This has been demonstrated in a number of different study designs and populations e

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MAESTRAL study: Initial results presented at the ERS congress

   Avelox® (moxifloxacin HCI) successfully met primary efficacy outcome of non-
    inferiority in overall study population
   In patients with confirmed bacterial exacerbations, moxifloxacin was associated with
    significantly lower clinical failure rates compared to the gold-standard therapy


Amsterdam, The Netherlands, September 25, 2011 – Bayer HealthCare today
presented positive results from the MAESTRAL (moxifloxacin in acute exacerbations
trial) study at the European Respiratory Society (ERS) Congress in Amsterdam. 1 This trial
compared the efficacy of Avelox® (moxifloxacin HCI) to that of the gold-standard beta-
lactam comparator - amoxicillin/clavulanic acid - in the treatment of AECOPD (acute
exacerbation of chronic obstructive pulmonary disease).


As frequent exacerbations of COPD are associated with high morbidity, mortality and a
marked reduction in quality of life, effective therapies are required. Approximately 50-70%
of exacerbations are caused by bacterial infections2 and these patients are expected to
benefit from a powerful, effective antibiotic therapy.


The primary endpoint of the study was clinical failure within eight weeks post-therapy. The
study demonstrated non-inferiority between 5 days of moxifloxacin once daily and 7 days
of amoxicillin/clavulanic acid twice daily. Moreover, in a pre-planned analysis moxifloxacin
demonstrated significantly lower clinical failure rates compared with amoxicillin/clavulanic
acid at eight weeks post-therapy in patients with bacteriologically confirmed
exacerbations. MAESTRAL is also the first ever trial to show a clear correlation between
bacterial eradication and longer-term improved clinical outcomes.


“MAESTRAL has given us some very exciting data showing that bacterial eradication
leads to better clinical outcomes. Moxifloxacin provides a real benefit in patients with



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bacterial AECOPD,” said Dr Robert Wilson of the Royal Brompton Hospital, London, UK
and the principal investigator of MAESTRAL.


“With moxifloxacin, we are happy to offer an effective and reliable short course once daily
treatment for acute exacerbation of chronic obstructive pulmonary disease to physicians
and patients. The MAESTRAL study results underline the well-founded benefits of
moxifloxacin,” said Dr. Flemming Ornskov, General Medicine, Bayer HealthCare.
Moxifloxacin is a well-tolerated and effective treatment option for acute bacterial
exacerbations in chronic obstructive pulmonary disease (AECOPD) patients. This has
been demonstrated in a number of different study designs and populations (e.g. TACTIC,
GIANT, EFEMAP, MOSAIC)3-6 which MAESTRAL now adds to.


MAESTRAL at the ERS congress:
Wilson R et al: Late-breaking abstract: Moxifloxacin (MXF) vs amoxicillin/clavulanic acid
(AMC) in acute exacerbations of COPD (AECOPD): Results of a large clinical trial with a
novel endpoint. Congress of the European Respiratory Society, 24-28 September, 2011,
Amsterdam, The Netherlands. Oral presentation 195, 25 September, 8.30 a.m., Room
3.2.


About MAESTRAL
MAESTRAL is a prospective, multinational, multicentre, randomised, double-blind,
double-dummy controlled Phase IV trial between moxifloxacin and amoxicillin/clavulanic
acid. Nearly 1,500 patients were enrolled in MAESTRAL – the largest antibiotic trial in
exacerbated patients with moderate-to-severe COPD conducted to date.


Of the 1,492 patients who were enrolled 1,372 patients were randomised. The per
protocol (PP) population of MAESTRAL consisted of 1,056 patients. Patients received
either five days of moxifloxacin 400 mg PO once daily or seven days of
amoxicillin/clavulanic acid 875/125 mg PO twice daily. The results show that moxifloxacin
was non-inferior to amoxicillin/clavulanic acid with respect to clinical failure rates at eight
weeks post-therapy in the PP population (20.6% vs 22.0%, respectively, 95% CI – 5.89%,
3.83%). Clinical failure rates in patients with bacteria isolated at baseline were
significantly lower in moxifloxacin vs amoxicillin/clavulanic acid-treated patients, with a
treatment difference of approximately 6% in favour of moxifloxacin in both the PP
(moxifloxacin 50/260, 19.2% vs amoxicillin/clavulanic acid 68/261, 26.1%; treatment
difference=6.9%, P=0.030) and ITT with pathogens populations (moxifloxacin 62/327,


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19.0% vs amoxicillin/clavulanic acid 85/335, 25.4%, treatment difference=6.4%, P=0.016).
Both regimens were well tolerated.


