce the seasonal allergy symptoms of children.”

Seasonal allergic rhinitis is a common chronic condition in children. Symptoms of seasonal allergies include nasal drainage, sneezing, watery eyes and itchy nose, eyes and throat. Studies indicate that seasonal allergy inflammation as well as the impairing side effects of older antihistamines can be disruptive to a child and may affect cognitive skills and function.

Allegra Oral Suspension has also been approved for the treatment of chronic idiopathic urticaria (CIU) in twice-daily 30 mg doses for pediatric patients 2 to 11 years of age and twice-daily 15 mg doses for pediatric patients 6 months to 2 years of age. CIU is a rare and bothersome condition characterized by hives lasting more than 6 weeks from an unknown cause. Its symptoms are caused by a reaction to an unknown trigger in the upper layers of the skin. The condition itself may cause severe itching, but is made worse by scratching.

Allegra Oral Suspension will have a berry flavor* and is expected to be available to consumers in time for the 2007 spring allergy season.

Artificial raspberry-cream flavoring

Important Safety Information

Side effects in children 6 months to 5 years old were similar to placebo. Side effects varied by age. The most commonly reported side effects were: vomiting, pyrexia, cough, otitis media and diarrhea.

Please see full prescribing information for Allegra Oral Suspension at http://products.sanofi-aventis.us/allegra_oral/allegra.pdf.

About sanofi-aventis

Sanofi-aventis is the world’s third largest pharmaceutical company, ranking number one in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine, and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY)

Forward Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words “expect,” “anticipates,” “believes,” “intends,” “estimates,” “plans” and similar expressions. Although sanofi-aventis’ management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward- Looking Statements” in sanofi-aventis’ annual report on Form 20-F for the year ended December 31, 2005. Other than as required by applicable law, sanofi- aventis does not undertake any obligation to update or revise any forward- looking information or statements.

sanofi-aventis
http://www.sanofi-aventis.com

FDA Approves Prescription Zaditor(R) For Over-The-Counter Relief From Itchy Eyes

Novartis Pharmaceuticals Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved prescription Zaditor(R) (ketotifen fumarate ophthalmic solution 0.025%), indicated for the temporary prevention of itchy eyes due to allergic conjunctivitis, for OTC use. An estimated 40 million Americans suffer from eye allergies. Whether in reaction to seasonal allergens including pollen and ragweed, or perennial allergens such as animal hair or pet dander, itchy eyes are a main complaint.

While most OTC products provide only 3-4 hours of short-term relief, Zaditor’s full prescription strength formula offers eye itch relief that works in minutes and lasts up to 12 hours with just one drop. This significantly reduces the number of doses required per day to keep affected eyes itch-free. In addition, Zaditor is the first OTC eye itch medication safe for use in children as young as three.

“Now for the first time, people who suffer from itchy eyes caused by allergens such as pollen or pet dander can get fast, long-acting relief over- the-counter with Zaditor,” says Marion Morton, Head of the US Novartis Ophthalmics Business Unit. “Because Zaditor is now available at full prescription strength without a prescription, consumers can save time and money without sacrificing long-lasting symptom relief.”

Zaditor is the only OTC drop to treat eye itch associated with pollen, ragweed, grass, animal hair and dander without the potentially negative effects of a decongestant. Many OTC eye drops contain topical decongestants, which constrict the blood vessels to reduce the appearance of redness in the eye. With regular use, these products can interfere with the eye’s natural ability to regulate the blood vessels, resulting in a continued redness for a period of time after discontinuation (rebound effect). Zaditor does not contain a decongestant and may be used without risk of rebound redness.

“The availability of Zaditor without a prescription greatly improves treatment options for eye itch sufferers,” said Jane MacEnroe, MD, Associate Director, Medical Information and Communication, Novartis Ophthalmics. “For the first time, patients can get lasting relief over-the-counter without worrying about potential side-effects associated with long-term use of topical decongestants found in other OTC eye itch drops.”

