New Report Highlights Increased Importance of Risk Reduction i…

VIENNA, Sept. 2, 2012 /PRNewswire-AsiaNet/ –

– New Expert Report on COPD Launched at a Press Conference at ERS 2012 -

Takeda today announced the launch of a new expert Report on COPD, introduced
at a Takeda organised press conference on the occasion of the 2012 European
Respiratory Society (ERS) Annual Congress taking place from 1- 5 September in
Vienna, Austria.

To view the Multimedia News Release, please click:

http://www.multivu.com/mnr/56582-expert-report-on-copd-launch

The Report, entitled ‘The Shifting Paradigm in Chronic Obstructive Pulmonary
Disease (COPD) Management,’ was initiated and developed by Takeda
Pharmaceuticals International GmbH and is a compilation of opinion articles
from a panel of key international respiratory experts, the European Federation
of Allergy and Airways Diseases Patients’ Association (EFA) and COPD patients,
reflecting updated guidance and research. The new expert Report was developed
in response to a recent shift in emphasis in COPD management which now places
future risk at equal importance to treatment of current disability.[1]
Treatment objectives are now divided into two groups: reducing symptoms and
reducing risk. [1]

Speaking at the launch of the new expert Report Dr Alan Kaplan, Chairperson
of the Respiratory Medicine Special Interest Focus Group of the College of
Family Physicians of Canada, said: "The management of stable COPD should,
according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD),
be based on a combined assessment of both the current symptom burden as well as
the future risk of disease progression. The importance of prevention is well
established in many other diseases, including cardiovascular disease, and it is
essential that we recognise and target this in COPD. The new expert Report aims
to support healthcare professionals at every level within respiratory care,
including GPs, nurses and consultants; providing suggestions and guidance to
help them in making more informed decisions and provide enhanced care and
counsel to COPD patients to improve their outcomes."

The shifting paradigm in COPD management is considered within the new expert
Report, alongside why an increased focus on future risk is so important. This
includes a review of what lessons can be learned from the cardiovascular arena
with regard to implementing a predictive and personalised risk assessment as
routine practice, the importance and impact of a positive patient-physician
relationship with regard to maintaining adherence to interventions that provide
long-term rather than immediate benefits, as well as a focus on the
pharmacological and non-pharmacological interventions available to support this
shift in COPD management.

Whilst there is no data yet showing the effect of different therapeutic
interventions in the patient categories as defined by the new GOLD assessment
algorithm (A-D), the novel anti-inflammatory agent, roflumilast, has been shown
to provide significant reductions in moderate/severe exacerbations when added
to bronchodilators in patients with COPD-associated chronic bronchitis, severe
lung function impairment and a history of frequent exacerbations (GOLD category
D). [2] The new expert Report draws on a post-hoc analysis presented at ERS
2012, which suggests that roflumilast significantly reduces exacerbations when
added to tiotropium in symptomatic COPD patients with moderate to severe lung
function impairment and a baseline mMRC grade ≥2 (GOLD category B and D)
by 45 percent. [3]

COPD is an important cause of death, illness and healthcare costs worldwide,
affecting about 210 million people and a leading cause of morbidity and
mortality. By 2030, COPD will be the third largest killer in the world. [4]

Reducing the number of exacerbations experienced by patients is still a
major unmet need in COPD and figures show that up to half of exacerbations are
not reported by patients. [5] COPD exacerbations are the most important
determinants of health status in COPD[5] and are important targets for
therapies both from the point of view of treating the event and prevention.

For more information please visit the Takeda Respiratory Newsroom

http://www.takedarespiratorynewsroom.com/

Notes to editors:

About COPD

A copy of the new expert Report and COPD backgrounder are available upon
request.

