Xolair® granted marketing authorization in Europe as novel therapy for severe allergic asthma

• Xolair provides asthma patients with one of the most significant advances in last 15 years
   
• The first monoclonal antibody approved for the treatment of asthma in Europe

Basel, October 27, 2005 - Novartis announced today that the European Commission has granted Marketing Authorization in all 25 EU member states for the novel asthma therapy Xolair® (omalizumab), considered by many experts to be one of the most significant advances in the last 15 years for helping patients with asthma.

 

Xolair's unique mechanism of action addresses the need to provide patients with a new injectable treatment that effectively controls asthma attacks and symptoms that often remain uncontrolled with current therapies.

 

As the first monoclonal antibody to be approved for the treatment of asthma, Xolair offers a unique therapeutic approach by blocking the action of IgE, an underlying cause of symptoms in allergic disease. Xolair is expected to become available in the first European countries within the next few weeks.

 

"Xolair represents a real advance in the management of asthma, having shown long-term efficacy and safety," said Professor Stephen Holgate of Southampton General Hospital, UK. "This approval provides a much-needed breakthrough in the fight against severe allergic asthma. It's exciting to know that we finally have a treatment approach that has the potential to transform the lives of those who have been previously debilitated by this condition and for whom previously we have had little to offer."

 

Patients with severe asthma are at greatest risk of hospitalization and death.1,2 According to the World Health Organization, more than 12,000 deaths are linked to asthma in Western Europe every year.3 Asthma affects an estimated 30 million people in Europe, with up to 90% experiencing allergic asthma and attacks often being triggered by environmental factors such as pollen, animal dander and dust mites.4,5 Around 20% of people with asthma in Western Europe are classified as having severe disease,6 and within this group some continue to experience inadequately controlled symptoms despite taking the best available therapy.7

 

"We believe Xolair is one of the most significant advances in asthma treatment in the last 15 years and are pleased that patients in Europe will now be able to benefit from this highly innovative therapy," said Joerg Reinhardt, Global Head of Development Novartis Pharma AG. "Novartis is proud to bring a medicine to the European markets that offers the potential for effective control of asthma attacks and symptoms in even patients with the most severe disease, where patients have been at significant risk of asthma exacerbations, hospitalization and death."

 

Xolair is administered by injection under the skin every two or four weeks, and targets the IgE antibody which is a root cause of the inflammatory cascade of symptoms in diseases such as allergic asthma. Clinical studies have shown that it significantly reduced the rate of asthma exacerbations (or 'attacks') and halved the rate of emergency medical visits in patients with severe persistent asthma.8 Benefits were seen even in patients whose asthma was inadequately controlled despite using the best available therapy8 and who were, as a consequence, at increased risk of life-threatening attacks.1,2

 

In Europe, Xolair is licensed as add-on therapy to improve asthma control in adults and adolescents (aged 12 and above) with severe persistent allergic asthma, who have the following, despite daily high-dose inhaled corticosteroids plus a long-acting inhaled beta2-agonist:

a positive skin test or in vitro reactivity to a perennial aeroallergen

reduced lung function (FEV1 <80%)

frequent daytime symptoms or night-time awakenings

multiple documented severe asthma exacerbations

Xolair treatment should only be considered for patients with convincing IgE-mediated asthma.

 

Xolair was approved by the US Food and Drug Administration (FDA) in June 2003. It has been prescribed to more than 52,000 patients worldwide following its approval, which includes other countries such as Australia, Brazil, Canada and Venezuela. Xolair has been developed under an agreement between Novartis Pharma AG, Genentech and Tanox.

 

The use of Xolair is supported by a comprehensive program of more than 30 clinical trials involving a total of approximately 5,500 patients. These demonstrated Xolair's efficacy in controlling symptoms, reducing asthma exacerbations and the need for emergency medical treatment, and improving quality of life, even in patients with severe allergic asthma that was uncontrolled by existing medication. Recent long-term data have shown that effective control was maintained for more than three years with Xolair, and that patients experienced improvements in their lung function and reductions in the need for inhaled corticosteroids.9

 

The potential benefits of anti-IgE therapy are already recognized in treatment guidelines such as those developed by the Global Initiative for Asthma (GINA). These recommend anti-IgE therapy as add-on treatment for patients with severe allergic asthma that is inadequately controlled by standard clinical options.10

 

The foregoing release contains certain forward-looking statements that can be identified by terminology such as "will", "is expected to", "potential", "long-term", or similar expressions, or by express or implied discussions regarding the potential that Xolair will be approved for sale in any additional markets, or regarding any potential future revenues from Xolair. Such forward-looking statements 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 sale in any additional market, or that it will achieve any particular sales level. In particular, management's expectations regarding commercialization of Xolair could be affected by, among other things, uncertainties relating to clinical trials; new clinical data, or additional analysis of existing 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; competition in general; government, industry and general public pricing pressures; as well as other risks and factors referred to in the Company'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 AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2004, the Group's businesses achieved net sales of USD 28.2 billion and pro forma net income of USD 5.6 billion. The Group invested approximately USD 4.1 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 91,700 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com

 

 

 

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