Triple Mechanism of Action

Zaditor is the only OTC eye itch drop with a triple-action formula to provide fast, durable efficacy at the source. It includes a:

— Potent antihistamine that rapidly relieves itchy eyes within minutes

— Mast cell stabilizer that provides extended relief for up to 12 hours

— Prevents the release of chemical mediators to stop the late phase allergic reaction

Histamines, a chemical made by the body during an allergic reaction, are a primary cause of itchy eyes. Unlike most OTC drops, Zaditor blocks the histamines that cause itchy eyes and prevents the release of additional histamines, treating the source of the itch, not just the symptoms.

Approved in 1999 for prescription use, Zaditor has become a leading treatment for the temporary prevention of itchy eyes due to allergic conjunctivitis. Zaditor will be available over-the-counter in drug and chain stores nationwide beginning January 2007. It has a suggested retail price of $14.99 for a 30-day supply. In clinical studies, Zaditor was well tolerated and any side effects are generally mild.

About Novartis Ophthalmics

Novartis Ophthalmics, a business unit of Novartis Pharmaceuticals Corporation, is a leader in research, development and manufacturing of leading ophthalmic pharmaceuticals that assist in the treatment of age-related macular degeneration, eye inflammation, glaucoma, ocular allergies and other disorders of the eye. Novartis Ophthalmics products are available in more than 110 different countries. Novartis products are made in Switzerland, France, the United States and Canada.

About Novartis Pharmaceuticals Corporation

Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG (NYSE: NVS), a world leader in offering medicines to protect health, treat disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. Novartis is the only company with leadership positions in both patented and generic pharmaceuticals. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. In 2005, the Group’s businesses achieved net sales of USD 32.2 billion and net income of USD 6.1 billion. Approximately USD 4.8 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 97,000 people and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com/.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as “will,” or similar expressions, or by express or implied discussions regarding potential future sales of Zaditor. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Zaditor to be materially different from any future results, performance or achievements expressed or implied by such statements. Management’s expectations regarding Zaditor could be affected by, among other things, competition in general; increased government, industry, and general public pricing pressures; unexpected clinical trial results, including additional analysis of Zaditor clinical data, or new clinical data; unexpected regulatory actions or delays or government regulation generally; the company’s ability to obtain or maintain patent or other proprietary intellectual property protection; and other risks and factors referred to in the Company’s current Form 20-F on file with the U.S. Securities and Exchange 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 information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

Novartis Ophthalmics
http://www.novartis.com/

Soy Formula Not Proven To Prevent Allergies In Infants

Although soy infant formulas were created to reduce the chances of babies developing allergies or food intolerances, there is no clear proof that soy or other specialized formulas lower those risks, a new review has found.

“There is no evidence that using any type of formula is better than exclusive breastfeeding for prevention of allergy,” said authors David Osborn, M.D., of Royal Prince Alfred Hospital and John Sinn, M.D., of Westmead Hospital, in Australia. “Specialized formulas should be restricted to situations where infants cannot exclusively breastfeed or when an infant develops a specific food allergy or hypersensitivity.”

Food allergies can include wheat, peanuts, cow’s milk and soy protein. Cow’s milk allergy is the most prevalent in children and has been documented in 1.8 percent of children along with 0.5 percent of children who have allergies to soy protein, the reviewers say.

Mothers who do not breastfeed introduce their infants to cow’s milk or soy formula early in life, which has been linked to an increased chance of the newborn developing allergy or food intolerance. In an effort to combat these risks, infants are often prescribed formulas such as hydrolyzed cow’s milk, adapted soy and hydrolyzed soy formula.

The aim of the systematic review was to determine whether soy infant formulas do indeed prevent allergy and food intolerance, and whether they are linked to any particular benefits or harms to an infant’s growth and development.

The review appears in the current issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates research in all aspects of health care. Systematic reviews draw evidence-based conclusions about medical practice after considering both the content and quality of existing trials on a topic.

The Cochrane reviewers analysed three studies that compared formulas for prolonged infant feeding. The enrollment size of each was considered small – with the combined number of infants totaling 875.

Reviewers did not include studies of infants already diagnosed with food allergies or food intolerances; instead, review studies evaluated infants considered at high risk of allergies based on a strong family history – infants whose parent or sibling had ever had a significant allergy.

The studies followed these infants into childhood up to 10 years of age to determine if they had developed allergies or intolerances.

Based on the results, the authors concluded there was no significant benefit from the use of a soy formula compared to a cow’s milk formula.

