REACT study to evaluate impact of Daxas® (roflumilast) in patients receiving standard COPD treatment

NycomedNycomed announced plans for an international phase III/IV study investigating the effect of Daxas® versus placebo on exacerbation rates in COPD patients who are concomitantly treated with fixed combination long-acting-ß2-agonists (LABA) and inhaled corticosteroids (ICS), with or without a long-acting muscarinic antagonist (LAMA). Use of Daxas® with the individual components of fixed combination and triple therapy has already been shown to reduce exacerbations and improve lung function.(1,2) The REACT study is the first to investigate Daxas when used in patients concomitantly treated with fixed combination treatment or triple therapy.

The REACT trial is a 52-week, randomised, double-blind, multi-centre study which will recruit approximately 2,000 patients from 21 countries. The primary endpoint is the reduction of moderate or severe COPD exacerbations per patient per year. Moderate exacerbations are defined as those requiring oral or parenteral glucocorticosteroids and severe exacerbations are defined as requiring hospitalisation and/or leading to death. Other exacerbation endpoints will also be assessed, including the proportion of patients experiencing an exacerbation and time to first, second and third exacerbation. Quality of life will be measured using the COPD Assessment Test (CAT questionnaire).(3)

The trial will recruit patients with severe COPD associated with chronic bronchitis and frequent exacerbations, reflecting the licence indication for Daxas. First patient enrolment is anticipated in second quarter 2011.

Anders Ullman, Executive Vice President, Research and Development at Nycomed, commented: "Many people with COPD, even those with optimum management, continue to have symptoms and frequent exacerbations affecting long-term outcomes and quality of life. We are confident that the REACT trial will provide further insights into how Daxas can be used most effectively and therefore help COPD patients receive the treatment they need."

Peter Calverley, Professor of Respiratory Medicine, University of Liverpool, UK, and Co-ordinating Investigator for the REACT trial, said: "As COPD progresses, patients suffer exacerbations or lung attacks which often require substantial medical intervention and can lead to hospitalisation. Studies have already shown that roflumilast significantly reduces exacerbations and the REACT trial will further our understanding of the role of roflumilast in everyday practice. We know that the outcome of this study will be eagerly awaited by patients and doctors alike."

Daxas was approved in Europe in July 2010 and in the US in February 2011 (US trade name: Daliresp(TM)).

About the REACT trial
The REACT trial is a large, international phase III/IV study that will evaluate the effect of Daxas® (roflumilast) on exacerbation rates in patients with COPD who are treated with fixed combinations of LABA and ICS, with or without LAMA treatment. The study is a 52-week, randomised, double-blind trial which evaluates roflumilast 500 mcg versus placebo on top of combination and triple therapy. The study will recruit approximately 2,000 patients and will be conducted in over 200 centres across 21 countries: Australia, Austria, Belgium, Brazil, Canada, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Korea, Netherlands, Poland, Russia, Slovakia, South Africa, Spain, Turkey, and UK.

About Daxas® (roflumilast)
Daxas (roflumilast) is an orally administered selective phosphodiesterase 4 (PDE4) enzyme inhibitor, which has been shown to inhibit COPD related inflammation with a novel mode of action.(4) Daxas, a once-a-day tablet, is the first drug in a new class of treatment for severe COPD and the first oral anti-inflammatory treatment specifically developed for COPD patients.

Four large randomized placebo controlled trials have shown that roflumilast significantly reduces exacerbations and improves lung function when added to first-line maintenance therapy.

Daxas is generally well tolerated. In clinical COPD trials involving 12,000 patients, the most commonly reported adverse reactions were diarrhoea (5.9%), weight decreased (3.4%), nausea (2.9%), abdominal pain (1.9%) and headache (1.7%). The majority of these adverse reactions were mild or moderate. These adverse reactions mainly occurred within the first weeks of therapy and mostly resolved on continued treatment.

Other pharmacological treatment for COPD patients includes the use of inhaled bronchodilators and inhaled corticosteroids.

About COPD
COPD remains a significant area of unmet medical need. It is a progressive and irreversible lung disease resulting in difficulty in breathing. The disease is characterised by severe episodes of worsening, called exacerbations or lung attacks. According to World Health Organization (WHO) estimates, 80 million people have moderate to severe COPD worldwide. More than 3 million people died of COPD in 2005, which corresponds to 5% of all deaths globally. The WHO predicts that total deaths from COPD could increase by more than 30% in the next 10 years unless urgent action is taken to reduce the underlying risk factors, especially smoking.

About Nycomed
Nycomed is a privately owned global pharmaceutical company with a diversified portfolio focused on branded medicines in gastroenterology, respiratory and inflammatory diseases, pain, osteoporosis and tissue management. A range of OTC products completes the portfolio.

Its R&D is structured around collaborations. In-licensing and expanding in emerging markets are cornerstones of the company's growth strategy.

Nycomed employs 12,500 associates worldwide, and its products are sold in more than 100 countries. It has strong platforms in Europe and in fast-growing markets such as Russia/CIS, Latin America, Asia and the Middle East. In the US and Japan its products are available through best in class partners.

Headquartered in Zurich, Switzerland, the company generated total sales of € 3.2 billion in 2010 and an adjusted EBITDA of € 851 million.

1. Fabbri LM, Calverley PMA, Izquierdo-Alonso JL et al. Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with long acting bronchodilators: two randomised clinical trials; The Lancet 2009; 374: 695-703
2. Rennard S, Calverley PMA, Goehring UM et al. Reduction of exacerbations by the PDE4 inhibitor roflumilast - the importance of defining different subsets of patients with COPD; Respiratory Research 2011; 12:18
3. Jones PW, Harding G, Berry P, et al. Development and first validation of the COPD Assessment Test; Eur Respir J 2009; 34(3): 648-654
4. Hatzelmann A, Morcillo EJ, Lungarella G, et al. The preclinical pharmacology of roflumilast - a selective, oral phosphodiesterase 4 inhibitor in development for chronic obstructive pulmonary disease; Pulmonary Pharmacology & Therapeutics 2010: 23(4): 235-56

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