February 26, 2007

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

First Asthma Census Highlights Lack Of Control Of Condition, UK

An Asthma UK census has revealed that only 4% of those people questioned have their asthma under control.

The shocking results follow Asthma UK's first ever asthma control census which was launched on World Asthma Day in May this year. It aimed to raise awareness amongst the 4.1 million adults with asthma in the UK that they may be putting up with symptoms that impact unnecessarily on their quality of life.

The Asthma Control Test, a 60-second, five-point questionnaire was completed online by over 16,000 people. The test which gives a score out of 25, helps to identify the level of asthma control.

Results also highlighted that more than a third of people experienced shortness of breath on a daily basis and for 1 in 4, using their reliever inhaler more than three times a day was a regular occurrence. This is a clear indication that their asthma is not under control as asthma management guidelines state that a person's asthma is not well managed if they use their reliever inhaler more than three times a week.

The census further revealed that as a person got older, their asthma worsened. For those that completed the test, scores decreased for the older age groups and showed that for many, being woken at night or earlier in the morning with asthma symptoms such as coughing or wheezing, was a regular occurrence.

Professor Martyn Partridge, Chief Medical Advisor at Asthma UK said: 'The results of this census highlight that a high proportion of people in the UK are putting up with unnecessary symptoms on a daily basis. They could be getting a better night's sleep, going about their everyday life without thinking about their asthma and using their reliever inhaler far less. With simple and safe medication, their asthma could be under control. I would advise making an appointment to see your GP or asthma nurse so that they can have an asthma review. The ultimate aim should be that you control your asthma, and not that it controls you.'

1. The Asthma Control Test is suitable for people with asthma aged 12 and over.

2. ©2002, by QualityMetric Incorporated. Asthma Control Test is a trademark of QualityMetric Incorporated. "US English version modified for use in UK"

3. Asthma UK is the charity dedicated to improving the health and well being of the 5.2 million people in the UK whose lives are affected by asthma. For up-to-date news on asthma, information and publications, visit the Asthma UK website http://www.asthma.org.uk.

4. For independent and confidential advice on asthma, call the Asthma UK Adviceline, which is staffed by asthma nurse specialists. It is open weekdays from 9am to 5pm on 08457 01 02 03. Or email an asthma nurse at http://www.asthma.org.uk/adviceline.

http://www.asthma.org.uk

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.

###

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

Specialist Clinic In Italy Studies Rare Disease

Angioedema is an uncommon condition characterized by swelling of the tissue under the skin. It is usually associated with urticaria ("hives"), and is often related to an allergy.

At times, angioedema occurs on its own, without urticaria, and it is difficult to diagnose a cause. This often takes years.

This study reports on 776 patients with angioedema without urticaria, seen over 11 years at a specialized clinic in Italy. From their research, Zingale and colleagues outline a practical approach to the differential diagnosis of patients presenting with angioedema.

In a related commentary, Bowen applauds the European approach to diagnosis and management of angioedema and encourages the development in Canada of patient data registries and national programs of comprehensive clinics for rare diseases.

###

Angiodema without uticaria: a large clinical survey - B. Cicardi et al
http://www.cmaj.ca/pressrelease/pg1065.pdf

Angiodema and the Canadian Network of Rare Blood Disorder Organizations: extending the Canadian hemophilia care model - T. Bowen
http://www.cmaj.ca/pressrelease/pg1083.pdf

Contact: Dr. Marco Cicardi
Canadian Medical Association Journal

Latest Data Demonstrate Boehringer Ingelheim's Pramipexole (Mirapexin®/Sifrol®) Improves Broad Spectrum Of Symptoms Of Restless Legs Syndrome

New data presented today show patients taking pramipexole (Mirapexin®/ Sifrol®) can experience significant improvements in a broad range of symptoms associated with Restless Legs Syndrome (RLS).1 In an additional study presented today, pramipexole was also shown to be well tolerated in RLS patients affected by concomitant diseases, which are commonly experienced in this patient group.2 The results of the studies were presented at the 10th International Congress of Parkinson's Disease and Movement Disorders (MDS) in Kyoto, Japan.

