Novartis has submitted an application to the Japanese health authorities for the approval of Xolair (omalizumab), a novel therapy which targets a root cause of allergic disease and offers an entirely new approach to the treatment of severe asthma.

Worldwide clinical trials have shown the potential of Xolair which is already approved in the US and European Union for controlling symptoms and reducing asthma exacerbations (or "attacks") and the need for emergency medical treatment, even in patients with the most severe disease that is poorly controlled by existing drugs.

An estimated four million people suffer with asthma in Japan. Despite advances in therapy, approximately 20 per cent of those with severe asthma have symptoms that remain inadequately controlled. Although the number of fatalities is decreasing, it is estimated that more than 3,000 people still die of the disease in Japan each year.

"We believe Xolair can potentially represent one of the most significant advances in asthma treatment for the last 15 years, so this is encouraging news for all those patients in Japan who are at high risk of potentially life-threatening asthma attacks," said James Shannon, MD, Global Head of Development at Novartis Pharma AG. "Xolair offers the potential for effective control even in patients with the most severe disease, whose lives have been dominated by the need to take multiple medications and to avoid any situation that could trigger their symptoms," Dr. Shannon said.

If the application is successful, Xolair will be the first monoclonal antibody to be approved for the treatment of asthma in Japan. Unlike other asthma therapies, Xolair is given by injection every two or four weeks and is unique in blocking the action of the Immunoglobin E (IgE) antibody, a root cause of inflammation of the airways in patients with diseases such as allergic asthma.

By targeting the underlying mechanism of the disease, Xolair can prevent the onset of serious and debilitating symptoms such as wheezing and shortness of breath, even in severely affected patients. The efficacy of the new therapy has already been recognized in international treatment guidelines such as those issued by the Global Initiative for Asthma (GINA), which recommend anti-IgE therapy as add-on treatment for patients with severe allergic asthma that is inadequately controlled by standard clinical options.

Xolair was launched in the US in July 2003, and was granted marketing approval in the European Union in October 2005. It is now approved in 47 countries and available in 15 including Australia, Brazil, Canada, Germany, Israel, Spain, UK and US. Xolair has been developed under an agreement between Novartis Pharma AG, Genentech, Inc. and Tanox, Inc.

The application submitted to the Japanese Ministry of Health, Labor and Welfare (MHLW) was supported by data from a clinical study showing a significant improvement in patients' lung function (measured by peak expiratory flow, or PEF) when treated with Xolair.

The multicenter, randomized, double-blind, parallel-group, placebo-controlled study involved 315 patients with moderate to severe allergic asthma who received 16 weeks' treatment with Xolair or placebo, with a 24-week follow-up period. Results showed that morning PEF in patients receiving Xolair increased by a mean of 15.45 L/min over baseline, compared to only 2.25 L/min in patients receiving placebo (P<0.0004).

"The distinct and significant improvement of asthma control in Japanese severe asthma patients demonstrates that Xolair could be used as a controller drug in Japan, in the same manner that it is used outside of Japan based on GINA guidelines," said Professor Ken Ohta, Medicine Department, Teikyo University School of Medicine, Japan.

"I hope that Xolair soon becomes available in clinical practice in Japan. I anticipate that it will play a significant role in the treatment of patients whose asthma is inadequately controlled," Dr. Ohta said.