The review supported previous evidence that mothers who choose to only breastfeed their infants for at least six months do reduce the incidence of allergy.

According to the American Academy of Pediatrics, women who don’t have health problems should “exclusively breastfeed their infants for at least the first six months of life.”

Breast milk provides the right balance of nutrients to help an infant grow into a strong and healthy toddler, according to the National Institute of Child Health and Human Development, and some of the nutrients in breast milk also help protect against some common childhood illnesses and infections.

Despite these benefits, many mothers still introduce their babies to cow’s milk or soy milk formula, which some nutritionists believe may not be an acceptable substitution.

“I personally do not advocate soy milk,” said nutritionist Susan M. Mudd, M.S., of Body Tech in Gaithersburg, MD. “Soy milk is a high allergen and previous soy-based infant formulas have actually been linked to impaired thyroid function and an extremely high amount of estrogen in some babies.”

However, Osborn says that those specific problems were reported “for some soy formulas that had high iodine contents -it is probably not the case with current ones.”

Nevertheless, “I would advise mothers to be careful of the risks,” Mudd said. “I’d tell them to ask their doctors about soy milk and conduct their own research before making a decision to put their infants on a soy diet.”

Osborn DA, Sinn J. Soy formula for prevention of allergy and food intolerance in infants. Cochrane Database of Systematic Reviews 2006, Issue 4.

The Cochrane Collaboration is an international nonprofit, independent organization that produces and disseminates systematic reviews of health care interventions and promotes the search for evidence in the form of clinical trials and other studies of interventions. Visit http://www.cochrane.org for more information.

Health Behavior News Service
Center for the Advancement of Health 2000 Florida Ave. NW, Ste 210
Washington, DC 20009
United States
http://www.hbns.org

CIMZIATM (Certolizumab Pegol) Maintained Response And Remission In Crohn’s Patients Previously Treated With Infliximab

New data from a post hoc analysis of the PRECiSE clinical trial program demonstrated that the anti-TNF CIMZIATM (certolizumab pegol) maintained response and remission in patients with moderate to severe Crohn’s disease, regardless of whether or not they had been previously treated with infliximab. These results build on the PRECiSE 2 study results previously presented, which showed that subcutaneous administration of CIMZIATM (certolizumab pegol), given every four weeks with an additional induction dose at week 2, demonstrated a statistically significant rate of response and remission at week 26 compared to placebo in patients responding at Week 6. CIMZIATM (certolizumab pegol) may offer an alternative to currently available therapies.

These new analyses will be presented this week at the 14th United European Gastroenterology Week (UEGW) in Berlin, Germany and the 2006 American College of Gastroenterology (ACG) Annual Scientific Meeting in Las Vegas, Nevada, USA.

“Physicians and patients appreciate new options when dealing with diseases and symptoms that can dramatically affect their daily lives, as is the case with patients suffering from Crohn’s disease,” said Stephen Hanauer, M.D., Professor of Medicine and Clinical Pharmacology Chief, Section of Gastroenterology and Nutrition, University of Chicago, USA, at the ACG. “The study reinforces that there is a clear need for new therapies such as CIMZIA, to provide patients with therapeutic options to better manage their disease and improve their quality of life.”

The new data, to be presented at UEGW and ACG by Professors Jean-Frederick Colombel, Department of Hepato-Gastroenterology, Claude Huriez Hospital, Lille, France and Hanauer respectively, analyzed the efficacy and tolerability of CIMZIATM (certolizumab pegol) in patients who had previously taken infliximab or not. Of those randomized at week 6, 68.7% of the infliximab-naпve patients and 44.2% of patients previously treated with infliximab achieved a clinical response, defined as ?100 point decrease in Crohn’s Disease Activity Index (CDAI)1.

A similar pattern of results was observed for remission at week 26, based on a CDAI score1
“It is important to determine whether a patient’s prior exposure to infliximab will affect the safety or effectiveness of newer therapies with distinct mechanisms of action,” said Colombel at the UEGW meeting. “This new information suggests that CIMZIA may be an effective new option for treating Crohn’s patients regardless of any previous infliximab treatment.”