In all studies presented, patients taking pramipexole rated clinically meaningful improvements to their night and day-time symptoms, as measured on the International Restless Legs Scale (IRLS). The IRLS measures several aspects of the condition, ranging from discomfort, the need to move around, and relief by moving around, to specific RLS symptoms such as sleep disturbance, day-time tiredness, mood disorder, as well as addressing overall severity, weekly frequency, daily severity, and impact on daily activities.1

"Patients with Restless Legs Syndrome need treatment that will help to improve all of their symptoms in the night and day-time. The new evidence presented today gives both clinicians and patients the confidence that pramipexole can be used to address the key aspects of this chronic condition," said Professor John W. Winkelman, MD, PhD, Medical Director of the Sleep Health Centre of Brigham and Women's Hospital, Boston, Massachusetts/USA and Harvard Medical School.

IRLS data were pooled from a total of 564 pramipexole recipients and 220 placebo recipients, all of whom had participated in one of three placebo-controlled double-blind randomised trials of pramipexole in RLS. Pramipexole improved symptoms across all IRLS subscores (range 0 to 4 points), versus placebo. The mean improvement in the pramipexole arm ranged from 0.9 points for 'impact on daily activities' and 1.0 for 'mood disturbance' to 1.8 points for 'need to move due to discomfort'.1 These results, confirmed by patients themselves, reinforce the overall benefits of pramipexole.

Broad range of patients

According to another study presented today at MDS, RLS patients with concomitant diseases, or who are taking additional therapies, benefited from treatment with pramipexole.2 It is very common for RLS patients to suffer from additional conditions, including seasonal allergy, hypertension and gastroesophageal reflux.2 Furthermore, patients frequently take medication for other conditions, including analgesics, anti-inflammatory and anti-rheumatic drugs, and agents affecting cardiovascular function.2

Results from a 12-week randomised, double-blind, placebo-controlled trial show that even with the high frequencies of concomitant diagnoses and therapies, pramipexole was associated with a significant 12-week reduction of IRLS by an adjusted mean of -13.5, compared with -9.3 for placebo (P<0.0001) .2 Therefore, patients with concomitant diseases or who are taking additional therapies can be effectively treated with pramipexole for their RLS symptoms.

"When you consider RLS is a chronic condition for which patients may need to take treatment over a long period of time, it is crucial that we explore how a drug clinically interacts with other treatments," Dr Winkelman added. "The data presented today add to our extensive knowledge on the safety of pramipexole and provide us with the reassurance that it can be used in the broadest range of patients."

Sustained symptom relief

The advantages of using pramipexole over an extended length of time were also demonstrated by data from three trials presented today at MDS.3,4,5 The results demonstrate that, over a 6-month period, pramipexole showed a substantial improvement in symptoms of RLS compared to placebo. This improvement was judged by both patients and their treating clinicians using specific RLS rating tools. Across all three trials at least 67 percent of patients judged themselves to be much better, or very much better, after completing 6 months of therapy.3,4,5 Additionally, clinicians rated improvements between 12.5 points3 and 16.9 points5 on the IRLS scale.

The data presented at MDS demonstrate that pramipexole addresses the broad range of RLS symptoms, can provide significant benefits to patients with RLS and comorbid conditions, and can also offer sustained relief from this chronic condition.

About Restless Legs Syndrome (RLS)

Restless Legs Syndrome is a neurological disorder characterised by an uncontrollable urge to move the legs, usually accompanied by unpleasant and sometimes painful sensations in the legs. Restless Legs Syndrome affects up to ten percent of the population worldwide aged between 30 and 79 years6 and around one-third of sufferers experience symptoms more than twice weekly causing moderate to severe distress7. The motor-restlessness worsens during the evening and night causing difficulty initiating and maintaining sleep. The sleep disruption can lead to excessive daytime sleepiness and compromise work performance. Restless Legs Syndrome also has considerable impact on social activities that require immobility.