About the new expert Report on COPD authors

The expert Report on COPD brings together key stakeholders within
respiratory care:

* Dr Ondrej Rybnicek, European Federation of Allergy and Airways Diseases
Patients’ Association (EFA)
* Dr Stephen Rennard, Larson Professor of Medicine, Department of Internal
Medicine, University of Nebraska Medical Center, Omaha, Nebraska
* Prof Andrew McIvor, Professor of Medicine, McMaster University, Canada
* Dr Alan Kaplan, Chairperson, Respiratory Medicine Special Interest Focus
Group, College of Family Physicians of Canada
* Prof Wisia Wedzicha, Professor of Respiratory Medicine, Centre for
Respiratory Medicine, UniversityCollegeLondon
* Prof Robert Horne, Professor of Behavioural Medicine, UCLSchool of
Pharmacy, Head of the Department of Practice and Policy, and Director of
the Centre for Behavioural Medicine
* The European Federation of Allergy and Airways Diseases Patients’
Associations (EFA), a European network of allergy, asthma and COPD
patient organisations. EFA serves the interests of patients by providing
information, education, peer contact and financial support.

http://www.efanet.org/

About Roflumilast

Roflumilast is the first anti-inflammatory treatment developed to target
COPD-specific inflammation with a novel mode of action. Its active component,
roflumilast, is a potent and selective inhibitor of the PDE4 enzyme. [6]

Four large randomised placebo controlled trials have shown that roflumilast
significantly reduces exacerbations and improves lung function when added to
long acting bronchodilators. [7,8,9]

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. [10]

Clinical COPD trials involved more than 12,000 patients. Roflumilast was
generally well tolerated. 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. [10]

About Takeda Pharmaceuticals International GmbH

Takeda Pharmaceuticals International GmbH headquartered in Zurich, is a
wholly owned subsidiary of Takeda Pharmaceutical Company Limited located in
Osaka, Japan. Takeda is a research-based global company with its main focus on
pharmaceuticals. As the largest pharmaceutical company in Japan and one of the
global leaders of the industry, Takeda is committed to strive towards better
health for patients worldwide through leading innovation in medicine.
Additional information about Takeda is available through its corporate website,

http://www.takeda.com/.

This press release has been issued by Takeda Pharmaceuticals International
GmbH, Thurgauerstrasse 130, CH-8152 Glattpark-Opfikon (Zurich), Switzerland

1. Global Strategy for the Diagnosis, Management and Prevention of COPD,
Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2011.
http://www.goldcopd.org (accessed July 2012).

2. Bateman ED, Rabe KF, Calverley PM, et al. Roflumilast with long-acting
beta 2-agonists for COPD: influence of exacerbation history, Eur Respir J
2011;38:553-560.

3. Fabbri LM, et al. Effects of roflumilast in highly symptomatic COPD
patients [abstract]. In: European Respiratory Society’s 22nd Annual Congress;
2012 Sept 1-5; Vienna, Austria: ERS; 2012. Abstract P742.

4. World Health Organization. COPD. Fact Sheet No 315. 2008.
http://www.who.int/mediacentre/factsheets/fs315/en/index.html (accessed June
2012)

5. Seemungal TAR, Donaldson GC, Paul EA,Bestall JC, Jeffries DJ, Wedzicha
JA. Effect of exacerbation on quality of life in patients with chronic
obstructive pulmonary disease. Am J Respir Crit Care Med 1998;157:1418-1422

6. 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.

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

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

9. Rabe KF. Update on roflumilast, a phosphodiesterase 4 inhibitor for the
treatment of chronic obstructive pulmonary disease. Br J Pharm 2011;163:53-67.

10. EU Summary of Product Characteristics, Daxas®, May 2011 (available at

http://www.ema.europa.eu/)

CONTACT: Fleishman-Hillard
Cheryl Pitcher
Tel: +44-7809-492191
Email: Cheryl.Pitcher@fleishmaneurope.com;

Takeda Pharmaceuticals International GmbH
Tobias Cottman
Tel: +41-79-2177252

SOURCE: Takeda Pharmaceuticals International GmbH