MAESTRAL has a unique study design. Compared with previous trials where only relative
small cohorts were used, MAESTRAL enrolled a very large number of patients (n=1,492)
at risk of poor outcomes. Short-term clinical endpoints seen in many clinical trials may not
give a true indicator of efficacy, therefore MAESTRAL tested clinical outcomes at a novel
eight week post-therapy endpoint. The investigators also took into account that patients
with COPD usually take a range of medications to treat the exacerbation, the underlying
COPD, and any concomitant illness – all of which can confound the study results.
MAESTRAL tackles this issue by recording all concomitant medications for the full
duration of the study and patients were prospectively stratified according to acute steroid
use for their current exacerbation. The study design also took into consideration that
heterogeneous patient populations are likely to include patients experiencing non-
bacterial exacerbation, where antibiotics are not of help. By choosing patients with
Anthonisen type 1 exacerbations (increased dyspnea, increased sputum volume, and
sputum purulence) the study population was enriched with patients in whom bacteria are
most likely to play a significant role.


About Avelox® (moxifloxacin)
Worldwide Avelox® is currently approved in 127 countries for the oral formulation and
114 countries for the intravenous (IV) formulation. To date, more than 142.4 million
patients worldwide have been treated with moxifloxacin tablets and approximately 6.6
million patients have received moxifloxacin IV (as at May 2011).


In Europe, Avelox® IV is approved to treat Community-Acquired Pneumonia and
complicated Skin and Skin Structure Infections. According to the label in the European
Union, moxifloxacin IV should be used only when it is considered inappropriate to use
antibacterial agents that are commonly recommended for the initial treatment of these
infections.


Avelox® tablets are approved in Europe. According to the European label, moxifloxacin
tablets should be used only when it is considered inappropriate to use antibacterial agents
that are commonly recommended for the initial treatment of these infections or when
these have failed to treat acute bacterial sinusitis (adequately diagnosed), acute
exacerbations of chronic bronchitis (adequately diagnosed), community acquired


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pneumonia, except severe cases and mild to moderate pelvic inflammatory disease (i.e.
infections of female upper genital tract, including salpingitis and endometritis), without an
associated tubo-ovarian or pelvic abscess. Moxifloxacin tablets are not recommended for
use in monotherapy of mild to moderate pelvic inflammatory disease but should be given
in combination with another appropriate antibacterial agent (e.g. a cephalosporin) due to
increasing moxifloxacin resistance of Neisseria gonorrhoeae unless moxifloxacin-resistant
Neisseria gonorrhoeae can be excluded.


Moxifloxacin tablets may also be used to complete a course of therapy in patients who
have shown improvement during initial treatment with intravenous moxifloxacin for
patients with community-acquired pneumonia or complicated skin and skin structure
infections. Moxifloxacin tablets should not be used to initiate therapy for any type of skin
and skin structure infection or in severe community-acquired pneumonia.


Consideration should be given to official guidance on the appropriate use of antibacterial
agents.


Licensed indication(s) can differ from country to country.

About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health
care, nutrition and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with
annual sales of EUR 16.9 billion (2010), is one of the world’s leading, innovative
companies in the healthcare and medical products industry and is based in Leverkusen,
Germany. The company combines the global activities of the Animal Health, Consumer
Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover
and manufacture products that will improve human and animal health worldwide. Bayer
HealthCare has a global workforce of 55,700 employees (Dec 31, 2010) and is
represented in more than 100 countries. Find more information at
www.bayerhealthcare.com.


Contact:
Astrid Kranz, Tel. +49 30 468-12057
E-Mail: astrid.kranz@bayer.com




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Stephanie Prate, Tel. +49 30 468-196053
E-Mail: stephanie.prate@bayer.com


Find more information at www.bayerpharma.com.
sp          (2011-0503E)

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer
Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to
material differences between the actual future results, financial situation, development or performance of the company
and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on
the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking
statements or to conform them to future events or developments.



    1.   Wilson R et al. Moxifloxacin (MXF) vs amoxicillin/clavulanic acid (AMC) in acute exacerbations of COPD (AECOPD): Results
         of a large clinical trial with a novel endpoint. European Respiratory Society meeting, 24–28 September, 2011, Amsterdam,
         The Netherlands. Oral presentation 195.
    2.   Ball P. Epidemiology and Treatment of Chronic Bronchitis and Its Exacerbations. CHEST 1995; 108: 43S–52S
    3.   Wilson R et al. Five day moxifloxacin therapy compared with 7 day clarithromycin therapy for the treatment of acute
         exacerbations of chronic bronchitis. Journal of Antimicrobial Chemotherapy 1999; 44: 501–513.
    4.   Miravitlles M et al. Characterisation of exacerbations of chronic bronchitis and COPD in Europe: the GIANT study.
         Therapeutic Advances in Respiratory Disease 2009; 3: 267–77.
    5.   Miravitlles M et al. The effect of various anti-microbial regimens on the clinical course of exacerbations of chronic bronchitis
         and chronic obstructive pulmonary disease in primary care. Clinical Drug Invest. 2004; 24: 63–72.
    6.   Wilson R et al. Short-term and long-term outcomes of moxifloxacin compared to standard antibiotic treatment in acute
         exacerbations of chronic bronchitis. CHEST 2004; 125: 953–64.




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