About pramipexole

Pramipexole (known in Europe under the trade names Sifrol® and Mirapexin® and in the U.S.A. as Mirapex®) is a compound from Boehringer Ingelheim research first licenced in 1997 for the treatment of the signs and symptoms of idiopathic Parkinson`s Disease, as monotherapy or in combination with levodopa. Pramipexole was licenced in April 2006 throughout the European Union for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (RLS) and is also licenced in Australia, Brazil, Canada, Mexico and others.

The most commonly reported adverse reactions in early and late Parkinson's disease in clinical trials were dizziness, involuntary movement, postural hypotension, constipation, hallucinations, headache, difficulty falling asleep, sleepiness, nausea and fatigue. The most commonly reported adverse reactions in clinical trials for Restless Legs Syndrome were nausea, headache, and tiredness.

Pramipexole may cause patients to fall asleep without any warning, even while doing normal daily activities such as driving. When taking pramipexole hallucinations may occur and sometimes patients may feel dizzy, sweaty or nauseated upon standing up. It should be noted that impulse control disorders/compulsive behaviours may occur while taking medicines to treat Parkinson`s disease, including pramipexole.

Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 143 affiliates in 47 countries and almost 37,500 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2005, Boehringer Ingelheim posted net sales of 9.5 billion euro while spending almost one fifth of net sales in its largest business segment Prescription Medicines on research and development.

References:

1 -- Winkelman JW et al. Pramipexole improves a broad range of facets of restless legs syndrome. Abstract #P374. Presented at MDS 2006, Kyoto, Japan.

2 -- Winkelman JW et al. Pramipexole is not affected by therapy for concomitant disease in patients with restless legs syndrome. Abstract #P400. Presented at MDS 2006, Kyoto, Japan.

3 -- Oertel WH et al. Six-month efficacy of pramipexole for restless legs syndrome: results from a 20-week extension of a 6-week study. Abstract #P405. Presented at MDS 2006, Kyoto, Japan.

4 -- Kupsch A., et al. Six-month efficacy of pramipexole in restless legs syndrome: results from a run-in phase for a 12-week study. Abstract #P373. Presented at MDS 2006, Kyoto, Japan.

5 -- Partinen M., et al. Sustained efficacy of pramipexole in restless legs syndrome: results from a 6-month extension of a 3-week trial. Abstract #P390. Presented at MDS 2006, Kyoto, Japan.

6 -- Phillips B et al. Epidemiology of restless legs symptoms in adults. Arch Intern Med 2000; 160(14): 2137-2141.

7 -- Allen RP, Walters AS, Montplaisir J, Hening W, Myers A, Bell TJ, et al. Restless Legs Syndrome prevalence and impact: REST general population study. Arch Intern Med 2005; 165: 1286-1292.

Boehringer Ingelheim
Boehringer Ingelheim

February 23, 2007

Eisai Introduces Rx-to-OTC Switch Product For Allergy-related Rhinitis And Skin Problems

Eisai has introduced a Rx-to-OTC switch product for allergic-related rhinitis and skin problems, available from November 1.

The product, 'Higuard', is the first Rx-to-OTC switch product of azelastine hydrochloride, an anti-allergy compound originally approved for prescription use. It is also effective in alleviating allergyc symptoms including rhinitis caused by pollens or house dusts and skin problems such as utricaria and eczema.

The active ingredient of Higuard azelastine hydrochloride exhibits anti-allergic effects by inhibiting and releasing leukotriens and histamine that cause allergy, relieving allergic symptoms including rhinitis (sneezing, runny and stuffy nose) and skin problems (urticaria, eczema, etc).

It is recommended that patients with seasonal allergic diseases be started on Higuard immediately before the beginning of the season to maximize the effect.

According to an Eisai survey, more than 50 percent of the people who suffer from pollen allergy answered that they constantly feel itching of skin, and 70 percent said that they experience allergic problems all year. Higuard is expected to serve the needs of such people acting on both rhinitis and skin problems.

