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| |  ATS: Viozan (AR-C68397AA) Showing Promising Results in COPD TORONTO, ON -- May 8, 2000 -- Results from Phase II clinical trials released by AstraZeneca show that its development drug, Viozan(TM) (AR-C68397AA), significantly improved the principal symptoms of chronic obstructive pulmonary disease (COPD). The data are being presented at the American Thoracic Society 2000, 96th International Conference in Toronto, Canada this week. "These results are encouraging and support further evaluation of Viozan for the treatment of COPD," commented Dr. Colin Reddrop, AstraZeneca's Vice President and Head, Respiratory and Inflammation R & D. "At present there are no drugs in the market developed specifically for the treatment of these symptoms, which include breathlessness, cough and sputum production. Effective treatment remains a significant unmet therapeutic need," said Dr. Reddrop. Viozan, a novel drug which acts as a dual D2 dopamine receptor agonist and a Beta 2 adrenoceptor agonist, was designed to inhibit sensory nerve activity in the lung. Pharmacological studies in animals and humans suggested this activity might translate to an effect on COPD symptoms. Two randomized, double-blind, placebo-controlled studies have been completed with Viozan pressurized metered dose inhaler to evaluate the clinical utility of this treatment approach. In the first study the efficacy and tolerability of Viozan was assessed in comparison with placebo as well as two standard COPD therapies, salbutamol and ipratropium bromide. In this four week study, 701 COPD patients were randomized to receive one of three Viozan doses (400 mcg, 600 mcg, or 1000 mcg), salbutamol (200 mcg), ipratropium bromide (40 mcg) or placebo three-times daily. The results of this study showed that Viozan (600 mcg three-times daily) produced a significant reduction in COPD symptoms (p<0.001) compared to placebo. At the dose regimens tested, salbutamol and ipratropium bromide showed only limited efficacy. In the second study the efficacy and tolerability of Viozan were investigated in a six-week trial of 872 COPD patients who were randomized to receive one of three Viozan doses (45 mcg, 270 mcg, or 495 mcg) or placebo delivered by pMDI three-times daily. Viozan reduced COPD symptoms in a dose-dependent manner, these differences being statistically significant with the two higher doses (p=0.038 and p=0.003, versus placebo respectively). At the two higher doses the improvement in symptoms was accompanied by a significant reduction in use of rescue bronchodilator as well as increases in patients health related quality of life as measured using the St. Georges Respiratory Questionnaire. Safety and tolerability data indicated that Viozan was generally well tolerated in these patients with COPD. Adverse events reported in the groups studied included (but were not necessarily drug-related) tremor, nausea, taste of treatment, headache, respiratory infection and chronic obstructive airway disease. Viozan is not currently approved for marketing in any country. Phase III trials for Viozan are underway in Europe and the U.S. and AstraZeneca anticipates filing new drug applications by the latter part of 2001. COPD is the term used to describe a disease state characterized by airflow obstruction due to chronic bronchitis or emphysema. This progressive disease is known to affect physical, emotional and social functioning, restricting the ability to perform everyday tasks and seriously impairing the patient's quality of life. An assessment of the global burden of disease in 1996 found COPD to be the fifth leading cause of death with an estimated 600 million cases, responsible for 2.8 million deaths worldwide. The single greatest risk factor for the development of COPD is tobacco smoking, which accounts for 80 percent-90 percent of all cases. COPD can occur in non-smokers, due to environmental pollution, occupational hazards and genetic abnormalities. AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of over $15 billion and leading positions in sales of gastrointestinal, oncology, anesthesia including pain management, cardiovascular, central nervous system (CNS) and respiratory products. Related Link: AstraZeneca.
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