Daxas (roflumilast) data analysis shows reduction in harmful lung attacks

Update: Daliresp (roflumilast) Now FDA Approved - March 1, 2011

?? Global survey published today shows long-term impact of exacerbations seriously underestimated1 ?? More than three quarters of patients surveyed suffer from exacerbations1 ?? New data analysis released at ERS shows the ability of Daxas® (roflumilast) to reduce frequency of harmful COPD (Chronic obstructive pulmonary disease) exacerbations2

ZURICH, Switzerland, Sept. 19, 2010-A global survey of clinicians and COPD patients released today shows that the long-term (12-month) impact of exacerbations (also known as lung attacks) is underestimated. This is despite evidence that the death rate one year after admission to hospital for a COPD exacerbation is worse than that for heart attacks.3 The survey, ‘Hidden Depths of COPD’, also showed that exacerbations are a major issue for most COPD patients, with nearly 70% of respondents saying they had experienced an exacerbation in the previous 12 months.

The ‘Hidden Depths of COPD’ survey, sponsored by an educational research grant from Nycomed, was conducted in 14 countries among 2,000 COPD patients and 1,400 doctors who manage the condition. It showed that exacerbations affect a patient’s ability to function across a wide range of basic everyday activities and have a profound impact on their social well-being and family-life.4 They also force patients to seek frequent medical assistance.

The results of the global survey coincide with the presentation of a new data analysis at the European Respiratory Society Congress 2010 in Barcelona examining the impact of Daxas® on frequent exacerbations in COPD patients with severe to very severe airflow obstruction, a history of exacerbations and chronic bronchitis. The analysis showed that the rate of frequent exacerbations was consistently lower and the time to exacerbation was significantly longer with Daxas® than with placebo. It also showed the greatest benefit of Daxas® was seen in patients with a history of frequent exacerbations (two or more per year).2 Professor Neil Barnes of London Chest Hospital, United Kingdom, said: “The results of our survey suggest there is a gap between what patients think of as controlled COPD and the reality they are experiencing. Despite two thirds thinking their COPD was well controlled they still reported suffering from significant numbers of exacerbations and needing to access unplanned treatment. These events can be unpleasant and frightening for patients, and are a particular burden for those who suffer from several of these events in a year.” Nycomed Thurgauerstrasse 130 Telephone: Internet: Corporate Communications 8152 Glattpark-Opfikon +41 44 555 15 10 www.nycomed.com Zurich, Switzerland Telefax: +41 44 555 15 50 Page 2 of 4 The new data analyses presented at ERS include a post hoc analysis of the Daxas (roflumilast) phase III trials showing that fewer patients using Daxas suffered from frequent exacerbations compared to placebo and that time to first, second and third exacerbations was significantly extended.

Professor Fernando Martinez of the University of Michigan, USA, commented: “These results demonstrate that roflumilast provides a new therapeutic option to prevent exacerbations in COPD patients, particularly for those who suffer from them frequently. Frequent exacerbations lead to the deterioration in health and quality of life for patients and affect their long term prognosis. This is why reducing exacerbations remains an important goal of COPD management.” Håkan Björklund, CEO of Nycomed, said: “The new data announced during ERS underlines the important role that Daxas can play in reducing the frequency of exacerbations in patients with severe COPD. With the launch of Daxas now underway in Germany we look forward to making these benefits available to patients and clinicians across Europe over the next 18 months.” Daxas® (roflumilast) has been approved in the European Union and has recently been launched in Germany, where it will be jointly marketed by Nycomed and MSD (known in the US and Canada as Merck & Co., Inc., based in Whitehouse Station, New Jersey, USA). Daxas will be launched in eight additional European countries by the end of this year. It is scheduled to be launched in other markets in 2011.