By Chris Lui, JCN Staff Writer

Copyright © 2006 JCN. All rights reserved. A division of Japan Corporate News Network KK.

JCN

Specialist Clinic In Italy Studies Rare Disease

Angioedema is an uncommon condition characterized by swelling of the tissue under the skin. It is usually associated with urticaria ("hives"), and is often related to an allergy.

At times, angioedema occurs on its own, without urticaria, and it is difficult to diagnose a cause. This often takes years.

This study reports on 776 patients with angioedema without urticaria, seen over 11 years at a specialized clinic in Italy. From their research, Zingale and colleagues outline a practical approach to the differential diagnosis of patients presenting with angioedema.

In a related commentary, Bowen applauds the European approach to diagnosis and management of angioedema and encourages the development in Canada of patient data registries and national programs of comprehensive clinics for rare diseases.

###

Angiodema without uticaria: a large clinical survey - B. Cicardi et al
http://www.cmaj.ca/pressrelease/pg1065.pdf

Angiodema and the Canadian Network of Rare Blood Disorder Organizations: extending the Canadian hemophilia care model - T. Bowen
http://www.cmaj.ca/pressrelease/pg1083.pdf

Contact: Dr. Marco Cicardi
Canadian Medical Association Journal

Latest Data Demonstrate Boehringer Ingelheim's Pramipexole (Mirapexin®/Sifrol®) Improves Broad Spectrum Of Symptoms Of Restless Legs Syndrome

New data presented today show patients taking pramipexole (Mirapexin®/ Sifrol®) can experience significant improvements in a broad range of symptoms associated with Restless Legs Syndrome (RLS).1 In an additional study presented today, pramipexole was also shown to be well tolerated in RLS patients affected by concomitant diseases, which are commonly experienced in this patient group.2 The results of the studies were presented at the 10th International Congress of Parkinson's Disease and Movement Disorders (MDS) in Kyoto, Japan.

In all studies presented, patients taking pramipexole rated clinically meaningful improvements to their night and day-time symptoms, as measured on the International Restless Legs Scale (IRLS). The IRLS measures several aspects of the condition, ranging from discomfort, the need to move around, and relief by moving around, to specific RLS symptoms such as sleep disturbance, day-time tiredness, mood disorder, as well as addressing overall severity, weekly frequency, daily severity, and impact on daily activities.1

"Patients with Restless Legs Syndrome need treatment that will help to improve all of their symptoms in the night and day-time. The new evidence presented today gives both clinicians and patients the confidence that pramipexole can be used to address the key aspects of this chronic condition," said Professor John W. Winkelman, MD, PhD, Medical Director of the Sleep Health Centre of Brigham and Women's Hospital, Boston, Massachusetts/USA and Harvard Medical School.

IRLS data were pooled from a total of 564 pramipexole recipients and 220 placebo recipients, all of whom had participated in one of three placebo-controlled double-blind randomised trials of pramipexole in RLS. Pramipexole improved symptoms across all IRLS subscores (range 0 to 4 points), versus placebo. The mean improvement in the pramipexole arm ranged from 0.9 points for 'impact on daily activities' and 1.0 for 'mood disturbance' to 1.8 points for 'need to move due to discomfort'.1 These results, confirmed by patients themselves, reinforce the overall benefits of pramipexole.

Broad range of patients

According to another study presented today at MDS, RLS patients with concomitant diseases, or who are taking additional therapies, benefited from treatment with pramipexole.2 It is very common for RLS patients to suffer from additional conditions, including seasonal allergy, hypertension and gastroesophageal reflux.2 Furthermore, patients frequently take medication for other conditions, including analgesics, anti-inflammatory and anti-rheumatic drugs, and agents affecting cardiovascular function.2

Results from a 12-week randomised, double-blind, placebo-controlled trial show that even with the high frequencies of concomitant diagnoses and therapies, pramipexole was associated with a significant 12-week reduction of IRLS by an adjusted mean of -13.5, compared with -9.3 for placebo (P<0.0001) .2 Therefore, patients with concomitant diseases or who are taking additional therapies can be effectively treated with pramipexole for their RLS symptoms.

