AstraZeneca Announces Symbicort Is Now Available In The U.S.

U.S. Asthma Sufferers Now Have a New Choice of Combination Therapy to Help Achieve Asthma Control

LONDON, June 25, 2007-AstraZeneca today announced that SYMBICORT® (budesonide/formoterol) pressurised Metered Dose Inhaler (pMDI) is now available in the United States for the long-term maintenance treatment of asthma in patients 12 years of age and older.
Administered twice daily, SYMBICORT pMDI is a combination of two proven asthma medications – budesonide, an inhaled corticosteroid (ICS), and formoterol, a rapid and long-acting beta agonist (LABA). This combination treatment offers patients improved asthma control as early as day one that is sustained over 12 weeks. U.S. studies have also demonstrated that SYMBICORT pMDI delivers a significant improvement in lung function within 15 minutes of beginning treatment.

SYMBICORT pMDI is approved for patients whose disease is not adequately controlled on another asthma-controller medication or whose disease severity clearly warrants initiation of treatment with two maintenance therapies. SYMBICORT pMDI is available in two dose strengths, 80/4.5 and 160/4.5 µg of budesonide and formoterol, respectively.

“The U.S. availability of SYMBICORT holds great promise for millions of Americans that suffer from asthma,” said Tony Zook, President and Chief Executive Officer, AstraZeneca in the U.S. “The addition of SYMBICORT to our U.S. respiratory portfolio reinforces AstraZeneca’s commitment to developing new, effective treatments, and provides patients and physicians with a treatment option that will help control patients’ asthma and improve and maintain lung health.”

Asthma is one of the most serious chronic medical conditions in the U.S. and it is estimated that around 20 million Americans suffer from asthma. In fact, 11 Americans die from asthma each day, which translates to more than 4,000 asthma deaths each year, many of which are avoidable with proper treatment and care.

SYMBICORT pMDI was approved by the U.S. Food and Drug Administration on July 21, 2006. The SYMBICORT pMDI submission was based on 27 Phase I, II, and III trials designed to assess the efficacy and safety of SYMBICORT in a pMDI. The approved indication is largely based on data from two pivotal double blind, placebo-controlled, 12-week trials involving 1,076 patients in the U.S., age 12 and older with asthma. These studies showed that both dosage strengths of SYMBICORT pMDI produced a greater improvement in lung function compared to the same doses of budesonide or formoterol administered alone or placebo. In addition, these studies demonstrated a more rapid improvement in lung function compared to budesonide and placebo. Clinically significant improvement in bronchodilatory response, or opening of the lung airways, occurred within 15 minutes of beginning treatment with SYMBICORT pMDI.

The safety of SYMBICORT pMDI is based on a robust U.S. development programme, which evaluated safety in over 6,000 patients treated with SYMBICORT pMDI in Phase I, II and III studies that were submitted to the FDA. SYMBICORT pMDI has safety data from long-term studies up to one year and a robust cardiac safety profile. In the US, as with all LABA-containing products on the market, Symbicort pMDI carries a boxed warning as requested by the FDA.

Symbicort® Turbuhaler (Dry Powder Inhaler) is already approved for treatment of asthma and/or COPD in more than 90 countries. Symbicort full year sales for 2006 reached $1,184 million. AstraZeneca has also demonstrated its commitment to the respiratory area through a novel research and development programme for Symbicort Turbuhaler, which has resulted in the development and approval of SYMBICORT® Maintenance and Reliever Therapy (Symbicort® SMART), in Europe and certain other countries outside the US.

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

Media Enquiries:
Edel McCaffrey, Tel: +44 (0) 207 304 5034
Steve Brown, Tel: +44 (0) 207 304 5033

Investor Relations:
Mina Blair, Tel: +44 (0) 207 304 5084
Jonathan Hunt, Tel: +44 (0) 207 304 5087
Karl Hard, Tel: +44 (0) 207 304 5322
Jörgen Winroth, Tel: +1 (212) 579 0506
Ed Seage, Tel: +1 302 886 4065   

Notes To Editors
The US SYMBICORT label is available on www.SYMBICORT-US.com
US Label Boxed Warning: Long-acting beta2-adrenergic agonists may increase the risk of asthma-related death. Therefore, when treating patients with asthma, SYMBICORT should only be used for patients not adequately controlled on other asthma-controller medications (e.g., low-to-medium dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with two maintenance therapies. Data from a large placebo-controlled US study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol may apply to formoterol (a long-acting beta2-adrenergic agonist), one of the active ingredients in SYMBICORT.
Symbicort SMART is a novel approach to managing asthma and the first to provide both maintenance and reliever therapy in one inhaler.
SYMBICORT pMDI is not approved for the SYMBICORT SMART approach and in the U.S., no filing has been made for SYMBICORT SMART for the SYMBICORT pMDI. There are no studies ongoing for SYMBICORT SMART use for SYMBICORT PMDI at this time.
Symbicort SMART has been approved in over 50 countries to date outside the US, including the EU member countries, Australia, Argentina, Brazil, Canada, Mexico, Philippines, South Africa, Switzerland, and Thailand. A series of worldwide launches are underway.
SYMBICORT is licensed for use in many countries outside the US for COPD and a regulatory filing will be submitted in the U.S. in the first half of 2008.

Asthma is a chronic inflammatory condition of the airways characterized by reversible airway obstruction. It is a variable condition that can change both daily and seasonally.

Almost half of these asthma sufferers remain undiagnosed and despite available treatments, it remains poorly controlled in many of those who are diagnosed.

Many asthma patients require maintenance treatment with an inhaled corticosteroid (ICS), which suppresses the underlying airway inflammation, and a bronchodilator (LABA), which relaxes the smooth muscle of the airways

Despite the availability of many treatments in the US for adults with asthma and guidelines on how to use them, asthma is still poorly controlled. The annual direct healthcare cost of the disease in the U.S. is approximately $11.5 billion. Indirect costs (e.g., lost productivity due to missed days at school or work) add another $4.6 billion, for a total cost of $16.1 billion.

Posted: June 2007


View comments

Hide
(web4)