Study Shows Potential Benefits of Xolair in Treating Children Suffering from Moderate or Severe Persistent Allergic Asthma Inadequately Controlled With Inhaled Corticosteroids

SEATTLE, November 08, 2008, 2008 /PRNewswire/ -- Data presented today at the American College of Allergy, Asthma & Immunology (ACAAI) show that Xolair(R) (Omalizumab) for Subcutaneous Use significantly reduced asthma attacks in children aged six through 11 with moderate or severe persistent allergic asthma inadequately controlled with inhaled corticosteroids. The study further defines the safety profile of Xolair in this patient population.

 

The Phase III study showed that children treated with Xolair demonstrated a 31% reduction in clinically significant asthma exacerbations compared to children treated with placebo at 24 weeks. After a year of treatment, children treated with Xolair suffered 43% fewer clinically significant asthma exacerbations than those receiving placebo.

 

Xolair is a biologic treatment currently approved for people 12 years of age and above with moderate-to-severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. It is the only approved therapy which blocks IgE (immunoglobulin E), a major component of allergic asthma. Genentech, co-marketer of Xolair, plans to submit these data to the US Food and Drug Administration (FDA) seeking to expand the current labeled indication for Xolair.

 

"Asthma is a life-threatening disease that can have serious health consequences in children. There are many children whose allergic asthma symptoms are just not adequately controlled despite optimal dosing with standard of care inhaled corticosteroid treatment," said principal investigator Bob Lanier, MD, Medical Director of the North Texas Institute for Clinical trials and Clinical Professor of Pediatrics at the . "In the Phase III study, children treated with Xolair experienced significantly fewer asthma exacerbations, or worsening attacks."

 

Asthma is the leading serious chronic illness of children in the US, affecting an estimated nine million children under the age of 18; of these children, 2.5 million suffer from allergic asthma, the most common type overall. Allergic asthma causes airway obstruction and inflammation, and can be triggered by allergens such as dust mites, pet dander, mold and cockroaches.

 

Among children aged five to 17, asthma is a leading cause of school absenteeism from a chronic illness, accounting for an annual loss of more than 12.8 million school days, and is the third leading cause of hospitalization for children under the age of 15.

 

 

The pivotal Phase III double-blind, randomized placebo-controlled study evaluated children aged six through 11 with moderate-to-severe allergic asthma uncontrolled despite inhaled corticosteroid (ICS) therapy. For eight weeks, ICS doses were optimized and baseline measures established in all study participants; 628 children still symptomatic after reaching optimized ICS dosing were randomized to receive add-on Xolair therapy or placebo. The study comprised a 24-week fixed-dose ICS phase, followed by a 28-week phase in which ICS doses could be reduced, and a 16-week safety follow-up period.

 

The study met its primary endpoint with Xolair-treated patients demonstrating a 31% reduction in clinically significant asthma exacerbations compared to patients treated with placebo at 24 weeks. The study also showed further support of the safety profile in a pediatric population aged six through 11. Adverse events were similar between groups and most (91%) were mild or moderate, with the most common being nasopharyngitis, sinusitis and upper respiratory tract infection. Two patients who were treated with Xolair withdrew from the study due to headache or bronchitis.

 

"We're encouraged by the Phase III clinical results that showed Xolair significantly reduced asthma exacerbations in children whose symptoms cannot be controlled with standard therapy," said John J. Orloff, MD, Head of US Medical and Drug Regulatory Affairs, North America at Novartis Pharmaceuticals Corporation. "Xolair represents a potentially important new approach to treating pediatric patients aged six through 11 with moderate or severe persistent allergic asthma inadequately controlled with inhaled corticosteroids."

 

Results from the trial were first presented at the European Respiratory Society Annual Congress in October 2008.

 

 

Xolair (Omalizumab) for Subcutaneous Use is a humanized monoclonal antibody for moderate-to-severe allergic asthma and the only approved therapy which blocks IgE (immunoglobulin E), a major component of allergic asthma. Xolair is indicated for adults and adolescents (12 years of age and above) with moderate-to-severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. Xolair has been shown to decrease the incidence of asthma exacerbations in these patients. Safety and efficacy have not been established in other allergic conditions.

 

 

 

Anaphylaxis is a life-threatening condition. Seek emergency medical treatment right away if symptoms occur. :

 

 

Patients should not receive Xolair if they have ever had an allergic reaction to a Xolair injection. Patients should not use Xolair if they are allergic to any of its ingredients.

 

In clinical studies 0.5% of patients receiving Xolair developed cancer, compared to 0.2% of patients receiving placebo injections.

 

In clinical studies, the most common side effects in patients receiving Xolair included injection-site reactions (45%), viral infections (23%), upper respiratory tract infection (20%), sinus infection (16%), headache (15%), and sore throat (11%).

 

Xolair is not a rescue medicine and should not be used to treat sudden asthma attacks. It is not a substitute for the medicines patients are already taking. Patients should not change or stop taking any of their other asthma medicines unless their doctor tells them to do so. Patients may not see an immediate improvement in their asthma when beginning Xolair therapy.

 

Please see Prescribing Information and the Medication Guide on www.Xolair.com for additional important information.

 

Xolair is co-marketed in the United States by Genentech, Inc. and Novartis Pharmaceuticals Corporation. Xolair was approved by the US FDA in June 2003 and is now available in 56 countries worldwide.

 

 

The foregoing release contains forward-looking statements that can be identified by terminology such as "potential", "planned", "plans", "seeking", "can", "estimated", "could", "potentially", "will", "may", or similar expressions, or by express or implied discussions regarding potential new indications or labelling for Xolair, or potential future revenues from Xolair. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of the Company regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Xolair to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Xolair will be approved for any additional indications or labelling in any market. Nor can there be any guarantee that Xolair will achieve any particular levels of revenue in the future. In particular, management's expectations regarding Xolair could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures the effect that the foregoing factors could have on the values attributed to the Group's assets and liabilities as recorded in the Group's consolidated balance sheet; and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US 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 Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, GI and respiratory areas. The company's mission is to improve people's lives by pioneering novel healthcare solutions.

 

Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG which provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in these areas. In 2007, the Group's continuing operations (excluding divestments in 2007) achieved net sales of USD 38.1 billion and net income of USD 6.5 billion. Approximately USD 6.4 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 97,000 full-time associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.

 

 

 

 

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CONTACT: US: Novartis Media Relations, Maureen Byrne, +1-862-778-1518(direct), or +1-973-714-0063 (cell), or AnnaFrable, +1-862-778-5388 (direct), or +1-732-673-5262 (cell),, both of NPC Communications; or Novartis InvestorRelations, Central phone: +41-61-324-7944, or Ruth Metzler-Arnold,+41-61-324-9980, or Pierre-Michel Bringer, +41-61-324-1065, or JohnGilardi, +41-61-324-3018, or Thomas Hungerbuehler, +41-61-324-8425, orIsabella Zinck, +41-61-324-7188, ; NorthAmerica: Richard Jarvis, +1-212-830-2433, or Jill Pozarek,+1-212-830-2445, or Edwin Valeriano, +1-212-830-2456 maureen.byrne@novartis.com anna.frable@novartis.com investor.relations@novartis.com

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Posted: November 2008

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