"When you consider RLS is a chronic condition for which patients may need to take treatment over a long period of time, it is crucial that we explore how a drug clinically interacts with other treatments," Dr Winkelman added. "The data presented today add to our extensive knowledge on the safety of pramipexole and provide us with the reassurance that it can be used in the broadest range of patients."

Sustained symptom relief

The advantages of using pramipexole over an extended length of time were also demonstrated by data from three trials presented today at MDS.3,4,5 The results demonstrate that, over a 6-month period, pramipexole showed a substantial improvement in symptoms of RLS compared to placebo. This improvement was judged by both patients and their treating clinicians using specific RLS rating tools. Across all three trials at least 67 percent of patients judged themselves to be much better, or very much better, after completing 6 months of therapy.3,4,5 Additionally, clinicians rated improvements between 12.5 points3 and 16.9 points5 on the IRLS scale.

The data presented at MDS demonstrate that pramipexole addresses the broad range of RLS symptoms, can provide significant benefits to patients with RLS and comorbid conditions, and can also offer sustained relief from this chronic condition.

About Restless Legs Syndrome (RLS)

Restless Legs Syndrome is a neurological disorder characterised by an uncontrollable urge to move the legs, usually accompanied by unpleasant and sometimes painful sensations in the legs. Restless Legs Syndrome affects up to ten percent of the population worldwide aged between 30 and 79 years6 and around one-third of sufferers experience symptoms more than twice weekly causing moderate to severe distress7. The motor-restlessness worsens during the evening and night causing difficulty initiating and maintaining sleep. The sleep disruption can lead to excessive daytime sleepiness and compromise work performance. Restless Legs Syndrome also has considerable impact on social activities that require immobility.

About pramipexole

Pramipexole (known in Europe under the trade names Sifrol® and Mirapexin® and in the U.S.A. as Mirapex®) is a compound from Boehringer Ingelheim research first licenced in 1997 for the treatment of the signs and symptoms of idiopathic Parkinson`s Disease, as monotherapy or in combination with levodopa. Pramipexole was licenced in April 2006 throughout the European Union for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (RLS) and is also licenced in Australia, Brazil, Canada, Mexico and others.

The most commonly reported adverse reactions in early and late Parkinson's disease in clinical trials were dizziness, involuntary movement, postural hypotension, constipation, hallucinations, headache, difficulty falling asleep, sleepiness, nausea and fatigue. The most commonly reported adverse reactions in clinical trials for Restless Legs Syndrome were nausea, headache, and tiredness.

Pramipexole may cause patients to fall asleep without any warning, even while doing normal daily activities such as driving. When taking pramipexole hallucinations may occur and sometimes patients may feel dizzy, sweaty or nauseated upon standing up. It should be noted that impulse control disorders/compulsive behaviours may occur while taking medicines to treat Parkinson`s disease, including pramipexole.

Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 143 affiliates in 47 countries and almost 37,500 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2005, Boehringer Ingelheim posted net sales of 9.5 billion euro while spending almost one fifth of net sales in its largest business segment Prescription Medicines on research and development.

References:

1 -- Winkelman JW et al. Pramipexole improves a broad range of facets of restless legs syndrome. Abstract #P374. Presented at MDS 2006, Kyoto, Japan.

2 -- Winkelman JW et al. Pramipexole is not affected by therapy for concomitant disease in patients with restless legs syndrome. Abstract #P400. Presented at MDS 2006, Kyoto, Japan.

3 -- Oertel WH et al. Six-month efficacy of pramipexole for restless legs syndrome: results from a 20-week extension of a 6-week study. Abstract #P405. Presented at MDS 2006, Kyoto, Japan.

4 -- Kupsch A., et al. Six-month efficacy of pramipexole in restless legs syndrome: results from a run-in phase for a 12-week study. Abstract #P373. Presented at MDS 2006, Kyoto, Japan.