About ‘Hidden Depths of COPD’ survey The survey was designed by the following scientific committee: ?? Professor Neil Barnes, Consultant Respiratory Physician, London Chest Hospital, United Kingdom ?? Professor Klaus F. Rabe, Professor of Pulmonary Medicine and Chairman of the Department of Pneumology, Leiden University Medical Center, Netherlands ?? Professor Peter Calverley, Professor of Respiratory Medicine at the University of Liverpool, and Honorary Consultant Physician at University Hospital Aintree, Liverpool, United Kingdom ?? Dr Alan Kaplan, Family Physician, Clinical Lecturer, University of Toronto.

Chairperson for The Family Physician Airways Group of Canada (FPAGC), Richmond Hill, Ontario, Canada The survey was conducted by ICM research (www.icmresearch.co.uk) and sponsored by an educational grant from Nycomed. ICM Research interviewed a random sample of 2,000 COPD patients and 1,400 physicians across 14 countries (Brazil, Canada, China, Denmark, France, Germany, Italy, Netherlands, Poland, South Korea, Spain, Australia, Turkey and the UK). The research was carried out between July 9 and September 2, 2010, and consisted of distinct physician and patient online self-completion surveys, questioning 150 COPD patients per market (100 in Denmark and Turkey) and 100 Physicians treating COPD patients per market. Patients were screened to ensure that they had been diagnosed with COPD (chronic bronchitis / emphysema / COPD) together with two related Nycomed Thurgauerstrasse 130 Telephone: Internet: Corporate Communications 8152 Glattpark-Opfikon +41 44 555 15 10 www.nycomed.com Zurich, Switzerland Telefax: +41 44 555 15 50 Page 3 of 4 symptoms. Physicians were screened to ensure they typically see a minimum of 20 (respiratory specialists) or 10 (general practitioners) COPD patients per month.

ICM Research is a member of the British Polling Council and abides by its rules.

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 action5. Daxas®, a once-a-day oral tablet, is the first drug in a new class of treatment for severe COPD and the first oral antiinflammatory treatment for COPD patients.

Four large randomized placebo controlled trials have shown that roflumilast significantly reduces exacerbations and improves lung function when added to firstline 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) Nycomed Thurgauerstrasse 130 Telephone: Internet: Corporate Communications 8152 Glattpark-Opfikon +41 44 555 15 10 www.nycomed.com Zurich, Switzerland Telefax: +41 44 555 15 50 Page 4 of 4 About Nycomed Nycomed is a privately owned global pharmaceutical company with a differentiated portfolio focused on branded medicines in gastroenterology, respiratory and inflammatory diseases, pain, osteoporosis and tissue management. An extensive range of OTC products completes the portfolio.

Its R&D is structured around partnerships and in-licensing is a cornerstone of the company's growth strategy.

Nycomed employs 12,000 associates worldwide, and its products are available in more than 100 countries. It has strong platforms in Europe and in fast-growing markets such as Russia/CIS and Latin America. While the US and Japan are commercialised through best-in-class partners, Nycomed plans to further strengthen its own position in key Asian markets.

Headquartered in Zurich, Switzerland, the company generated total sales of €3.2 billion in 2009 and an adjusted EBITDA of €1.1 billion.

For more information visit www.nycomed.com For further information Media: General phone: +41 44 555 15 10 Beatrix Benz, phone: +41 79 218 98 24 Tobias Cottmann, phone: +41 79 217 72 52 Investors: Christian B. Seidelin, phone: +41 44 555 1104 1 Hidden Depths of COPD survey. Nycomed Data on file. September 2010 2 Bateman E, Calverley PMA, Fabbri LM et al. Efficacy of roflumilast in patients with a history of frequent exacerbations: pooled data from pivotal 12-month studies. Abstract accepted for presentation at the European Respiratory Society Annual Congress in Barcelona, Spain, 18-22 September 2010 3 Halpin D. Mortality in COPD: Inevitable or Preventable? Insights from the Cardiovascular Arena. J Chron Obstruct Pulmon Dis 2008; 5(3): 187-200 4 Wilkinson TMA, Donaldson GC, Hurst JR et al. Early Therapy Improves Outcomes of Exacerbations of Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med 2004; 169: 1298-1303 5 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), doi: 10.1016/j.pupt.2010.03.011
 

Posted: September 2010

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