Nycomed announces REACT study to evaluate impact of Daxas® (roflumilast) in patients receiving standard COPD treatment
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Nycomed announces REACT study to evaluate impact of Daxas® (roflumilast) in
patients receiving standard COPD treatment
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* 12-month study to further evaluate Daxas® (roflumilast) when added to
standard fixed combination treatments and triple therapies
* Primary endpoint assessing the reduction in moderate or severe COPD
exacerbations per patient per year
Nycomed today announced plans for an international phase III/IV study
investigating the effect of Daxas® (500mcg tablets, once daily) 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.
(see http://www.who.int/respiratory/copd/burden/en/index.html)
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.
For more information visit www.nycomed.com
For further information
Media:
General phone: +41 44 555 15 10
Beatrix Benz, phone: +41 44 555 15 08
Investors:
Christian B. Seidelin, phone: +41 44 555 11 04
This press release has been issued by Nycomed International Management GmbH,
Thurgauerstrasse 130, CH-8152 Glattpark-Opfikon, Zurich, Switzerland.
(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
--- End of Message ---
Nycomed
Thurgauerstrasse 130 Glattpark-Opfikon Switzerland
Press Release Daxas REACT DE:
http://hugin.info/144179/R/1501547/436808.pdf
Press Release Daxas REACT EN:
http://hugin.info/144179/R/1501547/436807.pdf
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Datum: 30.03.2011 - 09:59 Uhr
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