5 -- Partinen M., et al. Sustained efficacy of pramipexole in restless legs syndrome: results from a 6-month extension of a 3-week trial. Abstract #P390. Presented at MDS 2006, Kyoto, Japan.

6 -- Phillips B et al. Epidemiology of restless legs symptoms in adults. Arch Intern Med 2000; 160(14): 2137-2141.

7 -- Allen RP, Walters AS, Montplaisir J, Hening W, Myers A, Bell TJ, et al. Restless Legs Syndrome prevalence and impact: REST general population study. Arch Intern Med 2005; 165: 1286-1292.

Boehringer Ingelheim
Boehringer Ingelheim

Identification Of Key Molecular Signaling Switch Involved In Allergic Disease: May Provide A New Target For Treatment Of Allergic Reactions

A research team has identified a key enzyme responsible for triggering a chain of events that results in allergic reaction, according to new study findings published online this week in Nature Immunology.

The work by researchers from Virginia Commonwealth University, the Hospital for Special Surgery and Weill Cornell Medical College in New York sets the stage for development of new strategies and target therapies that control allergic disease - the sixth leading cause of chronic disease in the United States.

Allergic diseases such as asthma and hay fever are problematic for about 30 percent of the population in the developed world. Researchers have developed various treatments to control allergy, but no cure has been found.

The team has demonstrated, for the first time, the role of a proteolytic enzyme called ADAM10 that releases a major allergy regulatory protein from the surface of cells and thereby promotes a stronger allergic response. The identification of drugs that inhibit ADAM10's ability to release this molecule could revolutionize treatment of asthma and allergic disease.

"Our research, for the first time, may represent a treatment strategy to prevent, rather than simply control IgE-mediated allergy," said Daniel Conrad, Ph.D., a professor in VCU's Department of Microbiology and Immunology. Conrad directed the research conducted at VCU. IgE is an antibody known to trigger Type I allergic disease.

"Understanding ADAM10's role in allergic disease makes it a potential target for the design of drugs to treat asthma and allergic disease," he said.

According to Conrad, the outcome of allergic disease can be modulated by high levels of the regulatory protein, known as CD23, which ultimately results in a decreased production of IgE. He said that when the regulatory protein is released from the cell surface by ADAM10 there is an increase in the production of IgE and therefore, increased allergy.

"These exciting results extend the known functions of ADAMs in development and disease. We hope our results will stimulate new research into how to block or activate the function of ADAMs involved in human disease, including allergic response, cancer and rheumatoid arthritis," said Carl P. Blobel, M.D., Ph.D, chair of the Arthritis and Tissue Degeneration Program at the Hospital for Special Surgery, and professor of Medicine and of Physiology and Biophysics at Weill Cornell Medical College. Blobel directed the research conducted at Weill Cornell.

According to Blobel, in addition to the critical role of ADAM10 in allergic disease through processing of CD23, ADAMs are also key molecules in cancer and rheumatoid arthritis. For example, he said, ADAMs are essential for activating the epidermal growth factor receptor, an established target for the treatment of cancers, such as colon cancer. Moreover, ADAMs release tumor necrosis factor alpha, currently the major target for treatment of rheumatoid arthritis.

Since the 1970s Conrad has been investigating the basic mechanism involved in allergic disease. Blobel has been investigating ADAM proteases since their discovery in the early 1990s.

###

This work was supported by grants from the National Institute of Allergy and Infectious Disease and the National Institute of General Medicine.

Gisela Weskamp, Ph.D., from the Arthritis and Tissue Degeneration Program of the Hospital for Special Surgery and Weill Cornell Medical College, and Jill W. Ford, a graduate student in Conrad's laboratory in the VCU Department of Microbiology and Immunology, were co-first authors for this study. Jamie Sturgill, also a graduate student in Conrad's laboratory, performed the studies looking at ADAM10 in human CD23 cleavage.

