Data to be presented at ERS 2011 reinforce benefit of Daxas® (roflumilast) as a treatment to target COPD inflammation

- New data analyses support the efficacy of Daxas® (roflumilast) to reduce exacerbation frequency

- Findings further enhance understanding of selective PDE4 inhibition to treat severe COPD

Nycomed today announced that data analyses supporting the use of Daxas® (roflumilast) to treat patients with severe chronic obstructive pulmonary disease (COPD) will be presented at the 2011 European Respiratory Society (ERS) Annual Congress taking place from 24 – 28 September in Amsterdam, Netherlands.

“Nycomed is committed to finding new and improved treatments for patients living with severe COPD and we believe Daxas has been an important introduction into the therapeutic options available to help manage this debilitating condition,” comments Anders Ullman, Executive Vice President, Research and Development at Nycomed. “The data to be presented at the upcoming ERS Annual Meeting confirm the sustained benefit that treatment with Daxas can bring to patients severely affected by COPD by targeting the underlying chronic inflammation. This is a new treatment approach and it exemplifies our continued commitment to address unmet needs in COPD treatment.”

New roflumilast related data will be presented in the following scientific sessions:

Poster discussions

- Peter MA Calverley et al. Impact of roflumilast treatment on the rate and duration of exacerbations and overall steroid load in patients with COPD (COPD Management, Sunday, September 25, 08.30-10.30, Room G104-105)

- Peter MA Calverley et al. Efficacy of roflumilast in former and current smokers with COPD (COPD Management, Sunday, September 25, 08.30-10.30, Room G104-105)

- Victoria Cano et al. Effect of roflumilast N-oxide on non typable Haemophilus influenzae (NTHi) interaction with human airway epithelial A549 cells (Epithelial cell biology, Monday, September 26, 14.45-16.45, Room D201-202)

- David SC Hui et al. Roflumilast in Asian Patients with COPD: A randomised placebo-controlled trial (Biomarkers and exacerbations of asthma and COPD, Tuesday, September 27, 08.30-10.30, Room D201-202)

- Jadwiga A Wedzicha et al. Efficacy of roflumilast in the frequent exacerbation COPD phenotype (Biomarkers and exacerbations of asthma and COPD, Tuesday, September 27, 08.30-10.30, Room D201-202)

- Gezim Lahu et al. Modelling and simulation in successful drug development programmes: characterisation of exacerbation reduction with roflumilast to corroborate the importance of defining patient subsets in COPD (Biomarkers and exacerbations of asthma and COPD, Tuesday, September 27, 08.30-10.30, Room D 201-202)

Thematic poster sessions

- Klaus F Rabe et al. Onset of action and effect of withdrawal of roflumilast in COPD (Bronchodilators in asthma and COPD, Sunday, September 25, 12.50-14.40, Hall 2-19)

- Licia Totani et al. Roflumilast N-oxide, a selective PDE4 inhibitor, curbs platelet-leukocyte interactions (Translational models of disease, Sunday, September 25, 12.50-14.40, Hall 2-18)

- Beatrice Arezzini et al. Roflumilast N-oxide, a selective PDE4 inhibitor, curbs bleomycin-induced lung fibroblast activation in vitro (Airway smooth muscle cells and fibroblasts: cell biology, Sunday, September 25, 12.50-14.40, Hall 2-13)

- Nassr Nassr et al. Effects of steady-state female hormones on single-dose pharmacokinetics of roflumilast and roflumilast N-oxide (Drug delivery and pharmacokinetics, Tuesday, September 27, 12.50-14.40, Hall 2-22)

- Amy Turner et al. Roflumilast potently inhibits CXCL1 mediated neutrophil migration in COPD patients (COPD: clinical studies and animal cell models, Tuesday, September 27, 12.50-14.40, Hall 2-14)

Further information on the Nycomed activities at ERS 2011 can be accessed at the Nycomed Online Newsroom at www.nycomedrespiratorynewsroom.com.

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.1 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 long acting bronchodilators.2,3

The Global Initiative for Chronic Obstructive Lung Disease (GOLD) included roflumilast as a new treatment option in the 2010 update of its COPD management guidelines, acknowledging its principal action to reduce inflammation and the clinical implications in terms of exacerbation reduction in GOLD stage III and IV COPD patients.4

Roflumilast is indicated in the EU for the maintenance treatment of severe COPD (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as an add-on to bronchodilator treatment.5

Daxas is generally well tolerated. In clinical COPD trials involving 12,000 patients, the most commonly reported adverse reactions were diarrhoea (5.9%), weight decrease (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.5

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 further information

Media:

Fleishman-Hillard

Stefanie de Borba, phone: +44 78 7280 86 63

Nycomed

General phone: +41 44 555 15 10

Tobias Cottmann, phone: +41 44 555 15 01

Investors:

Christian B. Seidelin, phone: +41 44 555 1104

1 Hatzelmann A, et al. The preclinical pharmacology of roflumilast – a selective, oral phosphodiesterase 4 inhibitor in development for chronic obstructive pulmonary disease, Pulm Pharm Ther 2010;23:235–256.

2 Calverley PMA, et al. Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials. Lancet 2009; 374: 685–94.

3 Fabbri LM, et al. Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials. Lancet 2009; 374: 695–703.

4 From the Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD).Global Strategy for Chronic Obstructive Lung Disease (GOLD) 2010. Available from http://www.goldcopd.org/

5 EU Summary of Product Characteristics, Daxas®, May 2011

Posted: September 2011

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