Daxas(R) (roflumilast) Data Analysis Shows Reduction in Harmful Lung Attacks

By Nycomed, PRNE
Sunday, September 19, 2010

ZURICH, September 20, 2010 -

    - Global Survey Published Today Shows Long-Term Impact of Exacerbations
      Seriously Underestimated[1]



    - More Than Three Quarters of Patients Surveyed Suffer From
      Exacerbations[1]

    - New Data Analysis Released at ERS Shows the Ability of Daxas(R)
      (roflumilast) to Reduce Frequency of Harmful COPD (Chronic Obstructive
      Pulmonary Disease) Exacerbations[2]

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(R) 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(R) than with placebo. It also showed the
greatest benefit of Daxas(R) 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."

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."

Hakan Bjorklund, 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(R) (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 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(R) (roflumilast)

Daxas(R) (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[5]. Daxas(R), a
once-a-day oral tablet, is the first drug in a new class of treatment for
severe COPD and the first oral anti-inflammatory treatment 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(R) 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 www.who.int/respiratory/copd/burden/en/index.html)

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 EUR3.2 billion in 2009 and an adjusted EBITDA of EUR1.1 billion.

For more information visit www.nycomed.com

———————————

[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

Daxas(R) is not marketed in Spain. *** Daxas(R) no está comercializado
en España.

    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

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

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