PRECiSE Clinical Trials Program

The PRECiSE Program, composed of four studies (PRECiSE 1, 2, 3, and 4), represents an innovative, large, comprehensive development program for CIMZIATM (certolizumab pegol) in Crohn’s disease, including over 1,300 patients, with a planned follow-up phase of up to five years.

PRECiSE 1 is a unique trial in patients with active Crohn’s disease – the first reported Phase III double-blind, placebo-controlled study of an anti-TNF extending to 26 weeks, in which eligible patients were randomized at study baseline without pre-selection of responders. Both co-primary endpoints were met with statistical significance.3

In the previously reported PRECiSE 2 study, patients responding at Week 6 to open-label induction therapy with CIMZIATM (certolizumab pegol) were randomized to either placebo (n=210) or CIMZIATM (certolizumab pegol) (n=215) and followed for a total of 26 weeks. In this trial, 62.8% of CIMZIATM (certolizumab pegol) patients, compared to 36.2% of placebo patients, maintained clinical response at Week 26 (p
Serious adverse events occurred in 5.6% of CIMZIATM (certolizumab pegol) patients during the double blind phase. One case of tuberculosis, which responded well to anti-tuberculosis therapy, was observed in the CIMZIATM (certolizumab pegol) arm of the PRECiSE 2 trial. Local injection reactions were low in PRECiSE 2 (2.8%), and less frequent than seen with placebo. The percentage of patients who tested positive for auto-antibody formation at Week 26 (and were negative at baseline) was only 8.3% for anti-nuclear antibodies and 1.0% for anti-double-stranded DNA antibodies in PRECiSE 2. No cases of lupus were reported.4

PRECiSE 3 and 4 are both long-term (up to five years) open-label trials assessing the longer-term efficacy, safety and tolerability of CIMZIATM (certolizumab pegol) in patients from PRECiSE 1 and PRECiSE 2, and are currently ongoing.

New Studies Initiated

UCB continues to study the clinical profile of CIMZIATM (certolizumab pegol) in Crohn’s disease. Enrollment has commenced in a new clinical trial involving 600 patients called WELCOME. The study will further examine the effects of CIMZIATM (certolizumab pegol) in patients failing or intolerant to infliximab. In addition, the MUSIC study will investigate the impact of CIMZIATM (certolizumab pegol) on endoscopic and mucosal healing, and the CONCISE trial will examine the corticosteroid-sparing effect of CIMZIATM (certolizumab pegol) in Crohn’s disease.

About CIMZIATM (certolizumab pegol)

UCB filed a BLA with the Food and Drug Administration (FDA) for CIMZIATM (certolizumab pegol) in the treatment of Crohn’s disease on February 28th, 2006 and on April 28, 2006 submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for the same indication. CIMZIATM (certolizumab pegol) is the first and only PEGylated Fab’ fragment of a humanized anti-TNF-alpha antibody (TNF-alpha; Tumour Necrosis Factor), evaluated as once-monthly dosing administered subcutaneously. The engineered Fab’ fragment retains the biologic potency of the original antibody without the cytotoxicity mediated by the Fc portion present in the original monoclonal antibodies. CIMZIATM (certolizumab pegol) has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha. Over the past decade, TNF-alpha has emerged as a major target of basic research and clinical investigation. This cytokine plays a key role in mediating pathological inflammation, and excess TNF-alpha production has been directly implicated in a wide variety of diseases.

About Crohn’s Disease

Crohn’s disease is a chronic, progressive and debilitating inflammatory disease of the gastrointestinal tract, most commonly affecting the end of the small intestine (the ileum) and beginning of the large intestine (the colon). Together with ulcerative colitis, Crohn’s disease belongs to the group of illnesses known as inflammatory bowel disease. Crohn’s disease affects nearly one million people worldwide, including an estimated 500,000 people in the United States and a further 500,000 people in Europe4. People with Crohn’s disease may suffer an ongoing cycle of “flare-up” and remission. Symptoms of the disease include persistent diarrhoea, abdominal pain, and loss of appetite/weight, fever or rectal bleeding. Severe symptoms may result in the need for surgical intervention. In an effort to provide Crohn’s disease patients with disease management information and resources designed expressly with their needs in mind, UCB has launched patient Web sites in the U.S (http://www.CrohnsandMe.com) and Europe (http://www.CrohnsandMe.eu). Both are dynamic, cutting-edge Web sites focused on helping patients thoroughly understand Crohn’s disease and live with it every day.