About VCU and the VCU Medical Center: Located on two downtown campuses in Richmond, Va., Virginia Commonwealth University ranks among the top 100 universities in the country in sponsored research and enrolls 30,000 students in more than 195 certificate, undergraduate, graduate, professional and doctoral programs in the arts, sciences and humanities in 15 schools and one college. Sixty-three of the university's programs are unique in Virginia, and 20 graduate and professional programs have been ranked by U.S. News & World Report as among the best of their kind. MCV Hospitals, clinics and the health sciences schools of Virginia Commonwealth University compose the VCU Medical Center, one of the leading academic medical centers in the country. For more, see http://www.vcu.edu/.

Contact: Sathya Achia-Abraham
Virginia Commonwealth University

Allergists Explore Rising Prevalence And Unmet Needs Attributed To Allergic Rhinitis

As the prevalence of allergic rhinitis appears to be rising, there are increasing concerns about its impact on health, sleep, work and school performance, as well as unmet patient needs regarding its treatment according to experts presenting new data at the Annual Meeting of the American College of Allergy, Asthma and Immunology (ACAAI).

"There is epidemiological evidence that the prevalence of allergic rhinitis is rising worldwide. Reports indicate that it has increased 100 percent in each of the last three decades in developed countries," said Eli O. Meltzer, M.D., co-director, Allergy & Asthma Medical Group & Research Center, and clinical professor of pediatrics at the University of California in San Diego.

"With allergic disorders estimated to affect some 1.4 billion people globally, there appears to be a worldwide epidemic of allergic diseases. Studies suggest this is likely a consequence of our changing environment, reduced infections and genetic susceptibilities."

According to Dr. Meltzer, the true prevalence of allergic rhinitis is unknown. Published prevalence rates differ because:

-- It is largely undiagnosed
-- There are differences in definitions of the condition
-- There are differences in sampling frame and data collections methods
-- The data are not collected by the federal government.

Current estimates indicate that more than 50 million people in the United States suffer from allergic rhinitis. It is the most prevalent chronic condition in patients under age 18. In one study, 42 percent of children had physician-diagnosed allergic rhinitis by 6 years of age.

Substantial Burden

Two landmark U.S. surveys - the Burden of Rhinitis Survey 2004 and the Allergies in America Survey 2006 - document the high prevalence and substantial burden of allergic rhinitis. Both surveys indicate a strong relationship between allergic rhinitis and co-morbidities including depression, migraine and asthma.

According to Michael S. Blaiss, M.D., clinical professor of pediatrics and medicine at the University of Tennessee Health Science Center in Memphis, Tenn., the scope and impact of allergic rhinitis has reached epidemic proportions and is estimated to account for 100 million days of lost work annually, 28 million days of lost productivity and 1.5 million missed school days per year. Allergic rhinitis is responsible for 16.7 million physician office visits per year and results in 5.9 billion dollars annually in direct expenditures.

"Many patients with allergic rhinitis suffer from symptoms that cause them to feel tired, miserable and irritable during allergy season," Dr. Blaiss said. "Lack of treatment, under-treatment, or non-adherence to treatment in allergic rhinitis may increase direct and indirect costs. This reinforces the need for patient education and for physicians to implement existing evidence-based guidelines for prevention and treatment."

Allergic rhinitis symptoms profoundly affect the quality of life as well as work productivity according to Myron J. Zitt, M.D., clinical associate professor of medicine, State University of New York, Stony Brook, N.Y. "Adults may have mood swings and be less efficient at work or at home. They often have a poor quality of sleep, may suffer from obstructive sleep apnea and thereby experience daytime fatigue." He noted a correlation between high pollen counts and low work productivity.

"Children with allergic rhinitis often experience increased shyness, anxiety and fatigue. Nasal congestion and other symptoms can cause significant impairment in learning and cognition," he said.

"Another area of concern is the trivialization of allergic rhinitis. It is an important illness, but it is underappreciated, under-diagnosed and under-treated. Polls show that only 19 percent of people taking medications for allergic rhinitis are being seen by a specialist, who are the best qualified to treat the disease," Dr. Zitt said.

