First-in-class asthma therapy Xolair® wins prestigious Prix Galien award for outstanding innovation in research and development
* Groundbreaking benefits of Xolair in severe asthma patients recognized by leading UK award for new pharmaceutical products
* Prix Galien highlights dedication of Novartis to innovation and advancing the treatment of asthma
Basel, September 27, 2006 - Xolair® (omalizumab), one of the most significant advances in treating asthma for the past 15 years, has been granted the prestigious national Prix Galien award in the United Kingdom for innovative research and development.
The prize, given jointly to Xolair and two other medications by a panel of independent experts, recognizes medicines that have made the greatest contribution during the previous year to improving patient care in the UK.
Xolair is a breakthrough treatment for those patients with severe, persistent allergic asthma. Unlike other asthma therapies, Xolair is a first-in-class antibody treatment that targets IgE, an antibody considered to be an underlying cause of the allergic inflammatory cascade that drives the onset of asthma attacks and symptoms. Up to 90% of asthma is classified as allergic and is associated with elevated levels of the antibody IgE.
“We are delighted that Xolair has been acknowledged for its contribution to advancing the treatment of asthma,” said James Shannon, MD, Global Head of Development at Novartis Pharma AG. “This award not only recognises the innovation that led to the creation of Xolair, but also the tremendous benefits that it offers to severe allergic asthma patients who are at high risk of potentially life-threatening asthma attacks.”
Xolair gained its first approval in 2002 and is now approved in 51 countries, including the US and in Europe. Xolair has been used to treat more than 52,000 patients around the world. It has been developed under an agreement between Novartis, Genentech and Tanox.
The Prix Galien is the only internationally recognized award of its kind and is judged by a panel of experts, headed by Professor Sir Michael Rawlins, Chairman of the National Institute for Health and Clinical Excellence (NICE). Other members include prominent clinicians such as Professor Parveen Kumar, President of the British Medical Association.
This year’s prize was awarded jointly to Xolair as well as Rotarix®, a rotavirus vaccine from GlaxoSmithKline, and Myozyme, an orphan drug for treatment of Pompe Disease from Genzyme.
Since 1970, Novartis has received 21 national Galien Prizes in various European countries for the innovative therapies Rimactan®, Parlodel®, Sandimmune®, Sandostatin®, Simulect®, Visudyne®, Glivec®, Zometa® and recently Xolair®.
Xolair represents the culmination of decades of research by scientists from Novartis, Genentech and Tanox. The role of the antibody IgE in allergic conditions was discovered in the 1960s, but the challenge of designing an antibody which could precisely target and block its action was a formidable one. Between them, the three companies investigated a series of possible molecules, and when their programs were combined in 1996, the most promising was selected for further development.
Following exhaustive clinical investigation, anti-IgE therapy has now finally become a reality. Xolair has proved particularly effective in patients with severe, difficult to treat asthma who can face regular life-threatening attacks and hospitalisations despite high-dose standard treatment such as corticosteroids,. Studies involving patients with severe persistent allergic asthma have shown that Xolair significantly decreased severe asthma attacks and almost halved emergency visits and hospitalisations.
Xolair was approved by the European Medicines Agency (EMEA) in October 2005 as add-on therapy to improve disease control in adults and adolescents (12 years of age and above) with IgE-mediated asthma.
There are 180,000 deaths worldwide associated with asthma every year, which translates into at least one death every hour in Western Europe,. The risk of asthma-related death is highest among the 2-5% of the 300 million people with asthma worldwide who suffer from severe symptoms, which cannot be controlled despite the best available therapy, such as high-dose corticosteroids,,. In addition, these people contribute significantly to the overall cost burden associated with asthma. New approaches to therapy are therefore urgently needed and Xolair marks an important milestone to progressing the understanding and treatment of allergic conditions such as asthma.
The foregoing release contains certain forward-looking statements that can be identified by terminology such as “can potentially represent”, “offers the potential” 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 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.
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