About UCB

UCB is a leading global biopharmaceutical company dedicated to the research, development and commercialization of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and oncology – UCB focuses on securing a leading position in severe disease categories. Employing over 8,300 people in 40 countries, UCB achieved revenues of Ђ 2.3 billion in 2005. With worldwide headquarters located in Brussels, Belgium, UCB is listed on the Euronext Brussels Exchange.

UCB S.A.
60 Allйe de la Recherche
B-1070
Brussels
Belgium
http://www.ucbgroup.com

FDA Approves Omnaris (ciclesonide) Nasal Spray For Allergic Rhinitis

The Food and Drug Administration (FDA) announced today the approval of Omnaris (ciclesonide) nasal spray, a new drug for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis, commonly known as hay fever, in adults and children 12 years of age and older.

Although the precise way Omnaris works is unknown, the drug is a corticosteroid. Corticosteroids are hormone-like drugs that suppress the immune response.

Allergic rhinitis is the medical term for the inflamed, runny nose that’s the main symptom of allergies. Seasonal allergic rhinitis is the most common allergic disease. About 35 million Americans suffer from this condition. The ailment’s classic symptoms are watery nasal discharge, and fits of sneezing, and itching that can affect not just the nose but the roof of the mouth, throat and the Eustachian tubes which connect the middle ear to the back of the throat.

The safety and efficacy of Omnaris nasal spray were studied in four randomized placebo controlled clinical trials ranging in duration from two weeks to a year. The studies assessed how well Omnaris treated symptoms (runny nose, nasal itching, sneezing, and nasal congestion) in patients with hay fever. The results of these trials showed that patients treated with Omnaris nasal spray had an 8-10 percent greater reduction in nasal symptoms compared to placebo. The difference between Omnaris nasal spray and placebo was significant.

The most common side effects in clinical studies were headache, nosebleeds, and inflammation of the nose and throat linings.

Omnaris is manufactured by ALTANA Pharma US, Inc. of Florham Park, NJ.

http://www.fda.gov

FDA Approves Prescription ZaditorR For Over-The-Counter Relief From Itchy Eyes

Novartis Pharmaceuticals Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved prescription Zaditor® (ketotifen fumarate ophthalmic solution 0.025%), indicated for the temporary prevention of itchy eyes due to allergic conjunctivitis, for OTC use. An estimated 40 million Americans suffer from eye allergies. Whether in reaction to seasonal allergens including pollen and ragweed, or perennial allergens such as animal hair or pet dander, itchy eyes are a main complaint.

While most OTC products provide only 3-4 hours of short-term relief, Zaditor’s full prescription strength formula offers eye itch relief that works in minutes and lasts up to 12 hours with just one drop. This significantly reduces the number of doses required per day to keep affected eyes itch-free. In addition, Zaditor is the first OTC eye itch medication safe for use in children as young as three.

“Now for the first time, people who suffer from itchy eyes caused by allergens such as pollen or pet dander can get fast, long-acting relief over-the-counter with Zaditor,” says Marion Morton, Head of the US Novartis Ophthalmics Business Unit. “Because Zaditor is now available at full prescription strength without a prescription, consumers can save time and money without sacrificing long-lasting symptom relief.”

Zaditor is the only OTC drop to treat eye itch associated with pollen, ragweed, grass, animal hair and dander without the potentially negative effects of a decongestant. Many OTC eye drops contain topical decongestants, which constrict the blood vessels to reduce the appearance of redness in the eye. With regular use, these products can interfere with the eye’s natural ability to regulate the blood vessels, resulting in a continued redness for a period of time after discontinuation (rebound effect). Zaditor does not contain a decongestant and may be used without risk of rebound redness.

“The availability of Zaditor without a prescription greatly improves treatment options for eye itch sufferers,” said Jane MacEnroe, MD, Associate Director, Medical Information and Communication, Novartis Ophthalmics. “For the first time, patients can get lasting relief over-the-counter without worrying about potential side-effects associated with long-term use of topical decongestants found in other OTC eye itch drops.”