In a Harris Interactive Survey of 4,000 patients who experience congestion, 93 percent of patients surveyed awaken feeling congested and 87 percent awaken feeling tired. Lack of relief of congestion affects their ability to concentrate (54 percent), performance of physical exercise and sports (63 percent) and time spent outdoors (73 percent).

Typical physical findings reported by Bobby Q. Lanier, M.D., clinical professor of pediatrics at the University North Texas Health Science Center in Fort Worth, include: the "Allergic Salute" wiping of the nose; "Allergic Shiners" referring to dark circles under the eyes; "Allergic Crease" around the nose; "Dennie's Lines" under the eyes; mouth breathing; red, itchy eyes and eye tearing.

"Comorbidities of allergic rhinitis are significant. Allergic rhinitis is present in 58 percent of asthma patients, and the treatment of allergic rhinitis reduces the incidence and severity of asthma. It also contributes between 40 percent to 80 percent of chronic rhinosinusitis. Nasal polyps reoccur in 36 percent of allergic individuals versus 18 percent in non-allergic individuals," said Dr. Lanier.

Treatment of Allergic Rhinitis

Recent surveys show that 37 percent of patients are not satisfied with their current allergy treatment, and patients may take up to 2 to 4 medications at a time for relief of allergy symptoms noted Dr. Lanier.

"Patients are not as well informed as they should be about their allergy medications," he said. Of those surveyed, 42 percent were confused by choices of medication, and 59 percent wished they knew more about the drugs they take.

"Healthcare providers overestimate patient satisfaction with therapy. Patient dissatisfaction often results in frequent medication changes or noncompliance. Lack of insurance coverage for prescribed medications influences patients' willingness to try new medications," Dr. Lanier said.

Current treatment options for allergic rhinitis are environmental control measures, medications, subcutaneous specific immunotherapy and allergen avoidance. Medications include oral antihistamines (sedating and non-sedating or low-sedating), intranasal antihistamines, intranasal corticosteroids or intranasal cromolyn sodium.

"New and emerging solutions for the treatment of allergic rhinitis are on the horizon," said William E. Berger, M.D., M.B.A., clinical professor, Department of Pediatrics, Division of Allergy and Immunology at the University of California in Irvine. "These therapies include sublingual immunotherapy (SLIT), anti-IgE therapy, new topical nasal antihistamines (olopatadine) and new topical nasal corticosteroids (ciclesonide)."

In Europe, SLIT is widely used for monosensitized patients with mild allergic disease. There is no product approved by the FDA, although clinical trials of SLIT are underway in the United States.

Anti-IgE therapy, a recombinant humanized monoclonal antibody (rhuMab) to IgE, is currently approved for allergic asthma and may have application for patients with severe allergic rhinitis.

According to Dr. Berger, the emerging allergic rhinitis treatments focus on meeting both patient and provider needs for rapid onset, long-lasting and convenient dosing. They will be safer and more cost-effective, and improve patient adherence. Physician's needs will be met for the introduction of newer, enhanced treatment choices that improve patient quality of life and immune tolerance. The newer therapies will also enhance the effective treatment of co-morbidities of allergic rhinitis.

Non-allergic Rhinitis

Non-allergic rhinitis is characterized by recurrent or chronic symptoms similar to those of allergic rhinitis, but the disorder is not caused by allergy. Examples of rhinitis are infectious rhinitis (the common cold), vasomotor rhinitis, non-allergic rhinitis with eosinophilia syndrome (NARES), hormonal rhinitis, certain types of occupational rhinitis, and gustatory and drug-induced rhinitis.

Irritants that can trigger vasomotor rhinitis include cigarette smoke, strong odors and fumes, including perfume, hair spray, other cosmetics, laundry detergents, cleaning solutions, pool chlorine, car exhaust and other air pollution. Other irritants are spices used in cooking, alcoholic beverages (particularly beer and wine), aspirin and certain medications.

Patient information on allergic diseases 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
85 W. Algonquin Rd., Ste 550
Arlington Heights, IL 60005
United States
http://www.acaai.org/