Triple Mechanism of Action Zaditor is the only OTC eye itch drop with a triple-action formula to provide fast, durable efficacy at the source. It includes a:

* Potent antihistamine that rapidly relieves itchy eyes within minutes
* Mast cell stabilizer that provides extended relief for up to 12 hours
* Prevents the release of chemical mediators to stop the late phase allergic reaction

Histamines, a chemical made by the body during an allergic reaction, are a primary cause of itchy eyes. Unlike most OTC drops, Zaditor blocks the histamines that cause itchy eyes and prevents the release of additional histamines, treating the source of the itch, not just the symptoms.

Approved in 1999 for prescription use, Zaditor has become a leading treatment for the temporary prevention of itchy eyes due to allergic conjunctivitis. Zaditor will be available over-the-counter in drug and chain stores nationwide beginning January 2007. It has a suggested retail price of $14.99 for a 30-day supply. In clinical studies, Zaditor was well tolerated and any side effects are generally mild.

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About Novartis Ophthalmics
Novartis Ophthalmics, a business unit of Novartis Pharmaceuticals Corporation, is a leader in research, development and manufacturing of leading ophthalmic pharmaceuticals that assist in the treatment of age-related macular degeneration, eye inflammation, glaucoma, ocular allergies and other disorders of the eye. Novartis Ophthalmics products are available in more than 110 different countries. Novartis products are made in Switzerland, France, the United States and Canada.

About Novartis Pharmaceuticals Corporation
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG (NYSE: NVS), a world leader in offering medicines to protect health, treat disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. Novartis is the only company with leadership positions in both patented and generic pharmaceuticals. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. In 2005, the Group’s businesses achieved net sales of USD 32.2 billion and net income of USD 6.1 billion. Approximately USD 4.8 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 97,000 people and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com/.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as “will,” or similar expressions, or by express or implied discussions regarding potential future sales of Zaditor. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Zaditor to be materially different from any future results, performance or achievements expressed or implied by such statements. Management’s expectations regarding Zaditor could be affected by, among other things, competition in general; increased government, industry, and general public pricing pressures; unexpected clinical trial results, including additional analysis of Zaditor clinical data, or new clinical data; unexpected regulatory actions or delays or government regulation generally; the company’s ability to obtain or maintain patent or other proprietary intellectual property protection; and other risks and factors referred to in the Company’s current Form 20-F on file with the U.S. Securities and Exchange 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 information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

Contact: Beth Rowan
Ruder Finn Public Relations

Allergy And Immunology On The Cusp Of Major Breakthroughs

Allergy and immunology is on the threshold of major therapeutic discoveries according to investigators presenting the latest research at the annual meeting of the American College of Allergy, Asthma and Immunology (ACAAI) in Philadelphia.

“Allergy and immunology is on the cusp of major breakthroughs based on a 40-year history of increasing our fundamental understanding of how the immune system and the allergic reaction part of the immune system works,” said ACAAI President-Elect Daniel Ein, M.D., program chair for the meeting. He is clinical professor of medicine at George Washington University School of Medicine and chief of the division of allergy at GWU Medical Center, Washington, D.C.

“With that understanding comes the opportunity to target therapies in more specific ways,” he said. “We’ve been attacking clinical problems with a broad approach, but we need to be more specific in the future with our therapies. It’s the fulfillment of and logical extension of the last 40 years of basic research. We chose the meeting theme, ‘We’ve Only Just Begun,’ because I think we’re in the early stages of a revolution in the treatment of allergic disease.”

Allergen immunotherapy, a widely used approach, aims to modulate an allergic patient’s immune response through administration of increasing doses of an extract which will eventually reduce or eliminate the patient’s symptoms.

Although conventional subcutaneous immunotherapy has been shown to be effective for the treatment of allergic rhinitis, asthma and venom sensitivity, considerable research is being devoted to the development of therapeutic vaccines for the treatment of allergic diseases to improve efficacy, lessen the time to achieve effectiveness, reduce the inconvenience and enhance safety. Alternative methods of administration such as oral and sublingual are also being investigated.

Allergic Asthma

“There is a great need for novel therapies for asthma, especially in the 10 percent of severe asthmatics who account for approximately 50 percent of the health care costs of asthma,” said David H. Broide, M.B., C.H.B., a professor of medicine at the University of California, San Diego.

“Although novel therapies frequently show promise in pre-clinical studies, only 8 percent of these therapies which are tested in human subjects prove to be safe and effective in humans with disease,” Dr. Broide said.

The ability to find novel therapies that are safe and effective is complicated by the fact that asthma is not a single gene/protein/mediator disorder, and there are over 100 genes linked to asthma. Some novel therapies already in use include leukotriene inhibitors and anti-IgE therapy. Researchers are also studying the efficacy of a wide range of promising therapeutics such as antibiotics, probiotics and TLR (Toll Like Receptors) ligands, cytokines (Anti-TNF, Anti-IL-5), and transcription factors.

Anti-IgE (Omalizumab) is a humanized monoclonal antibody and the only therapy which targets IgE, the root cause of allergic asthma. It is the first biotechnology derived treatment for allergic asthma and was approved by the FDA in June 2003 for the treatment of patients diagnosed with moderate-to-severe forms of the disease.

Food Allergy

Researchers are also looking at novel approaches for treating food allergy, which is a major health problem in industrialized nations. It affects between 6 percent – 8 percent of young children and 4 percent of adults. Current management of food allergy includes the avoidance of specific foods and the medical management of acute reactions.

Only a few foods, such as milk, eggs, peanuts, nuts, and fish and shellfish account for over 90 percent of all food allergic reactions. Attempts at primary prevention have largely not met with much success.

“There are several promising studies being conducted now that likely will result in new treatments for food allergy,” said Wesley Burks, M.D., professor and chief, Pediatric Allergy and Immunology at Duke University Medical Center, Durham, N.C.

One of the new therapies are on the horizon is Anti-IgE, which may be able to prevent severe food allergic reactions and can also be used in combination with other new therapies for treatment. Another is the use of modified allergenic proteins that may be able to “reverse” food allergy.

“Routes, other than subcutaneous, for the delivery of allergy immunotherapy for food allergy are being studied extensively now,” said Dr. Burks.

Other Novel Therapies for Allergic Diseases

A number of studies are now evaluating the safety and efficacy of non-traditional forms of immunomodulation, including sublingual immunotherapy (SLIT) and oral immunotherapy (OIT). But while allergen-specific SLIT and OIT seem to hold some promise for patients with milder types of allergic disease, they have not been approved by the FDA for use in the United States. There is still a need for blinded, placebo controlled studies of correct dosing, multi-allergen therapy, and in patients with more severe allergic diseases.

Yet another novel approach currently under study is the use of an allergen vaccine with immunostimulatory DNA according to Peter S. Creticos, M.D., Johns Hopkins Asthma & Allergy Center, Baltimore, Md. The vaccine, which could be administered in a few doses, would have important therapeutic implications for millions of patients with poorly controlled allergic rhinitis and asthma, who would be ideal candidates for such a form of immunomodulation.

A novel immunostimulatory DNA vaccine called AIC, which is aimed at patients with allergies to ragweed, has already undergone preliminary testing in France, Canada, and the United States. Data from studies in Europe have confirmed the safety of AIC, and a recent clinical trial through the Immune Tolerance Network of the NIH has demonstrated promising results for efficacy. Patients with fall seasonal allergic rhinitis showed improvements in a number of different measures, including seasonal symptom diary scores, quality of life scores, and medication usage.

The results from these clinical studies of patients with ragweed-induced allergic rhinitis demonstrate that AIC is less allergenic than conventional immunotherapeutic products and may offer the potential for an improved safety profile for immunotherapy, Dr. Creticos said.

Patient information on allergic diseases including asthma is available by calling the ACAAI toll free number at (800) 842-7777 or visiting its Web site at http://www.acaai.org.

About ACAAI

The American College of Allergy, Asthma and Immunology (ACAAI) is a professional medical organization headquartered in Arlington Heights, Ill., that promotes excellence in the practice of the subspecialty of allergy and immunology. The College, comprising more than 5,000 allergists-immunologists and related health care professionals, fosters a culture of collaboration and congeniality in which its members work together and with others toward the common goals of patient care, education, advocacy and research.

American College of Allergy, Asthma and Immunology (ACAAI)
85 W. Algonquin Rd., Ste 550
Arlington Heights, IL 60005
United States
http://www.acaai.org